COVID-19: US FDA Weighing UK Anaphylactic Reaction Reports For Pfizer Vaccine Labeling
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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No reactions have been observed with Moderna’s COVID vaccine, but none were seen in Pfizer’s trial either; proprietary components may complicate effort to find cause of anaphylactic reactions, but FDA and CDC officials express confidence in surveillance systems, and CBER’s Peter Marks suggests polyethylene glycol may be possible culprit.
Indian regulator is likely to ask Pfizer/BioNTech to conduct clinical trials before granting an accelerated approval, but recruitment could prove challenging for the COVID-19 vaccine as anaphylactic reactions in the US and UK sparks worry.
Sponsor and agency sought to proactively address questions about the potential for anaphylactic reactions with the COVID-19 vaccine given the early real-world experience with Pfizer’s inoculation, which is also uses mRNA technology.