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Thursday, October 28, 2021

FDA Doesn’t Stand With A Broader Rollout Of Pfizer Booster Shot

A Food and Drug Administration advisory panel voted unanimously on Friday in favor of a booster dose of the Pfizer-BioNTech Covid-19 vaccine for people 65 and older and for individuals at higher risk of serious disease, with the shot given at least six months after their initial vaccination.

FDA Doesn’t Stand With A Broader Rollout Of Pfizer Booster Shot

The vote followed an unexpected 16-2 vote by the independent committee against advising the Agency to approve boosters after hours of discussion for any 16 or older person. Members’ concerns focused on the quantity and quality of available data to weigh the long-term effectiveness of the booster and its safety for young people.

FDA Doesn't Stand With A Broader Rollout Of Pfizer Booster Shot

Next week, a separate panel of DCCs will discuss the parameters for the administration of the booster, which will likely include defining who describes the booster as a “high risk.” This could include individuals who have underlying conditions of health such as obesity and groups such as the health workers who are exposed to Covid-19 during their work. The FDA panel took an unofficial stroke poll for the latter group Friday.

The votes of the FDA panel, while not binding, form an unexpected barrier to the government’s plan that the boosters will begin to be widely administered early this coming week. However, under an emergency use authorization, the FDA Advisory Panel opted to accept a much narrower use, a bar below that which Pfizer wanted.

“I believe that this should demonstrate to the public that its members are FDA-independent,” says Archana Chatterjee of Rosalind Franklin University, a specialist in pediatric infectious diseases.

Pfizer Head of Research and Development, Vaccines Kathrin Jansen said in a statement that the firm “is going to work with the FDA following today’s meeting to deal with the questions of the committee since we remain confident that a booster dose for the larger population is beneficial.”

The FDA panel was part of a heated discussion of whether the evidence supports the broader booster vision of the administration. FDA scientists and external scientists discussed this. These worries appeared early on during the day-long panel meeting when speakers and committee members were unsure whether there was any obvious evidence that boosters benefit both young and older populations with weaker immune systems. 

“I will probably agree to the three-dose recommendation for those over 60 or 65,” said Paul Offit of Philadelphia Children’s Hospital, saying “I really have difficulty supporting this as written to anyone over or above 16.”

Others concentrated on the obvious lack of data on young people’s safety, particularly 16- and 17-year-olds.

Peter Marks, the leading regulator for FDA vaccines, asked members of the committee to review the “Total evidence to make your recommendation to us,” including Israel evidence that booster doses have reduced Covid’s risk of serious infections in his older population.

“The FDA decision is based on complex data that evolves before our eyes,” he said. “Different views exist. In order to aid regulatory determination, differences of opinion are critical”.

The vaccine efficacy against Covid infections and mild disease has fallen in recent months, Sara Olive, a doctor with the CDC’s National Center for Immunization and Respiratory Diseases said. But the disease and hospitalization remain high.

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