FDA Approves New COVID Shot Boosters for Children Without Testing

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WASHINGTON, D.C. – Today, Pfizer Inc. and BioNTech announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 shot for children 5 through 11 years of age, even though the companies have not completed the proper trials. The FDA stated, “For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.