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# Pfizer Covid Vaccine BLA Decision Due 1/2022
- URL: https://www.fdaweb.com/pfizer-covid-vaccine-bla-decision-due-1-2022/
- Published: 2021-07-16T12:00:00.000Z
- Updated: 2026-09-14T17:06:37.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149727

FDA has granted Pfizer/BioNTech a priority review for a BLA for their mRNA vaccine to prevent Covid-19 in individuals 16 years of age and older. The submission would move the vaccine’s regulatory status from an emergency use authorization (EUA) to full BLA approval. The agency has set a user fee review action date of 1/2022.

The companies completed a rolling BLA submission in May. completed the rolling submission of the BLA in May 2021\. It includes [clinical data](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-confirm-high-efficacy-and-no-serious?ref=fdaweb.com) from a pivotal Phase 3 clinical trial of the vaccine that demonstrated a favorable efficacy and safety profile observed up to six months after a second dose.

Additionally, the companies plan to submit a supplemental BLA for vaccine use in those aged 12 through 15 years once the required six months data is met. An expanded EUA for use in this population was granted in May.