FDA Approves GSK’s 5-in-1 Meningococcal Vaccine

On Feb. 14, 2025, British pharmaceutical and biotechnology company GSK plc announced that the U.S. Food and Drug Administration (FDA) approved its 5-in-1 meningococcal vaccine PENMENVY for licensure and use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of the bacterium Neisseria meningitidis (A, B, C, W, and Y), which is believed to commonly cause invasive meningococcal disease.¹

Prior to the approval of GSK’s meningococcal vaccine PENMENVY, Pfizer’s PENBRAYA™ was the other 5-in-1 meningococcal vaccine available targeting the five serogroups causing meningococcal disease, which was licensed by the FDA on Oct. 20, 2023 for use in adolescents and young adults aged 10 through 25 years.²

A 2019 study published in the journal Open Forum Infectious Diseases found that the frequency of invasive meningococcal disease had decreased sharply since 1977. In the United States, the annual incidence rate varies in multiyear cyclical waves, from 0.5 to 2.0 cases per 100, 000 people.³

GSK’s MenABCWY (PENMENVY) vaccine combines two of its meningococcal vaccines, BEXSEROand MENVEO, into a single 5-in-1 formulation. GSK said that the goal of this approach is to reduce the number of injections, simplifying the process of vaccination to incentivize completion of the two-dose series and increase vaccination coverage. They added that by streamlining the process, their goal is to reduce the overall burden of invasive meningococcal disease among unvaccinated adolescents who are at greater risk of infection and the reduce the potential for outbreaks.⁴

In the U.S., while meningococcal vaccine recommendations for all five serogroups have been in place since 2015, overall vaccination rates for invasive meningococcal disease remain low. GSK says this is partly due to the complex vaccination schedule. MenB is the most common cause of invasive meningococcal disease among U.S. adolescents and young adults, accounting for more than half of the cases in this group from 2017 to 2021. The U.S. Centers for Disease Control and Prevention (CDC) recommends meningococcal vaccinations for all adolescents, although fewer than 12 percent of U.S. adolescents have received two doses of the MenB vaccine.⁵

PENMENVY Can Cause Series Adverse Reactions

According to the package insert on the FDA’s website, the following side effects have been reported after the approval of GSK’s BEXSERO or MENVEO vaccines. These are important to note because PENMENVY contains the same components as these vaccines. Since the adverse effects were reported voluntarily from an unknown number of people, it is not always possible to accurately determine how often they occur.

Some of the adverse effects reported after meningococcal vaccines include lymphadenopathy, hearing impairment, ear pain, vertigo, vestibular disorder, eyelid ptosis, injection site reactions (including injection site pruritus, pain, erythema, inflammation, swelling, extensive swelling of the vaccinated limb, blisters at or around the injection site, and injection site nodule which may persist for more than one month), fatigue, malaise, pyrexia, allergic reactions, anaphylactic reactions, eye swelling, rash, hypersensitivity reactions, anaphylaxis, vaccination site cellulitis, head injury, alanine aminotransferase increase, body temperature increase, arthralgia, bone pain, dizziness, syncope, tonic convulsion, headache,  facial paresis,  balance disorder, vasovagal responses to injection, oropharyngeal pain, and skin exfoliation.⁶

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