Friday, September 24, 2021

FDA vaccines advisers recommend booster doses for people 65 and older and those at high risk

FDA vaccine advisers voted Friday to recommend emergency use authorization of a booster dose of Pfizer's vaccine for people 65 and older and those at high risk of severe Covid-19, six months after they get their first two shots.

 

But the FDA's Vaccines and Related Biological Products Advisory Committee rejected a broader application to approve booster doses of Pfizer's vaccines for everyone 16 and older, six months after they are fully vaccinated.

 

Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long-term efficacy of a booster dose.

 

Biden administration officials had previously announced a plan to begin administering booster doses to the general population this week, irritating some members of the committee. However, they had noted that any action would be pending sign off from the FDA and US Centers for Disease Control and Prevention.

 

Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University, noted Friday that the lively discussion and adjustments during the meeting proved committee members are truly independent advisers.

 

"I think this should demonstrate to the public that the members of this committee are independent of the FDA, and that in fact we do bring our voices to the table when we are asked to serve on this committee," she said.

 

The FDA will now make its decision on Pfizer's request, taking into account the committee's recommendation.

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