Research Progress in Methods of Risk & Benefit Assessment of Vaccines

doi:10.19803/j.1672-8629.2021.11.22

Abstract

Abstract: The way in which the risk & benefit of vaccines are assessed has become an important means by which regulators and vaccine manufactures assess vaccines. Currently, foreign methods of assessment of the risk & benefit of vaccines are not yet full-fledged and there are no universally-used ones. The methods of quality-adjusted life years and multi-criteria decision-making method were prevalent. the World Health Organization (WHO) developed the Global Benchmark Tool for the national regulatory system for medical products to assess national regulatory systems for vaccines, including requirements related to the risk & benefit assessment of vaccines. China is to gradually establish and improve methods of assessment of the risk & benefit vaccines. Meanwhile, regulatory authorities, public health institutions and vaccine manufacturers should build a shared data platform to provide more evidence, promote vaccine assessment and improve China's vaccine regulatory systems.

Key words: vaccines, risk benefit assessment, quality-adjusted life year, multi-criteria decision-making

CLC Number:

R186

LIU Chunguang, LIANG Gongshan, XU Changqing. Research Progress in Methods of Risk & Benefit Assessment of Vaccines[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1097-1100.

References

[1] WHO. Immunization[EB/OL].(2020-03-13)[2020-07-16]. https://www.who.int/topics/immunization/en/.
[2] Chen RT, Glanz JM, Vellozzi C.Pharmacoepidemiologic studies of vaccine safety[J]. Pharmacoepidemiology, 2012, 5(1):423-468.
[3] European Medicines Agency. Guideline on good pharmacovigilance practices. Vaccines for prophylaxis against infectious diseases[EB/OL].(2013-05-10)[2020-10-16].https://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/12/WC500157839.pdf.
[4] Schosser R.Risk/benefit evaluation of drugs: The role of the pharmaceutical industry in Germany[J]. Eur Surg Res, 2002, 34(1-2):203-205.
[5] Mt-Isa S, Hallgreen CE, Wang N, et al.Balancing benefit and risk of medicines: a systematic review and classification of available methodologies[J]. Pharmacoepidemiol Drug Saf, 2014. 23(7): 667-678.
[6] Pitman R, Fisman D, Zaric GS, et al.Dynamic transmission modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-5[J]. Value Health, 2012,15(6): 828-834.
[7] Zhou N, Xu HM.Research progress (onf BCG)) in children[J]. Journal of Pediatric Pharmacy, 2021, 27(3): 34-36.
[8] Clark M, Cameron DW.The benefits and risks of bacille Calmette-Guerin vaccination among infants at high risk for both tuberculosis and severe combined immunodeficiency: assessment by Markov model[J]. BMC Pediatr, 2006, 6: 5.
[9] Claxton K, Paulden M, Gravelle H, et al.Discounting and decision making in the economic evaluation of health-care technologies[J]. Health Econ, 2011, 20(1): 2-15.
[10] Goyal R.BCG vaccination in BCG scar negative children[J]. Indian Pediatrics, 1998, 6(32): 67.
[11] Brisson M, Van de Velde N, Boily MC. Different population-level vaccination effectiveness for HPV types 16, 18, 6 and 11[J].Sex Transm Infect, 2011, 87(1): 4143.
[12] Tang M, Yang Y, Hu SL.Theoretical basis and progress of multi-criteria decision analysis in healthcare decision-making[J]. Chinese Health Resources,2020,23(4):325-331.
[13] EMA. Launch of European project for monitoring benefits and risks of vaccines throughout their lifecycle[EB/OL].(2013-11-26)[2020-10-19]. https://www.ema.europa.eu/en/news/launch-european-project-monitoring-benefits-risks-vaccines-throughout-their-lifecycle.
[14] IMI mission and objectives Europe's partnership for health[EB/OL]. (2020-03-31) [2020-11-10]. https://www.imi.europa.eu/.
[15] Key organisations unite to improve benefit & risk assessments of vaccines ADVANCE project factsheet[EB/OL]. (2013-11-26) [2021-02-10]. https://www.imi.europa.eu/news-events/press-releases/key-organisations-unite-improve-benefit-risk-assessments-vaccines.
[16] WHO. List of vaccine producing countries with functional NRAs [EB/OL]. (2016-12-26) [2021-03-10]. https://www.who.int/initiatives/who-listed-authority-reg-authorities/list-of-vaccine-prod-countries.
[17] Gong L, Pan LY, Liu Y.Detection and evaluation of post-marketing safety alert signals for human papillomavirus 9-valent vaccine based on US vaccine adverse event reporting system (VAERS)[J]. Chinese Journal of Pharmacovigilance, 2019, 16(8): 478-488.
[18] Accelerated development of vaccine benefit-risk collaboration in Europe [EB/OL].(2019-03-31)[2020-11-10]. https://www.imi.europa.eu/projects-results/project-factsheets/advance.
[19] Pearce A, Marshall H, Bedford H, et al.Barriers to childhood immunisation: findings from the longitudinal study of australian children[J]. Vaccine, 2015, 33(29): 3377-3383
[20] Ruderfer D, Krilov LR.Vaccine-preventable outbreaks: still with us after all these years[J]. Pediatr Ann, 2015, 44(4): 76-81
[21] Weinstein MC, Siege JE, Gold MR, et al.Recommendations of the panel on cost-effectiveness in health and medicine[J].JAMA,1996,12(4):1253-1258.
[22] Jit M, Mibei W.Discounting in the evaluation of the cost-effectiveness of a vaccination programme: a critical review[J].Vaccine, 2015, 33(32): 3788-3794.