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2022-09-16| Trials & Approvals

Pfizer’s Pentavalent Vaccine Shines in Phase 3 Trials Before BLA Submission

by Reed Slater
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A five-in-one meningococcal vaccine could be just around the corner as Pfizer’s MenABCWY vaccine proved non-inferior to licensed vaccines in a pivotal Phase 3 trial. Based on the positive outcome of the study, Pfizer plans to submit the vaccine for a Biologics License Application (BLA) to the FDA before the end of the year. 

Veering Away from Traditional Meningococcal Vaccine Schedules

The primary benefit of developing a pentavalent vaccine is its ability to simplify the current vaccine schedule, which includes up to five doses of two different meningococcal vaccines. Pfizer designed its MenABCWY vaccine to accommodate all five predominant serogroups responsible for serious meningococcal infections in two doses. 

Meningococcal disease is uncommon but dangerous due to its 10-15% fatality rate and potential long-term complications, like hearing loss, neurologic damage, and limb loss, in survivors. Five serogroups, distinct variations in a virus or bacteria, are responsible for 96% of cases. These crucial five include serogroups A, B, C, W, and Y. Current licensed vaccines include quadrivalent options that cover A, C, W, and Y, with a separate vaccine option for serogroup B. 

Pfizer’s MenABCWY vaccine would be the first to provide coverage for all five serogroups, eliminating the need for more than one vaccine. The company developed the vaccine using its FDA-licensed serogroup B meningococcal vaccine, Trumenba, which it acquired in 2009 after purchasing Wyeth Pharmaceuticals, and its EU-licensed serogroup A, C, W, and Y vaccine, Nimenrix, which it bought from GSK in 2015. 

The CDC recommends two doses of a quadrivalent vaccine at 11 and 16 years old and two or three doses of a serogroup B vaccine before six months. By condensing the vaccine to cover all five serogroups, Pfizer hopes that MenABCWY can simplify the vaccine schedule to just two doses in patients ten to 25. 

Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development at Pfizer, said, “A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule in the

U.S. and improve vaccine coverage. Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease.”

Related Article: Pfizer Doses First Patients with an Influenza Vaccine in a Phase 3 Clinical Trial

Stellar Phase 3 Results Before Submitting an Application

Pfizer initiated the Phase 3 trial in June 2020 after recruiting 2,407 participants aged ten to 25. For the control group, some participants received two doses of Pfizer’s serogroup B vaccine, Trumenba, and at least one dose of GSK’s quadrivalent vaccine, Menveo. Some participants had received one dose of a quadrivalent vaccine before the trial, but none had received a serogroup B vaccine. 

The trial met all primary and secondary endpoints, demonstrating MenABCWY’s non-inferiority compared to licensed vaccine options. Additionally, a single dose of MenABCWY met the non-inferiority criteria compared to one dose of Menveo for the serogroups A, C, W, and Y. 

Pfizer is excited about the market opportunity MenABCWY represents because up to 52 million adolescents and teenagers in the US are in the range of receiving meningococcal vaccines. Based on the Phase 3 data, Pfizer plans to submit a BLA to the FDA later this year to bring the vaccine to the market.

A pentavalent vaccine could streamline meningococcal vaccine schedules for millions of individuals in the US and, based on MenABCWY’s performance in the clinic, Pfizer’s solution could come very soon. Once the company submits a BLA to the FDA in the fourth quarter of this year, it will only be a waiting game to see if the vaccine has what it takes to make it to market.

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