In this article:
-
Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have submitted an FDA supplemental marketing application for approval of omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for 12 years and older.
-
In January, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to harmonize the composition of COVID-19 vaccines across booster and primary series doses.
-
If this supplemental application is approved, people 12 or older can 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 before having access to the bivalent vaccine.
