(Reuters) – Pfizer Inc said that U.S. regulators should approve a third booster dose of the COVID-19 vaccine it developed with Germany’s BioNTech SA due to waning effectiveness of the shot over time, according to documents the drugmaker submitted to the U.S. Food and Drug Administration.
Pfizer said the totality of the available data supports the public health need for a third dose of the shot in individuals 16 years of age and older about six months after they received their second dose.
The FDA released the documents on Wednesday ahead of a meeting by an outside panel of experts on Friday to vote on whether or not to recommend U.S regulators approve the extra shots. The FDA has not yet published the briefing with its view on the issue.
(Reporting by Michael Erman; Editing by Chizu Nomiyama)
