Companies seek FDA approval for individuals aged 12 years and older to receive vaccinations for their primary series.
Pfizer Inc and BioNTech SE submitted a supplemental biologics license application (sBLA) to the FDA for approval of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for individuals aged 12 years and older.
If approved, individuals would be able to receive the COVID-19 vaccine for their primary series, rather than completing the primary series with the original vaccine [Comirnaty (COVID-19 Vaccine, mRNA); Pfizer] before having access to the bivalent vaccine.
The FDA approved the first BLA for the original vaccine in August 2021 for individuals aged 16 years and older and extended through an sBLA to include those aged 12 through 15 years old.
The bivalent vaccine is available in the United States under emergency use authorization as a single-booster dose for those aged 5 years and older and as a third dose in the 3-dose primary series for children aged 6 months through 4 years. The sBLA is the next step for full regulatory approval of the bivalent vaccine.
The submission is supported by clinical, manufacturing, and pre-clinical data, which demonstrate the immunogenicity, safety, and tolerability of the bivalent vaccine.
The study included individuals aged 55 years and older, with approximately 300 participants in the bivalent group and 300 in the comparator group receiving the original vaccine.
The bivalent vaccine met criteria for superiority over the original vaccine with respect to the Omicron BA.4/BA.5-neutralizing antibodies elicited.
Investigators found that the geomantic mean ratio (GMR) of the Omicron BA.4/BA.5-neutralizing antibodies was 2.91 at 1-month post-vaccination. For individuals aged 18 to 55 years, the GMR was 0.98, which met criteria for non-inferiority compared with individuals older than aged 55 years who received the bivalent vaccine.
For both age ranges, the pattern of results was the same, regardless of prior COVID-19 infection.
Investigators noted that the safety and tolerability profile of the bivalent vaccine remains similar to the original vaccine.
Additionally, the bivalent vaccine also induced a stronger neutralizing antibody response against newer Omicron sub lineages in individuals aged 55 years and older, including BA.2.75.2, BA.4.6, BQ.1.1, and XBB.1 compared with the original vaccine. For XBB.1, neutralizing antibody titers increased 4.8-fold following a booster does of the bivalent vaccine and 1.5-fold following a booster dose of the original vaccine.
In this subset, individuals with and without evidence of a prior infection were included.
Similar results have been observed with XBB.1.5.
Individuals aged 12 years and older who complete the primary series with the original vaccine, or will complete it with the bivalent vaccine, will still be able to receive a booster dose of the bivalent vaccine.
In the European Union, 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 aged 5 years and older who have completed a primary vaccine course for COVID-19.
The companies also plan to submit an application to the European Medicines Agency for a variation of the MA to include the bivalent vaccine as a primary course of vaccination for individuals aged 5 years and older and a line extension for the bivalent vaccines as a primary course of vaccination, as well as a booster for individuals aged 6 months through 4 years.
Pfizer and BioNTech submit supplemental biologics license application for USFDA approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for ages 12 years and older as primary series of booster. Pfizer. News release. February 24, 2023. Accessed February 24, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-supplemental-biologics-license-1