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On December 29, the National Medical Products Administration (NMPA) of China announced that the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 carrier) declared by CanSino Biotech has been approved
.
Public information shows that this is the tetravalent meningococcal conjugate vaccine Manhaixin independently developed by CanSino Bio.
Screenshot source: NMPA official website
Meningococcal meningitis is an acute and severe infectious disease caused by Neisseria meningitidis, which is transmitted through the respiratory tract or throat secretions of patients and carriers droplets, mainly by serogroups A, B, C, X, W135 or Y Cause
.
Children under 5 years of age, especially infants between 6 months and 2 years of age, have the highest incidence
According to CanSinoBio’s earlier press release, Manhaixin is a tetravalent meningococcal conjugate vaccine independently developed by the company.
It combines four common pathogenic meningococcal serogroups A, C, W135 and Y, respectively.
It is covalently bound with the carrier protein CRM197 to make the vaccine more extensive
.
At the same time, in the preparation process of the product, no preservative ingredients such as phenol are added, and no animal-derived ingredients are used, making the vaccine safer, environmentally friendly, and meeting the needs of special populations
In addition, the clinical trial results of Manhaixin showed that after 3 immunization procedures were used for 3 months old, 2 immunization procedures were used for 6-23 months of age, and 1 immunization procedure was used for healthy children aged 2-6 years.
All showed good safety and immunogenicity
.
In November 2019, CanSinoBio submitted Manhaixin's new drug registration application in China and was accepted.
The application was subsequently included in the priority review process by CDE on the grounds of "major special project"
.
According to the CDE announcement, this vaccine can produce a memory immune response after vaccination, which is used to prevent meningococcal meningitis caused by groups A, C, Y and W135
In July 2020, CanSino Bio and Pfizer signed a promotion service agreement.
Reference materials:
Reference materials:[1] On December 29, 2021, the drug approval document pending information is released.
[2] CanSinoBio's first domestic tetravalent meningococcal conjugate vaccine new drug registration application has been given priority review.
[3]CanSinoBio and Pfizer signed a promotion service agreement for a tetravalent meningococcal conjugate vaccine that is expected to be approved.
Retrieved Jul 26, 2020, from https://mp.
weixin.
qq.
com/s/Sg0-o1e0ctAgx8UVKgaevg
