Late this afternoon, the FDA Vaccines and Related Biological Products Advisory Committee voted to approve the Pfizer and Biotech COVID-19 vaccine. The committee voted 17 in favor, 4 against, and 1 abstention on approving the vaccine. Despite not being unanimous, most of the negative votes came from those concerned about the lack of data on 16- and 17-year-old trial subjects. There was no argument about the efficacy or safety of the vaccine in adults over the age of 18.
Several subgroups of individuals, including pregnant women and young children, will likely have to wait to get the vaccine in the U.S. until Pfizer can finish trials on those individuals. The FDA said Tuesday that there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women, and people with compromised immune systems.
The Pfizer clinical trial was published today in the New England Journal, where peer review validated the overwhelming efficacy and safety conclusions.
There were no patient limitations for the vaccine, although (as in the clinical trial) people with specific allergic reactions to vaccines were excluded from receiving the vaccine.
Fallout from the UK statements on potential allergic reactions did get attention at the meeting. (note, there was no further clarity from the regulators in the UK about the two adverse reactions they raised concerns about).
Dr. Paul Offit, Director of the Vaccine Education Center at Children’s Hospital of Philadelphia, one of the panel members and a distinguished vaccine researcher in the U.S., said he feared that statements by British regulators could lead “tens of millions” of people with severe allergies to reject the vaccine even though evidence of a link to the shots was totally unclear. He asked Pfizer to conduct a separate study of people with a history of severe allergies, because “this issue is not going to die until we have better data.”
He said he is not personally concerned about the safety of the vaccine and supports authorization, but wants the companies to run a separate study of people with egg or peanut allergies to reassure them that the vaccine is safe.
Dr. Offitt also pointed out that it will be difficult for people with severe allergies to know if they are allergic to the ingredients in the vaccine. People who are allergic to any of its ingredients have been told to avoid vaccination, he said, but “if you look at the components of that vaccine, which has probably the longest chemical name of any vaccine I’ve ever seen, nobody’s going to look at that name and say, ‘I’m allergic to that.’” Again, there are no known allergens or proteins in the vaccine that would cause specific concerns for individuals with food, drug, or environmental allergies.
Dr. Arnold Monto, the committee’s chair and an epidemiologist at the University of Michigan’s School of Public Health, agreed that more information on allergic reactions is warranted.
“Facts may be important, but perception drives a lot of decisions,” he said.
Pfizer officials reiterated that there were no cases of serious allergic reactions in the trial of 44,000 participants. People with a history of allergic reactions to vaccines (but not foods or drugs) were excluded from the study.
We will likely have full FDA approval in a day or so, and vaccinations should begin within a week. On a day when over 3,000 people in the U.S.A. died of COVID-19, this was very good news.