Aiming to extend its vaccine empire, Pfizer (NYSE:PFE) has announced that its meningococcal vaccine (MenABCWY) candidate met primary and secondary endpoints in a Phase 3 study.
The NCT04440163 study tested the vaccine in healthy individuals between the ages of 10 and 25.
The vaccine candidate demonstrated non-inferiority to the licensed vaccines Trumenba and Menveo for the five meningococcal serogroups that cause the most invasive meningococcal disease: serogroups A, B, C, W and Y.
If approved, the vaccine could be the first to protect against the five meningococcal serogroups.
Pfizer plans on filing for U.S. approval in the fourth quarter of 2022. The company also plans to seek authorization for the vaccine in other regions.
At present, FDA has approved discrete MenACWY and MenB vaccines.
The NCT04440163 study randomly assigned participants to receive two doses of MenABCWY or two doses of Trumenba plus one dose of Menveo. Pfizer is the developer of Trumenba, while Menveo is from GSK (NYSE:GSK).
The study was active-controlled and observer-blinded. A total of 78 study locations took part in the trial.
Pfizer said the vaccine was well-tolerated with a similar safety profile to licensed vaccines.
“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,” said Annaliesa Anderson, senior vice president and chief scientific officer, vaccine research and development at Pfizer. “Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease.”
Pfizer estimates that there are roughly 52 million adolescents and young adults in the age range for meningococcal vaccination based on CDC guidance.
PFE shares ticked down half a point to $45.94.
Filed Under: Infectious Disease