The first monthly safety update by the European Medicines Agency (EMA) on COVID-19 vaccines reports that there are no new adverse events associated with the Pfizer BioNTech vaccine, tozinameran (Comirnaty).
Safety data from EudraVigilance and other sources after the authorisation of Comirnaty were reviewed, including the assessment by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of deaths reported after vaccination with Comirnaty, including deaths in frail, elderly patients. PRAC concluded that the data did not show a link between vaccination with Comirnaty and deaths, and that the cases do not suggest a safety concern.
Anaphylaxis is a known side effect of Comirnaty but assessments of reports of suspected anaphylaxis found no new issues regarding this adverse event and a frequency estimate for Comirnaty-related anaphylaxis in the EU could not be determined.
Comirnaty is authorised in the EU for use in people over 15 years of age. PRAC concluded that based on current data, no amendment to Comirnaty product information is required on its use, including in frail elderly patients. However, PRAC requested that the marketing authorisation holder should continue to review all reports of suspected adverse events with a fatal outcome.
EMA. First COVID-19 vaccine safety update published. Internet Document : 29 Jan 2021. Available from: URL: https://www.ema.europa.eu/en/news/first-covid-19-vaccine-safety-update-published
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Safety update on COVID-19 vaccine Comirnaty finds no new concerns. Reactions Weekly 1842, 3 (2021). https://doi.org/10.1007/s40278-021-90739-8