Anaphylaxis Is Pharmacovigilance Focus As Moderna Vaccine Distribution Begins
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.
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Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.
CBER Director Peter Marks said the VRBPAC may need to opine on the immunogenicity data gathered for vaccine updates.
US FDA’s global first for Moderna’s vaccine gets a small mention as agency looks to pharmacovigilance, follow-up studies for both coronavirus inoculations that have now been authorized. Moderna's 18 December EUA comes after an even faster review than for Pfizer/BioNTech's vaccine.