GSK prepares for major vaccine launch with Penmenvy

USA – Global pharmaceutical company GSK has received approval from the U.S. Food and Drug Administration (FDA) for its new meningococcal vaccine, Penmenvy.

This five-in-one vaccine is expected to be one of GSK’s biggest product launches in 2025 and will compete with Pfizer’s Penbraya, which was approved in 2023 but has yet to make a major impact in the market.

Penmenvy provides protection against five of the six serogroups of Neisseria meningitidis—A, B, C, W, and Y.

These strains are responsible for most cases of invasive meningococcal disease (IMD) worldwide, with B, C, and Y being the most common in the U.S.

The vaccine is designed to reduce the number of injections needed, making it more convenient and potentially increasing vaccination rates among adolescents and young adults.

According to GSK, Penmenvy combines components from its two already-approved vaccines, Bexsero and Menveo, which together generated over £1.4 billion (US $1.8 billion) in sales last year, with Bexsero alone surpassing the £1 billion mark for the first time.

This strong market presence positions Penmenvy as a major competitor to Pfizer’s Penbraya, which combines elements from its older vaccines, Trumenba (MenB) and Nimenrix (MenACWY).

However, Pfizer’s meningococcal vaccines have not performed as well commercially, contributing only US $300 million in sales in 2023, and showing signs of decline.

The FDA’s approval of Penmenvy is based on successful Phase 3 trials, which demonstrated that two doses, given six months apart, were at least as effective in stimulating immunity as GSK’s existing vaccines given separately.

Despite vaccine recommendations for all five serogroups being in place since 2015, overall vaccination rates remain low in the U.S.

Currently, less than 13% of adolescents receive the recommended two-dose series, while around 32% get at least one dose.

GSK’s Chief Scientific Officer, Tony Wood, emphasized the importance of Penmenvy in protecting against serogroup B infections, which pose a higher risk to teenagers and young adults.

“We aim to help protect more teens and young adults at a life stage when they are at an increased risk,” he said.

GSK has identified Penmenvy as a key product for 2025, with the potential to reach peak sales of US $1 billion to US $2 billion.

Now that the vaccine has FDA approval, the next crucial step is securing recommendations from the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). Their meeting on February 26 will determine how Penmenvy will be used in clinical settings.

The success of Penmenvy is particularly significant for GSK following recent shifts in CDC recommendations for respiratory syncytial virus (RSV) vaccines, where GSK competes directly with Pfizer.

With these changes affecting the RSV market, Penmenvy is now seen as a vital part of GSK’s vaccine portfolio moving forward.