An experimental meningococcal vaccine that protects against five strains of the bacteria succeeded in a Phase 3 clinical trial, Pfizer said Thursday, potentially offering an alternative to existing shots that cover fewer variants and require more doses.
By the end of the year, the drugmaker plans to ask the Food and Drug Administration to approve the shot, which combines components of two Pfizer protein-based vaccines, Nimenrix and Trumenba. An approval would help Pfizer expand its vaccine business, which is led by the COVID-19 shot Comirnaty and the pneumococcal vaccines Prevnar 13 and 20.
Infections with the Neisseria meningitidis bacteria can cause meningococcal disease, including the dangerous swelling of the brain lining and spinal column known as meningococcal meningitis. Shots including GSK’s Menveo protect against four strains of the bacteria called ACWY, while GSK’s Bexsero and Pfizer’s Trumenba guard against a type called serogroup B.
Under recommendations from the Centers for Disease Control and Prevention, children ages 11 or 12 should receive a four-strain primary vaccination, while those age 10 or older at high risk of infection should receive a vaccination against meningococcal infection from serogroup B.
Tested in volunteers age 10 to 25, Pfizer’s vaccine could serve as a single shot that covers all major age groups and strains. Moreover, FDA approval could help Pfizer expand its U.S. meningococcal vaccine sales, as Nimenrix is not currently included in CDC recommendations.
The trial in 2,431 volunteers tested two shots of Pfizer’s five-strain vaccine, called MenABCWY, against one shot of Menveo and two of Trumenba. On the primary measure of immune response to all five strains, MenABCWY was statistically similar, or “non-inferior,” to the three-shot regimen, Pfizer said. MenABCWY had similar side effects to the licensed vaccines, the company added.
Pfizer recorded Nimenrix sales of $142 million through the first six months of 2022, up 49% over the $95 million sales of the first six months of 2021. Pfizer doesn’t break out sales of Trumenba, but its “other vaccines” line was $78 million for the first six months of 2022.
By comparison, GSK had sales of 447 million British pounds, or $579 million, from its meningitis vaccine business, while Sanofi had sales of 265 million euros, or $265 million, in the first six months of 2022.
GSK also has a five-strain vaccine in development, with a large Phase 3 trial due to report data soon.
Meningitis isn’t the only area where Pfizer and GSK are competing to get a new vaccine to market. Along with Johnson & Johnson and Moderna, the two are nearing FDA submission for a shot against respiratory syncytial disease.