The FDA will add a myocarditis warning on information sheets for Pfizer and Moderna vaccines

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Carlos Laforet Coll
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The US has found a link between vaccines and myocarditis cases in young people, but claims the benefits outweigh the risks

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News comes from the United States on mRNA vaccines against Covid-19. The FDA will add a warning about cardiac inflammation or myocarditis, on the Pfizer and Moderna package insert.





The United States has found a link between vaccines and myocarditis cases in young people, but argues that the benefits outweigh the risks. Advisory groups from the US Centers for Disease Control and Prevention (CDC) recently met to discuss reported cases of myocarditis and found that it is likely vaccine-related in adolescents and young people up to 16 years of age.

More than 177 million people have received at least one dose of the COVID-19 vaccine in the United States, and CDC continues to monitor the safety of COVID-19 vaccines for any health problems that occur after vaccination. Since April 2021, there have been more than a thousand reports to the Vaccine Adverse Event Reporting System (VAERS) of cases of heart inflammation - called myocarditis and pericarditis - occurring after COVID-19 mRNA vaccination (i.e. Pfizer-BioNTech, Moderna). in the United States, explains the CDC.

According to US doctors, these correlations can be considered rare given the hundreds of millions of vaccine doses administered:

CDC and its partners are actively monitoring these reports, reviewing data and medical records, to learn more about what happened and to understand any relationship to COVID-19 vaccination, he continues.

For this, the FDA will add a warning related to myocarditis on the package inserts of the two mRNA vaccines used against Covid.

According to the CDC,

the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis. In addition, most of the myocarditis and pericarditis patients who received treatment responded well to treatment and rest and quickly felt better.


What are the symptoms of myocarditis / pericarditis to report to my doctor after mRNA vaccination?


Are the following:

  • chest pain
  • Shortness of breath
  • tachycardia.

The facts are clear: this is an extremely rare side effect, and only an extremely small number of people will experience it after vaccination. Importantly, for young people who do, most cases are mild and individuals often recover on their own or with minimal treatment. Furthermore, we know that myocarditis and pericarditis are much more common if you contract COVID-19 and the risks to the heart from COVID-19 infection can be more serious.

added doctors, nurses and public health leaders along with the Department of Health and Human Services (HHS).

There is therefore no stop to mRNA vaccines for these age groups.

Sources of reference: CDC, HHS, The Guardian

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