GSK gets ready for its next big vaccine launch
Vaccines production line at GSK facility in Wavre, Belgium
GSK has garnered FDA approval for its pentavalent meningococcal vaccine Penmenvy, tipped as one of its major launches for 2025 and a rival to Pfizer's first-to-market Penbraya.
The shot protects against common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y), covering five of the six serogroups that cause most disease worldwide, with the B, C, and Y strains responsible for most cases of invasive meningococcal disease (IMD) encountered in the US.
According to the company, it reduces the number of injections needed and will help "improve vaccination rates and…protect more US adolescents and young adults" from the potentially devastating disease.
Penmenvy is a combination of GSK's already-approved vaccines Bexsero and Menveo, which together brought in more than £1.4 billion (around $1.8 billion) in sales last year with double-digit growth across all regions of the world and Bexsero topping the £1 billion sales threshold for the first time.
Pfizer's Penbraya also combines elements from its older meningococcal vaccines Trumenba (MenACWY) and Nimenrix (MenB), which have trailed behind GSK shots commercially since launch.
The five-in-one vaccine was approved in 2023 but hasn't made a major impact in the market yet, with sales not yet reaching a level to warrant being broken out in Pfizer's financial results, while Trumenba and Nirmenrix collectively contributed $300 million in 2023 but have been in decline.
FDA approval of Penmenvy comes on the back of phase 3 trials, which showed that two doses of the jab given six months apart were at least as effective at stimulating immunity against the target strains as GSK's current vaccines given separately.
While meningococcal vaccine recommendations for all five serogroups have been in place since 2015 in the US, annual immunisation rates for IMD have remained low overall. GSK said that less than 13% of adolescents currently receive the recommended two-dose vaccination series, while around 32% receive at least one dose.
GSK's chief scientific officer Tony Wood said Penmenvy can, in particular, play a role in reducing IMD caused by serogroup B, adding: "We aim to help protect more teens and young adults at a life stage when they are at an increased risk," he noted.
The company has previously said that the vaccine is one of its most important product launches for 2025, with the potential to make $1 billion to $2 billion in sales at its peak.
With FDA approval in hand, all eyes now are on the recommendations on Penmenvy's use from the CDC's Advisory Committee on Immunisation Practices (ACIP), which will determine how it may be used in clinical practice at a meeting scheduled for 26th February.
The MenABCWY shot's importance to GSK's vaccine business has increased since the ACIP changed its stance on respiratory syncytial virus (RSV) jabs – where GSK also competes head-to-head with Pfizer – narrowing its recommendations for both their products.
