Pfizer Inc said on Tuesday that the U.S. Food and Drug Administration had expanded the emergency use authorization (EUA) of the company and its partner BioNTech SE's bivalent COVID-19 vaccine as a single booster dose in certain children.
The amended authorization is for children six months through four years of age who have completed their initial three-dose vaccination with Pfizer's original shot.
In December, the U.S. health regulator had authorized Pfizer/BioNTech's updated shot as a third dose to those aged six months through four years, who have not completed their primary vaccination series or are yet to receive the third dose.
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The health regulator's amended authorization is based on data from 60 children, from the expanded age group, who completed primary vaccination with three doses and received a booster shot of Pfizer/BioNTech, and showed an immune response to both the original SARS-CoV-2 virus strain and to Omicron BA.4/BA.5.
Shots for youngest children in the United States were only approved in June last year, making them the last group to become eligible for vaccination.
{{/usCountry}}Shots for youngest children in the United States were only approved in June last year, making them the last group to become eligible for vaccination.
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Government data shows that only 2.7% children under the age of two and less than 5% of children aged two to four years who are eligible have completed their primary vaccination series as of Nov. 30, representing a slow uptake of the initial vaccine doses in young children.