New Delhi: Serum Institute of India’s (SII’s) 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).
Conjugate vaccine is a type of shot that uses part of a germ to prevent a disease. A WHO prequalification — which ensures a vaccine meets strict international quality, safety, and efficacy standards — allows MenFive to be procured by United Nations agencies and Gavi, The Vaccine Alliance, thus ensuring it reaches the most impoverished beneficiaries at no cost.
MenFive was developed through a 13-year collaboration between SII and the US-based global nonprofit PATH, with crucial funding from the UK government’s Foreign, Commonwealth and Development Office.
It offers protection 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. The prequalification was supported by extensive clinical studies in the Gambia, India, and Mali that, researchers said, demonstrated a high level of safety and immunogenicity.
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, SII said in a statement, adding that 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 have been known to provide better, longer-lasting protection against meningococcal disease (any illness caused by bacteria Neisseria meningitidis, often severe), it said.
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‘A turning point’
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 immunisation strategies — leaving 450 million people at risk of death or severe disability due to meningococcal disease.
MenFive is also the only vaccine that prevents meningitis caused by meningococcal group X, a pathogen increasingly implicated in meningitis outbreaks in Africa.
“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 of PATH’s meningitis vaccine development projects, in a statement.
“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.”
SII CEO Adar Poonawalla said that “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,” he added.
SII executive director Dr Rajeev Dhere described MenFive as a “much-required medical intervention that will be available at an extremely affordable price”.
The vaccine has been approved by the WHO for use in individuals aged 1 to 85, 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 on the most effective strategy for controlling meningococcal meningitis with the vaccine through a combination of proactive vaccination campaigns and as a replacement for other vaccines in the routine immunisation schedule.
(Edited by Sunanda Ranjan)
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