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SII’s MenFive receives WHO prequalification

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MenFive is currently undergoing an additional Phase 3 study in healthy children between 9 and 15 months of age in Mali, to examine MenFive’s safety and immunogenicity when administered alongside measles/rubella and yellow fever vaccine

MenFive, the first conjugate vaccine to protect against the five predominant causes of meningococcal meningitis in Africa has been prequalified by the World Health Organization (WHO). Developed through a 13-year collaboration between Serum Institute of India Pvt. Ltd. (SIIPL) and PATH, with crucial funding from the UK government’s Foreign, Commonwealth and Development Office, MenFive protects against meningococcal serogroups A, C, W, Y, and X and is designed to eliminate annual meningitis outbreaks and epidemics in the African meningitis belt—a string of 26 countries from Senegal and The Gambia in the west to Ethiopia in the east. It is also the only vaccine that prevents meningitis caused by meningococcal group X, a pathogen increasingly implicated in meningitis outbreaks in Africa.

WHO prequalification—which ensures a vaccine meets strict international quality, safety, and efficacy standards—was supported by extensive clinical studies in The Gambia, India, and Mali that demonstrated a high level of safety and immunogenicity. Importantly, prequalification allows MenFive to be procured by United Nations agencies and Gavi, The Vaccine Alliance.

Adar Poonawalla, CEO, Serum Institute of India, said, “MenFive is a game-changer vaccine developed through a powerful 13-year collaboration between SIIPL, PATH, and vital support from the UK government, in the fight against meningococcal meningitis in Africa. As the first conjugate vaccine to safeguard against the five predominant causes of this deadly disease, MenFive offers hope for a future free from annual outbreaks and epidemics in the African meningitis belt. It is a big moment as we, together, pave the way towards a healthier Africa, saving countless lives.”

MenFive builds on the legacy of MenAfriVac, SIIPL’s vaccine—developed in partnership with PATH and WHO—that eliminated serogroup A meningococcal meningitis outbreaks from the African meningitis belt following its 2010 introduction. MenFive is designed to prevent not just death from meningitis, but also disability in survivors who would suffer lifelong social and economic consequences. And, MenFive is expected to provide an affordable new intervention with two highly impactful health outcomes: 1) broad, highly effective direct protection against invasive meningococcal disease; and 2) indirect “herd” protection (to unvaccinated people) by markedly reducing the meningococci bacteria in the nose and throat that is key to transmission.

MenFive is approved by WHO for use in individuals 1 through 85 years of age and will initially be available for use in reactive vaccine campaigns for meningitis outbreaks. Discussions are currently underway among WHO, its partners, and affected countries as to the most effective strategy for controlling meningococcal meningitis with MenFive through a combination of proactive vaccination campaigns and as a replacement for MenAfriVac in the routine immunization schedule. Additionally, because MenFive is the only vaccine that protects against meningococcal serogroup X, it may have potential for use in other regions of the world.

MenFive is currently undergoing an additional Phase 3 study in healthy children between 9 and 15 months of age in Mali, to examine MenFive’s safety and immunogenicity when administered alongside measles/rubella and yellow fever vaccine. The study is being conducted by the Infectious Diseases Clinical Research Consortium in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Studies like this could help expand the availability of MenFive to ensure it protects as many people as possible and advance the goal of defeating meningococcal meningitis epidemics in Africa.

 

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