Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China

Guo, Biao, Page, Andrew, Wang, Huaqing, Taylor, Richard and McIntyre, Peter (2013) Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China. Vaccine, 31 4: 603-617. doi:10.1016/j.vaccine.2012.11.051


Author Guo, Biao
Page, Andrew
Wang, Huaqing
Taylor, Richard
McIntyre, Peter
Title Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China
Journal name Vaccine   Check publisher's open access policy
ISSN 0264-410X
1873-2518
Publication date 2013-01-11
Year available 2012
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1016/j.vaccine.2012.11.051
Volume 31
Issue 4
Start page 603
End page 617
Total pages 15
Place of publication London, United Kingdom
Publisher Elsevier
Collection year 2013
Language eng
Formatted abstract
Background: China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse.

Objectives: To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally.

Methods: Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages.

Results:
Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3–37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria–tetanus–pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3–181.1/100,000 doses for DTwP; range 3.5–92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world.

Conclusions: Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration.
Keyword Immunization programs
Adverse events following immunization
Systematic review
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Available online 29 November 2012

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Official 2013 Collection
School of Public Health Publications
 
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Created: Wed, 16 Jan 2013, 10:00:16 EST by Geraldine Fitzgerald on behalf of School of Public Health