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.