FDA Vaccine Authorization Controversies

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Day 155: Stay Safe Minnesota

The recent FDA emergency use authorization of covalent plasma for COVID-19 treatment has garnered widespread controversies.

FDA emergency use authorization of convalescent plasma for Covid-19 treatment has garnered widespread controversies. A recent New York Times headline reads – F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say.

In an exclusive interview with Reuters, Dr Anthony Fauci, the nation’s top infectious diseases expert, warned such a rush authorization is a bad idea.

Distributing a COVID-19 vaccine under special emergency use guidelines before it has been proved safe and effective in large trials is a bad idea that could have a chilling effect on the testing of other vaccines.

Dr Anthony Fauci, In Reuters Interview

There has been speculation that the FDA’s authorization was under political pressure from the White House and there is not sufficient scientific data to support its use. The Hill reports that FDA Commissioner Dr Stephan Hahn denied in the same Reuters interview that there was “any political considerations factored into the FDA authorizing the use of convalescent plasma from recovered patients as a coronavirus treatment”. Dr Hahn explained :

Previously when we did have a discussion with them, they were concerned that the data might not be robust enough. That’s why we did the validation … to provide further confirmation.

Dr Hahn (source: The Hill)

In the Reuters interview Dr Anthony Fauci said there are risks in rushing out a vaccine despite the urgent need.

  • “The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy.”
  • “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial”.
  • “An EUA is typically used for products to “diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product”.
  • “To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both. We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective.”

The Hill reports : “More than 100 possible vaccines to fight off the coronavirus are being developed around the world. Drug manufactures including Moderna, AstraZeneca and Pfizer have all developed candidates that are now in phase 3 clinical trials.”

Coronavirus Pandemic Watch

According to the MDH latest tally (as of Aug 28, 11 a.m.) the confirmed COVID-19 cases in Minnesota are 73,240 (out of 1,443,344 tested) with 1,810 deaths. According to Johns Hopkins database (as of Aug 28, 4:28 p.m.) there are 5,906,615 confirmed covid19 infection with 181,579 deaths. Globally the covid19 virus has infected 24,573,933 with 833,836 deaths.