ACIP Update to the Evidence to Recommendations for a Pfizer-BioNTech COVID-19 Booster in Children Ages 5-11 Years

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic with substantial societal and economic impacts on individual persons and communities. In the United States, more than 82 million cases and more than 998,000 COVID-19-associated deaths have been reported as of May 16, 2022. Persons of all ages are at risk for infection and severe disease. While children <18 years of age infected with SARS-CoV-2 are less likely to develop severe illness compared with adults, children are still at risk of developing severe illness and complications from COVID-19 and contribute to transmission in households and communities. A disproportionate burden of COVID-19 infections and deaths occur among racial and ethnic minority communities, including among children. Non-Hispanic Black, Hispanic/Latino and American Indian/American Native persons have experienced higher rates of disease, hospitalization and death compared with non-Hispanic Whites. This is likely related to inequities in social determinants of health that put racial and ethnic minority groups at increased risk for COVID-19, including income disparities, reduced access to healthcare, or higher rates of comorbid conditions.

On October 29, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine in persons ages 5-11 years for prevention of COVID-19. The vaccine was safe and met non-inferiority criteria for immunobridging compared with young adults ages 16-25 years in a randomized controlled clinical trial that included 2,268 participants randomized 2:1 to receive either vaccine or placebo.

On May 17, 2022, the FDA amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine. Following FDA’s regulatory action, CDC expanded eligibility of COVID-19 vaccine booster doses to everyone 5 years of age and older on May 19, 2022.

Additional background information supporting the ACIP recommendation on the use of additional or booster doses of COVID-19 vaccine can be found in the relevant publication of the recommendation referenced on the ACIP website.