GSK's 5-in-1 Meningococcal Vaccine Candidate BLA Accepted by FDA: A Potential Game-Changer in IMD Prevention

The FDA sign.

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GSK announced on April 16, 2024, a significant milestone has been achieved in the development of a meningococcal vaccine candidate, as the FDA has accepted the Biologics License Application (BLA). The vaccine, called the 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate, is a promising advancement in preventing invasive meningococcal disease (IMD). A regulatory decision is expected by February 14, 2025, which marks an important step towards potential approval.

CDC recommends meningococcal vaccination for all preteens and teenagers and, in certain situations, recommends the vaccine for other children and adults as well.

The BLA submission was supported by compelling data from a pivotal phase III trial, where all primary endpoints were successfully met. GSK's 5-in-1 MenABCWY vaccine candidate combines the antigenic components of 2 established meningococcal vaccines, Bexsero and Menveo. This innovative approach targets the 5 main groups of Neisseria meningitidis bacteria (Men A, B, C, W, and Y) responsible for the majority of IMD cases worldwide.

IMD is a severe and unpredictable illness that can lead to life-threatening complications, with mortality rates as high as 1 in 6 among those affected. Death comes as early as 24 hours. Meningitis is a medical condition characterized by the inflammation of the lining surrounding the brain and spinal cord. This inflammation can cause pressure on the brain, leading to symptoms such as severe headache, stiff neck, sensitivity to light, drowsiness, and convulsions. The progression of meningitis can be very rapid and may result in serious complications, including deafness, blindness, epilepsy, and learning difficulties. In severe cases, meningitis can even lead to death.

The 5-in-1 MenABCWY vaccine candidate developed by GSK has a significant advantage of simplifying immunization efforts. By reducing the number of injections required, it aims to streamline the process of immunization. This vaccine combines the protection offered by multiple vaccines into fewer shots, which can potentially increase vaccination coverage and reduce the overall burden of IMD. Adolescents who are not vaccinated are particularly at risk of infection and potential outbreaks, and this vaccine can help protect them.

Despite efforts to increase vaccination rates, IMD remains a significant public health concern in the US. Meningococcal vaccine recommendations covering all 5 serogroups have been in place since 2015, but annual immunization rates have remained low overall, partly due to the complexity of the vaccination schedule.

The announcement said, “The trial conducted by GSK was a phase III randomized, controlled, observer-blind, multi-country trial to evaluate the safety, tolerability, and immunogenicity of GSK’s MenABCWY vaccine candidate. The trial started in August 2020, and approximately 3,650 participants aged 10-25 were enrolled in the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia.”

Of great concern is that MenB, the most prevalent group of bacteria causing IMD in adolescents and young adults in the US, accounts for more than 50% of all IMD cases in this age group from 2017 to 2021. Despite this, vaccination coverage against MenB is not optimal, with less than 12% of US adolescents receiving the recommended initial and booster doses.

Moving forward, the potential approval of GSK's 5-in-1 MenABCWY vaccine candidate represents a significant opportunity to address the ongoing challenges associated with IMD prevention. By offering a simplified and comprehensive vaccination solution, this vaccine has the potential to improve vaccination rates, reduce the burden of disease, and ultimately save lives.