Since April 2021, increased cases of myocarditis and pericarditis have been reported in the United States after mRNA Covid-19 vaccination (Pfizer-BioNTech and Moderna), particularly in adolescents and young adults. There has NOT been a similar reporting pattern observed after receipt of the Johnson & Johnson vaccine.
On June 23, 2021, ACIP met to review reported cases of myocarditis or pericarditis in mRNA COVID-19 vaccine (Pfizer-BioNTech and Moderna) recipients. Cases of myocarditis or pericarditis have occurred predominantly in males aged 12-29 years, with symptoms typically developing within a few days after receipt of the second dose of vaccine.
ACIP reviewed the benefits and risks of mRNA COVID-19 vaccines in the United States and determined that the benefits of using mRNA COVID-19 vaccines under the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) clearly outweigh the risks of myocarditis and pericarditis in all people aged 12 years or older.
The FDA updated the EUA Fact Sheets to include information about the occurrence of myocarditis or pericarditis in some people following use of the vaccine. Based on the benefit-risk assessment, COVID-19 vaccination continues to be recommended for everyone aged 12 years and older under the FDA’s EUAs.
ACIP highlighted the need for continued monitoring of cases of myocarditis or pericarditis after receipt of mRNA COVID-19 vaccines, as well as patients’ clinical course and long-term outcomes. The benefit-risk analysis may be updated, as needed, to reflect changes in COVID-19 disease trends and additional information on the risk for myocarditis or pericarditis after mRNA COVID-19 vaccination.
Updated: July 13, 2021