The U.S. Food and Drug Administration (FDA) on Aug. 23 approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty, for individuals age 16 years and older. The vaccine continues to be available under emergency use authorization (EUA) for individuals ages 12 to 15 and for a third dose in certain immunocompromised patients. (Read more about the HHS announcement of the availability of COVID-19 booster shots in September 2021.)

In coming to the approval decision, the FDA reviewed updated data from the vaccine's clinical trial, which supported the EUA and included a longer follow-up duration in a larger population. The agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 years and older who did not have evidence of COVID-19 infection within one week of receiving a second vaccine dose. The vaccine was determined to be 91% effective in prevention of COVID-19 infection based on clinical trial results. More than one-half of clinical trial participants were followed for safety outcomes for at least four months following the second dose, while approximately 12,000 recipients were followed for at least six months.

In addition, the FDA conducted an evaluation of post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the vaccine and determined that data demonstrate increased risks, particularly within seven days after the second dose. The risk is higher among males younger than age 40 years, compared with females and older males, and highest in males ages 12 to 17 years. Short-term follow-up data suggest resolution of symptoms for most individuals, although some did require intensive care support. The vaccine prescribing information includes a warning about the risks of myocarditis and pericarditis.

The FDA and Centers for Disease Control and Prevention will continue to monitor for safety concerns. In addition, the FDA is requiring post-marketing studies to further assess the risks of myocarditis and pericarditis, including long-term outcomes among individuals who develop myocarditis following vaccination. Pfizer is also conducting additional post-marketing studies to evaluate pregnancy and infant outcomes among women who receive the vaccine during pregnancy, although this is not an FDA requirement.

For more details, see the full FDA press release. Access additional guidance, as well as vaccination resources for patients and clinicians, on ACC's COVID-19 Hub.

Clinical Topics: Cardiac Surgery, COVID-19 Hub, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Pericardial Disease, Prevention, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Heart Transplant

Keywords: Pregnancy, Myocarditis, United States Food and Drug Administration, COVID-19, Vaccines, Vaccination, Pericarditis, Centers for Disease Control and Prevention, U.S., Critical Care, Immunocompromised Host, Heart Transplantation, SARS-CoV-2, ACC Advocacy

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