Multivalent meningococcal meningitis vaccine from SII achieves WHO prequalification

New Delhi [India], July 25 : 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)
According to Adar Poonawalla, CEO, Serum Institute of India, MenFive is a game changer vaccine, "MenFive is a game-changer vaccine developed through a powerful 13-year collaboration between Serum Institute of India Private Limited (SIIPL) , PATH, and vital support from the UK government, in the fight against meningococcal meningitis in Africa."
PATH is a global nonprofit dedicated to achieving health equity.
"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," Poonawala said
"MenFive is a much-required medical intervention that will be available at an extremely affordable price", said Dr Rajeev Dhere, Executive Director of SIIPL.
"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," he added.
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.
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 per cent of cases if untreated. Anyone can contract meningococcal meningitis but children under age five—especially infants—are likely to suffer the most severe effects.1.
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 two 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.
"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," reads the statement.