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Pentavalent Meningococcal Vaccine Candidate Preps for FDA License

September 15, 2022 • 7:48 am CDT
by Selassie P.
(Precision Vaccinations)

New York-based Pfizer Inc. today announced positive top-line results from the pivotal Phase 3 clinical trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age.

Pfizer stated the trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause most invasive meningococcal disease: serogroups A, B, C, W, and Y.

This is essential news since current MenACWY and MenB vaccines are licensed separately, and no single vaccine is available to help protect against the five serogroups.

"We are very pleased with these positive Phase 3 data, which are the first for a MenABCWY vaccine candidate," said Annaliesa Anderson, Ph.D., SVP and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release issued on September 15, 2022.

"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."

Participants in the trial were randomly assigned to receive either two doses of MenABCWY or licensed vaccines (two doses of Trumenba® + one dose of Menveo®).

Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba®and one dose of Menveo®.

Additionally, a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo®.

Furthermore, in individuals who had not previously received a meningococcal vaccine, the proportion of subjects with ≥4-fold increases in immune responses was observed to be higher following either one or two doses of MenABCWY for serogroups A, C, W, and Y compared to one dose of Menveo®.

Finally, the proportion of subjects with ≥4-fold increases in immune responses was also higher against all four serogroup B strains following two doses of MenABCWY than two doses of Trumenba®.

Based on these Phase 3 results, which meet pre-determined criteria for licensure, Pfizer intends to submit a Biologics License Application to the U.S. FDA in the fourth quarter of 2022.

Other meningococcal vaccine news is posted at PrecisionVaccinations.

Note: This press release was manually curated for mobile readers.