The Food and Drug Administration released an analysis by Pfizer on the need for a booster shot of the Pfizer-BioNTech COVID-19 vaccine.
Pfizer’s analysis says data from Israel and the United States in the context of the delta variant suggests “that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.”
The company said the available data supports its request for FDA approval of a third dose of the COVID-19 vaccine to be given about six months after the second dose in people 16 years and older.
The agency posted the briefing document and data ahead of a public advisory committee meeting scheduled for Friday. The committee is the same one that voted in support of emergency authorization of the Pfizer-BioNTech vaccine in December.
In an unusual wrinkle, the FDA’s analysis, which would shed light on the agency’s stance, wasn’t released simultaneously. Typically the agency posts its own briefing document at the same time as a company’s.