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# Pfizer/BioNTech Booster Data Submitted to FDA
- URL: https://www.fdaweb.com/pfizer-biontech-booster-data-submitted-to-fda/
- Published: 2021-08-16T12:00:00.000Z
- Updated: 2026-09-14T17:10:43.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149940

Pfizer and BioNTech have submitted Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule,” the companies say. “Participants received a 30-µg booster dose of BNT162b2 8 to 9 months after receiving the second dose. [Results](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fs21.q4cdn.com%2F317678438%2Ffiles%2Fdoc%5Ffinancials%2F2021%2Fq2%2FQ2-2021-Earnings-Charts-FINAL.pdf&esheet=52477298&newsitemid=20210816005494&lan=en-US&anchor=Results&index=1&md5=f98afc92298804cd9ab7a559f5d47f45&ref=fdaweb.com) from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild type) compared to the levels observed after the two-dose primary series, as well as against the Beta variant and the highly infectious Delta variant.”

Phase 3 data on the third dose are expected shortly and will be submitted to the agency and other regulatory agencies. The companies plan to seek licensure of the third dose under a supplemental BLA in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in [May](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.pfizer.com%2Fnews%2Fpress-release%2Fpress-release-detail%2Fpfizer-and-biontech-initiate-rolling-submission-biologics&esheet=52477298&newsitemid=20210816005494&lan=en-US&anchor=May+2021&index=2&md5=8bcec5ff43a2956970940f03a98a30a3&ref=fdaweb.com).