Pfizer eyes up ‘significant opportunity’ for pentavalent meningococcal vaccine following positive top-line results from Phase 3 trial

15-Sep-2022 - Last updated on 15-Sep-2022 at 14:08 GMT

Pic:getty/wacomka

Pfizer will submit a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine (MenABCWY) to the US Food and Drug Administration (FDA) later this year, following positive top-line results from a Phase 3 trial.

Currently, MenACWY and MenB vaccines are licensed separately; with no single vaccine addressing all five serogroups.

Pfizer, therefore, believes it can make its mark with a pentavalent vaccine: with its candidate meeting all primary and secondary endpoints in the Phase 3 trial.

Boosting vaccination schedules

Five serogroups (A, B, C, W and Y) account for 96% of all invasive meningococcal disease cases worldwide, with serogroup B accounting for the majority of disease in adolescents and young adults in the US and Europe.

In the US, the current vaccination recommendations for adolescents and young adults include a MenACWY vaccine and a separate MenB vaccine, totaling four doses.

However, less than a third of adolescents receive even one dose of a MenB vaccine, and fewer complete the two-dose series, resulting in many adolescents being unprotected against meningococcal disease caused by serogroups A, B, C, W, and Y.

Pfizer, therefore, believes it can simplify the meningococcal vaccination schedule by reducing the total number of doses to provide protection against all five serogroups.

“The potential recommendation of a pentavalent vaccine in the US as an alternative to the existing MenACWY vaccines across both the 11- to 12-year-old and 16-year-old vaccination platforms provides a significant opportunity for Pfizer to enter the US,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

“MenACWY vaccine market and help protect more young people across the country. Today, we estimate there are approximately 52 million adolescents and young adults who are in the age range for meningococcal vaccination according to CDC guidance.

“We look forward to the public health impact a pentavalent vaccine may provide, and to strengthening our position as a global leader in the prevention of meningococcal disease.”

The pentavalent vaccine

Pfizer’s pentavalent meningococcal vaccine candidate combines its two licensed meningococcal vaccines, Trumenba and Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine). Approvals of Nimenrix and Trumenbavary by country.

The randomized, active-controlled and observer-blinded Phase 3 trial of Pfizer’s pentavalent meningococcal vaccine candidate (NCT04440163) was initiated in June 2020 and enrolled 2,431 healthy adolescents and young adults (10 through 25 years of age) from the US and Europe.

The study compared immune responses from the MenABCWY candidate to responses in control groups receiving licensed vaccines Trumenba(meningococcal group B vaccine) and Menveo(meningococcal group A, C, W-135, and Y conjugate vaccine), as well as to describe the safety profile of the MenABCWY vaccine.

Releasing the top-line results from the trial today, Pfizer reports that the trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups.

Based on these Phase 3 results, which meet pre-determined criteria for licensure, Pfizer intends to submit a Biologics License Application to the US Food and Drug Administration in the fourth quarter of this year. Submissions to additional regulatory authorities outside the US are also planned.