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For The Record  

FTR #1167 Bio-Psy-Op Apocalypse Now, Part 23: A Pound of Cure, Part 2

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FTR #1167: This pro­gram was record­ed in one, 60-minute seg­ment.

Intro­duc­tion: The pro­gram begins with ana­lyt­ic review of the mil­i­tary’s role in U.S. vac­cine devel­op­ment.

In pre­vi­ous posts and pro­grams, we have not­ed that Mod­er­na’s vac­cine work has been financed by DARPA. We have also not­ed that the over­all head of Oper­a­tion Warp Speed is Mon­cef Slaoui, for­mer­ly in charge of prod­uct devel­op­ment for Mod­er­na!

Of great sig­nif­i­cance is the cen­tral role of the mil­i­tary in the devel­op­ment of treat­ment for Covid-19:

  1. We note that: ” . . . . Remde­sivir pre­dates this pan­dem­ic. It was first con­sid­ered as a poten­tial treat­ment for Ebo­la, and was devel­oped through a long­stand­ing part­ner­ship between the U.S. Army and the Cen­ters for Dis­ease Con­trol and Pre­ven­tion. . . .”
  2. Jonathan King, who has chaired the micro­bial phys­i­ol­o­gy study sec­tion for the NIH has sound­ed the alarm about “vac­cine research” mask­ing offen­sive bio­log­i­cal war­fare research: “. . . . King, who has chaired the micro­bial phys­i­ol­o­gy study sec­tion for the NIH, believes that with­out inten­sive inde­pen­dent scruti­ny, the Pen­ta­gon is free to obscure its true goals. ‘The Defense Depart­ment appears to be pur­su­ing many nar­row, applied goals that are by nature offen­sive, such as the genet­ic ‘improve­ment’ of BW agents,’ King says. ‘But to achieve polit­i­cal accept­abil­i­ty, they mask these inten­tions under forms of research, such as vac­cine devel­op­ment, which sound defen­sive. . . .”
  3. Mod­er­na’s vac­cine devel­op­ment was over­seen by an unnamed Pen­ta­gon offi­cial: ” . . . . Moderna’s team was head­ed by a Defense Depart­ment offi­cial whom com­pa­ny exec­u­tives described only as ‘the major,’ say­ing they don’t know if his name is sup­posed to be a secret. . . . .”
  4. The per­va­sive role of the mil­i­tary in Oper­a­tion Warp Speed (the Trump admin­is­tra­tion’s vac­cine devel­op­ment pro­gram) has gen­er­at­ed alarm in civil­ian par­tic­i­pants:”. . . . Scores of Defense Depart­ment employ­ees are laced through the gov­ern­ment offices involved in the effort, mak­ing up a large por­tion of the fed­er­al per­son­nel devot­ed to the effort.  Those num­bers have led some cur­rent and for­mer offi­cials at the Cen­ters for Dis­ease Con­trol and Pre­ven­tion to pri­vate­ly grum­ble that the military’s role in Oper­a­tion Warp Speed was too large for a task that is, at its core, a pub­lic health cam­paign. . . .
  5. Gen­er­al Gus­tave Perna–one of the prin­ci­pals in Oper­a­tion Warp Speed–has cho­sen a retired Lieu­tenant Gen­er­al to over­see much of the pro­gram: ” . . . . ‘Frankly, it has been breath­tak­ing to watch,’ said Paul Ostrows­ki, the direc­tor of sup­ply, pro­duc­tion and dis­tri­b­u­tion for Oper­a­tion Warp Speed. He is a retired Army lieu­tenant gen­er­al who was select­ed to man­age logis­tics for the pro­gram by Gen. Gus­tave F. Per­na, the chief oper­at­ing offi­cer for Oper­a­tion Warp Speed. . . .”
  6. The mil­i­tary will be able to trace the des­ti­na­tion and admin­is­tra­tion of each dose: ” . . . . Mil­i­tary offi­cials also came up with the clever idea — if it works — to coor­di­nate the deliv­ery of vac­cines to drug­stores, med­ical cen­ters and oth­er immu­niza­tion sites by send­ing kits full of nee­dles, syringes and alco­hol wipes. Vac­cine mak­ers will be alert­ed when the kits arrive at an immu­niza­tion site so they know to ship dos­es. Once the first dose is giv­en, the man­u­fac­tur­er will be noti­fied so it can send the sec­ond dose with a patient’s name attached sev­er­al weeks lat­er. The mil­i­tary will also mon­i­tor vac­cine dis­tri­b­u­tion through an oper­a­tions cen­ter. ‘They will know where every vac­cine dose is,’ Mr. [Paul] Man­go said on a call with reporters. . . .”

Obfus­cat­ing the nature of U.S. vac­cine con­tract­ing is the fact that the con­tract­ing is done through ATI. ” . . . . In part, it’s because of the way many Oper­a­tion Warp Speed con­tracts have been exe­cut­ed, with their terms large­ly invis­i­ble to the pub­lic. . . . under the hood, the effort’s largest agree­ments with vac­cine companies—totaling more than $6 billion—have been man­aged by a third par­ty, a defense-ori­ent­ed non­prof­it called Advanced Tech­nol­o­gy Inter­na­tion­al (ATI). . . . with ATI as an inter­me­di­ary, these bil­lion-dol­lar deals instead fall under some­thing called an ‘oth­er trans­ac­tion agree­ment’ that isn’t sub­ject to the same kinds of cross-checks and account­abil­i­ty. . . .”

The bal­ance of the pro­gram con­sists of analy­sis of the cap­i­tal inter­ests behind BioNTech–the Ger­man cor­po­rate part­ner pro­duc­ing a Covid vac­cine with Pfiz­er.

Head­ed by a Ger­man MD cou­ple whose par­ents were “gas­tar­beit­er” (guest work­ers), BioN­Tech has soared expo­nen­tial­ly in val­ue since the approval of the vac­cine by a num­ber of coun­tries.

A dom­i­nant con­sid­er­a­tion in pow­er pol­i­tics remains the advi­so­ry to “Fol­low the Mon­ey.”

Against the back­ground of I.G. Far­ben and its suc­ces­sor com­pa­nies’ dom­i­nant posi­tion in both the glob­al phar­ma­ceu­ti­cal and chem­i­cal mar­ket, as well as its major posi­tion with­in the remark­able and dead­ly Bor­mann cap­i­tal net­work, the pro­gram explores the cap­i­tal­iza­tion of Uğur Şahin and Özlem Türe­ci’s Ganymed firm and BioN­Tech.

Of para­mount sig­nif­i­cance in both Ganymed (the cou­ple’s ini­tial com­mer­cial ven­ture) and BioN­tech are twin broth­ers Thomas and Andreas Stru­eng­mann.

Key points of analy­sis:

  1. The broth­ers are major play­ers in the phar­ma­ceu­ti­cal and biotech mar­ket.
  2. They keep a pur­pose­ful­ly low pro­fes­sion­al profile–a pro­fes­sion­al behav­ior char­ac­ter­is­tic of the dead­ly Bor­mann net­work.
  3. Thomas was an impor­tant mem­ber of the board of Wack­er Chemie, a major suc­ces­sor to two I.G. Far­ben sub­sidiary com­pa­nies.
  4. Wack­er Chemie has appar­ent­ly obfus­cat­ed its Nazi past.
  5. Andreas ini­ti­at­ed his med­ical career in apartheid South Africa, and the broth­ers’ Hexal firm began its sig­nif­i­cant inter­na­tion­al expan­sion in that coun­try. (The apartheid regime was an off­shoot of the Third Reich.)
  6. Firms that evolved from I.G. Far­ben fig­ure promi­nent­ly in the deal­ings of Hexal, Wack­er Chemie and BioN­Tech (Novar­tis, the Hoechst divi­sion of Sanofi-Aven­tis.)

1. In pre­vi­ous posts and pro­grams, we have not­ed that Mod­er­na’s vac­cine work has been financed by DARPA. We have also not­ed that the over­all head of Oper­a­tion Warp Speed is Mon­cef Slaoui, for­mer­ly in charge of prod­uct devel­op­ment for Mod­er­na!

Of great sig­nif­i­cance is the cen­tral role of the mil­i­tary in the devel­op­ment of treat­ment for Covid-19:

  1. We note that: ” . . . . Remde­sivir pre­dates this pan­dem­ic. It was first con­sid­ered as a poten­tial treat­ment for Ebo­la, and was devel­oped through a long­stand­ing part­ner­ship between the U.S. Army and the Cen­ters for Dis­ease Con­trol and Pre­ven­tion. . . .”
  2. Jonathan King, who has chaired the micro­bial phys­i­ol­o­gy study sec­tion for the NIH has sound­ed the alarm about “vac­cine research” mask­ing offen­sive bio­log­i­cal war­fare research: “. . . . King, who has chaired the micro­bial phys­i­ol­o­gy study sec­tion for the NIH, believes that with­out inten­sive inde­pen­dent scruti­ny, the Pen­ta­gon is free to obscure its true goals. ‘The Defense Depart­ment appears to be pur­su­ing many nar­row, applied goals that are by nature offen­sive, such as the genet­ic ‘improve­ment’ of BW agents,’ King says. ‘But to achieve polit­i­cal accept­abil­i­ty, they mask these inten­tions under forms of research, such as vac­cine devel­op­ment, which sound defen­sive. . . .”
  3. Mod­er­na’s vac­cine devel­op­ment was over­seen by an unnamed Pen­ta­gon offi­cial: ” . . . . Moderna’s team was head­ed by a Defense Depart­ment offi­cial whom com­pa­ny exec­u­tives described only as ‘the major,’ say­ing they don’t know if his name is sup­posed to be a secret. . . . .”
  4. The per­va­sive role of the mil­i­tary in Oper­a­tion Warp Speed (the Trump admin­is­tra­tion’s vac­cine devel­op­ment pro­gram) has gen­er­at­ed alarm in civil­ian par­tic­i­pants:”. . . . Scores of Defense Depart­ment employ­ees are laced through the gov­ern­ment offices involved in the effort, mak­ing up a large por­tion of the fed­er­al per­son­nel devot­ed to the effort.  Those num­bers have led some cur­rent and for­mer offi­cials at the Cen­ters for Dis­ease Con­trol and Pre­ven­tion to pri­vate­ly grum­ble that the military’s role in Oper­a­tion Warp Speed was too large for a task that is, at its core, a pub­lic health cam­paign. . . .
  5. Gen­er­al Gus­tave Perna–one of the prin­ci­pals in Oper­a­tion Warp Speed–has cho­sen a retired Lieu­tenant Gen­er­al to over­see much of the pro­gram: ” . . . . ‘Frankly, it has been breath­tak­ing to watch,’ said Paul Ostrows­ki, the direc­tor of sup­ply, pro­duc­tion and dis­tri­b­u­tion for Oper­a­tion Warp Speed. He is a retired Army lieu­tenant gen­er­al who was select­ed to man­age logis­tics for the pro­gram by Gen. Gus­tave F. Per­na, the chief oper­at­ing offi­cer for Oper­a­tion Warp Speed. . . .”
  6. The mil­i­tary will be able to trace the des­ti­na­tion and admin­is­tra­tion of each dose: ” . . . . Mil­i­tary offi­cials also came up with the clever idea — if it works — to coor­di­nate the deliv­ery of vac­cines to drug­stores, med­ical cen­ters and oth­er immu­niza­tion sites by send­ing kits full of nee­dles, syringes and alco­hol wipes. Vac­cine mak­ers will be alert­ed when the kits arrive at an immu­niza­tion site so they know to ship dos­es. Once the first dose is giv­en, the man­u­fac­tur­er will be noti­fied so it can send the sec­ond dose with a patient’s name attached sev­er­al weeks lat­er. The mil­i­tary will also mon­i­tor vac­cine dis­tri­b­u­tion through an oper­a­tions cen­ter. ‘They will know where every vac­cine dose is,’ Mr. [Paul] Man­go said on a call with reporters. . . .”

2. Obfus­cat­ing the nature of U.S. vac­cine con­tract­ing is the fact that the con­tract­ing is done through ATI. ” . . . . In part, it’s because of the way many Oper­a­tion Warp Speed con­tracts have been exe­cut­ed, with their terms large­ly invis­i­ble to the pub­lic. . . . under the hood, the effort’s largest agree­ments with vac­cine companies—totaling more than $6 billion—have been man­aged by a third par­ty, a defense-ori­ent­ed non­prof­it called Advanced Tech­nol­o­gy Inter­na­tion­al (ATI). . . . with ATI as an inter­me­di­ary, these bil­lion-dol­lar deals instead fall under some­thing called an ‘oth­er trans­ac­tion agree­ment’ that isn’t sub­ject to the same kinds of cross-checks and account­abil­i­ty. . . .”

“Why We Know So Lit­tle About Pfizer’s Vac­cine Deal with the US” by Katie Palmer; Quartz; 11/9/2020.

On Nov. 9, Pfiz­er and its part­ner BioN­Tech announced some ear­ly results for their Covid-19 vac­cine can­di­date. Data from a late-stage clin­i­cal tri­al show the two-dose shot could be 90% effec­tive at pre­vent­ing infections—a promis­ing devel­op­ment that quick­ly devolved into a fight for brag­ging rights.

Vice pres­i­dent Mike Pence attrib­uted the news to Oper­a­tion Warp Speed, the Trump administration’s “pub­lic-pri­vate part­ner­ship,” while Pfiz­er tried to take cred­it for its own work. Although the com­pa­ny did strike a deal worth $1.95 bil­lion for the US gov­ern­ment to pur­chase 100 mil­lion dos­es of the vac­cine, it empha­sized that it received no fed­er­al fund­ing for vac­cine research and devel­op­ment.

What’s behind the con­fu­sion? In part, it’s because of the way many Oper­a­tion Warp Speed con­tracts have been exe­cut­ed, with their terms large­ly invis­i­ble to the pub­lic.

Oper­a­tion Warp Speed (OWS) is the pub­lic face of the fed­er­al effort to rapid­ly devel­op and dis­trib­ute vac­cines and treat­ments for Covid-19. But under the hood, the effort’s largest agree­ments with vac­cine companies—totaling more than $6 billion—have been man­aged by a third par­ty, a defense-ori­ent­ed non­prof­it called Advanced Tech­nol­o­gy Inter­na­tion­al (ATI). A new crop of vac­cine agree­ments set to be made through ATI may be just as opaque as the first.

For more than 20 years, ATI has man­aged fed­er­al­ly-fund­ed research and devel­op­ment col­lab­o­ra­tions for the Depart­ment of Defense. One of those col­lab­o­ra­tions, the Med­ical CBRN Defense Con­sor­tium, is focused on pro­tect­ing mil­i­tary per­son­nel against chem­i­cal, bio­log­i­cal, radi­o­log­i­cal, and nuclear threats—including virus­es they could encounter in the line of duty, like Ebo­la.

So ATI had some expe­ri­ence with vac­cine deals before the pan­dem­ic. On Jun. 9, it made the shift to Covid-19 vac­cines, solic­it­ing com­pa­nies’ pro­pos­als for research, devel­op­ment, and large-scale man­u­fac­tur­ing. Less than a month lat­er, the US had made its first agree­ment, a deal with Novavax worth up to $1.6 bil­lion.

But the pre­cise terms of that deal, and the one with Pfiz­er that came short­ly after, are still unclear. . . .

. . . . It would be eas­i­er to under­stand the dif­fer­ence between invest­ment and procurement—and what Oper­a­tion Warp Speed could rea­son­ably take cred­it for—if the con­tracts were made pub­lic. Nor­mal­ly, when the gov­ern­ment makes an agree­ment with a con­trac­tor, it has to fol­low fed­er­al acqui­si­tion reg­u­la­tions. But with ATI as an inter­me­di­ary, these bil­lion-dol­lar deals instead fall under some­thing called an “oth­er trans­ac­tion agree­ment” that isn’t sub­ject to the same kinds of cross-checks and account­abil­i­ty. . . .

3. ATI rep­re­sents its func­tion as fol­lows:

“ATI Builds and Man­ages R & D Col­lab­o­ra­tions;” ATI—About Us.

ATI recruits, orga­nizes, and man­ages teams of large and small busi­ness­es, aca­d­e­m­ic insti­tu­tions, and non­prof­it orga­ni­za­tions to devel­op new tech­nolo­gies for our fed­er­al clients. We don’t bring our solu­tion; we bring the best solu­tion for the DoD’s most urgent chal­lenges.

A hall­mark of ATI-man­aged col­lab­o­ra­tions is access to non-tra­di­tion­als, inno­v­a­tive com­pa­nies that have not tra­di­tion­al­ly worked with Gov­ern­ment due to the com­plex­i­ty of Fed­er­al con­tract­ing. We vet these inno­va­tors, teach them how to work with the Gov­ern­ment, and pro­vide online and in-per­son forums where they can meet and part­ner with tra­di­tion­al defense con­trac­tors.

In today’s envi­ron­ment of increas­ing­ly sophis­ti­cat­ed adver­saries and rapid tech­nol­o­gy refresh, speed of tech­nol­o­gy acqui­si­tion is crit­i­cal to the DoD. ATI’s exper­tise in pro­gram man­age­ment and rapid con­tract­ing ensures that we deliv­er new tech­nolo­gies at the speed of mis­sion.

4. A Guardian arti­cle about the Ger­man-Turk­ish cou­ple has more infor­ma­tion on their ear­li­er busi­ness ven­tures.  Inter­est­ing­ly that they sim­ply start­ed their first com­pa­ny, Ganymed, because they were plan­ning on open­ing an aca­d­e­m­ic lab but research funds were hard to come by.

There is no expla­na­tion of where the ven­ture cap­i­tal start-up funds came from.

So the sto­ry of how Ganymed was actu­al­ly fund­ed seems like a sto­ry with learn­ing more about.  They found­ed BioN­Tech in 2008 with Aus­tri­an oncol­o­gy expert Christo­pher Huber, who still sits on the board:

“Uğur Şahin and Özlem Türe­ci: Ger­man ‘dream team’ behind vac­cine” by Philip Olter­mann; The Guardian; 11/10/2020.

The ‘Pruss­ian Turk’ couple’s com­pa­ny BioN­Tech devel­oped the break­through Covid vac­cine with Pfiz­er

Dr Özlem Türe­ci and Dr Uğur Şahin, who both have par­ents who came to Ger­many from Turkey in the late 1960s.

. . . . At Mainz uni­ver­si­ty hos­pi­tal, the cou­ple planned to set up a research lab to inves­ti­gate how immune sys­tems could be trained to attack can­cer­ous cells. When research funds were hard to come by “we sim­ply start­ed our own com­pa­ny”, Şahin told news por­tal Heise.

“Their first com­pa­ny, found­ed in 2001, was called Ganymed – not after the hand­some hero of Greek myth but a Turk­ish expres­sion rough­ly mean­ing “earned through hard work”, as Türe­ci told Süd­deutsche Zeitung. The com­pa­ny, which pio­neered pre­ci­sion anti­body ther­a­pies against can­cer, was sold to Japan­ese phar­ma com­pa­ny Astel­las for €1.4bn in 2016.

They found­ed their sec­ond com­pa­ny BioN­Tech in 2008 with the Aus­tri­an oncol­o­gist Christoph Huber, who still sits on the super­vi­so­ry board. . . .

5. His­tor­i­cal and infor­ma­tion­al back­ground on the Wack­er sub­sidiary firms of I.G. Far­ben are set forth in one of the books on the Spit­firelist web­site.

In Ger­many’s Mas­ter Plan–The Sto­ry of an Indus­tri­al Offen­sive by Joseph Borkin and Charles A. Welsh, we find that two of the sub­sidiary com­pa­nies of I.G. Far­ben are Alexan­der Wack­er A.-G. and Dr. Albert Wack­er G.m.b.H.

Ger­many’s Mas­ter Plan–The Sto­ry of an Indus­tri­al Offen­sive by Joseph Borkin and Charles A. Welsh; Duell, Sloan and Pierce [HC]; Copy­right 1943 by Joseph Borkin and Charles A. Welsh; pp. 328, 330.

Alexan­der Wack­er A.-G. (p. 328.)

Dr. Albert Wack­er G.m.b.H. (p. 330.)

6. The major share­hold­er in BioN­Tech is San­to Holding–an invest­ment firm for iden­ti­cal twin broth­ers Thomas and Andreas Strüng­mann (also spelled “Stru­eng­mann”).

The broth­ers appear to be major investors in the Ger­man biotech and health­care sec­tor.  They appear to have inten­tion­al­ly kept rel­a­tive­ly low per­son­al and cor­po­rate profiles–a char­ac­ter­is­tic of the dead­ly, effec­tive Bor­mann cap­i­tal orga­ni­za­tion.

Thomas Strüng­mann was on the super­vi­so­ry board of Wack­er Chemie AG until May of 2018, when he was replaced by Ann-Sophie Wack­er.

When replaced, he was described as a share­hold­er rep­re­sen­ta­tive.  First appoint­ed to the board in 2006, he appears to have been rep­re­sent­ing part of the Wack­er fam­i­ly on the board from 2006–2018.

Sum­ming up: Thomas Strüng­mann, one of the broth­ers who owns the Ger­man biotech and health­care invest­ment empire, was seem­ing­ly a Wack­er-fam­i­ly share­hold­er rep­re­sen­ta­tive on Wack­er Chemie’s super­vi­so­ry board for 12 years.  In terms of ties to the Under­ground Reich, it’s not noth­ing, and poten­tial­ly sig­nif­i­cant.  Wack­er Chemie is a glob­al chem­i­cal pow­er­house.  It’s US branch is Wack­er Chem­i­cal Corp.  It has offices around the globe.  It’s undoubt­ed­ly con­sid­ered a vital strate­gic asset.

It also turns out that the Strüng­mann broth­ers were investors in Ganymed, which is the com­pa­ny in the cou­ple ‘behind’ BioN­Tech found­ed in 2001 after they could­n’t find fund­ing for their aca­d­e­m­ic lab.  So these broth­ers have prob­a­bly been the mon­ey behind the cou­ple all along, although it’s unclear if they were the ini­tial investors in Ganymed.

” . . . . Investors in Ganymed includ­ed Ger­man invest­ment fund MIG Fonds as the fam­i­ly office of twins Thomas and Andreas Stru­eng­mann, who now hold a large stake in BioN­Tech. The broth­ers have long been big investors in biotech, hav­ing sold their gener­ic drug com­pa­ny Hexal to Swiss drug­mak­er Novar­tis for around $7 bil­lion in 2005. . . .”

The fol­low­ing arti­cle dis­cuss­es the Strüng­manns and their invest­ment roles in Ganymed and BioN­Tech. We also note, in pass­ing, that BioN­Tech’s growth involves the pur­chase of a valu­able facil­i­ty from Novar­tis, which, as we have seen, grew from the Swiss com­po­nent of I.G. Far­ben.:

 “Here are 5 things to know about BioN­Tech and the mar­ried cou­ple devel­op­ing the COVID-19 vac­cine with Pfiz­er” by Lina Saigol and Cal­lum Keown; Marketwatch.com; 11/13/2020.

When BioN­Tech made its stock mar­ket debut on Nas­daq last Octo­ber, the Ger­man biotech­nol­o­gy com­pa­ny was val­ued at just under $3.4 bil­lion.

Just over a year lat­er, BioN­Tech is now worth around $25 bil­lion and the Mainz, Ger­many-based com­pa­ny hit the head­lines ear­li­er this week as it became the front-run­ner in the race to bring a COVID-19 vac­cine to mar­ket.

Shares in BioN­Tech soared 14% on Mon­day after the com­pa­ny said its exper­i­men­tal shot, which is being devel­oped in part­ner­ship with U.S. drug­mak­er Pfiz­er was more than 90% effec­tive in pre­vent­ing COVID-19, based on ini­tial tri­al results from a Phase 3 clin­i­cal tri­al. This is the first coro­n­avirus vac­cine to prove its effi­ca­cy in a late-stage clin­i­cal study.

The stock was 3% up in ear­ly trad­ing on Tues­day and has now climbed 219% year-to-date. . . . .

HUSBAND AND WIFE TEAM BEHIND THE SCIENCE

In 2001, the pair found­ed Ganymed Phar­ma­ceu­ti­cals, a spin off from the uni­ver­si­ties of Mainz and Zurich that focused on devel­op­ing a new class of can­cer drugs called ide­al mon­o­clon­al anti­bod­ies.

Investors in Ganymed includ­ed Ger­man invest­ment fund MIG Fonds as the fam­i­ly office of twins Thomas and Andreas Stru­eng­mann, who now hold a large stake in BioNTech.The broth­ers have long been big investors in biotech, hav­ing sold their gener­ic drug com­pa­ny Hexal to Swiss drug­mak­er Novar­tis for around $7 bil­lion in 2005.

In 2016, Ganymed was sold to Japan­ese phar­ma­ceu­ti­cal com­pa­ny Astel­las Phar­ma for $1.4 bil­lion

BIONTECH’S IPO

BioN­Tech raised $150 mil­lion in its U.S. ini­tial pub­lic offer­ing on Nas­daq on Oct. 9, 2019, after it sold few­er shares and at a low­er price than orig­i­nal­ly planned, giv­ing the com­pa­ny a mar­ket val­u­a­tion of $3.4 bil­lion.

The IPO fol­lowed BioNTech’s $325 mil­lion fundrais­ing in July, which marked one of the biggest pri­vate financ­ing rounds for a Euro­pean biotech­nol­o­gy com­pa­ny in his­to­ry.

The fundrais­ing was led by Fideli­ty Man­age­ment & Research Com­pa­ny, with par­tic­i­pa­tion from both new and exist­ing investors, includ­ing the Strüng­mann Fam­i­ly Office.

Şahin and Türe­ci are now among the 100 rich­est Ger­mans, accord­ing to Ger­man news­pa­per Welt am Son­ntag.

RELATIONSHIP WITH PFIZER

. . . . In March this year, Pfiz­er and BioN­Tech announced plans to joint­ly devel­op a COVID-19 vac­cine. “We believe that by pair­ing Pfizer’s devel­op­ment, reg­u­la­to­ry and com­mer­cial capa­bil­i­ties with BioNTech’s mRNA vac­cine tech­nol­o­gy and exper­tise as one of the indus­try lead­ers, we are rein­forc­ing our com­mit­ment to do every­thing we can to com­bat this esca­lat­ing pan­dem­ic, as quick­ly as pos­si­ble,” said Mikael Dol­sten, Pfizer’s chief sci­en­tif­ic offi­cer, at the time.

The Pfiz­er-BioN­Tech vac­cine — called BNT162 — uses mes­sen­ger RNA (mRNA), the mol­e­cules in cells that con­trol pro­tein pro­duc­tion, to teach the immune sys­tem to make coro­n­avirus-fight­ing anti­bod­ies. The mRNA tech­nol­o­gy is also being used by Cam­bridge, Mass­a­chu­setts-based Mod­er­na and Cure­Vac . . . .

. . . . “BioN­Tech has been a loss-mak­ing com­pa­ny since our incep­tion 12 years ago and we’ve invest­ed over $1 bil­lion to devel­op our mRNA tech­nol­o­gy plat­form,” Ryan Richard­son, head of strat­e­gy at BioN­Tech, told a con­fer­ence on Tues­day.

VACCINE PRODUCTION

. . . . In June, BioN­Tech signed a €100 mil­lion debt financ­ing agree­ment with the Euro­pean Invest­ment Bank for the devel­op­ment of its exper­i­men­tal shot, to help scale-up its com­mer­cial man­u­fac­tur­ing capac­i­ty.

In Sep­tem­ber, it also received €375 mil­lion in fund­ing from the Ger­man Fed­er­al Min­istry of Edu­ca­tion and Research to sup­port its COVID-19 vac­cine pro­gram.

That same month, it announced the acqui­si­tion of a man­u­fac­tur­ing site in Mar­burg in west­ern Ger­many from Swiss phar­ma group Novar­tis. The state-of-the art facil­i­ty is expect­ed to expand BioNTech’s COVID-19 vac­cine pro­duc­tion capac­i­ty by up to 750 mil­lion dos­es a year, or more than 60 mil­lion dos­es a month, once ful­ly oper­a­tional, BioN­Tech said. . . .

8. A cor­po­rate “Sus­tain­abil­i­ty Report” from Wack­er AG that states that Thomas Strüng­mann was replaced as a share­hold­er rep­re­sen­ta­tive on the Super­vi­so­ry Board by Ann-Sophie Wack­er in May of 2018:

“Sus­tain­abil­i­ty Report;” Wacker.com.

. . . . At its meet­ing on March 6, 2018, the Super­vi­so­ry Board of Wack­er Chemie AG renewed the con­tract of Exec­u­tive Board mem­ber Auguste Willems for a fur­ther five years (until Decem­ber 31, 2023). On May 9, 2018, the Annu­al Share­hold­ers’ Meet­ing in Munich elect­ed the share­hold­er rep­re­sen­ta­tives for the Super­vi­so­ry Board. New­ly elect­ed was Ann-Sophie Wack­er, who replaced share­hold­er rep­re­sen­ta­tive Dr. Thomas Strüng­mann on the Super­vi­so­ry Board. . . .

9. A recent arti­cle notes Wack­er Chemie’s lack of address­ing its Nazi past.

“Draw­ing a Veil Over the Nazi Past” by Gilbert Krei­jger; Han­dels­blatt; 09/03/2016

. . . . Mr. Bähr, the his­to­ri­an, wants to see inde­pen­dent inves­ti­ga­tions into the Nazi his­to­ries of Ger­man house­hold and indus­tri­al goods mak­er Henkel, as well as con­struc­tion firm Bil­fin­ger, potash pro­duc­er K+S and Wack­er Chemie. He said indus­tri­al giant Siemens was “on the way” in con­duct­ing research. . . .

10. An arti­cle from May of 2005 that gives a good overview of the broad scope of Wack­er Chemie’s inter­ests.

Note the 49% stake in Wack­er Chemie owned by the Hoechst unit of Sanofi-Aven­tis.

Hoechst–one of the Big Three suc­ces­sor firms to I.G. Far­ben merged with the French phar­ma­ceu­ti­cal com­pa­ny.

“WACKER HOLDS OWN IN CHEMICAL WORLD” by Michael McCoy; Chem­i­cal  Engi­neer­ing News; 5/9/2005.

A per­son attend­ing Wack­er-Chemie’s annu­al press con­fer­ence in Munich last month could be excused for mis­tak­ing Wack­er for a pub­licly trad­ed firm. The com­pa­ny’s 2004 finan­cial results pre­sen­ta­tion mir­rored that of pub­lic Ger­man firms like BASF, Degus­sa, and Bay­er. Wack­er dis­trib­uted a detailed annu­al report, and its chief exec­u­tive offi­cer made a lengthy pre­sen­ta­tion, after which he patient­ly answered ques­tions from reporters.

But Wack­er is in fact a pri­vate com­pa­ny owned 51% by the Wack­er fam­i­ly and 49% by the Hoechst unit of Sanofi-Aven­tis. It was found­ed in 1914 by Alexan­der Wack­er and today is head­ed by his great-grand­son, Peter-Alexan­der Wack­er.

Many pri­vate firms rel­ish their anonymi­ty and give out lit­tle infor­ma­tion about their finan­cial con­di­tion. Wack­er has a dif­fer­ent phi­los­o­phy. Accord­ing to Peter-Alexan­der Wack­er, the com­pa­ny holds an annu­al press conference–and often a sub­se­quent tech­ni­cal briefing–because it desires the pub­lic expo­sure that the press can pro­vide. . . .

. . . . Although he may want to repli­cate the recog­ni­tion enjoyed by his pub­licly trad­ed com­peti­tors, Peter-Alexan­der Wack­er says he isn’t oth­er­wise envi­ous of them. After the pre­sen­ta­tion, he told C&EN that a big part of Wack­er’s strength is its abil­i­ty to make long-term invest­ments with­out wor­ry­ing about the short-term con­cerns of out­side investors.

“Sta­bil­i­ty is one of the biggest advan­tages of a pri­vate or fam­i­ly-owned com­pa­ny,” he said. “Sta­bil­i­ty means we are not look­ing at every quar­ter­ly result. We can go through cycles where the earn­ings are a lit­tle bit low­er because of high invest­ment costs. It is much eas­i­er if you are not on the radar screen every quar­ter.”

Pri­vate own­er­ship also allows Wack­er to put more mon­ey into R&D–some 6% of annu­al sales–than most pub­licly trad­ed chem­i­cal com­pa­nies, with­out hav­ing to fend off investor com­plaints of high spend­ing. And the com­pa­ny can put this research into prac­tice with expen­sive plant con­struc­tion projects that pub­lic com­pa­nies might shy away from. . . .

11. The Stru­eng­mann broth­ers got their start with the com­pa­ny their father, Ernst Stru­eng­mann, had start­ed, Dura­chemie.  Dura­chemie was sold off to raise the mon­ey they used to start the gener­ic drug mak­er Hexal, which was even­tu­al­ly sold off to Novar­tis–the firm that coa­lesced from the Swiss com­po­nent of I.G. Far­ben.

The fol­low­ing review of Hexal also notes that Andreas worked as a physi­cian in South Africa after get­ting his med­ical degree.  A key ele­ment in Hexa­l’s cor­po­rate devel­op­ment was the fir­m’s for­eign invest­ment, which began in South Africa near the end of the apartheid regime.

“Com­pa­ny His­to­ry;” Hexal-AG-Com­pa­ny.

Com­pa­ny His­to­ry:

. . . . Hexal was found­ed by twin broth­ers Thomas and Andreas Strüng­mann. The Strüng­mann broth­ers were no strangers to phar­ma­ceu­ti­cals: father Ernst Strüng­mann had ear­li­er found­ed the Frank­furt-based com­pa­ny Dura­chemie. While Andreas pur­sued his med­ical stud­ies, Thomas received a doc­tor­ate in busi­ness admin­is­tra­tion from the Uni­ver­si­ty of Augs­burg in 1977.

He then went to work for Scher­ing-Plough as a prod­uct man­ag­er, at first in Lucerne, before being trans­ferred to that com­pa­ny’s New Jer­sey branch in 1978. Strüng­man­n’s encounter with Amer­i­can “can-do” opti­mism was to have a last­ing impact, and became a dri­ving force behind Hexa­l’s suc­cess. Thomas Strüng­mann then returned to Ger­many, becom­ing Dura­chemie’s CEO in 1979. In the mean­time, Andreas had com­plet­ed his stud­ies and gone to work as a physi­cian in the South African bush where he was direct­ly con­front­ed with the urgent need for more afford­able med­i­cines. . . .

. . . . A key fac­tor in Hexa­l’s growth was its deci­sion ear­ly on to expand pro­duc­tion and dis­tri­b­u­tion into the glob­al mar­ket. The com­pa­ny’s first for­eign move came in 1990, when it opened a mar­ket­ing sub­sidiary in South Africa, with an office in the Dur­ban sub­urb of Pine­town. . . .

 

 

 

 

Discussion

6 comments for “FTR #1167 Bio-Psy-Op Apocalypse Now, Part 23: A Pound of Cure, Part 2”

  1. FYI, San­to Hold­ing turns up in the “Par­adise Papers”. They are linked to this EOS Africa group in Mal­ta. (reminder: a female Mal­tese journo who blew the lid on some of the Pana­ma Papers stuff years ago was mur­dered with a car bomb). This shows the ties of EOS.

    https://offshoreleaks.icij.org/nodes/55038905

    Dun­can Ran­dall is a South African who worked with EOS Africa. He has some very inter­est­ing ties.

    https://www.marketscreener.com/business-leaders/Duncan-Randall-0HQ6H0‑E/biography/

    I am fair­ly cer­tain that this is the same Dun­can Ran­dall, though I can­not find 100% con­fir­ma­tion of this.

    https://www.marketscreener.com/business-leaders/Duncan-Randall-0HQ6H0‑E/biography/

    Founder of The Progress Fund, Dun­can Ran­dall present­ly is Man­ag­ing Direc­tor at Tana Africa Cap­i­tal Man­agers Pty Ltd. Dr. Ran­dall is also Chief Exec­u­tive Offi­cer- FNB Enter­prise Solu­tions at FirstRand Bank Ltd.

    .
    NOTE: Tana was found­ed by mem­bers of the Oppen­heimer dia­mond fam­i­ly this fam­i­ly, like the Roth­schilds, are often part of anti­se­mit­ic con­spir­a­cy the­o­ries. How­ev­er, the patri­arch of the fam­i­ly, while born Jew­ish, con­vert­ed to Angli­can Chris­tian­i­ty over a cen­tu­ry ago. None of the mod­ern Oppen­heimers are Jews. As we shall see, they “played for the oth­er team”.

    http://www.tana-africa.com/pages/FOUNDING_SHAREHOLDERS.aspx

    “Tana Africa Cap­i­tal was estab­lished in 2011 as a 50/50 joint ven­ture between E. Oppen­heimer & Son and Temasek. The two like-mind­ed investors were unit­ed by the com­mon vision of cre­at­ing val­ue on the African con­ti­nent through cap­i­tal and busi­ness build­ing sup­port. To date the com­pa­ny has deployed more than US$250 mil­lion across the length and breadth of Africa.”

    This book looks inter­est­ing and cov­ers appar­ent ties between DeBeers and the Nazis. See the bold­ed sec­tion.

    https://books.google.com/books?id=raO8jHBdDhYC

    “Tak­ing us through sev­en decades of intrigue and ‑manip­u­la­tion that span the globe, Janine Roberts has writ­ten the most expan­sive and explo­sive expose ever on dia­monds; among Roberts’ rev­e­la­tions: How De Beers hides away rich dia­mond deposits-and where some of these are locat­ed. How a long-term com­pan­ion of Jack­ie Onas­sis was a CIA-linked mil­lion­aire dia­mond mer­chant tied to coups and dic­ta­tors in Cen­tral Africa. Just how dia­monds are “fixed” to make them more expen­sive. How major dia­mond com­pa­nies coop­er­at­ed with Hitler’s Ger­many-and how much they were paid. How indus­tri­al dia­mond sup­plies were arti­fi­cial­ly ‑restrict­ed to the Unit­ed States dur­ing World War II, severe­ly dam­ag­ing its war effort and how U.S. Intel­li­gence came to sus­pect trea­son. How a major dia­mond deposit in Arkansas was sab­o­taged to stop it com­ing into pro­duc­tion. How the White House was manip­u­lat­ed into buy­ing mil­lions of dia­monds it did not need and now must sell. How ter­ror­ism found its way into the dia­mond trade, not recent­ly but many decades ago. How dia­monds are secret­ly moved by the mil­lions around the world. ”

    NOTE: The “CIA-linked dia­mond mer­chant” was long­time Jack­ie O com­pan­ion Mau­rice Tem­pels­man. Tem­pels­man­’s CIA busi­ness agent was Richard Devlin, who was involved in the machi­na­tions to put Mobu­tu in charge of Con­go AND was CIA sta­tion chief in Laos dur­ing the Viet­nam War.

    https://en.wikipedia.org/wiki/Maurice_Tempelsman

    The Oppen­heimer’s part­ner in Tana Africa is Temasek, the state sov­er­eign wealth fund of Sin­ga­pore.

    https://www.scmp.com/week-asia/politics/article/2126198/oil-bribes-politicians-what-happened-clean-singapore

    “The US$55 mil­lion topped the near­ly US$19 mil­lion in bribes that were involved at a scan­dal at state-linked ship­builder Sin­ga­pore Tech­nolo­gies Marine, mak­ing it the biggest cor­rup­tion case to hit one of the so-called Sin­ga­pore Inc com­pa­nies linked to state sov­er­eign wealth firm Temasek Hold­ings.

    Temasek is huge in Asia and is cur­rent­ly build­ing an entire “smart city” with Mit­subishi in Indone­sia.”

    https://asia.nikkei.com/Business/Technology/In-Jakarta-suburb-Mitsubishi-and-Temasek-unit-plan-smart-city

    Posted by CinqueAnon | December 24, 2020, 6:01 pm
  2. Pres­i­dent Biden gave his first pres­i­den­tial address to the nation last night mark­ing the one-year anniver­sary of the World Health Orga­ni­za­tion’s dec­la­ra­tion that COVID-19 was a glob­al pan­dem­ic and the begin­nings of the COVID-19 lock­downs. It was undoubt­ed­ly a year the vast major­i­ty of the glob­al pop­u­lace would pre­fer to for­get.

    But here’s a quick reminder that for at least some indus­tries, 2020 was the gift that kept on giv­ing. And for at least some of the vac­cine man­u­fac­tur­ers, in par­tic­u­lar Mod­er­na and BioN­Tech, 2020 was the gift that kept on giv­ing and will prob­a­bly keep on giv­ing for years and per­haps decades to come, as reflect­ing by their wild stock surges. Oth­er large win­ners like Pfiz­er haven’t seen their stocks surge from the val­u­a­tions a year ago — val­u­a­tions that pre­ced­ed the his­to­ry stock sell­offs the fol­lowed the March 11 pan­dem­ic dec­la­ra­tion — but are still expect­ing rev­enues from vac­cines alone in 2021 to fall in the range of $15–30 bil­lion.

    So 2020 is the gift that’s def­i­nite­ly going to keep giv­ing in 2021 for these vac­cine man­u­fac­tur­ers, but as the arti­cle also notes, it’s still unclear if 2021 is going to be a one-off event for the indus­try or the start of a new annu­al glob­al coro­n­avirus vac­ci­na­tion mar­ket. That all remains to be seen. So for the vac­cine indus­try, 2020 might have been the gift that kept on giv­ing through 2021 or it might be the gift that keeps on giv­ing for­ev­er. And whether or not it’s a gift that’s giv­en just a 2021 or for­ev­er depends, in part, on the suc­cess of the glob­al vac­ci­na­tion roll­out at quelling the virus, if that’s even pos­si­ble, with the like­li­hood of a ‘for­ev­er gift’ ris­ing should the glob­al vac­ci­na­tion efforts fail. It’s a reminder that, from a prof­it-max­i­miza­tion per­spec­tive, the goal of the vac­cine man­u­fac­tur­ers should­n’t be to vac­ci­nate every­one. The goal should be to vac­ci­nate almost every­one, while leav­ing enough peo­ple avail­able to keep the virus cir­cu­lat­ing for years to come:

    The Guardian

    From Pfiz­er to Mod­er­na: who’s mak­ing bil­lions from Covid-19 vac­cines?

    The com­pa­nies in line for the biggest gains – and the share­hold­ers who have already made for­tunes

    Julia Kollewe
    Sat 6 Mar 2021 06.55 EST
    First pub­lished on Sat 6 Mar 2021 03.00 EST

    The arrival of Covid-19 vac­cines promis­es a return to more nor­mal life – and has cre­at­ed a glob­al mar­ket worth tens of bil­lions of dol­lars in annu­al sales for some phar­ma­ceu­ti­cal com­pa­nies.

    Among the biggest win­ners will be Mod­er­na and Pfiz­er – two very dif­fer­ent US phar­ma firms which are both charg­ing more than $30 per per­son for the pro­tec­tion of their two-dose vac­cines. While Mod­er­na was found­ed just 11 years ago, has nev­er made a prof­it and employed just 830 staff pre-pan­dem­ic, Pfiz­er traces its roots back to 1849, made a net prof­it of $9.6bn last year and employs near­ly 80,000 staff.

    ...

    Whether the mar­ket remains a mon­ey-spin­ner in the future depends on whether the vac­cines become the type that need just a one-off shot – as for measles – or if reg­u­lar vac­ci­na­tions will be required, such as for flu. But in the imme­di­ate future, there are big finan­cial returns up for grabs.

    ...

    ————————–

    1. Pfizer/BioNTech
    mRNA vac­cine

    Pfizer’s Comir­naty vac­cine, devel­oped with Germany’s BioN­Tech, is based on re-engi­neered mes­sen­ger RNA – the mol­e­cule that sends genet­ic instruc­tions from DNA to a cell’s pro­tein-mak­ing machin­ery. It was the first to be approved and has to be stored at ultra-low tem­per­a­tures (-70C). Gov­ern­ments have ordered about 780m shots, includ­ing the US (200m dos­es for $3.9bn) and the EU com­mis­sion (300m), while 40m dos­es will go to low­er-income nations via the Cov­ax facil­i­ty. It costs $39 (£28) for two dos­es in the US and about $30 in the EU.

    Expect­ed sales in 2021: $15bn-$30bn

    Pfiz­er, which splits costs and prof­it mar­gins equal­ly with BioN­Tech, expects $15bn in 2021 sales based on cur­rent deals. The final num­ber could be twice as high, as Pfiz­er says it can poten­tial­ly deliv­er 2bn dos­es this year. Bar­clays ana­lyst Carter Gould is pre­dict­ing sales of $21.5bn in 2021, $8.6bn next year and $1.95bn in 2023, on the assump­tion that the jab is giv­en as a one-off shot.

    Share price change over the past 12 months

    Pfiz­er: +1.8%

    BioN­Tech: +156%

    The two founders of BioN­Tech, the hus­band and wife team Ugur Sahin and Özlem Türe­ci – both doc­tors – became multi­bil­lion­aires last year, when the poten­tial of the vac­cine and the deal with Pfiz­er prompt­ed the shares to surge.

    ————————

    2. Mod­er­na
    mRNA vac­cine

    The vac­cine pro­duced by the US biotech firm, based in Mass­a­chu­setts, must be stored at freez­er tem­per­a­ture (-20C). The UK has ordered 17m dos­es, the EU bought 310m with an option for a fur­ther 150m in 2022, while the US gov­ern­ment ordered 300m shots. Japan pur­chased 50m shots. Mod­er­na charges $30 for the required two shots in the US and $36 in the EU.

    Expect­ed sales in 2021: $18bn-$20bn

    Mod­er­na has said it expects 2021 sales of $18.4bn. Bar­clays ana­lyst Gena Wang fore­casts sales of $19.6bn, $12.2bn in 2022, and $11.4bn in 2023, assum­ing recur­ring vac­ci­na­tions.

    Share price change over past 12 months

    +372%

    A group of investors that backed the com­pa­ny when it was found­ed in 2010 will have made sub­stan­tial returns. The chief exec­u­tive, Stéphane Ban­cel, a 48-year-old French exec­u­tive, owns 9% of the shares, now worth near­ly $5bn.

    ————————

    3. John­son & John­son
    Ade­n­ovirus vac­cine

    J&J’s jab, the world’s first sin­gle-shot Covid-19 vac­cine, was devel­oped by its Janssen divi­sion in Bel­gium. It uses ade­n­ovirus-26, a rare vari­ant of cold virus. It was approved in the US in late Feb­ru­ary and can be stored at stan­dard fridge tem­per­a­tures for at least three months. Big orders include the US, UK (30m dos­es plus option for 22m), the EU (up to 400m dos­es), and Cov­ax nations (500m dos­es through 2022).

    Expect­ed sales in 2021: up to $10bn

    The com­pa­ny aims to deliv­er at least 1bn dos­es this year, which would gen­er­ate $10bn. The US gov­ern­ment has ordered 100m dos­es, with the option to buy 200m more, and is pay­ing $10 a shot.

    Share price change over past 12 months

    +7.7%

    ————————

    4. AstraZeneca
    Ade­n­ovirus vec­tor vac­cine

    The vac­cine devel­oped with Oxford Uni­ver­si­ty uses a mod­i­fied chim­panzee cold virus and can be kept at fridge tem­per­a­ture. Viral vec­tor vac­cines use a harm­less virus to deliv­er a piece of genet­ic code to cells. Big orders have come from the UK (100m), the EU (up to 400m), the US (300m) and Japan (£120m).

    Expect­ed sales in 2021: $2bn-$3bn

    Ana­lysts at SVB Leerink are fore­cast­ing sales of $1.9bn this year and $3bn in 2022. The 2021 fig­ure could be far high­er if AstraZeneca achieves its ambi­tious tar­get of 3bn dos­es. The com­pa­ny has pledged to sup­ply the vac­cine on a not-for-prof­it basis dur­ing this pan­dem­ic, and charges $4.30 to $10 for two dos­es.

    Share price change in last 12 months

    -8.6%

    ————————

    5. Sino­vac
    Inac­ti­vat­ed virus vac­cine

    The Coro­n­aVac jab has been admin­is­tered for emer­gency use in sev­er­al Chi­nese cities since last sum­mer, and was approved by China’s reg­u­la­tor in ear­ly Feb­ru­ary. Sino­vac, which is based in Bei­jing, has struck deals with Brazil, Chile, Sin­ga­pore, Malaysia and the Philip­pines. In Jan­u­ary, Turkey and Indone­sia kicked off their vac­ci­na­tion cam­paigns with the jab. Sino­vac also plans to sup­ply 10m vac­cine dos­es to Cov­ax nations.

    Expect­ed sales in 2021: bil­lions of dol­lars, but unclear

    Sino­vac says it can pro­duce more than 1bn dos­es this year. The vac­cine has been priced at $60 for two shots in some Chi­nese cities. Sinovac’s Indone­sian part­ner Bio Far­ma, which has ordered at least 40m dos­es, said it would cost $27.20 for two dos­es local­ly.

    Share price change in last 12 months

    -21.6%

    ————————

    6. Gama­leya Institute/Russian Direct Invest­ment Fund
    Ade­n­ovirus vac­cine

    Although it has not been approved by the EU reg­u­la­tor yet, Hun­gary and Slo­va­kia have bought the Russ­ian vac­cine Sput­nik V. In total, more than 50 coun­tries, includ­ing Iran, Alge­ria and Mex­i­co, have ordered it. AstraZeneca is test­ing a two-shot com­bi­na­tion of its vac­cine with Sput­nik.

    Expect­ed sales in 2021: unclear but pos­si­bly bil­lions

    The devel­op­ers are strug­gling to mass-pro­duce Sput­nik in Rus­sia, but RDIF, a sov­er­eign wealth fund, told the Finan­cial Times last month that it had signed con­tracts with 15 man­u­fac­tur­ers in 10 coun­tries to pro­duce 1.4bn jabs. The devel­op­ers have said they would charge $20 or less for the required two dos­es inter­na­tion­al­ly but are pro­vid­ing it free in Rus­sia.

    ————————

    7. Novavax
    Recom­bi­nant pro­tein vac­cine

    The Novavax vac­cine uses a small frag­ment of a lab-made ver­sion of the Sars-CoV­‑2 spike pro­tein. The US firm hopes for reg­u­la­to­ry approval in the UK, US and oth­er coun­tries in the first half. The com­pa­ny has been research­ing vac­cines for more than 30 years and has nev­er before had a jab approved. It has agreed to sup­ply 300m dos­es so far, includ­ing the UK (60m dos­es), EU, Cana­da and Aus­tralia. It hopes to pro­duce 150m dos­es a month and is expect­ed to be cheap­er than rivals. Accord­ing to the Finan­cial Times, the com­pa­ny has agreed to charge $3 a shot in Africa. The vac­cine will also be made in Stock­ton-on-Tees, in north-east Eng­land, and can be be kept at fridge tem­per­a­ture.

    Expect­ed sales in 2021: ‘sev­er­al bil­lion dol­lars’

    Based on these deals, Novavax said this week it sees “the poten­tial for sev­er­al bil­lion dol­lars in rev­enue in the next 12 months”. This is set to rise, as Novavax expects to be able to make 2bn dos­es a year by mid-2021, thanks to a part­ner­ship with the Serum Insti­tute of India.

    Share price change in the past 12 months

    +1,128%

    The biggest finan­cial gains will go to fund man­agers such as Van­guard and Black­Rock, who are the biggest share­hold­ers.

    ————————

    Cure­Vac
    mRNA vac­cine

    Cure­Vac expects to pub­lish late-stage results for its CVn­Cov vac­cine in April and hopes to gain EU approval by June. The EU has pre-ordered 225m dos­es with the option to buy a fur­ther 180m. Unlike oth­er mRNA vac­cines, CureVac’s shot can be stored at fridge tem­per­a­ture. Togeth­er with GSK, which owns near­ly 10% of the Ger­man firm, it is seek­ing to devel­op next-gen­er­a­tion shots for mul­ti­ple emerg­ing Covid-19 vari­ants in one vac­cine.

    Expect­ed sales in 2021: unclear – pric­ing not yet revealed, but priced at a prof­it

    The Nas­daq-list­ed biotech aims to pro­duce up to 300m dos­es this year and 600m to 1bn dos­es in 2022. Cure­Vac says its jab requires less active ingre­di­ent than rivals but insists it can­not price it at cost because investors are expect­ing a return.

    Share price change

    +45.5%

    The biggest share­hold­er is Ger­man bil­lion­aire Diet­mar Hopp, the co-founder of the soft­ware firm SAP. He owns more than 80% of Cure­Vac, now worth more than $12bn.

    —————-

    “From Pfiz­er to Mod­er­na: who’s mak­ing bil­lions from Covid-19 vac­cines?” by Julia Kollewe; The Guardian; 03/06/2021

    Whether the mar­ket remains a mon­ey-spin­ner in the future depends on whether the vac­cines become the type that need just a one-off shot – as for measles – or if reg­u­lar vac­ci­na­tions will be required, such as for flu. But in the imme­di­ate future, there are big finan­cial returns up for grabs.”

    Are we look­ing at a for­ev­er-war against COVID? We don’t know yet, but if so, that means for­ev­er-prof­its for the win­ning vac­cine man­u­fac­tur­ers. But if that’s going to hap­pen, human­i­ty has to los­es the vac­ci­na­tion race in 2021.

    Now, in fair­ness, there’s almost no real­is­tic chance that the SARS-CoV­‑2 virus is going to be wiped out by measles sim­ply because the virus does­n’t appear to have the same kind of evo­lu­tion­ary fragili­ty that measles pos­sess that makes measles such a potent can­di­date for stop­ping with a vac­cine. There real­ly should­n’t be any expec­ta­tion that this virus is leav­ing in 2021 because the virus itself does­n’t appear to be amend­able to that, as the num­ber of dif­fer­ent vari­ants have already made clear.

    At the same time, if human­i­ty is going to win the vac­ci­na­tion race in 2021, that’s going to require the kind of mass forced vac­ci­na­tions cam­paigns that haven’t real­ly been con­ceived of yet. And in the era of far right mis­in­for­ma­tion and the threats of civ­il war in the US, it’s hard to imag­ine a mass forced vac­ci­na­tion cam­paign going over well. And that’s just in the US. There real­ly is no real­is­tic sce­nario where this virus dis­ap­pears.

    On the oth­er hand, we still could see a replay of past coro­n­avirus sce­nar­ios where the virus effec­tive­ly becomes a new com­mon cold coro­n­avirus with high­ly lim­it­ed mor­tal­i­ty rates. It might be the best sce­nario we can real­is­ti­cal­ly hope for and one that works for the vac­cine man­u­fac­tur­ers too. After all, that process of allow­ing the virus to flair out could take time, and it’s pos­si­ble some vul­ner­a­ble groups might still require vac­cines even at that point.

    But also keep in mind that one of the big inno­va­tions here is the devel­op­ment of new vac­cine devel­op­ment plat­forms that, in the­o­ry, allow from the rapid deploy­ment of new vac­cines against new virus­es in rapid time. That’s the promise of Mod­er­na and Pfiz­er’s mRNA tech­nol­o­gy. You can sequence a virus an basi­cal­ly imme­di­ate­ly design a new vac­cine. That capa­bil­i­ty did­n’t real­ly exist before 2020. A big part of the rea­son Mod­er­na and Pfiz­er are the big win­ners in this race is because they had their vac­cines ready to first. So if you’re a com­pa­ny with this kind of rapid vac­cine-devel­op­ment tech­nolo­gies ready to go, the next 2020 might be even more prof­itable because the mRNA tech­nol­o­gy will have already gone through this glob­al vet­ting process.

    And that’s why it’s look­ing like the biggest 2020 gift to the vac­cine indus­try isn’t the promise of SARS-CoV­‑2 vac­cine sales well into the future. It’s the promise of even big­ger and bet­ter ‘2020’ expe­ri­ences for the indus­try dur­ing the next glob­al pan­dem­ic thanks to the emer­gency approval of all these new vac­cine tech­nolo­gies. The next pan­dem­ic that’s bound to show up soon­er or lat­er, with a grow­ing bias towards soon­er.

    Posted by Pterrafractyl | March 12, 2021, 5:39 pm
  3. This arti­cle shows a poten­tial­ly promis­ing solu­tion by the US Army. The IG — Far­ben derivat­vive Phar­ma com­pa­nies do not want this to be a US gov­ern­ment suc­cess.

    A next-gen Army COVID vac­cine you’ve nev­er heard of has just begun human tri­als
    ABC News
    Sci­en­tists believe it might com­bat dead­ly vari­ants and even future pan­demics.

    By Matt Seyler April 8, 2021, 5:03 AM

    As more than 100 mil­lion Amer­i­cans were nee­dled and inoc­u­lat­ed against COVID-19 with dos­es pro­duced by phar­ma­ceu­ti­cal pow­er­hous­es like Pfiz­er and Mod­er­na, a scrap­py team of sci­en­tists in an Army lab just out­side the nation’s cap­i­tal qui­et­ly con­tin­ued manip­u­lat­ing pro­teins, test­ing mon­keys, work­ing to con­ceive a vac­cine of the future. This is the Wal­ter Reed Army Insti­tute of Research (WRAIR) in Sil­ver Spring, Mary­land.

    Over the last decade Mod­jar­rad also led the Army’s vac­cine efforts for Ebo­la and the Zika virus and was prin­ci­pal inves­ti­ga­tor of its cam­paign against MERS, a dis­ease itself caused by a coro­n­avirus. And though WRAIR is the old­est bio­med­ical research insti­tute with­in the Depart­ment of Defense, the emerg­ing infec­tious dis­eases branch is still young.

    From the begin­ning his focus was on next-gen­er­a­tion threats,

    The WRAIR vac­cine skips both the instruc­tion and cre­ation steps, bring­ing the already-formed spike pro­tein straight into the arm along with an immune-boost­ing adju­vant com­pound, quick­ly start­ing the anti­body response.

    And unlike oth­er pro­tein-based vac­cines being test­ed, the WRAIR can­di­date presents virus-look­ing nanopar­ti­cles, each with a con­sis­tent array of 24 spike pro­teins arranged in small bou­quets of three pro­trud­ing from a fer­ritin base.

    “There’s a lot of the­o­ries as to why some­thing pre­sent­ed in this fash­ion gives such a good immune response, but in some ways you can see it looks like a virus as well,” Mod­jar­rad said. “So it has some prop­er­ties that edu­cate the immune response in a way that it gives you a very strong, but also a broad response.”

    Test results with thou­sands of mice and dozens of mon­keys have been promis­ing.

    “We think (oth­er) vac­cines are prob­a­bly going to be pro­tec­tive against new vari­ants, but they might be decreased in their pro­tec­tion,” Mod­jar­rad said. “What we’ve seen with our vac­cine so far in ani­mals ... is that the vac­cine is not decreased in effec­tive­ness against those vari­ants at all. And it is effec­tive against oth­er coro­n­avirus­es like SARS‑1. So what we have devel­oped now is start­ing to look like a pan-SARS vac­cine ... and we’re going to start test­ing every­thing in between.”

    https://abcnews.go.com/Politics/gen-army-covid-vaccine-heard-begun-human-trials/story?id=76901332

    Posted by Mary Benton | April 16, 2021, 9:40 pm
  4. Pfiz­er CEO says a THIRD Covid vac­cine may be need­ed

    https://mol.im/a/9475955

    Posted by Mary Benton | April 16, 2021, 10:14 pm
  5. Here’s a sto­ry to keep an eye on with poten­tial­ly huge impli­ca­tions for the abil­i­ty of the devel­op­ing coun­tries to deal with future pan­demics: South Africa just devel­oped their own ver­sion of the mRNA coro­n­avirus vac­cine. It sounds like they basi­cal­ly just attempt­ed to repli­cate on their own what Mod­er­na did and have large­ly suc­ceed­ed. It’s poten­tial­ly quite an excit­ing devel­op­ment for South Africa, where less than 10% of the pop­u­la­tion has been vac­ci­nat­ed. But the impli­ca­tions go far beyond this pan­dem­ic. Don’t for­get that the sim­plic­i­ty of the mRNA vac­cine devel­op­ment process is a major part of their appeal, which allowed for Mod­er­na to announce on Jan 13, 2020, just days after the SARS-CoV­‑2 sequence was pub­lished to the world. So, in the­o­ry, this rel­a­tive­ly sim­ple and cheap vac­cine devel­op­ment process could be repli­cat­ed by coun­tries around the world for future emerg­ing dis­eases. It’s one of the under-appre­ci­at­ed aspect of the poten­tial for mRNA vac­cines: it makes vac­cine devel­op­ment poten­tial­ly acces­si­ble to devel­op­ing nations.

    But, of course, there’s a flip side to this osten­si­bly feel-good sto­ry: It’s not great news for Big Phar­ma. The world isn’t nec­es­sary going to be near­ly as reliant on large phar­ma­ceu­ti­cal com­pa­nies like Mod­er­na or Pfiz­er for their vac­cines for future out­breaks.

    That’s the con­text of South Africa’s big vac­cine announce­ment: it was the kind of break­through that’s going to prompt a big patent fight. The kind of patent fight with life-and-death-and-big-prof­it impli­ca­tions.

    And as we’ve seen, Mod­er­na has­n’t exact­ly been act­ing in good faith when it comes to these mRNA vac­cine patents. Recall the reports from back in August of 2020 about how Mod­er­na was fil­ing patent appli­ca­tions for an mRNA vac­cine that would pro­tect against a broad range of beta­coro­n­avirus­es. A vac­cine appli­ca­tion that neglect­ed to men­tion the fact that Mod­er­na received exten­sion help and sup­port from the NIH. Pos­si­bly relat­ed to those miss­ing dis­clo­sures is the fact that the patent appli­ca­tion gave a long list of beta­coro­n­avirus­es that this vac­cine would work for — MERS-CoV, SARS-CoV, HCoV-OC43, HCoV-229E, HCoV-NL63, HCoV-NL, HCoV-NH, HCoV-HKU1 — but no men­tion of SARS-CoV­‑2, despite the fact that the NIH and Mod­er­na joint infec­tious dis­ease research team final­ized the sequence for mRNA-1273 on Jan 13, 2020. That patent was orig­i­nal­ly filed on Feb 28, 2020. So about 6 weeks after Mod­er­na and the NIH designed their COVID mRNA vac­cine — which was designed in record time by uti­liz­ing the years of joint research for mRNA vac­cines — Mod­er­na pro­ceeds to file for a patent on basi­cal­ly the same mRNA vac­cine tech­nol­o­gy that can pro­tect against Beta­coro­n­avirus­es oth­er than SARS-CoV­‑2 with no men­tion of the NIH’s exten­sive involve­ment. It was more than a lit­tle sleazy.

    So what does Mod­er­na have to say about this South African vac­cine announce­ment? Noth­ing, so far. It’s an omi­nous silence:

    Nature

    South African sci­en­tists copy Moderna’s COVID vac­cine
    Researchers at WHO’s tech­nol­o­gy trans­fer hub com­plete first step in a project aimed at build­ing capac­i­ty for vac­cine man­u­fac­tur­ing in low- and mid­dle-income coun­tries.

    Amy Max­men
    Feb 03, 2022

    Researchers at a South African biotech­nol­o­gy com­pa­ny say they have near­ly cre­at­ed a copy of Moderna’s mes­sen­ger-RNA-based vac­cine against COVID-19, with­out Moderna’s involve­ment.

    The com­pa­ny, Afrigen Bio­log­ics and Vac­cines, in Cape Town, has made only microlitres of the vac­cine, based on data that Mod­er­na used to make its shot. But the achieve­ment is a mile­stone for a major ini­tia­tive launched by the World Health Orga­ni­za­tion (WHO) — a tech­nol­o­gy trans­fer hub meant to build capac­i­ty for vac­cine man­u­fac­tur­ing in low- and mid­dle-income coun­tries.

    Dur­ing the COVID-19 pan­dem­ic, the devel­op­ers of mRNA vac­cines — Mod­er­na and Pfiz­er, based in the Unit­ed States, and Germany’s BioN­Tech — have sent more than 70% of their dos­es to wealthy nations, accord­ing to vac­cine-track­ing analy­ses. Mean­while, mil­lions of vac­cine orders pur­chased by or promised to coun­tries in the glob­al south for these vac­cines have been delayed . “Mod­er­na and Pfizer-BioNTech’s vac­cines are main­ly still going to just the rich­est coun­tries,” says Mar­tin Friede, the WHO offi­cial coor­di­nat­ing the hub. “Our objec­tive is to empow­er oth­er coun­tries to make their own.”

    Many steps remain before Afrigen’s mRNA vac­cine mim­ic could be dis­trib­uted to peo­ple in Africa and beyond, and it def­i­nite­ly won’t help curb the pan­dem­ic this year. But the WHO hopes that the process of cre­at­ing it will lay the foun­da­tion for a more glob­al­ly dis­trib­uted mRNA vac­cine indus­try in the future.

    Ger­hardt Boukes, chief sci­en­tist at Afrigen — the firm at the core of the WHO’s hub — is proud to have helped com­plete this first step of the plan. Afrigen and its col­lab­o­ra­tors com­plet­ed the process, begin­ning with mRNA encod­ing a mod­i­fied por­tion of the SARS-CoV­‑2 coro­n­avirus, and fin­ish­ing by encap­su­lat­ing it in a lipid nanopar­ti­cle that deliv­ers the vac­cine to cells. “We didn’t have help from the major COVID vac­cine pro­duc­ers,” he says, “so we did it our­selves to show the world that it can be done, and be done here, on the African con­ti­nent.”

    Going it alone

    When the WHO launched its mRNA tech trans­fer hub in South Africa last June, it asked Mod­er­na, Pfiz­er and BioN­Tech to help teach researchers in the glob­al south how to make their COVID-19 vac­cines. But the com­pa­nies did not respond, and the WHO decid­ed to go ahead with­out their help. Friede says the WHO chose to repli­cate Moderna’s shot because more infor­ma­tion on its devel­op­ment is avail­able pub­li­cal­ly, com­pared with Pfizer-BioNTech’s vac­cine, and because Mod­er­na has vowed not to enforce its patents dur­ing the pan­dem­ic. Mod­er­na did not respond to requests from Nature to com­ment on the WHO’s deci­sion to copy its vac­cine.

    With funds from coun­tries includ­ing France, Ger­many and Bel­gium, South African researchers began chip­ping away at the project in late Sep­tem­ber. A team at the Uni­ver­si­ty of Wit­wa­ter­strand, in Johan­nes­burg, took the lead on exe­cut­ing the first step: mak­ing a DNA mol­e­cule that would serve as a tem­plate to syn­the­size the mRNA need­ed in the vac­cine. Although this sequence has been con­tro­ver­sial­ly patent­ed by Mod­er­na, researchers from Stan­ford Uni­ver­si­ty in Cal­i­for­nia had deposit­ed it into the online data­base Virological.org in March last year.

    Patrick Arbuth­not, direc­tor of gene ther­a­py research at the Uni­ver­si­ty of Wit­wa­ter­srand says, “We were not intim­i­dat­ed, because mRNA syn­the­sis is a fair­ly gener­ic pro­ce­dure.” Despite delays in the ship­ment of raw mate­ri­als, the team com­plet­ed this process in ten weeks and sent vials of mRNA to Afrigen in ear­ly Decem­ber.

    Dur­ing this peri­od, hav­ing heard about plans to mim­ic Moderna’s shot, sci­en­tists from around the world sent Afrigen researchers e‑mails offer­ing assis­tance. Some of them were researchers at the US Nation­al Insti­tutes of Health who had con­duct­ed foun­da­tion­al work on mRNA vac­cines. “It was extra­or­di­nary,” says Petro Terblanche, Afrigen’s man­ag­ing direc­tor. “I think a lot of sci­en­tists were dis­il­lu­sioned with what had hap­pened with vac­cine dis­tri­b­u­tion, and they want­ed to help get the world out of this dilem­ma.”

    On 5 Jan­u­ary, Afrigen’s researchers accom­plished anoth­er tricky part of the process: They encap­su­lat­ed the mRNA in a fat­ty nanopar­ti­cle made of a mix­ture of lipids. Boukes says they haven’t yet used Moderna’s spe­cif­ic lipid mix­ture, but rather anoth­er one that was imme­di­ate­ly avail­able from the man­u­fac­tur­er of the machine that the lab­o­ra­to­ry uses to cre­ate lipid nanopar­ti­cles. They plan to use Moderna’s lipid mix­ture in the com­ing days, as soon as one last ana­lyt­i­cal instru­ment arrives. After that, the team will analyse the for­mu­la­tion to ensure that it is tru­ly a near copy of Moderna’s vac­cine.

    An empow­er­ment process

    ...

    For the next phase of the project, sev­er­al com­pa­nies in the glob­al south will learn from Afrigen and attempt to cre­ate batch­es of vac­cines them­selves, in prepa­ra­tion for test­ing the shots in rodents. By the end of Novem­ber, the WHO expects a Mod­er­na mim­ic to be ready for phase I safe­ty tri­als in peo­ple.

    What hap­pens next year remains uncer­tain. Charles Gore, the direc­tor of the Med­i­cines Patent Pool, an inter­na­tion­al orga­ni­za­tion work­ing with the hub that is devot­ed to expand­ing drug and vac­cine access around the world, says that the ini­tia­tive has no inten­tion of infring­ing on Moderna’s patents. Lab­o­ra­to­ry research is gen­er­al­ly not sub­ject to patent rules, Gore explains.

    And once the vac­cine is ready for use, he hopes that Mod­er­na might then license its patents, or that by then, there will be alter­na­tives that these com­pa­nies could pro­duce with­out fear of a law­suit. Sci­en­tists at sev­er­al uni­ver­si­ties are cur­rent­ly devel­op­ing next-gen­er­a­tion mRNA vac­cines that might be cheap­er to make or that don’t require ultra­cold tem­per­a­tures for stor­age, as do Moderna’s and Pfizer-BioNTech’s.

    Although the pace of this effort will not solve the urgent need for vac­cines across Africa, many researchers from the con­ti­nent are enthu­si­as­tic because a reliance on vac­cines from West­ern coun­tries and com­pa­nies has proven dan­ger­ous dur­ing the pan­dem­ic — only about 10% of peo­ple in Africa have been ful­ly vac­ci­nat­ed — and this ini­tia­tive was cre­at­ed with a goal of help­ing nations pro­tect them­selves. “Glob­al health’s dys­func­tion derives from pow­er imbal­ances,” explains Olu­so­ji Adeyi, pres­i­dent of the non-prof­it orga­ni­za­tion Resilient Health Sys­tems, in Wash­ing­ton DC. “Address­ing that will come from coun­tries in the glob­al south devel­op­ing their own capa­bil­i­ties and tak­ing respon­si­bil­i­ty for their own health.”

    ———–

    “South African sci­en­tists copy Moderna’s COVID vac­cine” by Amy Max­men; Nature; 02/03/2022

    “Ger­hardt Boukes, chief sci­en­tist at Afrigen — the firm at the core of the WHO’s hub — is proud to have helped com­plete this first step of the plan. Afrigen and its col­lab­o­ra­tors com­plet­ed the process, begin­ning with mRNA encod­ing a mod­i­fied por­tion of the SARS-CoV­‑2 coro­n­avirus, and fin­ish­ing by encap­su­lat­ing it in a lipid nanopar­ti­cle that deliv­ers the vac­cine to cells. “We didn’t have help from the major COVID vac­cine pro­duc­ers,” he says, “so we did it our­selves to show the world that it can be done, and be done here, on the African con­ti­nent.”

    Africa can’t rely on Big Phar­ma. Clear­ly, with only about 10% of peo­ple on the whole con­ti­nent hav­ing been vac­ci­nat­ed yet. So Africa is going it alone. Not quite alone. The work is being done in con­junc­tion with the WHO’s tech­nol­o­gy trans­fer hub. And the WHO appears to have hopes that this project is a tem­plate for more glob­al­ly dis­trib­uted mRNA vac­cine indus­try to address future pan­demics. And yet the big West­ern vac­cine man­u­fac­tur­ers haven’t been part of it despite being asked to par­tic­i­pate. It does­n’t bode well:

    ...
    Dur­ing the COVID-19 pan­dem­ic, the devel­op­ers of mRNA vac­cines — Mod­er­na and Pfiz­er, based in the Unit­ed States, and Germany’s BioN­Tech — have sent more than 70% of their dos­es to wealthy nations, accord­ing to vac­cine-track­ing analy­ses. Mean­while, mil­lions of vac­cine orders pur­chased by or promised to coun­tries in the glob­al south for these vac­cines have been delayed . “Mod­er­na and Pfizer-BioNTech’s vac­cines are main­ly still going to just the rich­est coun­tries,” says Mar­tin Friede, the WHO offi­cial coor­di­nat­ing the hub. “Our objec­tive is to empow­er oth­er coun­tries to make their own.”

    Many steps remain before Afrigen’s mRNA vac­cine mim­ic could be dis­trib­uted to peo­ple in Africa and beyond, and it def­i­nite­ly won’t help curb the pan­dem­ic this year. But the WHO hopes that the process of cre­at­ing it will lay the foun­da­tion for a more glob­al­ly dis­trib­uted mRNA vac­cine indus­try in the future.

    ...

    When the WHO launched its mRNA tech trans­fer hub in South Africa last June, it asked Mod­er­na, Pfiz­er and BioN­Tech to help teach researchers in the glob­al south how to make their COVID-19 vac­cines. But the com­pa­nies did not respond, and the WHO decid­ed to go ahead with­out their help. Friede says the WHO chose to repli­cate Moderna’s shot because more infor­ma­tion on its devel­op­ment is avail­able pub­li­cal­ly, com­pared with Pfizer-BioNTech’s vac­cine, and because Mod­er­na has vowed not to enforce its patents dur­ing the pan­dem­ic. Mod­er­na did not respond to requests from Nature to com­ment on the WHO’s deci­sion to copy its vac­cine.

    ...

    Although the pace of this effort will not solve the urgent need for vac­cines across Africa, many researchers from the con­ti­nent are enthu­si­as­tic because a reliance on vac­cines from West­ern coun­tries and com­pa­nies has proven dan­ger­ous dur­ing the pan­dem­ic — only about 10% of peo­ple in Africa have been ful­ly vac­ci­nat­ed — and this ini­tia­tive was cre­at­ed with a goal of help­ing nations pro­tect them­selves. “Glob­al health’s dys­func­tion derives from pow­er imbal­ances,” explains Olu­so­ji Adeyi, pres­i­dent of the non-prof­it orga­ni­za­tion Resilient Health Sys­tems, in Wash­ing­ton DC. “Address­ing that will come from coun­tries in the glob­al south devel­op­ing their own capa­bil­i­ties and tak­ing respon­si­bil­i­ty for their own health.”
    ...

    Adding to the com­pli­ca­tions is the fact that they used a DNA sequence for the vac­cine that was already patent­ed by Mod­er­na, albeit con­tro­ver­sial­ly patent­ed:

    ...
    With funds from coun­tries includ­ing France, Ger­many and Bel­gium, South African researchers began chip­ping away at the project in late Sep­tem­ber. A team at the Uni­ver­si­ty of Wit­wa­ter­strand, in Johan­nes­burg, took the lead on exe­cut­ing the first step: mak­ing a DNA mol­e­cule that would serve as a tem­plate to syn­the­size the mRNA need­ed in the vac­cine. Although this sequence has been con­tro­ver­sial­ly patent­ed by Mod­er­na, researchers from Stan­ford Uni­ver­si­ty in Cal­i­for­nia had deposit­ed it into the online data­base Virological.org in March last year.

    Patrick Arbuth­not, direc­tor of gene ther­a­py research at the Uni­ver­si­ty of Wit­wa­ter­srand says, “We were not intim­i­dat­ed, because mRNA syn­the­sis is a fair­ly gener­ic pro­ce­dure.” Despite delays in the ship­ment of raw mate­ri­als, the team com­plet­ed this process in ten weeks and sent vials of mRNA to Afrigen in ear­ly Decem­ber.
    ...

    And note how researchers NIH who were work­ing direct­ly with Mod­er­na on the devel­op­ment of a gen­er­al coro­n­avirus vac­cine, and lat­er the crash-devel­op­ment of the SARS-CoV­‑2 vac­cine, are part of this ini­tia­tive. Togeth­er, this team is cre­at­ing a mim­ic of the Mod­er­na vac­cine:

    ...
    Dur­ing this peri­od, hav­ing heard about plans to mim­ic Moderna’s shot, sci­en­tists from around the world sent Afrigen researchers e‑mails offer­ing assis­tance. Some of them were researchers at the US Nation­al Insti­tutes of Health who had con­duct­ed foun­da­tion­al work on mRNA vac­cines. “It was extra­or­di­nary,” says Petro Terblanche, Afrigen’s man­ag­ing direc­tor. “I think a lot of sci­en­tists were dis­il­lu­sioned with what had hap­pened with vac­cine dis­tri­b­u­tion, and they want­ed to help get the world out of this dilem­ma.”

    On 5 Jan­u­ary, Afrigen’s researchers accom­plished anoth­er tricky part of the process: They encap­su­lat­ed the mRNA in a fat­ty nanopar­ti­cle made of a mix­ture of lipids. Boukes says they haven’t yet used Moderna’s spe­cif­ic lipid mix­ture, but rather anoth­er one that was imme­di­ate­ly avail­able from the man­u­fac­tur­er of the machine that the lab­o­ra­to­ry uses to cre­ate lipid nanopar­ti­cles. They plan to use Moderna’s lipid mix­ture in the com­ing days, as soon as one last ana­lyt­i­cal instru­ment arrives. After that, the team will analyse the for­mu­la­tion to ensure that it is tru­ly a near copy of Moderna’s vac­cine.
    ...

    And yet we are told by the peo­ple being this ini­tia­tive that they have no inten­tion of infring­ing on any of Mod­er­na’s patents. There’s even hope that Mod­er­na might then license its patents. In oth­er words, Mod­er­na’s coop­er­a­tion is required for this ini­tia­tive to actu­al­ly work with­out it descend­ing into a giant dis­gust­ing patent fight:

    ...
    For the next phase of the project, sev­er­al com­pa­nies in the glob­al south will learn from Afrigen and attempt to cre­ate batch­es of vac­cines them­selves, in prepa­ra­tion for test­ing the shots in rodents. By the end of Novem­ber, the WHO expects a Mod­er­na mim­ic to be ready for phase I safe­ty tri­als in peo­ple.

    What hap­pens next year remains uncer­tain. Charles Gore, the direc­tor of the Med­i­cines Patent Pool, an inter­na­tion­al orga­ni­za­tion work­ing with the hub that is devot­ed to expand­ing drug and vac­cine access around the world, says that the ini­tia­tive has no inten­tion of infring­ing on Moderna’s patents. Lab­o­ra­to­ry research is gen­er­al­ly not sub­ject to patent rules, Gore explains.

    And once the vac­cine is ready for use, he hopes that Mod­er­na might then license its patents, or that by then, there will be alter­na­tives that these com­pa­nies could pro­duce with­out fear of a law­suit. Sci­en­tists at sev­er­al uni­ver­si­ties are cur­rent­ly devel­op­ing next-gen­er­a­tion mRNA vac­cines that might be cheap­er to make or that don’t require ultra­cold tem­per­a­tures for stor­age, as do Moderna’s and Pfizer-BioNTech’s.
    ...

    All in all, it’s the kind of good news sto­ry that feels like the set­up for a nasty intel­lec­tu­al prop­er­ty fight down the line. The kind of intel­lec­tu­al prop­er­ty fight that could ensure Africa goes unvac­ci­nat­ed dur­ing the next pan­dem­ic.

    Posted by Pterrafractyl | February 4, 2022, 3:07 pm
  6. Here’s a pair of arti­cles relat­ed to the devel­op­ing sto­ry about South Africa’s attempts to cre­ate its own ver­sion of the mRNA COVID vac­cine and the attempts by the big West­ern phar­ma­ceu­ti­cal com­pa­nies to stop them. First, recall how South Africa’s vac­cine devel­op­ment pro­gram is being car­ried out in part­ner­ship with the World Health Orga­ni­za­tion (WHO) and some of the very same NIH researchers who worked close­ly with Mod­er­na based in devel­op­ing the COVID vac­cine. But pp+ of the major phar­ma­ceu­ti­cal com­pa­nies cur­rent­ly pro­duc­ing mRNA vac­cines — Mod­er­na, Pfiz­er, or BioN­Tech — are coop­er­at­ing with this pro­gram and are instead active­ly try­ing to kill it. Also recall how on the NIH and Mod­er­na are locked in an intel­lec­tu­al prop­er­ty dis­pute of their own, with Mod­er­na hav­ing filed a patent for a dif­fer­ent COVID mRNA vac­cine that appears to a range of beta­coro­n­avirus­es that infect humans except SARS-CoV­‑2, while seem­ing­ly attempt­ing to take full claim for the vac­cine-relat­ed patents and neglect­ing to even acknowl­edge the exten­sive efforts of NIH researchers.

    The first fol­low up arti­cle was pub­lished in Nature back in Novem­ber describ­ing the legal con­tours of the intel­lec­tu­al prop­er­ty fight devel­op­ing between the NIH and Mod­er­na. It’s not just a sin­gle patent. Mul­ti­ple patents cov­er­ing dif­fer­ent aspects of the vac­cine devel­op­ment process have been file, includ­ing patents involved with some of the basic chem­i­cal com­po­nents used in con­struct­ing these vac­cines. As the arti­cle notes, that’s the kind of patent that could poten­tial­ly block Mod­er­na’s com­peti­tors for devel­op­ing alter­na­tives. It’s a poten­tial­ly huge legal bat­tle unfold­ing. The kind of legal bat­tle that omi­nous­ly might end up get­ting resolved at the US Supreme Court.

    But while the Supreme Court might be in a posi­tion to resolve a US patent dis­pute between Mod­er­na and the NIH, it’s not quite a clear how the bat­tle over the South African WHO-backed mRNA ini­tia­tive will be set­tled. Because as the Com­mon Dreams arti­cle excerpt below points out, the South African WHO-pro­gram is entire­ly legal under South African law. The WHO is in com­plete agree­ment on this point. So that legal bat­tle is effec­tive­ly going to be an inter­na­tion­al fight over whether or not these West­ern phar­ma­ceu­ti­cal giants to force South Africa to end a pro­gram it deems to be entire­ly legal and vital to the health of the coun­try.

    As the Com­mon Dreams arti­cle also notes, that legal bat­tle between Mod­er­na and South Africa isn’t being just fought be Mod­er­na. BioN­Tech has already entered the fray via a non-prof­it rep­re­sen­ta­tive foun­da­tion, the kENUP Foun­da­tion. It turns out kENUP was argu­ing to the WHO back in August of 2021 that the South African project was­n’t sus­tain­able pre­cise­ly because Mod­er­na reserved the right to exer­cise inter­na­tion­al con­trol over its patents.

    Intrigu­ing­ly, kENUP had an alter­na­tive pro­pos­al that could osten­si­bly retain the intel­lec­tu­al prop­er­ty rights while mak­ing this tech­nol­o­gy avail­able to devel­op­ing coun­tries: BioN­Tech would build fac­to­ries in sea con­tain­ers that would be shipped down from Europe to Africa. Oh, and it turns out these sea con­tain­er fac­to­ries would ini­tial­ly be staffed by BioN­Tech employ­ees and oper­ate under a nov­el reg­u­la­to­ry regime that would effec­tive­ly remove them from local reg­u­la­to­ry over­sight. In oth­er words, this patent fight isn’t just a move to cap­ture the future of mRNA med­i­cine glob­al­ly. It’s also the lat­est attempt to sneak in some sort of cor­po­rate Char­ter City par­a­digm. And that’s all why, as we watch­ing these par­al­lel legal dis­putes play out, it’s going to be impor­tant to keep in mind that the play­ers in this fight have ambi­tions that go well beyond mRNA vac­cines:

    Nature
    600, 200–201 (2021)

    What the Moderna–NIH COVID vac­cine patent fight means for research
    Col­lab­o­ra­tors are locked in a high-stakes dis­pute over which researchers should be named as inven­tors on a key vac­cine patent appli­ca­tion.

    Hei­di Led­ford
    30 Novem­ber 2021

    It was a tes­ta­ment to the pow­er of col­lab­o­ra­tion: sci­en­tists at the biotech­nol­o­gy firm Mod­er­na Ther­a­peu­tics teamed up with gov­ern­ment researchers at the US Nation­al Insti­tutes of Health (NIH) to swift­ly pro­duce one of the world’s first suc­cess­ful COVID-19 vac­cines.

    But a boil­ing patent dis­pute between the col­lab­o­ra­tors also show­cas­es the com­plex­i­ties of team­work, as the two groups bat­tle over whether NIH researchers were unfair­ly left off as co-inven­tors on a piv­otal vac­cine patent appli­ca­tion.

    The stakes are high. Mod­er­na, which is based in Cam­bridge, Mass­a­chu­setts, has pro­ject­ed that it will make up to US$18 bil­lion on its COVID-19 vac­cine this year. Inven­tor sta­tus could enable the NIH to col­lect roy­al­ties — poten­tial­ly recoup­ing some of its invest­ment of tax­pay­er mon­ey — and to license the patent as it sees fit, includ­ing to com­pet­ing vac­cine mak­ers in low- and mid­dle-income coun­tries, where vac­cines are still painful­ly scarce.

    Nature looks at four key ques­tions about the patent spat and its poten­tial rip­ple effects on col­lab­o­ra­tions between gov­ern­ment and indus­try.

    What are Mod­er­na and the NIH fight­ing about?

    Before the COVID-19 pan­dem­ic struck, the NIH and Mod­er­na col­lab­o­rat­ed on the devel­op­ment of vac­cines for oth­er coro­n­avirus­es. So, when the news of the SARS-CoV­‑2 out­break reached them, it was only nat­ur­al that they work togeth­er on pro­duc­ing a vac­cine.

    The vac­cine they cre­at­ed con­tains mRNA that encodes a mod­i­fied form of the SARS-CoV­‑2 spike pro­tein. The mod­i­fi­ca­tions were intend­ed to hold the pro­tein in a sta­ble con­for­ma­tion that was deemed like­ly to trig­ger an immune response. The NIH has stat­ed in the past that these mod­i­fi­ca­tions were devel­oped by researchers at its Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases and oth­er col­lab­o­ra­tors, and it pub­lished anal­o­gous mod­i­fi­ca­tions in anoth­er coro­n­avirus in 20171.

    In drug and vac­cine devel­op­ment, it is com­mon for inven­tors to file mul­ti­ple patents — often dozens or more — to cov­er dif­fer­ent aspects of a sin­gle prod­uct. Mod­er­na has filed sev­er­al patent appli­ca­tions on its COVID-19 vac­cine that name NIH inves­ti­ga­tors as co-inven­tors.

    But some of its patent appli­ca­tions do not, includ­ing at least one that claims the mRNA sequence used in the vac­cine. In an August state­ment to the US Patent and Trade­mark Office, Mod­er­na acknowl­edged that the NIH had sub­mit­ted three of its researchers as co-inven­tors, but stood by its deci­sion to exclude them from the appli­ca­tion.

    The com­pa­ny argues that its researchers inde­pen­dent­ly devel­oped the mRNA sequence for the vac­cine. NIH researchers, how­ev­er, have said that they devel­oped the sequence and shared it with the com­pa­ny.

    The patent in ques­tion could be par­tic­u­lar­ly crit­i­cal because it cov­ers the prin­ci­pal com­po­nent of the vac­cine, says Christo­pher Morten, who spe­cial­izes in intel­lec­tu­al-prop­er­ty law at Colum­bia Law School in New York City: “A claim on the active ingre­di­ent in a phar­ma­ceu­ti­cal prod­uct is impor­tant, because it can be impos­si­ble for com­peti­tors to design around it.”

    Is it unusu­al for col­lab­o­ra­tors to fight over inven­tor sta­tus on a patent?

    Dis­putes over who deserves to be cred­it­ed on a patent are com­mon, par­tic­u­lar­ly in col­lab­o­ra­tions between insti­tu­tions, says Rebec­ca Eisen­berg, who stud­ies patent law and bio­phar­ma­ceu­ti­cal reg­u­la­tion at the Uni­ver­si­ty of Michi­gan Law School in Ann Arbor. There can be dif­fer­ent ways of defin­ing an inven­tion, for exam­ple, or patents can be struc­tured such that they only include one group’s con­tri­bu­tion. “Who­ev­er drafts the appli­ca­tion tends to draft around what they’ve done,” she says.

    An inven­tor is defined by US patent law as some­one who aids in the con­cep­tion of the inven­tion. Indi­vid­ual inven­tors in uni­ver­si­ties, gov­ern­ment agen­cies and com­pa­ny lab­o­ra­to­ries often assign their patent rights to the insti­tu­tion that they work for. But when it comes to col­lab­o­ra­tions, it can be dif­fi­cult to agree up front who will be named as an inven­tor on the patent. “You can address in advance who’s going to own the patent rights, but you can’t nec­es­sar­i­ly spec­i­fy who is going to be an inven­tor,” says Eisen­berg.

    ...

    Will the patent snub affect future public–private part­ner­ships?

    The US gov­ern­ment has a rep­u­ta­tion for not aggres­sive­ly enforc­ing its patent rights, says Chad Land­mon, a patent attor­ney at the law firm Axinn, Vel­trop & Harkrid­er in Hart­ford, Con­necti­cut. Instead, the gov­ern­ment often funds ear­ly-stage research, and then large­ly leaves it to indus­try part­ners to man­age intel­lec­tu­al prop­er­ty on lat­er stages of an inven­tion. Phar­ma­ceu­ti­cal com­pa­nies often invest heav­i­ly — some­times in the order of hun­dreds of mil­lions of dol­lars — in the final devel­op­ment of a ther­a­py; the gov­ern­ment has gen­er­al­ly con­sid­ered the poten­tial ben­e­fit to tax­pay­ers as the main reward for fund­ing ear­ly research.

    But polit­i­cal sen­ti­ment on this could be shift­ing, Land­mon says. Sev­er­al of the Demo­c­ra­t­ic pres­i­den­tial can­di­dates in the 2020 elec­tion — includ­ing Kamala Har­ris, now vice-pres­i­dent — pushed for the gov­ern­ment to become more assertive about intel­lec­tu­al prop­er­ty, par­tic­u­lar­ly if by doing so it could rein in the prices of pre­scrip­tion drugs. And in 2019, the gov­ern­ment took the unusu­al step of suing Gilead Sci­ences in Fos­ter City, Cal­i­for­nia, for infring­ing gov­ern­ment patents in the pro­duc­tion of HIV-pre­ven­tion drugs.

    Then came the pan­dem­ic, and con­cerns that patents could restrict vac­cine pro­duc­tion. At a meet­ing of the World Trade Asso­ci­a­tion in May, the Unit­ed States made a sur­prise announce­ment that it sup­port­ed waiv­ing patent pro­tec­tion on COVID-19 vac­cines.

    This, plus the NIH’s out­cry over its exclu­sion from the Mod­er­na patent, could sug­gest that the gov­ern­ment will take a more active stance in man­ag­ing intel­lec­tu­al prop­er­ty, Land­mon says: “My gen­er­al sense is that it’s point­ing in that direc­tion.”

    ...

    What hap­pens now?

    In Novem­ber, NIH chief Fran­cis Collins was quot­ed by Reuters news agency as say­ing that the patent dis­pute was not yet over. “Clear­ly this is some­thing that legal author­i­ties are going to have to fig­ure out,” he said.

    Mod­er­na has said that it offered the NIH co-own­er­ship of the patent in Sep­tem­ber, and that the agency could then license the patent “as they see fit”. But this is dif­fer­ent from inven­tor sta­tus: terms of co-own­er­ship would need to be nego­ti­at­ed, and could come with strings attached, says Morten. The NIH might also want its sci­en­tists on the patent for sci­en­tif­ic cred­it or polit­i­cal rea­sons, says Lisa Ouel­lette, who spe­cial­izes in vac­cine pro­duc­tion and patent law at Stan­ford Law School in Cal­i­for­nia.

    The NIH could choose to bring a law­suit and argue in court that Mod­er­na inap­pro­pri­ate­ly left off NIH researchers. If the court deter­mines that the NIH is cor­rect, and that the omis­sion was an unin­ten­tion­al over­sight, the patent might be cor­rect­ed. But if the court finds that Mod­er­na know­ing­ly deceived the patent office about NIH’s con­tri­bu­tion, the patent would no longer be valid.

    Such a case could involve por­ing over lab note­books to inves­ti­gate when Mod­er­na inves­ti­ga­tors deter­mined the mRNA sequence used in the vac­cine, and whether this pre-dat­ed the NIH team shar­ing its mRNA sequence with the com­pa­ny, says Morten.

    The poten­tial impact of the case on vac­cine pro­duc­tion is uncer­tain. Mod­er­na has already said that it would not enforce its patents on its COVID vac­cine dur­ing the pan­dem­ic, and patents are gen­er­al­ly not the key hur­dle to vac­cine pro­duc­tion, says Ouel­lette.

    Still, giv­en the unusu­al­ly high stakes in this dis­pute, it is like­ly that any deci­sion would prompt an appeal — poten­tial­ly all the way to the US Supreme Court — and the bat­tle could drag out for years. “With this patent, you could imag­ine the mag­ni­tude of the impor­tance of mak­ing sure it is cor­rect,” says Joy Goswa­mi, a tech­nol­o­gy-trans­fer offi­cer at the Uni­ver­si­ty of Delaware in Newark. “This is prob­a­bly going to be a long run.”

    ———-

    “What the Moderna–NIH COVID vac­cine patent fight means for research” by Hei­di Led­ford; Nature; 11/30/2021

    “The stakes are high. Mod­er­na, which is based in Cam­bridge, Mass­a­chu­setts, has pro­ject­ed that it will make up to US$18 bil­lion on its COVID-19 vac­cine this year. Inven­tor sta­tus could enable the NIH to col­lect roy­al­ties — poten­tial­ly recoup­ing some of its invest­ment of tax­pay­er mon­ey — and to license the patent as it sees fit, includ­ing to com­pet­ing vac­cine mak­ers in low- and mid­dle-income coun­tries, where vac­cines are still painful­ly scarce.

    It’s a legal bat­tle over whether or not Mod­er­na will retain the right to license its mRNA vac­cine patents as it sees fit. Around the world. Whether or not there’s a major pan­dem­ic rag­ing. Com­plete legal con­trol over the use of this mRNA vac­cine tech­nol­o­gy glob­al­ly. That’s what Mod­er­na is fight­ing for, pit­ting it against its own part­ner, the NIH.

    But Mod­er­na isn’t fight­ing for com­plete legal con­trol over the COVID-19 vac­cine. Instead, it’s over the coro­n­avirus vac­cine Mod­er­na and the NIH hap­pened to be work­ing on right when the pan­dem­ic erupt­ed. But it’s not sim­ply a patent for this gener­ic vac­cine. It’s mul­ti­ple patents over dif­fer­ent com­po­nents of the vac­cine, includ­ing one of the basic chem­i­cal con­stituents in the vac­cine. As the arti­cle notes, that’s the kind of patent that can effec­tive­ly block com­pe­ti­tion for a wide vari­ety of poten­tial vac­cines. So this is a patent fight over one of the build­ing blocks for mRNA vac­cines, and poten­tial­ly oth­er mRNA-based ther­a­peu­tics. Don’t for­get that the vac­cines weren’t for the first mRNA-based ther­a­py Mod­er­na was try­ing to devel­op. They only decid­ed to focus on vac­cines after the side-effects for more fre­quent mRNA injec­tions proved too dif­fi­cult to over­come. So if this basic chem­i­cal com­po­nent of the mRNA vac­cine also hap­pens to be a basic chem­i­cal com­po­nent of more gen­er­al mRNA-based ther­a­peu­tics, that patent could help lock in Mod­er­na’s con­trol over a much broad­er range of mRNA-based med­i­cine. The stakes are mas­sive:

    ...
    Before the COVID-19 pan­dem­ic struck, the NIH and Mod­er­na col­lab­o­rat­ed on the devel­op­ment of vac­cines for oth­er coro­n­avirus­es. So, when the news of the SARS-CoV­‑2 out­break reached them, it was only nat­ur­al that they work togeth­er on pro­duc­ing a vac­cine.

    The vac­cine they cre­at­ed con­tains mRNA that encodes a mod­i­fied form of the SARS-CoV­‑2 spike pro­tein. The mod­i­fi­ca­tions were intend­ed to hold the pro­tein in a sta­ble con­for­ma­tion that was deemed like­ly to trig­ger an immune response. The NIH has stat­ed in the past that these mod­i­fi­ca­tions were devel­oped by researchers at its Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases and oth­er col­lab­o­ra­tors, and it pub­lished anal­o­gous mod­i­fi­ca­tions in anoth­er coro­n­avirus in 20171.

    In drug and vac­cine devel­op­ment, it is com­mon for inven­tors to file mul­ti­ple patents — often dozens or more — to cov­er dif­fer­ent aspects of a sin­gle prod­uct. Mod­er­na has filed sev­er­al patent appli­ca­tions on its COVID-19 vac­cine that name NIH inves­ti­ga­tors as co-inven­tors.

    But some of its patent appli­ca­tions do not, includ­ing at least one that claims the mRNA sequence used in the vac­cine. In an August state­ment to the US Patent and Trade­mark Office, Mod­er­na acknowl­edged that the NIH had sub­mit­ted three of its researchers as co-inven­tors, but stood by its deci­sion to exclude them from the appli­ca­tion.

    The com­pa­ny argues that its researchers inde­pen­dent­ly devel­oped the mRNA sequence for the vac­cine. NIH researchers, how­ev­er, have said that they devel­oped the sequence and shared it with the com­pa­ny.

    The patent in ques­tion could be par­tic­u­lar­ly crit­i­cal because it cov­ers the prin­ci­pal com­po­nent of the vac­cine, says Christo­pher Morten, who spe­cial­izes in intel­lec­tu­al-prop­er­ty law at Colum­bia Law School in New York City: “A claim on the active ingre­di­ent in a phar­ma­ceu­ti­cal prod­uct is impor­tant, because it can be impos­si­ble for com­peti­tors to design around it.”
    ...

    And note how this legal bat­tle could end up being resolved: before the US Supreme Court. One of the most cor­po­rate-friend­ly courts in US his­to­ry:

    ...
    M0oderna has said that it offered the NIH co-own­er­ship of the patent in Sep­tem­ber, and that the agency could then license the patent “as they see fit”. But this is dif­fer­ent from inven­tor sta­tus: terms of co-own­er­ship would need to be nego­ti­at­ed, and could come with strings attached, says Morten. The NIH might also want its sci­en­tists on the patent for sci­en­tif­ic cred­it or polit­i­cal rea­sons, says Lisa Ouel­lette, who spe­cial­izes in vac­cine pro­duc­tion and patent law at Stan­ford Law School in Cal­i­for­nia.

    The NIH could choose to bring a law­suit and argue in court that Mod­er­na inap­pro­pri­ate­ly left off NIH researchers. If the court deter­mines that the NIH is cor­rect, and that the omis­sion was an unin­ten­tion­al over­sight, the patent might be cor­rect­ed. But if the court finds that Mod­er­na know­ing­ly deceived the patent office about NIH’s con­tri­bu­tion, the patent would no longer be valid.

    ...

    The poten­tial impact of the case on vac­cine pro­duc­tion is uncer­tain. Mod­er­na has already said that it would not enforce its patents on its COVID vac­cine dur­ing the pan­dem­ic, and patents are gen­er­al­ly not the key hur­dle to vac­cine pro­duc­tion, says Ouel­lette.

    Still, giv­en the unusu­al­ly high stakes in this dis­pute, it is like­ly that any deci­sion would prompt an appeal — poten­tial­ly all the way to the US Supreme Court — and the bat­tle could drag out for years. “With this patent, you could imag­ine the mag­ni­tude of the impor­tance of mak­ing sure it is cor­rect,” says Joy Goswa­mi, a tech­nol­o­gy-trans­fer offi­cer at the Uni­ver­si­ty of Delaware in Newark. “This is prob­a­bly going to be a long run.”
    ...

    So that’s some of what Mod­er­na has been up to. But don’t for­get that it’s not just Mod­er­na who is voic­ing strong oppo­si­tion to any­thing that might get weak­en the phar­ma­ceu­ti­cal indus­try’s intel­lec­tu­al prop­er­ty rights. It was­n’t just Mod­er­na who refused to coop­er­ate with the South Africa/WHO ini­tia­tive. Pfiz­er and BioN­Tech aren’t part­ner­ing either. Quite the oppo­site. As Jake John­son recent­ly wrote about in Com­mon Dreams, a foun­da­tion rep­re­sent­ing BioN­Tech, the kENUP foun­da­tion, was lob­by­ing the WHO back in August of 2021 to kill the South African project. The foun­da­tion basi­cal­ly warned that because Mod­er­na reserved the right to enforce its patents in the future the project was­n’t sus­tain­able. As oth­ers point­ed out, the project is entire­ly legal under South African law. So kENUP was basi­cal­ly argu­ing that the project should end because Mod­er­na is going to kill it by wag­ing some sort of legal chal­lenge to the project by assert­ing intel­lec­tu­al prop­er­ty rights.

    But kENUP was­n’t only rec­om­mend­ing that the WHO kill the project. It has an alter­na­tive solu­tion instead: ship fac­to­ries in sea con­tain­ers from Europe to Africa. These fac­to­ries would ini­tial­ly be staffed with BioN­Tech work­ers. And these fac­to­ries would come with a new reg­u­la­to­ry frame­work that crit­ics note would effec­tive­ly remove these fac­to­ries from the over­sight of local reg­u­la­to­ry bod­ies. It sounds like a fac­to­ry-scale ver­sion of Char­ter Cities. So in addi­tion to secur­ing patents that could cap­ture for these gov­ern­ment-backed ear­ly-movers the future of mRNA med­i­cine devel­op­ment, it appears the indus­try’s plans also include a new regime for enforc­ing those intel­lec­tu­al prop­er­ty rights glob­al­ly by empow­er­ing cor­po­ra­tions to oper­ate out­side of state over­sight:

    Com­mon Dreams

    Doc­u­ments Expose Phar­ma Effort to Kill Africa’s Covid Vac­cine Project

    “To push for the ter­mi­na­tion of this life­sav­ing project in order to pro­tect the inter­ests of phar­ma­ceu­ti­cal com­pa­nies is shame­ful,” said one advo­cate.

    Jake John­son
    Feb­ru­ary 10, 2022

    Doc­u­ments pub­lished Wednes­day by a promi­nent med­ical jour­nal reveal that a foun­da­tion rep­re­sent­ing the Ger­man com­pa­ny BioN­Tech—Pfiz­er’s Covid-19 vac­cine partner—has been work­ing behind the scenes to under­cut African sci­en­tists’ bur­geon­ing effort to pro­duce an mRNA-based coro­n­avirus vac­cine.

    In August, accord­ing to The BMJ, the kENUP Foun­da­tion urged South African gov­ern­ment offi­cials to shut down a World Health Orga­ni­za­tion-backed ini­tia­tive aim­ing to make an mRNA vac­cine using Mod­er­na’s shot as a tem­plate.

    “Phar­ma­ceu­ti­cal indus­try goons are threat­en­ing South African man­u­fac­tur­ers with patent infringe­ment.”

    “The WHO Vac­cine Tech­nol­o­gy Trans­fer Hub’s project of copy­ing the man­u­fac­tur­ing process of Mod­er­na’s Covid-19 vac­cine should be ter­mi­nat­ed imme­di­ate­ly. This is to pre­vent dam­age to Afrigen, Bio­Vac, and Mod­er­na,” the kENUP Foun­da­tion wrote in a 20-page doc­u­ment, refer­ring to two South African com­pa­nies tak­ing part in the vac­cine effort.

    As an alter­na­tive, The BMJ report­ed, kENUP pro­mot­ed “BioN­Tech’s pro­pos­al to ship mRNA fac­to­ries housed in sea con­tain­ers from Europe to Africa, ini­tial­ly staffed with BioN­Tech work­ers, and a pro­posed new reg­u­la­to­ry path­way to approve the vac­cines made in these fac­to­ries.”

    “The nov­el path­way has been described as pater­nal­is­tic and unwork­able by some experts, as it seems to bypass local reg­u­la­tors,” the out­let observed.

    South Africa’s mRNA project, which has recent­ly start­ed to bear fruit, was made nec­es­sary by the phar­ma­ceu­ti­cal indus­try’s per­sis­tent refusal to share its tech­nol­o­gy with the world, deny­ing low­er-income coun­tries the abil­i­ty to pro­duce their own shots. With­out sup­port from Big Phar­ma or rich gov­ern­ments, South African sci­en­tists and the WHO opt­ed to try to repli­cate Mod­er­na’s vac­cine using pub­licly avail­able infor­ma­tion, includ­ing the shot’s mRNA sequence.

    Safe­ty tri­als for the new vac­cine are expect­ed to begin lat­er this year.

    Pub­lic health cam­paign­ers who have praised the work of South African sci­en­tists respond­ed to the kENUP Foun­da­tion’s cam­paign with out­rage.

    “To push for the ter­mi­na­tion of this life­sav­ing project in order to pro­tect the inter­ests of phar­ma­ceu­ti­cal com­pa­nies is shame­ful, at a time when over 90% of peo­ple in the poor­est coun­tries still haven’t been ful­ly vac­ci­nat­ed,” Anna Mar­riott, health pol­i­cy man­ag­er at Oxfam Inter­na­tion­al, said in a state­ment Thurs­day. “What needs ter­mi­nat­ing are the phar­ma­ceu­ti­cal monop­o­lies lock­ing the life­sav­ing vac­cines out of reach for mil­lions of peo­ple across low- and mid­dle-income coun­tries.”

    “The fail­ure of rich coun­try gov­ern­ments to step in and break these all-pow­er­ful monop­o­lies is unfor­giv­able,” Mar­riott added. “They must end their blind faith that prof­it-hun­gry phar­ma cor­po­ra­tions will vol­un­tar­i­ly do the right thing by human­i­ty.”

    In its August mis­sive to South African offi­cials, the kENUP Foun­da­tion argued that the “sus­tain­abil­i­ty out­look” for the WHO-backed mRNA project “is not favor­able,” warn­ing that Mod­er­na could resume enforce­ment of patent rights once it deems the pan­dem­ic over, pos­ing poten­tial­ly seri­ous legal chal­lenges.

    But offi­cials work­ing on the project insist that it is not run­ning afoul of patent pro­tec­tions.

    “There’s no infringe­ment tak­ing place here what­so­ev­er,” Mar­tin Friede, a WHO offi­cial help­ing to coor­di­nate the ini­tia­tive, told Politi­co last week.

    In a Novem­ber state­ment, the Med­i­cines Patent Pool—a Unit­ed Nations-backed orga­ni­za­tion sup­port­ing the South Africa project—dismissed “unfound­ed rumors” that the mRNA vac­cine tech­nol­o­gy hub “intends to infringe patents.”

    “The Med­i­cines Patent Pool, which is respon­si­ble for the intel­lec­tu­al prop­er­ty and licens­ing ele­ments of the hub, wish­es to make it clear that this is not the case,” the orga­ni­za­tion said. “MPP will ensure that tech­nol­o­gy used in the hub is either not cov­ered by patents or that licens­es and/or com­mit­ments-not-to-enforce are in place to enable free­dom to oper­ate.”

    Charles Gore, exec­u­tive direc­tor of MPP, told The BMJ that “clear­ly, some­body has been going around Africa say­ing that we’re going to infringe patents, which is extreme­ly unfor­tu­nate since it’s com­plete­ly untrue.”

    As The BMJ explained, “South African law con­tains a pro­vi­sion autho­riz­ing sci­en­tists and man­u­fac­tur­ers to car­ry out research and devel­op­ment regard­less of patent pro­tec­tion, mean­ing that the hub’s reverse engi­neer­ing of Mod­er­na’s vac­cine is legal.”

    “Mod­er­na has also pub­licly promised not to enforce its Covid-19 relat­ed patents dur­ing the pan­dem­ic and said that it was will­ing to license its intel­lec­tu­al prop­er­ty after that peri­od,” the pub­li­ca­tion not­ed. “The hub is in talks with Mod­er­na to obtain such a license.”

    ...

    ———-

    “Doc­u­ments Expose Phar­ma Effort to Kill Africa’s Covid Vac­cine Project” by Jake John­son; Com­mon Dreams; 02/10/2022

    “In August, accord­ing to The BMJ, the kENUP Foun­da­tion urged South African gov­ern­ment offi­cials to shut down a World Health Orga­ni­za­tion-backed ini­tia­tive aim­ing to make an mRNA vac­cine using Mod­er­na’s shot as a tem­plate.”

    Like Mod­er­na, BioN­Tech isn’t tak­ing this patent fight lying down either. Not that BioN­Tech is going to open­ly oppose the South African ini­tia­tive. No, the com­pa­ny is instead rely­ing on the kENUP Foun­da­tion to stop the pro­gram. It was back in August of 2021 when kENUP argued that the WHO-backed joint project “is not favor­able” pre­cise­ly because Mod­er­na reserved the right to enforce its patents. It’s basi­cal­ly a warn­ing of what the indus­try is plan­ning. Not just Mod­er­na. And yet, as many point­ed out, what South Africa is doing is com­plete­ly legal under South African law. So this is the kind of fight that involves get­ting the inter­na­tion­al com­mu­ni­ty to effec­tive­ly coerce South Africa into end­ing this legal WHO-backed ini­tia­tive:

    ...
    In its August mis­sive to South African offi­cials, the kENUP Foun­da­tion argued that the “sus­tain­abil­i­ty out­look” for the WHO-backed mRNA project “is not favor­able,” warn­ing that Mod­er­na could resume enforce­ment of patent rights once it deems the pan­dem­ic over, pos­ing poten­tial­ly seri­ous legal chal­lenges.

    But offi­cials work­ing on the project insist that it is not run­ning afoul of patent pro­tec­tions.

    “There’s no infringe­ment tak­ing place here what­so­ev­er,” Mar­tin Friede, a WHO offi­cial help­ing to coor­di­nate the ini­tia­tive, told Politi­co last week.

    In a Novem­ber state­ment, the Med­i­cines Patent Pool—a Unit­ed Nations-backed orga­ni­za­tion sup­port­ing the South Africa project—dismissed “unfound­ed rumors” that the mRNA vac­cine tech­nol­o­gy hub “intends to infringe patents.”

    ...

    As The BMJ explained, “South African law con­tains a pro­vi­sion autho­riz­ing sci­en­tists and man­u­fac­tur­ers to car­ry out research and devel­op­ment regard­less of patent pro­tec­tion, mean­ing that the hub’s reverse engi­neer­ing of Mod­er­na’s vac­cine is legal.”
    ...

    And note what appears to be the indus­try-backed alter­na­tive sce­nario that promis­es to make these vac­cines avail­able (even­tu­al­ly) to devel­op­ing coun­tries while still retain­ing the phar­ma­ceu­ti­cal com­pa­nies’ prop­er­ty rights: fac­to­ries that will be shipped down from Europe to Africa. Oh, and these fac­to­ries won’t be gov­erned by the local reg­u­la­tions. Some sort of nov­el reg­u­la­to­ry path­way has been pitched that effec­tive­ly bypass­es local laws. So these indus­try isn’t just push­ing for com­plete con­trol over the licens­ing of its patents. It’s instead try­ing to achieve com­plete inter­na­tion­al con­trol over the reg­u­la­tion of its prod­ucts:

    ...
    As an alter­na­tive, The BMJ report­ed, kENUP pro­mot­ed “BioN­Tech’s pro­pos­al to ship mRNA fac­to­ries housed in sea con­tain­ers from Europe to Africa, ini­tial­ly staffed with BioN­Tech work­ers, and a pro­posed new reg­u­la­to­ry path­way to approve the vac­cines made in these fac­to­ries.”

    “The nov­el path­way has been described as pater­nal­is­tic and unwork­able by some experts, as it seems to bypass local reg­u­la­tors,” the out­let observed.
    ...

    It’s also worth not­ing that it’s not entire­ly clear if the plan is to place these fac­to­ries on land or keep them as float­ing sea-based fac­to­ries oper­at­ing off the shore of African coun­tries. Is the plan to have the vac­cines pro­duced in inter­na­tion­al waters or some­thing? We’ll see, but if so, that injects a whole ‘Seast­eading’ ele­ment to this agen­da too.

    So as we can see, the phar­ma­ceu­ti­cal indus­try isn’t just try­ing to steal mRNA patents from its gov­ern­ment part­ners at the same time it schemes for assert­ing con­trol over those patents glob­al­ly. It’s also a scheme to cap­ture glob­al sov­er­eign­ty for cor­po­rate enti­ties. At least the select cor­po­rate enti­ties that man­aged to cap­ture all the intel­lec­tu­al prop­er­ty rights.

    Posted by Pterrafractyl | February 14, 2022, 5:22 pm

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