Pfizer, BioNTech Seek Approval for Bivalent COVID-19 Vaccine as Primary Series

Pfizer and BioNTech have submitted a supplemental biologics license application (sBLA) to the FDA for approval of their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as both a primary series and booster dose. If approved, people 12 years or older would be able to receive the companies’ bivalent vaccine for their primary series, rather than completing their primary series with the original vaccine 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 pharma makers said in a press release.

The companies have also submitted an EUA for a fourth dose of the bivalent COVID-19 vaccine in children 6 months through 4 years of age. If the FDA authorizes, young children who have completed their primary series – either with three doses of the companies’ original vaccine or with two doses of the companies’ original and one dose of the bivalent vaccine – would be eligible to receive a 3-µg booster dose of the bivalent vaccine at least two months after the completion of their primary series.

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. The bivalent vaccine is currently available in the United States 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,” Pfizer and BioNTech said.

This sBLA submission is supported by clinical, preclinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine. Among study participants over 55 years of age, the bivalent vaccine met criteria for superiority over the original vaccine with respect to omicron BA.4/BA.5-neutralizing antibodies elicited.

For study participants aged 18 to 55, the vaccine met criteria for non-inferiority compared with 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, according to Pfizer and BioNTech.

Additionally, the CDC’s Advisory Committee for Immunization Practices (ACIP) said last week they are likely to recommend just one COVID-19 booster shot a year for older people and those with weakened immune systems, according to news reports. At its meeting last week, the COVID-19 working group of ACIP advised showing flexibility in recommendations for those with compromised or weakened immune systems to allow more frequent doses for those most vulnerable to severe COVID-19, per Reuters.

Last spring, the CDC recommended immunocompromised and people over age 50 receive an additional shot if they had received their first booster at least four months earlier. However, ACIP supports an annual booster campaign, likely in the fall, especially for populations considered at high risk, Sara Oliver, M.D., a CDC official who heads the advisory committee, said during the meeting, according to Reuters.

Importantly, “no formal recommendations were voted on by ACIP and the committee-highlighted recommendations can evolve based on future data in immunocompromised and older adults,” a Pfizer spokesperson told Formulary Watch. “We are continuing to collect, share and evaluate clinical data and real-world evidence regarding the effectiveness of the bivalent vaccines in helping to protect against COVID-19 and severe illness.”