WHO prequalifies meningococcal meningitis vaccine developed by Serum Institute and PATH

The World Health Organization (WHO) has prequalified the first conjugate vaccine against meningococcal meningitis named MenFive. Developed by Pune-based Serum Institute of India in a 13-year collaboration with PATH, a global non-profit, it is designed to safeguard against the five primary causes of the deadly disease in Africa. Crucial funding for its development came from the UK government’s Foreign, Commonwealth and Development Office. 

Meningococcal meningitis is a rapidly progressing bacterial infection that can prove fatal within hours, posing severe risks of brain damage, sepsis, and limb amputation, with a fatality rate of 50% if left untreated. While anyone can contract meningococcal meningitis, children under the age of five, especially infants, are most susceptible to its severe effects. 

The WHO prequalification means that the vaccine adheres to strict international quality, safety, and efficacy standards and allows MenFive to be procured by United Nations agencies and Gavi, The Vaccine Alliance. The prequalification was supported by extensive clinical studies conducted in The Gambia, India, and Mali. 

Traditionally, polysaccharide vaccines have been used in response to African meningitis epidemics. However, these vaccines offer only short-term protection, fail to promote herd immunity, and generally do not effectively safeguard infants and children aged under two. In contrast, conjugate vaccines like MenFive provide better and longer-lasting protection against meningococcal disease, the company said in a statement. 

SII said MenFive provides comprehensive protection against meningococcal serogroups A, C, W, Y, and X, aiming to eliminate the annual outbreaks and epidemics that afflict the African meningitis belt, which spans 26 countries from Senegal and The Gambia to Ethiopia. MenFive, as per claims, is the only vaccine capable of preventing meningitis caused by meningococcal group X, a pathogen increasingly implicated in outbreaks on the African continent. 

Calling it a “game-changer,” Adar Poonawalla, the CEO of SII, said, “There is hope for a future free from annual outbreaks and epidemics in the African meningitis belt, saving countless lives.” 

Although multivalent meningococcal conjugate vaccines that protect against serogroup A, C, W, and Y have been available globally for many years, they have remained unaffordable for countries in the meningitis belt. As a result, approximately 450 million individuals remain at risk of death or severe disability due to meningococcal disease. 

“MenFive is a much-required medical intervention that will be available at an extremely affordable price,” said Dr Rajeev Dhere, Executive Director of SII. 

MenFive is an advanced vaccine that builds upon the success of MenAfriVac, a vaccine that eliminated meningococcal meningitis outbreaks caused by serogroup A in the African meningitis belt following its introduction in 2010. MenFive goes beyond preventing deaths from meningitis; it also aims to protect survivors from lifelong social and economic consequences due to disability. 

This new vaccine is expected to have two significant health outcomes. First, it provides broad and highly effective direct protection against invasive meningococcal disease. Second, it offers indirect “herd” protection by reducing the transmission of meningococci bacteria in the nose and throat, benefiting unvaccinated individuals. 

MenFive has been approved by the WHO for use in individuals aged 1 to 85. Initially, it will be available for use in reactive vaccine campaigns during meningitis outbreaks. 

Currently, MenFive is undergoing an additional Phase 3 study in healthy children aged 9 to 15 months in Mali. The study, conducted by the Infectious Diseases Clinical Research Consortium in collaboration with the National Institute of Allergy and Infectious Diseases, aims to examine the safety and immunogenicity of MenFive when administered alongside measles/rubella and yellow fever vaccines.