سال 14، شماره 1 - ( بهمن و اسفند 1398 )                   جلد 14 شماره 1 صفحات 17-29 | برگشت به فهرست نسخه ها


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Nafian F, Nafian S, Kamali Doust Azad B. Regulatory and Biosafety Challenges for Vaccines. Iran J Med Microbiol. 2020; 14 (1) :17-29
URL: http://ijmm.ir/article-1-835-fa.html
نافیان فاطمه، نافیان سیمین، کمالی دوست آزاد بابک. چالش‌های نظارتی و ایمنی‌زیستی واکسن‌ها. مجله میکروب شناسی پزشکی ایران. 1398; 14 (1) :17-29

URL: http://ijmm.ir/article-1-835-fa.html


1- گروه بیوتکنولوژی پزشکی، دانشکده علوم پزشکی، دانشگاه تربیت مدرس، تهران ایران ، f.nafian@modares.ac.ir
2- گروه ژنتیک مولکولی، پژوهشگاه ملی مهندسی ژنتیک و زیست‌فناوری، تهران، ایران
3- گروه نانوبیوالکترونیک، دانشکده مهندسی برق و کامپیوتر، دانشگاه تهران، ایران
چکیده:   (292 مشاهده)
برنامه جهانی نظارت بر تولید و توسعه واکسن‌ها، امکان دسترسی به انواع ایمن و کارآمد آن را باکیفیت تضمین‌شده فراهم می‌‌آورد. در این برنامه، چالش‌های مرتبط با فناوری‌های سنجش محصولات جدید بررسی می‌شود و درک جامع‌تری نیز از سود و زیان محصولات حال حاضر به دست می‌آید. در نظارت آزمایشگاهی، روابط حاکم بر ایمنی و سلامت ارزیابی و خواص محصول و توانمندی سنجش آنها بهبود داده می‌شود. سپس روش‌های بالینی آنالیز سود-زیان واکسن‌ها و استانداردسازی فرایند نظارتی طراحی می‌شود. هدف از دستورالعمل جهانی نظارت، تبدیل تلاش‌های فعلی آژانس‌های نظارتی به یک طرح اجرایی هماهنگ در حمایت از اهداف ایمن‌سازی جهانی است. در این مقاله، نقش دانش نظارت برای دسترسی مناسب‌تر‌ به واکسن موثر تفسیر و شکاف‌های موجود در آن شناسایی بیان‌شده است. همچنین، چالش‌های پیاده‌سازی یک دستورالعمل واحد، بررسی و استراتژی رفع این نقایص مطرح می‌‌شود. هدف از ایجاد این دستورالعمل جهانی نیز اجرای اقدامات متحولانه توسط ناظران، دانشگاهیان و سایر ذینفعان است تا در حمایت از اهداف جهانی ایمن‌سازی واکسن‌ها، فرایندهای نظارتی هماهنگ داشته باشند.
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نوع مطالعه: مروری | موضوع مقاله: بیوتکنولوژی میکروبی
دریافت: ۱۳۹۸/۲/۳۰ | پذیرش: ۱۳۹۸/۵/۲۹ | انتشار الکترونیک: ۱۳۹۸/۱۲/۲۴

فهرست منابع
1. Nguyen M, Ball R, Midthun K, Lieu TA. The Food and Drug Administration's Post‐Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise. Pharmacoepidemiology and drug safety. 2012;21(S1):291-7. [DOI:10.1002/pds.2323] [PMID]
2. Burwen DR, Sandhu SK, MaCurdy TE, Kelman JA, Gibbs JM, Garcia B, et al. Surveillance for Guillain-Barre syndrome after influenza vaccination among the Medicare population, 2009-2010. American journal of public health. 2012;102(10):1921-7. [DOI:10.2105/AJPH.2011.300510] [PMID] [PMCID]
3. Destefano F, Vellozzi C. Facilitators Report, Lessons learned exercise, ECDC Vaccine Adverse Event Surveillance and Communication:(VAESCO II) project, Stockholm: European Centers for Disease Control and Prevention. 2009 [cited 2015 August 11].
4. Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: regulatory need. Arabian Journal of Chemistry. 2017;10:S3412-S25. [DOI:10.1016/j.arabjc.2014.01.025]
5. Schmeisser F, Vodeiko GM, Lugovtsev VY, Stout RR, Weir JP. An alternative method for preparation of pandemic influenza strain-specific antibody for vaccine potency determination. Vaccine. 2010;28(12):2442-9. [DOI:10.1016/j.vaccine.2009.12.079] [PMID]
6. Hardy S, Eichelberger M, Griffiths E, Weir JP, Wood D, Alfonso C. Confronting the next pandemic-workshop on lessons learned from potency testing of pandemic (H1N1) 2009 influenza vaccines and considerations for future potency tests, Ottawa, Canada, July 27-29, 2010. Influenza and other respiratory viruses. 2011;5(6):438-42. [DOI:10.1111/j.1750-2659.2011.00250.x] [PMID] [PMCID]
7. Lee M-S, Tseng F-C, Wang J-R, Chi C-Y, Chong P, Su I-J. Challenges to licensure of enterovirus 71 vaccines. PLoS neglected tropical diseases. 2012;6(8):e1737. [DOI:10.1371/journal.pntd.0001737] [PMID] [PMCID]
8. Mao Q, Li N, Yu X, Yao X, Li F, Lu F, et al. Antigenicity, animal protective effect and genetic characteristics of candidate vaccine strains of enterovirus 71. Archives of virology. 2012;157(1):37-41. [DOI:10.1007/s00705-011-1136-3] [PMID]
9. Luo S, Wu F, Ye X, Tao F, Tao J, Luo W, et al. Safety Comparison of Two Enterovirus 71 (EV71) Inactivated Vaccines in Yiwu, China. J Trop Pediatr. 2019. [DOI:10.1093/tropej/fmz004] [PMID]
10. Liang Z, Mao Q, Gao Q, Li X, Dong C, Yu X, et al. Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines. Vaccine. 2011;29(52):9668-74. [DOI:10.1016/j.vaccine.2011.10.018] [PMID]
11. Slomski A. Vaccines for Enterovirus 71. JAMA. 2014;311(16):1602-. [DOI:10.1001/jama.2014.4453]
12. Mao QY, Liao XY, Xiang YU, Nan LI, Zhu FC, Ying ZE, Liang ZL, Li FX, Wang JZ, Lu FM, Zhuang H. Dynamic change of mother-source neutralizing antibodies against enterovirus 71 and coxsackievirus A16 in infants. Chinese medical journal. 2010 Jul 1;123(13):1679-84.
13. Artaud C, Kara L, Launay O. Vaccine Development: From Preclinical Studies to Phase 1/2 Clinical Trials. Malaria Control and Elimination: Springer; 2019. p. 165-76. [DOI:10.1007/978-1-4939-9550-9_12] [PMID]
14. Cox MM. Recombinant protein vaccines produced in insect cells. Vaccine. 2012;30(10):1759-66. [DOI:10.1016/j.vaccine.2012.01.016] [PMID]
15. Graham BS, Mascola JR, Fauci AS. Novel vaccine technologies: essential components of an adequate response to emerging viral diseases. JAMA. 2018;319(14):1431-2. [DOI:10.1001/jama.2018.0345] [PMID]
16. Gristwood A. Fresh approaches to vaccine development. EMBO reports. 2018;19(8). [DOI:10.15252/embr.201846675] [PMID] [PMCID]
17. Barb AW, Freedberg DI, Battistel MD, Prestegard JH. NMR detection and characterization of sialylated glycoproteins and cell surface polysaccharides. Journal of biomolecular NMR. 2011;51(1-2):163. [DOI:10.1007/s10858-011-9550-0] [PMID] [PMCID]
18. An Y, Cipollo JF. An unbiased approach for analysis of protein glycosylation and application to influenza vaccine hemagglutinin. Analytical biochemistry. 2011;415(1):67-80. [DOI:10.1016/j.ab.2011.04.018] [PMID]
19. Haverland NA, Fox HS, Ciborowski P. Quantitative proteomics by SWATH-MS reveals altered expression of nucleic acid binding and regulatory proteins in HIV-1-infected macrophages. Journal of proteome research. 2014;13(4):2109-19. [DOI:10.1021/pr4012602] [PMID] [PMCID]
20. Onions D, Cote C, Love B, Toms B, Koduri S, Armstrong A, et al. Ensuring the safety of vaccine cell substrates by massively parallel sequencing of the transcriptome. Vaccine. 2011;29(41):7117-21. [DOI:10.1016/j.vaccine.2011.05.071] [PMID]
21. Uhlenhaut C, McClenahan S, Krause PR. Use of DOP-PCR in non-specific virus detection. PDA J Pharm Sci Technol. 2011;65(6):681-4. [DOI:10.5731/pdajpst.2011.00842] [PMID]
22. Victoria JG, Wang C, Jones MS, Jaing C, McLoughlin K, Gardner S, et al. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. Journal of virology. 2010;84(12):6033-40. [DOI:10.1128/JVI.02690-09] [PMID] [PMCID]
23. Baylis SA, Finsterbusch T, Bannert N, Blümel J, Mankertz A. Analysis of porcine circovirus type 1 detected in Rotarix vaccine. Vaccine. 2011;29(4):690-7. [DOI:10.1016/j.vaccine.2010.11.028] [PMID]
24. Gilliland SM, Forrest L, Carre H, Jenkins A, Berry N, Martin J, et al. Investigation of porcine circovirus contamination in human vaccines. Biologicals. 2012;40(4):270-7. [DOI:10.1016/j.biologicals.2012.02.002] [PMID]
25. Sahoo MK, Holubar M, Huang C, Mohamed-Hadley A, Liu Y, Waggoner JJ, et al. Detection of emerging vaccine-related polioviruses by deep sequencing. J Clin Microbiol. 2017;70(2):2162-5. [DOI:10.1128/JCM.00144-17] [PMID] [PMCID]
26. Zaitseva M, Romantseva T, Blinova K, Beren J, Sirota L, Drane D, et al. Use of human MonoMac6 cells for development of in vitro assay predictive of adjuvant safety in vivo. Vaccine. 2012;30(32):4859-65. [DOI:10.1016/j.vaccine.2012.05.002] [PMID]
27. Grohskopf LA. Prevention and control of seasonal influenza with vaccines. MMWR Recommendations and Reports. 2016;65-70. [DOI:10.15585/mmwr.rr6505a1] [PMID]
28. Wang TT, Palese P. Catching a moving target. Science. 2011;333(6044):834-5. [DOI:10.1126/science.1210724] [PMID]
29. Ovsyannikova IG, Poland GA. Vaccinomics: current findings, challenges and novel approaches for vaccine development. The AAPS journal. 2011;13(3):438-44. [DOI:10.1208/s12248-011-9281-x] [PMID] [PMCID]
30. Chen RT, Shimabukuro TT, Martin DB, Zuber PL, Weibel DM, Sturkenboom M. Enhancing vaccine safety capacity globally: A lifecycle perspective. Vaccine. 2015;33:46-54. [DOI:10.1016/j.vaccine.2015.06.073] [PMID] [PMCID]
31. Heyse J, Chan I. Review of statistical innovations in trials supporting vaccine clinical development. Statistics in Biopharmaceutical Research. 2016;8(1):128-42. [DOI:10.1080/19466315.2015.1093540]
32. Ball R, Horne D, Izurieta H, Sutherland A, Walderhaug M, Hsu H. Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration. Pediatrics. 2011;127(1):31-8. [DOI:10.1542/peds.2010-1722F] [PMID]
33. Bauch CT, Bhattacharyya S, Ball RF. Rapid emergence of free-riding behavior in new pediatric immunization programs. PLoS One. 2010;5(9):e12594. [DOI:10.1371/journal.pone.0012594] [PMID] [PMCID]
34. Martin D, Menschik D, Bryant-Genevier M, Ball R. Data mining for prospective early detection of safety signals in the Vaccine Adverse Event Reporting System (VAERS): a case study of febrile seizures after a 2010-2011 seasonal influenza virus vaccine. Drug safety. 2013;36(7):547-56. [DOI:10.1007/s40264-013-0051-9] [PMID]
35. Chakra CNA, Pariente A, Pinet M, Nkeng L, Moore N, Moride Y. Case series in drug safety. Drug Saf. 2010;33(12):1081-8. [DOI:10.2165/11539300-000000000-00000] [PMID]
36. Hüllermeier E. Case-based approximate reasoning: Springer Science & Business Media; 2007.
37. Markatou M, Don PK, Hu J, Wang F, Sun J, Sorrentino R, et al. Case-based reasoning in comparative effectiveness research. IBM Journal of Research and Development. 2012;56(5):4: 1-4: 12. [DOI:10.1147/JRD.2012.2198311]
38. Ball R, Botsis T. Can network analysis improve pattern recognition among adverse events following immunization reported to VAERS? Clinical Pharmacology & Therapeutics. 2011;90(2):271-8. [DOI:10.1038/clpt.2011.119] [PMID]
39. Botsis T, Nguyen MD, Woo EJ, Markatou M, Ball R. Text mining for the Vaccine Adverse Event Reporting System: medical text classification using informative feature selection. Journal of the American Medical Informatics Association. 2011;18(5):631-8. [DOI:10.1136/amiajnl-2010-000022] [PMID] [PMCID]
40. Pratt JW, Raiffa H, Schlaifer R. Introduction to statistical decision theory: MIT press; 1995.
41. Weissmahr RN, Schüpbach J, Böni J. Reverse transcriptase activity in chicken embryo fibroblast culture supernatants is associated with particles containing endogenous avian retrovirus EAV-0 RNA. Journal of Virology. 1997;71(4):3005-12. [DOI:10.1128/JVI.71.4.3005-3012.1997] [PMID] [PMCID]
42. World Health Organization. Reverse transcriptase activity in chicken-cell derived vaccine: WHO consultation, April 1998. Weekly Epidemiological Record= Relevé épidémiologique hebdomadaire. 1998;73(28):209-12.
43. Elmgren L, Li X, Wilson C, Ball R, Wang J, Cichutek K, et al. A global regulatory science agenda for vaccines. Vaccine. 2013;31(1):163-75. [DOI:10.1016/j.vaccine.2012.10.117] [PMID]
44. Duclos P. National Immunization Technical Advisory Groups (NITAGs): guidance for their establishment and strengthening. Vaccine. 2010;28(1):18-25. [DOI:10.1016/j.vaccine.2010.02.027] [PMID]
45. Ricciardi G, Toumi M, Weil-Olivier C, Ruitenberg E, Dankó D, Duru G, et al. Comparison of NITAG policies and working processes in selected developed countries. Vaccine. 2015;33(1):3-11. [DOI:10.1016/j.vaccine.2014.10.035] [PMID]
46. Adjagba A, Senouci K, Biellik R, Batmunkh N, Faye PC, Durupt A, et al. Supporting countries in establishing and strengthening NITAGs: lessons learned from 5 years of the SIVAC initiative. Vaccine. 2015;33(5):588-95. [DOI:10.1016/j.vaccine.2014.12.026] [PMID]
47. Chumakov KM. Methods to monitor molecular consistency of oral polio vaccine. Poliovirus: Methods and Protocols. 2016:263-77. [DOI:10.1007/978-1-4939-3292-4_14] [PMID]
48. Marko-Varga Gr, Baker MS, Boja ES, Rodriguez H, Fehniger TE. Biorepository regulatory frameworks: building parallel resources that both promote scientific investigation and protect human subjects. Journal of proteome research. 2014;13(12):5319-24. [DOI:10.1021/pr500475q] [PMID]
49. Graham JE, Borda-Rodriguez A, Huzair F, Zinck E. Capacity for a global vaccine safety system: the perspective of national regulatory authorities. Vaccine. 2012;30(33):4953-9. [DOI:10.1016/j.vaccine.2012.05.045] [PMID]
50. Yu YB, Taraban MB, Wang W, Briggs KT. Improving biopharmaceutical safety through verification-based quality control. Trends Biotechnol. 2017;35(12):1140-55. [DOI:10.1016/j.tibtech.2017.08.010] [PMID]
51. Zimmer J, Vieths S, Kaul S. Standardization and regulation of allergen products in the European :union:. Current allergy and asthma reports. 2016;16(3):21. [DOI:10.1007/s11882-016-0599-4] [PMID]
52. Commission EP, Medicines EDftQo, Healthcare. European pharmacopoeia: Council of Europe; 2010.
53. Cruz-Aponte M. Metapopulation and Non-proportional Vaccination Models Overview. Advances in the Mathematical Sciences. 2016,1(3):187-207888. [DOI:10.1007/978-3-319-34139-2_8]

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