US FDA vaccine advisers reject Pfizer's request to add booster dose of its COVID-19 vaccine, but may vote again

Some of the advisers -- a group of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts -- have said the process was rushed because of that target date.

"It is very important that the main message that we still transmit is that we have got to get everyone two doses. Everyone has got the get the primary series. This booster dose is not likely to make a big difference in the behavior of this pandemic." The company relied heavily on data from Israel, where vaccinated people started to get breakthrough infections. Israeli researchers earlier told the meeting that adding booster shots in Israel helped keep many people out of the hospital.

"One of the issues in this is that much of the data that's been presented and being discussed today is not peer-reviewed and has not been reviewed by FDA," Krause told the meeting of the Vaccines and Related Biological Products Advisory Committee. "It's a little disappointing that there's been very little reporting of the cellular immune responses and an entire focus on the neutralizing antisera," Kurilla said."Which clearly for that population at high risk is absolutely essential, but for the broad population in terms of their protection, which seems to be holding up well over time -- should be because of adequate cellular immune responses but we have no indication of that.

The FDA noted in its briefing documents that Pfizer's vaccine -- as well as vaccines made by Moderna and Johnson & Johnson -- still provide strong protection against severe disease, hospitalization and death, even if antibodies do wane over time.

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