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.

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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