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COVID-19: US FDA Weighing UK Anaphylactic Reaction Reports For Pfizer Vaccine Labeling

 
• By Sue Sutter

Agency could revisit contraindications and warnings regarding allergic reactions and anaphylaxis management depending upon what it hears from the MHRA; FDA and Pfizer say there was no signal for severe allergic reactions in the Phase III trial, but advisory committee member Paul Offit suggests a dedicated study is needed.

Reports of severe allergic reactions with Pfizer's vaccine in the UK may influence US labeling. • Source: Shutterstock

The US Food and Drug Administration could strengthen currently proposed contraindications and warnings for Pfizer Inc./BioNTech SE’s COVID-19 vaccine based upon what it learns from the UK about two reports there of anaphylactic reactions after inoculation in people with a known history of severe allergies.

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