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

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.

[1]  Antonio E Pérez,et al.  Vaccine-related adverse events in Cuban children, 1999-2008. , 2012, MEDICC review.

[2]  Cao Ling-sheng.  Comparative Study on Post-marketing Immunization Safety of Absorbed Diphtheria,Tetanus and Acellular Pertusis Combined Vaccine,and Absorbed Diphtheria,Tetanus and Whole-cell Pertusis Combined Vaccine in China , 2008 .

[3]  Sun Yin-qi.  Study on the Surveillance of Adverse Events Following Immunization in Hebei Province in 2005-2007 , 2008 .

[4]  T. Monath.  Review of the risks and benefits of yellow fever vaccination including some new analyses , 2012, Expert review of vaccines.

[5]  D. Moher,et al.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement , 2009, BMJ : British Medical Journal.

[6]  Wen-di Wu,et al.  [Analysis on the surveillance of adverse events following immunization in China, 2007-2008]. , 2009, Zhongguo yi miao he mian yi.

[7]  van der Maas Nat,et al.  Adverse events following immunization under the National Vaccination Programme of the Netherlands : Number XVI-Reports in 2009 , 2010 .

[8]  G. Lawrence,et al.  Surveillance of adverse events following immunisation for children aged less than 7 years, 1 January to 30 June 2004. , 2004, Communicable diseases intelligence quarterly report.

[9]  P. Azzopardi,et al.  Bacille Calmette-Guérin vaccine-related disease in HIV-infected children: a systematic review. , 2009, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease.

[10]  F. Cui,et al.  [Evaluation on impact of hepatitis B vaccine integrated into routine immunization in the areas of Ministry of Health/Global Alliance for Vaccine and Immunization (GAVI) Cooperation Project P.R. China]. , 2009, Zhongguo yi miao he mian yi.

[11]  U. Heininger,et al.  Surveillance for adverse events following immunization (AEFI) in Switzerland--1991-2001. , 2010, Vaccine.

[12]  M. Bonnet,et al.  World wide experience with inactivated poliovirus vaccine. , 2008, Vaccine.

[13]  E. Waldman,et al.  Vigilância de eventos adversos pós-vacinação e segurança de programas de imunização Surveillance of adverse effects following vaccination and safety of immunization programs , 2011 .

[14]  S. Bawikar,et al.  Surveillance of adverse events following immunization: 10 years' experience in Oman. , 2010, Eastern Mediterranean health journal = La revue de sante de la Mediterranee orientale = al-Majallah al-sihhiyah li-sharq al-mutawassit.

[15]  T. Williamson,et al.  Active and passive surveillance of yellow fever vaccine 17D or 17DD-associated serious adverse events: systematic review. , 2011, Vaccine.

[16]  S. Halperin,et al.  Acellular vaccines for preventing whooping cough in children. , 2014, The Cochrane database of systematic reviews.

[17]  Guo Biao.  Challenges,Opportunities,and Strategies on China National Immunization Program , 2006 .

[18]  D. Isaacs,et al.  Surveillance of adverse events following immunisation: Australia 2002 to 2003. , 2004, Communicable diseases intelligence quarterly report.

[19]  T. Jefferson,et al.  Unintended events following immunization with MMR: a systematic review. , 2003, Vaccine.

[20]  U. Moretti,et al.  Consultancy and surveillance of post-immunisation adverse events in the Veneto region of Italy for 1992-2008 , 2011, Human vaccines.

[21]  Cao Lei.  Data Analysis of National Pilot Surveillance of Adverse Events Following Immunization , 2007 .

[22]  Li Ke-li.  Analysis on Adverse Events Following Immunization Surveillance in China,2009 , 2011 .

[23]  T. Hovi.  Inactivated poliovirus vaccine and the final stages of poliovirus eradication. , 2001, Vaccine.

[24]  S. Rosenthal,et al.  The safety of acellular pertussis vaccine vs whole-cell pertussis vaccine. A postmarketing assessment. , 1996, Archives of pediatrics & adolescent medicine.

[25]  X. Liang,et al.  The role of the China Experts Advisory Committee on Immunization Program. , 2010, Vaccine.

[26]  Cao Ling-sheng.  Study on the Surveillance of Adverse Events Following Immunization in China,2005-2006 , 2007 .

[27]  Robert T. Chen,et al.  Morbidity and Mortality Weekly Report , 2002 .

[28]  Beibei Lu,et al.  Efficacy and Safety of Prophylactic Vaccines against Cervical HPV Infection and Diseases among Women: A Systematic Review & Meta-Analysis , 2011, BMC infectious diseases.

[29]  Stefania Salmaso,et al.  Vaccine adverse event monitoring systems across the European Union countries: time for unifying efforts. , 2009, Vaccine.

[30]  Ma Fu-bao.  Analysis and evaluation on the surveillance data of adverse events following immunization in 2008 in Jiangsu Province , 2010 .

[31]  W. Dowdle,et al.  Post-eradication poliovirus facility-associated community risks. , 2006, Biologicals : journal of the International Association of Biological Standardization.

[32]  L. Camacho,et al.  Surveillance system of vaccine adverse events and local data analysis--the experience in a middle-sized city in Brazil, 1999-2001. , 2005, Vaccine.

[33]  E. Waldman,et al.  Surveillance for adverse events after DTwP/Hib vaccination in Brazil: sensitivity and factors associated with reporting. , 2010, Vaccine.

[34]  Zheng Yin-ji.  Analysis on Immunization Safety in Shanghai in 2006 , 2008 .

[35]  F. Zhu.  Pertussis booster vaccine in China , 2011, Human vaccines.

[36]  Weizhong Yang,et al.  Progress toward measles elimination in the People's Republic of China, 2000-2009. , 2011, The Journal of infectious diseases.

[37]  R. Menzies,et al.  NSW Annual Adverse Events Following Immunisation Report, 2009. , 2010, New South Wales public health bulletin.

[38]  Yu Wang,et al.  Epidemiological serosurvey of hepatitis B in China--declining HBV prevalence due to hepatitis B vaccination. , 2009, Vaccine.

[39]  C. Ham.  Another five year plan for the NHS , 2009, BMJ : British Medical Journal.

[40]  Philippe Duclos,et al.  Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS , 2009, Expert review of vaccines.

[41]  Weizhong Yang,et al.  Safety of influenza A (H1N1) vaccine in postmarketing surveillance in China. , 2011, The New England journal of medicine.

[42]  M. Gold,et al.  Local reactions after the fourth dose of acellular pertussis vaccine in South Australia , 2003, The Medical journal of Australia.

[43]  D. Moher,et al.  Reprint--preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. , 2009, Physical therapy.

[44]  E. A. Waldman,et al.  Vigilância de eventos adversos pós-vacinação e segurança de programas de imunização , 2011 .

[45]  H. Bernstein,et al.  Safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis B, and inactivated polio vaccine coadministered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine. , 2007, Vaccine.

[46]  R. Menzies,et al.  Supplementary report: surveillance of adverse events following immunisation among children aged less than seven years in Australia, 1 January to 30 June 2009. , 2011, Communicable diseases intelligence quarterly report.

[47]  D. Isaacs,et al.  Annual report: surveillance of adverse events following immunisation in Australia, 2004. , 2010, Communicable diseases intelligence quarterly report.

[48]  M. Jing.  Measles Epidemiological Characteristics and Progress of Measles Elimination in China, 2010 , 2011 .