Statement on Myocarditis and Pericarditis

October 7, 2021 at 11:00 AM EDT

Moderna is aware of the decision of Health Authorities in Sweden and Finland to pause the vaccination of individuals under the age of 30.
 
At Moderna, the safety of the people who use our products is paramount. We are committed to helping to end the ongoing COVID-19 pandemic, that to date has affected millions of people around the world, and claimed the lives of over 4 million of them. 
 
Moderna is aware of the very rare occurrence of myocarditis and/or pericarditis following administration of mRNA vaccines against COVID-19. These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest. The risk of myocarditis is substantially increased for those who contract COVID-19, and vaccination is the best way to protect against this. A recent large analysis of 6.2 million people from the US Vaccine Safety Datalink (VSD) following mRNA COVID-19 vaccination did not identify an increased safety signal for either mRNA vaccine. Similarly, a study of over 2.3 million individuals conducted in the Kaiser Permanente network identified 15 cases of myocarditis in individuals receiving a mRNA vaccine, for an observed incidence of 5.8 cases per million people following the second dose of vaccine.
 
The Moderna COVID-19 Vaccine (Spikevax) has demonstrated substantial benefit. The protection afforded by the Moderna COVID-19 vaccine is highly robust and has been confirmed in the real-world setting as well as large, randomized trials including the Phase 3 COVE study. We continue to closely monitor the safety of all our products, both in clinical practice and in clinical trials.