FDA To Require Real Data Proving Safety and Effectiveness Of Vaccines

FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said that the FDA’s new COVID-19 vaccine framework will have two tiers. For people aged 65 or older, and for people who have a risk factor that places them at high risk for severe COVID-19 outcomes, manufacturers will only need to provide proof that a vaccine can trigger antibodies. For everyone else, or those without risk factors, the FDA is requiring data from randomized, controlled trials showing that a vaccine prevents symptomatic COVID-19 and secondary outcomes such as death.

HHS to Require Placebo-Controlled Trials for New Vaccines

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Top FDA Official Discloses She Never Received COVID-19 Vaccine

“We’re moving very quickly to make it such that there will be more transparency, more available data and information, so that people ... can see and evaluate for themselves sort of what the truths are and what’s known and unknown,” she said. “And I'll go ahead and put it that way, because one of the biggest misses, I think, in the previous several years is that there was no acknowledgement of what was unknown, right? There was there were only statements and assertions that were really more like beliefs or things that were desired to be true than they were true knowns.”