Let's unclog the FDA and save lives!
The FDA has not moved quickly enough given the gravity of the situation we face. Let's ask them to change.
A List of Requests to President Joseph R. Biden, Jr., HHS, FDA, and Congress:
The FDA should approve the following vaccines immediately:
Oxford-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).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.
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.
In conjunction with the CDC, study “First Doses First” and issue guidance on it.
Consider making it easier for over-the-counter in-home COVID19 tests to be approved.
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 20, 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.
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:
“Not having AstraZeneca COVID vaccine approved in the US is a blunder.” - Vincent Rajkumar, M.D. epidemiologist at the Mayo Clinic
“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.
Here’s what some other notable public figures have said:
“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), aerospace engineer and founder of The Mars Society.
Prof. Tyler Cowen on why FDA approval is the constraint on getting vaccines in arms, not manufacturing.
Alex Tabarrok on the FDA’s invisible graveyard.
Gennady Stolyarov II, FSA on why we must reject the precautionary principle and should have given people the right to try vaccines last spring.
Garret Jones, Ph.D. on the political influence on the FDA to slow walk the Oxford-AstraZeneca vaccine.