Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), United States.
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), United States.
Vaccine. 2018 Jan 25;36(4):553-558. doi: 10.1016/j.vaccine.2017.11.083. Epub 2017 Dec 14.
Vaccines should be stored and handled according to manufacturer specifications. Inadequate cold chain management can affect potency; but, limited data exist on adverse events (AE) following administration of vaccines kept outside of recommended temperatures.
To describe reports to the Vaccine Adverse Event Reporting System (VAERS) involving vaccines inappropriately stored outside of recommended temperatures and/or exposed to temperatures outside of manufacturer specifications for inappropriate amounts of time.
We searched the VAERS database (analytic period 2008-2012) for reports describing vaccines kept outside of recommended temperatures. We analyzed reports by vaccine type, length outside of recommended temperature and type of temperature excursion, AE following receipt of potentially compromised vaccine, and reasons for cold chain breakdown.
We identified 476 reports of vaccines kept outside of recommended temperatures; 77% described cluster incidents involving multiple patients. The most commonly reported vaccines were quadrivalent human papillomavirus (n = 146, 30%), 23-valent pneumococcal polysaccharide (n = 51, 11%), and measles, mumps, and rubella (n = 45, 9%). Length of time vaccines were kept outside of recommended temperatures ranged from 15 mins to 6 months (median 51 h). Most (n = 458, 96%) reports involved patients who were administered potentially compromised vaccines; AE were reported in 32 (7%), with local reactions (n = 21) most frequent. Two reports described multiple patients contracting diseases they were vaccinated against, indicating possible influenza vaccine failure. Lack of vigilance, inadequate training, and equipment failure were reasons cited for cold chain management breakdowns.
Our review does not indicate any substantial direct health risk from administration of vaccines kept outside of recommended temperatures. However, there are potential costs and risks, including vaccine wastage, possible decreased protection, and patient and parent inconvenience related to revaccination. Maintaining high vigilance, proper staff training, regular equipment maintenance, and having adequate auxiliary power are important components of comprehensive vaccine cold chain management.
疫苗应按照制造商的说明进行储存和处理。冷链管理不足会影响疫苗效力；但是，关于疫苗在推荐温度以外储存和/或暴露于制造商规定以外的温度下的时间过长而导致的不良事件（AE）的数据有限。
描述向疫苗不良事件报告系统（VAERS）报告的疫苗储存不当超出推荐温度和/或暴露于制造商规定的不适当时间的情况。
我们在 VAERS 数据库（分析期 2008-2012 年）中搜索了描述疫苗储存温度超出推荐温度的报告。我们根据疫苗类型、超出推荐温度的时间长度和温度变化类型、接种潜在受损疫苗后的 AE 以及冷链故障的原因对报告进行了分析。
我们确定了 476 份疫苗储存温度超出推荐温度的报告；77%的报告描述了涉及多名患者的群集事件。报告中最常见的疫苗是四价人乳头瘤病毒（n=146，30%）、23 价肺炎球菌多糖（n=51，11%）和麻疹、腮腺炎和风疹（n=45，9%）。疫苗储存温度超出推荐温度的时间范围从 15 分钟到 6 个月（中位数 51 小时）。大多数报告（n=458，96%）涉及接种潜在受损疫苗的患者；32 例（7%）报告了 AE，最常见的是局部反应（n=21）。有两份报告描述了多名患者患上了他们接种过的疾病，表明可能发生了流感疫苗失效。缺乏警惕、培训不足和设备故障是冷链管理失败的原因。
我们的综述并未表明疫苗在推荐温度以外储存会带来任何实质性的直接健康风险。但是，存在潜在的成本和风险，包括疫苗浪费、保护效果可能降低以及与重新接种相关的患者和家长不便。保持高度警惕、适当的员工培训、定期设备维护和充足的辅助电源是全面疫苗冷链管理的重要组成部分。
