CDC ‘Threading A Needle’ On COVID Vaccine Contraindication Guidance After ACIP Vote
Executive Summary
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.
You may also be interested in...
COVID Vaccine Authorization Changes Without Advisory Committee Becoming More Common
Decision to allow boosters for 12- to 15-year-old recipients of the Pfizer/BioNTech vaccine will go before CDC's ACIP, but like several other recent changes for COVID vaccines, the US FDA opted to skip its advisory committee.
Statin Label Change May Signal Broader US FDA Shift On Drug Use During Pregnancy
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.
Pfizer/BioNTech COVID-19 Vaccine's Positive Advisory Committee Complicated By Pediatric Issues
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.