Europe Confirms mRNA Vaccines Can Cause Heart Disease

The European Medicine Agency (EMA) announced on July 9, 2021, it had concluded that myocarditis and pericarditis could occur in very rare cases following vaccination with the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna).

The EMA's Committee concluded that the cases primarily occurred within 14 days after vaccination, more often after the second dose, and in younger adult men.

At this point in time, the EMA says there is no causal relationship with heart disease and the other COVID-19 vaccines Authorized in Europe, COVID-19 Vaccine Janssen and Vaxzevria,

Therefore, the EMA's vaccine committee recommends listing myocarditis and pericarditis as new side effects in the product information for these vaccines. As of May 2021, around 177 million doses of Comirnaty and 20 million doses of Spikevax had been given in Europe.

Furthermore, the EMA is raising this health risk awareness among healthcare professionals and people taking these vaccines. Myocarditis and pericarditis are heart inflammatory conditions. Symptoms can vary but often include breathlessness, a forceful heartbeat that may be irregular, and chest pain.

In reaching its conclusion, the Committee took into consideration all currently available evidence.

The EMA's analysis included an in-depth review of 145 cases of myocarditis in the European Economic Area (EEA) among people who received Comirnaty and 19 cases among people who received Spikevax. The committee also reviewed reports of 138 cases of pericarditis following the use of Comirnaty and 19 cases following the Spikevax vaccination.

Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Furthermore, they should consult applicable guidance and/or consult specialists (e.g., cardiologists) to diagnose and treat these conditions.

The 'EMA confirms that the benefits of all authorized COVID-19 vaccines continue to outweigh their risks, given the risk of COVID-19 illness and related complications. In addition, as scientific evidence shows, they reduce deaths and hospitalizations due to COVID-19.'

'As for all vaccines, the EMA will continue to monitor the vaccines’ safety and effectiveness and provide the public with the latest information, particularly as more adolescents and young adults are vaccinated and more second doses are given.'

This vaccine review was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. The PRAC’s recommendations will be submitted to EMA’s human medicine committee for endorsement.

Note: The United Kingdom Medicines & Healthcare Regulatory Agency announced similar concerns on July 9, 2021.