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# FDA Amends Pfizer Covid Vaccine EUA
- URL: https://www.fdaweb.com/fda-amends-pfizer-covid-vaccine-eua/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:27:13.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150849

FDA has amended the Pfizer/BioNTech emergency use authorization for their Covid-19 vaccine to: 

- expand the use of a single booster dose to include those ages 12-15;
- shorten the time between the completion of primary vaccination with the product and a booster dose to at least five months; and
- allow for a third primary series dose for certain immunocompromised children ages 5 through 11.

An agency [statement](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine?ref=fdaweb.com) says FDA has determined that the protective health benefits of a single booster dose of the Pfizer/BioNTech vaccine outweigh the potential risks in those ages 12-15\. It says the determination was made through a review of real-world data from Israel. The data showed there were no new safety concerns following a booster in this age group and no new cases of myocarditis or pericarditis reported to date in those individuals, the agency says.