GSK's 5-in-1 Meningococcal Vaccine Meets All Phase III Endpoints, Intensifying Competition with Pfizer

According to the SmartCom APP, GlaxoSmithKline (GSK.US) stated that its 5-valent meningococcal vaccine (MenABCWY) met all 11 primary endpoints in the Phase 3 trial.

The company said that the MenABCWY vaccine combines the antigen components of GSK's licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). The company stated that primary endpoint data showed that MenABCWY was not statistically inferior to Bexsero and Menveo, and the vaccine elicited a clinically meaningful immune response. The company added that the vaccine was well-tolerated, with a safety profile consistent with Bexsero and Menveo.

GSK Points Out That If MenABCXY Is Approved, the Vaccine Can Provide the Broadest Coverage of Meningococcal Serogroups and May Simplify Vaccination Schedules. Tony Wood, GSK's Chief Scientific Officer, Stated: "These Statistically Significant Phase III Data Are a Very Encouraging Step in Reducing the Incidence of Meningococcal Disease."

GSK is working with regulatory authorities to review the full Phase 3 data for Bexsero, including a supplemental Biologics License Application (sBLA).

In terms of competition, in December 2022, Pfizer (PFE.US) accepted the FDA's review of MenABCWY, a vaccine that also combines the components of two vaccines into one. In a late-stage study, Pfizer's MenABCWY was considered as effective as Pfizer's own meningococcal vaccine Trumenba and GSK's Menveo.

These two pharmaceutical giants have been fiercely competing in the vaccine field. Both companies have received approval from the FDA advisory panel for their respective RSV candidate vaccines targeting the elderly. As the U.S. drug regulatory agency is expected to make a decision in May, both companies have also been preparing for the vaccine rollout this year.

Meningococcal disease is any illness caused by the bacterium Neisseria meningitidis. According to the U.S. Centers for Disease Control and Prevention, these diseases can be severe and potentially fatal, including infections of the brain and spinal cord (meningitis) and the bloodstream.