Pfizer/BioNTech Seek Expanded Approval For Its Updated COVID-19 Shot As Primary Series Vaccination

Pfizer Inc PFE and BioNTech SE 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.
Related: Pfizer/BioNTech Get Ready For London Court Battle With Moderna Over COVID-19 Vaccine Patents.
The submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the bivalent vaccine's safety, tolerability, and immunogenicity.
Among study participants over 55, the bivalent vaccine met the criteria for superiority over the original vaccine for Omicron BA.4/BA.5-neutralizing antibodies elicited. The safety and tolerability profile of the bivalent vaccine remained similar to that of the original vaccine.
Compared to the original vaccine, the bivalent vaccine also induced a more robust neutralizing antibody response against newer Omicron sublineages in participants 55 and older.
For XBB.1, neutralizing antibody titers increased 4.8-fold following a booster dose of the companies' bivalent vaccine and 1.5-fold following a booster dose of the companies' original vaccine.
Price Action: PFE shares are down 1.61% at $41.62, and BNTX shares are down 2.65% at $130.83 on the last check Friday.

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