Pfizer Inc. said it has asked U.S. regulators for clearance of an additional COVID-19 booster shot for seniors, in a bid to protect vulnerable adults as immunity provided by the first three doses wanes.
The New York-based drugmaker and its German partner BioNTech SE said Tuesday that they have sought an emergency-use authorization from the Food and Drug Administration for a second booster of their vaccine, Comirnaty, for people 65 and older who have already received a booster of any of the authorized COVID-19 vaccines.
Pfizer and BioNTech said they submitted data to the FDA from Israel, which began offering a fourth shot to older people and health care workers last year as the omicron variant was circulating. The real-world data showed a fourth shot given at least four months after the third reduced the rate of infection and severe illness compared with those who were given just one booster shot, according to an analysis of Israeli Ministry of Health records for over 1.1 million adults 60 and older with no known history of coronavirus infection.