Multivalent Meningococcal Meningitis Vaccine From Serum Institute of India Gets WHO Prequalification
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). The vaccine is 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.
Meningococcal meningitis is a bacterial infection that sets in rapidly and can kill within hours. It can cause severe brain damage and sepsis leading to limb amputation and is fatal in 50 percent of cases if untreated. Anyone can contract meningococcal meningitis but children under age five—especially infants—are likely to suffer the most severe effects.
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 is a much-required medical intervention that will be available at an extremely affordable price,” says Dr Rajeev Dhere, Executive Director of SIIPL. “Making sure vaccines are available to those who need them most is a philosophy SIIPL has followed with all our products and continues to follow with MenFive,” he added.
Meningococcal meningitis is a bacterial infection that sets in rapidly and can kill within hours. It can cause severe brain damage and sepsis leading to limb amputation and is fatal in 50 percent of cases if untreated. Anyone can contract meningococcal meningitis but children under age five—especially infants—are likely to suffer the most severe effects.
Polysaccharide vaccines have traditionally been used in response to African meningitis epidemics, but they have limitations. They only provide short-term protection, don’t promote herd immunity and are not generally effective in infants and children younger than 2 years of age. Conjugate vaccines provide better, longer lasting protection against meningococcal disease.
Multivalent meningococcal conjugate vaccines that protect against serogroup A, C, W, and Y have been available on the global market for decades, but they aren’t affordable for meningitis belt countries to include in their meningitis prevention strategies—leaving 450 million people at risk of death or severe disability due to meningococcal disease.
“The prequalification of MenFive represents a turning point for the African meningitis belt and a step forward in the global effort to Defeat Meningitis by 2030,” says Dr Bill Hausdorff, director of PATH’s meningitis vaccine development projects. “The introduction of new multivalent meningococcal conjugate vaccines is a key strategy for bacterial meningitis prevention and control. MenFive is a critical addition to the toolbox that will save thousands of lives every year.”
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.
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.
