保持疫苗效力
每年,疫苗可防止 200 万至 300 万人死亡。据世界卫生组织称,2000 年至 2016 年期间接种疫苗后,全球麻疹相关死亡人数减少了 84%。过去 10 年,已有超过 10 亿儿童接种了疫苗。妥善处理和储存疫苗对于保持疫苗有效性至关重要。
按照特定准则处理疫苗的理由在于了解疫苗的成分。疫苗是生物制品,含有蛋白质,而且通常含有活病毒(但已减弱)。疫苗通常含有以下成分:1) 抗原:活性成分,无论是活的(但已减弱)还是灭活的,都会引发免疫反应。疫苗通过刺激人体免疫系统产生对特定疾病的免疫力。2) 铝凝胶或铝盐:佐剂,可促进对疫苗产生更好、更持久的反应。佐剂可最大限度地减少所需的抗原量。3) 抗生素:用于某些疫苗中,以防止在生产和储存过程中细菌生长。4) 鸡蛋蛋白:存在于用鸡蛋制成的疫苗中,例如流感疫苗和黄热病疫苗。5) 味精 (MSG) 和 2-苯氧乙醇:用于某些疫苗中,以防止热、光、酸或湿度的负面影响。 6) 硫柳汞:一种含汞的防腐剂,用于防止污染和有害细菌。然而,大多数疫苗不再含有这种成分。7) 悬浮液:无菌水、盐水或含蛋白质的液体。疫苗还含有甲醛,用于杀死生产过程中可能污染疫苗的病毒和细菌。大多数甲醛在包装前被去除。
Some vaccines must be refrigerated, while others require freezing. Knowing the specific requirements for each vaccine is crucial for maintaining potency, and avoiding wasted product and lost money. Discovering that a vaccine is no longer effective sometimes occurs after it has been administered. In 2017, Ventura County, California health officials realized that vaccines may have been accidentally frozen prior to being administered. Unfortunately, there was no way to identify who received the bad vaccines, so 23,000 people were alerted and given the option to be re-inoculated. Administering the vaccine to all 23,000 patients a second time, would have cost the county an additional $1.3 million. The impact of disgruntled citizens could result in an even higher price tag.
Before a vaccine can be approved for use, it is heavily tested to ensure it is effective and safe for consumers. With most vaccines, this evaluation period lasts years. During epidemics and pandemics, this testing period can be shortened. The Coronavirus is one example. A COVID-19 vaccine was identified within months, instead of years. Now that we have a viable vaccine, proper handling will be imperative.
The vaccine cold chain is a critical system of requirements, specialized equipment, and procedures, maintained from the time a vaccine is manufactured until it is administered. For a vaccine cold chain to be effective, three elements are crucial: a well-trained staff, an accurate inventory management and reliable storage and temperature monitoring. The cold chain is so important that any temperature excursion can negatively impact a vaccine’s effectiveness. For example, if a vaccine is not meant to be frozen, a single drop in temperature to 32°F or below, can render it completely ineffective. Making matters worse, there is typically no visual indication that a vaccine has been compromised. The life-saving ability of vaccines is too precious to take the risk. Temperature monitoring devices utilized should be appropriate for vaccines, and equipped with alarms, to alert stakeholders to temperature excursions.
Transporting vaccines locally is usually for such purposes as sharing between medical providers, responding to emergencies (SOP’s should be established), moving to off-site clinics or to quickly utilize inventory that is in danger of expiration. These are unique situations, however. Vaccines should not be routinely transported. When transport is necessary, appropriate portable transport units, packing materials and temperature monitoring devices should always be used. If a storage unit will not be available for the vaccines once received at the new location, it is advisable to use a portable vaccine refrigerator during transport. If a portable refrigerator is not available, the following are also acceptable: qualified container packout; conditioned water bottle transport system; manufacturer’s original shipping container (only if no other options are available). Each of these methods should always be equipped with a temperature monitoring device.
In an emergency, certain specific measures should be taken to preserve the vaccine inventory:
- Contact the alternative storage facility to prepare for transported vaccines;
- Only open refrigerator unit when ready to pack, or power is restored;
- Suspend vaccinations to prepare for transport whenever an emergency is anticipated, such as bad weather.
Shipping vaccines over long distances, such as with the Coronavirus vaccine, involves unique considerations. For example, the recently approved Pfizer’s COVID-19 vaccine, must be stored and shipped at -70°C. In order to maintain the appropriate temperature, the company is using special shipping containers which hold 20 pounds of dry ice pellets. Once received by healthcare providers for dispensing, there are special requirements for storage such as frequent addition of dry ice pellets to the storage container, and a limit on the number of times the container may be opened. Vaccines from Moderna and Astra-Zeneca will require transport and storage at 20°C and 2-8°C, respectively.
Now that Coronavirus vaccine distribution is in full swing, the FAA’s COVID-19 Vaccine Air Transport Team, established in October 2020, will respond to any issues surrounding air transport, and ensure shipping will continue 24 hours a day. Temperature monitoring devices specifically designed for use with various temperature profiles will be required in managing the COVID-19 vaccine cold chain. Given the speed at which COVID-19 vaccine distribution is occurring, real-time monitoring enables stakeholders to take decisive action if temperature excursions are observed. Forgetting to activate a data logger, as can frequently happen in fast-paced environments, is no longer the end of the world, thanks to patented features like Shadow Log. DeltaTrak provides multiple solutions to meet your vaccine transport and storage needs. Contact your DeltaTrak sales professional for more information.
References
世界卫生组织, https://www.who.int/en/news-room/fact-sheets/detail/immunization-coverage,2020 年 7 月 15 日。
世界卫生组织, https://www.who.int/campaigns/immunization-week/2018/en/,2018 年。
世界卫生组织/GAVI 联盟。 模块 2:疫苗和药物:相似之处和不同之处, https://isoponline.org/wp-content/uploads/2015/10/Differences-on-drugs-and-vaccines.pdf,2015 年。
Heredia Rodriguez,C。“疫苗有时储存不当,会降低其有效性”,USAtoday.com, https: //www.usatoday.com/story/news/health/2019/02/11/cdc-vaccines-children-stored-improperly-mishandled-reduce-effectiveness-dhhs-measles/2811629002/,2019 年 2 月 12 日。
Weise, E 和 Aspegran, E。“美国联邦航空管理局确认辉瑞新冠疫苗首次通过‘大规模空运’从比利时运抵美国,美国正准备分发疫苗”, https://www.usatoday.com/story/news/health/2020/11/29/pfizer-covid-vaccine-faa-belgium-air-shipment/6445339002/,2020 年 11 月 29 日