FDA Accepts for Review BLA for Pfizer’s Pentavalent Meningococcal Vaccine Candidate

The FDA has accepted a biologics license application for an investigational pentavalent meningococcal vaccine candidate (MenABCWY; Pfizer) for review.¹

Pfizer submitted the vaccine for the prevention of meningococcal disease, which is most commonly present in individuals aged 10 through 25 years.¹

“The FDA’s acceptance of our application for the pentavalent meningococcal vaccine candidate is an essential step toward helping protect individuals and communities against the most common types of meningococcal disease,” Annaliesa Anderson, PhD, senior vice president and chief scientific officer of Vaccine Research and Development at Pfizer, said in a statement.¹

“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,” Anderson said.¹

The vaccine candidate combines components of 2 vaccines, which help protect against the meningococcal serogroups that cause most cases of invasive meningococcal disease.¹

In the United States, the recommended vaccine schedule for adolescents and young adults includes 2 doses of MenACWY and a separate, shared clinical decision recommendation for MenB-specific vaccines in 2 doses.¹

If approved and recommended, the pentavalent vaccine candidate could be another routine recommendation option. It could potentially reduce the total number of doses needed for individuals to be fully vaccinated against the 5 serogroups, thus raising the number who are vaccinated.¹

The Prescription Drug Fee Act decision date is in October 2023.¹

The regulatory submission is supported by positive results from a controlled, observer-blinded, phase 3, randomized trial (NCT04440163), which evaluated more than 2400 individuals from Europe and the United States.¹

The trial met all primary and secondary endpoints, demonstrating non-inferiority to licensed vaccines for the 5 serogroups that cause the majority of invasive meningococcal.²

Individuals in the trial were randomly assigned to receive either 2 doses of the investigational drug or licensed vaccines, which consisted of 1 dose of Menveo (GSK) and 2 doses of Trumenb (Pfizer).²

Non-inferiority was demonstrated for MenABCWY in all 5 serotypes compared with the licensed vaccine regimen. Further, 1 dose of MenABCWY met the criteria for serogroups A, C, W, Y compared with 1 dose of Menveo.²

Further, in individuals who had not previously received a meningococcal vaccine, the proportion with a 4-fold or greater increase in immune response was observed to be higher in either 1 or 2 doses of the investigational vaccine for the serogroups A, C, W, and Y when compared with 1 dose of Menveo.²

Compared with 2 doses of Trumenba, 2 doses of MenABCWY demonstrated a higher proportion of individuals with a 4-fold or greater immune response against all 4 serogroup B strains.²

References

1. US FDA accepts for review the biologics license application for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents. Pfizer. News release. December 28, 2022. Accessed January 4, 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-review-biologics-license-application-pfizers

2. Pfizer announces positive top-line results from phase 3 trial of pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents. Pfizer. News release. September 15, 2022. Accessed January 4, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-trial-0