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Anaphylaxis Is Pharmacovigilance Focus As Moderna Vaccine Distribution Begins

 
• By Cathy Kelly

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.

CDC Adverse Event Mitigation Strategy Addresses Anaphylaxis

As distribution of Moderna, Inc.’s COVID-19 vaccine begins, post-authorization pharmacovigilance systems maintained by the US Centers for Disease Control and Prevention will be particularly interested in any potential anaphylaxis reactions.

No such reactions were seen in Moderna’s trial, but none had been observed in the trial of the Pfizer...

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