Who Decides When Vaccine Studies Are Done? Internal Documents Show Fauci Plays a Key Role.
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.
by Isaac Arnsdorf, Caroline Chen and Ryan Gabrielson
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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 that President Donald Trump wants to rush through an unproven vaccine. As Sen. Kamala Harris, the Democratic nominee for vice president, put it at last week’s debate, “If the public health professionals, if Dr. Fauci, if the doctors tell us that we should take it, I’ll be the first in line to take it.”
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. (The government did make an almost $2 billion deal with Pfizer to preorder up to 600 million doses of the company’s vaccine, but it isn’t contributing money to the vaccine’s development like it is for other companies.)
“(We) offered opportunities for collaboration with Pfizer,” said a spokesperson for the National Institutes of Allergy and Infectious Diseases, a branch of the NIH. “Pfizer chose to conduct their Phase 3 study without Operation Warp Speed or NIH support.”
Pfizer’s CEO, Albert Bourla, said Friday that the earliest his company would be ready to apply for authorization would be the third week of November. While Pfizer might know by the end of October if its vaccine is effective, it would need additional time to gather sufficient safety data to present to the FDA, Bourla said in an open letter on the company’s website.
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.
A DSMB is responsible for making recommendations such as halting the trial if there is a safety concern or letting the manufacturer know that there’s enough evidence to submit an application to the FDA. Ordinarily, a DSMB’s recommendation goes to the company running the trial. In this case, the U.S. government — which gets two representatives, one from the NIAID and one from the Biomedical Advanced Research and Development Authority — will also have a seat at the table in deciding what to do next. READ MORE HERE.