Pfizer/BioNTech COVID-19 shot sails through FDA panel after staffers sing its praises

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An expert panel discussed allergic reactions suffered by two healthcare workers in the U.K. who received Pfizer and BioNTech’s COVID-19 vaccine this week. (FDA)

Pfizer and BioNTech’s COVID-19 vaccine is one step closer to an emergency nod after an expert panel voted in favor of its emergency use Thursday evening.

The Vaccines and Related Biological Products Advisory Committee voted 17-4, with one panel member abstaining, that the benefits of the vaccine outweighed its risks for use in people 16 and older. The outcome was expected given the vaccine's 95% efficacy rate and FDA staffers' rosy outlook on the vaccine in briefing documents published Tuesday.

During their meeting, the panelists raised various concerns about the vaccine, including the relatively small number of trial participants aged 16 or 17 years old. Some panelists wished to exclude this age group from the emergency use authorization, but Ofer Levy, M.D., Ph.D. a physician and principal investigator at Boston Children’s Hospital, said this could throw a wrench in Pfizer’s plans to seek approval for the vaccine in children. Levy voted yes.

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Other panelists disagreed, saying there should be no impact on overall licensure for children by losing emergency use authorization in that age group.

At least one analyst figured concern about that age group could be the reason behind some no votes.

"While 'No' votes were left unexplained, some may have had to do with the '16 years of age and older' wording of the question, as several panelists believed that 16 and 17 year olds should be excluded,” RBC Capital Markets analyst Randall Stanicky wrote in a note to clients Thursday evening.

The panel also discussed allergic reactions suffered by two healthcare workers in the U.K. who received the vaccine this week. U.K. authorities have advised people with a history of significant allergic reactions not to get the vaccine.

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“I’m worried about these severe anaphylactic reactions for this reason: We don’t know the reasons for those two cases, we don’t know what they were allergic to, what their history of allergy was, only that they carried Epi-Pens,” said Paul Offit, M.D., a professor of pediatrics at Children’s Hospital of Philadelphia, who voted yes.

Despite warnings from the U.K.’s Medicines and Healthcare products Regulatory Agency and Operation Warp Speed chief Moncef Slaoui for people with severe allergies to avoid the vaccine, Offit emphasized the need to “drill down on these two people for the cause” of the reactions.

But the current guidelines for practitioners giving vaccines include the ability to handle reactions like anaphylaxis from any vaccine, not just the COVID-19 vaccine, Cody Meissner, M.D., a professor of pediatrics at Tufts University.

Oveta Fuller, Ph.D., an associate professor of microbiology and immunology at the University of Michigan who voted no, was concerned about the novelty of Pfizer and BioNTech’s mRNA vaccine and the relatively short amount of time the patients in the phase 3 trials were followed.

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“There is very little information about what happens to people who get the vaccine and then get exposed to COVID-19,” Fuller said, adding that the patients so far have only been followed for about two months. “We don’t even know what’s going to happen to people in the long term who get these lipid particles and mRNA vaccine. With this limited risk assessment, I think uptake in the community is going to be fairly poor,” she said.