Pfizer has announced positive top-line results from a pivotal phase 3 trial assessing the safety, tolerability and immunogenicity of its investigational meningococcal vaccine – MenABCWY – in healthy individuals aged ten to 25 years old.
Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours, and can result in life-altering, significant long-term disabilities for survivors.
Currently, MenACWY and MenB vaccines are licenced separately in the US, and no single vaccine is available to help protect against the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y.
If approved, Pfizer’s MenABCWY could help simplify the meningococcal vaccination schedule by reducing the total number of doses needed for individuals to be fully vaccinated against the five serogroups.
Annaliesa Anderson, senior vice president and chief scientific officer, vaccine research and development, Pfizer, said: “A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule in the US and improve vaccine coverage.
“Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease.”
The randomised, active-controlled and observer-blinded trial met all primary and secondary endpoints, with the two doses of the investigational vaccine demonstrating non-inferiority to licensed vaccines – two doses of Trumenba plus one dose of Menveo – for all five serogroups.
Moreover, a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo.
Based on the positive results, Pfizer has outlined its plans to submit a Biologics Licence Application (BLA) to the US Food and Drug Administration (FDA) in the fourth quarter of 2022. Submissions to additional regulatory authorities outside the US are also planned, the company said.
Angela Hwang, president, global biopharma business, Pfizer, said: “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 MenACWY vaccine market and help protect more young people across the country.”