Acellular pertussis vaccines in China

Lichan Wang1, Dianliang Lei, Shumin Zhang

  • 1Serum Division, National Institutes for Food and Drug Control, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Bejing 10050, China.

Vaccine
|October 23, 2012
PubMed

Insights

China

Area of Science:

  • Vaccinology
  • Immunology
  • Public Health

Background:

  • Whole-cell pertussis (Pw) vaccines were produced in China from the early 1960s.
  • Acellular pertussis (Pa) vaccines were introduced in 1995 and have largely replaced Pw vaccines.
  • A vaccine lot release system was established in 2001 to strengthen vaccine regulation.

Purpose of the Study:

  • To describe the current status of acellular pertussis (Pa) vaccine production in China.
  • To outline the quality control measures implemented for Pa vaccines.
  • To analyze quality control test data for Pa vaccines from 2006 to 2010.

Main Methods:

  • Review of Pa vaccine production processes in China.
  • Description of quality control testing protocols.
  • Analysis of historical quality control data (2006-2010).

Main Results:

  • Pa vaccines have been integrated into China's national immunization program.
  • Pa vaccines have been subject to lot release testing since 2006.
  • Analysis of quality control data from 2006-2010 provides insights into vaccine quality.

Conclusions:

  • The implementation of a vaccine lot release system enhances the regulation of pertussis vaccines in China.
  • The data analyzed reflects the quality control status of acellular pertussis vaccines in China.
  • Continued monitoring and analysis of vaccine quality are crucial for public health.