Pfizer (NYSE:PFE) says that the COVID-19 vaccine developed with its partner BioNTech (NASDAQ:BNTX) should be approved as a third shot given the diminishing effectiveness of the vaccine over time, according to company documents released by the FDA ahead of a meeting of an expert panel on Friday.
On Sept. 17, an advisory committee of the federal agency is set to decide whether to recommend the Pfizer (PFE)/BioNTech (BNTX) booster shot as the U.S. prepares for a wider rollout of COVID-19 boosters next week.
Pfizer (PFE) presented results from its own clinical trials and real-world data from the U.S. and Israel to support its view over the waning effectiveness of the vaccine.
The company is seeking the licensure of the additional dose in those aged 16 years and above, approximately six months after the second dose of the two-dose regimen, which has already been granted the full FDA approval.