当前位置:
首页
网刊
科学监管提高疫苗可及性
科学监管提高疫苗可及性
陈思伊1,2,张 彩1,2,黄小芬1,3,王 鑫1,3,赵勤俭1,3

1 厦门大学国家传染病诊断试剂与疫苗工程技术研究中心,厦门大学分子疫苗学与分子诊断学 国家重点实验室,厦门 361102;2 厦门大学生命科学学院,厦门 361102; 3 厦门大学公共卫生学院,厦门 361102
Enhanced vaccine accessibility through innovative regulatory sciences
(1 National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key  Laboratory of Molecular Vaccinology and Molecular Diagnostics, Xiamen 361102, China;  2 School of Life Science, Xiamen University, Xiamen 361102, China; 3 School of Public Health,  Xiamen University, Xiamen 361102, China)

摘要参考文献相关文章

起始页:2369

摘要:[摘要] 疫苗储存运输要遵循冷链运输(cold chain, CC)的要求,这很大程度上限制了疫苗的接种和普及,尤其是在那些贫困偏远地区。为扩大疫苗可及性,世界卫生组织(World Health Organization, WHO)于2012年首次提出了受控温度链(controlled temperature chain, CTC)法规,即在政府部门和WHO的监管下,在有充分热稳定性数据支持的前提下,若申报CTC的疫苗在不低于40 ℃下存放至少3 d后仍能保证效力,则该疫苗在免疫供应链后期无需冷链运输。CTC法规已成功应用在包括MenAfriVac在内的4个商品化疫苗上。本文介绍了CTC法规的内容和应用情况,通过科学监管提高疫苗可及性,减少不必要的浪费。

关键词:[关键词] 疫苗;科学监管;受控温度链;可及性;接种推广

通讯作者:

基金项目:

作者简介:

Abstract:[Abstract] The need to keep vaccine in a traditional cold chain (CC) is a constraining factor for many immunization campaigns, particularly in the resource-limited countries. Increased flexibility with an approach newly introduced in 2012 was implemented with meningitis a vaccine, MenAfriVac, across sub-Saharan Africa, after thorough review of the scientific data by regulatory authorities and World Health Organization (WHO). This approach was termed “controlled temperature chain” (CTC) by allowing the vaccines to be exposed at temperatures of up to 40 ℃ for a minimum of three days prior to the administration of the vaccine. There are four vaccines were licensed for CTC, including MenAfriVac. This article introduces the details and the applications of CTC. More efforts are underway to fully realize the potentials of the CTC strategy for increased vaccine accessibility and reduced wastage.

Key words:[Key words] vaccine; regulatory sciences; controlled temperature chain; accessibility; immunization campaign

    [1] ORGANIZATION WH. Immunization[EB/OL]. World Health Organization, 2016.http://www.who.int/topics/immunization/en/.
    [2] 吴星, 邵杰, 张军楠,等. 疫苗诱导机体免疫应答机制研究[J]. 微生物学免疫学进展, 2013,41(5): 47-50.
    [3] RANI MD. Cold chain-vaccine stability [J]. Int J Sci Res, 2016, 5(6): 344-346.
    [4] REN Q, XIONG H, LI Y, et al. Evaluation of an outside-the-cold-chain vaccine delivery strategy in remote regions of western China[J]. Public Health Reports, 2009, 124(5): 745-750.
    [5] ATEUDJIEU J, KENFACK B, NKONTCHOU BW, et al. Program on immunization and cold chain monitoring: the status in eight health districts in Cameroon[J]. BMC Res Notes, 2013, 6(1): 1-7.
    [6] HILL AB, KILGORE C, MCGLYNN M, et al. Improving global vaccine accessibility[J]. Curr Opin Biotechnol, 2016, 42:67-73.
    [7] ORGANIZATION WH. SAGE meeting of April 2012[EB/OL]. World Health Organization, 2012. http://www.who.int/immunization/sage/meetings/2012/april/presentations_background_docs/en/.
    [8] COMMITTEE IPA. Final meeting report and recommendations[C]. World Health Organization, 2012.
    [9] ORGANIZATION WH. WHO/paul-ehrlich-institut informal consultation on scientific and regulatory considerations on the stability evaluation of vaccines under controlled temperature chain (CTC)[C]. Langen, Germany: World Health Organization, 2013.
    [10] ZIPURSKY S, BOUALAM L, CHEIKH DO, et al. Assessing the potency of oral polio vaccine kept outside of the cold chain during a national immunization campaign in Chad[J]. Vaccine, 2011, 29(34): 5652-5656.
    [11] POPOVA O,IBARRA DE, PALACIOS P. Reaching more children with vaccines in developing countries: key challenges of innovation and delivery[J]. Curr Med Res Opin, 2016, 32(1): 177-181.
    [12] KARP CL, LANS D, ESPARZA J, et al. Evaluating the value proposition for improving vaccine thermostability to increase vaccine impact in low and middle-income countries[J]. Vaccine, 2015, 33(30): 3471-3479.
    [13] BURSTEIN R, DANSEREAU EA, CONNER RO, et al. Assessing vaccine cold chain storage quality: a cross-sectional study of health facilities in three African countries[J]. Lancet, 2013, 381(12): S25.
    [14] ENGLISH AL. Children: reducing mortality[J]. Wkly Epidemiol Rec, 2014,89(38): 418-420.
    [15] 吴婷, 张军, 赵勤俭, 等. 预防接种,不应动摇[J]. 中国科学:生命科学, 2016, 46(6): 782-784.
    [16] WHO. Getting started with vaccine vial monitors[M]. Geneva: World Health Organization, 2002: 1-19.
    [17] SAMANT Y, LANJEWAR H, BLOCK L, et al. Relationship between vaccine vial monitors and cold chain infrastructure in a rural district of India[J]. Rural Remote Health, 2007, 7(617): 1-14.
    [18] ORGANIZATION WH. Vaccine vial monitor (VVM)[EB/OL].World Health Organization,  2011. http://www.who.int/immunization_standards/vaccine_quality/vvm_10years_index/en/.
    [19] 舒俭德. 疫苗热标签[J]. 中国生物制品学杂志, 2010, 32(11): 1275-1276.
    [20] 袁平, 曹玲生, 曹雷, 等. 疫苗有效性监测卡的研发及国外使用概况[J]. 中国疫苗和免疫, 2011, 177(3): 270-274.
    [21] SMITH D, FERGUSON M, KRAUSE P, et al. WHO/health Canada drafting group meeting on scientific and regulatory considerations on the stability evaluation of vaccines under controlled temperature chain[C]. Ottawa, Canada: World Health Organization, 2012.
    [22] ORGANIZATION WH. WHO expert committee on biological Standardization, sixty-sixth report[C]. World Health Organization, 2016.
    [23] ORGANIZATION WH. What is a controlled temperature chain (CTC)[EB/OL]. World Health Organization, 2016. http://www.who.int/immunization/programmes_systems/supply_chain/resources/WHO_CTC_Infographic.pdf?ua=1.
    [24] JAMES VESPER TR. L-Pharmaceutical and vaccine quality illustrated[EB/OL]. 2016. http://epela.net/illustrated/index2.php?bolum=11.
    [25] KRISTENSEN DD, LORENSON T, BARTHOLOMEW K, et al. Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countries[J]. Vaccine, 2016, 34(7): 899-904.
    [26] KOUASSI DP, AKA LBN, BNI BVJ, et al. Practice of Controlled Temperature Chain (CTC) Technique during a Mass Vaccination Campaign in Cte d'Ivoire[J]. World J Vaccines, 2016, 6(1): 16-22.
    [27] KRISTIANSEN PA, JORGENSEN HJ, CAUGANT DA. Serogroup a meningococcal conjugate vaccines in Africa[J]. Expert Rev Vaccines, 2015, 14(11): 1441-1458.
    [28] PORTA MI, LENGLET A, DE WEERDT S, et al. Feasibility of a preventive mass vaccination campaign with two doses of oral cholera vaccine during a humanitarian emergency in South Sudan[J]. Trans R Soc Trop Med Hyg, 2014, 108(12): 810-815.
    [29] ORGANIZATION WH. Global vaccine action plan[C]. World Health Organization, 2014.
    [30] ORGANIZATION WH. HPV Vaccine Introduction Guide[EB/OL]. World Health Organization, 2016. http://www.who.int/immunization/diseases/hpv/HPV_vaccine_intro_guide_Draft_Sept2016.pdf?ua=.
    [31] ORGANIZATION WH. Immunization highlights: 2015[EB/OL]. World Health Organization, 2016. http://www.who.int/immunization/highlights/2015/immunization_highlights_2015_full/en/index2.html.
    [32] ORGANIZATION WH. Controlled temperature chain (CTC)[EB/OL].World Health Organization, 2016. http://www.who.int/immunization/programmes_systems/supply_chain/ctc/en/index1.html.
    [33] ORGANIZATION WH. First mass campaign using a vaccine outside the cold chain is successful[EB/OL]. World Health Organization, 2014. http://www.who.int/immunization/newsroom/press/19_02_2014_meningitis_vaccine_outside_cold_chain/en/.
    [34] ZIPURSKY S, DJINGAREY MH, LODJO JC, et al. Benefits of using vaccines out of the cold chain: delivering meningitis A vaccine in a controlled temperature chain during the mass immunization campaign in Benin[J]. Vaccine, 2014, 32(13): 1431-1435.
    [35] ORGANIZATION WH. Global vaccine action plan-monitoring, evaluation & accountability[C]. World Health Organization, 2016.
    [36] LYDON P, ZIPURSKY S, TEVI-BENISSAN C, et al. Economic benefits of keeping vaccines at ambient temperature during mass vaccination: the case of meningitis a vaccine in Chad[J]. B World Health Organ, 2014, 92(2): 86-92.