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FTR #1166 This program was recorded in one, 60-minute segment.
Introduction: Supplementing FTR #1138, this program continues discussion about drug treatments for, and vaccines to prevent, Covid-19.
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:
- The program notes 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. . . .”
- 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. . . .”
- 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. . . . .”
- 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. . . .”
- 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. . . .”
- 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. . . .”
This program begins with information about the ongoing professional massaging of Gilead Sciences’ anti-viral remdesivir.
The most positive studies have proved remdesivir/Veklury only modestly successful against SARS Cov‑2 (the virus that causes Covid-19). Remdesivir (now marketed under the brand name Veklury) has been propelled to the forefront of treatment regimens for the pandemic, a development which appears to diminish the chances for a competing, more effective drug to gain professional approval for treating Covid-19.
” . . . . Other studies have shown no benefit, including the World Health Organization’s Solidarity trial, released as a preprint on Oct. 15. Based on these results, the European Society of Intensive Care Medicine is now recommending that the drug not be routinely used in hospitalized Covid-19 patients. Infectious disease experts have stated that after examining all available evidence, we can reasonably conclude only that remdesivir may work. . . .”
Deeply disturbing, as well, is the news that the “positive news” about vaccine success and development has been generated by press releases from the companies that manufacture them: ” . . . . But the companies announced the findings in news releases, not in peer-reviewed scientific journals, and did not disclose the detailed data that would allow outside experts to evaluate their claims. Therefore, the results cannot be considered conclusive. The figures on effectiveness may change as the studies continue. . . .”
Program Highlights Include: The rapid spread of the disease is benefitting the speed-up of vaccine research; how regulatory procedures for Big Pharma products were already being attenuated before the Covid-19 “op;” review of the attenuated, manipulated NIAID study on remdesivir that generated positive news, a run-up in the stock price of Gilead Sciences and a boost for the market as a whole; review of the role of “Scientists to Stop Covid-19” in massaging the vetting process for remdesivir; review of the CDC’s closing of the USAMRIID in August of 2019 and the testing of remdeisivir at that facility in March of 2019; review of the insidious, incestuous relationship between the authorities “regulating” treatment of Lyme Disease and those who benefit from the administration of that treatment; review of Lyme Disease as a biological warfare weapon.
1. Expanding our coverage of Gilead Sciences’ anti-viral remdesivir, the program notes 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. . . .”
“Does Remdesivir Work?” by Ravi Gupta and Reshma Ramachandran; The New York Times; 11/18/2020.
When the Food and Drug Administration approves a new treatment or vaccine, as doctors we are assured that rigorous studies have proven it to be safe and effective. But the F.D.A.’s haphazard issuance of emergency use authorizations for Covid-19 treatments like hydroxychloroquine and convalescent plasma, whose potential benefits have not yet been backed up by data, has undermined this trust.
Early in the pandemic, the agency awarded an emergency use authorization for the antiviral drug remdesivir, based on evidence suggesting that it may be effective. Then last month, despite conflicting evidence, the F.D.A. prematurely granted its first full approval for Covid-19 treatment to remdesivir, now marketed as Veklury.
In early October, The New England Journal of Medicine published a report on the results of a trial funded by the National Institutes of Health that found that remdesivir decreased recovery time in Covid-19 patients who were hospitalized with less severe illness, but did not curb mortality. Other studies have shown no benefit, including the World Health Organization’s Solidarity trial, released as a preprint on Oct. 15.
Based on these results, the European Society of Intensive Care Medicine is now recommending that the drug not be routinely used in hospitalized Covid-19 patients. Infectious disease experts have stated that after examining all available evidence, we can reasonably conclude only that remdesivir may work.
Some have argued that the approval of Veklury is justified even if it is only mildly effective because there are no other proven therapies for Covid-19. This fails to acknowledge, however, the proven effectiveness of drugs like dexamethasone, a cheap and widely used steroid.
It also ignores years of assault on F.D.A. evidentiary standards, accelerated by the passage in 2016 of the 21st-Century Cures Act. This legislation, which sped up the F.D.A.’s approval process, was based on unfounded claims that the agency was too slow and hindered patients’ access to lifesaving drugs.
The F.D.A. is now increasingly approving new drugs based on weaker evidence, relying on “surrogate measures” like changes in tumor size in lieu of more meaningful clinical outcomes such as reduced mortality or hospitalizations. Recent cancer drugs, for example, have been approved without evidence of improving overall survival. Weaker standards are a boon to pharmaceutical companies, but they can also depress the development of truly innovative and effective treatments.
The F.D.A. has tried to offset its accelerated approval of Veklury by asking its maker, Gilead, to complete 29 post-market studies to further examine the drug’s effectiveness and safety. This is more than three to four times the number typically requested. It’s unclear, however, if these studies will ever be done. One report found that, five to six years following approval, only half of post-market studies had been completed and one-fifth hadn’t even been started.
Veklury’s approval could also have a chilling effect on the F.D.A.’s ability to issue emergency use authorizations for other potentially effective Covid-19 treatments, as the agency’s guidance requires there be “no adequate, approved and available alternative” for the disease. Just last week, the F.D.A. granted an authorization to an antibody treatment called bamlanivimab, for use in non-hospitalized patients with Covid-19 who are at the highest risk of developing severe disease. This may have been possible only because Veklury was approved specifically for hospitalized patients.
Veklury’s questionable effectiveness is even more problematic given the drug’s price. A course costs $3,120 — a huge price tag, and one that ignores the substantial public investment in the drug’s development.
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. It was repurposed for Covid-19 after multimillion-dollar trials sponsored by the N.I.H. suggested it could work against coronaviruses.
Despite Veklury’s questionable effectiveness, the F.D.A. has also awarded Gilead a “priority review voucher” worth $75 to $100 million. This voucher can be used by Gilead or sold to a different manufacturer to hasten review of another drug application. This would perpetuate the entry of other treatments that are hurriedly reviewed and, like remdesivir, may be of uncertain benefit.
The dangers posed by the F.D.A.’s rush in approving Veklury are compounded by the chaos of presumed political interference by the Trump administration. But the weakening of F.D.A. standards will most likely continue under the Biden administration. When he was vice president, Joe Biden strongly endorsed the 21st-Century Cures Act, and some in Congress are already pushing for its next iteration, Cures 2.0.
If passed, it would further erode the F.D.A.’s evidentiary standards. Among Cures 2.0 proposals is moving the basis for approval away from randomized, controlled trials, long considered the gold standard of evidence, and instead relying more on observational evidence and surrogate measures.
It is hard to ask people to wait for the evidence when there’s a treatment that could hold some promise, especially during a devastating pandemic. But the hasty approval of expensive new treatments like remdesivir isn’t the solution. Doctors like us must feel confident that the drugs approved by the F.D.A. are worth prescribing to our patients.
Ravi Gupta (@rgupta729) is an internal medicine physician and a fellow at the National Clinician Scholars Program at the University of Pennsylvania. Reshma Ramachandran (@reshmagar) is a family medicine physician and a fellow at the National Clinician Scholars Program at Yale University. They are both members of the Doctors for America Drug Affordability Action Team.
2a. Pivoting to discussion and review of the political, financial and corporate connections to the development of medicinal treatments for, and vaccines to prevent, Covid-19, we recap details relevant to the extraordinary timing of a 4/29 announcement of favorable results for a trial of remdesivir. That announcement drove equities markets higher and was beneficial to the stock of Gilead Sciences.
We present a Stat News article on the internal deliberations behind the decisions to modify the NIAID study. Of particular significance is the DSMB deliberation. Note the timeline of the DSMB deliberation, combined with the announcement on 4/29 that drove the markets higher.
- The decision was made to cut it short before the question of remdesivir’s impact on mortality could be answered: ” . . . .The National Institute of Allergy and Infectious Diseases has described to STAT in new detail how it made its fateful decision: to start giving remdesivir to patients who had been assigned to receive a placebo in the study, essentially limiting researchers’ ability to collect more data about whether the drug saves lives — something the study, called ACTT‑1, suggests but does not prove. In the trial, 8% of the participants given remdesivir died, compared with 11.6% of the placebo group, a difference that was not statistically significant. A top NIAID official said he had no regrets about the decision. ‘There certainly was unanimity within the institute that this was the right thing to do,’ said H. Clifford Lane, NIAID’s clinical director. . . .”
- In addition, patients scheduled to receive placebo received remdesivir, instead. ” . . . . Steven Nissen, a veteran trialist and cardiologist at the Cleveland Clinic, disagreed that giving placebo patients remdesivir was the right call. ‘I believe it is in society’s best interest to determine whether remdesivir can reduce mortality, and with the release of this information doing a placebo-controlled trial to determine if there is a mortality benefit will be very difficult,’ he said. ‘The question is: Was there a route, or is there a route, to determine if the drug can prevent death?’ The decision is ‘a lost opportunity,’ he said. . . .”
- Steven Nissen was not alone in his criticism of the NIAID’s decision. ” . . . .Peter Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, agreed with Nissen. ‘The core understanding of clinical research participation and clinical research conduct is we run the trial rigorously to provide the most accurate information about the right treatment,’ he said. And that answer, he argued, should ideally have determined whether remdesivir saves lives. The reason we have shut our whole society down, Bach said, is not to prevent Covid-19 patients from spending a few more days in the hospital. It is to prevent patients from dying. ‘Mortality is the right endpoint,’ he said. . . .”
- Not only was the administration of remdesivir instead of placebo prioritized, but the NIAID study itself was attenuated! ” . . . . But the change in the study’s main goal also changed the way the study would be analyzed. Now, the NIAID decided, the analysis would be calculated when 400 patients out of the 1,063 patients the study enrolled had recovered. If remdesivir turned out to be much more effective than expected, ‘interim’ analyses would be conducted at a third and two-thirds that number.The job of reviewing these analyses would fall to a committee of outside experts on what is known as an independent data and safety monitoring board, or DSMB. . . .”
- The performance of the DSMB for the remdesivir study is noteworthy: ” . . . . But the DSMB for the remdesivir study did not ever meet for an interim efficacy analysis, Lane said. All patients had been enrolled by April 20. The data for a DSMB meeting was cut off on April 22. The DSMB met and, on April 27, it made a recommendation to the NIAID. . . .”
- The DSMB meeting on 4/27 determined the switch from placebo to remdesivir. Of paramount importance is the fact that this was JUST BEFORE the 4/29 announcement that drove the markets higher and the same day on which key Trump aide–and former Gilead Sciences lobbyist Joe Grogan resigned! ” . . . . . That decision, Lane said, led the NIAID to conclude that patients who had been given placebo should be offered remdesivir, something that started happening after April 28. . . .”
- Dr. Ethan Weiss gave an accurate evaluation of the NIAID study: ” . . . . ‘We’ve squandered an incredible opportunity to do good science,’ [Dr. Ethan] Weiss said. ‘If we could ever go back and do something all over, it would be the infrastructure to actually learn something. Because we’re not learning enough.’ . . . .”
The remarkable handling of the NIAID study, the timing of the announcement of the altogether limited success of the attenuated trial and the rise in equities as a result of the announcement may be best understood in the context of the role played in Trump pandemic decision-making by an elite group of billionaires and scientists–including convicted felon Michael Milken (the “junk bond king”).
- ” . . . . Calling themselves ‘Scientists to Stop COVID-19,’ the collection of top researchers, billionaires and industry captains will act as an ‘ad hoc review board’ for the torrent of coronavirus research, ‘weeding out’ flawed data before it reaches policymakers, the Wall Street Journal reported on Monday. They are also acting as a go-between for pharmaceutical companies seeking to build a communication channel with Trump administration officials. The group . . . . has advised Nick Ayers, an aide to Vice President Mike Pence, as well as other agency heads, in the past month. Pence is heading up the White House coronavirus task force. . . .”
- ” . . . The brainy bunch is led by Thomas Cahill, a 33-year-old doctor who became a venture capitalist . . . . Cahill’s clout comes from building connections through his investment firm, Newpath Partners, with Silicon Valley’s Peter Thiel, the founder of PayPal, and billionaire businessmen Jim Palotta and Michael Milken. . . .”
Note that Peter Thiel played a dominant role in bankrolling Newpath Partners, and the other financial angel who elevated Cahill–Brian Sheth–introduced him to Tommy Hicks, Jr., the co-chairman of the RNC. In FTR #‘s 1111 and 1112, we looked at Hicks’ networking with Steve Bannon associate J. Kyle Bass, as well as his role in the inter-agency networks driving the anti-China effort.
” . . . . At the helm of the effort: The 33-year-old and very-much-under-the-radar venture capitalist Tom Cahill, who leads life sciences-focused Newpath Partners. Cahill completed his M.D. and PhD at Duke University a mere two years ago before landing at blue-chip investment firm Raptor Group through a friend. He went on to found Newpath with some $125 million after impressing well-connected names like venture capitalist Peter Thiel and Vista Equity Partners co-founder Brian Sheth. . . . It was through Sheth, for example, that Scientists to Stop Covid-19 connected with the co-chairman of the Republican National Committee, Thomas Hicks Jr. . . .”
The federal government’s extreme focus on remdesivir has been shaped, in large measure, by the influence of “Scientists to Stop COVID-19”:
- “Scientists to Stop Covid-19” is shepherding remdesivir: ” . . . . Scientists to Stop COVID-19 recommends that in this phase, the U.S. Food and Drug Administration (FDA) should work to coordinate with Gilead pharmaceuticals to focus on expediting the results of clinical trials of remdesivir, a drug identified as a potential treatment for COVID-19. The group also recommends administering doses of the drug to patients in an early stage of infection, and notes remdesivir will essentially be a placeholder until a more effective treatment is produced.
- The group is doing so by attenuating the regulatory process for coronavirus drugs: “Government entities and agencies appear to adhere to the recommendations outlined by the group, with the Journal reporting that the FDA and the Department of Veterans Affairs (VA) have implemented some of the suggestions, namely relaxing drug manufacturer regulations and requirements for potential coronavirus treatment drugs. . . .”
We conclude discussion of the remdesivir machinations with a piece about the timing of the announcement of Grogan’s departure.
” . . . . Grogan has served as the director of the White House Domestic Policy Council since February 2019, overseeing a broad array of policy issues including health care and regulation. . . . Grogan was one of the original members of the White House coronavirus task force launched in late January. . . . Grogan worked as a lobbyist for drug company Gilead Sciences before joining the Trump administration. . . .”
The departure was announced in the Wall Street Journal on the morning of Wednesday, April 29, the same day we got our first public reports of the NIAID clinical trial of remdesivir that was positive enough to show it shortened the time to recovery and the same day the FDA granted remdesivir emergency use status.
Note, again, the timing of the DSMB’s actions, as well as the influence of “Scientists to Stop Covid-19.”
2b. Of particular interest in the context of the professional massaging of remdesivir are the circumstances surrounding the CDC’s closure of the U.S. Army Medical Research Institute of Infectious Diseases. The USAMRIID–located at Ft. Detrick–had hosted Gilead Sciences’ animal trials of remdesivir. Remdesivir was developed to combat Ebola, and was a failure in its initial professional iteration.
In March of 2019, rhesus macaques were infected with Ebola at the USAMRIID as part of a project to allow remdesivir to be marketed as an Ebola treatment without meeting the professional standards of human testing. ” . . . This agreement was made possible through a 2018 Natural History Study (NHS) of Ebola virus conducted by USAMRIID in close collaboration with Gilead Sciences, Inc., the sponsor of remdesivir development . . .”
Many of the safety violations cited by the CDC in its critique of USAMRIID safety and security procedures concerned “non-human primates” infected with one or more “select agents” that were not named. The term “select agent” refers to a pathogen being used in laboratory procedures. Whether the “select agent” was Ebola, and whether the safety lapses were in connection with the remdesivir/rhesus monkey trials was not disclosed.
” . . . . Several of the laboratory violations the CDC noted in 2019 concerned ‘non-human primates’ infected with a ‘select agent’, the identity of which is unknown — it was redacted in all received documents, because disclosing the identity and location of the agent would endanger public health or safety, the agency says. In addition to Ebola, the lab works with other deadly agents like anthrax and smallpox. . . ..”
If, for the sake of argument, SARS-CoV‑2 research was indeed taking placing there was a very real risk of it escaping.
3a. 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. . . .
3b. Deeply disturbing, as well, is the news that the “positive news” about vaccine success and development has been generated by press releases from the companies that manufacture them:
“Another Vaccine Appears to Work Against the Virus” by Denise Grady; The New York Times; 11/17/2020.
. . . . But the companies announced the findings in news releases, not in peer-reviewed scientific journals, and did not disclose the detailed data that would allow outside experts to evaluate their claims. Therefore, the results cannot be considered conclusive. The figures on effectiveness may change as the studies continue. . . .
4a. 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. . . . .
4b. The rapid spread of the disease is benefitting the speed-up of vaccine research.
The coronavirus is spreading out of control in the United States, overwhelming health systems and killing more than 1,100 Americans a day. But there is a slender silver lining: It is hastening the testing of vaccines that could eventually end the pandemic.
The surging virus has already allowed Pfizer and Moderna to accelerate the testing of their vaccines, which appear to be very effective at preventing Covid-19.
And if, as seems inevitable, the virus continues to proliferate — it is spreading faster than ever in the United States and some other countries — it is likely to speed the evaluations of promising vaccine candidates from other pharmaceutical companies. . . .
5. Of great significance is the central role of the military in the development of treatment for Covid-19:
When President Trump talks about efforts to deliver the coronavirus vaccine to millions of Americans eager to return to their normal lives, he often says he is “counting on the military” to get it done. . . .
. . . . In reality, the role of the military has been less public and more pervasive than this characterization suggests. . . .
. . . . 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.
“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.
Wrangling volunteers for four expedited vaccine trials — a chore in any circumstance — became even more challenging during a pandemic, when asking hundreds of thousands of subjects to sit in hospital waiting rooms and other health care centers was often not feasible. The Pentagon has helped three companies — AstraZeneca, Moderna and Janssen — set up pop-up sites to conduct trials at 63 locations nationwide. . . .
. . . . These are the types of things that the military can quickly obtain through its contracting system, as well as any permits needed to set it all up. “We have the ability to set up large-scale housing capabilities throughout the entire world at a moment’s notice,” General Ostrowski said. . . .
. . . . 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. [Mango is the deputy chief of staff for policy at the Department of Health and Human Services and the main spokesman for Operation Warp Speed.–D.E.] “If a vaccine dose is at risk of expiring, they will gide the movement of that to someplace else.” . . . .
6. Pivoting to discussion of the politics of Lyme Disease treatment, we note that legal and regulatory rulings have enabled the patenting of living organisms and that has exacerbated the monetizing of Lyme Disease treatment. That monetization, in turn, has adversely affected the quality of care for afflicted patients. ” . . . . All of a sudden, the institutions that were supposed to be protectors of public health became business partners with Big Pharma. The university researchers who had previously shared information on dangerous emerging diseases were now delaying publishing their findings so they could become entrepreneurs and profit from patents through their university technology transfer groups. We essentially lost our system of scientific checks and balances. And this, in turn, has undermined patient trust in the institutions that are supposed to ‘do no harm.’ . . .”
. . . . Thinking back on my research for the Lyme documentary Under Our Skin, I concluded that there was much more money at stake with Lyme Disease. It was the first major new disease discovered after the Bayh-Dole Act and the Diamond v. Chakrabarty Supreme Court decision made it possible for the NIH, the CDC, and universities to patent and profit from “ownership” of live organisms. When the causative organism behind Lyme disease was announced, something akin to the Oklahoma Land Rush of 1889 began, as scientists within these institutions began furiously filing patents on the surface proteins and DNA of the Lyme spirochete, hoping to profit from future vaccines and diagnostic tests that used these markers–for example, an NIH employee who patents a bacterial surface protein used in a commercial test kit or a vaccine could receive up to $150,000 in royalty payments a year, an amount that might double his or her annual salary. All of a sudden, the institutions that were supposed to be protectors of public health became business partners with Big Pharma. The university researchers who had previously shared information on dangerous emerging diseases were now delaying publishing their findings so they could become entrepreneurs and profit from patents through their university technology transfer groups. We essentially lost our system of scientific checks and balances. And this, in turn, has undermined patient trust in the institutions that are supposed to “do no harm.”
With Lyme disease, there’s no profit incentive for proactively treating someone with a few weeks of inexpensive, off-patent antibiotics. It’s the patentable vaccines and mandatory tests-before-treatment that bring in the steady revenues year after year. . . .
7. Bitten author Kris Newby went up against the “Lyme Disease establishment” in an attempt to find out why the disease was being mis-diagnosed and ineffectively treated. Strikingly, a FOIA suit she filed was stonewalled, before finally yielding the documents she had so long sought.
The “experts” and their agenda was neatly, and alarmingly, summed up by Ms. Newby:
” . . . . The emails revealed a disturbing picture of a nonofficial group of government employees and guidelines authors that had been setting the national Lyme disease research agenda without public oversight or transparency. . . . Bottom line, the guidelines authors regularly convened in government-funded, closed-door meetings with hidden agendas that lined the pockets of academic researchers with significant commercial interests in Lyme disease tests and vaccines. A large percentage of government grants were awarded to the guideline authors and/or researchers in their labs. Part of the group’s stated mission, culled from these FOIA emails, was to run a covert ‘disinformation war’ and a ‘sociopolitical offensive’ to discredit Lyme patients, physicians, and journalists who questioned the group’s research and motives. In the FOIA-obtained emails, Lyme patients and their treating physicians were called ‘loonies’ and ‘quacks’ by Lyme guidelines authors and NIH employees. . . .”
. . . . In the IDSA [Infectious Diseases Society of America] guidelines, chronic Lyme isn’t classified as an ongoing, persistent infection; it’s considered either an autoimmune syndrome (in which a body’s immune system attacks itself) or a psychological condition caused by “the aches and pains of daily living” or “prior traumatic psychological events.” These guidelines were often used by medical insurers to deny treatment, and many of its authors are paid consulting fees to testify as expert witnesses in these insurance cases. In some states, the guideline recommendations take on the force of law, so that Lyme physicians who practice outside them are at risk of losing their medical licenses.
The protestors were angry because, as part of a 2008 antitrust settlement brought by Connecticut attorney general Richard Blumenthal (now a senator), the IDSA guidelines were supposed to appoint an expert panel without biases or conflicts to do a re-review of the guidelines. In the settlement press release, Blumenthal had written, “My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA’s guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.”
In response, the IDSA leadership selected a review panel of doctors and scientists, and they determined that “No changes or revisions to the 2006 Lyme guidelines are necessary at this time.”
Lorraine Johnson, JD, MBA, the chief executive officer of LymeDisease.org, and a champion of the IDSA antitrust suit, maintains that the review panel was stacked with like-minded cronies of the original guidelines’ authors and was therefore biased. She cites the recent article by research quality expert and Stanford professor John Ioannidis, MD, DSc, who recommends that “Professional societies should consider disentangling their specialists from guidelines and disease definitions and listen to what more impartial stakeholders think about their practices.”
Today, in 2019, these controversial guidelines and disputed tests are still influencing Lyme patient care.
People often ask me why the IDSA and CDC would support the problematic two-tier Lyme test. During my documentary research, I tried to get an answer to this question with a Freedom of Information Act (FOIA) request that solicited emails between three CDC employees and the IDSA guidelines authors. For five years the CDC strung me along with frivolous denials, unexplained delays, and false promises. In essence, the delays became an illegal, off-the-books FOIA denial. Some delays were attributed to understaffing, year-end deadlines, and CDC personnel out for vacation. At one point, my unanswered calls were blamed on a phone “dead zone” in the CDC’s new FOIA office. After the Lyme documentary Under Our Skin was released, I decided to double-down on my efforts to dislodge the FOIA request. My congressperson sent several letters to the CDC. The director of the documentary wrote a letter to President Obama. The FOIA ombudsman in the Office of Government Information Services repeatedly pressured the CDC to fulfill my request. I published blog posts about my plight and enlisted the support of a number of organizations dedicated to ensuring government transparency. Finally, the CDC sent three-thousand-plus FOIA pages, and I then understood its motivation for having delayed their release.
The emails revealed a disturbing picture of a nonofficial group of government employees and guidelines authors that had been setting the national Lyme disease research agenda without public oversight or transparency. Investigative journalist Mary Beth Pfeiffer of the Poughkeepsie Journal was given access to these emails, and on May 20, 2013. She published an expose on this group’s abuse of power.
Bottom line, the guidelines authors regularly convened in government-funded, closed-door meetings with hidden agendas that lined the pockets of academic researchers with significant commercial interests in Lyme disease tests and vaccines. A large percentage of government grants were awarded to the guideline authors and/or researchers in their labs.
Part of the group’s stated mission, culled from these FOIA emails, was to run a covert “disinformation war” and a “sociopolitical offensive” to discredit Lyme patients, physicians, and journalists who questioned the group’s research and motives. In the FOIA-obtained emails, Lyme patients and their treating physicians were called “loonies” and “quacks’ by Lyme guidelines authors and NIH employees.
Because my FOIA request ended up taking five years to process, Under Our Skin had been made and released without answering an important question: Were the government officials responsible for managing Lyme disease health policy being inappropriately influenced by outside commercial interests?
Through my FOIA request, I found that a majority of the authors of the 2006 IDSA Lyme diagnosis and treatment guidelines held direct or indirect commercial interests related to Lyme disease. By defining the disease and endorsing tests or vaccines for which they were patent holders, they and their institutions made more money.
Yet, now Willy’s confession had added another potential dimension to the story, another reason for the CDC to be undercounting Lyme cases—maybe government officials knew that something else, a pathogen in addition to Borrelia, possibly a bio-weapon, was causing the problems, and they wanted to keep a lid on it. . . .
Remember OyaGen? That was the small Rochester, New York, based biotech company discussed in FTR#1121 that claimed back in March 2020 to have discovered a compound that sounded almost miraculous in the context of the emerging coronavirus pandemic. That compound, dubbed Oya1, was described as effectively sterilizing cell cultures of the SARS-CoV‑2 virus. Best of all, it didn’t require a new round of safety testing because it had been examined as a cancer drug back in the 1960s and safe dosages were already known. And yet, despite this wonderful news, the founder of OyaGen, Harold Smith, was essentially pleading with the media to bring attention to the fact that the company wasn’t getting the kind of expedited permission by US authorities to carry out COVID-related tests that Smith felt the situation warranted. Adding to the mystery is the fact that OyaGen had been working directly with the US government’s federal integrated research facility in Fort Detrick, Maryland, when carrying out this research. So the US biomedical military research complex was involved with the government appeared to be dragging its feet on.
In the end, we never really learned what became of Oya1 or that promising research. Was that the last we were to hear about Oya1 and its incredible efficacy against COVID? Or were we going to eventually hear an update? Well, we finally got an update and wow is it kind of a doozy. It’s really a pair of updates.
First, there was update on Wednesday about Oya1 and COVID. As before, it’s local Rochester, New York, news covering this, despite the fact that this should arguably be international news: OyaGen announced the discovery that combining Oya1 with remdesivir results in substantially better results than just remdesivir We aren’t given any additional information on the nature of the studies that demonstrate the value of the Oya1 + remdesivir combination, although it doesn’t sound like it was clinical trials on infected patients because Harold Smith reiterated his complaint that the FDA wants more testing at the cost of millions of dollars before clinical trials can begin for the COVID use.
So it sounds like, once again, we are learning that Oya1 is a major improvement over remdesivir alone and yet, once again, clinical trials aren’t actually underway because the FDA refuses to fast-track them. 10 months after we first heard from OyaGen about their discovery that Oya1 was effectively sterilizing cell cultures of the SARS-CoV‑2 virus, followed by Harold Smith’s public cries for government approval to accelerate clinical trials, we’re now learning that Oya1 appears to actually make remdesivir useful against COVID. Isn’t this at least somewhat scandalous?
And then there’s the second recent update we got from OyaGen. This update was published directly by OyaGen itself over the PRNewswire service last week, announcing a new study jointly on Oya1 conducted by OyaGen. Like the study last year that demonstrated Oya1’s efficacy against SARS-CoV‑2, this study was done in collaboration with the NIH/NIAID Integrated Research Facility at Fort Detrick. But it wasn’t a study of Oya1’s effects on COVID. Instead, it was a study on Oya1’s effects on Ebola. Specifically, it was a study that demonstrated the utility of a new screening platform for antiviral drugs that identifies drugs that interfere with a particular component of the virus — the viral matrix (VP40) protein — which should, in theory, disrupt the ability of the virus to replicate itself.
Not only did the study find that Oya1 is far more effective than remdesivir at treating Ebola, it also found that combining Oya1 and remdesivir yielded the best overall results and required less of each drug. It sure sounds a lot like the story of Oya1 vs remdesivir against SARS-CoV‑2. Keep in mind that remdesivir was originally designed as a drug for Ebola. Also recall the 2019 study where remdesivir was compared to three other drugs as an Ebola treatment and consistently came in as the least effective.
But there was another significant finding in OyaGen’s new study: Oya1 was unexpectedly found to be highly effective against a variety of other viruses related to Ebola that they tested it against. The closely-related Marburg virus (MARV), along with the unrelated Lassa virus (LASV), cowpox virus (CPXV), and vaccinia virus (VACV). And it’s not at all clear HOW the drug is having these unrelated viruses because they don’t express VP40-like proteins. Based on these findings, the researchers conclude that Oya1 (called “sangivamycin” in the publication) could be a good candidate as a broad-spectrum antiviral drug. This is a huge finding if true, in part because identifying broad-spectrum anti-viral drugs has long been a major goal of public health officials as a key tool for dealing with emerging viruses and remdesivir has long been championed as a possible broad-spectrum drug, despite the disappointing results.
All in all, these two announcements from OyaGen provide further evidence that Oya1 might actually have been the miracle drug the world was searching for 10 months ago when it became clear we were in store for a global pandemic. And yet interest in the drug has remained tepid at best, despite the fact that this research is being produced in partnership with the NIH and Fort Detrick. It’s a real mystery.
Ok, first, here’s an article from a local Rochester news outlet about OyaGen’s new announcement that the Oya1 + remdesivir combination is a lot more effective than just remdesivir alone, the kind of finding that should generate global headlines but remains relegated to local Rochester news:
“Remedesivir alone is only mildly effective in treating the virus. That changed when mixed with Oya 1.”
So remdesivir alone is only midldly effective against COVID and yet Oya1 was shown last year to be highly effective in cell cultures and the Oya1 + remdesivir combination is even more effective. That makes it sound like Oya1 is doing most of the work but remdesivir does actually help Oya1 when used in combination. This should be a huge finding trumpeted around the world, and yet no one cares. Instead, we are against hearing Smith complain about the FDA refusing to fast-track clinical studies at the same time major federal funding has gone towards vaccines. Although, to correct Smith, there has been one major area of non-vaccine therapeutics that the US government has spent significant money on and that’s remdesivir. Again, why isn’t this more scandalous?
Ok, now here’s the next piece of news about Oya1 that should be very big news: a joint OyaGen/NIH study found Oya1 to be effective against not just Ebola but a broad variety of viruses, suggesting Oya1 might be the much sought-after “broad-spectrum” antiviral drug virologists have long desired. And yet this announcement wasn’t in a news piece. It was a PRNewsire piece released by OyaGen itself:
“About OYA1. OYA1 (a.k.a. sangivamycin) has broad-spectrum antiviral activity in laboratory-based assays against several viruses. The published study results showed that OYA1 was “highly effective” in reducing the spread of Ebola Virus infection in laboratory tests with the live Ebola virus carried out by NIAID. The data also suggest that OYA1 could be significantly more potent than Gilead Science’s remdesivir. In vitro studies showed that when OYA1 is dosed with remdesivir both compounds are markedly more effective inhibiting Ebola virus replication and do so at much lower doses than is needed with either compound alone. OYA1 proved equally effective in stopping Ebola infectivity when it was added at the time of infection or 24 hours after an infection.”
The news just keeps getting better. Not only can Oya1 help combat COVID, but Ebola too. And when Oya1 and remdesivir are combined, less of both is required, making it less likely drug-resistant strains will emerge:
But that announcement by OyaGen undersells the potential importance of this study. Because Oya1 (sangivamycin) wasn’t just shown to be effective against Ebola. It was shown to be effective against a variety of viruses, including viruses that don’t contain the proteins Oya1 is targeting, leading researchers to conclude that Oya1 might be a good candidate as a “broad-spectrum” antiviral drug. This is the holy grail of emerging infectious diseases:
“We identified a nucleoside analog, sangivamycin, that inhibited both EBOV VP40 association with the cell membrane and cellular virion-like particle release. As expected from these results, sangivamycin inhibited the replication of EBOV but, surprisingly, it also inhibited the replication of EBOV’s close relative, MARV, as well as the unrelated Lassa virus (LASV), cowpox virus (CPXV), and vaccinia virus (VACV), which do not express VP40 orthologs. Using an EBOV minigenome assay that does not encode or express VP40, we demonstrate that these broad-spectrum effects are likely due to a highly efficient secondary interaction with RdRps or other viral proteins required for viral replication and/or transcription. These data indicate that the VP40-based screening is suitable for the identification of novel EBOV MCMs and that sangivamycin could potentially be developed as a broad-spectrum antiviral once its mechanism of action is further clarified.”
Oya1 (sangivamycin) could potentially be developed as a broad-spectrum antiviral once its mechanism of action is further clarified. It’s demonstrated antiviral activity was so potent that the researchers couldn’t explain how it was working against many of these viruses. That’s the genuinely extremely exciting results just published by OyaGen in collaboration with NIH/NIAID/DCR/Integrated Research Facility at Fort Detrick. The top infectious disease lab in the world is signing off on these findings. And yet no one cares. Why is that?
There was great news on the vaccine front yesterday with reports that the studies have found the Moderna and Pfizer mRNA-based COVID vaccines are preventing asymptomatic infections, the kind of finding that bodes very well for the prospects of the vaccines allowing for the lifting of lockdowns and the reopening of economies. At the same time, we’re continuing to hear warnings about new vaccine-resistant SARS-CoV‑2 variants emerging that are going necessitate the development of new vaccines within a year. So the meta-news on the vaccine front is that we’re all going to be far more reliant on vaccines for the foreseeable future, in particular the new mRNA-based vaccines that hold of the promise of rapid redevelopment times in response to new variant.
And that, in turn, means the questions of the long-term safety of these new mRNA vaccines are only growing in importance too with billions of people slated to get a shot of this new technology this year. So at least, with billions of people slated to get a COVID vaccine of some form or another this year, the evidence required to assess the long-term safety should be arriving. Eventually. Right? Well, while that might be a reasonable assumption, it’s not actually the case. Because it turns out simply administering vaccines to massive numbers of people, without actually setting up a formal study involving randomized-controlled, doesn’t automatically yield answers to the questions of long-term safety. At least not when it comes to rare side-effects that become potentially huge problems when a vaccine is administered globally. You actually need studies designed to answer these kinds of questions. And, lo and behold, it turns out the Trump administration’s FDA decided to not require the vaccine manufacturers to commit to these long-term studies after the manufacturers balked over the costs. Surprise! So we’ve basically committed ourselves to a long-term reliance on mRNA vaccine technologies without the long-term studies. Which is a kind of a long-terms study on its own, albeit the kind of long-term study that probably wouldn’t get approval from oversight boards:
“But behind the scenes, there’s a lot we don’t know, especially about the vaccines made by Pfizer and Moderna, which employ a completely novel technology involving mRNA, a type of genetic material. The reason we don’t know it is because of a decision made back in December by the U.S. Food and Drug Administration (FDA). The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines. While the early results from the clinical trials look incredibly promising, we don’t actually know with any precision just how effective and safe they really are – and we probably never will. That might sound like the kind of hairsplitting that hardly matters when a pandemic is raging and people’s lives are at stake, but it does matter for future vaccination campaigns. It’s worth considering why the FDA did it and whether or not that’s how vaccines and other medical products should be regulated in the future.”
For whatever reason, when the FDA issued its emergency use authorizations back in December, the agency decided to allow the vaccine manufacturers to effectively end their long-term studies. This decision was driven, in part, by a fear that the emergency use authorization would effectively undermine long-term studies from the people already enrolled in vaccine studies dropping out to take the vaccine. But Anthony Fauci had a proposed solution for this: a “blinded crossover design.” But after the manufacturers complained about the costs of continuing the studies, the FDA decided to allow the manufacturers to make the decision themselves as to whether or not the studies would be continued:
Keep in mind that Moderna and Pfizer received billions of dollars from the US government to help with the development of these vaccines. Those are the companies complaining about the costs of the long-term studies.
It all raises the question: so what are the adequate long-term safety trials that are required before this new mRNA-based technology can be deemed to have been adequate tested? Well, here’s an article from December of 2017, less than two years before the outbreak began, about the challenges Modern and Pfizer faced in overcoming the long-term regulatory safety concerns for their new mRNA-based therapeutic platforms. These were mRNA therapies, not vaccines, that involved more regular administration of the mRNA shots, so the safety concerns applied to a level of shot frequency that people hopefully aren’t receiving for the vaccines. But the therapeutic scenarios they were testing still weren’t wildly different from the two-shot COVID vaccine experience most people who received the vaccine have already experienced. For example, in one study, scientists treated hemophilia in mice with the mRNA therapy, using three doses over five months, and discovered the kind of troubling immune response that prompted the scientists to question the long-term safety of the technology. So three shots, each presumably about 2.5 months apart, instead of the two shot vaccines about a month apart for the mRNA vaccine, were prompting long-term safety concerns in this study on mice. It’s certainly not a definitive finding either way, but that’s the point. Lot’s a significant questions remain unanswered, including questions about whether or not people are going to be expected to take at least two shots of this vaccine each year for the rest of their lives. The long-term risks of two shots a year are going to be very different from the long-term risks of just two shots once. And if we are to use the established regulatory standards for answer those questions, we would need to establish the medium-term safety of the mRNA technology at 10-times the dosages used in routine therapeutics. Only then would researchers be less concerned about the long-term safety:
“In a study published online today in Cell Reports, the company shows that there were no obvious health problems in mice given repeated doses of its latest generation of messenger RNA (mRNA) drugs. The finding is far from definitive evidence of safety, but it’s some of the first published animal research supporting the use of this type of RNA as long-term therapy in diseases like methylmalonic acidemia (MMA). “It’s good news for the mRNA delivery field and an important step,” says Kathryn Whitehead, a chemical engineer at Carnegie Mellon University in Pittsburgh, Pennsylvania, who was not involved in the study.”
Yes, the study published by Moderna in December of 2017 was notable not because it definitively established that weekly injections of mRNA for 5 weeks was safe. No, it was notable fore being one of the first published studies based on animal research of the safety of the long-term uses of this technology. At the study was just five weeks. It’s a hint about the status of our collective knowledge of the long-term established safety of this new technology that’s suddenly become the default-response to new coronavirus outbreaks. Status that doesn’t come close to the 10-fold safety tests researchers were saying was needed to truly answer regulatory questions about long-term safety:
And then, as we’ve seen, those regulatory questions about long-term safety were permanently waved away with the temporary emergency authorizations of yesteryear. It’s a curious decision to waive those safety trials away. After all, it’s not like a lack of studies is going to be assuring to the general public. Although, from the manufacturer’s standpoint, studies showing possible long-term risks would be far more disturbing to the public, which is presumably the point of dropping the long-term studies in the first place. That and saving cash. Because priorities.
So are we poised to see a wave of mysterious side-effects in coming years? Maybe. Under a worst-case scenario. But if there are long-term consequences to the regulator administration of this vaccine technology — twice a year for years to come — we’re probably going to find those consequences eventually. It’s inevitable with the number of people involved. What isn’t inevitable is connecting back those long-term consequences to the mRNA technology, especially if the long-term consequences are relatively rare and primarily hit certain vulnerable groups like the frail elderly. In other words, the large numbers of people getting the vaccine does automatically mean we’ll be able to learn about rare side-effects. Whether or not we’ll be able to connect those inevitable long-term consequences back to the administration vaccines is another question entirely because long-term studies designed to actually answer those kinds of questions are required when answer questions about relatively rare side-effects. Study design matters. Even more so, actually running the study matters. Jabbing a a billion people and hoping the answers shake out in the long run doesn’t count. Oops.
We just got another update on OyaGen and the seemingly miraculous Oya1 antiviral drug First, recall how back in January we learned that OyaGen announced a set of compelling findings that were consistent with the early reports of Oya1’s possesses powerful antiviral properties. Not only did they find that a Oya1 + remdesivir cocktail worked synergistically against COVID-19, they also found that Oya1 was working against not just SARS-CoV‑2 but a broad spectrum of deadly viruses like Ebola and the Lassa virus. In other words, Oya1 was sounding a lot more like the broad-spectrum antiviral that US government has been hoping remdesivir would turn out to be.
But those reported findings were based on tests with cell cultures, not actual patients. So the question of how Oya1 works against these diseases in the real world has yet to be answered, in part because the clinical testing has been given fast-track authorization by the FDA. And yet Oya1 has already undergone clinical safety tests decades ago when it was investigated as a cancer drug and found to be safe. Recall how this inability to get Oya1 expedited clinical testing has been one of the ongoing complaints by OyaGen founder Harold Smith since the start of the pandemic.
We’re now learning how Oya1 is going to be tested on patients and brought to the market: OyaGen has partnered with Tonix Pharmaceuticals to carry out the clinical tests and exclusively distribute the drug, which will now be called TNX-3500. So it’s progress. Surprisingly slow progress considering the context — the context that OyaGen was touting the results from the joing OyaGen/Fort Detrick research showing remarkable antiviral efficacy against SARS-CoV‑2 back in March of 2020 right when the pandemic was getting underway — but it’s progress nonetheless. So now it’s OyaGen and Tonix who are pleading with the FDA for the expedited clinical trials.
Now, given that vaccines for COVID-19 are already available we can expect the immediate urgency that would have justified expedited clinical trials for the drugs over the last year to be somewhat attenuated. But it’s not as if the world is out of the woods yet on this pandemic. We still have no idea what kind of new variants might emerge (or be ‘made to order’ and released) over the next year. But we do know if a new nasty vaccine-resistant variant does emerge, remdesivir is at best a mildly helpful drug and wholly inadequate as an emergency fall back. The drug just hasn’t panned out as initially hoped and the world really does still have an urgent need for highly effective therapeutics. That’s the context of this announcement from OyaGen. An announcement that still includes pleas for expedited clinical trials:
““We believe that its potency on SARS-CoV‑2 inhibition in tissue culture and its tolerability in humans from prior studies suggests that TNX-3500 may qualify for expedited clinical development.””
It’s that plea again. The same plea for expedited clinical trials (on a drug already found to be safe for humans) we’ve been hearing from OyaGen since its remarkable cell culture findings back in March of 2020. A plea for expedited clinical trials amplified by further findings published with Fort Detrick researchers in December demonstrating a seemingly incredible broad-spectrum efficacy against a range of deadly viruses included Ebola along with the earlier results in cell cultures showing Oya1 (TNX-3500) is 65-times more potent than remdesivir in inhibiting the SARS-CoV‑2 virus. Even better, combining Oya1 with remdesivir was found to be synergistic. None of these incredible findings can be put to use without those clinical trials. Just imagine what a game-changer it would be in terms of reopening societies if this drug was available right now:
Also keep in mind that there’s inevitably going to be a large chunk of the populace that simply refuses to take a COVID vaccine no matter what. The larger that group is the more important it’s going to be to have effective therapeutics.
But it’s now up to Tonix to push the drug through these clinical trials. Will OyaGen’s partnership with Tonix finally make those clinical trials happen? We’ll see, but keep in mind that OyaGen’s other research partner all along has been Fort Detrick. You almost couldn’t ask for a better-connected research partner than Fort Detrick in terms of lending credibility to your findings and yet those clinical trials still haven’t happened. This story has been developing for over a year now and we still have no idea what is causing these delays. So we can conclude that Tonix has its work cut out for it in terms of bringing this drug to market. But we still can’t conclude why.
This article talks about a new technology being tested at Walter Reed’s infectious disease branch on animals with spike ferritin nanoparticle, or SpFN, vaccine has shown effectiveness against not only the current SARS-CoV‑2 variants, but also against the completely different SARS-CoV‑1 outbreak that occurred in 2003. This synthetic antibody can generate a broad range of anti-body responses to protect against many types of coronaviruses.
https://www.defenseone.com/technology/2021/06/may-not-be-big-one-army-scientists-warn-deadlier-pandemics-come/174853/
‘This May Not Be The Big One’: Army Scientists Warn of Deadlier Pandemics to Come
BY TARA COPP
SENIOR PENTAGON REPORTER, DEFENSE ONE
JUNE 21, 2021
The service is closing in on a “pan-coronavirus” vaccine and on synthetic antibodies that could protect a population before spread. But that may not be enough.
June 21, 2021
The U.S. Army scientists who have spent the last year finding vaccines and therapeutics to stop COVID-19 cautioned that the nation remains vulnerable to a viral pandemic—one that could be even deadlier than the current one.
Since the earliest days of the COVID-19 pandemic, the emerging infectious diseases branch at the Walter Reed Army Institute of Research has worked to develop a vaccine that would help patients fend off not only the original virus strain but also new variants.
In initial tests on monkeys, horses, hamsters, and sharks, Walter Reed’s spike ferritin nanoparticle, or SpFN, vaccine has shown effectiveness against not only the current SARS-CoV‑2 variants, but also against the completely different SARS-CoV‑1 outbreak that occurred in 2003, the head of Walter Reed’s infectious diseases branch said at the Defense One 2021 Tech Summit Monday.
“If we try to chase the viruses after they emerge, we’re always going to be behind,” said Dr. Kayvon Modjarrad, director of Walter Reed’s infectious diseases branch. “So the approach that we took with our vaccine, the nanoparticle approach, in which we can place parts of different coronaviruses on to the same vaccine to educate the immune system about different coronaviruses all at the same time.”
Walter Reed’s vaccine is now in the early stages of human trials.
“And we see the same thing over and over again: a very potent immune response and a very broad immune response,” Modjarrad said. “So if we show even a fraction of what we’re seeing in our animal studies in humans, then we’ll have a very good confidence that this is going to be a very good option as a next-generation vaccine.”
Dr. Dimitra Stratis-Cullum, director of the Army’s transformational synthetic-biology for military environments program at the U.S. Army Combat Capabilities Development Command, Army Research Laboratory, was tasked early on to assist the Houston Methodist Research Institute develop blood plasma as a COVID-19 therapeutic. She’s now working on developing a large dataset, a library of COVID strains that would help the lab then create and distribute synthetic antibodies to preemptively prevent a spread.
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Creating a pan-coronavirus vaccine—or synthesizing antibodies slightly ahead of a known outbreak still isn’t enough, the scientists cautioned.
“We don’t want to just treat what’s in front of us now,” Stratis-Cullum said. “I think we really need to be resilient. From an Army perspective. We need to be agile, we need to adapt to the threat that we don’t know that’s coming.”
The likelihood this generation will see another pandemic during its lifetime “is high,” Modjarrad said. “We have seen the acceleration of these pathogens and the epidemics that they precipitate. And it may not be a coronavirus, this may not be the big one. There may be something that’s more transmissible and more deadly ahead of us.”
“We have to think more broadly, not just about COVID-19, not just about coronavirus, but all emerging infectious threats coming into the future,” he said.