Serum Institute's multivalent meningococcal meningitis vaccine gets WHO prequalification

The Serum Institute of India (SII), world's largest vaccine maker by volumes on Wednesday said its vaccine to protect against the five predominant causes of meningococcal meningitis in Africa has been prequalified by the World Health Organisation (WHO), making the vaccine eligible to be procured by United Nations agencies and Gavi, the Vaccine Alliance.

The MenFive vaccine has been developed through a 13-year collaboration between the Serum institute and PATH, a global nonprofit, with funding from the UK government’s Foreign, Commonwealth and Development Office.

The prequalification by WHO, which ensures a vaccine meets strict international quality, safety, and efficacy standards, was supported by extensive clinical studies in Gambia, India, and Mali.


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.

“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,” Adar Poonawalla, CEO of SII.

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.

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.

SII said 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 SII's MenAfriVac in the routine immunization schedule. Additionally, because MenFive is the only vaccine that protects against meningococcal serogroup X, it may have potential for use in other regions of the world.