SII, PATH Meningococcal Meningitis conjugate Vaccine receives WHO Prequalification

The World Health Organisation (WHO) has prequalified MenFive, the first conjugate vaccine to protect against the five most common causes of meningococcal meningitis in Africa. MenFive is a 13-year collaboration between Serum Institute of India Pvt Ltd (SII) and PATH, with critical funding from the UK government's Foreign, Commonwealth and Development Office. It is designed to eliminate annual meningitis outbreaks and epidemics in the African meningitis belt, which stretches from Senegal and The Gambia in the west to Ethiopia in the east.

WHO prequalification, which ensures that a vaccine meets strict international quality, safety, and efficacy standards, was backed up by extensive clinical trials in The Gambia, India, and Mali that demonstrated a high level of safety and immunogenicity. Importantly, prequalification allows United Nations agencies and Gavi, The Vaccine Alliance, to obtain MenFive. "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," said Adar Poonawalla, CEO of Serum Institute of India. “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. 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.