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USTP Director of Scholarship Dan Elton’s Letter to the FDA’s Vaccine Committee Meeting on the Emergency Use Authorization of the Johnson & Johnson Vaccine

USTP Director of Scholarship Dan Elton’s Letter to the FDA’s Vaccine Committee Meeting on the Emergency Use Authorization of the Johnson & Johnson Vaccine

 

Daniel C. Elton, Ph.D.


The public can comment on the FDA’s committee meeting tomorrow (February 26th) to discuss the Emergency Use Authorization for the Johnson & Johnson / Janssen vaccine candidate. Members of the public can submit comments via an online system here or via the mail. Attached is my letter. The main theme is transparency.  

 

To the VRBP Advisory Committee:

I am writing to request the FDA exhibit full transparency and show their cost-benefit calculations which justified such a long delay in approving the J&J/Janssen vaccine. Taxpayers deserve decisions that are made on the basis of rational cost-benefit analysis informed by the best science and data available. There is an incredible fog around key decisions that have greatly affected Americans during the COVID-19 pandemic – such as the FDA’s decisions that made it hard for at-home tests to be approved, HHS & FDA decisions not to pursue or support human challenge trials, and the FDA’s deadly decision to delay approvals of life-saving vaccines, most shockingly the AstraZeneca vaccine. With 2,000 – 3,000 Americans dying every day and millions of Americans desperate for life-saving vaccines (as evidenced by long lines across the country) it is only fair that taxpayers know the reasons for the FDA’s delays.

In a relentless pursuit of safety the FDA has ironically ignored the greatest safety concern to the American people – the SARS-CoV2 virus, and many have died needlessly as a result. Beyond normal expected utility based utilitarian calculations, the proactionary principle(s), developed by philosopher Max More and extended by Steve Fuller and others provide a good blueprint for conducting rational cost benefit analysis. It is my belief that the procedures the FDA have used to decide if and when to approve this vaccine have not utilized even the most rudimentary cost-benefit analyses, and lives have been lost as a result. I am open to changing my mind, however, if the FDA can produce a cost-benefit calculation that informed their decision making.

The interim Phase III collection period for the Janssen vaccine ended January 22 and they submitted their EUA application on February 4th. The American people have had to wait 22+ days for the EUA to be granted. Between February 4th – 26th, around 52,500 Americans will have lost their lives to COVID-19 (extrapolating the death rate forward 2 days from February 24th). In that time, countless others will have suffered under the ravages of the disease and the numerous sequela of “long COVID”. Even among those who have been lucky enough not to have their bodies invaded by the virus, most have suffered brutal economic and psychological effects from the pandemic.

As economist Tyler Cowen points out, it is a fallacy to think that manufacturing is the main bottleneck to getting life-saving vaccines to American people. Millions of doses of both the Pfizer and Moderna vaccines were available when the FDA finally approved them, showing that FDA approval was a larger constraint than manufacturing. While J&J may not have as many vaccines produced by February 26th as Moderna & Pfizer did at their EUA, if an expectation of an earlier EUA had been set by the FDA the company would have had a stronger incentive to ramp up production. It is incorrect to view the manufacturing and approval as independent – both are linked, with the timeframe set for one affecting the timeframe for the other. In economic terms, the elasticity of manufacturing to demand is not zero. Production of J&J’s vaccine began long ago so they could provide vaccines for their Phase I/IIa trial which began on July 22, 2020. While the company has faced production setbacks, a GSA report (GAO-21-265) estimates they will have 2 million doses available on February 26th.

The government of South Africa announced on February 10th that they would start administering the J&J vaccine to frontline health care workers. Now imagine if the FDA had made the J&J vaccine available just two weeks prior and assume that 2 million doses could therefore be distributed two weeks earlier as a result. At the current monthly rate of deaths, the average american has a 1/9,410 chance of dying from COVID-19 every 2 weeks. The risk of dying from the J&J vaccine, by contrast, based on the Phase I/II data and our prior knowledge about similar vaccines, is at most 1/1,000,000 (likely an overestimate). Assuming the vaccine is 100% effective at preventing death from COVID-19 (a safe assumption based on the current science), delivery of 2 million J&J vaccines 2 weeks earlier could save 212 lives and reduce suffering in many more. However, this number is obviously an underestimate because the vaccines will be distributed to the elderly and those with pre-existing conditions first, who have a 10x – 100x higher chance of dying from COVID-19 than the average American. So, the true number of lives that would have been saved is in the ballpark range 2,120-20,120.

The FDA’s decision to delay approval of the AstraZeneca vaccine by demanding additional American Phase III trial participants represents an even more egregious decision which surely cost thousands of Americans their lives. To be respectful of the purpose of the meeting at hand, however, I have restricted my discussion here to the J&J vaccine alone.

I ask that the FDA produce a cost-benefit analysis and clearly explain the reasons for the following decisions:

  • The reason the FDA did not allow the J&J vaccine to be made available via the FDA’s Expanded Access Program after excellent Phase I/II safety & immunogenicity data was published The Lancet on January 13th, 2021. (side note: see this article in STAT)
  • The reason the FDA did not recommend and/or advocate that those with a high risk of dying from COVID-19 obtain the J&J vaccine via the Right-to-Try pathway prior to EUA.
  • The reason the FDA, in October, created a requirement for a median 2 month follow up period in Phase III trials.
  • The reason the FDA decided not to recommend J&J use challenge trials to demonstrate the efficacy of their vaccine in a faster manner.
  • The reason the FDA decided not to allow pre-distribution of the J&J vaccine prior to EUA to speed up distribution.
  • The reason the FDA did not implement rolling reviews for the J&J vaccine.
  • The reason the FDA decided it needed 22 days to review J&J’s EUA application.

For each point, a cost-benefit calculation should be provided including a list of costs and benefits to the action vs the opposite action, ideally expressed in terms of quality-adjusted life years (QALYs) saved or lost.

Finally, I ask that in their communications and messaging the FDA focus on the efficacy of the J&J vaccine against hospitalization and death, especially against the South African variant, so Americans are informed first and foremost about the most important benefits of this vaccine.

Respectfully,
Daniel C. Elton, Ph.D.

 

Dan Elton, Ph. D., is Director of Scholarship for the U.S. Transhumanist Party.  You can find him on Twitter at @moreisdifferent, where he accepts direct messages. If you like his content, check out his website and subscribe to his newsletter on Substack.

A Polite List of Requests to the FDA – Article by Dan Elton

A Polite List of Requests to the FDA – Article by Dan Elton

Daniel C. Elton, Ph.D.


A List of Requests to President Joseph R. Biden, Jr.,
HHS, FDA, and Congress: 

Approve the following vaccines for emergency use immediately: 


Give people the right to try the following vaccines: 

Seriously study and consider these actions: 

  • Allow hospitals and pharmacies to start stockpiling unapproved vaccines so they can be rapidly disseminated upon approval. 
  • Allow Moderna to give fractional doses. Data from Moderna’s clinical trials have illustrated that people between ages of 18 and 55 who received two 50-microgram doses showed an identical immune response to the standard of two 100-microgram doses.
  • Allow all age groups to get the vaccine. Research published in the journal Science indicates that as of October 2020, “individuals aged 20-49 are the only age groups sustaining resurgent SARS-CoV-2 transmission with reproduction numbers well above one”. Thus, targeting vaccines at these groups may accelerate the end of the pandemic and save more lives than continuing to restrict the vaccines to the elderly and vulnerable.
  • Consider making “First Doses First” national policy.


The FDA has not moved fast enough given the gravity of the situation we face. Consider the following: 

  • Pfizer sent its paperwork to the FDA on November 22, 2020, but rather than immediately convening its panel of experts, the FDA scheduled a review meeting for December 10. During that three-week wait, 27,000 Americans died of COVID-19. According to Dr. Marty Makary, a professor of public health policy at the Johns Hopkins Bloomberg School of Public Health who has conducted over a hundred clinical studies during his career, the FDA “could have done the approval in 24-48 hours without cutting any corners”.  The slow rollout that followed after the FDA approved the vaccine on December 11 was not due to delays in production – Pfizer had millions of doses produced and sitting in cold storage at the time of the approval. 
  • While Americans were waiting for the Pfizer vaccine that millions of their taxpayer dollars had been invested in, the FDA went dark for 4 days during the Thanksgiving holiday, with almost all of its 17,000 employees taking that time off, including those working on critical COVID-19-related work. 
  • Moderna sent its paperwork to the FDA on November 30, 2020. As with the Pfizer vaccine, the FDA needlessly delayed the approval by scheduling the review meeting for December 17. 
  • The FDA’s equivalents in the EU, Canada, Switzerland, UK, Israel, and Singapore all use rolling reviews, evaluating data as it becomes available for the sake of efficiency. The FDA does not. 
  • The Sputnik V vaccine was approved September 4, 2020, over 150 days ago. In a paper in The Lancet, phase III results indicate it has an effectiveness of 91.6% and excellent safety profile. 
  • China began administering the CanSino Biologica vaccine to its military in June after Phase I and Phase II clinical trials established safety and immune response. (The phase II results were published in The Lancet on July 20th, 2020). China approved the vaccine for their public on December 24, 2020. 


Here’s what public-health experts are saying:
 


“The F.D.A. needs to catch up to the science… They are inadvertently killing people by not following the science.” – Michael Mina, Epidemiologist, Immunologist, Physician, Harvard Medical School.

“We’ve gone from ‘Operation Warp Speed’ to develop a vaccine to ‘Operation Turtle Speed’ to review it… The FDA needs to stop playing games and authorize the Oxford-AstraZeneca vaccine.  It’s safe, cheap ($2-$3 a dose), and is the easiest vaccine to distribute.”Marty Makary, M.D., a professor of health policy at the Johns Hopkins University School of Medicine. 

I do think we’ve been too conservative… companies that potentially make public health diagnostic tests did not feel that there was, for example, a pathway to get those approved at the F.D.A.”Vivek Murphy, President Biden’s nominee for Surgeon General.

“We’ve already bought 300 million doses of the AstraZeneca-Oxford vaccine. We’ve paid for it — over a billion dollars — so let’s use it… I know we have some of that vaccine stockpiled.”Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and the lead developer of a COVID-19 vaccine being produced in India.


More quotes from notable public figures: 

“For years the FDA was focused on, don’t repeat thalidomide. Drugs must be safe. AIDS forced a hard reckoning. The people who are dying while you wait matter. But this is a third, even harder conceptual change. Stopping the spread of the disease matters. And the FDA does not have the years it took to make the AIDS change of mindset.”John Cochrane, Senior Fellow at the Hoover Institution. 

The new strains spread quickly. The speed of our countermeasures will decide our fate. What feels like reasonable delays in our normal experience of time — a few weeks here for Congress to debate a bill, a few weeks there for the F.D.A. to hold meetings — could lead to the kind of explosive infections that overwhelm our hospitals and fill our morgues.”Ezra Klein, co-founder of Vox.

“The US failure to authorize the AstraZeneca vaccine in the midst of a pandemic when thousands are dying daily and a factory in Baltimore is warmed up and ready to run is a tragedy and dereliction of duty of epic proportions. The AZ vaccine should be given an EUA immediately and made available in pharmacies for anyone who wants it while continuing to prioritize Moderna and Pfizer for the elderly and essential workers.”Alex Tabarrok, Bartley J. Madden Chair in Economics, George Mason University. 

“It’s amazing that not only is this vaccine (AstraZeneca) not approved, there’s no political pressure to approve it.”Matthew Yglesias, author of One Billion Americans: The Case for Thinking Bigger.

“The UK has authorized #AstraZeneca vaccine for #CV19 but #FDA won’t “because of questions about its efficacy among older people.”
Then authorize its use for younger people!
Dear FDA: Get out of the way!
Over 7,000 Americans died of CV19 in the past two days!
You are murdering us!”
– @Robert Zubrin on Twitter, author of The Case for Mars and The Case for Space.

Further reading: 

Dan Elton, Ph. D., is Director of Scholarship for the U.S. Transhumanist Party.  You can find him on Twitter at @moreisdifferent, where he accepts direct messages. 

U.S. Transhumanist Party Interview with Bobby Ridge

U.S. Transhumanist Party Interview with Bobby Ridge

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Gennady Stolyarov II and Bobby Ridge


Gennady Stolyarov II, Chairman of the United States Transhumanist Party, interviews Bobby Ridge, a researcher into transhumanist philosophy and the scientific method and the new Secretary-Treasurer of the United States and Nevada Transhumanist Parties.

Watch this conversation regarding the subjects of Mr. Ridge’s research, the scientific method, and transhumanism more generally.

Bobby Ridge has a Bachelor’s Degree in Biomedical Science from California State University of Sacramento (CSUS) and is striving to achieve his MD in Neurology. He only recently became a Transhumanist. He conducts research for CSUS’s Psychology Department and his own personal research on the epistemology and Scientiometrics of the Scientific Method. He also co-owns Togo’s in Citrus Heights, CA. Mr. Ridge considers transhumanism to describe the future of humanity taking its next steps in evolution, which are both puissant and daunting. With the exponential increase in information technology, Mr. Ridge considers it important for us to become a science-based species to prevent a dystopian-type future from occurring.

Become a member of the U.S. Transhumanist Party for free by filling out this form.