CDC ‘Threading A Needle’ On COVID Vaccine Contraindication Guidance After ACIP Vote
Allergic contraindication, use in pregnancy to be addressed in CDC guidance. Advisory committee urges language be modified to clarify that those with severe food and environmental allergies may receive the vaccine. At press briefing after FDA grants emergency use authorization to Pfizer/BioNTech’s COVID vaccine for persons in the US 16 years of age and older, CBER's Peter Marks addresses the 'foolhardy' conjecture that one dose is adequate.
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Agency is removing warning contraindicating use of statins during pregnancy; the move comes after FDA has permitted COVID-19 vaccination of pregnant women and amidst push for their enrollment in clinical trials.
US FDA expected to quickly clear the first emergency use authorization for a COVID-19 vaccine following 17-4 VRBPAC vote, but a disorganized committee ending made it unclear why some members voted no. Pediatric data was at issue for at least two voters, though.
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.