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# Pfizer/BioNTech sBLA for Harmonized Covid Shot
- URL: https://www.fdaweb.com/pfizer-biontech-sbla-for-harmonized-covid-shot/
- Published: 2023-02-24T12:00:00.000Z
- Updated: 2026-09-14T18:17:18.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153851

Pfizer and BioNTech have submitted a supplemental BLA that seeks approval of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for use as a primary series and booster dose for individuals 12 years of age and older. The submission adheres to last month’s Vaccines and Related Biological Products Advisory Committee meeting that unanimously voted (21 to 0) to recommend that Covid-19 vaccine composition be “harmonized” so that one vaccine composition can cover the primary series in newly vaccinated and booster doses in those already vaccinated. Most panel members agreed that from a public health perspective, simplifying the vaccine composition will help increase vaccinations in the current unvaccinated population, and in those needing booster shots ([see earlier story](https://www.fdaweb.com/panel-backs-plan-to-harmonize-covid-vaccine-composition/)).

“If this sBLA is approved, people 12 years or older would be able to receive the companies’ Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for their primary series, rather than completing their primary series with the original vaccine (Comirnaty (Covid-19 vaccine, mRNA)) before having access to the bivalent vaccine,” the companies say. “Individuals in this age group who completed their primary series with the original vaccine or will complete it with the bivalent vaccine would still be eligible to receive a booster dose of the bivalent vaccine.”

Currently, the bivalent vaccine is available in the U.S. under an emergency use authorization (EUA) as a single booster dose for ages five years and older and as the third dose in the three-dose primary series for children six months through four years of age. Because EUAs are intended for short-term needs, the BLA will, if approved, convert the EUA to a traditional BLA approval, the companies add.