Warning about possible risk of myocarditis/pericarditis with mRNA vaccines


The European Medicines Agency's Safety Committee 

On 9 July 2021, the Pharmacovigilance Risk Assessment Committee (PRAC), of the European Medicines Agency (EMA), concluded that myocarditis and pericarditis can occur in very rare instances after administration of the Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) COVID-19 vaccines. The Committee is therefore recommending that myocarditis and pericarditis be incorporated as new side effect of these vaccines, along with a warning to raise awareness among health professionals and people receiving these vaccines.

The Committee reached this conclusion after reviewing 321 cases that occurred in the European Economic Area (EEA, consisting of the European Union countries plus Iceland, Liechtenstein, and Norway), involving 145 cases of myocarditis and 138 cases of pericarditis in people who received the Comirnaty vaccine, in addition to 19 cases of myocarditis and 19 of pericarditis in people who received the Spikevax vaccine. As of 31 May 2021, approximately 177 million doses of Comirnaty and 20 million doses of Spikevax had been administered in the EEA. The Committee also reviewed information on cases reported in the rest of the world.

PRAC concluded that most of the cases occurred within 14 days of vaccination, most often in young men, after the second dose. In five of the cases that occurred in the EEA, subsequent deaths were reported; these occurred in individuals who were elderly or who had concomitant diseases. 

The Committee is recommending that healthcare professionals be alert to the signs and symptoms of myocarditis and pericarditis in individuals who received mRNA vaccines, and that people receiving these vaccines be told to seek immediate medical attention if they experience symptoms indicative of myocarditis or pericarditis, such as shortness of breath, an unusually strong and sometimes irregular heartbeat, and chest pain.

The EMA confirms that the benefits of all licensed COVID-19 vaccines outweigh the risks of contracting COVID-19 and the associated complications.

Source: https://www.ema.europa.eu/en/news/comirnaty-spikevax-possible-link-very-rare-cases-myocarditispericarditis    


 COVID-19 subcommittee of the Global Advisory Committee on Vaccine Safety (GACVS) 

On 9 July 2021, WHO published an update to the guidance issued by the COVID-19 subcommittee of WHO’s Global Advisory Committee on Vaccine Safety (GACVS). After reviewing all information available to date, including actions taken by the United States FDA and the EMA, it notes the following: 

  • The benefits of mRNA COVID-19 vaccines in reducing hospitalizations and deaths from COVID-19 infections outweigh the risks.
  • Very rare cases of myocarditis and pericarditis have been reported after administration of mRNA COVID-19 vaccines; these occurred more frequently in young men, after the second dose of the vaccine, usually within a few days after vaccination. Current evidence suggests a probable causal association between myocarditis and the mRNA vaccines.
  • Available data suggest that cases of myocarditis and pericarditis after vaccination are generally mild and respond to conservative treatment (e.g., rest, treatment with non-steroidal anti-inflammatory drugs, etc.).

Monitoring is being carried out to determine the long-term outcomes.

The GACVS subcommittee will continue to review this signal as more data become available.

Source: https://www.who.int/news/item/09-07-2021-gacvs-guidance-myocarditis-pericarditis-covid-19-mrna-vaccines      

 U.S. Food and Drug Administration

On 25 June 2021, the U.S. Food and Drug Administration (FDA) announced that, having reviewed the existing information and taken into account the discussion at the meeting of the Advisory Committee on Immunization Practices, of the Centers for Disease Control and Prevention (CDC), it decided to include in the Moderna and Pfizer-BioNTech COVID-19 vaccine fact sheets a warning concerning the possible increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.

The warning in the fact sheets for health professionals will indicate that reports of adverse event suggest that there is an increased risk of myocarditis and pericarditis, particularly after the second dose, with the onset of symptoms occurring a few days after vaccination. The fact sheets for the general population will emphasize that people who receive these vaccines should seek immediate medical attention if they experience chest pain, shortness of breath, or heart palpitations following vaccination. 

Source: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021   

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