Sanofi Healthcare India has submitted the application for grant of permission to import Meningococcal vaccine but the subject expert committee of CDSCO requires further information to grant permission.
Sanofi Healthcare India has submitted the application for grant of permission to import Meningococcal Polysaccharide (Serogroups A, C, Y and W135) Tetanus Toxoid Conjugate Vaccine along with Phase III Global Clinical Study Report titled “Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in healthy adults, adolescents, and children in India and healthy adolescents and children in the Republic of South Africa”.
Meningococcal polysaccharide vaccines are used to prevent infection from certain groups of Neisseria meningitidis bacteria, which can cause serious illnesses like meningitis and meningococcemia.
After detailed deliberation, the Subject Expert Committee (SEC) noted the results of the Phase III Global Clinical Study and recommended that the firm should submit additional information for further deliberation.
SED suggested that the firm should submit the non-inferiority of hSBA vaccine sero- protection after vaccination for Indian population of 2–17 years age group. And the firm should submit the comparability clinical trial data summary of Indian and global population for the age group of above 55 years.
The Meeting of SEC - Vaccine to review proposals and advice Drugs Controller General (India) in matters for Biologicals & PAC proposals was held on 29.04.2025
