Sept. 15 Reuters - Pfizer Inc. said that U.S. regulators should approve a third booster dose of COVID - 19 vaccine it developed with the BioNTech SA in Germany 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 available data supports the public health need for a third dose of the shot in individuals 16 years old and older about six months after receiving their second dose.
The FDA released the documents on Wednesday ahead of a meeting on Friday by an additional panel of experts to vote on whether or not to recommend the U.S. regulators approve the extra shots. The FDA has yet published the briefing with its view on the matter.