Skip to content
U.S. Transhumanist Party – Official Website
  • Home
  • Posts
  • Values
  • Platform
  • Leadership
  • Advisors
  • Candidates
  • Highlights
  • FAQ
  • States & Allies
  • Free Membership
  • Facebook
  • Twitter
  • Search Icon

U.S. Transhumanist Party – Official Website

U.S. Transhumanist Party – PUTTING SCIENCE, HEALTH, & TECHNOLOGY AT THE FOREFRONT OF AMERICAN POLITICS

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

February 26, 2021 Dan Elton Comments 0 Comment

 

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.


Guest Articles
AstraZeneca, FDA, Food and Drug Administration, Johnson & Johnson, Precautionary Principle, proactionary principle, unclogTheFDA, vaccine approval, vaccines

Post navigation

PREVIOUS
Micronationalism and Seasteading – Tools for a Better Future – Article by Jan-Olav Spiekermann
NEXT
Forecasting Whole-Brain Connectomics – A Kurzweilian Approach – Article by Dan Elton

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Social Media

Constitution of the U.S. Transhumanist Party

Transhumanist Bill of Rights – Version 3.0

U.S. Transhumanist Party Facebook Feed

Free Transhumanist Symbols

Guidelines for Community Conduct

SUBMIT A POST

Subject Categories

    - Life Extension
    - Artificial Intelligence
    - Space Colonization
    - Robotics
    - Biotechnology
    - Nanotechnology
    - Autonomous Vehicles
    - 3D Printing
    - Cryptocurrencies
    - Vertical Farming
    - Universal Basic Income
    - Existential Risk
    - Rationality

Hashtags

    #USTranshumanistParty, #TranshumanistParty, #TranshumanistPolitics, #TomRoss2024, #RossTwedt2024

Recent Posts

  • Art Ramon Appointed as Chairman of Arizona Transhumanist Party as David Shumaker Transitions to Emeritus Role
  • RADICAL LIFE SUBTRACTION: Navigating An Uncomfortable Discourse – Article by Tom Ross
  • THE WA.I.TER RULE: Unveiling True Character Through AI Interactions – Article by Tom Ross
  • “PLAYING GOD” ACCUSATION: Unraveling the Controversy Surrounding Transhumanism – Article by Tom Ross
  • CONSPIRACY CAMPAIGN: Leaning into the Unconventional – Article by Tom Ross
  • Ending Aging Forum 2023 – Announcement by SENS Research Foundation
  • U.S. Transhumanist Party Virtual Enlightenment Salon with Miguel Conner – July 16, 2023
  • U.S. Transhumanist Party Virtual Enlightenment Salon with Brent Nally – July 2, 2023
  • U.S. Transhumanist Party Stream – Nigerian Student Tech Innovators: Nonso Nolly and Frederick Onwuka
  • Five Misconceptions About Radical Life Extension – Article by Arjun Khemani
  • Validating One’s Virtues and Vices – Article by Zach Richardson
  • Sorry, Dr. Coughlin, “Aging” and “Old Age” Are Real, and They Suck – Article by Dan Elton
  • U.S. Transhumanist Party 2023 Electronic Primary Results – Tom Ross Endorsed as Candidate for President of the United States, Daniel Twedt Selected as Candidate for Vice-President
  • U.S. Transhumanist Party Presidential Candidate Roundtable – Tom Ross and Daniel Twedt – May 7, 2023 – and Subsequent Candidate Answers to Viewer Questions
  • A Transhumanist “Minimum Effective Dose” for Humanitarian Needs – Article by Zach Richardson
  • The Class Struggle of Longevity – Article by Luis Arroyo
  • U.S. Transhumanist Party Call for 2024 Presidential Candidates and Outline of 2023 Endorsement and Primary Process
  • Universal Sign Language – Transhuman / Transhumanism / Transhumanist – Post by Art Ramon Garcia, Jr.
  • The Anti-Aging Manifesto by Mat Alex Richards
  • U.S. Transhumanist Party Virtual Enlightenment Salon with Makiko Yoshioka – June 5, 2022

Recent Comments

  • Vladimir Shakirov on U.S. Transhumanist Party General Discussion Thread for 2023
  • Zach Richardson on Five Misconceptions About Radical Life Extension – Article by Arjun Khemani
  • Jason Mallory on U.S. Transhumanist Party 2023 Electronic Primary Results – Tom Ross Endorsed as Candidate for President of the United States, Daniel Twedt Selected as Candidate for Vice-President
  • Ben Ballweg on U.S. Transhumanist Party 2023 Electronic Primary Results – Tom Ross Endorsed as Candidate for President of the United States, Daniel Twedt Selected as Candidate for Vice-President
  • Jess H. Brewer on U.S. Transhumanist Party Presidential Candidate Roundtable – Tom Ross and Daniel Twedt – May 7, 2023 – and Subsequent Candidate Answers to Viewer Questions

Archives

  • September 2023 (6)
  • August 2023 (1)
  • July 2023 (4)
  • May 2023 (3)
  • April 2023 (3)
  • March 2023 (2)
  • February 2023 (12)
  • January 2023 (24)
  • December 2022 (2)
  • November 2022 (2)
  • October 2022 (3)
  • August 2022 (3)
  • July 2022 (2)
  • May 2022 (6)
  • March 2022 (3)
  • February 2022 (4)
  • January 2022 (7)
  • December 2021 (11)
  • November 2021 (4)
  • October 2021 (5)
  • September 2021 (2)
  • August 2021 (2)
  • July 2021 (4)
  • June 2021 (2)
  • May 2021 (6)
  • April 2021 (7)
  • March 2021 (4)
  • February 2021 (5)
  • January 2021 (6)
  • December 2020 (10)
  • November 2020 (4)
  • October 2020 (2)
  • September 2020 (1)
  • August 2020 (4)
  • July 2020 (5)
  • June 2020 (6)
  • May 2020 (3)
  • April 2020 (3)
  • March 2020 (6)
  • February 2020 (1)
  • January 2020 (6)
  • December 2019 (3)
  • November 2019 (2)
  • October 2019 (9)
  • September 2019 (10)
  • August 2019 (12)
  • July 2019 (18)
  • June 2019 (17)
  • May 2019 (12)
  • April 2019 (8)
  • March 2019 (12)
  • February 2019 (7)
  • January 2019 (13)
  • December 2018 (9)
  • November 2018 (5)
  • October 2018 (9)
  • September 2018 (5)
  • August 2018 (10)
  • July 2018 (13)
  • June 2018 (14)
  • May 2018 (8)
  • April 2018 (8)
  • March 2018 (10)
  • February 2018 (15)
  • January 2018 (17)
  • December 2017 (8)
  • November 2017 (17)
  • October 2017 (19)
  • September 2017 (11)
  • August 2017 (11)
  • July 2017 (16)
  • June 2017 (15)
  • May 2017 (10)
  • April 2017 (7)
  • March 2017 (8)
  • February 2017 (16)
  • January 2017 (8)
  • December 2016 (6)
  • November 2016 (5)

Categories

  • Allied Projects
  • Announcements
  • Art
  • Candidates
  • Discussion Panels
  • Distributed Computing
  • Exposure Periods
  • Foreign Ambassadors
  • General Discussion
  • Guest Articles
  • Inclusion
  • Interviews
  • Official Ballots
  • Petitions
  • Platform
  • Presentations
  • Press Releases
  • Research
  • Sample Ballots
  • Science Fiction
  • Statements
  • Tolerance
  • Virtual Enlightenment Salons
  • Vote Results
  • Working Groups

Victor Run Virtual Race – June 4-6, 2021

Historical Archive – 2020 U.S. Presidential Ticket – Charlie Kam and Liz Parrish

© 2023   Copyright - U.S. Transhumanist Party - All Rights Reserved | WordPress design: Art Ramon Paintings