SII, PATH meningococcal meningitis conjugate vaccine receives WHO prequalification

Pune: MenFive, the first conjugate vaccine to protect against the five predominant causes of meningococcal meningitis in Africa, has been prequalified by the World Health Organisation (WHO). Developed through a 13-year collaboration between Serum Institute of India Pvt Ltd (SII) 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 is a much-required medical intervention that will be available at an extremely affordable price,” said Dr Rajeev Dhere, Executive Director, SII. “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.”

“This landmark scientific achievement will have huge implications for improving public health,” said Andrew Mitchell, International Development Minister, UK. “Having access to a new, affordable vaccine will save lives, prevent long-term illness, and move us closer to defeating meningitis by 2030. I am incredibly proud that the UK has supported PATH and the Serum Institute of India in this major achievement.”

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.

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.

“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,” said Dr Bill Hausdorff, Director, 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.”

“Meningococcal meningitis has long been a torment for meningitis belt countries,” said Dr Nanthalile Mugala, Chief, Africa Region, PATH. “The 2010 introduction of meningococcal A vaccine—which eliminated meningitis A epidemics from the African meningitis belt—was a landmark achievement that showed freedom from meningococcal meningitis was possible. But it was only the beginning of the story. With MenFive, we now have the potential to finally end all meningococcal meningitis epidemics in Africa, once and for all.”

MenFive is designed to prevent not just death from meningitis, but also disability in survivors who would suffer lifelong social and economic consequences. The vaccine 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 one 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 immunisation schedule. Additionally, because MenFive is the only vaccine that protects against meningococcal serogroup X, it may have the potential for use in other regions of the world.

MenFive® is currently undergoing an additional Phase 3 study in healthy children between nine and 15 months of age in Mali, to examine the vaccine’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.