15-Member Panel Of Scientists, Lawyers And Medical Professions Meet To Discuss Coronavirus Vaccines
PITTSBURGH (KDKA) -- The Vaccine and Related Biological Products Advisory Committee is meeting to discuss coronavirus vaccines.
The 15-member panel consists of experts with various backgrounds.
"From scientists to medical clinicians to lawyers," says AHN Director of Microbiology Kelly Stefano, Ph.D. "It's a group of experts who really have no vested interest, if you will, in making sure that vaccine A gets to market. And this sounds like it was a special convened meeting specifically to talk about what to do for a COVID vaccine."
The panel reviews a wide range of important information.
"I would want to see the data from the vaccine. I would want to see the diversity of the population of people who were enrolled. I would want to know any adverse events or side effects that were observed. And I would like the immunogenicity, so how effective this vaccine was at eliciting an immune response and what they're defining as a good immune response," Dr. Stefano says.
The panelists will also review the recent pauses in research because of safety concerns.
"They are going to want to know what was done to evaluate whether that was related to the vaccine or whether it was related to another cause altogether, a preexisting health condition. Or did they actually contract COVID during this process and it was COVID-related and not vaccine-related," said Dr. Stefano.
One recent concern -- a 28-year-old study participant in Brazil who died of coronavirus. He got a placebo, though.
"The likelihood of anything being contributed in that placebo is very small," says Dr. Stefano. "He was part of the study. So they have to take that seriously."
The panel will also discuss what happens if a vaccine receives emergency use authorization and how that would affect ongoing clinical trials. They'll have to examine the topic of reinfection and how that would influence vaccine development.
Disagreements are inevitable, but as a jury, the goal is to reach a consensus. Dr. Stefano has been listening to the proceedings.
"They're talking about everything. From the actual trials themselves and how far we are and timelines to the public perception of a vaccine and how we improve public perception so that people will want to get the vaccine," Dr. Stefano said.
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"If we have a vaccine available and people don't take it, we won't reach the level of immunity we need to combat COVID effectively," she added.
The committee only advises the FDA. The FDA is not obligated to follow the committee's recommendations, but it usually does.
