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FDA Expands Use of Pfizer-BioNTech COVID-19 Vaccine

January 3, 2022


FDA announced on Jan. 3, 2022, that it was amending the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand single booster doses to children 12 through 15 years of age. The agency reviewed data from Israel from individuals aged 12–15 who received a booster dose five months after the primary two-dose vaccination series, allowing FDA to reassess the risk/benefit of the use of boosters in younger adolescents.

“The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals,” FDA stated in a press release.

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