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

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

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

February 3, 2021 Dan Elton Comments 0 Comment

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: 

  • AstraZeneca. Phase III peer-reviewed studies indicate it has an efficacy of 70%, ranging from 62% to 90% with different dosing regimens. It has nearly a 100% efficacy at preventing COVID-19 hospitalizations and death.  Data from Phase I/II and II/III trials (both published in The Lancet months ago) support the safety of the vaccine in addition to the massive Phase III study.

    The AstraZeneca vaccine has been approved in the EU and 19 other countries, including the UK, India, and Brazil. It is also the first COVID-19 vaccine shown to reduce transmission in a scientific study. The US has already secured 300 million doses of the vaccine, costing over $1 billion to US taxpayers. There is a factory in Baltimore producing this vaccine, and there are likely many doses already sitting on the factory floor. The FDA will not allow AstraZeneca to distribute the vaccine to healthcare providers until it is approved. Right now, the FDA projects they won’t approve the vaccine until April. With 2,000 dying every day and many more suffering from COVID-19, we believe that is unacceptable. We need the FDA to do the right thing and if necessary, we need President Biden and/or Congress to act.
  • Johnson & Johnson. (Janssen Pharmaceutica, Ad26.COV2.S) Interim Phase III trial results show an effectiveness of 72% in the United States, and an effectiveness of 100% against hospitalization and death. Phase I/II and Phase III trials show safety. Initial Phase III data shows it is 85% effective against severe disease from the South African variant (B1.351) as well. 
  • NovaVax. Interim Phase III data from the UK shows an effectiveness of 89.3%. Phase I/II trials show safety.


Give people the right to try the following vaccines: 

  • CureVac (Zorecimeran mRNA vaccine, has Phase I data showing safety and immune response) 

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: 

  • Prof. Tyler Cowen on why FDA approval is the constraint on getting vaccines in arms, not manufacturing.  
  • Gennady Stolyarov II, FSA on why we must reject the precautionary principle and should have given people the right to try vaccines last spring. 
  • Daniel Elton, Ph.D. on how we can judge the likely safety and effectiveness of new vaccines even prior to any study data coming in. 

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. 


Guest Articles
approval, AstraZeneca, COVID-19, covid19, FDA, Food and Drug Administration, Johnson & Johnson, Moderna, NovaVax, Pfizer, Precautionary Principle, vaccination, vaccines

Post navigation

PREVIOUS
U.S. Transhumanist Party Secretary Pavel Ilin Protests in New York City Against Vladimir Putin’s Regime
NEXT
Micronationalism and Seasteading – Tools for a Better Future – Article by Jan-Olav Spiekermann

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

  • MIND THE GAP: Bridging the Generation Gap in Longevity Science – Article by Tom Ross
  • U.S. Transhumanist Party Virtual Enlightenment Salon with Michael Rae – August 6, 2023
  • U.S. Transhumanist Party Virtual Enlightenment Salon with Adam Gries – August 13, 2023
  • U.S. Transhumanist Party Report from Longevity Summit Dublin 2023 – August 20, 2023
  • The U.S. Transhumanist Party Urges You to Sign the Dublin Longevity Declaration
  • U.S. Transhumanist Party Virtual Enlightenment Salon – USTP Officers’ Perspectives on Longevity
  • U.S. Transhumanist Party Virtual Enlightenment Salon with Eleanor Davies – September 3, 2023
  • U.S. Transhumanist Party Virtual Enlightenment Salon with Anastasia Egorova – September 10, 2023
  • U.S. Transhumanist Party Virtual Enlightenment Salon with David Patterson – September 17, 2023
  • U.S. Transhumanist Party Enlightenment Salon with Zack Varkaris / Austin Biotec – September 24, 2023
  • U.S. Transhumanist Party International Longevity Day Virtual Enlightenment Salon – October 1, 2023
  • 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

Recent Comments

  • Dan Elton on Five Misconceptions About Radical Life Extension – Article by Arjun Khemani
  • CCRN on Five Misconceptions About Radical Life Extension – Article by Arjun Khemani
  • 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

Archives

  • October 2023 (11)
  • 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