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FDA Likely to Report Pfizer-BioNTech COVID-19 Vaccine is Safe and Effective, Push to EUA

December 8, 2020

Via: BioSpace

As Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, starts to begin distribution in the UK, scientists from the U.S. Food and Drug Administration ((FDA) have released company data ahead of this week’s advisory committee review appearing to confirm the vaccine’s safety and efficacy. The FDA’s endorsement of the vaccine’s effectiveness and safety represents a crucial step toward distributing the vaccine across the U.S.

The document prepared and released by FDA staff indicates scientists from the agency plan to tell the advisory committee on Thursday that the available clinical trial data are adequate to support its safe and effective use in public immunization programs.

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