Pfizer’s analysis says data from Israel and the United States in the context of the delta variant “suggest that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.”
The company says the available data support its request for FDA approval of a third dose of COVID 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 Friday. The committee is the same one that voted in support of emergency authorization of the Pfizer-BioNTech vaccine last 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.
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