ACIP evidence to recommendations for use of moderna COVID-19 vaccine in children ages 6 months – 5 years and Pfizer-BioNTech COVID-19 vaccine in children ages 6 months – 4 years under an Emergency use authorization
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he 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 85 million cases and more than 1,000,000 COVID-19-associated deaths have been reported as of June 14, 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 June 17, 2022, the Food and Drug Administration (FDA) authorized an Emergency Use Authorization (EUA) for a 2-dose Moderna COVID-19 vaccine primary series for administration to children ages 6 months through 5 years. The FDA also authorized a 3rd primary series dose of the Moderna COVID-19 vaccine to children ages 6 months through 5 years with certain kinds of immunocompromise. Furthermore, the FDA authorized an EUA for a 3-dose Pfizer-BioNTech COVID-19 vaccine primary series for administration to children ages 6 months through 4 years. Following FDA’s regulatory action, CDC expanded eligibly of COVID-19 vaccines to everyone ages 6 months and older on June 18, 2022.
Additional background information supporting the ACIP recommendation on the use of Moderna COVID-19 vaccine for children ages 6 months through 4 years and Pfizer-BioNTech COVID-19 vaccine for children ages 6 months through 5 years can be found in the relevant publication of the recommendation referenced on the ACIP website.