AIM MCV4 vaccine clinical application has been accepted for CDE approval, coming into the frontiers

2021-11-27 Source:AIM Vaccine

Clinical test application for ACW135 meningococcal polysaccharide vaccine (MCV4) as independently developed by AIM Vaccine has been accepted by Center for Drug Evaluation, NMPA for approval. This indicates the initiation of formal approval of MCV4 for clinical tests. 

Presently, there are only three foreign enterprises engaged in production of MCV4 worldwide, and no product has been approved for listing in China. AIM Vaccine comes into the frontier in China in terms of R&D of such key product.

By using polysaccharide protein coupling technology, MCV4 independently developed by AIM Vaccine has realized grouping of common pathogenic meningococci serums as represented by A, C, W135 and Y for covalent bonding with carrier protein CRM197. As compared with MAV vaccines on sales in the market, it has more extensive protection scope and effect.

Epidemic cerebrospinal meningitis (known as ECM) is a serious infectious disease caused by neisseria meningitides. The incidence rate among children under 5 years old, especially infants under 12 months old is the highest in China. The program as issued by WHO to defeat meningitis in by 2030 advocates “elimination of meningitis as an epidemic disease to reduce the numbers cases and death toll of meningitis available for prevention with the help of vaccines by 80%”. 

34 countries worldwide have incorporated combined vaccines for 4v ECM into national immune planning. As indicated by AIM, MCV4 is expected to induce immune response among children under 2 years old. Such product will make up deficiencies to meningococcal vaccines for infants under 2 years old in China once approved for launch.