Every­one has one choice when it comes to the COVID pan­dem­ic: take the mRNA vac­cines or not. That’s obvi­ous­ly not true. There are plen­ty of non-mRNA COVID vac­cines cur­rent­ly avail­able. But it’s hard to ignore how the under­ly­ing mes­sage to the pub­lic in the US about COVID vac­cines has large­ly been to take the mRNA vac­cines or not get vac­ci­nat­ed at all. The non-mRNA vac­cines have effec­tive­ly been ‘unper­son­ed’ in the cov­er­age of the pan­dem­ic.

That’s been the case from the very begin­ning of the pan­dem­ic. But it may have been tak­en to a new absurd lev­el in the fol­low­ing arti­cle in the Atlantic about a rare side-effect from mRNA recent­ly report­ed: A Bel­gian immu­nol­o­gist long involved in study­ing new med­i­cines, includ­ing the mRNA vac­cines, had to report an unfor­tu­nate find­ing. And a very per­son­al find­ing at that. Short­ly after get­ting an mRNA boost­er, Gold­man’s case of lym­phoma grew dra­mat­i­cal­ly worse right around the spot of the injec­tion.

And while Gold­man is just a sin­gle case, the data points were quite com­pelling. Gold­man’s angioim­munoblas­tic T‑cell lym­phoma affects fol­lic­u­lar helper T cells, and research has already found that mRNA vac­cines are par­tic­u­lar­ly effec­tive at pro­vid­ing an extra ‘oomph’ to the body’s fol­lic­u­lar helper T cells. Also, Gold­man’s tumor has a muta­tion known to pre­dis­pose T‑cells to go rogue.

But that research show­ing mRNA vac­cine specif­i­cal­ly pro­vide an extra ‘oomph’ to T‑cells also poten­tial­ly relates to that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics — which require numer­ous shots over years — to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set backs. And yet observers were just forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als. It was one of the high­ly con­ve­nient aspects of the whole mRNA vac­cine sit­u­a­tion: the side effects from the LNP deliv­ery vehi­cle just might be desir­able and have an adju­vant-like effect in the con­text of a vac­cine if those side effects end up revving up the immune sys­tem. So it should­n’t be par­tic­u­lar­ly sur­pris­ing when we learn that there might be rare side effects involv­ing an over­ly-revved-up immune sys­tem. The extra immuno­log­i­cal ‘oomph’ from the mRNA vac­cines was tout­ed as a sell­ing point, after all.

So we have to ask: is the extra immuno­log­i­cal ‘oomph’ tar­get­ing fol­lic­u­lar ‘helper’ T‑cells trig­gered specif­i­cal­ly by mRNA vac­cines — and which may have exac­er­bat­ed Gold­man’s lym­phoma — at all relat­ed to the side-effects observed by the LNP deliv­ery vehi­cles? It’s the kind of ques­tion we had bet­ter hope researchers are ask­ing. But that brings us to anoth­er part of this sto­ry: as the arti­cle describes, the med­ical estab­lish­ment is basi­cal­ly inca­pable of real­ly study­ing these rel­a­tive­ly rare side effects. If some­thing can’t be sta­tis­ti­cal­ly con­firmed with a ran­dom­ized con­trolled tri­al (RCT), the med­ical estab­lish­ment is high­ly prone to ignore it. And rare side-effects are very often going to be too rare to set up an RCT.

But then there’s the fact that immuno­log­i­cal dis­or­ders can man­i­fest in all sorts of ways. We should­n’t expect just a sin­gle type of symp­tom to show up if, for exam­ple, T‑cells are being turned rogue. So even if rare side-effects have a com­mon under­ly­ing immuno­log­i­cal cause we’re going to be poised to miss it.

But when there’s plen­ty of non-mRNA COVID vac­cine options avail­able, the ques­tion of whether or not the risks of the mRNA vac­cines for lym­phoma patients are worth the cost/benefit trade­offs in the face of unknown risks is kind of beside the point. Just give the can­cer patients one of the non-mRNA vac­cines instead. And that brings us to the tru­ly bizarre aspect of this sto­ry. Because as we’re going to see, while Michel Gold­man appears to be gen­uine­ly torn as to whether or not he’s will­ing to take a sec­ond mRNA COVID boost­er shoot after the expe­ri­ence he had with the first shot, he does­n’t appear to have con­sid­ered at all the pos­si­bil­i­ty of tak­ing one of the non-mRNA vac­cines. Like it just does­n’t even come up as an option in the entire arti­cle.

It’s the lat­est exam­ple of this bizarre hyper-pref­er­ence for what are still exper­i­men­tal mRNA vac­cines. We’ve already seen how the mRNA boost­ers are being approved based on mouse tri­al data alone. We also saw how the FDA issued a warn­ing about the John­son & John­son vac­cine back in May for a very rare side effect despite the fact that those vac­cines appeared to actu­al­ly have the best effi­ca­cy against vari­ants. And as we’re going to see the arti­cle, even Gold­man him­self was com­ment­ing on how the AstraZeneca vac­cine side-effects were far less of a risk than the risk of COVID itself. Gold­man, who resides in Europe, pre­sum­ably has access to that vac­cine. But he’s not tak­ing it. It’s mRNA vac­cines or noth­ing for Michel Gold­man. For rea­sons that remain entire­ly unex­plained to this day:

The Atlantic

Did a Famous Doctor’s COVID Shot Make His Can­cer Worse?

A life­long pro­mot­er of vac­cines sus­pects he might be the rare, unfor­tu­nate excep­tion.

By Rox­anne Kham­si
Sep­tem­ber 24, 2022, 8 AM ET

On Sep­tem­ber 22 of last year, Michel Gold­man, a Bel­gian immu­nol­o­gist and one of Europe’s best-known cham­pi­ons of med­ical research, walked into a clin­ic near his house, rolled up his sleeve, and had a boost­er shot deliv­ered to his arm. He knew he’d need it more than most.

Just a few weeks ear­li­er, Michel, 67, had been to see his younger broth­er, Serge, the head of nuclear med­i­cine at the hos­pi­tal of the Uni­ver­sité Libre de Brux­elles, where both men are pro­fes­sors. Michel was hav­ing night sweats, and he could feel swollen lymph nodes in his neck, so his broth­er brought him in for a full-body CT scan. When the images came through to Serge’s com­put­er they revealed a smat­ter­ing of inky spots, bunched near Michel’s left armpit and run­ning up along his neck. It was can­cer of the immune system—lymphoma.

Giv­en his own area of exper­tise, Michel under­stood this meant he’d soon be immuno­com­pro­mised by chemother­a­py. With anoth­er win­ter on the way—and per­haps anoth­er wave of SARS-CoV­‑2 infections—that meant he had just a nar­row win­dow of oppor­tu­ni­ty in which his body would respond in full to COVID vac­ci­na­tion. Hav­ing received two dos­es of Pfiz­er the pri­or spring, Michel quick­ly went to get his third. If he was about to spend months absorb­ing poi­son as he tried to beat a dead­ly can­cer, at least he’d have the most pro­tec­tion pos­si­ble from the pan­dem­ic.

With­in a few days, though, Michel was some­how feel­ing even worse. His night sweats got much more intense, and he found himself—quite out of character—taking after­noon naps. Most wor­ry­ing­ly, his lymph nodes were even more swollen than before. He con­ferred with Serge again, and they set up anoth­er body scan for Sep­tem­ber 30, six days before Michel was sched­uled to start his can­cer treat­ment. Once again he sat in the radi­ol­o­gy wait­ing room while his broth­er wait­ed for the pic­tures to appear on his com­put­er.

Serge’s bushy eye­brows fur­rowed when he spoke with Michel after hav­ing seen the scans. (“I will always remem­ber his face, it was just incred­i­ble,” Michel told me.) The pic­tures showed a brand-new bar­rage of can­cer lesions—so many spots that it looked like some­one had set off fire­works inside Michel’s body. More than that, the lesions were now promi­nent on both sides of the body, with new clus­ters bloom­ing in Michel’s right armpit in par­tic­u­lar, and along the right side of his neck.

When Michel’s hema­tol­o­gist saw the scan, she told him to report direct­ly to the near­est hos­pi­tal phar­ma­cy. He’d have to start on steroid pills right away, she told him. Such a swift pro­gres­sion for lym­phoma in just three weeks was high­ly unusu­al, and he could not risk wait­ing a sin­gle day longer.

As he fol­lowed these instruc­tions, Michel felt a gnaw­ing wor­ry that his COVID boost­er shot had some­how made him sick­er. His broth­er was har­bor­ing a sim­i­lar con­cern. The asym­met­ri­cal clus­ter of can­cer­ous nodes around Michel’s left armpit on the ini­tial scan had already seemed “a bit dis­turb­ing,” as his broth­er said; espe­cial­ly giv­en that Michel’s first two dos­es of vac­cine had been deliv­ered on that side. Now he’d had a boost­er shot in the oth­er arm, and the cancer’s asym­me­try was flipped.

The broth­ers knew this might be just an eerie coin­ci­dence. But they couldn’t shake the feel­ing that Michel had expe­ri­enced what would be a very rare yet life-threat­en­ing side effect of COVID vac­ci­na­tion. For a doc­tor who had spent four decades study­ing and advo­cat­ing for new med­i­cines, that feel­ing would unfold into many months of delib­er­a­tion and self-doubt. Michel used to run an insti­tute for vac­cine-tech­nol­o­gy research, and he’s spo­ken out to reas­sure the pub­lic about the safe­ty of the COVID vac­cines, and of the mRNA vac­cines in par­tic­u­lar. In Decem­ber 2020, he told an inter­view­er that “if there was a real prob­lem with the tech­nol­o­gy, we’d have seen it before now for sure.” His “main con­cern,” he con­tin­ued, was that peo­ple would use the mere pos­si­bil­i­ty of side effects “as an argu­ment not to be vac­ci­nat­ed.”

But now that pos­si­bil­i­ty appeared to be splat­tered all across his med­ical charts. Michel Gold­man, cham­pi­on of the mRNA vac­cines, sus­pect­ed that he was their unlucky vic­tim.

I hap­pened to speak with Michel by phone in April 2021, months before his can­cer diag­no­sis. I’d called him to dis­cuss anoth­er poten­tial side effect of COVID vac­ci­na­tion, one asso­ci­at­ed in par­tic­u­lar with the shot made by AstraZeneca. By that point, 220 peo­ple who’d received that vac­cine had devel­oped an unusual—and very dangerous—blood-clotting syn­drome, which was char­ac­ter­ized by an atyp­i­cal low platelet count. At least sev­en peo­ple in the U.K. alone had died of the com­pli­ca­tion. Michel patient­ly laid out the dif­fer­ent mech­a­nisms that might explain this strange con­di­tion. But he was quick to add that the mRNA COVID vac­cines were built in a way that could mit­i­gate the risk of this par­tic­u­lar prob­lem.

Michel cur­rent­ly leads the I3h insti­tute, a uni­ver­si­ty hub aimed at assist­ing in drug-design projects; in an ear­li­er post­ing, he head­ed a $2 bil­lion Euro­pean endeav­or to accel­er­ate the research of new med­i­cines. As such, he’s spent many years attend­ing to the pos­si­ble risks—even tiny ones—of nov­el med­ical treat­ments. He has raised aware­ness about the iron over­load that used to afflict dial­y­sis patients before the advent of a drug known as ery­thro­poi­etin, for exam­ple; and looked for signs of “cytokine storms” in kid­ney-trans­plant recip­i­ents who received mon­o­clon­al-anti­body treat­ments. So when a pletho­ra of new vac­cines for COVID emerged in the first year of the pan­dem­ic, he was watch­ing very close­ly.

When we talked about the poten­tial side effects of the AstraZeneca vac­cine last year, Michel made it clear that, in the big pic­ture, any chance of seri­ous com­pli­ca­tions from the shots would be orders of mag­ni­tude small­er than the chance of com­pli­ca­tions from the pan­dem­ic ill­ness itself. If COVID vac­cines caused clot­ting dis­or­ders or myocardi­tis in a tiny per­cent­age of those who received them, he assured me, COVID would lead to stroke or heart inflam­ma­tion in a much larg­er group.

The risks and ben­e­fits for each vac­cine should be weighed against each oth­er, he con­tin­ued. If AstraZeneca were the only option, then its pro­tec­tion might be worth the very small risk of devel­op­ing a rare blood dis­or­der. But giv­en the avail­abil­i­ty of Pfiz­er, Mod­er­na, and oth­er COVID vac­cines, many peo­ple could opt for a safer alter­na­tive.

Now that risk-ben­e­fit cal­cu­la­tion has been thrust upon him in a per­son­al and ter­ri­fy­ing way. By the time we spoke again, he’d become a can­cer patient who sus­pect­ed that his mRNA vac­cine might have made things worse. Michel is reserved by nature, prone to mak­ing mat­ter-of-fact remarks rather than emo­tive mus­ings. In this case, I found him more guard­ed than ever, and I could tell he’d strug­gled over how he should describe his own experience—or, indeed, whether he should even be describ­ing it at all. Per­haps his hypoth­e­sis was wrong, and the course of his can­cer had had noth­ing to do with the shots. Or maybe the can­cer and the mRNA vac­cine were con­nect­ed, but the risk of get­ting immu­nized was still just a tiny speck beside the ben­e­fits. Apply­ing the same log­ic that he’d used before, he decid­ed it made sense to go pub­lic with this the­o­ry. If oth­er peo­ple with the same lym­phoma felt the need to hedge their bets, they might con­sid­er hold­ing off on the Pfiz­er and Mod­er­na shots.

Michel knew that by speak­ing out about anoth­er poten­tial rare effect—especially with­out hard proof—he’d be intro­duc­ing a dif­fer­ent kind of risk. Recent years had already seen a rise in anti-vac­cine dis­in­for­ma­tion, and pro­test­ers have thrown men­stru­al blood at state leg­is­la­tors and issued death threats to pub­lic-health offi­cials. Fear­mon­gers have made the prob­lem worse by cit­ing scary-sound­ing data from the Vac­cine Adverse Event Report­ing Sys­tem, a U.S. gov­ern­ment data­base of pos­si­ble side effects from immu­niza­tions, with insuf­fi­cient con­text. In Europe, French police used tear gas to dis­perse anti-vac­cine pro­test­ers who were aim­ing fire­works at offi­cers in July of 2021; a vac­ci­na­tion cen­ter was set ablaze in Poland a few weeks lat­er. Michel was well aware of all this trend; in fact, he’d been sound­ing the alarm about the spread of vac­cine mis­in­for­ma­tion online before the. If he shared his own expe­ri­ence of can­cer, might that make the prob­lem worse?

This was not a rea­son to remain silent, Michel even­tu­al­ly decid­ed. It was a rea­son to speak care­ful­ly.

...

Michel’s can­cer was the kind that attacks the body’s T cells, which coor­di­nate the immune response to invad­ing pathogens. T‑cell lym­phomas come in rough­ly 30 dif­fer­ent sub­types; Michel’s, known as angioim­munoblas­tic T‑cell lym­phoma, affects what are called fol­lic­u­lar helper T cells, which hang out in the ton­sils and the lymph nodes, among oth­er tis­sues.. Fol­lic­u­lar helper T cells serve a cru­cial role in the cas­cade of events to pro­tect the body after dan­ger­ous invaders have arrived. That process begins with den­drit­ic cells, which iden­ti­fy a virus or oth­er pathogen and present exam­ples of it to the rest of the immune sys­tem. The helper T cells do just as their name sug­gests: They help pass that mes­sage along to B cells, which end up mak­ing pro­tec­tive anti­bod­ies against the virus.

Michel had recent­ly learned that mRNA vac­cines, such as the Pfiz­er shots he had received, are espe­cial­ly effec­tive at gen­er­at­ing that mes­sage, and spurring its pas­sage through the helper T cells. Some researchers argue that the COVID vac­cines from Pfiz­er and Mod­er­na have been more pro­tec­tive than oth­ers for exact­ly this rea­son: They rev up those cells with extra oomph. Now Michel began to won­der whether that oomph could, in ultra­rare cas­es, turn out to be a lia­bil­i­ty. Per­haps the shots gave such a jolt to his helper T cells that they went berserk. If they were prone to form­ing tumors, or if they were already can­cer­ous, then over­stim­u­la­tion could have made the prob­lem even worse.

As the days went by, Michel found oth­er clues sug­gest­ing that the link was real, and that the mRNA vac­cines might be risky for a spe­cif­ic sub­set of the pop­u­la­tion. He learned that body scans of some of those who get vac­cines, includ­ing can­cer patients, have shown height­ened activ­i­ty in the lymph nodes near the armpit on the side where the shot was received. He also came across anoth­er, very impor­tant clue. In 2018, a team of researchers based at Colum­bia University’s Insti­tute for Can­cer Genet­ics had pub­lished an intrigu­ing study using mice with a pair of gene muta­tions that, when they co-occur, pre­dis­pose T cells to go rogue. (Michel’s tumor, which had been sequenced by this point, showed the same two muta­tions.) When these mice were inject­ed with sheep red-blood cells—as an exper­i­men­tal stand-in for invad­ing microbes—the ani­mals devel­oped the sub­type of lym­phoma that was diag­nosed in Michel.

Now Michel had a the­o­ry to explain the bleak coin­ci­dence that had befall­en him. Serge agreed that it made sense. The broth­ers had co-writ­ten research papers in the past, includ­ing ones on the use of stem cells for heart repair and den­drit­ic-cell vac­cines for can­cer. It was time for them to write anoth­er.

On Octo­ber 20 of last year, Hans-Georg Eich­ler, a clin­i­cal phar­ma­col­o­gist and for­mer senior med­ical offi­cer for the Euro­pean Med­i­cines Agency, opened up his email to find a mes­sage from Michel. The two have known each oth­er for more than a decade. “I hope that you are well,” the mes­sage start­ed, “which is not real­ly my case ...” Michel had past­ed in a link to a med­ical report, not yet pub­lished. “I am curi­ous to hear your thoughts,” he wrote.

The paper, titled “Rapid Pro­gres­sion of Angioim­munoblas­tic T Cell Lym­phoma Fol­low­ing BNT162b2 mRNA Vac­cine Boost­er Shot” and cred­it­ed to Serge Gold­man, Michel Gold­man, and six of their Bel­gian col­leagues, would run in the jour­nal Fron­tiers in Med­i­cine a few weeks lat­er. (Michel is that journal’s edi­tor in chief; he recused him­self from the process of edit­ing and peer review.) It begins by describ­ing “a 66-year-old man with no sig­nif­i­cant med­ical his­to­ry” who had been diag­nosed with lym­phoma that wors­ened fol­low­ing a boost­er dose of COVID-19 vac­cine. The Gold­mans’ unusu­al con­nec­tion to the data—the fact that the 66-year-old man in ques­tion was Michel—comes across oblique­ly in the text. An ethics state­ment, print­ed at the end of the case report, includes the line: “Being one of the authors, the patient con­sent­ed to the pub­li­ca­tion.”

Eich­ler, who had close­ly fol­lowed the furor over vac­cine-asso­ci­at­ed blood-clot dis­or­ders the pre­vi­ous spring, replied that evening: “I have read the paper and am very impressed … It is the most respon­si­ble and coura­geous thing you could do under the worst pos­si­ble cir­cum­stances.”

“I would say that 95 per­cent of the reac­tions were extreme­ly friend­ly,” Michel told me lat­er. But as he’d feared, anti-vac­cine activists picked up on the sto­ry. “The lymph nodes of those who have tak­en these shots are explod­ing, bur­geon­ing, and bulging with this tox­ic bioweapon,” a right-wing influ­encer named Jane Ruby wrote on Telegram beneath a screen­shot of Michel’s CT scans, which had appeared in his pub­lished paper (and are repro­duced in this arti­cle). “LYMPHOMA — That’s right… Can­cer of the lym­phat­ic sys­tem … STOP THIS FROM GETTING INTO BABIES AND CHILDREN!!!!!” Ruby’s claims were ampli­fied on Nat­ur­al News, among oth­er anti-vac­ci­na­tion sites where, again, the very images that Michel’s broth­er had used to diag­nose his ill­ness were pre­sent­ed as shock­ing evi­dence of vaccination’s dan­gers. “PHOTOS: LYMPHOMA CANCER EXPLODING IN THE BOOSTED,” one web­site said.

When I told Michel about these online posts, he shook his head in dis­ap­point­ment. “They’re look­ing for any­thing to sup­port their crazy vision,” he said. “It makes me sad about the world in which we are liv­ing.” That’s not to say he was sur­prised. Michel knew, for instance, that med­ical experts have dis­pelled false rumors about vac­cines infect­ing peo­ple with COVID-19. He told me that he’d obsessed over get­ting the tone of the man­u­script exact­ly right, so as not to fuel vac­cine skep­ti­cism. He was care­ful, for exam­ple, to describe the vac­cine as pos­si­bly “induc­ing” the “pro­gres­sion” of his cancer—rather than “caus­ing” it to sur­face. “I spent hours and hours,” he said. “I’ve nev­er spent so much time on details in a paper.”

Extreme­ly rare cas­es like Michel’s cre­ate a tricky ter­rain for sci­ence com­mu­ni­ca­tion. Even a clin­i­cal tri­al with thou­sands of par­tic­i­pants might nev­er turn up a sin­gle case of some­one’s can­cer wors­en­ing after vac­ci­na­tion. In that con­text, experts can’t assign a sta­tis­ti­cal esti­mate of the risk across the wider pop­u­la­tion. Sci­ence jour­nal­ists may be wary of report­ing on the sto­ry for that rea­son. In fact, when Michel first told me about his can­cer and about the paper he’d writ­ten with his broth­er, I said that I couldn’t write about it. I was wor­ried that some read­ers would mis­in­ter­pret my arti­cle, and mis­tak­en­ly see it as a rea­son not to get vac­ci­nat­ed. As I write this, I’m still con­cerned that you might do exact­ly that.

But the sci­en­tif­ic lit­er­a­ture is sprin­kled with odd cas­es like Michel’s that have puz­zled doc­tors. The Gold­mans’ paper fol­lows ear­li­er iso­lat­ed reports sug­gest­ing a pos­si­ble link between COVID-19 vac­ci­na­tion and lym­phoma. Aaron Man­gold, who heads the divi­sion of clin­i­cal der­ma­tol­ogy at the Mayo Clin­ic in Ari­zona, co-authored a paper pub­lished in May 2021 about a patient whose rare skin lym­phoma recurred after his ini­tial Pfiz­er shot. The tumor­ous ulcer appeared in the armpit of the same arm in which the man had received the injec­tion, and then regressed spon­ta­neous­ly. A sec­ond shot of the vac­cine, deliv­ered three weeks lat­er, pro­duced no fur­ther lesions, Man­gold told me, and the whole ordeal could have sim­ply been a coin­ci­dence. He felt that he’d been “thread­ing the nee­dle” to go pub­lic with the case report giv­en that uncer­tain­ty.

Ladan Zand, a nephrol­o­gist at the Mayo Clin­ic in Rochester, Min­neso­ta, faced the same conun­drum when she co-authored a paper last year detail­ing five patients who had a relapse of kid­ney dis­ease fol­low­ing mRNA COVID vac­ci­na­tion. Her team also doc­u­ment­ed eight patients who were new­ly diag­nosed with the dis­ease, known as glomeru­lonephri­tis, after receiv­ing the shot. But Zand cau­tions that those patients might have had under­ly­ing kid­ney dis­ease and not been aware of it. Peo­ple infect­ed with the nov­el coro­n­avirus also show high­er rates of kid­ney-func­tion decline over time. “I spend half of my vis­its now ask­ing patients to get vac­ci­nat­ed,” she said. “If you were to com­pare the risks and ben­e­fits, the ben­e­fits of the vac­cine way out­weigh the risk of rare enti­ties that, for the most part, seem to be self-lim­it­ing.”

William Mur­phy, an immu­nol­o­gist at UC Davis, told me that Michel’s before-and-after CT scans were fas­ci­nat­ing in the con­text of the mouse study from Colum­bia. The cancer’s behav­ior cer­tain­ly appeared to be relat­ed to the vac­cine, he said, “giv­en the huge dif­fer­ence in the scans of the tumor pro­gres­sion in a very short peri­od of time.” But one can’t be cer­tain, how­ev­er strik­ing the data. It’s just a case report, he added—one patient.

The Gold­mans’ paper, for its part, notes that it would be “pre­ma­ture” to extrap­o­late the find­ings from Michel to oth­er patients with the same kind of can­cer, and that the link, even if it were proved, should not dis­cour­age gen­er­al uptake of “much-need­ed vac­cines.” An unusu­al para­graph tacked onto the bot­tom of the arti­cle under­scores the point. Marked “Patient Per­spec­tive,” and writ­ten in the third per­son, it notes that Michel him­self “remains con­vinced that mRNA vac­cines rep­re­sent very effi­cient prod­ucts with a favor­able ben­e­fit-risk ratio,” and that he hopes the report will encour­age fur­ther research.

In mid-Feb­ru­ary, Michel spiked a sud­den fever. COVID had final­ly caught up with him.

Giv­en that he was immuno­com­pro­mised by six rounds of can­cer chemother­a­py, Michel knew that his doc­tors would need to act quick­ly. He soon received an infu­sion of the mon­o­clon­al-anti­body drug sotro­vimab, and man­aged to recov­er with­out inci­dent; his lymph nodes stayed bless­ed­ly qui­et, and there was no resur­gence of his can­cer. Now he’s eli­gi­ble for a sec­ond boost­er shot, but he’s not sure whether he should take it. “I don’t know what I will do,” he said.

Would anoth­er dose of the vac­cine cause anoth­er round of can­cer lesions? Michel and the sci­en­tists who have been in touch with him are still mulling the evi­dence about whether his orig­i­nal can­cer flare was sim­ply a fluke. Steven Hor­witz, a med­ical oncol­o­gist at Memo­r­i­al Sloan Ket­ter­ing who focus­es on the care of patients with lym­phoma, has looked more close­ly at vac­cine side effects since hear­ing about Michel’s case, and feels reas­sured by what he’s found. “Of our patients who received mRNA COVID vac­cines, we have not seen any clear­ly relat­ed and doc­u­ment­ed relaps­es or pro­gres­sions,” he told me via email. Mean­while, lym­phomas and the treat­ments giv­en for them can weak­en the immune sys­tem, putting affect­ed patients at high­er risk of severe COVID-19 if infect­ed. “Vac­ci­na­tion remains the most effec­tive way to mit­i­gate that risk,” he said.

I reached out to the mak­ers of the mRNA COVID vac­cines to ask about Michel’s case. A rep­re­sen­ta­tive for Pfiz­er not­ed that the com­pa­ny takes such reports “very seri­ous­ly” but that, “to date, there has been no iden­ti­fied cor­re­la­tion between the vac­cine and can­cer.” Moderna’s chief med­ical offi­cer, Paul Bur­ton, told me that the com­pa­ny keeps care­ful track of safe­ty data and has not found any rela­tion­ship between vac­ci­na­tion and lym­phoma. He also point­ed to the case of a 61-year-old woman with can­cer of the sali­vary gland whose tumor shrank to about one-quar­ter of its orig­i­nal size in the month after she received a sec­ond dose of the Mod­er­na vac­cine. “Now, did it real­ly regress because the per­son got a mes­sen­ger RNA vac­cine?” he asked. “I don’t know. I think biol­o­gy is tru­ly a remark­able thing.”

While Michel remains unsure about his fourth shot, he has con­tin­ued to be out­spo­ken on the ben­e­fits of vac­ci­na­tion over­all, and often speaks to Bel­gian media on the top­ic. At the same time, he has become a stronger advo­cate for broad­er track­ing of adverse events from vaccines—an endeav­or he and oth­ers in drug devel­op­ment call “phar­ma­covig­i­lance.” “We need to make sure that some phar­ma­covig­i­lance pro­grams are pow­ered to detect very, very rare side effects,” Michel told me. Eich­ler, who was involved in drug reg­u­la­tion for the Euro­pean Med­i­cines Agency, said that while some doc­tors may be “afi­ciona­dos” of ran­dom­ized con­trolled tri­als as the only valid source of med­ical evi­dence, oth­er types of infor­ma­tion are need­ed. Michel’s case shows why: You’ve got a patient “who is a pro­fes­sor of med­i­cine, who expe­ri­ences the side effects and says, ‘Okay, this must be a side effect,’” Eich­ler said. That “rings the bells. Could Michel have ever come up in an RCT? My answer is prob­a­bly not.”

...

Around the time of his Feb­ru­ary fol­low-up, Michel received a mes­sage from a doc­tor who had read his self-ref­er­en­tial case report. The doctor’s moth­er had been diag­nosed with the same sub­type of lym­phoma that Michel has fol­low­ing a COVID boost­er shot. More recent­ly, he got an email from a woman whose sis­ter had been vac­ci­nat­ed and received that diag­no­sis the fol­low­ing month. Again, these could be coin­ci­dences. Or maybe they are the sec­ond and third data points in a grow­ing set. The pos­si­ble con­nec­tion between Michel’s lym­phoma flare and his COVID-19 vac­ci­na­tion occu­pies much of his think­ing these days. “If it exists, it must be very rare,” he said. But he doesn’t regret going pub­lic with his case. “I’m still con­vinced it was the right thing to do.”

———–

“Did a Famous Doctor’s COVID Shot Make His Can­cer Worse?” By Rox­anne Kham­si; The Atlantic; 09/24/2022

“As he fol­lowed these instruc­tions, Michel felt a gnaw­ing wor­ry that his COVID boost­er shot had some­how made him sick­er. His broth­er was har­bor­ing a sim­i­lar con­cern. The asym­met­ri­cal clus­ter of can­cer­ous nodes around Michel’s left armpit on the ini­tial scan had already seemed “a bit dis­turb­ing,” as his broth­er said; espe­cial­ly giv­en that Michel’s first two dos­es of vac­cine had been deliv­ered on that side. Now he’d had a boost­er shot in the oth­er arm, and the cancer’s asym­me­try was flipped.”

It was cause-and-effect hypoth­e­sis that was hard ignore: Michel Gold­man’s lym­phoma got dra­mat­i­cal­ly worse almost imme­di­ate­ly after get­ting the shot. But that was just the start of the evi­dence. The dots were thee to con­nect: Gold­man’s angioim­munoblas­tic T‑cell lym­phoma affects fol­lic­u­lar helper T cells, and research has already found that mRNA vac­cines are par­tic­u­lar­ly effec­tive at pro­vid­ing an extra ‘oomph’ to the body’s fol­lic­u­lar helper T cells. And Gold­man’s tumor has a muta­tion known to pre­dis­pose T‑cells to go rogue. Gold­man’s cas­es is only one data point, but a pret­ty com­pelling data point.

And again, recall that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics — which require numer­ous shots over years — to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set backs. And yet observers were just forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als. It was one of the high­ly con­ve­nient aspects of the whole mRNA vac­cine sit­u­a­tion: the side effects from the LNP deliv­ery vehi­cle just might be desir­able and have an adju­vant-like effect in the con­text of a vac­cine if those side effects end up revving up the immune sys­tem. So it should­n’t be par­tic­u­lar­ly sur­pris­ing when we learn that there might be rare side effects involv­ing an over­ly-revved-up immune sys­tem. The extra immuno­log­i­cal ‘oomph’ from the mRNA vac­cines was tout­ed as a sell­ing point, after all:

...
Michel’s can­cer was the kind that attacks the body’s T cells, which coor­di­nate the immune response to invad­ing pathogens. T‑cell lym­phomas come in rough­ly 30 dif­fer­ent sub­types; Michel’s, known as angioim­munoblas­tic T‑cell lym­phoma, affects what are called fol­lic­u­lar helper T cells, which hang out in the ton­sils and the lymph nodes, among oth­er tis­sues.. Fol­lic­u­lar helper T cells serve a cru­cial role in the cas­cade of events to pro­tect the body after dan­ger­ous invaders have arrived. That process begins with den­drit­ic cells, which iden­ti­fy a virus or oth­er pathogen and present exam­ples of it to the rest of the immune sys­tem. The helper T cells do just as their name sug­gests: They help pass that mes­sage along to B cells, which end up mak­ing pro­tec­tive anti­bod­ies against the virus.

Michel had recent­ly learned that mRNA vac­cines, such as the Pfiz­er shots he had received, are espe­cial­ly effec­tive at gen­er­at­ing that mes­sage, and spurring its pas­sage through the helper T cells. Some researchers argue that the COVID vac­cines from Pfiz­er and Mod­er­na have been more pro­tec­tive than oth­ers for exact­ly this rea­son: They rev up those cells with extra oomph. Now Michel began to won­der whether that oomph could, in ultra­rare cas­es, turn out to be a lia­bil­i­ty. Per­haps the shots gave such a jolt to his helper T cells that they went berserk. If they were prone to form­ing tumors, or if they were already can­cer­ous, then over­stim­u­la­tion could have made the prob­lem even worse.

As the days went by, Michel found oth­er clues sug­gest­ing that the link was real, and that the mRNA vac­cines might be risky for a spe­cif­ic sub­set of the pop­u­la­tion. He learned that body scans of some of those who get vac­cines, includ­ing can­cer patients, have shown height­ened activ­i­ty in the lymph nodes near the armpit on the side where the shot was received. He also came across anoth­er, very impor­tant clue. In 2018, a team of researchers based at Colum­bia University’s Insti­tute for Can­cer Genet­ics had pub­lished an intrigu­ing study using mice with a pair of gene muta­tions that, when they co-occur, pre­dis­pose T cells to go rogue. (Michel’s tumor, which had been sequenced by this point, showed the same two muta­tions.) When these mice were inject­ed with sheep red-blood cells—as an exper­i­men­tal stand-in for invad­ing microbes—the ani­mals devel­oped the sub­type of lym­phoma that was diag­nosed in Michel.

Now Michel had a the­o­ry to explain the bleak coin­ci­dence that had befall­en him. Serge agreed that it made sense. The broth­ers had co-writ­ten research papers in the past, includ­ing ones on the use of stem cells for heart repair and den­drit­ic-cell vac­cines for can­cer. It was time for them to write anoth­er.
...

And yet, as this arti­cle describes, the med­ical estab­lish­ment does­n’t seem to be very well equipped for iden­ti­fy­ing and hon­ing in on these kinds of rare events. Even reporters are wary of report­ing on such events unless they can be sta­tis­ti­cal­ly estab­lished across a larg­er patient pop­u­la­tion which sim­ply may not be pos­si­ble for a lot of rare con­di­tions. That’s part of the sto­ry here: risks that can’t be stud­ied via a ran­dom­ized-con­trolled clin­i­cal tri­als (RCTs) are sys­tem­at­i­cal­ly ignored. And yet, if mRNA vac­cines are poten­tial­ly caus­ing immune sys­tems to go hay­wire in some patients, we can’t expect that to man­i­fest as a sin­gle dis­ease. Out of con­trol immune sys­tems man­i­fest in all sorts of ways. So you could have a shared under­ly­ing cause man­i­fest­ing as all sorts of dif­fer­ent rare events that we sys­tem­at­i­cal­ly over­look:

...

Extreme­ly rare cas­es like Michel’s cre­ate a tricky ter­rain for sci­ence com­mu­ni­ca­tion. Even a clin­i­cal tri­al with thou­sands of par­tic­i­pants might nev­er turn up a sin­gle case of some­one’s can­cer wors­en­ing after vac­ci­na­tion. In that con­text, experts can’t assign a sta­tis­ti­cal esti­mate of the risk across the wider pop­u­la­tion. Sci­ence jour­nal­ists may be wary of report­ing on the sto­ry for that rea­son. In fact, when Michel first told me about his can­cer and about the paper he’d writ­ten with his broth­er, I said that I couldn’t write about it. I was wor­ried that some read­ers would mis­in­ter­pret my arti­cle, and mis­tak­en­ly see it as a rea­son not to get vac­ci­nat­ed. As I write this, I’m still con­cerned that you might do exact­ly that.

But the sci­en­tif­ic lit­er­a­ture is sprin­kled with odd cas­es like Michel’s that have puz­zled doc­tors. The Gold­mans’ paper fol­lows ear­li­er iso­lat­ed reports sug­gest­ing a pos­si­ble link between COVID-19 vac­ci­na­tion and lym­phoma. Aaron Man­gold, who heads the divi­sion of clin­i­cal der­ma­tol­ogy at the Mayo Clin­ic in Ari­zona, co-authored a paper pub­lished in May 2021 about a patient whose rare skin lym­phoma recurred after his ini­tial Pfiz­er shot. The tumor­ous ulcer appeared in the armpit of the same arm in which the man had received the injec­tion, and then regressed spon­ta­neous­ly. A sec­ond shot of the vac­cine, deliv­ered three weeks lat­er, pro­duced no fur­ther lesions, Man­gold told me, and the whole ordeal could have sim­ply been a coin­ci­dence. He felt that he’d been “thread­ing the nee­dle” to go pub­lic with the case report giv­en that uncer­tain­ty.

Ladan Zand, a nephrol­o­gist at the Mayo Clin­ic in Rochester, Min­neso­ta, faced the same conun­drum when she co-authored a paper last year detail­ing five patients who had a relapse of kid­ney dis­ease fol­low­ing mRNA COVID vac­ci­na­tion. Her team also doc­u­ment­ed eight patients who were new­ly diag­nosed with the dis­ease, known as glomeru­lonephri­tis, after receiv­ing the shot. But Zand cau­tions that those patients might have had under­ly­ing kid­ney dis­ease and not been aware of it. Peo­ple infect­ed with the nov­el coro­n­avirus also show high­er rates of kid­ney-func­tion decline over time. “I spend half of my vis­its now ask­ing patients to get vac­ci­nat­ed,” she said. “If you were to com­pare the risks and ben­e­fits, the ben­e­fits of the vac­cine way out­weigh the risk of rare enti­ties that, for the most part, seem to be self-lim­it­ing.”

...

While Michel remains unsure about his fourth shot, he has con­tin­ued to be out­spo­ken on the ben­e­fits of vac­ci­na­tion over­all, and often speaks to Bel­gian media on the top­ic. At the same time, he has become a stronger advo­cate for broad­er track­ing of adverse events from vaccines—an endeav­or he and oth­ers in drug devel­op­ment call “phar­ma­covig­i­lance.” “We need to make sure that some phar­ma­covig­i­lance pro­grams are pow­ered to detect very, very rare side effects,” Michel told me. Eich­ler, who was involved in drug reg­u­la­tion for the Euro­pean Med­i­cines Agency, said that while some doc­tors may be “afi­ciona­dos” of ran­dom­ized con­trolled tri­als as the only valid source of med­ical evi­dence, oth­er types of infor­ma­tion are need­ed. Michel’s case shows why: You’ve got a patient “who is a pro­fes­sor of med­i­cine, who expe­ri­ences the side effects and says, ‘Okay, this must be a side effect,’” Eich­ler said. That “rings the bells. Could Michel have ever come up in an RCT? My answer is prob­a­bly not.”
...

But then we get to the tru­ly inex­plic­a­ble aspects of this sto­ry: if the dan­ger asso­ci­at­ed with the COVID vac­cines are asso­ci­at­ed with the effect on T‑cells induced by specif­i­cal­ly mRNA vac­cines, what about all the non-mRNA COVID vac­cine options for patients like Gold­man? Can’t he just take the AstraZeneca vac­cine instead? Or the John­son & John­son vac­cine? How about the new­ly-approved Novavax vac­cine? There are plen­ty of non-mRNA options. And Gold­man him­self even empha­sized how the risks found with these oth­er vac­cines were vast­ly out­weighed by the risks of COVID:

...
I hap­pened to speak with Michel by phone in April 2021, months before his can­cer diag­no­sis. I’d called him to dis­cuss anoth­er poten­tial side effect of COVID vac­ci­na­tion, one asso­ci­at­ed in par­tic­u­lar with the shot made by AstraZeneca. By that point, 220 peo­ple who’d received that vac­cine had devel­oped an unusual—and very dangerous—blood-clotting syn­drome, which was char­ac­ter­ized by an atyp­i­cal low platelet count. At least sev­en peo­ple in the U.K. alone had died of the com­pli­ca­tion. Michel patient­ly laid out the dif­fer­ent mech­a­nisms that might explain this strange con­di­tion. But he was quick to add that the mRNA COVID vac­cines were built in a way that could mit­i­gate the risk of this par­tic­u­lar prob­lem.

...

When we talked about the poten­tial side effects of the AstraZeneca vac­cine last year, Michel made it clear that, in the big pic­ture, any chance of seri­ous com­pli­ca­tions from the shots would be orders of mag­ni­tude small­er than the chance of com­pli­ca­tions from the pan­dem­ic ill­ness itself. If COVID vac­cines caused clot­ting dis­or­ders or myocardi­tis in a tiny per­cent­age of those who received them, he assured me, COVID would lead to stroke or heart inflam­ma­tion in a much larg­er group.

The risks and ben­e­fits for each vac­cine should be weighed against each oth­er, he con­tin­ued. If AstraZeneca were the only option, then its pro­tec­tion might be worth the very small risk of devel­op­ing a rare blood dis­or­der. But giv­en the avail­abil­i­ty of Pfiz­er, Mod­er­na, and oth­er COVID vac­cines, many peo­ple could opt for a safer alter­na­tive.
...

And yet, despite Gold­man’s assur­ances about the safe­ty of the AstraZeneca vac­cine, we find that he’s appar­ent­ly still try­ing to decide whether or not to get anoth­er mRNA boost­er shot or no vac­cine at all. WTF!?!?! Why?! Why not just take one of the non-mRNA vac­cines? It’s tru­ly bizarre:

...
The Gold­mans’ paper, for its part, notes that it would be “pre­ma­ture” to extrap­o­late the find­ings from Michel to oth­er patients with the same kind of can­cer, and that the link, even if it were proved, should not dis­cour­age gen­er­al uptake of “much-need­ed vac­cines.” An unusu­al para­graph tacked onto the bot­tom of the arti­cle under­scores the point. Marked “Patient Per­spec­tive,” and writ­ten in the third per­son, it notes that Michel him­self “remains con­vinced that mRNA vac­cines rep­re­sent very effi­cient prod­ucts with a favor­able ben­e­fit-risk ratio,” and that he hopes the report will encour­age fur­ther research.

In mid-Feb­ru­ary, Michel spiked a sud­den fever. COVID had final­ly caught up with him.

Giv­en that he was immuno­com­pro­mised by six rounds of can­cer chemother­a­py, Michel knew that his doc­tors would need to act quick­ly. He soon received an infu­sion of the mon­o­clon­al-anti­body drug sotro­vimab, and man­aged to recov­er with­out inci­dent; his lymph nodes stayed bless­ed­ly qui­et, and there was no resur­gence of his can­cer. Now he’s eli­gi­ble for a sec­ond boost­er shot, but he’s not sure whether he should take it. “I don’t know what I will do,” he said.

Would anoth­er dose of the vac­cine cause anoth­er round of can­cer lesions? Michel and the sci­en­tists who have been in touch with him are still mulling the evi­dence about whether his orig­i­nal can­cer flare was sim­ply a fluke. Steven Hor­witz, a med­ical oncol­o­gist at Memo­r­i­al Sloan Ket­ter­ing who focus­es on the care of patients with lym­phoma, has looked more close­ly at vac­cine side effects since hear­ing about Michel’s case, and feels reas­sured by what he’s found. “Of our patients who received mRNA COVID vac­cines, we have not seen any clear­ly relat­ed and doc­u­ment­ed relaps­es or pro­gres­sions,” he told me via email. Mean­while, lym­phomas and the treat­ments giv­en for them can weak­en the immune sys­tem, putting affect­ed patients at high­er risk of severe COVID-19 if infect­ed. “Vac­ci­na­tion remains the most effec­tive way to mit­i­gate that risk,” he said.

...

Around the time of his Feb­ru­ary fol­low-up, Michel received a mes­sage from a doc­tor who had read his self-ref­er­en­tial case report. The doctor’s moth­er had been diag­nosed with the same sub­type of lym­phoma that Michel has fol­low­ing a COVID boost­er shot. More recent­ly, he got an email from a woman whose sis­ter had been vac­ci­nat­ed and received that diag­no­sis the fol­low­ing month. Again, these could be coin­ci­dences. Or maybe they are the sec­ond and third data points in a grow­ing set. The pos­si­ble con­nec­tion between Michel’s lym­phoma flare and his COVID-19 vac­ci­na­tion occu­pies much of his think­ing these days. “If it exists, it must be very rare,” he said. But he doesn’t regret going pub­lic with his case. “I’m still con­vinced it was the right thing to do.”
...

So best of luck to Michel Gold­man in his bat­tle with lym­phoma. A bat­tle that hope­ful­ly won’t involve any new bouts of COVID. And/or any new rare side-effects that get sys­tem­at­i­cal­ly ignored.

Here’s an arti­cle from a few weeks ago fol­low­ing up on one of the more dis­turb­ing sto­ries to emerge from the COVID pan­dem­ic. The sto­ry also poten­tial­ly relates to Metabio­ta and the devel­op­ment of pan­dem­ic insur­ance prod­ucts:

Recall how Palan­tir man­aged to get gov­ern­ment con­tracts to help mon­i­tor the COVID out­break. And not just with the CDC in the US. As of April of 2020, Palan­tir was work­ing with over a dozen gov­ern­ments in assist­ing their COVID response, includ­ing the UK’s Nation­al Health Ser­vice (NHS). Palan­tir’s NHS con­tract involved using Palan­tir’s Foundry plat­form to help the NHS deter­mine cur­rent occu­pan­cy lev­els at hos­pi­tals, down to the num­ber and type of beds, as well as the capac­i­ty of acci­dent and emer­gency, depart­ments and wait­ing times. Palan­tir was get­ting access to some pret­ty gran­u­lar UK med­ical data. The kind of data that could pre­sum­ably be very handy for any com­pa­ny involved with pre­dict­ing and track­ing emerg­ing pan­demics. And with the NHS putting up a new £360 mil­lion con­tract com­ing for ten­der for a major new data plat­form, it sounds like Palan­tir is very keen on get­ting that con­tract and tak­ing steps to make it hap­pen. Steps like hir­ing key NHS offi­cials.

And now we’re learn­ing that Palan­tir has plans to expand its foot­print in the UK health sys­tem. Secret plans. Well, for­mer­ly secret plans. Plans to avoid pub­lic scruti­ny by buy­ing expand­ing in this mar­ket indi­rect­ly. Instead of Palan­tir direct­ly offer­ing ser­vices to UK health data firms, the com­pa­ny is going on a buy­ing spree instead, tar­get­ing small health data firms across the UK.

Intrigu­ing­ly, it sounds like Palan­tir is offer­ing the founders of these firms extra sweet deals if the founders agree to shift their data and ser­vices to Palan­tir’s Foundry. In oth­er words, Palan­tir real­ly wants to get its hands on that data. This is par­tic­u­lar­ly inter­est­ing giv­en that, as we’re going to see, the exist­ing NHS con­tracts with Palan­tir are explic­it that “the data con­trol stays with the own­er of the data, not with Palan­tir.” So at the same time Palan­tir appears to be poised to place itself at the heart of the NHS’s health­care data, but not nec­es­sar­i­ly with ‘con­trol’ over that data, the com­pa­ny is simul­ta­ne­ous­ly going around buy up small UK health data firms in a push to get as much of that data into Palan­tir’s inter­nal Foundry plat­form as pos­si­ble.

And this is all, of course, hap­pen­ing under the watch of a UK gov­ern­ment that appears to be ani­mat­ed by the ghost of Ayn Rand. That’s the broad­er con­text here: the cur­rent right-wing UK gov­ern­ment is keen on hand­ing as much of the pub­lic sec­tor over to the pri­vate sec­tor as pos­si­ble. Out­sourc­ing the NHS’s health data ser­vices to a fas­cist like Peter Thiel just makes sense. Fas­cist sense, but that’s the kind of sense guid­ing the UK these days, which is why we should prob­a­bly start ask­ing what oth­er kind of fas­cist goals might be achiev­able once you hand a nation’s health care data over to one of the world’s lead­ing fas­cists:

Finan­cial Times

Palan­tir gears up to expand its reach into UK’s NHS
US data ana­lyt­ics group hires health ser­vice exec­u­tives in bid to secure £360mn con­tract

Mad­hu­mi­ta Mur­gia and Sarah Neville in Lon­don
June 8 2022

US data ana­lyt­ics group Palan­tir is gear­ing up to become the under­ly­ing oper­at­ing sys­tem for the UK’s Nation­al Health Ser­vice, poach­ing senior NHS offi­cials as part of a bid to win a £360mn con­tract to man­age the data of mil­lions of patients across Eng­land.

The com­pa­ny, best known for its ties to the secu­ri­ty, defence and intel­li­gence sec­tors, has been the NHS’s go-to data ana­lyt­ics provider dur­ing its Covid-19 cri­sis response. Its Foundry soft­ware was used in the man­age­ment of ven­ti­la­tors and PPE equip­ment, deliv­ery of the nation­wide vac­ci­na­tion pro­gramme and help­ing to tack­le the back­log of 6mn patients wait­ing for elec­tive care.

The secre­tive com­pa­ny, co-found­ed by Peter Thiel, an ear­ly investor in Face­book and promi­nent sup­port­er of for­mer US pres­i­dent Don­ald Trump, is now manoeu­vring to expand its reach into the NHS over the next decade.

That push has prompt­ed pri­va­cy activists and some with­in the NHS to voice con­cerns about Palantir’s suit­abil­i­ty to run nation­al health sys­tems as well as the dan­gers of the NHS rely­ing on a sin­gle pri­vate com­pa­ny for its key func­tions.

Over the next few months, Palan­tir will bid for the five-year £360mn con­tract for the pro­posed Fed­er­at­ed Data Plat­form (FDP), a new data tool to con­nect and inte­grate patient and oth­er data sources from across the health sys­tem, so real-time deci­sions can be made effec­tive­ly by clin­i­cians and bureau­crats. The con­tract is due to be award­ed in Novem­ber this year.

“This would be the veins through which patient data would flow, very much the oper­at­ing sys­tem for data in the NHS,” said Phil Booth, founder of health data advo­ca­cy group med­Con­fi­den­tial. “This is clear­ly a core ele­ment of the NHS’s entire dig­i­tal trans­for­ma­tion pro­gramme.”

To help its chances, Palan­tir has hired two senior NHS offi­cials in recent months — Indra Joshi, the NHS’s for­mer head of arti­fi­cial intel­li­gence, and Har­jeet Dhali­w­al, for­mer deputy to Ming Tang, NHS England’s data chief, who is respon­si­ble for the FDP con­tract and for Palantir’s pre­vi­ous con­tracts with the NHS.

A for­mer senior health offi­cial said that eye­brows with­in the ser­vice had been raised by “the revolv­ing door between gov­ern­ment, NHS and Palan­tir”.

The UK is a key mar­ket for Palan­tir, which employs more than 600 peo­ple — its largest sin­gle office — and plans to hire an addi­tion­al 250 staff this year. The com­pa­ny already process­es sen­si­tive nation­al secu­ri­ty data for UK pub­lic author­i­ties, includ­ing the Min­istry of Defence and cab­i­net office.

“Palan­tir has said this is a must-win deal for them,” said a per­son with knowl­edge of Palantir’s expan­sion plans in the UK. “This is a five-year con­tract, with an option for an exten­sion for two years. [Many peo­ple] think it’s real­ly £1bn over 10 years. Once Palan­tir is in, how are you going to remove them?”

The move comes as Palantir’s growth slows sig­nif­i­cant­ly. Its sales in the first quar­ter of this year rose 31 per cent, com­pared with a rise of 49 per cent in the same peri­od last year.

Although the com­pa­ny has said it wants to piv­ot to doing more com­mer­cial work, gov­ern­ment con­tracts still have a big impact on its finan­cial health. Gov­ern­ment rev­enue was up 16 per cent year on year in the first quar­ter, com­pared with a 76 per cent increase the year before.

Accord­ing to sev­er­al fig­ures at the NHS and at its sup­pli­ers, Palan­tir is viewed as the fron­trun­ner for the FDP con­tract, which runs until 2027. The plat­form will be used for the nation­al man­age­ment of vac­cines and immu­ni­sa­tion pro­grammes, pop­u­la­tion health, elec­tive wait­ing lists and med­i­cines and equip­ment sup­ply chains, among oth­er appli­ca­tions.

In an infor­ma­tion pack pro­vid­ed to poten­tial sup­pli­ers by the NHS, and seen by the Finan­cial Times, Palantir’s tech­nol­o­gy was laud­ed as a mod­el. “The cur­rent plat­form (Foundry) is . . . deliv­er­ing huge ben­e­fits and was crit­i­cal to the suc­cess of the vac­ci­na­tion and PPE pro­grammes.”

Rolling out this type of sys­tem across the rest of the health ser­vice “has the poten­tial to deliv­er £3.6bn ben­e­fits over 10 years”, the doc­u­ment said.

One senior NHS offi­cial said Palan­tir was well-placed to win the bid, par­tic­u­lar­ly when its work was assessed against fail­ures else­where in the Covid response, notably defi­cien­cies in the pro­gramme to test and track con­tacts of infect­ed peo­ple.

“If you were to com­pare the [suc­cess­ful] work that Palan­tir did in vac­cines and PPE, with the work that Palan­tir didn’t do, which was test and trace . . . [Palan­tir] hasn’t let us down,” he said.

Oth­er poten­tial bid­ders could include con­sult­ing firms such as Accen­ture, PwC and KPMG, who have tech­nol­o­gy part­ners such as Ora­cle and Microsoft.

...

NHS Eng­land said the pro­cure­ment process would start in ear­ly July and that it would be an open pro­cure­ment to allow all sup­pli­ers a chance to bid.

“The NHS should not be com­mis­sion­ing a sin­gle sup­pli­er to be the provider of its oper­at­ing sys­tem for data for Eng­land. We need to be build­ing the capac­i­ty to do that our­selves,” said Booth of med­Con­fi­den­tial. “What­ev­er sup­pli­er is con­tract­ed should be com­plete­ly trans­par­ent, but Palan­tir is a black box.”

Palantir’s involve­ment in the NHS has been par­tic­u­lar­ly con­tro­ver­sial among civ­il lib­er­ties groups. Last July, a group of pri­va­cy cam­paign­ers led by tech jus­tice group Fox­glove launched the “No Palan­tir in Our NHS” cam­paign owing to its work with the US immi­gra­tion ser­vice and close links to nation­al secu­ri­ty agen­cies.

While a senior NHS offi­cial acknowl­edged the ques­tion of data secu­ri­ty was “com­plete­ly valid”, he said NHS Eng­land had “gone into this in a lot of depth” and believed that Palan­tir was “one of the few com­pa­nies that can actu­al­ly address those con­cerns legit­i­mate­ly”. Under the licence agree­ments that the NHS has pre­vi­ous­ly entered into with the com­pa­ny, “the data con­trol stays with the own­er of the data, not with Palan­tir”, he not­ed.

Not all are con­vinced. “Many are already con­cerned about com­mer­cial inter­ests hav­ing involve­ment at all, let alone a com­pa­ny that helped Don­ald Trump with his ICE deten­tions at the Mex­i­can bor­der,” said Booth. “Is this a prop­er cor­po­rate enti­ty to be work­ing at the heart of the NHS?”

————

“Palan­tir gears up to expand its reach into UK’s NHS” by Mad­hu­mi­ta Mur­gia and Sarah Neville; Finan­cial Times; 06/08/2022

“Over the next few months, Palan­tir will bid for the five-year £360mn con­tract for the pro­posed Fed­er­at­ed Data Plat­form (FDP), a new data tool to con­nect and inte­grate patient and oth­er data sources from across the health sys­tem, so real-time deci­sions can be made effec­tive­ly by clin­i­cians and bureau­crats. The con­tract is due to be award­ed in Novem­ber this year.”

It’s a mas­sive prize: a five-year £360mn con­tract to build a new data plat­form that will con­nect a myr­i­ad of health data sources. And a con­tract that’s almost guar­an­teed to be extend­ed for at least anoth­er five years and prob­a­bly indef­i­nite­ly. And based on insid­er com­ments, it sounds like Palan­tir is the like­ly choice for this con­tract when the gov­ern­ment ulti­mate­ly makes that deci­sion next month. Yes, Palan­tir — a com­pa­ny found­ed by an open fas­cist and financed by the CIA — is poised to get embed­ded at the heart of the NHS oper­a­tions for the fore­see­able future:

...
The com­pa­ny, best known for its ties to the secu­ri­ty, defence and intel­li­gence sec­tors, has been the NHS’s go-to data ana­lyt­ics provider dur­ing its Covid-19 cri­sis response. Its Foundry soft­ware was used in the man­age­ment of ven­ti­la­tors and PPE equip­ment, deliv­ery of the nation­wide vac­ci­na­tion pro­gramme and help­ing to tack­le the back­log of 6mn patients wait­ing for elec­tive care.

...

That push has prompt­ed pri­va­cy activists and some with­in the NHS to voice con­cerns about Palantir’s suit­abil­i­ty to run nation­al health sys­tems as well as the dan­gers of the NHS rely­ing on a sin­gle pri­vate com­pa­ny for its key func­tions.

...

“Palan­tir has said this is a must-win deal for them,” said a per­son with knowl­edge of Palantir’s expan­sion plans in the UK. “This is a five-year con­tract, with an option for an exten­sion for two years. [Many peo­ple] think it’s real­ly £1bn over 10 years. Once Palan­tir is in, how are you going to remove them?”

...

Accord­ing to sev­er­al fig­ures at the NHS and at its sup­pli­ers, Palan­tir is viewed as the fron­trun­ner for the FDP con­tract, which runs until 2027. The plat­form will be used for the nation­al man­age­ment of vac­cines and immu­ni­sa­tion pro­grammes, pop­u­la­tion health, elec­tive wait­ing lists and med­i­cines and equip­ment sup­ply chains, among oth­er appli­ca­tions.

In an infor­ma­tion pack pro­vid­ed to poten­tial sup­pli­ers by the NHS, and seen by the Finan­cial Times, Palantir’s tech­nol­o­gy was laud­ed as a mod­el. “The cur­rent plat­form (Foundry) is . . . deliv­er­ing huge ben­e­fits and was crit­i­cal to the suc­cess of the vac­ci­na­tion and PPE pro­grammes.”

Rolling out this type of sys­tem across the rest of the health ser­vice “has the poten­tial to deliv­er £3.6bn ben­e­fits over 10 years”, the doc­u­ment said.

One senior NHS offi­cial said Palan­tir was well-placed to win the bid, par­tic­u­lar­ly when its work was assessed against fail­ures else­where in the Covid response, notably defi­cien­cies in the pro­gramme to test and track con­tacts of infect­ed peo­ple.

“If you were to com­pare the [suc­cess­ful] work that Palan­tir did in vac­cines and PPE, with the work that Palan­tir didn’t do, which was test and trace . . . [Palan­tir] hasn’t let us down,” he said.
...

But as good as its chances are, Palan­tir isn’t tak­ing any chances with the hir­ing of key NHS offi­cials in recent months. The mes­sage is clear: NHS offi­cials can expect cushy job offers from Palan­tir in exchange for this con­tract:

...
To help its chances, Palan­tir has hired two senior NHS offi­cials in recent months — Indra Joshi, the NHS’s for­mer head of arti­fi­cial intel­li­gence, and Har­jeet Dhali­w­al, for­mer deputy to Ming Tang, NHS England’s data chief, who is respon­si­ble for the FDP con­tract and for Palantir’s pre­vi­ous con­tracts with the NHS.

A for­mer senior health offi­cial said that eye­brows with­in the ser­vice had been raised by “the revolv­ing door between gov­ern­ment, NHS and Palan­tir”.
...

Final­ly, note the key assur­ance we’re hear­ing about data pri­va­cy con­cerns: The data processed by Palan­tir’s sys­tems for the NHS Under the pre­vi­ous licens­ing agree­ments came with the stip­u­la­tion that “the data con­trol stays with the own­er of the data, not with Palan­tir.” So if they sta­tus quo is main­tain, Palan­tir could end up at the heart of the NHS’s health data pro­cess­ing while not actu­al­ly hav­ing con­trol of the data. It would be inter­est­ing to know what exact­ly that kind of arrange­ment entails in terms of real world data pri­va­cy impli­ca­tions. Because whether or not Palan­tir ‘con­trols’ the data, it pre­sum­ably needs to be able to access it if it’s going to be offer­ing these ser­vices:

...
Palantir’s involve­ment in the NHS has been par­tic­u­lar­ly con­tro­ver­sial among civ­il lib­er­ties groups. Last July, a group of pri­va­cy cam­paign­ers led by tech jus­tice group Fox­glove launched the “No Palan­tir in Our NHS” cam­paign owing to its work with the US immi­gra­tion ser­vice and close links to nation­al secu­ri­ty agen­cies.

While a senior NHS offi­cial acknowl­edged the ques­tion of data secu­ri­ty was “com­plete­ly valid”, he said NHS Eng­land had “gone into this in a lot of depth” and believed that Palan­tir was “one of the few com­pa­nies that can actu­al­ly address those con­cerns legit­i­mate­ly”. Under the licence agree­ments that the NHS has pre­vi­ous­ly entered into with the com­pa­ny, “the data con­trol stays with the own­er of the data, not with Palan­tir”, he not­ed.

Not all are con­vinced. “Many are already con­cerned about com­mer­cial inter­ests hav­ing involve­ment at all, let alone a com­pa­ny that helped Don­ald Trump with his ICE deten­tions at the Mex­i­can bor­der,” said Booth. “Is this a prop­er cor­po­rate enti­ty to be work­ing at the heart of the NHS?”
...

And that ‘data con­trol’ arrange­ment brings us to the lat­est update we got on Palan­tir’s plans for expand­ing its NHS foot­print. Secur­ing that £360mn con­tract is just the one part of this expan­sion. The more pub­lic part. There’s a qui­et part too: Palan­tir has been try­ing to qui­et­ly ‘hoover up’ all sorts of UK health data firms. The idea is that by buy­ing firms out­right, Palan­tir can avoid some of the polit­i­cal resis­tance it faces with things like NHS con­tracts.

And then we get to this inter­est­ing detail: it also sounds like Palan­tir has been sweet­en­ing the buy­out deals for these small firms if the founders of the firms agree to move their data and ser­vices over to Palan­tir’s Foundry. That sure sounds like a recipe for gain­ing con­trol over that data. So what have to ask, what else is Palan­tir plan­ning on using this data for? Pan­dem­ic insur­ance-relat­ed data analy­sis is one pos­si­bil­i­ty that comes to mind but it’s just one exam­ple of the array of pos­si­ble appli­ca­tion for this kind of data. That’s part of what makes this sto­ry some­thing to watch: Palan­tir does­n’t just want those NHS con­tracts. The com­pa­ny wants that health data and it’s ‘hoover­ing up’ firms across the UK to get it:

Bloomberg

Peter Thiel’s Palan­tir Had Secret Plan to Crack UK’s NHS: ‘Buy­ing Our Way In’

* US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals
* Sil­i­con Val­ley data firm bid­ding for £360 mil­lion NHS con­tract

By Olivia Solon
Sep­tem­ber 30, 2022 at 12:00 AM CDT

Palan­tir Tech­nolo­gies had a secret plan to deep­en its rela­tion­ship with the UK’s Nation­al Health Ser­vice with­out pub­lic scruti­ny.

The US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals that already had an exist­ing rela­tion­ship with the NHS, accord­ing to emails and strat­e­gy doc­u­ments seen by Bloomberg. This approach would hope­ful­ly allow Palan­tir to avoid fur­ther scruti­ny in work­ing with one of the largest depos­i­to­ries of health data.

Palantir’s region­al head Louis Mosley described the strat­e­gy in an email enti­tled “Buy­ing our way in…!” sent in Sept. 2021, which out­lined “hoover­ing up” small busi­ness­es serv­ing the NHS to “take a lot of ground and take down a lot of polit­i­cal resis­tance.”

The NHS, one of the world’s largest employ­ers with a recent annu­al bud­get close to £190 bil­lion ($208 bil­lion), has become a key client for Palan­tir. It hired the US tech firm to help with its Covid-19 response, and cur­rent­ly has a £360 mil­lion con­tract com­ing up for ten­der — a deal Palan­tir is hop­ing to win.

While Palan­tir has so far been unsuc­cess­ful in buy­ing up NHS sup­pli­ers, the doc­u­ments seen by Bloomberg show how Palan­tir hopes to deep­en its busi­ness with a key client, both by mak­ing key hires from the NHS and via poten­tial acqui­si­tions.

Palan­tir has con­sis­tent­ly faced crit­i­cism in coun­tries includ­ing the US and UK from civ­il lib­er­ties groups, who have been con­cerned by its track record for pro­vid­ing tools to gov­ern­ment agen­cies that help enable broad sur­veil­lance of pop­u­la­tions, for exam­ple by US Cus­toms and Enforce­ment to find undoc­u­ment­ed migrants for depor­ta­tion. Law­mak­ers in the UK have also voiced con­cern over Palantir’s tech­nol­o­gy.

...

‘Start Scop­ing’

Co-found­ed in 2003 by Face­book Inc. board mem­ber Peter Thiel, Palan­tir quick­ly won the atten­tion and finan­cial back­ing of In-Q-Tel, the ven­ture invest­ing arm of the U.S. Cen­tral Intel­li­gence Agency. The start­up count­ed the CIA among its first cus­tomers, and cul­ti­vat­ed an ear­ly rep­u­ta­tion for secre­cy.

Named for the all-see­ing stones used in J.R.R. Tolkien’s fic­tion­al The Lord of the Rings tril­o­gy, Palan­tir now counts dozens of US gov­ern­ment agen­cies as cus­tomers, with a a sig­nif­i­cant num­ber in the nation­al secu­ri­ty and defense space. Palan­tir lead­er­ship has for­sworn doing busi­ness in Chi­na and oth­er regions not aligned with US inter­ests, ele­vat­ing the impor­tance of UK deals. How­ev­er, despite pre­dict­ing $1.9 bil­lion in rev­enue for 2022, the firm has strug­gled to turn a prof­it. It’s share price is down about 56% so far this year.

Accord­ing to Mosley’s email to col­leagues, suit­able UK takeover tar­gets were those with cred­i­ble lead­er­ship, annu­al rev­enue of between £5 mil­lion and £50 mil­lion, and already sell­ing soft­ware ser­vices to the NHS. Founders would be offered a “v. gen­er­ous buy­out sched­ule (say 10x, espe­cial­ly if all stock),” he wrote.

Palan­tir would offer com­pen­sa­tion to founders for their equi­ty stake if they shift­ed all of their ser­vices into Palantir’s main data han­dling plat­form, Foundry, which was designed to orga­nize data from dis­parate sources.

“I doubt any­body else is like­ly to come along and offer them some­thing as gen­er­ous as we would (we might even be their only real exit option),” Mosley wrote.

Ear­ly in the Covid-19 pan­dem­ic, Foundry was used by the NHS to track the take-up of vac­cines and, more recent­ly, to man­age the back­log of patients wait­ing for elec­tive surg­eries. Since 2020, Palan­tir secured more than £37 mil­lion in con­tracts with the NHS and the Depart­ment of Health and Social Care, accord­ing to pub­lic spend­ing track­er Advice­Cloud.

One of the com­pa­nies Palan­tir sought to acquire, short­ly before Mosley emailed his plan, was Beau­ti­ful Infor­ma­tion, an NHS-pri­vate part­ner­ship that gen­er­ates real-time infor­ma­tion for hos­pi­tals to use for bal­anc­ing resources with patient demand. Palan­tir lost out to Cana­di­an health-tech firm Vital­Hub Corp, which announced it bought Beau­ti­ful Infor­ma­tion for £1.55 mil­lion in Jan­u­ary.

“I’m keen to start scop­ing more acqui­si­tion tar­gets like [Beau­ti­ful Infor­ma­tion],” Mosley wrote, adding that he had “a kit­ty,” a British term for a pot of mon­ey.

Late in 2021, Palan­tir was also in advanced talks to invest more than £21 mil­lion into British data-ana­lyt­ics firm Sen­syne, in a deal code­named “Project Gon­dor” — a ref­er­ence to a fic­tion­al king­dom depict­ed in The Lord of the Rings — in return for Sen­syne using Palantir’s Foundry, accord­ing to an inter­nal doc­u­ment seen by Bloomberg.

“There is noth­ing unusu­al about a com­pa­ny explor­ing invest­ments or acqui­si­tions,” Palantir’s spokesman said. He said the com­pa­ny had been approached with “two such oppor­tu­ni­ties” in 2021. “We declined to pro­ceed with either and have not acquired any com­pa­nies that work with the NHS,” he said.

...

Palan­tir was also part of a group of sev­er­al investors that con­tributed $230 mil­lion to sup­port Baby­lon Hold­ings Ltd. going pub­lic in 2021, as part of a longer-term part­ner­ship between the two com­pa­nies that saw Baby­lon migrate some of its data to Palantir’s Foundry plat­form, Bloomberg report­ed.

Lob­by Efforts

Deals and takeovers were only part of Palantir’s approach, how­ev­er, the mes­sages seen by Bloomberg show. At the same time as the Baby­lon part­ner­ship, Palan­tir urged indus­try lob­by group TechUK to encour­age gov­ern­ment agen­cies to buy com­mer­cial off-the-shelf prod­ucts, such as Foundry, instead of build­ing their own bespoke tools.

...

Palan­tir hired Glob­al Coun­sel — the strate­gic advi­so­ry firm co-found­ed by Peter Man­del­son, a British Lord and for­mer lead­ing advis­er to ex-Prime Min­is­ter Tony Blair — to help lob­by UK gov­ern­ment. It also recent­ly hired Indra Joshi and Har­jeet Dhali­w­al, key fig­ures from the NHS.

“Glob­al Counsel’s work for Palan­tir is a mat­ter of pub­lic record,” a spokesper­son said in an emailed state­ment. “The rel­e­vant dec­la­ra­tions to statu­to­ry reg­is­ters and the NHS in rela­tion to this work have been made.”

Crit­ics have chal­lenged the NHS’s lack of trans­paren­cy over hasti­ly exe­cut­ed deals dur­ing the pan­dem­ic. Palan­tir was paid a nom­i­nal £1 fee in March 2020 to run a Covid-19 data store to help the NHS allo­cate resources more effi­cient­ly, but has used the work as a case study in pitch­es for oth­er NHS con­tracts, accord­ing to two senior NHS offi­cials who were not autho­rized to speak to the media.

Ahead of that deal, Palan­tir spent months woo­ing NHS chiefs, the Bureau of Inves­tiga­tive Jour­nal­ism report­ed in Feb­ru­ary 2021. In Decem­ber 2020, Palan­tir was grant­ed a new con­tract to con­tin­ue the data-store work in a £23.5 mil­lion deal that was not sub­ject to a pub­lic ten­der process.

Palan­tir declined to com­ment, but NHS Eng­land said in a state­ment at the time that it had “always act­ed in accor­dance with its legal respon­si­bil­i­ties.”

Despite hir­ing Glob­al Coun­sel, Palan­tir received crit­i­cism from law­mak­ers over their deep­en­ing rela­tion­ship with the NHS.

“Patient trust is vital to our NHS, so for­eign tech com­pa­nies such as Palan­tir, with their his­to­ry of sup­port­ing mass sur­veil­lance, assist­ing in drone strikes, immi­gra­tion raids and pre­dic­tive polic­ing, must not be placed at the heart of our NHS,” British law­mak­er David Davis, a mem­ber of the Con­ser­v­a­tive Par­ty and for­mer Sec­re­tary of State for Exit­ing the Euro­pean Union, said dur­ing a House of Com­mons debate in June 2021.

Inde­pen­dent media com­pa­ny Open­Democ­ra­cy sued the UK gov­ern­ment with the sup­port of legal non­prof­it Fox­glove for award­ing busi­ness to Palan­tir with­out a pub­lic ten­der process. The gov­ern­ment agreed not to extend the con­tract beyond Covid with­out a pub­lic con­sul­ta­tion. The push-back con­tin­ued in Sept. 2021, when the Depart­ment of Health and Social Care end­ed anoth­er data deal with Palan­tir, Bloomberg report­ed.

Cori Crid­er, found­ing direc­tor of Fox­glove, said there are “real con­cerns” about whether Palan­tir offers the NHS val­ue for mon­ey, “or whether there is just a ‘shiny dash­board’ think­ing infect­ing some offi­cials.”

It’s not known when the NHS will make a deci­sion for its upcom­ing £360 mil­lion ten­der. Oth­er poten­tial bid­ders include major con­sult­ing firms as well as large US tech com­pa­nies.

“Foundry as a piece of soft­ware is entire­ly com­pe­tent,” said Phil Booth, coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial, adding that he did not have con­cerns about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry.

How­ev­er, he said that Palantir’s his­to­ry as a “Peter Thiel-backed, CIA-ini­ti­at­ed com­pa­ny” could deter patients from shar­ing their data. “We should get rid of Palan­tir and build our own open-source soft­ware,” he said.

———–

“Peter Thiel’s Palan­tir Had Secret Plan to Crack UK’s NHS: ‘Buy­ing Our Way In’” By Olivia Solon; Bloomberg; 09/30/2022

“The US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals that already had an exist­ing rela­tion­ship with the NHS, accord­ing to emails and strat­e­gy doc­u­ments seen by Bloomberg. This approach would hope­ful­ly allow Palan­tir to avoid fur­ther scruti­ny in work­ing with one of the largest depos­i­to­ries of health data.”

You can see why Palan­tir is keen on this strat­e­gy: instead of deal­ing with all the headaches and pub­lic rela­tions chal­lenges of hav­ing Palan­tir direct­ly get new con­tracts with the UK’s NHS, just have Palan­tir buy up com­pa­nies that are already work­ing with NHS data. As long as Palan­tir can man­age to “hoover up” enough small com­pa­nies it’s only a mat­ter of time before its foothold is secured:

...
Palantir’s region­al head Louis Mosley described the strat­e­gy in an email enti­tled “Buy­ing our way in…!” sent in Sept. 2021, which out­lined “hoover­ing up” small busi­ness­es serv­ing the NHS to “take a lot of ground and take down a lot of polit­i­cal resis­tance.”

...

While Palan­tir has so far been unsuc­cess­ful in buy­ing up NHS sup­pli­ers, the doc­u­ments seen by Bloomberg show how Palan­tir hopes to deep­en its busi­ness with a key client, both by mak­ing key hires from the NHS and via poten­tial acqui­si­tions.

...

Ear­ly in the Covid-19 pan­dem­ic, Foundry was used by the NHS to track the take-up of vac­cines and, more recent­ly, to man­age the back­log of patients wait­ing for elec­tive surg­eries. Since 2020, Palan­tir secured more than £37 mil­lion in con­tracts with the NHS and the Depart­ment of Health and Social Care, accord­ing to pub­lic spend­ing track­er Advice­Cloud.
...

But buy­ing the UK health data firms was just the first step. The sec­ond step is to con­vince the new­ly-pur­chased firms to move all of their ser­vices to Palan­tir’s Foundry plat­form. It’s a reminder that Big Data giants have a lot of ways of get­ting their hands on pre­cious data. It’s also the kind of episode that rais­es the ques­tion of how many oth­er health data firms from around the world may have already made this qui­et­ly deci­sion to move their data and ser­vices to Palan­tir’s Foundry. Mov­ing this data into Palan­tir qui­et­ly and with­out the pub­lic notic­ing is at the core of the plan, after all:

...
Accord­ing to Mosley’s email to col­leagues, suit­able UK takeover tar­gets were those with cred­i­ble lead­er­ship, annu­al rev­enue of between £5 mil­lion and £50 mil­lion, and already sell­ing soft­ware ser­vices to the NHS. Founders would be offered a “v. gen­er­ous buy­out sched­ule (say 10x, espe­cial­ly if all stock),” he wrote.

Palan­tir would offer com­pen­sa­tion to founders for their equi­ty stake if they shift­ed all of their ser­vices into Palantir’s main data han­dling plat­form, Foundry, which was designed to orga­nize data from dis­parate sources.

“I doubt any­body else is like­ly to come along and offer them some­thing as gen­er­ous as we would (we might even be their only real exit option),” Mosley wrote.

...

Late in 2021, Palan­tir was also in advanced talks to invest more than £21 mil­lion into British data-ana­lyt­ics firm Sen­syne, in a deal code­named “Project Gon­dor” — a ref­er­ence to a fic­tion­al king­dom depict­ed in The Lord of the Rings — in return for Sen­syne using Palantir’s Foundry, accord­ing to an inter­nal doc­u­ment seen by Bloomberg.

“There is noth­ing unusu­al about a com­pa­ny explor­ing invest­ments or acqui­si­tions,” Palantir’s spokesman said. He said the com­pa­ny had been approached with “two such oppor­tu­ni­ties” in 2021. “We declined to pro­ceed with either and have not acquired any com­pa­nies that work with the NHS,” he said.

...

Palan­tir was also part of a group of sev­er­al investors that con­tributed $230 mil­lion to sup­port Baby­lon Hold­ings Ltd. going pub­lic in 2021, as part of a longer-term part­ner­ship between the two com­pa­nies that saw Baby­lon migrate some of its data to Palantir’s Foundry plat­form, Bloomberg report­ed.
...

And then there’s the oth­er angle to Palan­tir’s strat­e­gy: lob­by­ing gov­ern­ment offi­cials and/or hir­ing them for lucra­tive jobs. It’s a strat­e­gy that has clear­ly already worked, as the £23.5 mil­lion deal Decem­ber 2020, con­tract to con­tin­ue the Palan­tir’s COVID-relat­ed work that was not sub­ject to a pub­lic ten­der process. Lob­by­ing works:

...
Deals and takeovers were only part of Palantir’s approach, how­ev­er, the mes­sages seen by Bloomberg show. At the same time as the Baby­lon part­ner­ship, Palan­tir urged indus­try lob­by group TechUK to encour­age gov­ern­ment agen­cies to buy com­mer­cial off-the-shelf prod­ucts, such as Foundry, instead of build­ing their own bespoke tools.

...

Palan­tir hired Glob­al Coun­sel — the strate­gic advi­so­ry firm co-found­ed by Peter Man­del­son, a British Lord and for­mer lead­ing advis­er to ex-Prime Min­is­ter Tony Blair — to help lob­by UK gov­ern­ment. It also recent­ly hired Indra Joshi and Har­jeet Dhali­w­al, key fig­ures from the NHS.

“Glob­al Counsel’s work for Palan­tir is a mat­ter of pub­lic record,” a spokesper­son said in an emailed state­ment. “The rel­e­vant dec­la­ra­tions to statu­to­ry reg­is­ters and the NHS in rela­tion to this work have been made.”

Crit­ics have chal­lenged the NHS’s lack of trans­paren­cy over hasti­ly exe­cut­ed deals dur­ing the pan­dem­ic. Palan­tir was paid a nom­i­nal £1 fee in March 2020 to run a Covid-19 data store to help the NHS allo­cate resources more effi­cient­ly, but has used the work as a case study in pitch­es for oth­er NHS con­tracts, accord­ing to two senior NHS offi­cials who were not autho­rized to speak to the media.

Ahead of that deal, Palan­tir spent months woo­ing NHS chiefs, the Bureau of Inves­tiga­tive Jour­nal­ism report­ed in Feb­ru­ary 2021. In Decem­ber 2020, Palan­tir was grant­ed a new con­tract to con­tin­ue the data-store work in a £23.5 mil­lion deal that was not sub­ject to a pub­lic ten­der process.

...

Inde­pen­dent media com­pa­ny Open­Democ­ra­cy sued the UK gov­ern­ment with the sup­port of legal non­prof­it Fox­glove for award­ing busi­ness to Palan­tir with­out a pub­lic ten­der process. The gov­ern­ment agreed not to extend the con­tract beyond Covid with­out a pub­lic con­sul­ta­tion. The push-back con­tin­ued in Sept. 2021, when the Depart­ment of Health and Social Care end­ed anoth­er data deal with Palan­tir, Bloomberg report­ed.

Cori Crid­er, found­ing direc­tor of Fox­glove, said there are “real con­cerns” about whether Palan­tir offers the NHS val­ue for mon­ey, “or whether there is just a ‘shiny dash­board’ think­ing infect­ing some offi­cials.”
...

Final­ly, note the rather laugh­able assur­ances we’re get­ting, of all places, the coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial: we should­n’t be con­cerned about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry. Yes, because we should all be super assured that Foundry — a plat­form built by a com­pa­ny long financed by the CIA’s In-Q-Tel — would­n’t spy on any data inap­pro­pri­ate­ly. That’s the appar­ent atti­tude held by the peo­ple tasked with cham­pi­oning patient data:

...
It’s not known when the NHS will make a deci­sion for its upcom­ing £360 mil­lion ten­der. Oth­er poten­tial bid­ders include major con­sult­ing firms as well as large US tech com­pa­nies.

“Foundry as a piece of soft­ware is entire­ly com­pe­tent,” said Phil Booth, coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial, adding that he did not have con­cerns about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry.

How­ev­er, he said that Palantir’s his­to­ry as a “Peter Thiel-backed, CIA-ini­ti­at­ed com­pa­ny” could deter patients from shar­ing their data. “We should get rid of Palan­tir and build our own open-source soft­ware,” he said.
...

This is prob­a­bly a good time to recall that one of fas­cis­m’s best friends is a col­lec­tive sense of “we could­n’t imag­ine they would do things like that.” And also a good time to start imag­in­ing what a fas­cist might want to do with all of that data.

The biotech indus­try has expe­ri­enced noth­ing less than a rev­o­lu­tion in recent years. Includ­ing an appar­ent rev­o­lu­tion in the speed at which new vac­cines and ther­a­peu­tics can be brought to mar­ket as evi­denced by the recent deci­sion to release the new mRNA Omi­cron-tar­get­ing boost­er vac­cines based entire­ly on mouse tri­al data. As we’ve seen from all the sto­ry about the ‘gain-of-func­tion’ exper­i­ments on coro­n­avirus and test­ing their lethal­i­ty on mice, a mouse’s immune sys­tem can behave very dif­fer­ent­ly from humans. But that’s the deci­sion that reg­u­la­tors made.

And as we’re going to see in the fol­low­ing Unlim­it­ed Hang­out piece by Whit­ney Webb from back in August, it appears that the reg­u­la­to­ry envi­ron­ment for biotech in the US is poised to get even ‘loosers’. At least that’s one of the main ambi­tions of Nation­al Resilience, a new com­pa­ny that only came into exis­tence in Novem­ber of 2020. As we’re going to see, this is a com­pa­ny with ‘juice’. Not only did the com­pa­ny score a major invest­ment by the gov­ern­ment of Cana­da last July in its Ontario facil­i­ties, but it turns out the genet­ic mate­r­i­al for Mod­er­na’s Omi­cron mRNA boost­ers is pro­duced by Nation­al Resilience.

So what made Mod­er­na decide to out­source its mRNA sup­pli­er to a com­pa­ny that did­n’t exist even two years ago? Well, that’s where the com­pa­ny’s deep con­nec­tions to both the gov­ern­ment and indus­try come into focus. Because Nation­al Resilience is stacked with a ‘Who’s Who’ list of insid­ers. The com­pa­ny was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen. But as we’re going to see, Nel­son actu­al­ly attrib­ut­es the idea for Nation­al Resilience to a Luciana Borio, then the vice-pres­i­dent of In-Q-Tel. The CEO of In-Q-Tel, Chris Dar­by, also sites on the board of direc­tors, along with Palan­tir’s Joe Lons­dale. Recall the role Lons­dale played in get­ting Sau­di mon­ey invest­ed in Sil­i­con Val­ley. Anoth­er fig­ure on Nation­al Resilience’s board with expe­ri­ence in the pri­va­tized intel­li­gence sec­tor is Drew Oet­ting of Cer­berus, the own­er of Dyn­Corp. Oth­er notable indus­try fig­ures involved with the com­pa­ny include for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb and the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann.

Also keep in mind the exten­sive role the US gov­ern­ment has already played in the devel­op­ment of Mod­er­na’s mRNA vac­cines. That long-stand­ing gov­ern­ment part­ner­ship came to light after Mod­er­na sued Pfiz­er claim­ing patent infringe­ment on a broad-spec­trum beta­coro­n­avirus vac­cine, with Mod­er­na assert­ing that it was con­duct­ing human mRNA vac­cine tri­als with US researchers as far back as 2015. Also recall how Mod­er­na ‘returned the favor’ for this gov­ern­ment sup­port by fil­ing patents that left out prop­er acknowl­edg­ment for the gov­ern­ment sci­en­tists work result­ing in gov­ern­ment law­suits. So we have Mod­er­na — a com­pa­ny that owes its exis­tence to major invest­ments from the US gov­ern­ment — decid­ing to out­source the genet­ic mate­ri­als for the new Omi­cron boost­ers to a brand new com­pa­ny stacked with peo­ple from the intel­li­gence world.

But mak­ing the genet­ic mate­ri­als for mRNA ther­a­pies is far from Nation­al Resilience’s only ambi­tions. The com­pa­ny plans on becom­ing a key sup­pli­er of a vari­ety of bio­log­ics for the entire indus­try rang­ing from gene ther­a­pies, viral vec­tors, exper­i­men­tal vac­cines to oth­er “med­i­cines of tomor­row.”. In oth­er words, this com­pa­ny is plan­ning on spe­cial­iz­ing in exact­ly the kind of syn­thet­ic biol­o­gy tech­niques that are at the heart of mod­ern ‘dual use’ bio­log­i­cal war­fare research like what the Eco­HealthAl­liance was engaged in with ‘gain-of-func­tion’ coro­n­avirus­es. But Nation­al Resilience does­n’t appear to be plan­ning on car­ry­ing out this research on its own behalf. Instead, it wants to become the “AWS of biotech”, which sure sounds like a kind ‘gain-of-func­tion for-hire’ ser­vice.

And then we get to per­haps the most dis­turb­ing ser­vice the com­pa­ny is plan­ning on offer­ing clients: “reg­u­la­to­ry sup­port”. That’s the term the com­pa­ny is using to describe ser­vices that sound like gov­ern­ment lob­by­ing designed to push prod­ucts through the reg­u­la­to­ry hur­dles faster. Again, don’t for­get that the lat­est Omi­cron boost­er were approved based on mouse tri­als alone. And it sounds like Nation­al Resilience is plan­ning on ensur­ing more deci­sions like that will hap­pen in the future:

Unlim­it­ed Hang­out

RNA for Moderna’s Omi­cron Boost­er Man­u­fac­tured by CIA-Linked Com­pa­ny
Since late last year, mes­sen­ger RNA for Moderna’s COVID-19 vac­cines, includ­ing its recent­ly refor­mu­lat­ed Omi­cron boost­er, has been exclu­sive­ly man­u­fac­tured by a lit­tle known com­pa­ny with sig­nif­i­cant ties to US intel­li­gence.

by Whit­ney Webb
August 17, 2022

Ear­li­er this week, the Unit­ed King­dom became the first coun­try to approve Moderna’s refor­mu­lat­ed ver­sion of its COVID-19 vac­cine, which claims to pro­vide pro­tec­tion against both the orig­i­nal form of the virus and the sig­nif­i­cant­ly less lethal but more trans­mis­si­ble Omi­cron vari­ant. The prod­uct was approved by the UK’s Med­i­cines and Health­care Prod­ucts Reg­u­la­to­ry Agency (MHRA) with the sup­port of the UK government’s Com­mis­sion on Human Med­i­cines.

Described by UK offi­cials as a “sharp­ened tool” in the nation’s con­tin­ued vac­ci­na­tion cam­paign, the refor­mu­lat­ed vac­cine com­bines the pre­vi­ous­ly approved COVID-19 vac­cine with a “vac­cine can­di­date” tar­get­ing the Omi­cron vari­ant BA.1. That vac­cine can­di­date has nev­er been pre­vi­ous­ly approved and has not been the sub­ject of inde­pen­dent study. The MHRA approved the vac­cine based on a sin­gle, incom­plete human tri­al cur­rent­ly being con­duct­ed by Mod­er­na. The com­pa­ny pro­mot­ed incom­plete data from that tri­al in com­pa­ny press releas­es in June and July. The study has yet to be pub­lished in a med­ical jour­nal or peer reviewed. No con­cerns have been raised by any reg­u­la­to­ry agency, includ­ing the MHRA, regard­ing Moderna’s past his­to­ry of engag­ing in sus­pect and like­ly ille­gal activ­i­ty in past prod­uct tri­als, includ­ing for its orig­i­nal COVID-19 vac­cine.

...

How­ev­er, unlike the company’s orig­i­nal COVID-19 vac­cine, the genet­ic mate­r­i­al, or mes­sen­ger RNA (mRNA), for this new vac­cine, includ­ing the new­ly for­mu­lat­ed genet­ic mate­r­i­al meant to pro­vide pro­tec­tion against the Omi­cron vari­ant, is being man­u­fac­tured, not by Mod­er­na, but by a rel­a­tive­ly new com­pa­ny that has received hard­ly any media atten­tion, despite its overt links to US intel­li­gence. Last Sep­tem­ber, it was qui­et­ly announced that a com­pa­ny called Nation­al Resilience (often referred to sim­ply as Resilience) would begin man­u­fac­tur­ing the mRNA for Mod­er­na COVID-19 vac­cine prod­ucts. Under the terms of the mul­ti-year agree­ment, “Resilience will pro­duce mRNA for the Mod­er­na COVID-19 vac­cine at its facil­i­ty in Mis­sis­sauga, Ontario, for dis­tri­b­u­tion world­wide.”

“Rein­vent­ing Bio­man­u­fac­tur­ing”

Nation­al Resilience was found­ed rel­a­tive­ly recent­ly, in Novem­ber 2020, and describes itself as “a man­u­fac­tur­ing and tech­nol­o­gy com­pa­ny ded­i­cat­ed to broad­en­ing access to com­plex med­i­cines and pro­tect­ing bio­phar­ma­ceu­ti­cal sup­ply chains against dis­rup­tion.” It has since been build­ing “a sus­tain­able net­work of high-tech, end-to-end man­u­fac­tur­ing solu­tions with the aim to ensure the med­i­cines of today and tomor­row can be made quick­ly, safe­ly, and at scale.” It fur­therplans to “rein­vent bio­man­u­fac­tur­ing” and “democ­ra­tize access to med­i­cines,” name­ly gene ther­a­pies, exper­i­men­tal vac­cines and oth­er “med­i­cines of tomor­row.”

In pur­suit of those goals, the com­pa­ny announced it would “active­ly invest in devel­op­ing pow­er­ful new tech­nolo­gies to man­u­fac­ture com­plex med­i­cines that are defin­ing the future of ther­a­peu­tics, includ­ing cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins.” It was found­ed with the report­ed inten­tion “to build a bet­ter sys­tem for man­u­fac­tur­ing com­plex med­i­cines to fight dead­ly dis­eases” as a way to improve post-COVID “pan­dem­ic pre­pared­ness.”

The com­pa­ny ini­tial­ly mar­ket­ed its man­u­fac­tur­ing capa­bil­i­ties as “the Resilience plat­form”, and offers prin­ci­pal­ly “RNA Modal­i­ties”, includ­ing RNA devel­op­ment for vac­cines, gene edit­ing and ther­a­peu­tics; and “Virus Pro­duc­tion”, includ­ing viral vec­tors, oncolyt­ic virus­es (i.e. a virus engi­neered to pref­er­en­tial­ly attack can­cer cells), virus­es for use in vac­cine devel­op­ment and gene-edit­ed virus­es for unspec­i­fied pur­pos­es. It is worth not­ing that, to date, many con­tro­ver­sial “gain-of-func­tion” exper­i­ments have jus­ti­fied mod­i­fy­ing virus­es for the same pur­pos­es as described by Nation­al Resilience’s Virus Pro­duc­tion capa­bil­i­ties. In addi­tion, Nation­al Resilience offers prod­uct for­mu­la­tions and oth­er modal­i­ties, such as bio­log­ics and cell ther­a­pies, to its clien­tele and the “Virus Pro­duc­tion” of its web­site has since been removed.

Nation­al Resilience, being such a young com­pa­ny, has very few clients and there is lit­tle pub­licly avail­able infor­ma­tion on its man­u­fac­tur­ing capa­bil­i­ties aside from the company’s web­site. The firm only acquired its first com­mer­cial man­u­fac­tur­ing plant in March 2021, locat­ed in Boston, MA and pur­chased from Sanofi, fol­lowed short­ly there­after by the acqui­si­tion of anoth­er sep­a­rate plant locat­ed in Mis­sis­sauga, Ontario, Cana­da. Makeovers were announced for the plants, but lit­tle is pub­licly known about their progress. Pri­or to the acqui­si­tions, the com­pa­ny had been sub­leas­ing a Bay area facil­i­ty in Fre­mont, Cal­i­for­nia. Reporters were puz­zled at the time as to why a com­pa­ny with rough­ly 700 employ­ees at the time had acquired a total of 599,00 square feet of man­u­fac­tur­ing space after hav­ing only emerged from stealth less than 6 months pri­or.

In April 2021, Nation­al Resilience acquired Olo­gy Bioser­vices Inc., which had received a $37 mil­lion con­tract from the US mil­i­tary the pre­vi­ous Novem­ber to devel­op an advanced anti-COVID-19 mon­o­clon­al anti­body treat­ment. This acqui­si­tion also pro­vid­ed Nation­al Resilience with its first Biosafe­ty Lev­el 3 (BSL‑3) lab­o­ra­to­ry and the abil­i­ty to man­u­fac­ture cell and gene ther­a­pies, live viral vac­cines and vec­tors and oncolyt­ic virus­es.

Despite being in the ear­li­est stages of devel­op­ing its “rev­o­lu­tion­ary” man­u­fac­tur­ing capa­bil­i­ties, Nation­al Resilience entered into a part­ner­ship with the Gov­ern­ment of Cana­da in July of last year. Per that agree­ment, the Cana­di­an gov­ern­ment plans to invest CAD 199.2 mil­lion (about $154.9 mil­lion) into Nation­al Resilience’s Ontario-based sub­sidiary, Resilience Biotech­nolo­gies Inc. Most of those funds are des­tined for use in expand­ing the Ontario facil­i­ty that Resilience acquired last March and which is now man­u­fac­tur­ing the mRNA for Moderna’s COVID-19 prod­ucts. Canada’s Min­is­ter of Inno­va­tion, Sci­ence and Indus­try, François-Philippe Cham­pagne, assert­ed at the time that the invest­ment would “build future pan­dem­ic pre­pared­ness” and help “to grow Canada’s life sci­ence ecosys­tem as an engine for our eco­nom­ic recov­ery.” More recent­ly, in 2022, the com­pa­ny has announced a few new clients – Take­da, Opus Genet­ics and the US Depart­ment of Defense.

Accord­ing to Nation­al Resilience’s exec­u­tives, the company’s ambi­tions appar­ent­ly go far beyond man­u­fac­tur­ing RNA and virus­es. For instance, Resilience CEO Rahul Singhvi has claimed that the com­pa­ny is seek­ing to build “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem.” Yet, Singhvi has declined to offer much in the way of specifics when it comes to exact­ly how the com­pa­ny plans to become the planet’s most elite bio­man­u­fac­tur­ing com­pa­ny.

In an inter­view with The San Fran­cis­co Busi­ness Times, Singhvi states that Resilience is look­ing to fill its mas­sive man­u­fac­tur­ing plants with “tech­nolo­gies and peo­ple that can set and apply new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies as well as RNA-based treat­ments.” Pri­or to Resilience, Singhvi was CEO of NovaVax and an oper­at­ing part­ner at Flag­ship Pio­neer­ing, which played a major role in the cre­ation and rise of Mod­er­na.

Singhvi has fur­ther insist­ed that Nation­al Resilience is “not a ther­a­peu­tics com­pa­ny, not a con­trac­tor and not a tools com­pa­ny” and instead aims “to boost pro­duc­tion using the new ther­a­peu­tic modal­i­ties” such as RNA-based treat­ments, which have become nor­mal­ized in the COVID-19 era. Where­as con­tract man­u­fac­tur­ers “are like kitchens, with pots and pans ready for any recipe,” “what we’re try­ing to do is fix the recipes,” Singhvi has explained. One mem­ber of Resilience’s board of direc­tors, for­mer FDA Com­mis­sion­er and Pfiz­er Board mem­ber Scott Got­tlieb, has described the com­pa­ny as seek­ing to act as the equiv­a­lent of Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try.

Essen­tial­ly, Resilience bills itself as offer­ing solu­tions that will allow “futur­is­tic” med­i­cines, includ­ing mRNA vac­cines, to be pro­duced more quick­ly and more effi­cient­ly, with the appar­ent goal of monop­o­liz­ing cer­tain parts of the bio­man­u­fac­tur­ing process. It also appears poised to become the man­u­fac­tur­er of choice for mRNA vac­cines and exper­i­men­tal ther­a­peu­tics in the event of a future pan­dem­ic, which some pub­lic health “phil­an­thropists” like Bill Gates have said is immi­nent.

Per­haps the company’s most note­wor­thy ambi­tion relates to their claims that they sup­port clients through the gov­ern­ment reg­u­la­to­ry process. Giv­en the company’s empha­sis on speedy mass pro­duc­tion of exper­i­men­tal gene ther­a­pies, its stat­ed inten­tion of get­ting the “futur­is­tic” med­ical prod­ucts it man­u­fac­tures to mar­ket as quick­ly as pos­si­ble seems at odds with the slow­er, tra­di­tion­al reg­u­la­to­ry process­es. Indeed, one could eas­i­ly argue that the approvals of mRNA vac­cines for the first time in human his­to­ry dur­ing the COVID-19 cri­sis were only pos­si­ble because of the major relax­ing of reg­u­la­to­ry pro­ce­durse and safe­ty test­ing due to the per­ceived urgency of the sit­u­a­tion.

Resilience seems intent on see­ing that phe­nom­e­non repeat itself. As pre­vi­ous­ly men­tioned, the com­pa­ny claims to allow for the set­ting and appli­ca­tion of “new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies” and also says it plans to become a “tech­nol­o­gy-aggre­gat­ing stan­dards bear­er that helps ther­a­pies come to mar­ket more effi­cient­ly.” It pre­vi­ous­ly offered on its web­site “reg­u­la­to­ry sup­port” and “strat­e­gy con­sult­ing” to clients, sug­gest­ing that it would seek to medi­ate between clients and gov­ern­ment reg­u­la­tors in order to ful­fill its goal of hav­ing the prod­ucts it man­u­fac­tures tak­en to mar­ket more quick­ly. In addi­tion, upon launch, the com­pa­ny claimed it planned to obtain unspec­i­fied “reg­u­la­to­ry capa­bil­i­ties.” If so, it is cer­tain­ly notable that for­mer top Food and Drug Admin­is­tra­tion (FDA) offi­cials are either on the company’s board or, as will be not­ed short­ly, played a major role in the company’s cre­ation.

The Peo­ple Behind Resilience

Resilience was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen, who is known for lis­ten­ing “to science’s ear­li­est whis­pers, even when data are too ear­ly for just about any­one else.” Nelsen was one of the ear­li­est investors in Illu­mi­na, a Cal­i­for­nia-based gene-sequenc­ing hard­ware and soft­ware giant that is believed to cur­rent­ly dom­i­nate the field of genomics. As men­tioned in a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion, Illu­mi­na is close­ly tied to the DARPA-equiv­a­lent of the Well­come Trust known as Well­come Leap, which is also focused on “futur­is­tic” and tran­shu­man­ist “med­i­cines.” Nelsen is now chair­man of Nation­al Resilience’s board, which is a “Who’s Who” of big play­ers from the US Nation­al Secu­ri­ty State, Big Phar­ma and Phar­ma-relat­ed “phil­an­thropy.”

How­ev­er, while Nelsen has been giv­en much of the cred­it for cre­at­ing Resilience, he revealed in one inter­view that the idea for the com­pa­ny had actu­al­ly come from some­one else – Luciana Borio. In July of last year, Nelsen revealed that it was while talk­ing to Borio about “her work run­ning pan­dem­ic pre­pared­ness on the NSC [Nation­al Secu­ri­ty Coun­cil]” that had “helped lead to the launch of Nelsen’s $800 mil­lion bio­log­ics man­u­fac­tur­ing start­up Resilience.”

At the time of their con­ver­sa­tion, Borio was the vice pres­i­dent of In-Q-tel, the ven­ture cap­i­tal arm of the CIA that has been used since its cre­ation in the ear­ly 2000s to found a num­ber of com­pa­nies, many of which act as Agency fronts. Pri­or to In-Q-Tel, she served as direc­tor for med­ical and biode­fense pre­pared­ness at the Nation­al Secu­ri­ty Coun­cil dur­ing the Trump admin­is­tra­tion and had pre­vi­ous­ly been the act­ing chief sci­en­tist at the FDA from 2015 to 2017.

Borio is cur­rent­ly a senior fel­low for glob­al health at the Coun­cil on For­eign Rela­tions, a con­sul­tant to Gold­man Sachs, a mem­ber of the Bill Gates-fund­ed vac­cine alliance CEPI, and a part­ner at Nelsen’s ven­ture cap­i­tal firm ARCH Ven­ture Part­ners, which funds Resilience. Nelsen’s ARCH pre­vi­ous­ly fund­ed Nanosys, the com­pa­ny of the con­tro­ver­sial sci­en­tist Charles Lieber. Around the time of her con­ver­sa­tion with Nelsen that led to Resilience’s cre­ation, Borio was co-writ­ing a pol­i­cy paper for the Johns Hop­kins Cen­ter for Health Secu­ri­ty that rec­om­mend­ed link­ing COVID-19 vac­ci­na­tion sta­tus with food stamp pro­grams and rent assis­tance as a pos­si­ble means of coerc­ing cer­tain pop­u­la­tions to take the exper­i­men­tal vac­cine.

Borio is hard­ly Resilience’s only In-Q-Tel con­nec­tion, as the CEO of In-Q-Tel, Chris Dar­by, sits on the company’s board of direc­tors. Dar­by is also on the board of direc­tors of the CIA Offi­cers Memo­r­i­al Foun­da­tion. Dar­by was also recent­ly a mem­ber of the Nation­al Secu­ri­ty Com­mis­sion on Arti­fi­cial Intel­li­gence (NSCAI), where mem­bers of the mil­i­tary, intel­li­gence com­mu­ni­ty and Sil­i­con Valley’s top firms argued for the need to reduce the use of “lega­cy sys­tems” in favor of AI-focused alter­na­tives as a nation­al secu­ri­ty imper­a­tive. Among those “lega­cy sys­tems” iden­ti­fied by the NSCAI were in-per­son doc­tor vis­its and even receiv­ing med­ical care from a human doc­tor, as opposed to an AI “doc­tor.” The NSCAI also argued for the removal of “reg­u­la­to­ry bar­ri­ers” that pre­vent these new tech­nolo­gies from replac­ing “lega­cy sys­tems.”

Anoth­er notable board mem­ber, in dis­cussing Resilience’s intel­li­gence ties, is Drew Oet­ting. Oet­ting works for Cer­berus Cap­i­tal Man­age­ment, the firm head­ed by Steve Fein­berg who pre­vi­ous­ly led the President’s Intel­li­gence Advi­so­ry Board under the Trump admin­is­tra­tion. Cer­berus is notably the par­ent com­pa­ny of Dyn­Corp, a con­tro­ver­sial US nation­al secu­ri­ty con­trac­tor tied to numer­ous scan­dals, includ­ing scan­dals relat­ed to sex traf­fick­ing in con­flict zones. Oet­ting is also part of the CIA-linked Thorn NGO osten­si­bly focused on tack­ling child traf­fick­ing that was the sub­ject of a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion.

Oet­ting is also the co-founder of 8VC, a ven­ture cap­i­tal firm that is one of the main investors in Resilience. 8VC’s oth­er co-founder is Joe Lons­dale and Oet­ting “start­ed his career” as Lonsdale’s chief of staff. Lons­dale is the co-founder, along­side Peter Thiel and Alex Karp, of Palan­tir, a CIA front com­pa­ny and intel­li­gence con­trac­tor that is the suc­ces­sor to DARPA’s con­tro­ver­sial Total Infor­ma­tion Aware­ness (TIA) mass sur­veil­lance and data-min­ing pro­gram. In addi­tion, Oet­ting pre­vi­ous­ly worked for Bill Gates’ invest­ment fund.

Also worth not­ing is the pres­ence of Joseph Robert Ker­rey, for­mer US Sen­a­tor for Nebras­ka and a for­mer mem­ber of the con­flict-of-inter­est-rid­den 9/11 Com­mis­sion, on Resilience’s board. Ker­rey is cur­rent­ly man­ag­ing direc­tor of Allen & Co., a New York invest­ment bank­ing firm which has host­ed an annu­al “sum­mer camp for bil­lion­aires” since 1983. Allen & Co. has long been a major play­er in net­works where orga­nized crime and intel­li­gence inter­sect, and is men­tioned repeat­ed­ly through­out my upcom­ing book One Nation Under Black­mail. For instance, Charles and Her­bert Allen, who ran the firm for decades, had con­sid­er­able busi­ness deal­ings with orga­nized crime king­pins and front­men for noto­ri­ous gang­sters like Mey­er Lan­sky, par­tic­u­lar­ly in the Bahamas. They were also busi­ness part­ners of Leslie Wexner’s men­tors A. Alfred Taub­man and Max Fish­er as well as asso­ciates of Earl Bri­an, one of the archi­tects of the PROMIS soft­ware scan­dal – which saw orga­nized crime and intel­li­gence net­works coop­er­ate to steal and then com­pro­mise the PROMIS soft­ware for black­mail and clan­des­tine intel­li­gence-gath­er­ing pur­pos­es. Allen & Co. was a major investor in Brian’s busi­ness inter­ests in the tech­nol­o­gy indus­try that Bri­an used in attempts to bank­rupt the devel­op­ers of PROMIS, Inslaw Inc. and to mar­ket ver­sions of PROMIS that had been com­pro­mised first by Israeli intel­li­gence and, lat­er, the CIA.

In addi­tion to these intel­li­gence-linked indi­vid­u­als, the rest of Resilience’s board includes the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann; for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb; two for­mer exec­u­tives at John­son & John­son; for­mer pres­i­dent and CEO of Teva Phar­ma­ceu­ti­cals North Amer­i­can branch, George Bar­rett; Cal­Tech pro­fes­sor and board mem­ber of Alpha­bet (i.e. Google) and Illu­mi­na, Frances Arnold; for­mer exec­u­tive at Genen­tech and Mer­ck, Patrick Yang; and Resilience CEO Rahul Singhvi./b>.

To Boost or Not to Boost

It is cer­tain­ly telling that the nor­mal­ly pub­lic­i­ty hun­gry Mod­er­na has said so lit­tle about its part­ner­ship with Resilience and that Resilience, despite its ambi­tious plans, has also avoid­ed the media lime­light. Con­sid­er­ing Moderna’s his­to­ry and Resilience’s con­nec­tions, there may be more to this part­ner­ship that meets the eye and con­cerned mem­bers of the pub­lic would do well to keep a very close eye on Resilience, its part­ner­ships, and the prod­ucts it is man­u­fac­tur­ing.

...

———-

“RNA for Moderna’s Omi­cron Boost­er Man­u­fac­tured by CIA-Linked Com­pa­ny” by Whit­ney Webb; Unlim­it­ed Hang­out; 08/17/2022

“How­ev­er, unlike the company’s orig­i­nal COVID-19 vac­cine, the genet­ic mate­r­i­al, or mes­sen­ger RNA (mRNA), for this new vac­cine, includ­ing the new­ly for­mu­lat­ed genet­ic mate­r­i­al meant to pro­vide pro­tec­tion against the Omi­cron vari­ant, is being man­u­fac­tured, not by Mod­er­na, but by a rel­a­tive­ly new com­pa­ny that has received hard­ly any media atten­tion, despite its overt links to US intel­li­gence. Last Sep­tem­ber, it was qui­et­ly announced that a com­pa­ny called Nation­al Resilience (often referred to sim­ply as Resilience) would begin man­u­fac­tur­ing the mRNA for Mod­er­na COVID-19 vac­cine prod­ucts. Under the terms of the mul­ti-year agree­ment, “Resilience will pro­duce mRNA for the Mod­er­na COVID-19 vac­cine at its facil­i­ty in Mis­sis­sauga, Ontario, for dis­tri­b­u­tion world­wide.””

A com­pa­ny that did­n’t exist at the start of the pan­dem­ic, Nation­al Resilience, is going to be man­u­fac­tur­ing the actu­al genet­ic mate­r­i­al used for the new round of Omi­cron-tar­get­ing mRNA boost­ers. The same boost­ers that were approved for pub­lic use based on mouse data. So we prob­a­bly should­n’t be sur­prised to learn that Nation­al Resilience is stacked with fig­ures from the intel­li­gence com­mu­ni­ty. Or that it entered into a part­ner­ship with the gov­ern­ment of Cana­da in July of 2021, with a $154.9 mil­lion gov­ern­ment invest­ment in Nation­al Resilience’s Ontario sub­sidiary. This is a com­pa­ny with ‘juice’ when it comes to be the biotech world and gov­ern­ment. And Mod­er­na seems to be eager to hand over this cru­cial part of the man­u­fac­tur­ing sup­ply chain to this new com­pa­ny bristling with gov­ern­ment insid­ers.

This is a good time to recall the exten­sive sup­port from the US gov­ern­ment Mod­er­na has received over the years. That long-stand­ing gov­ern­ment part­ner­ship came to light after Mod­er­na sued Pfiz­er claim­ing patent infringe­ment on a broad-spec­trum beta­coro­n­avirus vac­cine, with Mod­er­na assert­ing that it was con­duct­ing human mRNA vac­cine tri­als with US researchers as far back as 2015. Also recall how Mod­er­na ‘returned the favor’ for this gov­ern­ment sup­port by fil­ing patents that left out prop­er acknowl­edg­ment for the gov­ern­ment sci­en­tists work result­ing in gov­ern­ment law­suits. Mod­er­na has­n’t exact­ly been lack­ing grand ambi­tions of its own, which makes its deci­sion to hand over its mRNA sup­ply chain for its still-grow­ing vac­cine busi­ness to this new com­pa­ny all the more note­wor­thy:

...
Described by UK offi­cials as a “sharp­ened tool” in the nation’s con­tin­ued vac­ci­na­tion cam­paign, the refor­mu­lat­ed vac­cine com­bines the pre­vi­ous­ly approved COVID-19 vac­cine with a “vac­cine can­di­date” tar­get­ing the Omi­cron vari­ant BA.1. That vac­cine can­di­date has nev­er been pre­vi­ous­ly approved and has not been the sub­ject of inde­pen­dent study. The MHRA approved the vac­cine based on a sin­gle, incom­plete human tri­al cur­rent­ly being con­duct­ed by Mod­er­na. The com­pa­ny pro­mot­ed incom­plete data from that tri­al in com­pa­ny press releas­es in June and July. The study has yet to be pub­lished in a med­ical jour­nal or peer reviewed. No con­cerns have been raised by any reg­u­la­to­ry agency, includ­ing the MHRA, regard­ing Moderna’s past his­to­ry of engag­ing in sus­pect and like­ly ille­gal activ­i­ty in past prod­uct tri­als, includ­ing for its orig­i­nal COVID-19 vac­cine.

...

Despite being in the ear­li­est stages of devel­op­ing its “rev­o­lu­tion­ary” man­u­fac­tur­ing capa­bil­i­ties, Nation­al Resilience entered into a part­ner­ship with the Gov­ern­ment of Cana­da in July of last year. Per that agree­ment, the Cana­di­an gov­ern­ment plans to invest CAD 199.2 mil­lion (about $154.9 mil­lion) into Nation­al Resilience’s Ontario-based sub­sidiary, Resilience Biotech­nolo­gies Inc. Most of those funds are des­tined for use in expand­ing the Ontario facil­i­ty that Resilience acquired last March and which is now man­u­fac­tur­ing the mRNA for Moderna’s COVID-19 prod­ucts. Canada’s Min­is­ter of Inno­va­tion, Sci­ence and Indus­try, François-Philippe Cham­pagne, assert­ed at the time that the invest­ment would “build future pan­dem­ic pre­pared­ness” and help “to grow Canada’s life sci­ence ecosys­tem as an engine for our eco­nom­ic recov­ery.” More recent­ly, in 2022, the com­pa­ny has announced a few new clients – Take­da, Opus Genet­ics and the US Depart­ment of Defense.
...

Adding to the remark­able nature of Nation­al Resilience’s sud­den rise is the com­pa­ny’s state ambi­tion: It’s out to “rein­vent bio­man­u­fac­tur­ing” with a focus on cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins. And based on its suc­cess in cap­tur­ing the Mod­er­na mRNA sup­ply con­tract, and the com­pa­ny’s deep indus­try con­tacts, we have every rea­son to sus­pect the com­pa­ny to become a major play­er in those sec­tors too. The com­pa­ny clear­ly has both gov­ern­men­tal and cor­po­rate ‘juice’:

...
Nation­al Resilience was found­ed rel­a­tive­ly recent­ly, in Novem­ber 2020, and describes itself as “a man­u­fac­tur­ing and tech­nol­o­gy com­pa­ny ded­i­cat­ed to broad­en­ing access to com­plex med­i­cines and pro­tect­ing bio­phar­ma­ceu­ti­cal sup­ply chains against dis­rup­tion.” It has since been build­ing “a sus­tain­able net­work of high-tech, end-to-end man­u­fac­tur­ing solu­tions with the aim to ensure the med­i­cines of today and tomor­row can be made quick­ly, safe­ly, and at scale.” It fur­therplans to “rein­vent bio­man­u­fac­tur­ing” and “democ­ra­tize access to med­i­cines,” name­ly gene ther­a­pies, exper­i­men­tal vac­cines and oth­er “med­i­cines of tomor­row.”

In pur­suit of those goals, the com­pa­ny announced it would “active­ly invest in devel­op­ing pow­er­ful new tech­nolo­gies to man­u­fac­ture com­plex med­i­cines that are defin­ing the future of ther­a­peu­tics, includ­ing cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins.” It was found­ed with the report­ed inten­tion “to build a bet­ter sys­tem for man­u­fac­tur­ing com­plex med­i­cines to fight dead­ly dis­eases” as a way to improve post-COVID “pan­dem­ic pre­pared­ness.”
...

All of these gov­ern­ment ties make the heavy over­lap between Nation­al Resilience’s ambi­tions of cre­at­ing “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem” and the kind of ‘gain-of-func­tion’ research that Pen­ta­gon-financed groups like the Eco­HealthAl­liance all the more intrigu­ing. All signs point towards Nation­al Resilience plan­ning on car­ry­ing out that kind of research, or at least facil­i­tat­ing that kind of research for oth­ers as part of the “Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try” ser­vice mod­el they are try­ing to build. All of the pieces are in place for the cre­ation of a ‘AWS for biotech’ gov­ern­ment-backed monop­oly. A gov­ern­ment-backed monop­oly that the gov­ern­ment-backed Mod­er­na appears to be more than will­ing to help bring into exis­tence:

...
The com­pa­ny ini­tial­ly mar­ket­ed its man­u­fac­tur­ing capa­bil­i­ties as “the Resilience plat­form”, and offers prin­ci­pal­ly “RNA Modal­i­ties”, includ­ing RNA devel­op­ment for vac­cines, gene edit­ing and ther­a­peu­tics; and “Virus Pro­duc­tion”, includ­ing viral vec­tors, oncolyt­ic virus­es (i.e. a virus engi­neered to pref­er­en­tial­ly attack can­cer cells), virus­es for use in vac­cine devel­op­ment and gene-edit­ed virus­es for unspec­i­fied pur­pos­es. It is worth not­ing that, to date, many con­tro­ver­sial “gain-of-func­tion” exper­i­ments have jus­ti­fied mod­i­fy­ing virus­es for the same pur­pos­es as described by Nation­al Resilience’s Virus Pro­duc­tion capa­bil­i­ties. In addi­tion, Nation­al Resilience offers prod­uct for­mu­la­tions and oth­er modal­i­ties, such as bio­log­ics and cell ther­a­pies, to its clien­tele and the “Virus Pro­duc­tion” of its web­site has since been removed.

...

Accord­ing to Nation­al Resilience’s exec­u­tives, the company’s ambi­tions appar­ent­ly go far beyond man­u­fac­tur­ing RNA and virus­es. For instance, Resilience CEO Rahul Singhvi has claimed that the com­pa­ny is seek­ing to build “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem.” Yet, Singhvi has declined to offer much in the way of specifics when it comes to exact­ly how the com­pa­ny plans to become the planet’s most elite bio­man­u­fac­tur­ing com­pa­ny.

...

Singhvi has fur­ther insist­ed that Nation­al Resilience is “not a ther­a­peu­tics com­pa­ny, not a con­trac­tor and not a tools com­pa­ny” and instead aims “to boost pro­duc­tion using the new ther­a­peu­tic modal­i­ties” such as RNA-based treat­ments, which have become nor­mal­ized in the COVID-19 era. Where­as con­tract man­u­fac­tur­ers “are like kitchens, with pots and pans ready for any recipe,” “what we’re try­ing to do is fix the recipes,” Singhvi has explained. One mem­ber of Resilience’s board of direc­tors, for­mer FDA Com­mis­sion­er and Pfiz­er Board mem­ber Scott Got­tlieb, has described the com­pa­ny as seek­ing to act as the equiv­a­lent of Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try.

Essen­tial­ly, Resilience bills itself as offer­ing solu­tions that will allow “futur­is­tic” med­i­cines, includ­ing mRNA vac­cines, to be pro­duced more quick­ly and more effi­cient­ly, with the appar­ent goal of monop­o­liz­ing cer­tain parts of the bio­man­u­fac­tur­ing process. It also appears poised to become the man­u­fac­tur­er of choice for mRNA vac­cines and exper­i­men­tal ther­a­peu­tics in the event of a future pan­dem­ic, which some pub­lic health “phil­an­thropists” like Bill Gates have said is immi­nent.
...

Those deep gov­ern­ment ties also bring us to what could be the most omi­nous part of Nation­al Resilience’s busi­ness plans: offer­ing the ser­vice of sup­port­ing clients through the gov­ern­ment reg­u­la­to­ry process with a goal of get­ting prod­ucts to mar­ket more quick­ly. These ambi­tions are, of course, build­ing on the prece­dent of moves like the deci­sion to approve the lat­est mRNA boost­ers based entire­ly mouse data. In oth­er words, we should expect a lot more sto­ries about med­i­cines being approved based on mouse-tri­als-only if Nation­al Resilience is suc­cess­ful in deliv­er­ing these ser­vices:

...
Per­haps the company’s most note­wor­thy ambi­tion relates to their claims that they sup­port clients through the gov­ern­ment reg­u­la­to­ry process. Giv­en the company’s empha­sis on speedy mass pro­duc­tion of exper­i­men­tal gene ther­a­pies, its stat­ed inten­tion of get­ting the “futur­is­tic” med­ical prod­ucts it man­u­fac­tures to mar­ket as quick­ly as pos­si­ble seems at odds with the slow­er, tra­di­tion­al reg­u­la­to­ry process­es. Indeed, one could eas­i­ly argue that the approvals of mRNA vac­cines for the first time in human his­to­ry dur­ing the COVID-19 cri­sis were only pos­si­ble because of the major relax­ing of reg­u­la­to­ry pro­ce­durse and safe­ty test­ing due to the per­ceived urgency of the sit­u­a­tion.

Resilience seems intent on see­ing that phe­nom­e­non repeat itself. As pre­vi­ous­ly men­tioned, the com­pa­ny claims to allow for the set­ting and appli­ca­tion of “new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies” and also says it plans to become a “tech­nol­o­gy-aggre­gat­ing stan­dards bear­er that helps ther­a­pies come to mar­ket more effi­cient­ly.” It pre­vi­ous­ly offered on its web­site “reg­u­la­to­ry sup­port” and “strat­e­gy con­sult­ing” to clients, sug­gest­ing that it would seek to medi­ate between clients and gov­ern­ment reg­u­la­tors in order to ful­fill its goal of hav­ing the prod­ucts it man­u­fac­tures tak­en to mar­ket more quick­ly. In addi­tion, upon launch, the com­pa­ny claimed it planned to obtain unspec­i­fied “reg­u­la­to­ry capa­bil­i­ties.” If so, it is cer­tain­ly notable that for­mer top Food and Drug Admin­is­tra­tion (FDA) offi­cials are either on the company’s board or, as will be not­ed short­ly, played a major role in the company’s cre­ation.

...

And those grand ambi­tions of becom­ing the ‘AWS for biotech’ and a ‘bureau­cra­cy-whis­per­er’ that gets clients prod­ucts rapid­ly pushed through reg­u­la­to­ry review are made all the more alarm­ing when we learn that the idea for this com­pa­ny appar­ent­ly orig­i­nat­ed with Luciana Borio, then the vice pres­i­dent of In-Q-Tel. Nation­al Resilience does­n’t just have ‘juice’. It has CIA ‘juice’. You can’t get more con­nect­ed. This is the kind of com­pa­ny that could rede­fine this indus­try:

...
Resilience was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen, who is known for lis­ten­ing “to science’s ear­li­est whis­pers, even when data are too ear­ly for just about any­one else.” Nelsen was one of the ear­li­est investors in Illu­mi­na, a Cal­i­for­nia-based gene-sequenc­ing hard­ware and soft­ware giant that is believed to cur­rent­ly dom­i­nate the field of genomics. As men­tioned in a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion, Illu­mi­na is close­ly tied to the DARPA-equiv­a­lent of the Well­come Trust known as Well­come Leap, which is also focused on “futur­is­tic” and tran­shu­man­ist “med­i­cines.” Nelsen is now chair­man of Nation­al Resilience’s board, which is a “Who’s Who” of big play­ers from the US Nation­al Secu­ri­ty State, Big Phar­ma and Phar­ma-relat­ed “phil­an­thropy.”

How­ev­er, while Nelsen has been giv­en much of the cred­it for cre­at­ing Resilience, he revealed in one inter­view that the idea for the com­pa­ny had actu­al­ly come from some­one else – Luciana Borio. In July of last year, Nelsen revealed that it was while talk­ing to Borio about “her work run­ning pan­dem­ic pre­pared­ness on the NSC [Nation­al Secu­ri­ty Coun­cil]” that had “helped lead to the launch of Nelsen’s $800 mil­lion bio­log­ics man­u­fac­tur­ing start­up Resilience.”

At the time of their con­ver­sa­tion, Borio was the vice pres­i­dent of In-Q-tel, the ven­ture cap­i­tal arm of the CIA that has been used since its cre­ation in the ear­ly 2000s to found a num­ber of com­pa­nies, many of which act as Agency fronts. Pri­or to In-Q-Tel, she served as direc­tor for med­ical and biode­fense pre­pared­ness at the Nation­al Secu­ri­ty Coun­cil dur­ing the Trump admin­is­tra­tion and had pre­vi­ous­ly been the act­ing chief sci­en­tist at the FDA from 2015 to 2017.

Borio is cur­rent­ly a senior fel­low for glob­al health at the Coun­cil on For­eign Rela­tions, a con­sul­tant to Gold­man Sachs, a mem­ber of the Bill Gates-fund­ed vac­cine alliance CEPI, and a part­ner at Nelsen’s ven­ture cap­i­tal firm ARCH Ven­ture Part­ners, which funds Resilience. Nelsen’s ARCH pre­vi­ous­ly fund­ed Nanosys, the com­pa­ny of the con­tro­ver­sial sci­en­tist Charles Lieber. Around the time of her con­ver­sa­tion with Nelsen that led to Resilience’s cre­ation, Borio was co-writ­ing a pol­i­cy paper for the Johns Hop­kins Cen­ter for Health Secu­ri­ty that rec­om­mend­ed link­ing COVID-19 vac­ci­na­tion sta­tus with food stamp pro­grams and rent assis­tance as a pos­si­ble means of coerc­ing cer­tain pop­u­la­tions to take the exper­i­men­tal vac­cine.

Borio is hard­ly Resilience’s only In-Q-Tel con­nec­tion, as the CEO of In-Q-Tel, Chris Dar­by, sits on the company’s board of direc­tors. Dar­by is also on the board of direc­tors of the CIA Offi­cers Memo­r­i­al Foun­da­tion. Dar­by was also recent­ly a mem­ber of the Nation­al Secu­ri­ty Com­mis­sion on Arti­fi­cial Intel­li­gence (NSCAI), where mem­bers of the mil­i­tary, intel­li­gence com­mu­ni­ty and Sil­i­con Valley’s top firms argued for the need to reduce the use of “lega­cy sys­tems” in favor of AI-focused alter­na­tives as a nation­al secu­ri­ty imper­a­tive. Among those “lega­cy sys­tems” iden­ti­fied by the NSCAI were in-per­son doc­tor vis­its and even receiv­ing med­ical care from a human doc­tor, as opposed to an AI “doc­tor.” The NSCAI also argued for the removal of “reg­u­la­to­ry bar­ri­ers” that pre­vent these new tech­nolo­gies from replac­ing “lega­cy sys­tems.”
...

Beyond Luciana Borio, Nation­al Resilience’s intel­li­gence ties include Drew Oet­ting of Steve Fein­berg’s Cer­berus Cap­i­tal Man­age­ment and Palan­tir’s Joe Lons­dale. It’s worth recall­ing at this point how Lons­dale played a key role in get­ting Sau­di mon­ey into Sil­i­con Val­ley. And while “Nation­al Resilience” clear­ly has close ties to the US gov­ern­ment, its con­tracts with Cana­da also make clear that it’s not exclu­sive­ly oper­at­ing in the US. You have to won­der how much Sau­di mon­ey Lons­dale will end up get­ting direct­ed into this ven­ture:

...
Anoth­er notable board mem­ber, in dis­cussing Resilience’s intel­li­gence ties, is Drew Oet­ting. Oet­ting works for Cer­berus Cap­i­tal Man­age­ment, the firm head­ed by Steve Fein­berg who pre­vi­ous­ly led the President’s Intel­li­gence Advi­so­ry Board under the Trump admin­is­tra­tion. Cer­berus is notably the par­ent com­pa­ny of Dyn­Corp, a con­tro­ver­sial US nation­al secu­ri­ty con­trac­tor tied to numer­ous scan­dals, includ­ing scan­dals relat­ed to sex traf­fick­ing in con­flict zones. Oet­ting is also part of the CIA-linked Thorn NGO osten­si­bly focused on tack­ling child traf­fick­ing that was the sub­ject of a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion.

Oet­ting is also the co-founder of 8VC, a ven­ture cap­i­tal firm that is one of the main investors in Resilience. 8VC’s oth­er co-founder is Joe Lons­dale and Oet­ting “start­ed his career” as Lonsdale’s chief of staff. Lons­dale is the co-founder, along­side Peter Thiel and Alex Karp, of Palan­tir, a CIA front com­pa­ny and intel­li­gence con­trac­tor that is the suc­ces­sor to DARPA’s con­tro­ver­sial Total Infor­ma­tion Aware­ness (TIA) mass sur­veil­lance and data-min­ing pro­gram. In addi­tion, Oet­ting pre­vi­ous­ly worked for Bill Gates’ invest­ment fund.

Also worth not­ing is the pres­ence of Joseph Robert Ker­rey, for­mer US Sen­a­tor for Nebras­ka and a for­mer mem­ber of the con­flict-of-inter­est-rid­den 9/11 Com­mis­sion, on Resilience’s board. Ker­rey is cur­rent­ly man­ag­ing direc­tor of Allen & Co., a New York invest­ment bank­ing firm which has host­ed an annu­al “sum­mer camp for bil­lion­aires” since 1983. Allen & Co. has long been a major play­er in net­works where orga­nized crime and intel­li­gence inter­sect, and is men­tioned repeat­ed­ly through­out my upcom­ing book One Nation Under Black­mail. For instance, Charles and Her­bert Allen, who ran the firm for decades, had con­sid­er­able busi­ness deal­ings with orga­nized crime king­pins and front­men for noto­ri­ous gang­sters like Mey­er Lan­sky, par­tic­u­lar­ly in the Bahamas. They were also busi­ness part­ners of Leslie Wexner’s men­tors A. Alfred Taub­man and Max Fish­er as well as asso­ciates of Earl Bri­an, one of the archi­tects of the PROMIS soft­ware scan­dal – which saw orga­nized crime and intel­li­gence net­works coop­er­ate to steal and then com­pro­mise the PROMIS soft­ware for black­mail and clan­des­tine intel­li­gence-gath­er­ing pur­pos­es. Allen & Co. was a major investor in Brian’s busi­ness inter­ests in the tech­nol­o­gy indus­try that Bri­an used in attempts to bank­rupt the devel­op­ers of PROMIS, Inslaw Inc. and to mar­ket ver­sions of PROMIS that had been com­pro­mised first by Israeli intel­li­gence and, lat­er, the CIA.

In addi­tion to these intel­li­gence-linked indi­vid­u­als, the rest of Resilience’s board includes the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann; for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb; two for­mer exec­u­tives at John­son & John­son; for­mer pres­i­dent and CEO of Teva Phar­ma­ceu­ti­cals North Amer­i­can branch, George Bar­rett; Cal­Tech pro­fes­sor and board mem­ber of Alpha­bet (i.e. Google) and Illu­mi­na, Frances Arnold; for­mer exec­u­tive at Genen­tech and Mer­ck, Patrick Yang; and Resilience CEO Rahul Singhvi..
...

The sky is the lim­it for Nation­al Resilience. We’ll see how long it takes before the com­pa­ny man­ages to achieve some­thing close to a monop­oly sta­tus in dif­fer­ent parts of the biotech sup­ply-chain, both in the US and glob­al­ly. But it appears to be a mat­ter of time. Just as it also appears to be just a mat­ter of time before we are forced to learn nasty lessons about allow­ing com­pa­nies stacked with insid­ers to rush new biotech­nolo­gies to mar­ket. Nasty wild­ly prof­itable lessons that we will learn noth­ing from, no doubt.

The new biva­lent mRNA COVID boost­ers — boost­ers designed with the spike pro­teins of both the orig­i­nal COVID19 strain as well as the new Omi­cron BA.5 vari­ant — haven’t been with­out their share of mys­ter­ies. For starters, there’s the fact that the genet­ic mate­r­i­al for the boost­ers is being pro­duced by a lit­tle-known recent­ly formed com­pa­ny, Nation­al Resilience, stacked with fig­ures from the intel­li­gence com­mu­ni­ty. Then there’s the deci­sion to issue the new mRNA biva­lent COVID boost­ers based on mouse-tri­al data, skip­ping the human safe­ty-tri­als. As we saw in that recent sto­ry about the ‘gain-of-func­tion’ exper­i­ments on hybrid COVID virus­es con­duct­ed at Boston Uni­ver­si­ty, the behav­ior of the mouse immune sys­tem can’t eas­i­ly be used as a proxy for how the human immune sys­tem might response. But the deci­sion to release the new biva­lent vac­cines based entire­ly on mouse data was made, with a goal of speed­ing up the deliv­ery of the new biva­lent vac­cine to the pub­lic in time for the fall, when COVID cas­es are expect­ed to rise again.

That brings us to the fol­low­ing pair of arti­cles that should raise more ques­tions about the reg­u­la­to­ry process­es behind these deci­sions and the extent to which the pub­lic is reliant on data from Mod­er­na and Pfiz­er alone. First, it appears that these new biva­lent boost­ers don’t actu­al­ly demon­strate a sta­tis­ti­cal­ly sig­nif­i­cant improve­ment in anti­body lev­els over the orig­i­nal vac­cine. They aren’t worse than the orig­i­nal vac­cine, and even slight­ly bet­ter accord­ing to these stud­ies. Just not actu­al­ly bet­ter to the point of sta­tis­ti­cal sig­nif­i­cance.

The ques­tion of whether or not the new biva­lent vac­cines are actu­al­ly bet­ter isn’t just an aca­d­e­m­ic area of inquiry. Again, the deci­sion to release the vac­cines based entire­ly on mouse data was ground­ed in a con­vic­tion that these were indeed bet­ter vac­cines for the newest strains and it was impor­tant to get them to the pub­lic as soon as pos­si­ble.

But as we’re going to see, there are still mil­lions of read­i­ly avail­able orig­i­nal mRNA vac­cines that are sched­uled to expire in com­ing months. The mass expir­ing of those orig­i­nal vac­cines is obvi­ous­ly great new for Nation­al Resilience, which will have to fill in the gap with new vac­cines. But is it a good for the pub­lic? As the fol­low­ing arti­cle notes, The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill. And once those fed­er­al sup­plies are exhaust­ed (or expired), there will be no more free vac­cines in the US. With the GOP like­ly retak­ing con­trol of Con­gress next year it’s hard to imag­ine those stalled COVID fund­ing requests get­ting processed. Eschew­ing the orig­i­nal vac­cines that are about to expire while push­ing the new biva­lent vac­cines is basi­cal­ly a recipe for blow­ing through that fed­er­al sup­ply as soon as pos­si­ble. And that would be a poten­tial­ly jus­ti­fi­able deci­sion if the new biva­lent vac­cines are indeed more effec­tive. But if not, it’s just a recipe for pulling fed­er­al­ly-fund­ed free vac­cines out of the mar­ket soon­er rather than lat­er.

That’s all part of the con­text of fol­low­ing pair of arti­cles. Two new stud­ies both sug­gest the biva­lent vac­cines basi­cal­ly per­form the same as the orig­i­nal. So how has the US fed­er­al gov­ern­ment respond­ed to those find­ings? Well, the White House­’s top COVID offi­cial, Dr. Ashish Jha , start­ed off by point­ing out that the two stud­ies had rel­a­tive­ly small sam­ple sizes. Jha then point­ed to upcom­ing stud­ies cur­rent­ly being con­duct­ed by Mod­er­na and Pfiz­er with more patients which he expects will indeed show a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence between the per­for­mance of the orig­i­nal vac­cine and the new biva­lent vac­cines. In oth­er words, the fed­er­al gov­ern­men­t’s response to these two new stud­ies is basi­cal­ly “let’s opti­misti­cal­ly wait for more data to come in before arriv­ing at con­clu­sions”.

Jha’s opti­mism was­n’t entire­ly unfound­ed. As we’re going to see in the sec­ond arti­cle excerpt below, Pfiz­er announced two weeks ago that it found the new boost­ers increased the neu­tral­iz­ing anti­bod­ies sev­en days after the shot against the BA.4 and BA.5 sub­vari­ants in a study involv­ing 80 vol­un­teers. Both Pfiz­er and Mod­er­na are expect­ed to release more data on their stud­ies in com­ing weeks, with Mod­er­na expect­ing to have sta­tis­ti­cal­ly pow­ered data by the end of the year.

But as Dan Barouch of Har­vard Med­ical School, one of the authors of one of the two new stud­ies that did­n’t find a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence between the old and new vac­cines, points out, find­ing a “sta­tis­ti­cal­ly sig­nif­i­cant” dif­fer­ence in the per­for­mance of the vac­cines isn’t actu­al­ly the same as find­ing a clin­i­cal­ly sig­nif­i­cant dif­fer­ence. Don’t for­get that these new stud­ies did indeed find high­er lev­els of anti­bod­ies get­ting gen­er­at­ed by the new biva­lent vac­cines. But not much high­er. The dif­fer­ence was small enough that, giv­en the rel­a­tive­ly small sam­ple size, the researchers could­n’t claim to have found a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in the anti­body lev­els. Sim­ply increas­ing the num­ber of peo­ple in these stud­ies will increase the sta­tis­ti­cal sam­pling pow­er and make it more and more like­ly that a “sta­tis­ti­cal­ly sig­nif­i­cant” find­ing will be arrived at. But it’s entire­ly pos­si­ble that stud­ies with more peo­ple will sim­ply con­firm the rel­a­tive­ly small boost in anti­bod­ies from the biva­lent vac­cines. Is a rel­a­tive­ly small boost actu­al­ly a mean­ing­ful dif­fer­ence in a clin­i­cal sense? That’s the dis­tinc­tion Barouch was mak­ing between “sta­tis­ti­cal­ly sig­nif­i­cant” dif­fer­ences and “clin­i­cal­ly sig­nif­i­cant” dif­fer­ences.

But there’s anoth­er angle to this sto­ry: it turns out recent­ly pub­lished data on mice showed the new biva­lent vac­cines to be quite promis­ing and con­fer much bet­ter pro­tec­tion than the orig­i­nal vac­cines. So at the same time ear­ly stud­ies are find­ing no dif­fer­ence between the orig­i­nal and new vac­cines in humans, we’re get­ting stud­ies on mice sug­gest­ing the new vac­cines are actu­al­ly much bet­ter. And this all for vac­cines that are already avail­able based entire­ly on mouse data under the assump­tion that doing so is impor­tant to get the enhanced pro­tec­tion from the new vac­cines avail­able to the pub­lic as soon as pos­si­ble. Over­all, it’s the kind of sto­ry that under­scores just how much gam­bling and guess­work is involved in this whole process. Gam­bles, guess­work, and repeat­ed assur­ances from the indus­try that every­thing is going great:

CBS News

White House still expects new COVID boost­ers will offer bet­ter pro­tec­tion, but two new stud­ies cast doubt

By Alexan­der Tin
Updat­ed on: Octo­ber 28, 2022 / 1:28 PM

The White House­’s top COVID-19 offi­cial says he still expects the pro­tec­tion against the Omi­cron BA.5 vari­ant offered by the new COVID vac­cine boost­ers will be bet­ter than their pre­de­ces­sors, despite two stud­ies that appear to ques­tion that assump­tion. In an inter­view with CBS News, Dr. Ashish Jha also said he does not think anoth­er immi­nent change to the COVID boost­ers will be need­ed.

Jha’s com­ments come after researchers found, in two small­er groups of vol­un­teers, data sug­gest­ing that the updat­ed boost­ers pro­vide only sim­i­lar but not supe­ri­or anti­body boosts against BA.5, com­pared to the orig­i­nal vac­cine for­mu­la.

“I do think that the pro­tec­tion against infec­tion is going to be bet­ter than if you were get­ting the orig­i­nal pro­to­type boost­er,” Jha told CBS News.

Jha said he was not sur­prised about the new study results and praised the two sci­en­tists — Dan Barouch of Har­vard Med­ical School and David Ho of Colum­bia Uni­ver­si­ty — who led each of the research teams behind the pre­lim­i­nary find­ings.

How­ev­er, he pre­dict­ed that the “well-con­trolled tri­als” with “larg­er sam­ples” now under­way from vac­cine mak­ers could yield more favor­able results about the boost­ers’ per­for­mance.

The stud­ies did turn up high­er anti­body respons­es after the updat­ed boost­er, Jha said, even if they were too small to be sta­tis­ti­cal­ly sig­nif­i­cant.

“I expect we’re going to see at least that size ben­e­fit, prob­a­bly big­ger, in the Pfiz­er and Mod­er­na stud­ies,” Jha said.

Jha’s com­ments are in line with expec­ta­tions pre­vi­ous­ly voiced by fed­er­al health offi­cials from across the Biden admin­is­tra­tion, who have argued for months that the updat­ed boost­ers being rolled out this fall would out­per­form the orig­i­nal for­mu­la­tions.

In a state­ment, the FDA’s top vac­cines offi­cial said data “from larg­er, well con­trolled stud­ies that are not sub­ject to the same lim­i­ta­tion of these small­er stud­ies are expect­ed to be avail­able in the near future” and urged Amer­i­cans to seek out an updat­ed boost­er.

“Addi­tion­al­ly, even mod­est improve­ments in vac­cine response to the biva­lent boost­ers could have impor­tant pos­i­tive con­se­quences on pub­lic health,” said a state­ment from Dr. Peter Marks, head of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research.

The new boost­ers are known as “biva­lent” because they include both a com­po­nent tar­get­ing the orig­i­nal “pro­to­type” strain and anoth­er aimed at the BA.4 and BA.5 vari­ants.

Ear­ly data from ani­mals test­ed with the new shots had been promis­ing. Pre­vi­ous ver­sions tar­get­ing oth­er strains tri­aled on humans also sug­gest­ed a biva­lent for­mu­la­tion would also offer at least an “incre­men­tal” improve­ment, health author­i­ties con­clud­ed.

...

“Mod­est and non­signif­i­cant”

But this week, two stud­ies seemed to upend those expec­ta­tions.

“There was no sig­nif­i­cant dif­fer­ence in neu­tral­iza­tion of any SARS-CoV­‑2 vari­ant test­ed between indi­vid­u­als who received a fourth mono­va­lent vac­cine and those who received a fourth dose of a biva­lent vac­cine,” con­clud­ed one study, which has yet to be peer-reviewed, post­ed by the team led by Ho.

Sci­en­tists drew blood from peo­ple rough­ly a month after they had got­ten the new shot and test­ed their anti­body respons­es against “pseudovirus­es” — essen­tial­ly mock-ups of dif­fer­ent vari­ants, includ­ing BA.5.

Barouch’s team per­formed a sim­i­lar exper­i­ment against BA.5. They turned up only “a mod­est and non­signif­i­cant” improve­ment from the updat­ed boost­ers in their study, which has also yet to be peer-reviewed.

“If that very small dif­fer­ence holds up in a much larg­er study, then a much larg­er study might actu­al­ly say that’s a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence. The ques­tion is, is it clin­i­cal­ly rel­e­vant? And I don’t believe that that lev­el of dif­fer­ence is clin­i­cal­ly rel­e­vant,” Barouch said in an inter­view.

Barouch said a phe­nom­e­non called immune imprint­ing may turn out to be the cul­prit for the dis­ap­point­ing immune response to the updat­ed boost­er.

Immune imprint­ing, also known as “orig­i­nal anti­genic sin,” refers to the the­o­ry that the ini­tial expo­sure peo­ple had to an ear­li­er strain of the virus — either from infec­tion or vac­ci­na­tion — may hin­der the abil­i­ty of the body to pro­duce anti­bod­ies to new strains.

Both the vac­cine com­pa­nies and health offi­cials had pre­vi­ous­ly down­played the hur­dle this phe­nom­e­non might pose to the new shots.

Barouch acknowl­edged there was a pos­si­bil­i­ty that respons­es against BA.5 could improve after more weeks fol­low­ing the updat­ed boost­er, but cau­tioned that we have seen anti­bod­ies decline in the months after pre­vi­ous mRNA COVID shots.

His team also mea­sured anoth­er part of the immune response from T cells. Those were “not sub­stan­tial­ly” boost­ed by addi­tion­al shots from either the biva­lent or orig­i­nal for­mu­la­tions.

“We all talk about anti­bod­ies, the focus has been on anti­bod­ies, but there’s two sides to the immune sys­tem: anti­bod­ies and T cells. And we believe that both are impor­tant for pro­tec­tion against severe dis­ease,” said Barouch.

Updat­ing the vac­cines

The new stud­ies come as the Biden admin­is­tra­tion is prepar­ing for key deci­sions about the coun­try’s COVID-19 vac­cine sup­ply.

Mil­lions of dos­es of the orig­i­nal mono­va­lent vac­cine, which is still being used for pri­ma­ry series shots, are due to expire over the com­ing months. Boost­ers also still need to be green­light­ed for the youngest age group: chil­dren down to 6 months old.

The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill, which will prompt a shift to the pri­vate mar­ket.

...

“We will have our BA.4/5 data by year end and ours will be sta­tis­ti­cal­ly pow­ered,” Mod­er­na spokesper­son Chris Rid­ley said in an email.

Rid­ley also point­ed to results from a pre­vi­ous biva­lent for­mu­la­tion by Mod­er­na tar­get­ed at the BA.1 vari­ant, which was pub­lished in The New Eng­land Jour­nal of Med­i­cine a few weeks ago.

Pfiz­er and their Ger­man part­ner BioN­Tech announced find­ing “pos­i­tive ear­ly data” from their updat­ed shots ear­li­er this month. Pfiz­er spokesper­son Steve Dane­hy said they expect to “have addi­tion­al data in com­ing weeks” on the shots.

“We’re going to want to make pol­i­cy deci­sions based on more defin­i­tive, larg­er stud­ies, which are com­ing soon,” Jha said.

———-

“White House still expects new COVID boost­ers will offer bet­ter pro­tec­tion, but two new stud­ies cast doubt” By Alexan­der Tin; CBS News; 10/28/2022

“How­ev­er, he pre­dict­ed that the “well-con­trolled tri­als” with “larg­er sam­ples” now under­way from vac­cine mak­ers could yield more favor­able results about the boost­ers’ per­for­mance.”

Dr. Ashish Jha clear­ly was­n’t dis­suad­ed from the con­vic­tion that the new biva­lent vac­cines are bet­ter. We just need to wait for the stud­ies from the vac­cine man­u­fac­tur­ers. Jha went on to point out that the two new stud­ies did find that new boost­ers pro­duced high­er anti­body lev­els. They’re just not high­er enough to reach the lev­el of sta­tis­ti­cal sig­nif­i­cance based on the rel­a­tive­ly small sam­ple sizes. Jha even pre­dict­ed that Mod­er­na’s and Pfiz­er’s bet­ter-pow­ered stud­ies will show a larg­er rel­a­tive advan­tage to the new boost­ers. We’ll see, but that’s what Jha is pre­dict­ing, which isn’t sur­pris­ing since the fed­er­al gov­ern­men­t’s deci­sion to release the new boost­ers on mouse data alone was based on a near cer­tain con­vic­tion that the new boost­ers would be bet­ter:

...
Jha said he was not sur­prised about the new study results and praised the two sci­en­tists — Dan Barouch of Har­vard Med­ical School and David Ho of Colum­bia Uni­ver­si­ty — who led each of the research teams behind the pre­lim­i­nary find­ings.

...

The stud­ies did turn up high­er anti­body respons­es after the updat­ed boost­er, Jha said, even if they were too small to be sta­tis­ti­cal­ly sig­nif­i­cant.

“I expect we’re going to see at least that size ben­e­fit, prob­a­bly big­ger, in the Pfiz­er and Mod­er­na stud­ies,” Jha said.

Jha’s com­ments are in line with expec­ta­tions pre­vi­ous­ly voiced by fed­er­al health offi­cials from across the Biden admin­is­tra­tion, who have argued for months that the updat­ed boost­ers being rolled out this fall would out­per­form the orig­i­nal for­mu­la­tions.

In a state­ment, the FDA’s top vac­cines offi­cial said data “from larg­er, well con­trolled stud­ies that are not sub­ject to the same lim­i­ta­tion of these small­er stud­ies are expect­ed to be avail­able in the near future” and urged Amer­i­cans to seek out an updat­ed boost­er.

“Addi­tion­al­ly, even mod­est improve­ments in vac­cine response to the biva­lent boost­ers could have impor­tant pos­i­tive con­se­quences on pub­lic health,” said a state­ment from Dr. Peter Marks, head of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research.
...

In addi­tion, it appears that data on mice also found that the new boost­ers trig­gered high­er anti­body respons­es. It’s going to be inter­est­ing to see how dif­fer­ent the study results on mice and humans end up being for these boost­ers as bet­ter-pow­ered stud­ies are report­ed:

...
Ear­ly data from ani­mals test­ed with the new shots had been promis­ing. Pre­vi­ous ver­sions tar­get­ing oth­er strains tri­aled on humans also sug­gest­ed a biva­lent for­mu­la­tion would also offer at least an “incre­men­tal” improve­ment, health author­i­ties con­clud­ed.
...

And Jha’s pre­dic­tion that the Mod­er­na and Pfiz­er stud­ies will show not just a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence but a larg­er dif­fer­ence between the old and new boost­ers isn’t just Jha voic­ing opti­mism. AS Dr. Barouch, the author of one of two new stud­ies, points out, a sta­t­i­cal­ly sig­nif­i­cant dif­fer­ence may not be a clin­i­cal­ly sig­nif­i­cant dif­fer­ence. Which means it’s entire­ly pos­si­ble future bet­ter-pow­ered stud­ies will indeed reveal a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence, but still not a clin­i­cal­ly sig­nif­i­cant dif­fer­ence:

...
But this week, two stud­ies seemed to upend those expec­ta­tions.

“There was no sig­nif­i­cant dif­fer­ence in neu­tral­iza­tion of any SARS-CoV­‑2 vari­ant test­ed between indi­vid­u­als who received a fourth mono­va­lent vac­cine and those who received a fourth dose of a biva­lent vac­cine,” con­clud­ed one study, which has yet to be peer-reviewed, post­ed by the team led by Ho.

Sci­en­tists drew blood from peo­ple rough­ly a month after they had got­ten the new shot and test­ed their anti­body respons­es against “pseudovirus­es” — essen­tial­ly mock-ups of dif­fer­ent vari­ants, includ­ing BA.5.

Barouch’s team per­formed a sim­i­lar exper­i­ment against BA.5. They turned up only “a mod­est and non­signif­i­cant” improve­ment from the updat­ed boost­ers in their study, which has also yet to be peer-reviewed.

“If that very small dif­fer­ence holds up in a much larg­er study, then a much larg­er study might actu­al­ly say that’s a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence. The ques­tion is, is it clin­i­cal­ly rel­e­vant? And I don’t believe that that lev­el of dif­fer­ence is clin­i­cal­ly rel­e­vant,” Barouch said in an inter­view.
...

And that dis­tinc­tion between sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ences and clin­i­cal­ly sig­nif­i­cant dif­fer­ences get at the heart of the ques­tion over whether or not the fed­er­al gov­ern­ment is just wast­ing and throw­ing away the mil­lions of orig­i­nal vac­cines that are slat­ed to expire in com­ing months. With the fed­er­al gov­ern­ment get­ting out of the busi­ness of pro­vid­ing free vac­cines next year, this is arguably a deci­sion to toss away usable vac­cines and has­ten the end of freely avail­able vac­cines:

...
The new stud­ies come as the Biden admin­is­tra­tion is prepar­ing for key deci­sions about the coun­try’s COVID-19 vac­cine sup­ply.

Mil­lions of dos­es of the orig­i­nal mono­va­lent vac­cine, which is still being used for pri­ma­ry series shots, are due to expire over the com­ing months. Boost­ers also still need to be green­light­ed for the youngest age group: chil­dren down to 6 months old.

The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill, which will prompt a shift to the pri­vate mar­ket.
...

Inter­est­ing­ly, Barouch points to a known bio­log­i­cal phe­nom­e­na that could explain why the biva­lent vac­cines don’t improve respons­es as pre­dict­ed: “orig­i­nal anti­genic sin”, or the the­o­ry that the body tends to remem­ber the orig­i­nal ver­sion of a virus bet­ter than it adapts to new­er ver­sions. Note how Mod­er­na, Pfiz­er, and health offi­cials appeared to down­play this the­o­ry. It’s going to be very inter­est­ing to see if this the­o­ry pans out:

...
Barouch said a phe­nom­e­non called immune imprint­ing may turn out to be the cul­prit for the dis­ap­point­ing immune response to the updat­ed boost­er.

Immune imprint­ing, also known as “orig­i­nal anti­genic sin,” refers to the the­o­ry that the ini­tial expo­sure peo­ple had to an ear­li­er strain of the virus — either from infec­tion or vac­ci­na­tion — may hin­der the abil­i­ty of the body to pro­duce anti­bod­ies to new strains.

Both the vac­cine com­pa­nies and health offi­cials had pre­vi­ous­ly down­played the hur­dle this phe­nom­e­non might pose to the new shots.

Barouch acknowl­edged there was a pos­si­bil­i­ty that respons­es against BA.5 could improve after more weeks fol­low­ing the updat­ed boost­er, but cau­tioned that we have seen anti­bod­ies decline in the months after pre­vi­ous mRNA COVID shots.

His team also mea­sured anoth­er part of the immune response from T cells. Those were “not sub­stan­tial­ly” boost­ed by addi­tion­al shots from either the biva­lent or orig­i­nal for­mu­la­tions.

“We all talk about anti­bod­ies, the focus has been on anti­bod­ies, but there’s two sides to the immune sys­tem: anti­bod­ies and T cells. And we believe that both are impor­tant for pro­tec­tion against severe dis­ease,” said Barouch.
...

Final­ly, note that Mod­er­na is pre­dict­ing its sta­tis­ti­cal­ly robust stud­ies by the end of the year. Pfiz­er already had some ini­tial pos­i­tive reports:

...
“We will have our BA.4/5 data by year end and ours will be sta­tis­ti­cal­ly pow­ered,” Mod­er­na spokesper­son Chris Rid­ley said in an email.

Rid­ley also point­ed to results from a pre­vi­ous biva­lent for­mu­la­tion by Mod­er­na tar­get­ed at the BA.1 vari­ant, which was pub­lished in The New Eng­land Jour­nal of Med­i­cine a few weeks ago.

Pfiz­er and their Ger­man part­ner BioN­Tech announced find­ing “pos­i­tive ear­ly data” from their updat­ed shots ear­li­er this month. Pfiz­er spokesper­son Steve Dane­hy said they expect to “have addi­tion­al data in com­ing weeks” on the shots.

“We’re going t want to make pol­i­cy deci­sions based on more defin­i­tive, larg­er stud­ies, which are com­ing soon,” Jha said.
...

Will Mod­er­na actu­al­ly deliv­er that larg­er study on time? And will the pub­lic get to see all of the rel­e­vant data or will we just be asked to trust them? We’ll see.

So let’s take a clos­er look at that ear­ly report from Pfiz­er. As we’re going to see, while the com­pa­ny has excit­ed­ly tout­ed the rel­a­tive­ly high­er anti­body lev­els that its new biva­lent vac­cine appeared to induce in a tri­al of 80 vol­un­teers, that com­pa­ny has yet to pub­licly release effi­ca­cy data. That data is pre­sum­ably com­ing. But it’s hard to get super excit­ed with only 80 peo­ple. That’s not exact­ly a huge sta­tis­ti­cal­ly robust sam­ple, espe­cial­ly when you con­sid­er­ing all the dif­fer­ent demo­graph­ic groups those 80 peo­ple could fall under. It sounds like Pfiz­er just broke it into two groups: ages 18–55, and 55+. So it was real­ly just ~40 peo­ple in each of those groups. Again, not exact­ly huge. So it’s going to be very inter­est­ing to see the details that Pfiz­er even­tu­al­ly releas­es on its full study. But the fact that they only have 80 peo­ple rais­es the pos­si­bil­i­ty that we’re going to see results from Pfiz­er and Mod­er­na that are very dif­fer­ent from these oth­er two stud­ies and yet don’t actu­al­ly have that much more sta­tis­ti­cal pow­er behind them. What will reg­u­la­tors do in that case?:

Bloomberg

Pfiz­er Says Boost­er Lifts Anti­bod­ies for Omi­cron Vari­ants

* Com­pa­nies release ear­ly anti­body data on mod­i­fied vac­cine
* Amid slow boost­er cam­paign, Amer­i­cans await effi­ca­cy data

By Marthe Four­cade and Riley Grif­fin
Octo­ber 13, 2022 at 6:18 AM CDT
Updat­ed on Octo­ber 13, 2022 at 8:42 AM CDT

Pfiz­er Inc. and its Ger­man vac­cine part­ner said their boost­er tai­lored to the lat­est omi­cron vari­ants raised more anti­bod­ies against the dom­i­nant strains of Covid-19 when com­pared with the orig­i­nal shot designed to fight the form of the virus.

Blood from 80 vol­un­teers col­lect­ed sev­en days after the boost­er shot showed an increase in neu­tral­iz­ing anti­bod­ies against the BA.4 and BA.5 sub­vari­ants in a study, Pfiz­er and BioN­Tech SE said in a state­ment Thurs­day.

The vac­cines were autho­rized with­out data show­ing their per­for­mance in humans. Pfiz­er and BioN­Tech plan to release addi­tion­al data in com­ing weeks mea­sur­ing immune respons­es one month fol­low­ing admin­is­tra­tion of the new biva­lent boost­er. They have not shared data on the shot’s effi­ca­cy, which would offer a bet­ter mea­sure of pro­tec­tion against wide­ly cir­cu­lat­ing vari­ants.

“While we expect more mature immune-response data from the clin­i­cal tri­al of our omi­cron BA.4/BA.5‑adapted biva­lent vac­cine in the com­ing weeks, we are pleased to see encour­ag­ing respons­es just one week after vac­ci­na­tion in younger and old­er adults,” Pfiz­er Chief Exec­u­tive Albert Bourla said in the state­ment. “These ear­ly data sug­gest that our biva­lent vac­cine is antic­i­pat­ed to pro­vide bet­ter pro­tec­tion against cur­rent­ly cir­cu­lat­ing vari­ants than the orig­i­nal vac­cine, and poten­tial­ly help to curb future surges in cas­es this win­ter.”

The vac­cine part­ners stud­ied two cohorts that had been giv­en the new vac­cine: one includ­ed those ages 18 to 55, and the oth­er includ­ing those 55 and up. The old­er cohort that demon­strat­ed a weak­er anti­body response against BA.4/BA.5 com­pared to the younger cohort, the com­pa­nies said.

The US fall boost­er cam­paign has thus far fal­tered. Only 11.5 mil­lion Amer­i­cans have been admin­is­tered a new­ly mod­i­fied vac­cine from Pfiz­er-BioN­Tech or Mod­er­na Inc., a frac­tion com­pared to pre­vi­ous boost­er cam­paigns. On Wednes­day, US reg­u­la­tors expand­ed access to the new biva­lent boost­er shots to include chil­dren ages 5 and up.

...

———–

“Pfiz­er Says Boost­er Lifts Anti­bod­ies for Omi­cron Vari­ants” By Marthe Four­cade and Riley Grif­fin; Bloomberg; 10/13/2022

“Blood from 80 vol­un­teers col­lect­ed sev­en days after the boost­er shot showed an increase in neu­tral­iz­ing anti­bod­ies against the BA.4 and BA.5 sub­vari­ants in a study, Pfiz­er and BioN­Tech SE said in a state­ment Thurs­day.”

80 vol­un­teers is pre­sum­ably larg­er than the two new­ly released stud­ies that found no dif­fer­ence between the orig­i­nal and new boost­ers. And yet 80 peo­ple isn’t like some vast pool. And the small­er the dif­fer­ence you’re try­ing to mea­sure the greater the sta­tis­ti­cal pow­er that is required.

But also note that Pfiz­er isn’t real­ly tell us how much high­er the anti­body lev­els are that are elicit­ed by the new vac­cine vs the orig­i­nal. Just that they are high­er. Well, that’s what those oth­er stud­ies found too: the new vac­cines did stim­u­late high­er anti­body lev­els. But not much high­er. The dif­fer­ence was so small that they could­n’t claim sta­tis­ti­cal sig­nif­i­cance. So is that what Pfiz­er found too? Or did the com­pa­ny see much greater dif­fer­ence? We have no idea. Just as we have no idea about the actu­al effi­ca­cy of the vac­cine. Pfiz­er isn’t report­ing that:

...
The vac­cines were autho­rized with­out data show­ing their per­for­mance in humans. Pfiz­er and BioN­Tech plan to release addi­tion­al data in com­ing weeks mea­sur­ing immune respons­es one month fol­low­ing admin­is­tra­tion of the new biva­lent boost­er. They have not shared data on the shot’s effi­ca­cy, which would offer a bet­ter mea­sure of pro­tec­tion against wide­ly cir­cu­lat­ing vari­ants.
...

If Pfiz­er find­ing one ‘break­through’ infec­tion after anoth­er? That might explain why it does­n’t want to report on the effi­ca­cy.

Final­ly, notice the glar­ing data point miss­ing in all of this: non-mRNA COVID vac­cines. Sure, they exist. The J&J boost­er is still hypo­thet­i­cal­ly avail­able despite the US gov­ern­ments clear attempts to push every­one onto the mRNA vac­cines. And the Novavax boost­er just received approval. But almost no one is get­ting those shots. Where are the stud­ies com­par­ing these vac­cine tech­nolo­gies? Don’t for­get how the J&J vac­cine appeared to be the best per­former for long-term effi­ca­cy back in May right when the US gov­ern­ment advised against its use based on a rare blood­clot­ting issue. How can it be that there’s so lit­tle inter­est­ing in these com­par­isons? Who knows, but that’s the state of affairs. There is a clear and very strong gov­ern­men­tal pref­er­ence for the mRNA vac­cines over­all oth­er options. That’s abun­dant­ly clear. What isn’t clear is why that pref­er­ence exists and it’s get­ting less and less clear with each study, or lack there­of.

Reg­u­la­to­ry cap­ture has long been a fea­ture of how the US gov­ern­ment oper­ates. It’s one of the fun fact about how the US works that has been loom­ing over the devel­op­ment of the COVID vac­cines from the begin­ning. Because as we’ve seen, the US gov­ern­ment has­n’t just been an enthu­si­as­tic cham­pi­on of the exper­i­ment mRNA vac­cine tech­nol­o­gy devel­oped by Mod­er­na. They’ve been part­ners in devel­op­ing the tech­nol­o­gy for years, with bil­lions of dol­lars in US tax­pay­er dol­lars hav­ing gone into this research. It’s a fea­ture of the his­to­ry of the devel­op­ment of these new tech­nolo­gies that becomes unfor­tu­nate­ly top­i­cal when­ev­er there’s a new sto­ry rais­ing ques­tions about the safe­ty or effec­tive­ness of the vac­cines. Sto­ries like how the new biva­lent covid boost­ers were approved based large­ly on mouse tri­als. Tiny mouse tri­als. Or then there’s sto­ries like how the FDA basi­cal­ly killed the John­son & John­son vac­cine based on a very rare side-effect, despite data show­ing the J&J vac­cine was out­per­form­ing the oth­er vac­cines when it came to the long-term dura­bil­i­ty of the anti­bod­ies.

So it should come as lit­tle sur­prise at this point to learn that the advi­so­ry pan­els the FDA and CDC relied on to pro­vide inde­pen­dent advice on whether or not to approve the new new COVID mRNA boost­ers are now pissed at the FDA and CDC. And Mod­er­na. Because as the fol­low­ing piece describes, it appears that the FDA, CDC, and Mod­er­na all col­lud­ed to with­hold data from these advi­so­ry pan­els the Mod­er­na had already gath­ered indi­cat­ing that the biva­lent COVID boost­ers are pos­si­bly less effec­tive at pre­vent an infec­tion than the orig­i­nal mRNA vac­cine for­mu­la­tion.

Yep, first the FDA held a day-long meet­ing on June 28 with a pan­el of inde­pen­dent experts about the new boost­ers. The pres­i­dent of Mod­er­na was also invit­ed to present to the pan­el and shared the results of a new Mod­er­na study that had just been preprint­ed (non-peer reviewed) three days before the meet­ing. The study showed the new biva­lent vac­cine elicit­ed high­er anti­body lev­els. But also high­er infec­tion rates. The high­er anti­body lev­els were excit­ed­ly shared to the pan­el. Noth­ing about the high­er infec­tion rates was shared.

So why did­n’t the FDA share this info about high­er infec­tion rates with the pan­el? The FDA was aware of Mod­er­na’s preprint­ed study, after all. We’ll we’re told that the FDA just did­n’t have enough time to review it. That’s the excuse giv­en for how Mod­er­na’s pres­i­dent was allowed to selec­tive­ly share results with the pan­el and the FDA leav­ing the pan­elists in the dark.

The FDA ulti­mate­ly approved the biva­lent boost­ers on August 31. The next day, the CDC held an inde­pen­dent pan­el of its own to review the new biva­lent boost­ers. Again, peo­ple from Mod­er­na were there to selec­tive­ly present how the new boost­ers result­ed in high­er anti­body lev­els while leav­ing out the data about the high­er infec­tion rates entire­ly. On Sep­tem­ber 13, the FDA final­ly pub­lished the data it based its approval on, includ­ing the infec­tion data. So the FDA only pub­licly released the data from Mod­er­na show­ing pos­si­bly low­er effi­ca­cy for the new boost­ers only after the CDC’s pan­el gave its own stamp of approval with­out know­ing about the low­er effi­ca­cy find­ings.

So what was the CDC’s excuse for keep­ing the pan­el in the dark? Well, accord­ing to the CDC spokesper­son, the “CDC was aware” of the data that would lat­er be pub­lished in The New Eng­land Jour­nal of Med­i­cine. Also, they added that assess­ing infec­tions was an “explorato­ry objec­tive of the study,” which was “not designed to assess vac­cine effec­tive­ness.” It’s not exact­ly a com­pelling excuse. Final­ly, they point­ed out that in assess­ing infec­tions, “researchers used dif­fer­ent dura­tions and points in time among a very small group of peo­ple,” and because of the lim­i­ta­tions of the data, it was not fea­tured at the meet­ing. In oth­er words, the Mod­er­na study was poor­ly-pow­ered crap.

Which is was by all indi­ca­tions. And that’s part of the sto­ry here: Mod­er­na’s poor­ly-pow­ered crap study was appar­ent­ly fine for use when it increased the chances of the vac­cines get­ting approved. But when it comes to the data show­ing reduced effec­tive­ness we can just ignore it because of the poor sta­tis­ti­cal pow­er. It’s all quite con­ve­nient. Con­ve­nient for Mod­er­na and any Mod­er­na super-fans that inhab­it the fed­er­al reg­u­la­to­ry bureau­cra­cy. As Dr. Paul Offit, one of the inde­pen­dent experts who is now livid over this scan­dal, put it, his faith in the whole approval process has been shak­en. Which should raise plen­ty of ques­tions for the rest of us:

CNN

FDA vac­cine advis­ers ‘dis­ap­point­ed’ and ‘angry’ that ear­ly data about new Covid-19 boost­er shot wasn’t pre­sent­ed for review last year

By Eliz­a­beth Cohen and Nao­mi Thomas, CNN
Pub­lished 6:35 AM EST, Wed Jan­u­ary 11, 2023

CNN — Some vac­cine advis­ers to the fed­er­al gov­ern­ment say they’re “dis­ap­point­ed” and “angry” that gov­ern­ment sci­en­tists and the phar­ma­ceu­ti­cal com­pa­ny Mod­er­na didn’t present a set of infec­tion data on the company’s new Covid-19 boost­er dur­ing meet­ings last year when the advis­ers dis­cussed whether the shot should be autho­rized and made avail­able to the pub­lic.

That data sug­gest­ed the pos­si­bil­i­ty that the updat­ed boost­er might not be any more effec­tive at pre­vent­ing Covid-19 infec­tions than the orig­i­nal shots.

The data was ear­ly and had many lim­i­ta­tions, but sev­er­al advis­ers told CNN that they were con­cerned about a lack of trans­paren­cy.

US tax­pay­ers spent near­ly $5 bil­lion on the new boost­er, which has been giv­en to more than 48.2 mil­lion peo­ple in the US.

“I was angry to find out that there was data that was rel­e­vant to our deci­sion that we didn’t get to see,” said Dr. Paul Offit, a mem­ber of the Vac­cines and Relat­ed Bio­log­i­cal Prod­ucts Advi­so­ry Com­mit­tee, a group of exter­nal advis­ers that helps the FDA make vac­cine deci­sions. “Deci­sions that are made for the pub­lic have to be made based on all avail­able infor­ma­tion – not just some infor­ma­tion, but all infor­ma­tion.”

At a meet­ing of this FDA advi­so­ry group in June and a meet­ing in Sep­tem­ber of a pan­el that advis­es the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion, the experts were pre­sent­ed with reams of infor­ma­tion indi­cat­ing that the new vac­cine worked bet­ter than the one already on shelves, accord­ing to a review of videos and tran­scripts of those meet­ings and slide pre­sen­ta­tions made by Mod­er­na, CDC and FDA offi­cials.

That data – called immuno­genic­i­ty data – was based on blood work done on study par­tic­i­pants to assess how well each vac­cine elicit­ed anti­bod­ies that fight off the Omi­cron strain of the virus that caus­es Covid-19.

The data that was not pre­sent­ed to the experts looked at actu­al infec­tions: who caught Covid-19 and who did not.

It found that 1.9% of the study par­tic­i­pants who received the orig­i­nal boost­er became infect­ed. Among those who got the updat­ed biva­lent vac­cine – the one that sci­en­tists hoped would work bet­ter – a high­er per­cent­age, 3.2%, became infect­ed. Both ver­sions of the shot were found to be safe.

This infec­tion data was far from com­plete. The num­ber of study sub­jects who became infect­ed was very small, and both the patients and the researchers were aware of who was get­ting the orig­i­nal shot and who was get­ting the new boost­er.

Despite these imper­fec­tions, the data was includ­ed in a preprint study that was post­ed online in June, again in Sep­tem­ber in an FDA doc­u­ment and then lat­er that month in a top med­ical jour­nal – and advis­ers to the FDA and the CDC said the data should have been shared with them, too.

“It’s not a group of chil­dren. We under­stand how to inter­pret these results,” said Dr. Eric Rubin, a mem­ber of the FDA vac­cine advi­so­ry com­mit­tee.

The six FDA and CDC advis­ers inter­viewed by CNN said that this infec­tion data wouldn’t have changed how they vot­ed, because the data had such lim­i­ta­tions, but it still should have been pre­sent­ed to them.

“There should always be full trans­paren­cy,” said Dr. Arnold Mon­to, a pro­fes­sor of epi­demi­ol­o­gy at the Uni­ver­si­ty of Michi­gan School of Pub­lic Health and act­ing chair of the FDA advis­ers’ group. “These data should not be dis­missed. They are ear­ly, but they indi­cate that we need to look at them and see what their val­ue is.”

Dr. Pablo Sanchez, a mem­ber of the CDC’s pan­el, called the Advi­so­ry Com­mit­tee on Immu­niza­tion Prac­tices, said that if the data “was looked at as part of the study, it should have been pre­sent­ed to the advis­ers pri­or to their deci­sion.”

The FDA and the CDC con­vene their advi­so­ry board meet­ings and make pre­sen­ta­tions to the advis­ers. At last year’s meet­ings, Mod­er­na exec­u­tives made pre­sen­ta­tions, as well. The advis­ers then make their rec­om­men­da­tions to the agen­cies, and the agen­cies decide whether to autho­rize the shots and rec­om­mend them to the pub­lic.

Mod­er­na spokesman Christo­pher Rid­ley said in an email to CNN that the com­pa­ny shared the infec­tion data with the FDA and post­ed the study man­u­script before the agency’s pan­el meet­ing in June “in response to requests that we share an update from the ongo­ing study.”

That study preprint was post­ed online June 25, three days before the FDA advis­ers met.

Michael Fel­ber­baum, an FDA spokesman, told CNN in an email that “the FDA received the preprint less than a day pri­or to the advi­so­ry com­mit­tee meet­ing,” and “the infor­ma­tion was there­fore not pro­vid­ed in an ade­quate time­frame for it to be includ­ed in the agency’s meet­ing mate­ri­als, and gen­er­al­ly the FDA only dis­cuss­es data at advi­so­ry com­mit­tee meet­ings that the agency has had the oppor­tu­ni­ty to sub­stan­tive­ly review.”

“Numer­ous stud­ies sup­port the find­ing that the COVID-19 vac­cines remain the best defense against the most dev­as­tat­ing con­se­quences of COVID-19 such as hos­pi­tal­iza­tion and death, and that the updat­ed vac­cines may help pro­vide bet­ter pro­tec­tion against the cur­rent­ly cir­cu­lat­ing vari­ants,” Fel­ber­baum wrote.

He added that “through­out the pan­dem­ic, the FDA has remained as trans­par­ent as pos­si­ble regard­ing its process­es and deci­sion-mak­ing regard­ing the COVID-19 vac­cines” and that Mod­er­na could have cho­sen to present the data at the FDA advi­so­ry com­mit­tee meet­ing.

Kris­ten Nord­lund, a CDC spokes­woman, said that “due to the many lim­i­ta­tions involv­ing this clin­i­cal data, it was not fea­tured” in the CDC’s advi­so­ry com­mit­tee dis­cus­sion.

Empha­sis on trans­paren­cy

The advis­ers said there are three main rea­sons why it mat­ters that the infec­tion data was not pre­sent­ed to them.

One, they said, is the poten­tial impact of their deci­sion: If Amer­i­cans were going to be get­ting these shots, all avail­able data should be brought to the table for con­sid­er­a­tion.

Two, the advi­so­ry com­mit­tee meet­ings are streamed live online, and reg­u­la­to­ry agen­cies around the world use the infor­ma­tion to help make deci­sions about vac­cines in their coun­tries.

Three, they stressed that trans­paren­cy is impor­tant. The pub­lic doesn’t wit­ness con­ver­sa­tions among FDA offi­cials or between agency offi­cials and phar­ma­ceu­ti­cal com­pa­ny exec­u­tives, but they do get to watch the advi­so­ry pan­els’ pro­ceed­ings.

...

Infec­tion data not includ­ed in pre­sen­ta­tions by FDA and Mod­er­na

Last sum­mer, as the FDA’s and CDC’s out­side advis­ers con­sid­ered the updat­ed boost­ers, the stakes were high. They knew that in just a mat­ter of months, win­ter would be approach­ing, and Covid rates could spike. They also knew the orig­i­nal vac­cine was get­ting less effec­tive with each new vari­ant and that the addi­tion of the Omi­cron strain in the updat­ed boost­er might help bat­tle the virus.

The FDA advis­ers – 21 vot­ing mem­bers, includ­ing infec­tious dis­ease experts and vac­ci­nol­o­gists from Stan­ford, the Uni­ver­si­ty of Penn­syl­va­nia and Har­vard – met for a full day on June 28.

Dr. Stephen Hoge, the pres­i­dent of Mod­er­na, made a pre­sen­ta­tion to the advis­ers and fre­quent­ly referred to infor­ma­tion from the preprint study that had been post­ed three days before. The study was fund­ed by Mod­er­na and led by com­pa­ny sci­en­tists, and it had not been sub­ject­ed to peer review or pub­lished in a med­ical jour­nal.

The data Hoge shared with the advis­ers demon­strat­ed that blood tests on about 800 study par­tic­i­pants indi­cat­ed that the new biva­lent boost­er was “supe­ri­or” at increas­ing anti­bod­ies to the Omi­cron vari­ant com­pared with the orig­i­nal vac­cine.

Hoge did not men­tion anoth­er part of the study that cast a less-pos­i­tive light on the updat­ed shot.

In that part, the researchers gave some par­tic­i­pants the exist­ing vac­cine and oth­er par­tic­i­pants the updat­ed boost­er, and then they kept track of who became infect­ed with Covid-19.

Among the hun­dreds of par­tic­i­pants who received the orig­i­nal vac­cine and showed no evi­dence of a pri­or Covid-19 infec­tion, over the peri­od of the small study, 1.9% became infect­ed. Among the hun­dreds who received the new biva­lent vac­cine, a high­er per­cent­age, 3.2%, became infect­ed. The preprint did not indi­cate whether these find­ings were sta­tis­ti­cal­ly sig­nif­i­cant.

A 22-page FDA brief­ing doc­u­ment giv­en to the advis­ers did not men­tion this infec­tion data.

Dr. Jer­ry Weir, direc­tor of the Divi­sion of Viral Prod­ucts at the FDA’s Office of Vac­cines Research and Review, also did not men­tion the infec­tion data in his pre­sen­ta­tion to the advis­ers.

At the end of the June 28 meet­ing, the FDA advis­ers vot­ed 19–2 to rec­om­mend the inclu­sion of an Omi­cron vari­ant for the Covid-19 boost­er vac­cine. Offit, a pro­fes­sor of vac­ci­nol­o­gy at the Perel­man School of Med­i­cine at the Uni­ver­si­ty of Penn­syl­va­nia, and Dr. Hen­ry Bern­stein, a pro­fes­sor of pedi­atrics at the Zuck­er School of Med­i­cine at Hofstra/Northwell in New York, vot­ed in oppo­si­tion.

Over the next month, the US gov­ern­ment announced agree­ments to pur­chase the biva­lent boost­er from Pfiz­er and Mod­er­na: a con­tract for $3.2 bil­lion with Pfiz­er and for $1.74 bil­lion with Mod­er­na.

Lim­i­ta­tions of Moderna’s infec­tion data

The infec­tion data that wasn’t includ­ed in the Mod­er­na and FDA pre­sen­ta­tions has sev­er­al seri­ous lim­i­ta­tions, accord­ing to the six advis­ers who spoke to CNN.

First, the num­bers were very small: The study ana­lyzed only hun­dreds of patients, and only 16 became infect­ed. None of them end­ed up in the emer­gency room or were hos­pi­tal­ized.

...

Sec­ond, par­tic­i­pants were not ran­dom­ly assigned to receive either the orig­i­nal or new vac­cine, and the study was not dou­ble-blind, mean­ing the par­tic­i­pants and the researchers knew who was receiv­ing which shot. Lack of ran­dom­iza­tion and blind­ing can bias study results.

Third, the pri­ma­ry pur­pose of the study was not to study infec­tion rates but to do immuno­genic­i­ty analy­ses, tak­ing blood from par­tic­i­pants and exam­in­ing their anti­body respons­es to the vac­cine.

...

“The pri­ma­ry objec­tive of the study was to assess the safe­ty and immuno­genic­i­ty of the biva­lent vac­cine. The study was not ran­dom­ized and did not con­trol for infec­tion risk between arms, mak­ing com­par­i­son of a rel­a­tive­ly small num­ber of cas­es prob­lem­at­ic,” he wrote.

Near­ly $5 bil­lion for updat­ed boost­ers

On August 31, about two months after the FDA advis­ers’ meet­ing, the agency autho­rized the Mod­er­na biva­lent vac­cines. The Mod­er­na infec­tion data was includ­ed in the agency’s writ­ten deci­sion, but it wasn’t post­ed online until Sep­tem­ber 13, accord­ing to Fel­ber­baum, the FDA spokesman.

On Sep­tem­ber 1, the CDC advis­ers – 14 vot­ing mem­bers – met to con­sid­er whether to rec­om­mend the biva­lent boost­ers for Amer­i­cans to get in the fall. Sev­er­al CDC sci­en­tists pre­sent­ed data at that meet­ing but did not include the infec­tion data.

Nord­lund, the CDC spokes­woman, said in her email that the “CDC was aware” of the data that would lat­er be pub­lished in The New Eng­land Jour­nal of Med­i­cine but that assess­ing infec­tions was an “explorato­ry objec­tive of the study,” which was “not designed to assess vac­cine effec­tive­ness.” She added that in assess­ing infec­tions, “researchers used dif­fer­ent dura­tions and points in time among a very small group of peo­ple,” and because of the lim­i­ta­tions of the data, it was not fea­tured at the meet­ing.

“CDC vac­cine rec­om­men­da­tions are made fol­low­ing an eval­u­a­tion and pre­sen­ta­tion of high-qual­i­ty vac­cine effi­ca­cy or immuno­bridg­ing data,” Nord­lund wrote.

Dr. William Schaffn­er, a non-vot­ing mem­ber of the CDC’s advi­so­ry com­mit­tee, called Nordlund’s argu­ment “very weak.”

“The data are lim­it­ed, but they are infor­ma­tive, and I think one would have antic­i­pat­ed that a com­plete pre­sen­ta­tion would have includ­ed them,” said Schaffn­er, an infec­tious dis­ease spe­cial­ist at Van­der­bilt Uni­ver­si­ty Med­ical Cen­ter.

Dr. Jacque­line Miller, a senior vice pres­i­dent at Mod­er­na, pre­sent­ed to the advis­ers. Like her col­league Hoge, the com­pa­ny pres­i­dent, she showed mate­r­i­al sug­gest­ing that the biva­lent vac­cine was supe­ri­or and did not show slides detail­ing the sta­tis­tics about the infec­tion rates, accord­ing to a copy of the slides she pre­sent­ed.

Sev­er­al hours into the meet­ing, one of the CDC advis­ers, Dr. Sybil Cineas, an asso­ciate pro­fes­sor of med­i­cine at the War­ren Alpert Med­ical School of Brown Uni­ver­si­ty, asked Miller about cas­es of Covid-19 among study sub­jects who received the orig­i­nal vac­cine ver­sus the updat­ed biva­lent boost­er.

Miller said that among sub­jects with no evi­dence of pri­or infec­tion, as well as those with evi­dence of pri­or infec­tion, the dis­ease inci­dence rates were 2.4% for the group who received the orig­i­nal vac­cine and 2.5% for those who got the biva­lent boost­er.

That data would be pub­lished two weeks lat­er in The New Eng­land Jour­nal of Med­i­cine.

When she answered Cineas’ ques­tion, Miller did not men­tion oth­er aspects of the infec­tion data in the pub­lished study. That data indi­cat­ed that among hun­dreds of par­tic­i­pants with no pre­vi­ous Covid-19 infec­tions, infec­tion occurred in 1.9% of those who’d received the old vac­cine and in 3.2% of those who’d received the new biva­lent vac­cine. She also did not men­tion break­downs of whether par­tic­i­pants were sick with Covid or had asymp­to­matic ill­ness­es. The study, like the preprint, did not men­tion whether any of these find­ings were sta­tis­ti­cal­ly sig­nif­i­cant.

At the end of the meet­ing, the CDC advis­ers vot­ed 13–1 in favor of rec­om­mend­ing the biva­lent boost­er, with Sanchez, a pro­fes­sor of pedi­atrics at the Ohio State Uni­ver­si­ty Col­lege of Med­i­cine, vot­ing in oppo­si­tion. CDC Direc­tor Dr. Rochelle Walen­sky signed off on the rec­om­men­da­tion lat­er that day, and the vac­cines were made avail­able to the pub­lic. Cur­rent­ly, they are the only boost­er avail­able once some­one has had their pri­ma­ry series of a Covid-19 vac­cine.

More than six months after the FDA advis­ers met, Mod­er­na still has not released data from a ran­dom­ized Phase 3 tri­al com­par­ing infec­tions in par­tic­i­pants who received the new boost­er with those who received the old shot. The com­pa­ny expects to release such results “short­ly” with about 3,000 par­tic­i­pants, accord­ing to Rid­ley.

Pfiz­er does not “cur­rent­ly have data on inci­dence of infec­tion post biva­lent boost­er. How­ev­er, we con­tin­ue to mon­i­tor real-world data and col­lect data from our own stud­ies,” accord­ing to a state­ment from Jer­i­ca Pitts, senior direc­tor of glob­al media rela­tions.

Togeth­er, the new updat­ed boost­ers from Pfiz­er and Mod­er­na cost tax­pay­ers near­ly $5 bil­lion. To put that in per­spec­tive, that’s about the size of the annu­al bud­get for the state of Delaware.

For­mer FDA sci­en­tist: No excuse for exclud­ing infec­tion data

A for­mer FDA sci­en­tist who helped run the agency’s vac­cine divi­sion told CNN that if he were still at the agency, he would have advo­cat­ed for shar­ing the infec­tion infor­ma­tion with the advis­ers, even if it was made avail­able only a short time before the meet­ing.

“I don’t think there’s any excuse for exclud­ing it,” even with its imper­fec­tions, said Dr. Philip Krause, who served as deputy direc­tor of the FDA’s Office of Vac­cine Research and Review until he resigned in Octo­ber 2021.

“The company’s fail­ure to present this infor­ma­tion at the [FDA advis­ers meet­ing] and the omis­sion of dis­cus­sion about the data at that meet­ing rais­es ques­tions about the abil­i­ty of the process to pro­vide a full and trans­par­ent review of the data,” he added.

Krause said his main con­cern was pre­serv­ing – or regain­ing – the pub­lic trust in the FDA.

“That’s the crit­i­cal thing,” he said. “The FDA’s objec­tive review of the data is what is pro­vid­ing the great, great val­ue to the Amer­i­can peo­ple, because this way they know that some­body who doesn’t have a stake in the out­come has looked at the deep­est pos­si­ble lev­el at these data.”

FDA and CDC vac­cine advis­ers echoed Krause’s con­cerns about trans­paren­cy.

“I think that as much data that’s avail­able should be made pub­lic and avail­able for dis­cus­sion by advi­so­ry groups so that the pub­lic can see, yes, the avail­able sci­ence has been eval­u­at­ed as best as [pos­si­ble] at that par­tic­u­lar time,” said Bern­stein, the mem­ber of the FDA advi­so­ry com­mit­tee.

Bern­stein added that he was dis­ap­point­ed that the data had not been pre­sent­ed to him and the oth­er advis­ers.

Offit, the mem­ber from the Uni­ver­si­ty of Penn­syl­va­nia, said he was angry.

“I was angry to find out that there was data that was rel­e­vant to our deci­sion that I didn’t get to see. Angry because they should trust us to make the deci­sion based on all the data. These agen­cies, whether it’s the FDA or CDC, can’t make that deci­sion for us. That’s the point of hav­ing an inde­pen­dent advi­so­ry com­mit­tee,” he said.

‘It shook my faith’

About a month after the CDC advis­ers met, stud­ies were released from researchers at Har­vard and Colum­bia sug­gest­ing that the new vac­cines didn’t work any bet­ter than the orig­i­nal.

Those stud­ies, which were very small and only in preprint and not in a med­ical jour­nal, mea­sured immune respons­es after peo­ple got the biva­lent vac­cine com­pared with the orig­i­nal ver­sion of the vac­cine.

“We essen­tial­ly see no dif­fer­ence” between the old boost­ers and the new about a month after the shot, said Dr. David Ho, a pro­fes­sor of micro­bi­ol­o­gy and immunol­o­gy at Colum­bia whose team authored one of the stud­ies.

Pres­i­dent Joe Biden and oth­er admin­is­tra­tion offi­cials con­tin­ue to empha­size that the updat­ed boost­er is the best way to avoid hos­pi­tal­iza­tion or death from Covid-19. But near­ly four months after its release, only 15.4% of the US pop­u­la­tion age 5 and old­er has opt­ed to get the shot, accord­ing to CDC data.

On Jan­u­ary 26, the advis­ers are sched­uled to meet again to dis­cuss future Covid-19 vac­ci­na­tion reg­i­mens.

Offit, the FDA vac­cine advis­er, said the Colum­bia and Har­vard stud­ies con­vinced him even more that the infec­tion data and all the relat­ed caveats should have been giv­en to the advis­ers from the begin­ning.

“This was not accept­able. I under­stand we’re in the mid­dle of a pan­dem­ic. I under­stand we’re build­ing the plane while it’s still in the air, but you can’t do this,” he said. “It did shake my faith. It shook my faith in how these deci­sions were being made.”

——–

“FDA vac­cine advis­ers ‘dis­ap­point­ed’ and ‘angry’ that ear­ly data about new Covid-19 boost­er shot wasn’t pre­sent­ed for review last year” by Eliz­a­beth Cohen and Nao­mi Thomas; CNN; 01/11/2023

“At a meet­ing of this FDA advi­so­ry group in June and a meet­ing in Sep­tem­ber of a pan­el that advis­es the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion, the experts were pre­sent­ed with reams of infor­ma­tion indi­cat­ing that the new vac­cine worked bet­ter than the one already on shelves, accord­ing to a review of videos and tran­scripts of those meet­ings and slide pre­sen­ta­tions made by Mod­er­na, CDC and FDA offi­cials.”

An FDA advi­so­ry group in June and a Sep­tem­ber meet­ing at the CDC and last year, where out­side experts on an inde­pen­dent advi­so­ry pan­el were pre­sent­ed infor­ma­tion indi­ca­tion that at the new biva­lent Mod­er­na mRNA vac­cines real­ly did per­form bet­ter than the orig­i­nal for­mu­la­tion. Mod­er­na, the FDA, and CDC all played a role in pre­sent­ing this infor­ma­tion to the inde­pen­dent experts. Infor­ma­tion that sys­tem­at­i­cal­ly left out the results from Mod­er­na’s stud­ies show­ing no improve­ment over the orig­i­nal vac­cines in terms of actu­al infec­tions. In fact, the new biva­lent vac­cines per­formed even worse than the orig­i­nal vac­cine in terms of infec­tions. That ear­ly data was avail­able when these meet­ings took place. Some of that ear­ly data was even shared, like the data show­ing high­er anti­body lev­els result­ing from the biva­lent boost­ers. And yet some­how the data show­ing high­er rates of infec­tion was sys­tem­at­i­cal­ly left out of all these pre­sen­ta­tions to the advi­so­ry pan­el. So this was­n’t just Mod­er­na play­ing fast and loose with the avail­able data. The FDA and CDC were play­ing their roles too. It’s the kind of sit­u­a­tion that just screams ‘reg­u­la­to­ry cap­ture’:

...
That data – called immuno­genic­i­ty data – was based on blood work done on study par­tic­i­pants to assess how well each vac­cine elicit­ed anti­bod­ies that fight off the Omi­cron strain of the virus that caus­es Covid-19.

The data that was not pre­sent­ed to the experts looked at actu­al infec­tions: who caught Covid-19 and who did not.

It found that 1.9% of the study par­tic­i­pants who received the orig­i­nal boost­er became infect­ed. Among those who got the updat­ed biva­lent vac­cine – the one that sci­en­tists hoped would work bet­ter – a high­er per­cent­age, 3.2%, became infect­ed. Both ver­sions of the shot were found to be safe.

This infec­tion data was far from com­plete. The num­ber of study sub­jects who became infect­ed was very small, and both the patients and the researchers were aware of who was get­ting the orig­i­nal shot and who was get­ting the new boost­er.

Despite these imper­fec­tions, the data was includ­ed in a preprint study that was post­ed online in June, again in Sep­tem­ber in an FDA doc­u­ment and then lat­er that month in a top med­ical jour­nal – and advis­ers to the FDA and the CDC said the data should have been shared with them, too.
...

And as we can see, part of the way this cen­sor­ship was car­ried out was via Mod­er­na’s release of the preprint ear­ly data — data show­ing high­er infec­tion rates for the biva­lent boost­ers — just days before the June 28 FDA meet­ing, which appar­ent­ly gave Mod­er­na and the FDA an excuse to with­hold the study on the premise that the three days was­n’t enough time to review it. So what was the CDC’s excuse for leav­ing the data out of its Sep­tem­ber meet­ing with the inde­pen­dent pan­el? We are told that the CDC decid­ed to leave it out, “due to the many lim­i­ta­tions involv­ing this clin­i­cal data, it was not fea­tured.”:

...
The FDA and the CDC con­vene their advi­so­ry board meet­ings and make pre­sen­ta­tions to the advis­ers. At last year’s meet­ings, Mod­er­na exec­u­tives made pre­sen­ta­tions, as well. The advis­ers then make their rec­om­men­da­tions to the agen­cies, and the agen­cies decide whether to autho­rize the shots and rec­om­mend them to the pub­lic.

Mod­er­na spokesman Christo­pher Rid­ley said in an email to CNN that the com­pa­ny shared the infec­tion data with the FDA and post­ed the study man­u­script before the agency’s pan­el meet­ing in June “in response to requests that we share an update from the ongo­ing study.”

That study preprint was post­ed online June 25, three days before the FDA advis­ers met.

Michael Fel­ber­baum, an FDA spokesman, told CNN in an email that “the FDA received the preprint less than a day pri­or to the advi­so­ry com­mit­tee meet­ing,” and “the infor­ma­tion was there­fore not pro­vid­ed in an ade­quate time­frame for it to be includ­ed in the agency’s meet­ing mate­ri­als, and gen­er­al­ly the FDA only dis­cuss­es data at advi­so­ry com­mit­tee meet­ings that the agency has had the oppor­tu­ni­ty to sub­stan­tive­ly review.”

“Numer­ous stud­ies sup­port the find­ing that the COVID-19 vac­cines remain the best defense against the most dev­as­tat­ing con­se­quences of COVID-19 such as hos­pi­tal­iza­tion and death, and that the updat­ed vac­cines may help pro­vide bet­ter pro­tec­tion against the cur­rent­ly cir­cu­lat­ing vari­ants,” Fel­ber­baum wrote.

He added that “through­out the pan­dem­ic, the FDA has remained as trans­par­ent as pos­si­ble regard­ing its process­es and deci­sion-mak­ing regard­ing the COVID-19 vac­cines” and that Mod­er­na could have cho­sen to present the data at the FDA advi­so­ry com­mit­tee meet­ing.

Kris­ten Nord­lund, a CDC spokes­woman, said that “due to the many lim­i­ta­tions involv­ing this clin­i­cal data, it was not fea­tured” in the CDC’s advi­so­ry com­mit­tee dis­cus­sion.
...

And yet, despite the CDC and FDA mak­ing the deci­sion to leave Mod­er­na’s preprint­ed study out of its pan­el review dur­ing that day-long June 28 meet­ing, we learn that Mod­er­na’s pres­i­dent nonethe­less made fre­quent ref­er­ences to the preprint­ed study’s results. At least the parts about high­er anti­body lev­els that he want­ed to share. But no men­tion of the high­er infec­tion rates. That’s the sto­ry here: the FDA, CDC, and Mod­er­na effec­tive­ly teamed up to bam­boo­zle this pan­el of inde­pen­dent experts:

...
Infec­tion data not includ­ed in pre­sen­ta­tions by FDA and Mod­er­na

Last sum­mer, as the FDA’s and CDC’s out­side advis­ers con­sid­ered the updat­ed boost­ers, the stakes were high. They knew that in just a mat­ter of months, win­ter would be approach­ing, and Covid rates could spike. They also knew the orig­i­nal vac­cine was get­ting less effec­tive with each new vari­ant and that the addi­tion of the Omi­cron strain in the updat­ed boost­er might help bat­tle the virus.

The FDA advis­ers – 21 vot­ing mem­bers, includ­ing infec­tious dis­ease experts and vac­ci­nol­o­gists from Stan­ford, the Uni­ver­si­ty of Penn­syl­va­nia and Har­vard – met for a full day on June 28.

Dr. Stephen Hoge, the pres­i­dent of Mod­er­na, made a pre­sen­ta­tion to the advis­ers and fre­quent­ly referred to infor­ma­tion from the preprint study that had been post­ed three days before. The study was fund­ed by Mod­er­na and led by com­pa­ny sci­en­tists, and it had not been sub­ject­ed to peer review or pub­lished in a med­ical jour­nal.

The data Hoge shared with the advis­ers demon­strat­ed that blood tests on about 800 study par­tic­i­pants indi­cat­ed that the new biva­lent boost­er was “supe­ri­or” at increas­ing anti­bod­ies to the Omi­cron vari­ant com­pared with the orig­i­nal vac­cine.

Hoge did not men­tion anoth­er part of the study that cast a less-pos­i­tive light on the updat­ed shot.

In that part, the researchers gave some par­tic­i­pants the exist­ing vac­cine and oth­er par­tic­i­pants the updat­ed boost­er, and then they kept track of who became infect­ed with Covid-19.

Among the hun­dreds of par­tic­i­pants who received the orig­i­nal vac­cine and showed no evi­dence of a pri­or Covid-19 infec­tion, over the peri­od of the small study, 1.9% became infect­ed. Among the hun­dreds who received the new biva­lent vac­cine, a high­er per­cent­age, 3.2%, became infect­ed. The preprint did not indi­cate whether these find­ings were sta­tis­ti­cal­ly sig­nif­i­cant.

A 22-page FDA brief­ing doc­u­ment giv­en to the advis­ers did not men­tion this infec­tion data.
...

And note how even the experts serv­ing on this advi­so­ry pan­el who still approve of the biva­lent vac­cine are angered over this sto­ry. As they should be. These are the experts tasked with sift­ing through all the avail­able data and mak­ing an inde­pen­dent rec­om­men­da­tion. The check and bal­ances of this sys­tem were cor­rupt­ed:

...
“It’s not a group of chil­dren. We under­stand how to inter­pret these results,” said Dr. Eric Rubin, a mem­ber of the FDA vac­cine advi­so­ry com­mit­tee.

The six FDA and CDC advis­ers inter­viewed by CNN said that this infec­tion data wouldn’t have changed how they vot­ed, because the data had such lim­i­ta­tions, but it still should have been pre­sent­ed to them.

“There should always be full trans­paren­cy,” said Dr. Arnold Mon­to, a pro­fes­sor of epi­demi­ol­o­gy at the Uni­ver­si­ty of Michi­gan School of Pub­lic Health and act­ing chair of the FDA advis­ers’ group. “These data should not be dis­missed. They are ear­ly, but they indi­cate that we need to look at them and see what their val­ue is.”

Dr. Pablo Sanchez, a mem­ber of the CDC’s pan­el, called the Advi­so­ry Com­mit­tee on Immu­niza­tion Prac­tices, said that if the data “was looked at as part of the study, it should have been pre­sent­ed to the advis­ers pri­or to their deci­sion.”
...

Also note the oth­er games at work with the release of Mod­er­na’s find­ings: the FDA autho­rized the use of the biva­lent vac­cines on August 31. A deci­sion the FDA did­n’t post online the data that it based that deci­sion on until Sep­tem­ber 13, which includ­ed the Mod­er­na infec­tion data. But it was Sep­tem­ber 1 when the CDC held its own “Advi­so­ry Com­mit­tee on Immu­niza­tion Prac­tices” and that infec­tion data was once again with­held from pan­el. So what’s the CDC’s expla­na­tion? Well, the agency acknowl­edges that it was “aware” that the infec­tion data would be lat­er pub­lished in the New Eng­land Jour­nal of Med­i­cine and that the focus of the meet­ing was on vac­cine safe­ty, not vac­cine effec­tive­ness. It was, as Dr. William Schaffn­er put it, a “very weak” defense:

...
On August 31, about two months after the FDA advis­ers’ meet­ing, the agency autho­rized the Mod­er­na biva­lent vac­cines. The Mod­er­na infec­tion data was includ­ed in the agency’s writ­ten deci­sion, but it wasn’t post­ed online until Sep­tem­ber 13, accord­ing to Fel­ber­baum, the FDA spokesman.

On Sep­tem­ber 1, the CDC advis­ers – 14 vot­ing mem­bers – met to con­sid­er whether to rec­om­mend the biva­lent boost­ers for Amer­i­cans to get in the fall. Sev­er­al CDC sci­en­tists pre­sent­ed data at that meet­ing but did not include the infec­tion data.

Nord­lund, the CDC spokes­woman, said in her email that the “CDC was aware” of the data that would lat­er be pub­lished in The New Eng­land Jour­nal of Med­i­cine but that assess­ing infec­tions was an “explorato­ry objec­tive of the study,” which was “not designed to assess vac­cine effec­tive­ness.” She added that in assess­ing infec­tions, “researchers used dif­fer­ent dura­tions and points in time among a very small group of peo­ple,” and because of the lim­i­ta­tions of the data, it was not fea­tured at the meet­ing.

“CDC vac­cine rec­om­men­da­tions are made fol­low­ing an eval­u­a­tion and pre­sen­ta­tion of high-qual­i­ty vac­cine effi­ca­cy or immuno­bridg­ing data,” Nord­lund wrote.

Dr. William Schaffn­er, a non-vot­ing mem­ber of the CDC’s advi­so­ry com­mit­tee, called Nordlund’s argu­ment “very weak.”

“The data are lim­it­ed, but they are infor­ma­tive, and I think one would have antic­i­pat­ed that a com­plete pre­sen­ta­tion would have includ­ed them,” said Schaffn­er, an infec­tious dis­ease spe­cial­ist at Van­der­bilt Uni­ver­si­ty Med­ical Cen­ter.
...

And at that Sep­tem­ber 1 CDC meet­ing, we again find some­one from Mod­er­na pro­mot­ing the results of the com­pa­ny’s preprint­ed study but still leav­ing out the infec­tion data from that same study. There’s just no deny­ing this was a gross coverup:

...
Dr. Jacque­line Miller, a senior vice pres­i­dent at Mod­er­na, pre­sent­ed to the advis­ers. Like her col­league Hoge, the com­pa­ny pres­i­dent, she showed mate­r­i­al sug­gest­ing that the biva­lent vac­cine was supe­ri­or and did not show slides detail­ing the sta­tis­tics about the infec­tion rates, accord­ing to a copy of the slides she pre­sent­ed.

Sev­er­al hours into the meet­ing, one of the CDC advis­ers, Dr. Sybil Cineas, an asso­ciate pro­fes­sor of med­i­cine at the War­ren Alpert Med­ical School of Brown Uni­ver­si­ty, asked Miller about cas­es of Covid-19 among study sub­jects who received the orig­i­nal vac­cine ver­sus the updat­ed biva­lent boost­er.

Miller said that among sub­jects with no evi­dence of pri­or infec­tion, as well as those with evi­dence of pri­or infec­tion, the dis­ease inci­dence rates were 2.4% for the group who received the orig­i­nal vac­cine and 2.5% for those who got the biva­lent boost­er.

That data would be pub­lished two weeks lat­er in The New Eng­land Jour­nal of Med­i­cine.

When she answered Cineas’ ques­tion, Miller did not men­tion oth­er aspects of the infec­tion data in the pub­lished study. That data indi­cat­ed that among hun­dreds of par­tic­i­pants with no pre­vi­ous Covid-19 infec­tions, infec­tion occurred in 1.9% of those who’d received the old vac­cine and in 3.2% of those who’d received the new biva­lent vac­cine. She also did not men­tion break­downs of whether par­tic­i­pants were sick with Covid or had asymp­to­matic ill­ness­es. The study, like the preprint, did not men­tion whether any of these find­ings were sta­tis­ti­cal­ly sig­nif­i­cant.
...

Even Dr. Philip Krause — who served as deputy direc­tor of the FDA’s Office of Vac­cine Research and Review until he resigned in Octo­ber 2021 — is call­ing the FDA’s deci­sion a fail­ure that rais­es ques­tions about the abil­i­ty of the process to oper­ate trans­par­ent­ly:

...
A for­mer FDA sci­en­tist who helped run the agency’s vac­cine divi­sion told CNN that if he were still at the agency, he would have advo­cat­ed for shar­ing the infec­tion infor­ma­tion with the advis­ers, even if it was made avail­able only a short time before the meet­ing.

“I don’t think there’s any excuse for exclud­ing it,” even with its imper­fec­tions, said Dr. Philip Krause, who served as deputy direc­tor of the FDA’s Office of Vac­cine Research and Review until he resigned in Octo­ber 2021.

“The company’s fail­ure to present this infor­ma­tion at the [FDA advis­ers meet­ing] and the omis­sion of dis­cus­sion about the data at that meet­ing rais­es ques­tions about the abil­i­ty of the process to pro­vide a full and trans­par­ent review of the data,” he added.
...

And as Dr. Paul Offit — one of two mem­ber of the 19-mem­ber FDA advi­so­ry pan­el to vote against approv­ing the biva­lent vac­cine — reminds us, the whole pur­pose of giv­ing all the rel­e­vant data to an inde­pen­dent advi­so­ry pan­el is to have an out­side group of experts weigh­ing in on these deci­sions. In oth­er words, they cor­rupt­ed the integri­ty of the process:

...
FDA and CDC vac­cine advis­ers echoed Krause’s con­cerns about trans­paren­cy.

“I think that as much data that’s avail­able should be made pub­lic and avail­able for dis­cus­sion by advi­so­ry groups so that the pub­lic can see, yes, the avail­able sci­ence has been eval­u­at­ed as best as [pos­si­ble] at that par­tic­u­lar time,” said Bern­stein, the mem­ber of the FDA advi­so­ry com­mit­tee.

Bern­stein added that he was dis­ap­point­ed that the data had not been pre­sent­ed to him and the oth­er advis­ers.

Offit, the mem­ber from the Uni­ver­si­ty of Penn­syl­va­nia, said he was angry.

“I was angry to find out that there was data that was rel­e­vant to our deci­sion that I didn’t get to see. Angry because they should trust us to make the deci­sion based on all the data. These agen­cies, whether it’s the FDA or CDC, can’t make that deci­sion for us. That’s the point of hav­ing an inde­pen­dent advi­so­ry com­mit­tee,” he said.
...

And then we get to the inde­pen­dent study that came out in Octo­ber that found basi­cal­ly no dif­fer­ence between the orig­i­nal mRNA Mod­er­na vac­cine and the biva­lent boost­er. As Dr. Offit describes, it’s the kind of expe­ri­ence that shook his faith in the whole process:

...
About a month after the CDC advis­ers met, stud­ies were released from researchers at Har­vard and Colum­bia sug­gest­ing that the new vac­cines didn’t work any bet­ter than the orig­i­nal.

Those stud­ies, which were very small and only in preprint and not in a med­ical jour­nal, mea­sured immune respons­es after peo­ple got the biva­lent vac­cine com­pared with the orig­i­nal ver­sion of the vac­cine.

“We essen­tial­ly see no dif­fer­ence” between the old boost­ers and the new about a month after the shot, said Dr. David Ho, a pro­fes­sor of micro­bi­ol­o­gy and immunol­o­gy at Colum­bia whose team authored one of the stud­ies.

...

Offit, the FDA vac­cine advis­er, said the Colum­bia and Har­vard stud­ies con­vinced him even more that the infec­tion data and all the relat­ed caveats should have been giv­en to the advis­ers from the begin­ning.

“This was not accept­able. I under­stand we’re in the mid­dle of a pan­dem­ic. I under­stand we’re build­ing the plane while it’s still in the air, but you can’t do this,” he said. “It did shake my faith. It shook my faith in how these deci­sions were being made.”
...

So are bet­ter-pow­ered stud­ies on the way that can at least cre­ate some clar­i­ty on these ques­tions and vac­cine effec­tive­ness? Well, Mod­er­na still has­n’t released data from a ran­dom­ized Phase 3 tri­al com­par­ing infec­tions in par­tic­i­pants who received the new boost­er with those who received the old shot. But we can expect those results “short­ly”. And Pfiz­er just isn’t ask­ing the ques­tion it seems. Although recall how the com­pa­ny released a study back in Octo­ber tout­ing how its boost­er lift­ed anti­body lev­els while neglect­ing to pro­vide data on shot’s effi­ca­cy. In oth­er words, don’t held your breath:

...
More than six months after the FDA advis­ers met, Mod­er­na still has not released data from a ran­dom­ized Phase 3 tri­al com­par­ing infec­tions in par­tic­i­pants who received the new boost­er with those who received the old shot. The com­pa­ny expects to release such results “short­ly” with about 3,000 par­tic­i­pants, accord­ing to Rid­ley.

Pfiz­er does not “cur­rent­ly have data on inci­dence of infec­tion post biva­lent boost­er. How­ev­er, we con­tin­ue to mon­i­tor real-world data and col­lect data from our own stud­ies,” accord­ing to a state­ment from Jer­i­ca Pitts, senior direc­tor of glob­al media rela­tions.
...

Final­ly, let’s just keep in mind one of the oth­er dis­turb­ing details in this sto­ry: these mRNA boost­ers are cur­rent­ly the ONLY boost­ers avail­able in the US:

...
At the end of the meet­ing, the CDC advis­ers vot­ed 13–1 in favor of rec­om­mend­ing the biva­lent boost­er, with Sanchez, a pro­fes­sor of pedi­atrics at the Ohio State Uni­ver­si­ty Col­lege of Med­i­cine, vot­ing in oppo­si­tion. CDC Direc­tor Dr. Rochelle Walen­sky signed off on the rec­om­men­da­tion lat­er that day, and the vac­cines were made avail­able to the pub­lic. Cur­rent­ly, they are the only boost­er avail­able once some­one has had their pri­ma­ry series of a Covid-19 vac­cine.
...

Want a boost­er? Well, you can choose between the Mod­er­na mRNA boost­er that was appar­ent­ly cod­dled through the whole approval process. Or the Pfiz­er boost­er, which basi­cal­ly got to pig­gy-back off of Mod­er­na’s favored sta­tus. Despite the array of COVID vac­cines that have been devel­oped in recent years, those are the only two read­i­ly avail­able boost­er options today in the US. Fun­ny how that hap­pened.

@Pterrafractyl–

Bril­liant, impor­tant, inci­sive!

Great, great work!

Best,

Dave

The per­ils of reg­u­la­to­ry cap­ture is noth­ing new for the US. Per­ils that have become all the more acute in the era of COVID and the num­ber of ques­tions that have already arisen over the reg­u­la­to­ry treat­ment of the var­i­ous COVID vac­cines. Reg­u­la­to­ry treat­ment that, as we’ve seen, seems to be heav­i­ly weight­ed towards push­ing as many peo­ple into tak­ing the mRNA COVID vac­cines as pos­si­ble. Favoritism that man­i­fest­ed as both approval the mRNA vac­cines despite shaky safe­ty evi­dence while simul­ta­ne­ous­ly block­ing or lim­it­ing the approval of non-mRNA alter­na­tives for high­ly ques­tion­able rea­sons. For exam­ple, there was that dis­turb­ing report from back in Jan­u­ary about how the FDA, CDC, and Mod­er­na all seemed to col­lude in with­hold­ing from an inde­pen­dent advi­so­ry pan­el unflat­ter­ing data about the effi­ca­cy of the new biva­lent COVID vac­cines. And then there was the FDA deci­sion back in May of 2022 that effec­tive­ly killed the J&J vac­cine as as pub­lic option after warn­ing the pub­lic away from the J&J vac­cine based on some very rare side effects, despite evi­dence that the J&J vac­cine pro­vid­ed bet­ter long-term defens­es against COVID.

But the J&J vac­cine was just one of the non-mRNA alter­na­tives made avail­able in the US. US-based Novavax already released its own pro­tein-based COVID vac­cine. And yet that vac­cine was only giv­en emer­gency autho­riza­tion approval for pri­ma­ry shots in July of 2022 and emer­gency autho­riza­tion for a first boost­er shot in Octo­ber of 2022. But ONLY the first boost­er shot. There remains NO non-mRNA vac­cines avail­able for addi­tion­al boost­er shots in the US to this day. It’s a sit­u­a­tion that just screams “Reg­u­la­to­ry Cap­ture!”

That ongo­ing reg­u­la­to­ry cap­ture is a big part of the con­text of the fol­low­ing arti­cles. And not just the reg­u­la­to­ry cap­ture of the US gov­ern­ment. It turns out the EU is expe­ri­enc­ing a COVID reg­u­la­to­ry-cap­ture scan­dal of its own. A scan­dal cen­tered around none oth­er then EU Com­mis­sions Pres­i­dent Ursu­la von der Leyen. Yep, it turns out that von der Leyen and Pfiz­er CEO Albert Bourla were exchang­ing text mes­sages in the lead up to a mas­sive multi­bil­lion euro con­tract to pur­chase mil­lions of mRNA COVID vac­cines. Text mes­sage that the EU par­lia­ment has a keen inter­est in review­ing. But nei­ther von der Leyen nor Bourla has any inter­est in hand­ing them over.

In response, the par­lia­men­tary COVID-19 com­mit­tee issues for­mal invites to both von der Leyen and Bourla back in Jan­u­ary to pub­licly answer ques­tions about these mes­sages and the con­tracts. The prob­lem is these are non-legal­ly-bind­ing invites and both refused. So are the con­tents of those text mes­sages going to remain a secret for­ev­er? Sort of. We got an update on this par­lia­men­tary stand­off between von der Leyen and the par­lia­ment a cou­ple of weeks ago: first, the New York Times launched a law­suit against the EU Com­mis­sion to force the release of the texts. Then, a few days lat­er, we learned that the Con­fer­ence of Presidents—the EU Parliament’s polit­i­cal lead­ers— decid­ed to sim­ply hold ‘an exchange of views’ with Ursu­la von der Leyen in a pri­vate ses­sion. It’s not a great look.

So while ques­tions about the reg­u­la­to­ry cap­ture of the US vac­cine mar­kets don’t appear to be going away any time soon, we can’t for­get that the EU isn’t immune to reg­u­la­to­ry cap­ture of its own. But there’s anoth­er angle here to keep in mind: Pfiz­er pre­sum­ably isn’t the only enti­ty that was involved with lob­by­ing von der Leyen in the lead up to that mas­sive con­tract. Pfiz­er’s part­ner in the vac­cine, after all, is Ger­man biotech start­up BioN­Tech. And as we’ve seen, while BioN­Tech is typ­i­cal­ly described as a small Ger­man start­up firm, its insti­tu­tion­al investors include fig­ures like the twin broth­ers Thomas and Andreas Stru­eng­mann, who have deep ties to the Ger­man biotech indus­try.

What kind of lob­by­ing role is BioN­Tech’s insti­tu­tion­al investor com­mu­ni­ty play­ing in the lob­by­ing of gov­ern­ments over COVID vac­cine poli­cies? It’s a ques­tion that’s been asked quite a bit when it comes to Mod­er­na and Pfiz­er, not so much BioN­Tech. And yet, it’s hard to imag­ine Pfiz­er was the only enti­ty swap­ping texts with von der Leyen about a mas­sive EU vac­cine pur­chase. Why would­n’t BioN­Tech have been involved with lob­by­ing the EU Com­mis­sion Pres­i­dent who hap­pens to hale from Ger­many? Espe­cial­ly when she is noto­ri­ous being a cor­rupt cor­po­rate shill.

Oh, and as the fol­low­ing arti­cle warns, it turns out Novavax is at risk of going bank­rupt this year, thanks in part to the US gov­ern­men­t’s refusal to grant it more than just emer­gency autho­riza­tion sta­tus. So the the only remain­ing com­pa­ny mak­ing a non-mRNA vac­cine read­i­ly avail­able in the mar­ket in the US is prob­a­bly going out of busi­ness. Great news for Mod­er­na and Pfizer/BioNTech. Even bet­ter news dur­ing the next pan­dem­ic. Also keep in mind that, while the Novavax vac­cine was already approved by the Euro­pean Union, Cana­da, South Korea, Aus­tralia, New Zealand and Indone­sia as for May of 2022, months before US reg­u­la­tors gave their ini­tial emer­gency approval, Novavax won’t be pro­vid­ed too many more vac­cines to the EU after it goes out of busi­ness either.

It’s just the lat­est exam­ple of how the reg­u­la­to­ry cap­ture of the vac­cine mar­kets isn’t just a lin­ger­ing prob­lem but a grow­ing one. And not just in the US, appar­ent­ly.

Ok, first, here’s a look at the warn­ing just issued by Novavax a few days ago. A warn­ing the “sig­nif­i­cant uncer­tain­ty” fac­ing the com­pa­ny. Sig­nif­i­cant uncer­tain­ty over whether or not the com­pa­ny will even sur­vive the year:

Bar­ron’s

Novavax Says There Is ‘Sub­stan­tial Doubt’ Around Its Abil­i­ty to Con­tin­ue Oper­at­ing This Year

By Josh Nathan-Kazis
Feb. 28, 2023 4:02 pm ET

Covid-19 vac­cine man­u­fac­tur­er Novavax said Tues­day that there is “sub­stan­tial doubt” about its abil­i­ty to con­tin­ue oper­at­ing through this year.

In a quar­ter­ly earn­ings report issued after the mar­ket closed, the com­pa­ny said that it expects to have enough cash to fund its oper­a­tions through the year, but that expec­ta­tion is “sub­ject to sig­nif­i­cant uncer­tain­ty” relat­ed to 2023 rev­enues, among oth­er fac­tors.

“Giv­en these uncer­tain­ties, sub­stan­tial doubt exists regard­ing our abil­i­ty to con­tin­ue as a going con­cern through one year from the date that these finan­cial state­ments are issued,” Novavax (tick­er: NVAX) said in its state­ment.

Novavax report­ed a net loss of $658 mil­lion in 2022. Rev­enues for 2022 were $2 bil­lion, while expens­es were $2.6 bil­lion. The com­pa­ny had $1.3 bil­lion in cash and cash equiv­a­lents at the end of 2022.

Those results are worse than the full-year guid­ance Novavax laid out in ear­ly 2022. At the time, the com­pa­ny said it expect­ed 2022 rev­enues of between $4 bil­lion and $5 bil­lion, though it ratch­eted those expec­ta­tions down over the course of the year.

While Novavax sold 3.2 mil­lion dos­es of its Covid-19 vac­cine to the U.S. gov­ern­ment last July, and anoth­er 1.5 mil­lion dos­es in Jan­u­ary, those U.S. con­tracts will like­ly dry up as the coun­try switch­es to a com­mer­cial mar­ket for the Covid-19 vac­cines.

The move to a com­mer­cial mar­ket will force Novavax to com­pete direct­ly against the far-bet­ter-resourced Pfiz­er (PFE) and Mod­er­na (MRNA), cast­ing sig­nif­i­cant ques­tions over its 2023 rev­enues. Pfiz­er and Mod­er­na are both fore­cast­ing big dips in their 2023 Covid-19 vac­cine rev­enues; unlike those com­pa­nies, Novavax has nei­ther a mas­sive war chest nor a broad port­fo­lio of oth­er drugs to fall back on.

Novavax shares were down 10% so far this year as of 2:30 p.m. on Tues­day, and 89% over the past 12 months.

...

Despite promis­ing clin­i­cal data, Novavax has strug­gled to bring its Covid-19 vac­cine to mar­ket, and it sub­stan­tial­ly lags behind its com­peti­tors. While the Mod­er­na and Pfiz­er Covid-19 vac­cines both have full approval from the Food and Drug Admin­is­tra­tion, Novavax’s Covid-19 vac­cine remains avail­able only under an emer­gency use autho­riza­tion. What’s more, it is only autho­rized as a boost­er for peo­ple who can­not or won’t take an mRNA-based vac­cine.

Only 80,000 dos­es of the Novavax vac­cine have been admin­is­tered in the U.S., com­pared with hun­dreds of mil­lions of dos­es of Mod­er­na and Pfiz­er, accord­ing to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion.

Barron’s wrote in Jan­u­ary that Novavax has an oppor­tu­ni­ty to under­cut Mod­er­na and Pfiz­er by offer­ing its vac­cine at sharply low­er prices than the mRNA-based vac­cine man­u­fac­tur­ers have dis­cussed.

“The big guys are kind of set­ting the price points at this point,” John Trizzi­no, Novavax’s chief com­mer­cial offi­cer, told Barron’s at the time. “We’re not going to be yet dis­clos­ing what our pric­ing strat­e­gy is. It’s a lever we will use to our advan­tage based on a vari­ety of oth­er fac­tors.”

That strat­e­gy, how­ev­er, is con­tin­gent on the com­pa­ny stay­ing in busi­ness. That’s no longer a giv­en.

————

“Novavax Says There Is ‘Sub­stan­tial Doubt’ Around Its Abil­i­ty to Con­tin­ue Oper­at­ing This Year” By Josh Nathan-Kazis; Bar­ron’s; 02/28/2023

“In a quar­ter­ly earn­ings report issued after the mar­ket closed, the com­pa­ny said that it expects to have enough cash to fund its oper­a­tions through the year, but that expec­ta­tion is “sub­ject to sig­nif­i­cant uncer­tain­ty” relat­ed to 2023 rev­enues, among oth­er fac­tors.”

Will Novavax even be in busi­ness a year from now? Who knows? There’s already “sig­nif­i­cant uncer­tain­ty” about that very ques­tion. The kind of “sig­nif­i­cant uncer­tain­ty” Novavax’s deep-pock­et­ed com­peti­tors like Mod­er­na and Pfiz­er don’t have to wor­ry about. As a result, the US COVID vac­cine mar­ket is poised to go from almost entire­ly dom­i­nat­ed by the mRNA vac­cines to entire­ly dom­i­nat­ed:

...
While Novavax sold 3.2 mil­lion dos­es of its Covid-19 vac­cine to the U.S. gov­ern­ment last July, and anoth­er 1.5 mil­lion dos­es in Jan­u­ary, those U.S. con­tracts will like­ly dry up as the coun­try switch­es to a com­mer­cial mar­ket for the Covid-19 vac­cines.

The move to a com­mer­cial mar­ket will force Novavax to com­pete direct­ly against the far-bet­ter-resourced Pfiz­er (PFE) and Mod­er­na (MRNA), cast­ing sig­nif­i­cant ques­tions over its 2023 rev­enues. Pfiz­er and Mod­er­na are both fore­cast­ing big dips in their 2023 Covid-19 vac­cine rev­enues; unlike those com­pa­nies, Novavax has nei­ther a mas­sive war chest nor a broad port­fo­lio of oth­er drugs to fall back on.

Novavax shares were down 10% so far this year as of 2:30 p.m. on Tues­day, and 89% over the past 12 months.
...

And note the under­ly­ing rea­son Novavax’s finan­cial future remains in doubt: US reg­u­la­tors are still refus­ing to give the vac­cine the same ‘full approval’ giv­en to the Mod­er­na and Pfiz­er mRNA vac­cines despite promis­ing clin­i­cal data. And, again, note that it’s not just that the Novavax vac­cine is only autho­rized as a boost­er for peo­ple who refuse the mRNA vac­cines in the US. That only applies to the first boost­er fol­low­ing your pri­ma­ry vac­ci­na­tion. The Novavax vac­cine remains unavail­able for any fol­low up boost­ers in the US. That’s on top of the FDA’s advi­so­ry back in May of 2022 that effec­tive­ly warned the pub­lic away from the J&J vac­cine based on some very rare side effects, despite evi­dence that the J&J vac­cine pro­vid­ed bet­ter long-term defens­es against COVID. The mRNA vac­cines of Mod­er­na and Pfiz­er remain the only boost­ers avail­able in the US after your ini­tial boost­er. That’s part of the con­text of this warn­ing from Novavax: there’s is still only mRNA vac­cines avail­able in the US after you’ve received a boost­er. It’s as if US reg­u­la­tors are intent on ensur­ing there’s no oth­er option and every­one either has to take an mRNA vac­cine or go unvac­ci­nat­ed. Why?

...

Despite promis­ing clin­i­cal data, Novavax has strug­gled to bring its Covid-19 vac­cine to mar­ket, and it sub­stan­tial­ly lags behind its com­peti­tors. While the Mod­er­na and Pfiz­er Covid-19 vac­cines both have full approval from the Food and Drug Admin­is­tra­tion, Novavax’s Covid-19 vac­cine remains avail­able only under an emer­gency use autho­riza­tion. What’s more, it is only autho­rized as a boost­er for peo­ple who can­not or won’t take an mRNA-based vac­cine.

Only 80,000 dos­es of the Novavax vac­cine have been admin­is­tered in the U.S., com­pared with hun­dreds of mil­lions of dos­es of Mod­er­na and Pfiz­er, accord­ing to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion.
...

And note the oth­er per­verse side effect of Novavax’s finan­cial per­il: Novavax was basi­cal­ly the only mar­ket com­pe­ti­tion Mod­er­na and Pfiz­er faced in the US now that the cost of COVID vac­cines is no longer being cov­ered by the gov­ern­ment:

...
Barron’s wrote in Jan­u­ary that Novavax has an oppor­tu­ni­ty to under­cut Mod­er­na and Pfiz­er by offer­ing its vac­cine at sharply low­er prices than the mRNA-based vac­cine man­u­fac­tur­ers have dis­cussed.

...

That strat­e­gy, how­ev­er, is con­tin­gent on the com­pa­ny stay­ing in busi­ness. That’s no longer a giv­en.
...

It’s like Mod­er­na of Pfiz­er can’t lose in the US. Again, are we look­ing at reg­u­la­to­ry cap­ture? And if so, who are the main play­ers in dri­ving this? Mod­er­na? Pfiz­er? The gov­ern­ment agen­cies that part­nered on devel­op­ing these tech­nolo­gies? A group effort?

And let’s not for­get one of the oth­er actors in this space: Pfiz­er part­ner BioN­Tech. As we’ve seen, while BioN­Tech is typ­i­cal­ly described as a small Ger­man start­up firm, its insti­tu­tion­al investors include fig­ures like the twin broth­ers Thomas and Andreas Stru­eng­mann, who have deep ties to the Ger­man biotech indus­try. What role might BioN­Tech’s pow­er­ful insti­tu­tion­al investors be play­ing in any sort of shady deal­ings with gov­ern­ments regard­ing COVID vac­cine poli­cies?

Those are just some of the ques­tions raised in a scan­dal that’s been slow­ly unfold­ing for months now. An EU scan­dal focused on none oth­er than EU Com­mis­sion Pres­i­dent Ursu­la von der Leyen. Specif­i­cal­ly, text mes­sages exchanged between von der Leyen and Pfiz­er CEO Albert Bourla in the lead up to a mas­sive multi­bil­lion euro pur­chase of the Pfizer/BioNTech mRNA vac­cine. Law­mak­ers have a num­ber of ques­tions about that con­tract. But — sur­prise! — it turns out nei­ther von der Leyen nor Bourla has any inter­est in shar­ing those texts. In response, the EU COVID-19 par­lia­men­tary com­mit­tee issued ‘invi­ta­tions’ to von der Leyen and Bourla to pub­licly explain these con­tracts beck in Jan­u­ary. Invi­a­tions that, as we’ll see, are non-bind­ing invi­ta­tions both can refuse. Take a guess was to how that played out:

Politico.eu

MEPs want to grill von der Leyen over Pfiz­er vac­cine con­tract

The Euro­pean Parliament’s COVID-19 com­mit­tee will ask the Euro­pean Com­mis­sion pres­i­dent to appear before the pan­el.

By Car­lo Mar­tus­cel­li
Jan­u­ary 11, 2023 5:31 pm CET

An unwant­ed invite may soon be land­ing in Ursu­la von der Leyen’s mail­box.

The MEPs lead­ing the Euro­pean Par­lia­men­t’s COVID-19 com­mit­tee have decid­ed to ask the pres­i­dent of the Euro­pean Com­mis­sion to appear pub­licly in front of the pan­el, accord­ing to a state­ment sent exclu­sive­ly to POLITICO by the com­mit­tee’s chair, Bel­gian MEP Kath­leen Van Brempt.

Law­mak­ers want to ask von der Leyen about her role nego­ti­at­ing a mas­sive, multi­bil­lion euro coro­n­avirus vac­cine con­tract signed at the height of the pan­dem­ic. It was in the run-up to this con­tract that she is report­ed to have exchanged text mes­sages with Pfiz­er’s Chief Exec­u­tive Albert Bourla.

“The Euro­pean Union has spent a lot of pub­lic resources into the pro­duc­tion and pur­chase of vac­cines dur­ing the pan­dem­ic,” Van Brempt said in the state­ment. “[T]he Par­lia­ment has the right to obtain full trans­paren­cy on the modal­i­ties of these expen­di­tures and the pre­lim­i­nary nego­ti­a­tions lead­ing up to them.”

So far, the Com­mis­sion Pres­i­dent has dodged ques­tions about what went down in those cru­cial months.

Nei­ther the EU’s ombuds­man or the Court of Audi­tors have been able to shed a light on the murky deal­ings. The Euro­pean Pub­lic Pros­e­cu­tor’s Office, which is armed with legal pow­ers that the oth­er watch­dog agen­cies lack, has opened an inves­ti­ga­tion into the vac­cine con­tracts, with­out say­ing whether the Com­mis­sion Pres­i­dent is its tar­get.

The COVID pan­el has been look­ing into the deal — the third and largest con­tract signed with Pfiz­er and its Ger­man part­ner BioN­Tech — and has so far heard from both the Court of Audi­tors and the ombuds­man. But Bourla refused the sum­mons, send­ing an under­ling in his stead.

Fol­low­ing the Par­lia­men­t’s rules, the invite will be sent to Par­lia­ment Pres­i­dent Rober­ta Met­so­la, who will decide then whether to ask von der Leyen to attend the hear­ing. Met­so­la is a mem­ber of the cen­ter-right Euro­pean Peo­ple’s Par­ty group, the same one that placed the Com­mis­sion Pres­i­dent in her role.

The invi­ta­tion, if it does arrive, does­n’t have any legal force. Like Bourla, von der Leyen can refuse to appear. But with calls for greater trans­paren­cy grow­ing loud­er as the Qatar­gate cor­rup­tion scan­dal engulfs Brus­sels, she may feel like she can’t say no.

It’s not just von der Leyen who is in the MEPs’ crosshairs. Van Brempt said in her state­ment that the com­mit­tee would also ask to revoke Pfiz­er’s Euro­pean Par­lia­ment access priv­i­leges in response to Bourla’s refusal to tes­ti­fy. It’s hap­pened in the past: Law­mak­ers vot­ed to ban Mon­san­to lob­by­ists in 2017 after the com­pa­ny refused to turn up to a hear­ing. But it’s not auto­mat­ic — the deci­sion would have to be approved through the Par­lia­men­t’s inter­nal process­es. And indi­vid­ual MEPs can con­tin­ue to sign in Pfiz­er lob­by­ists as pri­vate guests.

...

———-

“MEPs want to grill von der Leyen over Pfiz­er vac­cine con­tract” By Car­lo Mar­tus­cel­li; Politico.eu; 01/11/2023

“Law­mak­ers want to ask von der Leyen about her role nego­ti­at­ing a mas­sive, multi­bil­lion euro coro­n­avirus vac­cine con­tract signed at the height of the pan­dem­ic. It was in the run-up to this con­tract that she is report­ed to have exchanged text mes­sages with Pfiz­er’s Chief Exec­u­tive Albert Bourla.”

What hap­pened to the text mes­sages exchanged between EU Com­mis­sion Pres­i­dent Ursu­la von dery Leyen and Pfiz­er CEO Albert Bourla exchanged dur­ing the lead up to the mas­sive multi­bil­lion euro vac­cine con­tract? *Poof* All gone. But it’s not just that law­mak­ers can’t get their hands on those texts. They can’t get a straight answer from either von der Leyen or Bourla, who both resist­ed par­lia­men­tary invi­ta­tion to explain their actions. It’s not just a cov­er up. It’s a cov­er up being done right out in the open:

...
“The Euro­pean Union has spent a lot of pub­lic resources into the pro­duc­tion and pur­chase of vac­cines dur­ing the pan­dem­ic,” Van Brempt said in the state­ment. “[T]he Par­lia­ment has the right to obtain full trans­paren­cy on the modal­i­ties of these expen­di­tures and the pre­lim­i­nary nego­ti­a­tions lead­ing up to them.”

So far, the Com­mis­sion Pres­i­dent has dodged ques­tions about what went down in those cru­cial months.

Nei­ther the EU’s ombuds­man or the Court of Audi­tors have been able to shed a light on the murky deal­ings. The Euro­pean Pub­lic Pros­e­cu­tor’s Office, which is armed with legal pow­ers that the oth­er watch­dog agen­cies lack, has opened an inves­ti­ga­tion into the vac­cine con­tracts, with­out say­ing whether the Com­mis­sion Pres­i­dent is its tar­get.

The COVID pan­el has been look­ing into the deal — the third and largest con­tract signed with Pfiz­er and its Ger­man part­ner BioN­Tech — and has so far heard from both the Court of Audi­tors and the ombuds­man. But Bourla refused the sum­mons, send­ing an under­ling in his stead.

Fol­low­ing the Par­lia­men­t’s rules, the invite will be sent to Par­lia­ment Pres­i­dent Rober­ta Met­so­la, who will decide then whether to ask von der Leyen to attend the hear­ing. Met­so­la is a mem­ber of the cen­ter-right Euro­pean Peo­ple’s Par­ty group, the same one that placed the Com­mis­sion Pres­i­dent in her role.

The invi­ta­tion, if it does arrive, does­n’t have any legal force. Like Bourla, von der Leyen can refuse to appear. But with calls for greater trans­paren­cy grow­ing loud­er as the Qatar­gate cor­rup­tion scan­dal engulfs Brus­sels, she may feel like she can’t say no.
...

That as the sta­tus of the inquiry back in Jan­u­ary. Flash for­ward to a cou­ple of weeks ago and we got the fol­low­ing updates: First, the New York Times was suing the EU Com­mis­sion for the release of the texts. Then, a cou­ple days lat­er, we are informed that the Con­fer­ence of Presidents—the EU Parliament’s polit­i­cal lead­ers— decid­ed to sim­ply hold ‘an exchange of views’ with Ursu­la von der Leyen in a pri­vate ses­sion:

The Euro­pean Con­ser­v­a­tive

Noth­ing To Hide? Von der Leyen To Be Ques­tioned Behind Closed Doors

Calls for trans­paren­cy in the EU insti­tu­tions are only grow­ing loud­er in the wake of Qatar­gate. As such, this new deci­sion for pri­vate ques­tion­ing will dam­age the cred­i­bil­i­ty of the EU Par­lia­ment.

Tad­hg Pid­geon
— Feb­ru­ary 16, 2023

Ursu­la von der Leyen will like­ly be ques­tioned by EU par­lia­men­tary offi­cials behind closed doors for her role in the EU’s vac­cine pro­cure­ment deal, anony­mous sources close to the EP admin­is­tra­tion have just revealed to The Euro­pean Con­ser­v­a­tive. Many MEPs had been call­ing for a trans­par­ent inves­ti­ga­tion of the Com­mis­sion president’s actions, but it appears they will not get their way.

The EU Parliament’s COVID-19 Com­mit­tee vot­ed last month to invite von der Leyen to pub­licly answer ques­tions from the pan­el. By pro­ce­dure, the invi­ta­tion was for­ward­ed for a deci­sion to the pres­i­dent of the par­lia­ment, Rober­ta Met­so­la.

Instead, the Con­fer­ence of Presidents—the EU Parliament’s polit­i­cal leaders—have just now, at their meet­ing with Met­so­la, decid­ed to sim­ply hold ‘an exchange of views’ with Ursu­la von der Leyen in a pri­vate ses­sion.

Sources also con­firmed that at the Con­fer­ence, only rep­re­sen­ta­tives of the ECR and ID Groups protest­ed against the deci­sion, on the grounds that the inquiry should be held open­ly and include more MEPs—which a ques­tion­ing in front of the COVID com­mit­tee would have done.

This comes as the Euro­pean Com­mis­sion is being tak­en to court by the New York Times for fail­ing to release the text mes­sages between Pres­i­dent von der Leyen and Pfiz­er CEO Albert Bourla. Addi­tion­al­ly, French and Ital­ian media have point­ed out that her hus­band Heiko von der Leyen was a sci­en­tif­ic direc­tor at Orge­n­e­sis, a Pfiz­er sub­sidiary, which received some €320 mil­lion in funds from the Ital­ian gov­ern­ment, rais­ing sus­pi­cions that the agree­ment between the Com­mis­sion pres­i­dent and Pfiz­er may have been self-serv­ing.

...

COVID-19 Com­mit­tee chair, Social­ist MEP Kath­leen Van Brempt, insist­ed a clear account­ing be made of EU expens­es:

The Euro­pean Union has spent a lot of pub­lic resources on the pro­duc­tion and pur­chase of vac­cines dur­ing the pan­dem­ic, the Par­lia­ment has the right to obtain full trans­paren­cy on the modal­i­ties of these expen­di­tures and the pre­lim­i­nary nego­ti­a­tions lead­ing up to them.

Anoth­er active mem­ber of the com­mit­tee, Cris­t­ian Tehre, a Roman­ian MEP with the ECR Group, called into ques­tion von der Leyen’s integri­ty:

The man­date of Ursu­la von der Leyen as pres­i­dent of the Euro­pean Com­mis­sion is a com­plete fail­ure. Her refusal to dis­close the con­tracts, as well as her back door deals, to not come and answer ques­tions from MEPs in an open ses­sion proves that she is total­ly unfit for the job. She has to come into the Par­lia­ment and answer ques­tions in a pub­lic ses­sion in the COVID Com­mit­tee not because we say so, but because it is the right thing to do.

In short, if there is noth­ing to hide, why is von der Leyen hid­ing?

————

“Noth­ing To Hide? Von der Leyen To Be Ques­tioned Behind Closed Doors” by Tad­hg Pid­geon; The Euro­pean Con­ser­v­a­tive; 02/16/2023

“Instead, the Con­fer­ence of Presidents—the EU Parliament’s polit­i­cal leaders—have just now, at their meet­ing with Met­so­la, decid­ed to sim­ply hold ‘an exchange of views’ with Ursu­la von der Leyen in a pri­vate ses­sion.”

They tried to get Ursu­la von der Leyen to pub­licly answer these ques­tions. The EU Parliament’s COVID-19 Com­mit­tee vot­ed back in Jan­u­ary to make the invi­ta­tion for a pub­lic response. An invi­ta­tion that, as we saw above, von der Leyen had no legal oblig­a­tion to com­ply with. And it appears she used that pow­er to refuse the invite with this report from a cou­ple of weeks ago about the “Con­fer­ence of Pres­i­dents” decid­ing to instead hold a pri­vate ‘exchange of views’:

...
The EU Parliament’s COVID-19 Com­mit­tee vot­ed last month to invite von der Leyen to pub­licly answer ques­tions from the pan­el. By pro­ce­dure, the invi­ta­tion was for­ward­ed for a deci­sion to the pres­i­dent of the par­lia­ment, Rober­ta Met­so­la.

...

This comes as the Euro­pean Com­mis­sion is being tak­en to court by the New York Times for fail­ing to release the text mes­sages between Pres­i­dent von der Leyen and Pfiz­er CEO Albert Bourla. Addi­tion­al­ly, French and Ital­ian media have point­ed out that her hus­band Heiko von der Leyen was a sci­en­tif­ic direc­tor at Orge­n­e­sis, a Pfiz­er sub­sidiary, which received some €320 mil­lion in funds from the Ital­ian gov­ern­ment, rais­ing sus­pi­cions that the agree­ment between the Com­mis­sion pres­i­dent and Pfiz­er may have been self-serv­ing.
...

.
And note the dis­turb­ing appar­ent rel­a­tive lack of par­lia­men­tary con­cern over these cor­rup­tion issues: it was appar­ent­ly only rep­re­sen­ta­tives of the cen­ter-right ECR and far right ID Groups who protest­ed this capit­u­la­tion. It does­n’t bode well:

...
Sources also con­firmed that at the Con­fer­ence, only rep­re­sen­ta­tives of the ECR and ID Groups protest­ed against the deci­sion, on the grounds that the inquiry should be held open­ly and include more MEPs—which a ques­tion­ing in front of the COVID com­mit­tee would have done.
...

Will the EU’s con­ser­v­a­tives ulti­mate­ly hold Ursu­la von der Leyen’s feet to the fire over cor­po­rate cor­rup­tion? Hold­ing politi­cians account­able for being cor­rupt cor­po­ratists isn’t exact­ly a typ­i­cal right-wing theme. But it appears that the EU’s right-wingers are the only ones ani­mat­ed by the issue, which is all the more remark­able giv­en von der Leyen’s con­ser­v­a­tive cre­den­tials. Are we see­ing sort sort of intra-right-wing pow­er play at work? Time will tell, but it does­n’t appear we should expect any pub­lic rev­e­la­tions about the behind-the-scenes deal­ings that went into that multi­bil­lion euro COVID vac­cine con­tract. It’s not actu­al­ly clear what to expect at this point. Oth­er than more rushed exper­i­ment mRNA vac­cines. We can pre­sum­ably expect a lot more of those.

Don’t wor­ry. If there was a prob­lem we would know by now.

That’s the gen­er­al pub­lic mes­sage the US pub­lic has received when it comes to the safe­ty and effi­ca­cy of the COVID vac­cines. Exper­i­men­tal vac­cines, sure, but vac­cines that have now been admin­is­tered to hun­dreds of mil­lions of peo­ple around the world. Sure­ly, if there was a dan­ger, we would know by now, right?

It would be nice if these were valid assur­ances. But as we’re going to see in the fol­low­ing NY Times piece, a grow­ing num­ber of peo­ple, includ­ing vac­cine experts, are rais­ing alarms about the safe­ty of these vac­cines. And it’s not just the vac­cines them­selves that they are alarmed about. It’s the US’s sys­tem for track­ing and inves­ti­gat­ing vac­cine injuries that has these experts so alarmed. A sys­tem seem­ing­ly designed to not find a prob­lem in the first place.

The arti­cle a fas­ci­nat­ing piece of jour­nal­ism. On the one hand, it’s filled with all of the now-stan­dard assur­ances that the risk of injury from the COVID vac­cines is exceed­ing­ly rare. But those assur­ances are fed to the read­ers in an arti­cle lit­er­al­ly about how thou­sands of peo­ple report­ing vac­cine injuries are feel­ing ignored and gaslit by US fed­er­al agen­cies like the FDA or CDC. And this includes experts like Dr. Gre­go­ry Poland, the edi­tor in chief of the jour­nal Vac­cine. Or Dr. Bud­dy Creech, who led sev­er­al Covid vac­cine tri­als at Van­der­bilt Uni­ver­si­ty. Both report­ed vac­cine injuries short­ly after their shots. As Akiko Iwasa­ki, an immu­nol­o­gist and vac­cine expert at Yale Uni­ver­si­ty, observes, peo­ple who say they have post-vac­ci­na­tion injuries are “just com­plete­ly ignored and dis­missed and gaslight­ed.”

It sounds like Dr Poland, who con­tin­ues to suf­fer from tin­ni­tus that start­ed short­ly after his first shot, took his injuries up direct­ly with col­leagues at the CDC, but that led nowhere. As Poland put it, “If they have done stud­ies, those stud­ies should be pub­lished.”

Dr Creech, who also expe­ri­enced tin­ni­tus and a rac­ing heart after each shot, adds that his post-vac­cine symp­toms were very sim­i­lar to what he expe­ri­enced from an acute case of COVID. As Creech puts it, “Regard­less, when our patients expe­ri­ence a side effect that may or may not be relat­ed to the vac­cine, we owe it to them to inves­ti­gate that as com­plete­ly as we can.”

It’s those calls for inves­ti­ga­tions into the safe­ty of these vac­cines that bring us to the bomb­shell admis­sion found near the end of the arti­cle: the NIH is con­duct­ing vir­tu­al­ly no stud­ies on the safe­ty of these vac­cines. Dr William Mur­phy, a can­cer researcher who worked at the NIH for 12 years, has report­ed­ly been prod­ding fed­er­al health offi­cials to con­duct these stud­ies. But as he puts it, offi­cials each respond­ed with “that very tired mantra: ‘But the virus is worse.’” Mur­phy points out, “Yes, the virus is worse, but that doesn’t obvi­ate doing research to make sure that there may be oth­er options.”

Now, if a com­plete lack of safe­ty stud­ies sounds unbe­liev­able, recall how the Phase III clin­i­cal tri­als for the COVID mRNA vac­cines where con­duct­ed at the same time the Phase II tri­als — which are intend­ed to assess longer-term safe­ty con­cerns — were still under­way. Also recall how, when Mod­er­na ini­tial­ly released ear­ly results from its Phase I tri­als tout­ing how it dis­cov­ered the vac­cine trig­gered the pro­duc­tion of neu­tral­iz­ing anti­bod­ies, it was data based on only 8 indi­vid­u­als in a tri­al of 45 peo­ple and all we were told about the demo­graph­ics of those 8 peo­ple was that they were aged 18–55, leav­ing open the ques­tion of how effec­tive the vac­cine is in the elder­ly adults. And when Mod­er­na did release results on its Phase I tri­als for the elder­ly, that tri­al was based on just 20 indi­vid­u­als. And let’s not for­get about how the FDA, CDC, and Mod­er­na all seemed to col­lude in with­hold­ing from an inde­pen­dent advi­so­ry pan­el unflat­ter­ing data about the effi­ca­cy of the new biva­lent COVID vac­cines. So it’s not like the US gov­ern­ment had ever con­duct­ed seri­ous inves­ti­ga­tions into the safe­ty of these exper­i­ment vac­cines. The sam­ple sizes of the inves­ti­ga­tions con­duct­ed thus far have been so tiny there was almost no sta­tis­ti­cal pow­er behind them and there­fore no abil­i­ty to detect any­thing oth­er than fair­ly com­mon side effects. Learn­ing that there are still no NIH safe­ty stud­ies at all is kind of what we should have expect­ed at this point.

That com­plete lack of safe­ty stud­ies par­tial­ly explains the prob­lems peo­ple are fac­ing when try­ing to report, and poten­tial­ly get com­pen­sat­ed for, their vac­cine injuries. Because no stud­ies means the gov­ern­ment does­n’t know what side effects are even pos­si­ble and what to look for when sift­ing through the reports of vac­cine injury. For exam­ple, the lack of for­mal def­i­n­i­tions for many of these types of injuries, like “brain fog”, is cit­ed as part of the rea­son fed­er­al researchers haven’t been iden­ti­fy­ing entire class­es of injury.

As a result, there are lit­er­al­ly just four seri­ous side effects from the COVID vac­cines cur­rent­ly offi­cial­ly rec­og­nized by the US fed­er­al gov­ern­ment. One of those side effects — ana­phy­lax­is — is a risk with any vac­cine. Two of those side effects — Guil­lain-Bar­ré syn­drome and blood clots — are tied to the John­son & John­son (J&J) vac­cine.

Just one side effect — myocardi­tis, espe­cial­ly in boys and young men — is for­mal­ly attrib­uted to the mRNA vac­cines only have one side effect iden­ti­fied by US agen­cies. And as we’re going to see, that only came after the Israeli gov­ern­ment arrived at that con­clu­sion. Ini­tial­ly, the FDA assert­ed that there was no evi­dence of a myocardi­tis risk.

There are oth­er exam­ples of how gov­ern­ments are find­ing side effects in the mRNA vac­cines that still aren’t offi­cial­ly rec­og­nized by the US. A gov­ern­ment study out of Hong Kong con­duct­ed an inves­ti­ga­tion of med­ical records of patients and even paid peo­ple to come for­ward with prob­lems they expe­ri­enced and detect­ed “a lot of mild cas­es that oth­er coun­tries would not oth­er­wise pick up,” includ­ing rare cas­es of shin­gles fol­low­ing vac­ci­na­tion. The Euro­pean Med­i­cines Agency has attrib­uted facial paral­y­sis, tin­gling sen­sa­tions and numb­ness to the mRNA vac­cines. And a study out of Aus­tralia pub­lished back in March exam­ined Aus­tralian health records and found a sta­tis­ti­cal­ly sig­nif­i­cant increase in both tin­ni­tus and ver­ti­go. The FDA cites a lack of evi­dence in its refusal to rec­og­nize tin­ni­tus as a pos­si­ble side effect. Sim­i­lar­ly, last month, an expert pan­el con­vened by the Nation­al Acad­e­mies con­clud­ed that for the vast major­i­ty of side effects, there was not enough data to accept or reject a link.

When asked if the US’s vac­cine-safe­ty sur­veil­lance was suf­fi­cient dur­ing a recent con­gres­sion­al hear­ing, Dr Peter Marks, direc­tor of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research, admit­ted “I do believe we could do bet­ter.”

But it’s the state­ments by Dr Janet Wood­cock, the for­mer head of the Food and Drug Admin­is­tra­tion who retired in Feb­ru­ary, dur­ing recent inter­view that under­scores the seri­ous­ness of the US gov­ern­men­t’s fail­ure to even acknowl­edge vac­cine-relat­ed injuries are hap­pen­ing. Wood­cock said she believed that some recip­i­ents had expe­ri­enced uncom­mon but “seri­ous” and “life-chang­ing” reac­tions beyond those described by fed­er­al agen­cies. “I feel bad for those peo­ple,” said Wood­cock. “I believe their suf­fer­ing should be acknowl­edged, that they have real prob­lems, and they should be tak­en seri­ous­ly.” “I’m dis­ap­point­ed in myself,” she added. “I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.” It’s pret­ty rare when we hear that kind of remorse from a for­mer pub­lic offi­cial who just left office. But it hap­pened and the stuff Wood­cock is remorse­ful about is still ongo­ing.

The FDA isn’t the only agency let­ting down vic­tims of vac­cine-injuries. The fed­er­al gov­ern­men­t’s tra­di­tion­al pro­gram for com­pen­sat­ing vac­cine-injury vic­tims, the Nation­al Vac­cine Injury Com­pen­sa­tion Pro­gram, which has no cap on its poten­tial com­pen­sa­tion, does­n’t apply to COVID vac­cines because Con­gress has­n’t made them sub­ject to the excise tax that pays for it. Instead, COVID vac­cine claims are addressed by Coun­ter­mea­sures Injury Com­pen­sa­tion Pro­gram with a $50,000 cap and strin­gent stan­dards of proof. The entire pro­gram only had four staff mem­bers at the begin­ning of pan­dem­ic and still only has 35. We’re told that of the over 13,000 claims made to fed­er­al vac­cine-injury com­pen­sa­tion pro­grams, only 19 per­cent have been reviewed, with just 47 deemed eli­gi­ble four com­pen­sa­tion. Of those 47 cas­es, just twelve have been paid out with an aver­age com­pen­sa­tion of $3,600.

That’s the shock­ing, but trag­i­cal­ly not sur­pris­ing, update about the state of affairs for the US gov­ern­men­t’s han­dling of the vac­cine injuries for what is still an exper­i­men­tal set of vac­cines. It’s an alarm­ing state of affairs giv­en the facts.

And yet, it’s hard not to notice that this NY Times arti­cle could have been a lot harsh­er, espe­cial­ly when it comes to the mRNA vac­cines where the arti­cle can be vague about whether or not the mRNA or J&J vac­cines were involved. And there’s no men­tion at all of the large­ly ignored Novavax vac­cine. The arti­cle starts off with the sto­ry of some­one who expe­ri­enced severe side effect from what they sus­pect was a con­t­a­m­i­nat­ed J&J batch, which was a real issue for the J&J vac­cine when ingre­di­ents from the AstraZeneca vac­cine were dis­cov­ered in some of the batch­es. But most of the rest of the accounts don’t state which vac­cine was involved so we’re kind of left guess­ing who had an mRNA-relat­ed issue. And while there are plen­ty of assur­ances that side effects have been rare and the vac­cines have been shown to be safe, the fact that the NIH is con­duct­ing no safe­ty tri­als at all is men­tioned once near the end. It’s a damn­ing arti­cle but it could have been a lot more damn­ing in terms of how the damn­ing data was pre­sent­ed.

That mod­er­at­ed style of pre­sent­ing these damn­ing facts is itself note­wor­thy giv­en that we’re talk­ing about a sto­ry that is ulti­mate­ly a con­tin­u­a­tion of the much broad­er sto­ry of the US gov­ern­men­t’s extreme­ly favor­able treat­ment of the mRNA vac­cines. Vac­cines that, in Mod­er­na’s case, the US gov­ern­ment co-devel­oped, as we learned from the patent fights that fol­lowed. Every­thing is fine, or prob­a­bly fine, and not real­ly any­thing one needs to wor­ry about. That’s been the pre­vail­ing nar­ra­tive about the mRNA vac­cines from the start, when it was way too ear­ly to make that deter­mi­na­tion, and it’s still more or less the nar­ra­tive today in a sto­ry filled with damn­ing facts about the state of affairs.

Still, it’s an impor­tant arti­cle updat­ing us on the sit­u­a­tion. All the more so com­ing from the New York Times. Because it’s not like we should expect the sit­u­a­tion to improve even after a report like this. For what­ev­er rea­son, the US gov­ern­ment is absolute­ly com­mit­ted to giv­ing the mRNA vac­cines it co-devel­oped the ‘all clear’. There isn’t a lot we can do about this state of affairs oth­er than be aware of it:

The New York Times

Thou­sands Believe Covid Vac­cines Harmed Them. Is Any­one Lis­ten­ing?

All vac­cines have at least occa­sion­al side effects. But peo­ple who say they were injured by Covid vac­cines believe their cas­es have been ignored.

By Apoor­va Man­davil­li

Apoor­va Man­davil­li spent more than a year talk­ing to dozens of experts in vac­cine sci­ence, pol­i­cy­mak­ers and peo­ple who said they had expe­ri­enced seri­ous side effects after receiv­ing a Covid-19 vac­cine.
May 3, 2024

With­in min­utes of get­ting the John­son & John­son Covid-19 vac­cine, Michelle Zim­mer­man felt pain rac­ing from her left arm up to her ear and down to her fin­ger­tips. With­in days, she was unbear­ably sen­si­tive to light and strug­gled to remem­ber sim­ple facts.

She was 37, with a Ph.D. in neu­ro­science, and until then could ride her bicy­cle 20 miles, teach a dance class and give a lec­ture on arti­fi­cial intel­li­gence, all in the same day. Now, more than three years lat­er, she lives with her par­ents. Even­tu­al­ly diag­nosed with brain dam­age, she can­not work, dri­ve or even stand for long peri­ods of time.

“When I let myself think about the dev­as­ta­tion of what this has done to my life, and how much I’ve lost, some­times it feels even too hard to com­pre­hend,” said Dr. Zim­mer­man, who believes her injury is due to a con­t­a­m­i­nat­ed vac­cine batch.

...

Dr. Zimmerman’s account is among the more har­row­ing, but thou­sands of Amer­i­cans believe they suf­fered seri­ous side effects fol­low­ing Covid vac­ci­na­tion. As of April, just over 13,000 vac­cine-injury com­pen­sa­tion claims have been filed with the fed­er­al gov­ern­ment — but to lit­tle avail. Only 19 per­cent have been reviewed. Only 47 of those were deemed eli­gi­ble for com­pen­sa­tion, and only 12 have been paid out, at an aver­age of about $3,600.

Some sci­en­tists fear that patients with real injuries are being denied help and believe that more needs to be done to clar­i­fy the pos­si­ble risks.

“At least long Covid has been some­what rec­og­nized,” said Akiko Iwasa­ki, an immu­nol­o­gist and vac­cine expert at Yale Uni­ver­si­ty. But peo­ple who say they have post-vac­ci­na­tion injuries are “just com­plete­ly ignored and dis­missed and gaslight­ed,” she added.

In inter­views and email exchanges con­duct­ed over sev­er­al months, fed­er­al health offi­cials insist­ed that seri­ous side effects were extreme­ly rare and that their sur­veil­lance efforts were more than suf­fi­cient to detect pat­terns of adverse events.

“Hun­dreds of mil­lions of peo­ple in the Unit­ed States have safe­ly received Covid vac­cines under the most intense safe­ty mon­i­tor­ing in U.S. his­to­ry,” Jeff Nes­bit, a spokesman for the Depart­ment of Health and Human Ser­vices, said in an emailed state­ment.

But in a recent inter­view, Dr. Janet Wood­cock, a long­time leader of the Food and Drug Admin­is­tra­tion, who retired in Feb­ru­ary, said she believed that some recip­i­ents had expe­ri­enced uncom­mon but “seri­ous” and “life-chang­ing” reac­tions beyond those described by fed­er­al agen­cies.

“I feel bad for those peo­ple,” said Dr. Wood­cock, who became the F.D.A.’s act­ing com­mis­sion­er in Jan­u­ary 2021 as the vac­cines were rolling out. “I believe their suf­fer­ing should be acknowl­edged, that they have real prob­lems, and they should be tak­en seri­ous­ly.”

“I’m dis­ap­point­ed in myself,” she added. “I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.”

...

The nation’s frag­ment­ed health care sys­tem com­pli­cates detec­tion of very rare side effects, a process that depends on an analy­sis of huge amounts of data. That’s a dif­fi­cult task when a patient may be test­ed for Covid at Wal­greens, get vac­ci­nat­ed at CVS, go to a local clin­ic for minor ail­ments and seek care at a hos­pi­tal for seri­ous con­di­tions. Each place may rely on dif­fer­ent health record sys­tems.

There is no cen­tral repos­i­to­ry of vac­cine recip­i­ents, nor of med­ical records, and no easy to way to pool these data. Reports to the largest fed­er­al data­base of so-called adverse events can be made by any­one, about any­thing. It’s not even clear what offi­cials should be look­ing for.

“I mean, you’re not going to find ‘brain fog’ in the med­ical record or claims data, and so then you’re not going to find” a sig­nal that it may be linked to vac­ci­na­tion, Dr. Wood­cock said. If such a side effect is not acknowl­edged by fed­er­al offi­cials, “it’s because it doesn’t have a good research def­i­n­i­tion,” she added. “It isn’t, like, malev­o­lence on their part.”

The government’s under­staffed com­pen­sa­tion fund has paid so lit­tle because it offi­cial­ly rec­og­nizes few side effects for Covid vac­cines. And vac­cine sup­port­ers, includ­ing fed­er­al offi­cials, wor­ry that even a whis­per of pos­si­ble side effects feeds into mis­in­for­ma­tion spread by a vit­ri­olic anti-vac­cine move­ment.

‘I’m Not Real’

Patients who believe they expe­ri­enced seri­ous side effects say they have received lit­tle sup­port or acknowl­edg­ment.

Shaun Bar­cav­age, 54, a nurse prac­ti­tion­er in New York City who has worked on clin­i­cal tri­als for H.I.V. and Covid, said that ever since his first Covid shot, mere­ly stand­ing up sent his heart rac­ing — a symp­tom sug­ges­tive of pos­tur­al ortho­sta­t­ic tachy­car­dia syn­drome, a neu­ro­log­i­cal dis­or­der that some stud­ies have linked to both Covid and, much less often, vac­ci­na­tion.

He also expe­ri­enced sting­ing pain in his eyes, mouth and gen­i­tals, which has abat­ed, and tin­ni­tus, which has not.

“I can’t get the gov­ern­ment to help me,” Mr. Bar­cav­age said of his fruit­less pleas to fed­er­al agen­cies and elect­ed rep­re­sen­ta­tives. “I am told I’m not real. I’m told I’m rare. I’m told I’m coin­ci­dence.”

Renee France, 49, a phys­i­cal ther­a­pist in Seat­tle, devel­oped Bell’s pal­sy — a form of facial paral­y­sis, usu­al­ly tem­po­rary — and a dra­mat­ic rash that neat­ly bisect­ed her face. Bell’s pal­sy is a known side effect of oth­er vac­cines, and it has been linked to Covid vac­ci­na­tion in some stud­ies.

But Ms. France said doc­tors were dis­mis­sive of any con­nec­tion to the Covid vac­cines. The rash, a bout of shin­gles, debil­i­tat­ed her for three weeks, so Ms. France report­ed it to fed­er­al data­bas­es twice.

“I thought for sure some­one would reach out, but no one ever did,” she said.

Sim­i­lar sen­ti­ments were echoed in inter­views, con­duct­ed over more than a year, with 30 peo­ple who said they had been harmed by Covid shots. They described a vari­ety of symp­toms fol­low­ing vac­ci­na­tion, some neu­ro­log­i­cal, some autoim­mune, some car­dio­vas­cu­lar.

All said they had been turned away by physi­cians, told their symp­toms were psy­cho­so­mat­ic, or labeled anti-vac­cine by fam­i­ly and friends — despite the fact that they sup­port­ed vac­cines.

Even lead­ing experts in vac­cine sci­ence have run up against dis­be­lief and ambiva­lence.

Dr. Gre­go­ry Poland, 68, edi­tor in chief of the jour­nal Vac­cine, said that a loud whoosh­ing sound in his ears had accom­pa­nied every moment since his first shot, but that his entreaties to col­leagues at the Cen­ters for Dis­ease Con­trol and Pre­ven­tion to explore the phe­nom­e­non, tin­ni­tus, had led nowhere.

He received polite respons­es to his many emails, but “I just don’t get any sense of move­ment,” he said.

“If they have done stud­ies, those stud­ies should be pub­lished,” Dr. Poland added. In despair that he might “nev­er hear silence again,” he has sought solace in med­i­ta­tion and his reli­gious faith.

Dr. Bud­dy Creech, 50, who led sev­er­al Covid vac­cine tri­als at Van­der­bilt Uni­ver­si­ty, said his tin­ni­tus and rac­ing heart last­ed about a week after each shot. “It’s very sim­i­lar to what I expe­ri­enced dur­ing acute Covid, back in March of 2020,” Dr. Creech said.

Research may ulti­mate­ly find that most report­ed side effects are unre­lat­ed to the vac­cine, he acknowl­edged. Many can be caused by Covid itself.

“Regard­less, when our patients expe­ri­ence a side effect that may or may not be relat­ed to the vac­cine, we owe it to them to inves­ti­gate that as com­plete­ly as we can,” Dr. Creech said.

Fed­er­al health offi­cials say they do not believe that the Covid vac­cines caused the ill­ness­es described by patients like Mr. Bar­cav­age, Dr. Zim­mer­man and Ms. France. The vac­cines may cause tran­sient reac­tions, such as swelling, fatigue and fever, accord­ing to the C.D.C., but the agency has doc­u­ment­ed only four seri­ous but rare side effects.

Two are asso­ci­at­ed with the John­son & John­son vac­cine, which is no longer avail­able in the Unit­ed States: Guil­lain-Bar­ré syn­drome, a known side effect of oth­er vac­cines, includ­ing the flu shot; and a blood-clot­ting dis­or­der.

The C.D.C. also links mRNA vac­cines made by Pfiz­er-BioN­Tech and Mod­er­na to heart inflam­ma­tion, or myocardi­tis, espe­cial­ly in boys and young men. And the agency warns of ana­phy­lax­is, or severe aller­gic reac­tion, which can occur after any vac­ci­na­tion.

Lis­ten­ing for Sig­nals

Agency sci­en­tists are mon­i­tor­ing large data­bas­es con­tain­ing med­ical infor­ma­tion on mil­lions of Amer­i­cans for pat­terns that might sug­gest a hith­er­to unknown side effect of vac­ci­na­tion, said Dr. Deme­tre Daskalakis, direc­tor of the C.D.C.’s Nation­al Cen­ter for Immu­niza­tion and Res­pi­ra­to­ry Dis­eases.

“We toe the line by report­ing the sig­nals that we think are real sig­nals and report­ing them as soon as we iden­ti­fy them as sig­nals,” he said. The agency’s sys­tems for mon­i­tor­ing vac­cine safe­ty are “pret­ty close” to ide­al, he said.

Those nation­al sur­veil­lance efforts include the Vac­cine Adverse Event Report­ing Sys­tem (VAERS). It is the largest data­base, but also the least reli­able: Reports of side effects can be sub­mit­ted by any­one and are not vet­ted, so they may be sub­ject to bias or manip­u­la­tion.

The sys­tem con­tains rough­ly one mil­lion reports regard­ing Covid vac­ci­na­tion, the vast major­i­ty for mild events, accord­ing to the C.D.C.

Fed­er­al researchers also comb through data­bas­es that com­bine elec­tron­ic health records and insur­ance claims on tens of mil­lions of Amer­i­cans. The sci­en­tists mon­i­tor the data for 23 con­di­tions that may occur fol­low­ing Covid vac­ci­na­tion. Offi­cials remain alert to oth­ers that may pop up, Dr. Daskalakis said.

But there are gaps, some experts not­ed. The Covid shots admin­is­tered at mass vac­ci­na­tion sites were not record­ed in insur­ance claims data­bas­es, for exam­ple, and med­ical records in the Unit­ed States are not cen­tral­ized.

...

An expert pan­el con­vened by the Nation­al Acad­e­mies con­clud­ed in April that for the vast major­i­ty of side effects, there was not enough data to accept or reject a link.

Asked at a recent con­gres­sion­al hear­ing whether the nation’s vac­cine-safe­ty sur­veil­lance was suf­fi­cient, Dr. Peter Marks, direc­tor of the F.D.A.’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research, said, “I do believe we could do bet­ter.”

A Red Flag

In some coun­tries with cen­tral­ized health care sys­tems, offi­cials have active­ly sought out reports of seri­ous side effects of Covid vac­cines and reached con­clu­sions that U.S. health author­i­ties have not.

In Hong Kong, the gov­ern­ment ana­lyzed cen­tral­ized med­ical records of patients after vac­ci­na­tion and paid peo­ple to come for­ward with prob­lems. The strat­e­gy iden­ti­fied “a lot of mild cas­es that oth­er coun­tries would not oth­er­wise pick up,” said Ian Wong, a researcher at the Uni­ver­si­ty of Hong Kong who led the nation’s vac­cine safe­ty efforts.

That includ­ed the find­ing that in rare instances — about sev­en per mil­lion dos­es — the Pfiz­er-BioN­Tech vac­cine trig­gered a bout of shin­gles seri­ous enough to require hos­pi­tal­iza­tion.

The Euro­pean Med­i­cines Agency has linked the Pfiz­er and Mod­er­na vac­cines to facial paral­y­sis, tin­gling sen­sa­tions and numb­ness. The E.M.A. also counts tin­ni­tus as a side effect of the John­son & John­son vac­cine, although the Amer­i­can health agen­cies do not. There are more than 17,000 reports of tin­ni­tus fol­low­ing Covid vac­ci­na­tion in VAERS.

Are the two linked? It’s not clear. As many as one in four adults has some form of tin­ni­tus. Stress, anx­i­ety, grief and aging can lead to the con­di­tion, as can infec­tions like Covid itself and the flu.

There is no test or scan for tin­ni­tus, and sci­en­tists can­not eas­i­ly study it because the inner ear is tiny, del­i­cate and encased in bone, said Dr. Kon­stan­ti­na Stankovic, an oto­laryn­gol­o­gist at Stan­ford Uni­ver­si­ty.

Still, an analy­sis of health records from near­ly 2.6 mil­lion peo­ple in the Unit­ed States found that about 0.04 per­cent, or about 1,000, were diag­nosed with tin­ni­tus with­in three weeks of their first mRNA shot. In March, researchers in Aus­tralia pub­lished a study link­ing tin­ni­tus and ver­ti­go to the vac­cines.

The F.D.A. is mon­i­tor­ing reports of tin­ni­tus, but “at this time, the avail­able evi­dence does not sug­gest a causal asso­ci­a­tion with the Covid-19 vac­cines,” the agency said in a state­ment.

Despite sur­veil­lance efforts, U.S. offi­cials were not the first to iden­ti­fy a sig­nif­i­cant Covid vac­cine side effect: myocardi­tis in young peo­ple receiv­ing mRNA vac­cines. It was Israeli author­i­ties who first raised the alarm in April 2021. Offi­cials in the Unit­ed States said at the time that they had not seen a link.

On May 22, 2021, news broke that the C.D.C. was inves­ti­gat­ing a “rel­a­tive­ly few” cas­es of myocardi­tis. By June 23, the num­ber of myocardi­tis reports in VAERS had risen to more than 1,200 — a hint that it is impor­tant to tell doc­tors and patients what to look for.

Lat­er analy­ses showed that the risk for myocardi­tis and peri­cardi­tis, a relat­ed con­di­tion, is high­est after a sec­ond dose of an mRNA Covid vac­cine in ado­les­cent males aged 12 to 17 years.

In many peo­ple, vac­cine-relat­ed myocardi­tis is tran­sient. But some patients con­tin­ue to expe­ri­ence pain, breath­less­ness and depres­sion, and some show per­sis­tent changes on heart scans. The C.D.C. has said there were no con­firmed deaths relat­ed to myocardi­tis, but in fact there have been sev­er­al accounts of deaths report­ed post-vac­ci­na­tion.

Per­va­sive Mis­in­for­ma­tion

The rise of the anti-vac­cine move­ment has made it dif­fi­cult for sci­en­tists, in and out of gov­ern­ment, to can­did­ly address poten­tial side effects, some experts said. Much of the nar­ra­tive on the pur­port­ed dan­gers of Covid vac­cines is patent­ly false, or at least exag­ger­at­ed, cooked up by savvy anti-vac­cine cam­paigns.

...

Among the hun­dreds of mil­lions of Amer­i­cans who were immu­nized for Covid, some num­ber would have had heart attacks or strokes any­way. Some women would have mis­car­ried. How to dis­tin­guish those caused by the vac­cine from those that are coin­ci­dences? The only way to resolve the ques­tion is intense research.

But the Nation­al Insti­tutes of Health is con­duct­ing vir­tu­al­ly no stud­ies on Covid vac­cine safe­ty, sev­er­al experts not­ed. William Mur­phy, a can­cer researcher who worked at the N.I.H. for 12 years, has been prod­ding fed­er­al health offi­cials to ini­ti­ate these stud­ies since 2021.

The offi­cials each respond­ed with “that very tired mantra: ‘But the virus is worse,’” Dr. Mur­phy recalled. “Yes, the virus is worse, but that doesn’t obvi­ate doing research to make sure that there may be oth­er options.”

A deep­er under­stand­ing of pos­si­ble side effects, and who is at risk for them, could have impli­ca­tions for the design of future vac­cines, or may indi­cate that for some young and healthy peo­ple, the ben­e­fit of Covid shots may no longer out­weigh the risks — as some Euro­pean coun­tries have deter­mined.

...

The fed­er­al gov­ern­ment has long run the Nation­al Vac­cine Injury Com­pen­sa­tion Pro­gram, designed to com­pen­sate peo­ple who suf­fer injuries after vac­ci­na­tion. Estab­lished more than three decades ago, the pro­gram sets no lim­it on the amounts award­ed to peo­ple found to have been harmed.

But Covid vac­cines are not cov­ered by that fund because Con­gress has not made them sub­ject to the excise tax that pays for it. Some law­mak­ers have intro­duced bills to make the change.

Instead, claims regard­ing Covid vac­cines go to the Coun­ter­mea­sures Injury Com­pen­sa­tion Pro­gram. Intend­ed for pub­lic health emer­gen­cies, this pro­gram has nar­row cri­te­ria to pay out and sets a lim­it of $50,000, with strin­gent stan­dards of proof.

It requires appli­cants to prove with­in a year of the injury that it was “the direct result” of get­ting the Covid vac­cine, based on “com­pelling, reli­able, valid, med­ical, and sci­en­tif­ic evi­dence.”

The pro­gram had only four staff mem­bers at the begin­ning of the pan­dem­ic, and now has 35 peo­ple eval­u­at­ing claims. Still, it has reviewed only a frac­tion of the 13,000 claims filed, and has paid out only a dozen.

Dr. Ilka War­shawsky, a 58-year-old pathol­o­gist, said she lost all hear­ing in her right ear after a Covid boost­er shot. But hear­ing loss is not a rec­og­nized side effect of Covid vac­ci­na­tion.

The com­pen­sa­tion pro­gram for Covid vac­cines sets a high bar for proof, she said, yet offers lit­tle infor­ma­tion on how to meet it: “These adverse events can be debil­i­tat­ing and life-alter­ing, and so it’s very upset­ting that they’re not acknowl­edged or addressed.”

...

———

“Thou­sands Believe Covid Vac­cines Harmed Them. Is Any­one Lis­ten­ing?” By Apoor­va Man­davil­li; The New York Times; 05/03/2024

“Dr. Zimmerman’s account is among the more har­row­ing, but thou­sands of Amer­i­cans believe they suf­fered seri­ous side effects fol­low­ing Covid vac­ci­na­tion. As of April, just over 13,000 vac­cine-injury com­pen­sa­tion claims have been filed with the fed­er­al gov­ern­ment — but to lit­tle avail. Only 19 per­cent have been reviewed. Only 47 of those were deemed eli­gi­ble for com­pen­sa­tion, and only 12 have been paid out, at an aver­age of about $3,600.”

COVID vac­cine injuries are indeed being report­ed. Over 13,000 hav­ing been filed with the US fed­er­al gov­ern­ment. But with only 19 per­cent of those claims hav­ing even been reviewed and only 12 claims ever paid, it’s very unclear what’s actu­al­ly being done with those reports. That’s the thrust of the mes­sage this NY Times piece: the pri­ma­ry response by the US gov­ern­ment to peo­ple report­ing vac­cine side-effects is silence. Silence that amounts to gaslight­ing, with peo­ple effec­tive­ly being told they don’t exist.

And yet, as we can see in the report­ing on this piece, the focus is put on dan­gers asso­ci­at­ed with the J&J vac­cine that has now been dis­con­tin­ued. It start off talk­ing about a rare, and by all account unusu­al­ly severe, case of a J&J vac­cine side effect expe­ri­ence by some­one who believes her injury was due to vac­cine con­t­a­m­i­na­tion. And there were indeed issues with J&J vac­cines get­ting con­t­a­m­i­nat­ed with parts of the AstraZeneca COVID vac­cine, result­ing in mil­lions of dos­es get­ting thrown out. Some sort of J&J vac­cine con­t­a­m­i­na­tion side effect sounds quite plau­si­ble.

But as we’ve also seen, the US gov­ern­ment did­n’t ban the J&J vac­cine over con­t­a­m­i­na­tion issues. It was due to a very rare blood-clot­ting dis­or­der that got the J&J vac­cine banned in the US in May of 2022, leav­ing ONLY mRNA vac­cine options avail­able in the US at that point. And that’s despite the fact that the J&J vac­cine appears to have demon­strat­ed bet­ter long-term pro­tec­tion com­pared to the mRNA vac­cines. It’s that seem­ing­ly pref­er­en­tial treat­ment of the mRNA-based vac­cines that’s part of the sto­ry here. Almost every­one giv­en a COVID vac­cine in the US got an mRNA vac­cine, and no J&J vac­cines have been avail­able in the US for almost two years. And yet this arti­cle starts off with a hor­ror sto­ry about an extreme­ly rare J&J injury that may be due to a tran­si­to­ry vac­cine con­t­a­m­i­na­tion issue:

...
With­in min­utes of get­ting the John­son & John­son Covid-19 vac­cine, Michelle Zim­mer­man felt pain rac­ing from her left arm up to her ear and down to her fin­ger­tips. With­in days, she was unbear­ably sen­si­tive to light and strug­gled to remem­ber sim­ple facts.

She was 37, with a Ph.D. in neu­ro­science, and until then could ride her bicy­cle 20 miles, teach a dance class and give a lec­ture on arti­fi­cial intel­li­gence, all in the same day. Now, more than three years lat­er, she lives with her par­ents. Even­tu­al­ly diag­nosed with brain dam­age, she can­not work, dri­ve or even stand for long peri­ods of time.

“When I let myself think about the dev­as­ta­tion of what this has done to my life, and how much I’ve lost, some­times it feels even too hard to com­pre­hend,” said Dr. Zim­mer­man, who believes her injury is due to a con­t­a­m­i­nat­ed vac­cine batch.

...

Some sci­en­tists fear that patients with real injuries are being denied help and believe that more needs to be done to clar­i­fy the pos­si­ble risks.

“At least long Covid has been some­what rec­og­nized,” said Akiko Iwasa­ki, an immu­nol­o­gist and vac­cine expert at Yale Uni­ver­si­ty. But peo­ple who say they have post-vac­ci­na­tion injuries are “just com­plete­ly ignored and dis­missed and gaslight­ed,” she added.
...

And note the state­ments we’re get­ting from US gov­ern­ment agen­cies, char­ac­ter­iz­ing the vac­cine injury inves­ti­ga­tions as “the most intense safe­ty mon­i­tor­ing in U.S. his­to­ry” and “pret­ty close” to ide­al. That’s part of the gaslight­ing:

...
In inter­views and email exchanges con­duct­ed over sev­er­al months, fed­er­al health offi­cials insist­ed that seri­ous side effects were extreme­ly rare and that their sur­veil­lance efforts were more than suf­fi­cient to detect pat­terns of adverse events.

“Hun­dreds of mil­lions of peo­ple in the Unit­ed States have safe­ly received Covid vac­cines under the most intense safe­ty mon­i­tor­ing in U.S. his­to­ry,” Jeff Nes­bit, a spokesman for the Depart­ment of Health and Human Ser­vices, said in an emailed state­ment.

...

Agency sci­en­tists are mon­i­tor­ing large data­bas­es con­tain­ing med­ical infor­ma­tion on mil­lions of Amer­i­cans for pat­terns that might sug­gest a hith­er­to unknown side effect of vac­ci­na­tion, said Dr. Deme­tre Daskalakis, direc­tor of the C.D.C.’s Nation­al Cen­ter for Immu­niza­tion and Res­pi­ra­to­ry Dis­eases.

“We toe the line by report­ing the sig­nals that we think are real sig­nals and report­ing them as soon as we iden­ti­fy them as sig­nals,” he said. The agency’s sys­tems for mon­i­tor­ing vac­cine safe­ty are “pret­ty close” to ide­al, he said.
...

Com­pare the above state­ments with the dis­turb­ing admis­sions from recent­ly-retired FDA leader Dr. Janet Wood­cock or cur­rent direc­tor of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research Dr. Peter Marks: Marks admits “we could do bet­ter”, while Wood­cock appears to be express­ing per­son­al remorse over the fail­ure of the FDA to ade­quate­ly address the claims of vac­cine injury:

...
But in a recent inter­view, Dr. Janet Wood­cock, a long­time leader of the Food and Drug Admin­is­tra­tion, who retired in Feb­ru­ary, said she believed that some recip­i­ents had expe­ri­enced uncom­mon but “seri­ous” and “life-chang­ing” reac­tions beyond those described by fed­er­al agen­cies.

“I feel bad for those peo­ple,” said Dr. Wood­cock, who became the F.D.A.’s act­ing com­mis­sion­er in Jan­u­ary 2021 as the vac­cines were rolling out. “I believe their suf­fer­ing should be acknowl­edged, that they have real prob­lems, and they should be tak­en seri­ous­ly.”

“I’m dis­ap­point­ed in myself,” she added. “I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.”

...

Asked at a recent con­gres­sion­al hear­ing whether the nation’s vac­cine-safe­ty sur­veil­lance was suf­fi­cient, Dr. Peter Marks, direc­tor of the F.D.A.’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research, said, “I do believe we could do bet­ter.”
...

And then there’s the dis­may expressed by one expert after anoth­er over the non-respons­es they are expe­ri­enc­ing with the fed­er­al gov­ern­ment in the face of all these unad­dressed claims of vac­cine injury. Experts like Dr. Bud­dy Creech, who actu­al­ly led a COVID vac­cine tri­al at Van­der­bilt Uni­ver­si­ty, expe­ri­enced side effects after each shot he took. And the edi­tor in chief of the jour­nal Vac­cine, Dr. Gre­go­ry Poland, has his own per­son­al COVID vac­cine injury expe­ri­ence and yet even he can’t get a rea­son­able response from his col­leagues in that CDC. And note how Poland refers to the lack of pub­lished stud­ies on the safe­ty of these vac­cines. Again, the guy is the edi­tor in chief of the jour­nal Vac­cine. If any­one is going to be famil­iar with the pub­lished lit­er­a­ture on vac­cine safe­ty, it’s him:

...
Even lead­ing experts in vac­cine sci­ence have run up against dis­be­lief and ambiva­lence.

Dr. Gre­go­ry Poland, 68, edi­tor in chief of the jour­nal Vac­cine, said that a loud whoosh­ing sound in his ears had accom­pa­nied every moment since his first shot, but that his entreaties to col­leagues at the Cen­ters for Dis­ease Con­trol and Pre­ven­tion to explore the phe­nom­e­non, tin­ni­tus, had led nowhere.

He received polite respons­es to his many emails, but “I just don’t get any sense of move­ment,” he said.

“If they have done stud­ies, those stud­ies should be pub­lished,” Dr. Poland added. In despair that he might “nev­er hear silence again,” he has sought solace in med­i­ta­tion and his reli­gious faith.

Dr. Bud­dy Creech, 50, who led sev­er­al Covid vac­cine tri­als at Van­der­bilt Uni­ver­si­ty, said his tin­ni­tus and rac­ing heart last­ed about a week after each shot. “It’s very sim­i­lar to what I expe­ri­enced dur­ing acute Covid, back in March of 2020,” Dr. Creech said.

Research may ulti­mate­ly find that most report­ed side effects are unre­lat­ed to the vac­cine, he acknowl­edged. Many can be caused by Covid itself.

“Regard­less, when our patients expe­ri­ence a side effect that may or may not be relat­ed to the vac­cine, we owe it to them to inves­ti­gate that as com­plete­ly as we can,” Dr. Creech said.
...

And then we start get­ting to the nit­ty grit­ty of why it is that the US gov­ern­ment has done such a poor job of cat­a­loging and inves­ti­gat­ing vac­cine COVID injuries: the fed­er­al gov­ern­ment has­n’t even prop­er­ly defined a num­ber of poten­tial side effects like “brain fog”. It’s a pret­ty effec­tive means of sys­tem­at­i­cal­ly not find­ing side effects. Espe­cial­ly side effects that might be nov­el to mRNA vac­cines:

...
There is no cen­tral repos­i­to­ry of vac­cine recip­i­ents, nor of med­ical records, and no easy to way to pool these data. Reports to the largest fed­er­al data­base of so-called adverse events can be made by any­one, about any­thing. It’s not even clear what offi­cials should be look­ing for.

“I mean, you’re not going to find ‘brain fog’ in the med­ical record or claims data, and so then you’re not going to find” a sig­nal that it may be linked to vac­ci­na­tion, Dr. Wood­cock said. If such a side effect is not acknowl­edged by fed­er­al offi­cials, “it’s because it doesn’t have a good research def­i­n­i­tion,” she added. “It isn’t, like, malev­o­lence on their part.”

The government’s under­staffed com­pen­sa­tion fund has paid so lit­tle because it offi­cial­ly rec­og­nizes few side effects for Covid vac­cines. And vac­cine sup­port­ers, includ­ing fed­er­al offi­cials, wor­ry that even a whis­per of pos­si­ble side effects feeds into mis­in­for­ma­tion spread by a vit­ri­olic anti-vac­cine move­ment.
...

And that we get to the part of the arti­cle that includes a num­ber of anec­dotes about peo­ple expe­ri­enc­ing side effects but run­ning into a wall when they try to report it. A wall that is imposed in part due to the fact that the US gov­ern­ment cur­rent­ly only rec­og­nizes four dif­fer­ent pos­si­ble COVID vac­cine side effects and two of those side effects — Guil­lain-Bar­ré syn­drome and blood clots — are spe­cif­ic to the J&J vac­cine. The only pos­si­ble side effects from the mRNA vac­cine cur­rent­ly rec­og­nized by the US gov­ern­ment are ana­phy­lax­is — which can hap­pen with any vac­cine — and myocardi­tis in young boys and men. And as we’re going to see, that myocardi­tis was ini­tial­ly refut­ed by the US gov­ern­ment. It was only after the Israeli gov­ern­ment arrived at that con­clu­sion that the US gov­ern­ment con­ced­ed that the mRNA vac­cines might cause that side effect. Also Note how there is not men­tion of which vac­cine any of these peo­ple took, as opposed to the open­ing anec­dote that made clear it was the J&J vac­cine that was the cul­prit. Even in this sto­ry about the inad­e­quate report­ing of vac­cine injuries, there a pal­pa­ble hes­i­tan­cy even acknowl­edge that the mRNA vac­cines might be a cul­prit:

...
Shaun Bar­cav­age, 54, a nurse prac­ti­tion­er in New York City who has worked on clin­i­cal tri­als for H.I.V. and Covid, said that ever since his first Covid shot, mere­ly stand­ing up sent his heart rac­ing — a symp­tom sug­ges­tive of pos­tur­al ortho­sta­t­ic tachy­car­dia syn­drome, a neu­ro­log­i­cal dis­or­der that some stud­ies have linked to both Covid and, much less often, vac­ci­na­tion.

He also expe­ri­enced sting­ing pain in his eyes, mouth and gen­i­tals, which has abat­ed, and tin­ni­tus, which has not.

“I can’t get the gov­ern­ment to help me,” Mr. Bar­cav­age said of his fruit­less pleas to fed­er­al agen­cies and elect­ed rep­re­sen­ta­tives. “I am told I’m not real. I’m told I’m rare. I’m told I’m coin­ci­dence.”

Renee France, 49, a phys­i­cal ther­a­pist in Seat­tle, devel­oped Bell’s pal­sy — a form of facial paral­y­sis, usu­al­ly tem­po­rary — and a dra­mat­ic rash that neat­ly bisect­ed her face. Bell’s pal­sy is a known side effect of oth­er vac­cines, and it has been linked to Covid vac­ci­na­tion in some stud­ies.

But Ms. France said doc­tors were dis­mis­sive of any con­nec­tion to the Covid vac­cines. The rash, a bout of shin­gles, debil­i­tat­ed her for three weeks, so Ms. France report­ed it to fed­er­al data­bas­es twice.

“I thought for sure some­one would reach out, but no one ever did,” she said.

Sim­i­lar sen­ti­ments were echoed in inter­views, con­duct­ed over more than a year, with 30 peo­ple who said they had been harmed by Covid shots. They described a vari­ety of symp­toms fol­low­ing vac­ci­na­tion, some neu­ro­log­i­cal, some autoim­mune, some car­dio­vas­cu­lar.

All said they had been turned away by physi­cians, told their symp­toms were psy­cho­so­mat­ic, or labeled anti-vac­cine by fam­i­ly and friends — despite the fact that they sup­port­ed vac­cines.

...

Fed­er­al health offi­cials say they do not believe that the Covid vac­cines caused the ill­ness­es described by patients like Mr. Bar­cav­age, Dr. Zim­mer­man and Ms. France. The vac­cines may cause tran­sient reac­tions, such as swelling, fatigue and fever, accord­ing to the C.D.C., but the agency has doc­u­ment­ed only four seri­ous but rare side effects.

Two are asso­ci­at­ed with the John­son & John­son vac­cine, which is no longer avail­able in the Unit­ed States: Guil­lain-Bar­ré syn­drome, a known side effect of oth­er vac­cines, includ­ing the flu shot; and a blood-clot­ting dis­or­der.

The C.D.C. also links mRNA vac­cines made by Pfiz­er-BioN­Tech and Mod­er­na to heart inflam­ma­tion, or myocardi­tis, espe­cial­ly in boys and young men. And the agency warns of ana­phy­lax­is, or severe aller­gic reac­tion, which can occur after any vac­ci­na­tion.
...

Note that, while there’s just four four pos­si­ble seri­ous COVID vac­cine side effects rec­og­nized by the US fed­er­al gov­ern­ment right now, fed­er­al sci­en­tists tasked with mon­i­tor­ing the data in the Vac­cine Adverse Event Report­ing Sys­tem (VAERS) are look­ing for around 23 con­di­tions that may occur fol­low­ing a COVID vac­ci­na­tion. So fed­er­al researchers are cast­ing a wider net. They just aren’t find­ing any­thing. Which brings us to the absolute­ly shock­ing — but not sur­pris­ing — admis­sion by sev­er­al experts includ­ing NIH can­cer researcher Dr William Mur­phy: the NIH is con­duct­ing vir­tu­al­ly no stud­ies on COVID vac­cine safe­ty. And if that sounds unbe­liev­able, don’t for­get how the FDA approved the new Omi­cron tar­get­ed-vac­cines based sole­ly on safe­ty stud­ies con­duct­ed on mice. A com­plete lack of stud­ies is very plau­si­ble at this point:

...
Those nation­al sur­veil­lance efforts include the Vac­cine Adverse Event Report­ing Sys­tem (VAERS). It is the largest data­base, but also the least reli­able: Reports of side effects can be sub­mit­ted by any­one and are not vet­ted, so they may be sub­ject to bias or manip­u­la­tion.

The sys­tem con­tains rough­ly one mil­lion reports regard­ing Covid vac­ci­na­tion, the vast major­i­ty for mild events, accord­ing to the C.D.C.

Fed­er­al researchers also comb through data­bas­es that com­bine elec­tron­ic health records and insur­ance claims on tens of mil­lions of Amer­i­cans. The sci­en­tists mon­i­tor the data for 23 con­di­tions that may occur fol­low­ing Covid vac­ci­na­tion. Offi­cials remain alert to oth­ers that may pop up, Dr. Daskalakis said.

But there are gaps, some experts not­ed. The Covid shots admin­is­tered at mass vac­ci­na­tion sites were not record­ed in insur­ance claims data­bas­es, for exam­ple, and med­ical records in the Unit­ed States are not cen­tral­ized.

...

An expert pan­el con­vened by the Nation­al Acad­e­mies con­clud­ed in April that for the vast major­i­ty of side effects, there was not enough data to accept or reject a link.

...

But the Nation­al Insti­tutes of Health is con­duct­ing vir­tu­al­ly no stud­ies on Covid vac­cine safe­ty, sev­er­al experts not­ed. William Mur­phy, a can­cer researcher who worked at the N.I.H. for 12 years, has been prod­ding fed­er­al health offi­cials to ini­ti­ate these stud­ies since 2021.

The offi­cials each respond­ed with “that very tired mantra: ‘But the virus is worse,’” Dr. Mur­phy recalled. “Yes, the virus is worse, but that doesn’t obvi­ate doing research to make sure that there may be oth­er options.”

A deep­er under­stand­ing of pos­si­ble side effects, and who is at risk for them, could have impli­ca­tions for the design of future vac­cines, or may indi­cate that for some young and healthy peo­ple, the ben­e­fit of Covid shots may no longer out­weigh the risks — as some Euro­pean coun­tries have deter­mined.
...

And then there’s the fact that oth­er gov­ern­ments are find­ing side effects that some­how are elud­ing the US gov­ern­men­t’s efforts (or non-efforts, as the case may me). And that includes the mRNA-vac­cine-induced myocardi­tis , which the US gov­ern­ment ini­tial­ly dis­missed. It was only after Israel arrived at that con­clu­sion that we saw the US accept that find­ing. So we have to ask, did the US gov­ern­ment ini­tial­ly dis­miss the pos­si­bil­i­ty of myocardi­tis due to inves­ti­ga­tions that con­clud­ed there was no risk? Or was it due to a lack of any inves­ti­ga­tions and there­fore a lack of find­ings?

...
In some coun­tries with cen­tral­ized health care sys­tems, offi­cials have active­ly sought out reports of seri­ous side effects of Covid vac­cines and reached con­clu­sions that U.S. health author­i­ties have not.

In Hong Kong, the gov­ern­ment ana­lyzed cen­tral­ized med­ical records of patients after vac­ci­na­tion and paid peo­ple to come for­ward with prob­lems. The strat­e­gy iden­ti­fied “a lot of mild cas­es that oth­er coun­tries would not oth­er­wise pick up,” said Ian Wong, a researcher at the Uni­ver­si­ty of Hong Kong who led the nation’s vac­cine safe­ty efforts.

That includ­ed the find­ing that in rare instances — about sev­en per mil­lion dos­es — the Pfiz­er-BioN­Tech vac­cine trig­gered a bout of shin­gles seri­ous enough to require hos­pi­tal­iza­tion.

The Euro­pean Med­i­cines Agency has linked the Pfiz­er and Mod­er­na vac­cines to facial paral­y­sis, tin­gling sen­sa­tions and numb­ness. The E.M.A. also counts tin­ni­tus as a side effect of the John­son & John­son vac­cine, although the Amer­i­can health agen­cies do not. There are more than 17,000 reports of tin­ni­tus fol­low­ing Covid vac­ci­na­tion in VAERS.

...

Despite sur­veil­lance efforts, U.S. offi­cials were not the first to iden­ti­fy a sig­nif­i­cant Covid vac­cine side effect: myocardi­tis in young peo­ple receiv­ing mRNA vac­cines. It was Israeli author­i­ties who first raised the alarm in April 2021. Offi­cials in the Unit­ed States said at the time that they had not seen a link.
...

Final­ly, we get to this out­ra­geous state of affairs: the COVID vac­cines aren’t actu­al­ly cov­ered by the Nation­al Vac­cine Injury Com­pen­sa­tion Pro­gram due to con­gres­sion­al inac­tion. Instead, injured indi­vid­u­als have to seek com­pen­sa­tion from the Coun­ter­mea­sures Injury Com­pen­sa­tion Pro­gram, which is under­staffed and a vague­ly high bar for get­ting any com­pen­sa­tion. It’s a gaslight­ing scam:

...
The fed­er­al gov­ern­ment has long run the Nation­al Vac­cine Injury Com­pen­sa­tion Pro­gram, designed to com­pen­sate peo­ple who suf­fer injuries after vac­ci­na­tion. Estab­lished more than three decades ago, the pro­gram sets no lim­it on the amounts award­ed to peo­ple found to have been harmed.

But Covid vac­cines are not cov­ered by that fund because Con­gress has not made them sub­ject to the excise tax that pays for it. Some law­mak­ers have intro­duced bills to make the change.

Instead, claims regard­ing Covid vac­cines go to the Coun­ter­mea­sures Injury Com­pen­sa­tion Pro­gram. Intend­ed for pub­lic health emer­gen­cies, this pro­gram has nar­row cri­te­ria to pay out and sets a lim­it of $50,000, with strin­gent stan­dards of proof.

...

The pro­gram had only four staff mem­bers at the begin­ning of the pan­dem­ic, and now has 35 peo­ple eval­u­at­ing claims. Still, it has reviewed only a frac­tion of the 13,000 claims filed, and has paid out only a dozen.

Dr. Ilka War­shawsky, a 58-year-old pathol­o­gist, said she lost all hear­ing in her right ear after a Covid boost­er shot. But hear­ing loss is not a rec­og­nized side effect of Covid vac­ci­na­tion.

The com­pen­sa­tion pro­gram for Covid vac­cines sets a high bar for proof, she said, yet offers lit­tle infor­ma­tion on how to meet it: “These adverse events can be debil­i­tat­ing and life-alter­ing, and so it’s very upset­ting that they’re not acknowl­edged or addressed.”
...

Good luck nav­i­gat­ing the Coun­ter­mea­sures Injury Com­pen­sa­tion Pro­gram and its mys­te­ri­ous­ly high stan­dards of proof.

But let’s not for­get that these issues aren’t exclu­sive­ly COVID vac­cine issues. They’re just exclu­sive­ly COVID vac­cine issues today because the COVID vac­cines are the only exper­i­men­tal vac­cines with this odd­ly adamant gov­ern­ment sup­port behind it. We’re only a pan­dem­ic away from a new round of emer­gency rapid­ly-devel­oped exper­i­men­tal vac­cines. Will it be some sort of super bird flu? Maybe anoth­er coro­n­avirus strain, but even more hor­ri­ble this time. Who knows. But anoth­er pan­dem­ic is com­ing. That’s inevitable. All the more so in today’s age of syn­thet­ic biol­o­gy and indus­tri­al farm­ing prac­tices. A new pan­dem­ic has always been an inevitabil­i­ty. It’s a mat­ter of when, not if.

Which also means it’s a mat­ter when, not if, we are all asked to take a new rapid­ly pro­duced exper­i­men­tal vac­cine. That’s impor­tant con­text to keep in mind with this sto­ry. Because a tem­plate for future pan­demics is being estab­lished here. And that dis­turb­ing state of affairs described in this NY Times piece is a big part of the pre­vail­ing tem­plate. The fact that this arti­cle was pub­lished days ago and has­n’t caused any sort of dis­cernible pub­lic response is also part of the tem­plate. It’s a stu­pid tem­plate.