Meningococcal group B vaccine(Pfizer Inc.)

GSK’s five-in-one meningococcal vaccine Penmenvy has been approved by the US Food and Drug Administration (FDA) for use in individuals aged from ten to 25 years. Invasive meningococcal disease (IMD) is an uncommon but serious illness caused by the bacterium Neisseria meningitidis. It is a major cause of meningitis and septicaemia, and can result in long-term consequences such as neurological damage, amputations and hearing loss. Although anyone can contract IMD, babies, young children and those who are in their late teens and early adulthood are among those at the highest risk. GSK’s Penmenvy combines the antigenic components of its approved Bexsero and Menveo meningococcal vaccines to target five common IMD-causing serotypes (A, B, C, W and Y). It is hoped that the combination vaccine will simplify meningococcal delivery and lead to higher vaccine uptake. The FDA’s decision was supported by positive results from two late-stage trials, which evaluated Penmenvy’s safety, tolerability and immune response in over 4,800 people aged ten to 25 years. GSK’s chief scientific officer, Tony Wood, said the company is “excited about the opportunities ahead to help improve meningococcal vaccination coverage in the US, especially for IMD caused by serogroup B”. Also commenting on the approval, Judy Klein, president and founder of Unity Consortium, a non-profit organisation focused on adolescent health and immunisation in the US, said: “The consequences of IMD can be devastating for those who contract it, for their families and friends”. She continued: “Pentavalent menABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.” The authorisation follows the FDA’s approval of Pfizer’s pentavalent meningococcal vaccine in October 2023. Like Penmenvy, Penbraya combines the components from Pfizer’s Trumenba and Nimenrix meningococcal vaccines to protect against serotypes A,B, C, W and Y. The US Centers for Disease Control and Prevention, which has noted that combining vaccines may mean that more adolescents and young adults get their recommended vaccines on time, will now meet to discuss recommendations for the appropriate use of Penmenvy.

GSK's pentavalent vaccine offers protection against the five most common serogroups that cause invasive meningococcal disease. 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 noninferiority to one dose of Menveo. In addition, the shot elicited noninferior 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. The 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 Pharma. By 2030, Penmenvy should pick up blockbuster sales of $1.1 billion worldwide, while Penbraya is looking at $606 million that year, Evaluate 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 vice president 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.