EMA had released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified.
Summary points:
- The latest safety data for this vaccine are in line with the known side effect profile, and the related reviews are presented in this update.
- Reports of suspected severe allergic reaction have not identified new aspects regarding the nature of this known side effect.
- No specific safety concern has been identified for vaccine use in frail elderly individuals.
- The benefits of Comirnaty in preventing COVID-19 continue to outweigh any risks, and there are no recommended changes regarding the use the vaccine.
- PRAC noted that a recent analysis in the United States estimated the frequency of anaphylaxis as approximately 11 cases per million doses of Comirnaty administered
- Given concerns which arose from Norway about deaths reported in frail elderly individuals after vaccination with Comirnaty, PRAC reviewed the current reports of suspected side effects with fatal outcome in individuals of any age. This review did not suggest a safety concern. In many cases concerning individuals above 65 years of age, progression of (multiple) pre-existing diseases seemed to be a plausible explanation for death. In some individuals, palliative care had already been initiated before vaccination.
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