Pfizer has secured a significant regulatory victory in the race to introduce the first five-pronged meningitis vaccine in the United States, gaining FDA approval for their pentavalent vaccine, known as Penbraya. This vaccine effectively safeguards against the most common serogroups responsible for meningococcal disease among adolescents and adults aged 10 to 25.
Penbraya represents a fusion of elements from Pfizer’s existing meningococcal vaccines, Trumenba and Nimenrix, offering protection against serogroups A, B, C, W, and Y. These serogroups collectively account for the majority of invasive meningococcal disease cases. Previously, immunization against all five groups required two separate vaccines, entailing four separate injections. A pivotal point of Pfizer’s marketing strategy for Penbraya is its unique characteristic of only requiring two doses, simplifying the standard of care and potentially increasing vaccination rates.
The FDA granted Pfizer this regulatory win based on findings from both phase 2 and phase 3 trials, including a late-stage study that compared Pfizer’s pentavalent vaccine with other meningitis vaccines already approved in the US.
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In addition to Pfizer, GSK’s Bexsero has been a rival in the market for meningococcal B vaccines, contending with Trumenba. Furthermore, GSK manufactures Menveo, a vaccine designed to combat meningococcal groups A, C, W-135, and Y. However, Pfizer now stands ready to disrupt this market with a vaccine offering protection against serogroups A, B, C, W, and Y in a single shot.
Beyond the FDA’s approval, the CDC’s advisory committee on immunization practices is set to evaluate how Pfizer’s vaccine should be utilized on October 25.
While Pfizer’s approval has given Penbraya a head start in the market, GSK is not far behind with its own pentavalent contender, referred to as MenABCWY. In May, GSK revealed results of a study comparing their investigational MenABCWY vaccine with a combination of Bexsero and Menveo. GSK’s research found their vaccine candidate to be noninferior to the Bexsero-Menveo combination for individuals aged 10 to 25 years across all five targeted serotypes. This competition promises exciting developments in the field of meningitis vaccines.
