The U.S. Food and Drug Administration (FDA) on Sept. 22 amended its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for a single booster dose six months after the completion of the second dose in patients ages 65 years and older; patients ages 18 to 64 years at high risk of severe COVID-19; and patients ages 18 to 64 years whose institutional or occupational exposure to the virus puts them at high risk of serious COVID-19 complications. 

The U.S. Department of Health and Human Services (HHS) in August announced that booster shots of the Pfizer-BioNTech and Moderna COVID-19 vaccines would be available beginning in September; however, the announcement was subject to an independent FDA evaluation to determine safety and effectiveness of a third dose, as well as a recommendation for a third dose from the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). The CDC ACIP met Sept. 23 to discuss a recommendation for a third dose and also endorsed the use of Pfizer-BioNTech's COVID-19 booster shot for elderly people and those who may be at risk of developing severe disease. Recommendations made by the ACIP are reviewed by the CDC director and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report.

In coming to the decision to authorize a third dose, the FDA considered safety and immune response data from a subset of participants from the original clinical trial of the Pfizer-BioNTech vaccine, as well as real-world data on the vaccine’s efficacy over a sustained period of time provided by both U.S. and international sources.

The FDA in August amended the EUA to allow for a third dose 28 days after the second dose for individuals age 18 years or older for the Moderna COVID-19 vaccine and individuals age 12 years or older for the Pfizer-BioNTech COVID-19 vaccine "who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise."

The Sept. 22 announcement allowing booster shots in certain individuals applies only to the Pfizer-BioNTech COVID-19 vaccine. Read 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: Congenital Heart Disease and Pediatric Cardiology, COVID-19 Hub, Prevention, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Prevention

Keywords: ACC Advocacy, SARS-CoV-2, Immunity, Centers for Disease Control and Prevention, U.S., Vaccines, Immunization, Secondary, Vaccination, COVID-19, United States Food and Drug Administration, COVID-19 Vaccines, Middle Aged, Adult, Young Adult, Adolescent

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