> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Expands Pfizer Covid Vaccine to 12-15 Year Olds
- URL: https://www.fdaweb.com/fda-expands-pfizer-covid-vaccine-to-12-15-year-olds/
- Published: 2021-05-10T12:00:00.000Z
- Updated: 2026-09-14T16:58:08.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149286

FDA has expanded the emergency use authorization for Pfizer-BioNTech’s Covid-19 vaccine to include adolescents aged 12 through 15 years. The expanded EUA was based effectiveness data showing the vaccine was 100% effective in preventing Covid-19\. FDA says no cases of Covid-19 occurred among 1,005 vaccine recipients and 16 cases of Covid occurred among 978 placebo recipients.

Safety data included 2,260 participants aged 12 through 15 years. “Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo” an agency release says. “More than half of the participants were followed for safety for at least two months following the second dose.” The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted one to three days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain, [FDA says](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use?ref=fdaweb.com).