Europe Investigates Heart Risks Related to mRNA Vaccines

The European Medicines Agency (EMA) announced today the Pharmacovigilance Risk Assessment Committee (PRAC) is assessing further data and information on the risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna).

The PRAC has now asked the companies that market these vaccines to perform an in-depth review of all published data on the association of myocarditis and pericarditis, including clinical trial data, data from the literature, and data available in the public domain.

The PRAC had previously reviewed cases of myocarditis and pericarditis spontaneously reported in the European Economic Area.

The review concluded in July 2021 with a recommendation to list both heart conditions as side effects in the product information for these COVID-19 vaccines, together with a warning to raise awareness among healthcare professionals and people getting these vaccines.

The EMA stated in a press release 'it will continue to monitor the vaccines' safety and effectiveness and will communicate further when new information becomes available.'

The U.S. Food and Drug Administration staff and vaccine advisory committee recently reviewed mRNA COVID-19 Vaccine-Associated Myocarditis data presented by Matthew Oster, MD, MPH, on October 26, 2021.

Previously, the U.S. CDC vaccine advisory committee reviewed 'Myocarditis Analyses in the Vaccine Safety Datalink: Rapid Cycle Analyses and "Head-to-Head" Product Comparisons,' presented by Nicola Klein, MD, Ph.D., on October 22, 2021.

The CDC clinical considerations say, 'Since April 2021, increased cases of myocarditis and pericarditis have been reported in the U.S. after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna), particularly in adolescents and young adults.'  

Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the lining outside the heart. 

In both cases, the body's immune system is causing inflammation in response to an infection or some other trigger.

Symptoms can include chest pain, shortness of breath, or palpitations. The severity of cases of myocarditis and pericarditis can vary.

According to the CDC, for the cases reported after mRNA COVID-19 vaccination, most who presented to medical care have responded well to medications and rest.