'Today's discussion provides transparency about the data we will request and evaluate'
s part of its routine review process, the U.S. Food and Drug Administration , the agency responsible for evaluating and deciding if the handful of COVID-19 vaccines currently being studied are safe and effective enough to use by people around the world, convened a committee on Oct. 22 to allow experts and the public to learn about and comment on the review process.
The FDA confirmed it will consider a COVID-19 vaccine effective if it achieves 50% effectiveness in protecting against the illness. The members and speakers debated about what this protection means, and raised the possibility that it could indicate that immunized people would still get infected, but then not progress on to serious disease.
Another unresolved issue centers around what will happen to ongoing placebo controlled studies if one or more of the vaccines are given EUA ahead of others. Given that the virus is still spreading in parts of the U.S., participants in ongoing trials may want to drop out of their studies and get vaccinated with an authorized shot, once available. But because the trials are all blinded, neither they, nor their doctors, will know if they received the experimental vaccine or a placebo.
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