Pfizer Reportedly Set To Request Authorization For Second Covid Booster Shot For Seniors
Topline
Pfizer-BioNTech might file a request as quickly as Tuesday for emergency authorization for a second Covid booster shot for individuals 65 and older, an age group for which the U.S. Meals and Drug Administration has often been fast to approve new vaccine pictures, the Washington Put up reported Tuesday citing unnamed sources.
A resident at The Palace, an impartial dwelling group for seniors, at Coral Gables in Miami, … [+]
Eva Marie Uzcategui Trinkl/Anadolu Company through Getty Photographs
Key Information
Pfizer’s utility to the FDA is anticipated to incorporate knowledge from real-world research in Israel, the place a second booster shot has already been licensed for older people, three unnamed sources advised the Washington Put up.
The FDA might assess Pfizer’s utility shortly, notably if the company determines the information supporting the applying is simple, the Washington Put up reported.
Senior residents are already essentially the most vaccinated and most boosted age group within the U.S.— 95% of individuals 65 and older have acquired no less than one Covid shot in comparison with 76.7% of the overall inhabitants, and 88.9% have been totally vaccinated in comparison with 65.3% of the overall inhabitants, whereas 66.8% had acquired a booster dose in comparison with 44.3% of the overall inhabitants, in line with knowledge from the U.S. Facilities for Illness Management and Prevention.
Pfizer didn’t instantly reply to a request for remark.
Key Background
When deciding whether or not to subject an authorization, the FDA should assess what the out there scientific proof signifies concerning the recognized or potential dangers and advantages of a vaccine dose to a specific group. The FDA has beforehand been fast to approve Covid vaccine doses for older individuals, who’re typically at higher risk of extreme Covid signs. September 17, the company’s vaccine advisory panel voted strongly towards authorizing Pfizer’s first booster shot for all individuals 16 and up, however voted unanimously to suggest a primary booster dose for individuals 65 and up, in addition to individuals “at excessive danger of extreme Covid-19” and a few individuals whose jobs might expose them to Covid. September 22, the FDA authorized a Pfizer booster dose for all individuals 65 and older and to youthful individuals at excessive danger of extreme Covid. The company didn’t expand eligibility for Pfizer’s booster to all individuals 16 and over till December 9. March 10, Pfizer CEO Albert Bourla told the Washington Put up that the omicron variant had severely eroded the safety provided by a two-dose vaccination, and {that a} second booster shot will in all probability finally be crucial for everybody.
Additional Studying
“FDA Advisory Panel Recommends Towards Pfizer Covid Boosters—Besides For Folks Over 65” (Forbes)
