Meningococcal vaccines in China

Figures & data

Figure 1. Reported meningococcal meningitis and death cases in China, 2002–2019

Red columns and the blue line represent the annual reported and death cases, respectively.

Figure 2. Number of lot release of different types of meningococcal vaccines in China, 2010–2019

Hib-MenAC represents a combination vaccine based on Haemophilus influenza type b (Hib) and meningococcal A and C polysaccharide conjugated with tetanus toxoid; MenPV and MenCV represent meningococcal polysaccharide vaccines and protein-polysaccharide conjugate vaccines, respectively.

Table 1. Quality control tests for the bulk of different meningococcal vaccines used in China

	Release specifications
Test	Serogroup A MenPV	Serogroup A/C MenPV	Serogroup A\C/Y/W135 MenPV	Serogroup A/C MenCV*
Bulk
Identity test	Positive	Positive	Positive	Positive
Phosphorus content (mg/g)	Serogroup A ≥ 80	Serogroup A ≥ 80	Serogroup A ≥ 80	Serogroup A ≥ 80
Sialic acid content (mg/g)	N/A	Serogroup C ≥ 800	Serogroup C ≥ 800; Both serogroup Y and W135 ≥ 560	Serogroup C ≥ 800
O-acetyl content (mmol/g)	≥ 2	Serogroup A ≥ 2; Serogroup C ≥ 1.5	Serogroup A ≥ 2; Serogroup C ≥ 1.5; Both serogroup Y and W135 ≥ 0.3	Serogroup A ≥ 2; Serogroup C ≥ 1.5
Protein content (mg/g)	< 10	Both < 8	Both serogroup A and C < 8; Both serogroup Y and W135 < 10	Both < 8
Nucleic acid (mg/g)	< 10	Serogroup A < 8; Serogroup C < 9	Both serogroup A and C < 8; Both serogroup Y and W135 < 10	Both < 8
Molecular size (KD)	≤ 0.4	Both ≤ 0.4	All ≤ 0.4	All ≤ 0.4
Distribution of molecular size (Recovery rate of KD < 0.5)	> 76%	Serogroup A > 76%; Serogroup C > 80%	Both serogroup A > 76%; Serogroup C, Y and W135 > 80%	Serogroup A > 76%; Serogroup C > 80%
Polysaccharide derivatization rate	N/A	N/A	N/A	Should meet approval requirements
Sterility test	Sterile	Sterile	Sterile	Sterile
Endotoxin test (EU/µg)	≤ 25	Both ≤ 12	All ≤ 12.5	Both ≤ 25

All data are from The Chinese Pharmacopoeia (2020 version) 3rd Part. MenPV and MenCV represents meningococcal polysaccharide vaccines and protein-polysaccharide conjugate vaccines, respectively; *The content of bound polysaccharide, free polysaccharide, protein, polysaccharide/protein ratio, molecular size distribution, and sterility tests are further required for the quality control of conjugated bulks,