GSK has shared pivotal data that could help fend off Pfizer’s attack on its blockbuster vaccine franchise. The phase 3 results show the five-in-one meningitis vaccine is immunologically effective against the most common strains, keeping GSK tucked in behind Pfizer in the race to market.
Currently, GSK’s Bexsero competes against Pfizer’s Trumenba for the meningococcal B vaccine market. GSK also makes Menveo, a vaccine against meningococcal groups A, C, W-135 and Y. Sanofi competes with Menveo through its MenACWY vaccines Menactra and MenQuadfi. Pfizer is aiming to disrupt the market with a shot that protects against the serogroups A, B, C, W and Y and is under review at the FDA.
GSK, which generated blockbuster sales from its meningitis franchise last year, has a rival MenABCWY that is nipping at the heels of Pfizer’s candidate. Having reported a phase 3 win in March, GSK used an infectious disease meeting to share the results of the study on Friday.
The study compared the investigational MenABCWY vaccine to the combination of Bexsero and Menveo. GSK found its vaccine candidate was noninferior to the Bexsero-Menveo combination in people aged 10 to 25 years across all five of the targeted serotypes. A separate confirmatory arm of the trial found the MenABCWY candidate showed effectiveness against a panel of 110 meningococcal serogroup B strains.
With the panel accounting for 95% of strains circulating in the U.S., GSK sees the confirmatory arm as evidence of the ability of the vaccine to protect people from the pathogen. The arm used the broadest panel of circulating meningitis strains to date, GSK Chief Scientific Officer Tony Wood, Ph.D., said in a statement.
GSK is working with regulatory agencies to review the data. If the MenABCWY vaccine comes to market, GSK thinks it could increase vaccination coverage—which for meningitis B currently languishes at 31% among adolescents in the U.S.—by simplifying immunization schedules. Pfizer has the same idea and, with a FDA decision date for its filing set for October, is the current front-runner.