Departments of Pediatrics and Community Health & Epidemiology, Dalhousie University and Canadian Center for Vaccinology, IWK Health, Halifax, Nova Scotia, Canada.
Brighton Collaboration, A program of The Task Force for Global Health, Decatur, Georgia, USA.
Clin Infect Dis. 2022 Aug 15;75(Suppl 1):S11-S17. doi: 10.1093/cid/ciac407.
Within 2 years after the start of the coronavirus disease 2019 (COVID-19) pandemic, novel severe acute respiratory syndrome coronavirus 2 vaccines were developed, rigorously evaluated in large phase 3 trials, and administered to more than 5 billion individuals globally. However, adverse events of special interest (AESIs) have been described post-implementation, including myocarditis after receipt of messenger RNA (mRNA) vaccines and thrombosis with thrombocytopenia syndrome after receipt of adenoviral vector vaccines. AESIs are rare (<1 to 10/100 000 vaccinees) and less frequent than COVID-19 complications, though they have associated morbidity and mortality. The diversity of COVID-19 vaccine platforms (eg, mRNA, viral vector, protein) and rates of AESIs both between and within platforms (eg, higher rate of myocarditis after mRNA-1273 vs BNT162b2 vaccines) present an important opportunity to advance vaccine safety science. The International Network of Special Immunization Services has been formed with experts in vaccine safety, systems biology, and other relevant disciplines to study cases of AESIs and matched controls to uncover the pathogenesis of rare AESIs and inform vaccine development.
在 2019 年冠状病毒病（COVID-19）大流行开始后的 2 年内，新型严重急性呼吸系统综合征冠状病毒 2 型疫苗被开发出来，并在大规模 3 期试验中进行了严格评估，在全球范围内为超过 50 亿人接种。然而，在实施后描述了特殊关注的不良事件（AESI），包括信使 RNA（mRNA）疫苗接种后的心肌炎和腺病毒载体疫苗接种后的血栓性血小板减少综合征。AESI 罕见（<1 至 10/100000 名疫苗接种者），且比 COVID-19 并发症的频率低，但它们与发病率和死亡率相关。COVID-19 疫苗平台（例如 mRNA、病毒载体、蛋白）的多样性以及平台之间和平台内的 AESI 发生率（例如，mRNA-1273 疫苗接种后心肌炎的发生率更高）为推进疫苗安全科学提供了重要机会。国际特殊免疫服务网络已经成立，拥有疫苗安全、系统生物学和其他相关学科的专家，以研究 AESI 病例和匹配对照，揭示罕见 AESI 的发病机制，并为疫苗开发提供信息。
