The FDA is the entity that will verify the results of the trials and approve any vaccine that passes - the efficacy of each will be measured against each other to produce the best one, if more than one passes.
Dr. Fauci has pledged that this process is a good one and that Americans should trust the FDA.
Dr. Anthony Fauci will see data from government-funded vaccine trials before the FDA does. One caveat: Pfizer’s study, which is ahead of the others, isn’t included in his purview.
Dr. Anthony Fauci, the nation’s top infectious disease official, will oversee most of the ongoing COVID-19 vaccine trials in the U.S., but not that of the current front-runner made by Pfizer, documents obtained by ProPublica show.
According to a draft charter spelling out how most of the advanced COVID-19 vaccine trials will be monitored, Fauci is the “designated senior representative” of the U.S. government who will be part of the first look at the results. That puts Fauci in the room with the companies — including Moderna, Johnson & Johnson and AstraZeneca — in deciding whether the vaccines are ready to seek approval from the Food and Drug Administration.
Fauci’s role, which has not been previously reported and was confirmed for ProPublica by the National Institutes of Health, could offer some reassurance in the face of widespread concerns.
But there’s a big caveat. Fauci doesn’t have the same hands-on role for the vaccine that seems poised to show results soonest: Pfizer’s. That’s because Pfizer opted not to accept government funding and participate in the federal program to develop a coronavirus vaccine, known as Operation Warp Speed.
Fauci’s role in overseeing the companies that are participating in Operation Warp Speed arises from a unique arrangement that the government set up to monitor the trials. Typically, clinical trials set up their own independent panels of scientists, known as a data safety monitoring board or DSMB, to watch out for safety concerns or early signs of success. But all of the vaccine trials in Operation Warp Speed are sharing a common DSMB whose members were selected by Fauci’s agency, the NIAID. They’re also sharing a network of clinical trial sites where some volunteers are recruited for the studies.
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ProPublica 10/16/2020 - Who Decides When Vaccine Studies Are Done?
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