Pfizer and BioNTech submit application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children under 5 years

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On Dec. 5, 2022, Pfizer and BioNTech announced that the companies had submitted an application to the U.S. Food and Drug Administration for emergency use authorization of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-ᄉg dose in the three-dose primary series for children 6 months through 4 years of age.

With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization.

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Source: BioNTech
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