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

11 Dec 2020

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.

At a 10 December meeting of the Vaccines and Related Biological Products Advisory Committee, Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, said the agency and Pfizer have been working for weeks on labeling and fact

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