FDA Approves GSK’s PENMENVY 5-in-1 Meningococcal Vaccine
GSK plc (LSE/NYSE: GSK) has announced that the U.S. Food and Drug Administration (FDA) has approved its PENMENVY vaccine (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25. The vaccine protects against five key serogroups of Neisseria meningitidis (A, B, C, W, and Y), which are responsible for invasive meningococcal disease (IMD), a serious and often life-threatening infection.
Combination of Established Vaccines
PENMENVY combines the components of GSK’s two well-established meningococcal vaccines: BEXSERO (Meningococcal Group B Vaccine) and MENVEO (Meningococcal Groups A, C, W, and Y Conjugate Vaccine). This combination offers broad protection, making it the first pentavalent meningococcal vaccine. The approval followed positive results from two phase III trials (NCT04502693; NCT04707391), which assessed the safety, tolerability, and immune response of the vaccine in over 4,800 participants aged 10 to 25. These studies demonstrated that the vaccine’s safety profile was consistent with GSK’s previously licensed meningococcal vaccines.
A Step Forward in Protecting Adolescents and Young Adults
Tony Wood, Chief Scientific Officer at GSK, expressed enthusiasm for the approval, highlighting the opportunity to improve meningococcal vaccination coverage in the U.S. He noted that the approval especially addresses the significant risk posed by serogroup B, which is the leading cause of IMD among adolescents and young adults. Currently, less than 13% of this population receives the recommended two-dose MenB vaccine series, with only about 32% receiving at least one dose. With this new vaccine, GSK aims to make vaccination easier and more accessible by integrating MenABCWY into healthcare provider practices, ultimately offering protection against five meningococcal serogroups.
Addressing Unmet Needs in Disease Prevention
Judy Klein, President and Founder of Unity Consortium, a nonprofit organization focused on adolescent health, also welcomed the approval, emphasizing that meningococcal disease can have devastating consequences, including death and long-term complications. She highlighted that the new pentavalent vaccine would make it easier for adolescents to get the protection they need against all five serogroups.
Potential Impact on Public Health
The Centers for Disease Control and Prevention (CDC) has issued vaccination recommendations for protection against the five meningococcal serogroups targeted by the vaccine. As a result, integrating MenABCWY could significantly improve vaccination rates among U.S. adolescents. Three out of four MenB doses administered in the U.S. are manufactured by GSK, positioning the company as a leader in meningococcal vaccines. MenB vaccines must be completed with the same manufacturer’s vaccine, making GSK’s leadership in the U.S. market even more significant.
On February 26, 2025, the CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to vote on recommendations regarding the appropriate use of the MenABCWY vaccine for adolescents and young adults.
Understanding Invasive Meningococcal Disease (IMD)
Invasive meningococcal disease, though rare, is a serious and fast-progressing illness that can lead to death in up to one in six cases within 24 hours of symptom onset. Early symptoms are often mistaken for the flu, which can delay diagnosis and treatment. Survivors may experience long-term health issues such as brain damage, amputations, hearing loss, and nervous system complications. Adolescents and young adults, particularly those aged 16 to 23, are at higher risk for contracting IMD, especially in environments like college dormitories where the bacteria spread more easily through close contact, shared utensils, or smoking devices.
About PENMENVY
PENMENVY is an injectable vaccine designed for intramuscular use. It consists of a lyophilized MenACWY component (powder) and a liquid MenB component, which are combined just before administration. The vaccine is specifically approved in the U.S. for preventing invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged 10 to 25 years.
Important Safety Information
As with any vaccine, there are some safety considerations. PENMENVY should not be administered to individuals with a severe allergic reaction to the vaccine or its components. The vaccine may not provide full protection against all strains of serogroup B, and immunocompromised individuals may experience reduced immune responses. Additionally, a history of Guillain-Barré syndrome should be considered when administering the vaccine.
Common side effects after vaccination include pain at the injection site, fatigue, headache, myalgia, and nausea, with symptoms generally resolving within a few days.
About BEXSERO
BEXSERO, GSK’s Meningococcal Group B Vaccine, has been approved in over 55 countries and is used in 18 national immunization programs worldwide to prevent IMD caused by Neisseria meningitidis serogroup B. Since its launch in 2015, more than 110 million doses have been distributed globally, underscoring its impact in preventing disease.
