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

Executive Summary

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.

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