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Europe Confirms COVID-19 Vaccine Side Effects

May 13, 2022 • 3:33 am CDT
European Medicines Agency
(Precision Vaccinations)

The European Medicines Agency (EMA) recently confirmed the safety of COVID-19 vaccines authorized in the European Union (EU). More than 870 million doses of vaccines have been given to people in the EU and European Economic Area (EEA) as of late April 2022.

The pharmacovigilance plan for COVID-19 vaccines includes monthly summary safety reports (MSSRs), which the marketing authorization holders compile to support timely and continuous benefit-risk evaluations for COVID-19 vaccines.

Collecting reports of medical events and problems that occur following the use of a medicine, and therefore might be side effects, is one of the pillars of the EU safety monitoring system.

As of May 12, 2022, the EMA's MSSR reported data as of April 24, 2022:

  • Comirnaty: About 600 million doses of Comirnaty in adults and about 27 million doses of Comirnaty in people below 18 years of age were administered in the EU/EEA; 743,735 cases of suspected side effects were spontaneously reported from EU/EEA countries; 7,765 of these reported a fatal outcome.
  • SpikeVax: About 153 million doses of Spikevax in adults and about 1.9 million doses of Spikevax in people below 18 years of age; 206,920 cases of suspected side effects were spontaneously reported from EU/EEA countries; 1,025 of these reported a fatal outcome.
  • Vaxzevria: About 69 million doses of Vaxzevria in adults were administered in the EU/EEA; 276,697 cases of suspected side effects were spontaneously reported from EU/EEA countries; 1,529 of these reported a fatal outcome.
  • Jcovden: About 19.4 million doses of Jcovden (Janssen/J&J) in adults were administered in the EU/EEA; 48,410 cases of suspected side effects were spontaneously reported from EU/EEA countries; 311 of these reported a fatal outcome.
  • Nuvaxovid: About 178,000 doses of Nuvaxovid (Novavax) in adults were administered in the EU/EEA from authorization; 294 cases of suspected side effects were spontaneously reported from EU/EEA countries; none of these reported a fatal outcome.

The EMA’s detailed assessments consider all available data, including clinical trial results, reports of suspected side effects, epidemiological studies monitoring the vaccine's safety, toxicological investigations, and other relevant information.

These spontaneous reports are collected in EudraVigilance, the EU database used for monitoring and analyzing suspected side effects. In addition, publicly available information can be accessed via EudraVigilance, a European database of suspected drug reaction reports.

Note: The EMA report was manually edited for clarity and curated for mobile readership.

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