In the race to secure U.S. approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK.
Friday, the U.S. FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. The shot is approved for adolescents and adults between the ages of 10 and 25.
Penbraya mixes components from two of the company’s other meningococcal vaccines—Trumenba and Nimenrix—which together tackle serogroups A, B, C, W and Y.
Those serogroups account for nearly all invasive meningococcal disease. Prior to Pfizer’s Penbraya approval, protection from all five groups required four injections from two separate vaccines.
Chief to Pfizer’s marketing pitch for Penbraya is that the shot needs only be administered twice. The company figures this feature will streamline standard of care and potentially boost the number of people who get vaccinated.
The FDA handed Pfizer its regulatory win based on results from the company’s phase 2 and phase 3 trials, which included a late-stage study pitting Pfizer’s pentavalent shot against other meningitis vaccines currently approved in the U.S.
Besides Pfizer, GSK’s Bexsero has competed with Trumenba for the meningococcal B vaccine market. GSK also makes Menveo, a vaccine against meningococcal groups A, C, W-135 and Y.
Sanofi separately markets its own MenACWY vaccines called Menactra and MenQuadfi.
Now, though, Pfizer is poised to disrupt the market with a shot that protects against the serogroups A, B, C, W and Y.
Beyond the shot’s approval, the Centers for Disease Control and Prevention’s advisory committee on immunization practices is set to weigh in on how Pfizer’s vaccine should be used on Oct. 25.
While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor, coded MenABCWY.
In May, GSK unveiled study results pitting the investigational MenABCWY vaccine against a 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.