FDA Accepts BLA for Pfizer Meningococcal Vaccine

The company’s vaccine candidate, MenABCWY, which is indicated for adolescents was given a Prescription Drug User Fee Act (PDUFA) goal date for later this year.

fda bla


The FDA recently announced it had accepted the Biologics License Application (BLA) for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY).

“We believe our investigational MenABCWY vaccine, if approved and recommended, could help simplify the meningococcal vaccination schedule for adolescents and young adults, and in turn improve vaccination rates, and provide the broadest serogroup coverage of any meningococcal vaccine. The pentavalent vaccine candidate was well-tolerated in clinical trials, with a safety profile consistent with currently licensed meningococcal vaccines,” Annaliesa Anderson, PhD, senior vice president and Chief Scientific Officer, Vaccine Research and Development, Pfizer, said in a statement.

According to the company, this pentavalent meningococcal vaccine combines the components the components from its two licensed meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine). Together, the 5 serogroups included in MenABCWY are responsible for the majority of currently circulating meningococcal disease globally.

The Centers for Disease Control and Prevention estimates approximately 55 million adolescents and young adults are in the age range for meningococcal vaccination (11-23 years old) in the United States.

What the Data Shows

Back in September, the company reported phase 3 trial data. The pivotal study assessed the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. 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 Trumenbaand 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. And, 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 observed to be higher against all four serogroup B strains following two doses of MenABCWY compared to two doses of Trumenba. The pentavalent vaccine candidate was well-tolerated, with a safety profile consistent with licensed vaccines.

“We are very pleased with these positive phase 3 data, which are the first for a MenABCWY vaccine candidate,” Pfizer’s Anderson said at the time.

According to the Pfizer statement, a goal date for a decision by the FDA on the vaccine application is October of this year.

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