Multivalent meningococcal meningitis vaccine from Serum Institute of India achieves WHO prequalification
Conjugation chemistry developed at Fina Biosolutions and exclusively licensed to the Serum Institute of India Pvt. Ltd. (SIIPL) is used link proteins to each of the meningococcal polysaccharides of MenFive®. The high efficiency of the chemistry, along with their considerable bioprocessing capabliities, are key to SIIPL creating a highly effective and low-cost conjugate vaccine.
A key step forward in protecting African meningitis belt countries from deadly and debilitating meningitis epidemics
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).
Developed through a 13-year collaboration between Serum Institute of India Pvt Ltd (SIIPL) 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 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.”
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 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.