Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine for Ages 12 Years and Older as Primary Series or Booster

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for individuals 12 years of age and older.

On January 26, 2023, the U.S. 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 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. 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.

The original BLA for COMIRNATY as the primary series was approved in August 2021 for ages 16 years and older and later extended through an sBLA to include ages 12 through 15 years of age. Currently, the bivalent vaccine is available in the U.S. under Emergency Use Authorization (EUA) as a single booster dose for ages 5 years and older and as the third dose in the three-dose primary series for children 6 months through 4 years of age. As EUA is not meant to be a long-term status, this sBLA is the next step toward full regulatory approval of the bivalent vaccine.

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine. Among study participants over 55 years of age (n=~300 per group (individuals receiving the bivalent vaccine vs. comparator group receiving the original vaccine)), the bivalent vaccine met criteria for superiority over the original vaccine with respect to Omicron BA.4/BA.5-neutralizing antibodies elicited. Measured at one-month post-vaccination, the geometric mean ratio (GMR) of Omicron BA.4/BA.5-neutralizing antibodies was 2.91 (95% CI: 2.45, 3.44). For study participants aged 18 to 55 (n=~300) who received the bivalent vaccine, GMR was 0.98 (95% CI: 0.83, 1.16), which met criteria for non-inferiority compared to participants over 55 years of age who received the bivalent vaccine. For both age groups, the pattern of results was the same regardless of prior SARS-CoV-2 infection. The safety and tolerability profile of the bivalent vaccine remained similar to that of the original vaccine.1

The bivalent vaccine also induced a stronger neutralizing antibody response against newer Omicron sublineages in participants 55 years of age and older, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1, compared to the original vaccine. For XBB.1, neutralizing antibody titers increased 4.8-fold (95% CI: 3.3,6.9) following a booster dose of the companies’ bivalent vaccine and 1.5-fold (95% CI: 1.3,1.8) following a booster dose of the companies’ original vaccine.1 This subset of individuals included those with and without evidence of prior infection. Similar results have been observe for XBB.1.5, which currently accounts for more than 80% of COVID-19 cases in the U.S.2,3

In the European Union (EU), the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine was granted full marketing authorization (MA) for administration as a booster dose in individuals 5 years of age and older who have completed a primary vaccination course against COVID-19. The companies also plan to submit applications to the European Medicines Agency (EMA) for a variation of the MA to also include the bivalent vaccine as a primary course of vaccination in individuals 5 years of age and older and a line extension for the bivalent vaccine as a primary course of vaccination and booster for individuals 6 months of age through 4 years.

The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (Original) and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.