COVID-19 vaccine booster for children aged 12–15.

The FDA reviewed data from Israel from children 12–15 years old who received a booster five months after the primary Pfizer-BioNTech COVID-19 vaccine and is amending the Emergency Use Authorization (EUA) to allow the booster five months after the primary two-dose vaccination for children aged 12–15.

In addition, real-world data that has become available provide additional evidence supporting to amend the EUA and shorten the time to booster dose.

The FDA stated in a press release (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine) that data show no new safety concerns have been reported in the 4.1 million subjects over 16 years old who have received a booster dose at least five months after they received their first two doses. Similarly, no new safety concerns have been reported in the younger children aged 12–15.

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