"Pfizer’s two-year run with the only 5-in-1 meningococcal vaccine on the U.S. market has come to an end. Now, GSK is ready to play catch up after nabbing its own FDA approval.
The FDA approved the British drugmaker's Penmenvy vaccine to protect people ages 10 to 25 against meningococcal serogroups A, B, C, W and Y (MenABCWY), which together cause the most invasive meningococcal disease (IMD) cases globally. The shot mixes the antigenic components of GSK’s established meningococcal vaccines Bexsero and Menveo, which target MenB and MenACWY, respectively, to offer broader coverage in fewer doses.
With the approval, GSK adds a key new option to its market-leading meningitis vaccine portfolio. In a phase 3 study, GSK's vaccine—given in two doses six months apart—showed immunological non-inferiority to one dose of Menveo. In addition, the shot elicited non-inferior immune responses against 110 MenB strains compared to two doses of Bexsero. Maximum protection is key for IMD, an “uncommon yet devastating disease,” Cindy Burman, GSK's U.S. medical affairs lead for its meningococcal portfolio, said in an interview. As it stands, vaccine uptake has been “relatively low,” with only 32% of adolescents having started their MenB vaccination series and less than 13% going on to complete the two-dose series, Burman explained.
Adults between the ages of 16 and 23 years are at a particularly high risk for the illness, which can be fatal in as little as 24 hours from onset, due to more common behaviors that help spread the bacteria, GSK noted in its release.
The current schedule for meningococcal vaccines is somewhat complex, and the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has issued a shared clinical decision-making recommendation for MenB vaccines. This means the vaccination decision for adolescents can be made together by vaccine recipients, parents and healthcare providers.
These factors, as well as “some confusion” on the available vaccines and the importance of getting both, contribute to the low uptake rates, according to Burman.
GSK’s pentavalent option comes well after vaccine rival Pfizer and its Penbraya hit the market in 2023. That shot similarly mixes components from the company’s other meningococcal vaccines, Trumenba and Nimenrix, to cover MenABCWY groups. Pfizer's shot is also approved as a two-dose series administered six months apart.
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ACIP has already discussed potentially adopting the same recommendation for Penmenvy that it issued for Penbraya, which covers 16-year-olds when both MenB and MenACWY vaccines are appropriate at the same doctor visit. GSK hopes that the committee will officially issue a similar decision at its next meeting on Feb. 26.
Despite Pfizer’s head start, GSK is expected to keep its spot in the meningococcal market lead, according to insights from Norstella's Evaluate Vantage. By 2030, Penmenvy should pick up blockbuster sales of $1.1 billion worldwide, while Penbraya is looking at $606 million that year, Evaluate Vantage forecasts. Even though Pfizer has had two years to carve out its own space, GSK’s version should benefit from the company’s leading position in the MenB and MenACWY spaces, Norstella’s VP of thought leadership, Daniel Chancellor, noted in his analysis.
The company’s two established vaccines continue to boost sales for GSK’s greater vaccine portfolio, with Bexsero crossing the $1 billion milestone in 2024 and Menveo adding 387 million euros ($406 million) in sales.