Pfizer finds out vax fate today
FDA committee voting on use includes Hub docs
An independent advisory committee convened by the FDA, which includes three of Boston’s top doctors, may grant Pfizer’s coronavirus vaccine emergency use authorization today in a historic move that could change the course of the pandemic.
“The big overall question is the question of risk versus benefit — how high is the risk of the vaccine from the data that we have and how much benefit the people who get the vaccine are likely to derive from it,” said Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and professor at the Harvard T.H. Chan School of Public Health.
Rubin is a temporary voting member on the Vaccines and Related Biological Products Advisory Committee, the independent, highly vetted, diverse group of scholars charged with deciding if the vaccine will be granted emergency use authorization. It’s his first time on the panel.
“I’m super excited. I feel really privileged to be able to do it,” Rubin said.
Rubin said he expects today’s meeting will largely explore the small details in the data and the risks.
Rubin is one of three Boston doctors on the committee. Dr. H. Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, and Dr. Ofer Levy, director of the Precision Vaccines program at Boston Children’s Hospital, are also voting members.
“People are dying in record numbers of coronavirus, we need an answer to that,” said Levy, who has served as a member of VRBPAC in the past.
He said he will enter today’s meeting with an open mind, intent on listening and learning.
“It’s exciting but it’s also a weight of responsibility,” Levy said. “It’s not lost on me how serious what we are doing is and I also trust the process.”
Transparency in the vaccine process is key, both Levy and Rubin said, noting that the Food and Drug Administration briefings and meeting are available to the public.
The virtual meeting, which is open to the public, will start at 9 a.m. and will include a presentation on emergency use authorization, epidemiology, safety and efficacy, public comment and a presentation from Pfizer officials. Members will begin the voting process at 3 p.m., according to the agenda.
Both Levy and Rubin said a lot of unknowns remain about the vaccine such as its effect on pregnant women, children and coronavirus transmission. However, more answers will surface as it is rolled out.