Europe Confirms Low-Risk of Myocarditis or Pericarditis Following mRNA Vaccination
The European Medicine Agency safety committee (PRAC) reviewed new data on the known risk of myocarditis and pericarditis following vaccination with the Comirnaty and Spikevax vaccines.
These heart conditions can develop within just a few days after mRNA vaccination and have primarily occurred within 14 days. And they have more often been observed after the second vaccination in young men.
This PRAC review included two extensive European epidemiological studies.
One study was conducted using data from the French national health system, and the other was based on Nordic registry data.
Based on the reviewed data, the PRAC has determined that the risk for both conditions is overall “very rare.”
This finding means that up to one in 10,000 vaccinated people may be affected.
The EMA reconfirmed on December 3, 2021, that the benefits of all authorized COVID-19 vaccines continue to outweigh their risks, given the chance of COVID-19 illness and related complications, and as scientific evidence shows, that they reduce deaths and hospitalizations due to COVID-19.
The EMA is a decentralized agency of the European Union (EU) based in The Netherlands governed by an independent Management Board responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.