2021年尼日利亚阿斯利康和莫德纳新冠疫苗接种人群队列事件监测及反应原性和不良事件评估的可行性
Feasibility of cohort event monitoring and assessment of reactogenicity and adverse events among a cohort of AstraZeneca and Moderna COVID-19 vaccine recipients in Nigeria, 2021.
作者信息
Bolu Omotayo, Alo Oluwafemi D, Iwara Emem, Longley Ashley T, Hadley Ikwe, Ogar Comfort K, Ezekwe Chukwuka, Elemuwa Uchenna, Adedokun Oluwasanmi, Ramadhani Habib O, Ohakanu Stephen, Ortiz Nancy, Antonza Gladys, Abubakar Asmau, Asekun Adeyelu, Fraden Bitrus, Chen Robert, Nordenberg Dale, Adebajo Sylvia, Adeyeye Moji Christianah, Stafford Kristen A
机构信息
Global Immunization Division, Global Health Center, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Center for International Health, Education, and Biosecurity, Maryland Global Initiatives Corporation-an affiliate of the University of Maryland Baltimore, Abuja, Federal Capital Territory, Nigeria.
出版信息
Vaccine. 2025 Apr 11;52:126907. doi: 10.1016/j.vaccine.2025.126907. Epub 2025 Mar 12.
BACKGROUND
To generate COVID-19 vaccine safety data in Nigeria, passive reporting was supplemented with cohort event monitoring (CEM), an active surveillance system. We described reactogenicity within 7 days and adverse events up to 3 months after each AstraZeneca or Moderna COVID-19 vaccine dose while assessing the feasibility of implementing CEM in a low- to middle-income country (LMIC) during a mass vaccination campaign.
METHODS
Participants were aged ≥18 years with access to mobile phones who received the first dose of an authorized COVID-19 vaccine from participating health facilities in 6 states of Nigeria during September and October 2021. Data collectors interviewed participants via phone on days 0, 3, 7, and thereafter every 7 days for 3 months. The same schedule was restarted if a participant received a second vaccine dose. Proportions of participant-reported adverse events following COVID-19 vaccine receipt were calculated. Investigation and causality assessment were conducted on deaths using the World Health Organization causality guidelines.
RESULTS
We enrolled 12,317 participants (AstraZeneca 6990; Moderna 5327); 6167/6990 (88.2 %) AstraZeneca and 4879/5327 (91.6 %) Moderna recipients completed a follow-up interview days 0-7 after the first dose; among them, 2685/6167 (43.5 %) AstraZeneca and 3533/4879 (72.4 %) Moderna recipients reported local reactions and 2456/6167 (39.8 %) AstraZeneca and 2087/4879 (42.8 %) Moderna recipients reported systemic reactions. Overall, 3891/6990 (55.7 %) AstraZeneca and 3978/5327 (72.8 %) Moderna recipients received a second dose of COVID-19 vaccine, among whom 897/3891 (23 %) AstraZeneca and 1979/3978 (49.7 %) Moderna recipients reported local reactions and 727/3891 (18.7 %) AstraZeneca and 1680/3978 (42.2 %) Moderna recipients reported systemic reactions. Among all enrolled, 11 died; there was no evidence to suggest any deaths were vaccine-related.
CONCLUSIONS
No unexpected patterns of adverse events were detected, providing additional data on the safety of these COVID-19 vaccines in Nigerian adults. We demonstrated that implementing CEM was feasible and may be valuable for safety monitoring of vaccines introduced in LMICs.
背景
为了获取尼日利亚新冠肺炎疫苗的安全性数据，被动报告辅以队列事件监测（CEM）这一主动监测系统。我们描述了接种每剂阿斯利康或莫德纳新冠肺炎疫苗后7天内的反应原性以及长达3个月的不良事件，同时评估了在低收入和中等收入国家（LMIC）大规模疫苗接种活动期间实施CEM的可行性。
方法
参与者年龄≥18岁且拥有手机，于2021年9月至10月期间在尼日利亚6个州的参与卫生机构接种了第一剂授权的新冠肺炎疫苗。数据收集者在第0天、第3天、第7天通过电话采访参与者，此后每7天采访一次，为期3个月。如果参与者接种了第二剂疫苗，则重新开始相同的时间表。计算了参与者报告的接种新冠肺炎疫苗后不良事件的比例。使用世界卫生组织因果关系指南对死亡病例进行调查和因果关系评估。
结果
我们招募了12317名参与者（阿斯利康6990名；莫德纳5327名）；6167/6990（88.2%）的阿斯利康疫苗接种者和4879/5327（91.6%）的莫德纳疫苗接种者在第一剂疫苗接种后的第0 - 7天完成了随访访谈；其中，2685/6167（43.5%）的阿斯利康疫苗接种者和3533/4879（72.4%）的莫德纳疫苗接种者报告了局部反应，2456/6167（39.8%）的阿斯利康疫苗接种者和2087/4879（42.8%）的莫德纳疫苗接种者报告了全身反应。总体而言，3891/6990（55.7%）的阿斯利康疫苗接种者和3978/5327（72.8%）的莫德纳疫苗接种者接种了第二剂新冠肺炎疫苗，其中897/3891（23%）的阿斯利康疫苗接种者和1979/3978（49.7%）的莫德纳疫苗接种者报告了局部反应，727/3891（18.7%）的阿斯利康疫苗接种者和1680/3978（42.2%）的莫德纳疫苗接种者报告了全身反应。在所有登记的参与者中，有11人死亡；没有证据表明任何死亡与疫苗有关。
结论
未检测到不良事件的意外模式，为这些新冠肺炎疫苗在尼日利亚成年人中的安全性提供了更多数据。我们证明了实施CEM是可行的，并且可能对低收入和中等收入国家引入的疫苗的安全性监测有价值。
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