sBLA submitted for FDA approval of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine for ages 12 years and older as primary series or booster for COVID 19

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.

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.

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. This subset of individuals included those with and without evidence of prior infection. Similar results have been observe for XBB.1., which currently accounts for more than 80% of COVID-19 cases in the U.S.