President and CEO, Extensio et Progressio, Collonge-Bellerive, Switzerland.
Sensitech Life Sciences, Beverly, MA, USA.
Expert Rev Vaccines. 2022 Jun;21(6):799-810. doi: 10.1080/14760584.2022.2061462. Epub 2022 Apr 8.
Vaccines have continually proven their inestimable value to the world through the eradication of smallpox, gains achieved toward a polio-free world, and controlling other vaccine-preventable diseases. Although vaccines require certain temperatures and conditions to maintain their potency, supply chain controls vary greatly at different legs of the global journey. Vaccine manufacture is closely managed, but inconsistencies plague the cold chain when vaccines are shipped and stored in variable conditions. Monitoring vaccine temperatures throughout the cold chain is of paramount importance to ensure quality. The emerging COVID-19 vaccines present the world with new challenges and additional opportunities to establish best practices for safeguarding human health.
We review the risks associated with the vaccine cold chain that require temperature monitoring throughout shipment and storage. Electronic and chemical monitoring devices are compared along with data needs. Regulatory oversight and guidance are also discussed.
Regulatory oversight has contributed to the creation of a risk management and quality culture among private sector players in the vaccine field. Meanwhile, the public sector (the main player at the country level) remains largely untouched by regulatory oversight. Adherence to best practices shall only be possible with increased regulatory oversight of public sector operations.
疫苗通过根除天花、在实现无脊髓灰质炎世界方面取得的进展以及控制其他可通过疫苗预防的疾病，不断证明其对世界的巨大价值。尽管疫苗需要一定的温度和条件来保持其效力，但全球旅行的不同阶段的供应链控制差异很大。疫苗生产受到严格管理，但当疫苗在不同条件下运输和储存时，冷链会出现不一致的情况。在整个冷链中监测疫苗温度对于确保质量至关重要。新出现的 COVID-19 疫苗给世界带来了新的挑战和更多机会，以建立保护人类健康的最佳实践。
我们回顾了与疫苗冷链相关的风险，这些风险需要在运输和储存过程中进行温度监测。比较了电子和化学监测设备以及数据需求。还讨论了监管监督和指导。
监管监督有助于在疫苗领域的私营部门参与者中建立风险管理和质量文化。与此同时，公共部门（国家一级的主要参与者）在很大程度上仍不受监管监督的影响。只有加强对公共部门运作的监管监督，才能遵守最佳实践。
