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EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.
According to a July 9, 2021 press release, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax (Pfizer/BioNTech and Moderna vaccines, respectively).
PRAC considered all currently available evidence in reaching its conclusion, which included an in-depth review of 145 cases of myocarditis in the European Economic Area in people who had received Comirnaty and 19 cases in people who had received Spikevax. Additionally, the committee reviewed 138 cases of pericarditis in people who had received Comirnaty and 19 cases in those who had received Spikevax.
As a result of its review, PRAC has recommended that myocarditis and pericarditis are listed in the product information for both vaccines as new side effects. Furthermore, a warning should be included in the product information to raise awareness to healthcare professionals and patients to the risks of the potential side effects.
EMA confirmed that the benefits of all COVID-19 vaccines authorized for use in the European Union continue to outweigh the risks, but it will continue to monitor safety and effectiveness of the vaccines. Any new safety concerns will be communicated to the public and will be tackled via the necessary actions by the regulatory agency.