Objective The roll-out of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine has brought many logistical challenges, such as the absence of comprehensive stability data leading to strict handling instructions during dilution and administration. Accidental mishandling therefore presents challenging clinical dilemmas, which often led vaccine providers to err on the side of caution and discard mishandled vials rather than risk administering ineffective vaccine. This study aims to answer key questions about the vaccine’s stability to allow for a more informed decision-making process should a non-conformity occur. Methods Residual vaccine in freshly used, but appropriately stored vials collected from vaccination centres in Brighton, UK, were tested after exposure to various handling conditions and analysed by dynamic light scattering to determine the size of the lipid-mRNA nanoparticles, and gel electrophoresis to visualise the mRNA integrity and separation from the lipid formulation. Results Knocking or dropping vaccine samples from small heights resulted in lowest levels of instability, indicating low risk of compromising clinical efficacy. However, repeated drawing and injecting through 23 G needles at high speed and, more significantly, shaking and vortexing led to progressive increase in the size and polydispersity index of the lipid-mRNA nanoparticles, coupled with or caused by up to ~50% release of mRNA from the lipid formulation. This is thought to impact the vaccine’s efficacy due to lack of free mRNA protection and cellular internalisation. Conclusions These results reiterate the importance of adhering to the manufacturer’s instructions on handling, especially with regard to shaking and exposing the vaccine to excessive vibration. Data are available in a public, open access repository. Raw data and analysis are available in repository entitled: Data for 'Stability testing of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine – a translational study in UK vaccination centres' at the following URL: .

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Pfizer-BioNTech BNT162b2 COVID-19 疫苗的稳定性测试：英国疫苗接种中心的转化研究

目的辉瑞-BioNTech BNT162b2 COVID-19疫苗的推出带来了许多后勤挑战，例如缺乏全面的稳定性数据，导致在稀释和给药过程中需要严格的处理说明。因此，意外处理不当会带来具有挑战性的临床困境，这通常会导致疫苗提供者宁可谨慎行事，并丢弃处理不当的小瓶，而不是冒着接种无效疫苗的风险。本研究旨在回答有关疫苗稳定性的关键问题，以便在出现不合格情况时做出更明智的决策过程。方法 从英国布莱顿的疫苗接种中心收集的新鲜使用但适当储存的小瓶中的残留疫苗，在暴露于各种处理条件后进行测试，并通过动态光散射分析以确定脂质-mRNA纳米颗粒的大小，并通过凝胶电泳观察mRNA的完整性和与脂质制剂的分离。结果 从小高度敲击或掉落疫苗样本导致最低水平的不稳定性，表明影响临床疗效的风险较低。然而，通过 23 G 针头高速反复抽吸和注射，更显着的是，摇晃和涡旋导致脂质-mRNA 纳米颗粒的大小和多分散指数逐渐增加，与高达约 50% 的来自脂质制剂的 mRNA。由于缺乏游离 mRNA 保护和细胞内化，这被认为会影响疫苗的功效。结论 这些结果重申了遵守制造商操作说明的重要性，特别是在摇晃疫苗和将疫苗暴露于过度振动方面。数据可在公共、开放访问的存储库中获得。原始数据和分析可在题为“辉瑞-BioNTech BNT162b2 COVID-19 疫苗的稳定性测试 - 英国疫苗接种中心的转化研究”的数据存储库中获得，网址如下：.