ACIP updates on mRNA COVID-19 vaccine after myocarditis reported with vaccine recipients

July 7, 2021

An elevated risk for myocarditis among mRNA COVID-19 vaccinees has been observed, particularly in males aged 12 to 29 years, according to a new report from the Advisory Committee on Immunization Practices (ACIP), released the Centers for Disease Control and Prevention (CDC) in its Morbidity and Mortality Weekly Report.

On June 23, 2021, ACIP concluded that the benefits of COVID-19 vaccination to individual persons and at the population level clearly outweighed the risks of myocarditis after vaccination. Continued use of mRNA COVID-19 vaccines in all recommended age groups will prevent morbidity and mortality from COVID-19 that far exceed the number of cases of myocarditis expected. Information regarding the risk for myocarditis with mRNA COVID-19 vaccines should be disseminated to providers to share with vaccine recipients.

In December 2020, the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine, and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively. In May 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12–15 years; ACIP recommends that all persons aged ≥12 years receive a COVID-19 vaccine.

Both Pfizer-BioNTech and Moderna vaccines are mRNA vaccines encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both mRNA vaccines were authorized and recommended as a two-dose schedule, with second doses administered 21 days (Pfizer-BioNTech) or 28 days (Moderna) after the first dose.

After reports of myocarditis and pericarditis in mRNA vaccine recipients, which predominantly occurred in young males after the second dose, an ACIP meeting was rapidly convened to review reported cases of myocarditis and pericarditis and discuss the benefits and risks of mRNA COVID-19 vaccination in the United States. Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. Hereafter, myocarditis is used to refer to myocarditis, pericarditis, or myopericarditis.

Myocarditis typically occurs more commonly in males than in females, and incidence is highest among infants, adolescents, and young adults. The clinical presentation and severity of myocarditis vary among patients. Supportive therapy is a mainstay of treatment, with targeted cardiac medications or interventions as needed. Current guidelines from the American Heart Association and American College of Cardiology recommend exercise restriction until the heart recovers.

The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. The EUA fact sheets should be provided before vaccination; in addition, CDC has developed patient and provider education materials about the possibility of myocarditis and symptoms of concern, to ensure prompt recognition and management of myocarditis.

Since June 2020, ACIP has convened 15 public meetings to review data on COVID-19 epidemiology and use of COVID-19 vaccines. The ACIP COVID-19 Vaccines Work Group, comprising experts in infectious diseases, vaccinology, vaccine safety, public health, and ethics, has held weekly meetings since April 2020 to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccination programs.

After reports of myocarditis, the work group met twice to review clinical trial and post authorization safety data for myocarditis after receipt of mRNA COVID-19 vaccines. The work group also reviewed a benefit-risk assessment of myocarditis events after receipt of mRNA COVID-19 vaccines, considering recent epidemiology of COVID-19 and sequelae of COVID-19, including myocarditis and multisystem inflammatory syndrome in children (MIS-C).

The ACIP COVID-19 Vaccines Safety Technical (VaST) Work Group, comprising independent vaccine safety expert consultants, had also reviewed safety data on myocarditis after receipt of mRNA COVID-19 vaccines at its weekly meetings. The findings from the VaST and the ACIP COVID-19 Vaccines Work Group assessments, including a summary of the data reviewed, were presented to ACIP during its meeting on June 23, 2021.

ACIP also reviewed population-level considerations regarding vaccination. No alternatives to mRNA COVID-19 vaccines for adolescents will be available for the foreseeable future, and vaccination of adolescents offers protection against COVID-19 that can be important for returning to educational, social, and extracurricular activities. Higher levels of vaccination coverage can reduce community transmission, which can protect against development and circulation of emerging variants.

Regarding health equity considerations, racial and ethnic minority groups have higher rates of COVID-19 and severe disease; potential changes in vaccine policy, or anything that would affect vaccination coverage for adolescents or young adults, might disproportionately affect those groups with the highest rates of poor COVID-19 outcomes.

CDC has provided guidance regarding evaluation and management of myocarditis after mRNA COVID-19 vaccine.

CDC has the report.

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