As the race for the first coronavirus vaccines rounds the final turn, an obscure but influential panel of Food and Drug Administration advisers is emerging as a crucial referee.
The group of academic scientists, doctors and federal health officials will scrutinize safety and efficacy data on every coronavirus vaccine candidate, and make a pivotal recommendation to the FDA on whether to greenlight or shelve each shot.
Although its decisions aren’t binding, the panel has taken on an outsized importance leading up to its first coronavirus meeting on Oct. 22. President Donald Trump has repeatedly said that a shot could come before Election Day — and has accused the FDA of standing in the way of progress. Meanwhile, the agency is trying to hold the line on new, stricter standards for authorizing the emergency use of any vaccine, and safety concerns have paused late-stage trials of two of the four frontrunner vaccine candidates.
The political backdrop, and plummeting public confidence in the race for a vaccine, could make the first coronavirus gathering of the Vaccines and Related Biological Products Advisory Committee one of the most-watched in FDA history. Topics the group expects to cover include some of the thorniest and most fundamental questions in vaccine development, such as when a vaccine can truly be declared safe and where to set the bar for efficacy during a deadly global pandemic.
“It’s a group of nerdy virologists sitting around,” said Paul Offit, a University of Pennsylvania vaccine expert who sits on the panel and co-developed the rotavirus shot. “You don’t see many situation comedies about a group of fun-loving virologists and epidemiologists. For a reason.”
Nevertheless, the FDA is preparing for tens of thousands of people to tune into the panel’s initial meeting — a departure from past practice for similar advisory committees attended largely in person by DC-area experts and academics. Such meetings normally attract an online audience of just 100 to 1,500 people, an FDA spokesperson said.
No single vaccine is expected to be ready for review by Oct. 22. But the advisory group is on standby to discuss the merits of each shot as drugmakers file applications for FDA authorization or approval — making the panel a prominent player in the final crucial months of the United States’ vaccine push.
“We don’t work for the government nor do we work for the industry. We’re just supposed to come there and look at data,” said Offit.
The 20-member committee is a mix of physicians, statisticians, vaccine and infectious disease experts along with two drug company representatives and a consumer representative, in this case a lawyer. A five-person cluster hails from FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, but the rest work outside the government.
The vaccine group is one of dozen expert panels convened by the FDA to review data or discuss a hot-button