> ## 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.

# EUA Expanded for Pfizer Covid Vaccine
- URL: https://www.fdaweb.com/eua-expanded-for-pfizer-covid-vaccine/
- Published: 2021-12-09T12:00:00.000Z
- Updated: 2026-09-14T17:25:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150745

FDA has granted Pfizer and BioNTech an expanded emergency use authorization for their Covid-19 vaccine booster to include individuals 16 years of age and older. The booster dose is intended to be administered at least six months after completing a two-shot primary vaccination series. The companies say they plan to submit a supplemental BLA seeking approval of the booster dose of in individuals 16 years of age and older. It will include efficacy and safety data from a [Phase 3 trial](https://www.globenewswire.com/Tracker?data=MIvovpnbWTtZKqIPgPJgx1Zk6rHy1sMkk-c6Gy-FeWJvP3CVQdLBLBP77RvpVkA5E2e%5FEwLJ2U%5FgdijzbOhBTKCqQ3m3iNpxD5BGF2I27bJouBsWyQzYfreSgTYDII24vDMkIMbz-mF0Ci8zhItWkf4aBOYU6ordfybAiceHKfBwemEaL0XIwlQh2FHXt2Y%5FNHus3MfCG%5FCcFySC%5FodwtQ==&ref=fdaweb.com) showing that a 30-ug booster dose administered to individuals 16 years and older who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster.