The European Medicines Agency has published a communication to healthcare professionals (DHPC) containing important information for healthcare workers who prescribe, dispense or administer the mRNA COVID-19 vaccines Comirnaty and Spikevax (Moderna).
Dear healthcare professional!
BIONTECH/PFIZER and MODERNA BIOTECH SPAIN, S.L., in agreement with the European Medicines Agency (EMA) and [the National Competent Authority], inform you of the following:
Summary
- Rare cases of myocarditis and pericarditis were reported after immunization with the mRNA COVID-19 vaccines Comirnaty and Spikevax (Moderna).
- The cases were mainly recorded within 14 days after vaccination, more often after the second dose among young men.
- Available data indicate that the clinical manifestations of myocarditis and pericarditis after vaccination are similar to their manifestations in general.
- Healthcare professionals should pay attention to the signs and symptoms of myocarditis and pericarditis.
- Healthcare professionals should advise vaccinated persons to seek medical attention immediately if they experience chest pain, shortness of breath or tachycardia.
Information on a safety issue
mRNA vaccines against COVID-19, Comirnaty and Spikevax (Moderna), were approved in the EU for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus in persons aged 12 years and older (Comirnaty) and aged 18 years and older (Spikevax (Moderna)), respectively.
Cases of myocarditis and pericarditis associated with mRNA COVID-19 vaccines have been reported.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) analyzed all available data and concluded that a causal relationship between the use of COVID-19 mRNA vaccines and the occurrence of myocarditis and pericarditis is at least a reasonable possibility. The instructions for medical use of these vaccines must be updated accordingly in the sections “Special warnings and precautions for use” and “Adverse reactions”.
The benefit of vaccination continues to outweigh any risks.
As of 31 May 2021, in the European Economic Area there were 145 cases of myocarditis among people vaccinated with Comirnaty and 19 cases with Spikevax (Moderna). In addition, there were 138 cases of pericarditis after the use of Comirnaty and 19 cases with Spikevax (Moderna).
According to estimates, as of 31 May 2021, about 177 million doses of Comirnaty and 20 million doses of Spikevax (Moderna) had been administered in the European Economic Area.
The full text of the communication to healthcare professionals on the safety of the use of mRNA COVID-19 Vaccines Comirnaty and Spikevax (Moderna) can be found at the corresponding linkhttps://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-covid-19-mrna-vaccines-comirnaty-spikevax-risk_en.pdf
