The U.S. Food and Drug Administration (FDA) on Oct. 29 issued an emergency use authorization (EUA) to allow children ages 5 to 11 to receive the Pfizer-BioNTech COVID-19 vaccine. The authorization is based on FDA's evaluation of data and a recommendation from an independent advisory committee.

The vaccine's safety was studied in approximately 3,100 children ages 5 to 11, and no serious side effects have been reported. Immune responses in children were comparable to those of individuals ages 16 to 25 years, and the vaccine was 90.7% effective in preventing COVID-19 infection in children ages 5 to 11. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will meet next week to discuss clinical recommendations. The vaccine is administered to children in a two-dose series, three weeks apart, at one-third the dose used for individuals ages 12 years and older.

The FDA and CDC safety surveillance systems previously identified increased risks of myocarditis and pericarditis following COVID-19 vaccination, particularly with the second dose, with males ages 12 to 17 having the highest risk. FDA conducted a benefit-risk assessment to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine could prevent in children ages 5 to 11 vs. the number of potential myocarditis cases and associated hospitalizations, ICU admissions and deaths. Overall, the agency's model predicted that the benefits of the vaccine would outweigh the risks in children.

Pfizer has updated its safety monitoring plan and will evaluate myocarditis, pericarditis and other events of interest in children ages 5 to 11 years. In addition, FDA and CDC are continuing to monitor COVID-19 vaccine safety to allow for rapid detection and investigation of potential safety problems.

Read the full FDA press release and access vaccine resources for patients and clinicians at ACC's COVID-19 Hub.

Clinical Topics: COVID-19 Hub, Heart Failure and Cardiomyopathies, Pericardial Disease, Prevention

Keywords: COVID-19 Vaccines, Myocarditis, United States Food and Drug Administration, COVID-19, Vaccines, Vaccination, Drug-Related Side Effects and Adverse Reactions, Immunization, Centers for Disease Control and Prevention, U.S., Pericarditis, Immunity, SARS-CoV-2, ACC Advocacy

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