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Pfizer COVID Vaccine May Be Safe for Limited Approval, FDA Staff Says

Pfizer's COVID-19 vaccine appears to be adequately safe and effective for a limited approval, according to the findings in a review by federal regulators released Tuesday.

The US Food and Drug Administration (FDA) posted a briefing document ahead of the December 10 Vaccines and Related Biological Products Advisory Committee meeting (VRBPAC).

New York-based Pfizer applied on November 20 for an emergency use authorization (EUA) for its vaccine, developed with BioNTech, as reported by Medscape Medical News. The companies want FDA clearance for use of the vaccine for people ages 16 and older, with a proposed regimen of two doses administered 21 days apart.

In their report, FDA staff said that data from research involving about 38,000 participants "suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA" for Pfizer's vaccine.

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