Surveillance of adverse events following immunization in China: Past, present, and future

Vaccine

Volumn 33, Issue 32, 2015, Pages 4041-4046

  Liu, Dawei ^a   Wu, Wendi ^a,b   Li, Keli ^a   Xu, Disha ^a   Ye, Jiakai ^a   Li, Li ^a   Wang, Huaqing ^a  

^a CHINESE CENTER FOR DISEASE CONTROL AND PREVENTION   (China)

^b TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

Author keywords

Adverse events following immunization (AEFI); Surveillance; Vaccination

Indexed keywords

VACCINE;

ADVERSE DRUG REACTION; ARTICLE; CHINA; DISEASE SURVEILLANCE; DRUG SURVEILLANCE PROGRAM; HEALTH SURVEY; HUMAN; IMMUNIZATION; INCIDENCE; INFORMATION SYSTEM; ONLINE SYSTEM; PRACTICE GUIDELINE; PREDICTIVE VALUE; PRIORITY JOURNAL; ADVERSE EFFECTS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EPIDEMIOLOGICAL MONITORING; PATHOLOGY;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CHINA; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EPIDEMIOLOGICAL MONITORING; HUMANS; IMMUNIZATION;

EID: 84937526232     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.04.060     Document Type: Article

References (43)

1. Black Steven, Zuber Patrick LF Global trends and challenges in vaccine safety. Pediatr Health 2009, 3(4):329-335.
2. Wilson Christopher B., Marcuse Edgar K. Vaccine safety-vaccine benefits: science and the public's perception. Nat Rev Immunol 2001, 1:160-165.
3. Griffin Marie R., Braun M.Miles, Bart Kenneth J. What should an ideal vaccine postlicensure safety system be?. Am J Public Health 2009, 99(S2):345-350.
4. Breugelmans Gabrielle J., Gessner Bradford Surveillance of serious adverse events following immunization in resource poor settings. BMC Proc 2011, 5(S1):32.
5. Cao L.-s., Yuan P. Thinking of China National Immunization Program information management system. Chin J Vaccines Immun 2010, 16(6):553-557.
6. Zheng J.-s., Zhou Y.-q., Wang H.-q., et al. The role of the China Experts Advisory Committee on Immunization Program. Vaccine 2010, 28(S1):84-87.
7. Guo B., Page Andrew, Wang H., et al. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China. Vaccine 2013, 31:603-617.
8. China Ministry of Health Regulations on appraisal and management of abnormal reactions following immunization 1980, China Ministry of Health, Beijing.
9. Guo B. Challenges, opportunities, and strategies on China National Immunization Program. Chin J Vaccines Immun 2006, 12(5):6.
10. World Health Organization, Western Pacific Regional Office Immunization safety surveillance: guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization 1999, World Health Organization, Manila.
11. Liu D.-W., Guo B., Cao L.-S., et al. Study on the surveillance of adverse events following immunization in China, 2005-2006. Chin J Vaccines Immun 2007, 13(6):505-513.
12. Yue C.-y., Li K.-l., Guo B., et al. Analysis on pilot surveillance counties of adverse events following immunization in China. Chin J Vaccines Immun 2012, 18(3):246-251.
13. Wu W.-D., Liu D.-W., Wu B.-B., Bao H.-H., Yue C.-Y., Lin P., et al. Analysis on the surveillance of adverse events following immunization in China, 2007-2008. Chin J Vaccines Immun 2009, 15(6):481-489.
14. Liang X.-F., Li L., Liu D.-W., et al. Safety of influenzaA (H1N1) vaccine in postmarketing surveillance in China. N Engl J Med 2011, 364(7):638-647.
15. China Ministry of Health, Food and Drug administration of China National guideline for the surveillance of adverse events following immunization 2010, China Ministry of Health, Food and Drug administration of China, Beijing.
16. Law on the Prevention and Treatment of Infectious Diseases of the People's Republic of China Order of the President of the People's Republic of China (no. 17) 2004, Law on the Prevention and Treatment of Infectious Diseases of the People's Republic of China, Beijing.
17. Drug Administration Law of the People's Republic of China Order of the President of the People's Republic of China (no. 45) 2001, Drug Administration Law of the People's Republic of China, Beijing.
18. Administrative Regulation on the Circulation of Vaccines and Vaccination State Council of the People's Republic of China (decree no. 434) 2005, Administrative Regulation on the Circulation of Vaccines and Vaccination, Beijing.
19. Regulations on Preparedness for and Responses to Public Health Emergencies State Council of the People's Republic of China (decree no. 376) 2003, Regulations on Preparedness for and Responses to Public Health Emergencies, Beijing.
20. Wu W.-D., Liu D.-W., Li K.-L., et al. Analysis on adverse events following immunization surveillance in China, 2009. Chin J Vaccines Immun 2011, 17(2):99-107.
21. Wu W.-D., Liu D.-W., Li K.-L., et al. Analysis on adverse events following immunization surveillance in China, 2010. Chin J Vaccines Immun 2012, 18(5):385-397.
22. Wu W.-D., Li K.-L., Zheng J.-s., et al. Analysis on surveillance data of adverse events following immunization in China, 2011. Chin J Vaccines Immun 2013, 19(2):97-109.
23. Wu W.-D., Liu D.-W., Li K.-L., et al. Analysis on surveillance data of adverse events following immunization in China, 2012. Chin J Vaccines Immun 2014, 20(1):1-12.
24. Wu W.-D., Liu D.-W., Li K.-L., et al. Analysis on the adverse event following immunization after supplementary immunization activity of measles contained vaccine in China, 2010. Chin J Vaccines Immun 2012, 18(5):402-407. 455.
25. Wang Yali, Dong Duo, Chen Gang, et al. Post-marketing surveillance live-attenuated Japanese encephalitis vaccine safety in China. Vaccine 2014, 32:5875-5879.
26. Isaacs David, Lawrence Glenda, Boyd Ian, et al. Reporting of adverse events following immunization in Australia. J Paediatr Child Health 2005, 41:163-166.
27. CDC The vaccine adverse event reporting system (VAERS) 2014, CDC, 〈http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/F/vaers-def.pdf〉 [assessed 3/11/2014].
28. Cao L., Zheng J.-s., Cao L.-s., et al. Analysis on the Coverage of National Immunization Program Vaccines Reported in China, 2012. Chin J Vaccines Immun 2013, 19(5):389-396.
29. Banks D., Woo E.J., Burwen D.R., et al. Comparing data mining methods on the VAERS database. Pharmacoepidemiol Drug Saf 2005, 14(9):601-609.
30. Singleton James A., Lloyd Jenifer C., Mootrey Gina T., et al. An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system. Vaccine 1999, 17:2908-2917.
31. Identification Methods for Adverse Reaction Following Immunization Order of the Ministry of Health of the People's Republic of China (no. 60) 2008, Identification Methods for Adverse Reaction Following Immunization, Beijing.
32. Bonhoeffer Jan, Heininger Ulrich Editorial: standardized case definitions of adverse events following immunization (AEFI). Vaccine 2004, 22:547-550.
33. Golda Michael S., Gidudu Jane, Erlewyn-Lajeunessec Mich, et al. Can the Brighton Collaboration case definitions be used to improve the quality of Adverse Event Following Immunization (AEFI) reporting? Anaphylaxis as a case study. Vaccine 2010, 28:4487-4498.
34. World Health Organization Immunization safety surveillance: guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization 2013, World Health Organization, Manila. 2nd ed. Western Pacific Regional Office WHO (Ed.).
35. Stephenson W.P., Hauben M. Data mining for signals in spontaneous reporting databases: proceed with caution. Pharmacoepidemiol Drug Saf 2007, 16(4):359-365.
36. Iskander J., Pool V., Zhou W., et al. Data mining in the US using the vaccine adverse event reporting system. Drug Saf 2006, 29(5):375-384.
37. Bate A., Lindquist M., Edwards I.R., et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 1998, 54(4):315-321.
38. Miller Matthew, Turner Nikki Suggestions for improving the monitoring of adverse events following immunization in New Zealand. NZMJ 2002, 115(1162):1-6.
39. Huang Y.-L., Moon Jinhee, Segal Jobi B. A comparison of active adverse event surveillance systems worldwide. Drug Saf 2014, 37:581-596.
40. Chen Robert T., Glasser John W., Rhodes Philip H., et al. Vaccine Safety Datalink Project: a New Tool for Improving Vaccine Safety Monitoring in the United States. Pediatrics 1997, 99:765-773.
41. Gold Michael, Dugdale Sarah, Woodman Richard J., et al. Use of the Australian Childhood Immunisation Register for vaccine safety data linkage. Vaccine 2010, 28:4308-4311.
42. Tu Haibo, Yu Yingtao, Yang Peng, et al. Building clinical data groups for electronic medical record in China. J Med Syst 2012, 36:723-736.
43. Ali Mohammad, Canh Do Gia, Clemens John D., et al. The vaccine data link in Nha Trang, Vietnam: a progress report on the implementation of a database to detect adverse events related to vaccinations. Vaccine 2003, 21:1681-1686.