Research Center for Environmental Determinants of Health (RCEDH), Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Social Development and Health Promotion Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.
BMC Public Health. 2023 Jul 24;23(1):1415. doi: 10.1186/s12889-023-16265-8.
Regarding the paucity of evidence on the side effects of the booster dose of Oxford AstraZeneca vaccine in vaccinated people with Sinopharm or Sputnik V, we aimed to set up a cohort event monitoring (CEM) study to capture adverse events occurring in individuals who will receive the booster doses of AstraZeneca (either the first or second booster dose) following being vaccinated with Sinopharm or sputnik V vaccines in Iran.
The present study is an active COVID-19 vaccine safety surveillance through an observational prospective cohort study that will be conducted in vaccination centers in Iran. The study will be conducted in twelve provinces of Iran. Study sites are vaccination centers where the AstraZeneca vaccine is administered to the cohort population. The study population includes all individuals who have received two doses of Sinopharm or Sputnik V vaccines and either the first or second booster dose of AstraZeneca according to the national guidelines for immunization in Iran in 2023. We are planning to include 30,000 eligible people in this study. Each individual will be followed up for 13 weeks after either the first or second booster dose of the AstraZeneca vaccine. Furthermore, convenience sampling is used to include participants in the present study. Participation in the study will be strictly voluntary.
With the planned study we will provide a valid epidemiological evidence to improve the understanding of the safety of the booster dose of the AstraZeneca and to better evaluate the effectiveness of public health interventions. This could help policy makers in managing the COVID-19 pandemic according to scientific evidence.
关于接种了科兴或卫星 V 疫苗的人群接种牛津阿斯利康疫苗加强针的副作用证据有限，我们旨在建立一个队列事件监测（CEM）研究，以捕捉在伊朗接种科兴或卫星 V 疫苗后将接种阿斯利康加强针（第一针或第二针）的个体中发生的不良事件。
本研究是通过一项观察性前瞻性队列研究对 COVID-19 疫苗安全性进行主动监测，将在伊朗的疫苗接种中心进行。该研究将在伊朗的 12 个省份进行。研究地点是接种中心，在那里将向队列人群接种阿斯利康疫苗。研究人群包括所有根据 2023 年伊朗国家免疫指南接种了两剂科兴或卫星 V 疫苗且将接种一剂或第二剂阿斯利康加强针的个体。我们计划在这项研究中纳入 30000 名符合条件的人。每个个体将在接种阿斯利康加强针后的 13 周内进行随访。此外，方便抽样用于纳入本研究的参与者。参与研究将完全是自愿的。
通过计划中的研究，我们将提供有效的流行病学证据，以提高对阿斯利康加强针安全性的认识，并更好地评估公共卫生干预措施的有效性。这可以帮助决策者根据科学证据管理 COVID-19 大流行。
