Lambo Jonathan, Keli Sirving, Kaplan Shaheen Khan, Njideaka-Kevin Temiloluwa, Arja Sireesha Bala, Khedir Omer Altahir Alaa, Olonade Itunu, Kumar Rohit
Department of Epidemiology and Evidence-based Medicine, Avalon University School of Medicine, Willemstad, Curaçao.
Infect Dis (Lond). 2025 Feb;57(2):137-149. doi: 10.1080/23744235.2024.2399108. Epub 2024 Sep 3.
BNT162b2 and mRNA-1273 COVID-19 vaccines have been used for mass vaccinations in Curaçao, the Caribbean but information on adverse events (AEs)in this population is unavailable. This study describes the characteristics of vaccinees that incurred AEs, explores the associations between AEs by vaccine and doses, and estimates the rate of AEs.
Vaccination and AEs data for all persons of age 5 years (range 5-105 years) and older who received two doses of COVID-19 vaccine at 71 centres in Curaçao between February 24, 2021, and April 5, 2023, were included in this retrospective observational study.
The vaccines differed significantly in the frequency distribution of vaccinees by age, age groups, sex, AEs, and prior COVID-19 infection. Occurrence of AEs was strongly associated with mRNA vaccine brand, sex, number of doses, but not with age, age group, and prior COVID-19 infection. Of 209,720 doses, 84 persons (0.04%) incurred AEs following two doses of mRNA vaccines (overall rate of 40.1 per 100,000 persons (95% CI 32.4-49.6). AEs were also significantly higher in females compared to males.AE rates associated with BNT162b2, and mRNA-1273 vaccines were low, but BNT162b2 vaccinees incurred substantially significantly higher AE rates (58.3 per 100,000 persons, 95% CI 45.4-74.9) than mRNA-1273 vaccinees (21.9 per 100,000 persons, 95% CI 14.6-32.8). mRNA-1273 vaccine was associated with a significantly lower risk of AEs.
AE reporting varied by age, sex, and vaccine used as well as the number of doses. Future studies with follow-up and longer-term reporting of AEs should be conducted.
BNT162b2和mRNA-1273新冠疫苗已在加勒比地区的库拉索岛用于大规模疫苗接种，但该人群中不良事件（AE）的相关信息尚不可知。本研究描述了发生不良事件的接种者特征，探讨了不良事件与疫苗及剂量之间的关联，并估计了不良事件发生率。
本回顾性观察研究纳入了2021年2月24日至2023年4月5日期间在库拉索岛71个中心接种两剂新冠疫苗的所有5岁（年龄范围5 - 105岁）及以上人群的疫苗接种和不良事件数据。
两种疫苗在接种者的年龄、年龄组、性别、不良事件及既往新冠病毒感染情况的频率分布上存在显著差异。不良事件的发生与mRNA疫苗品牌、性别、接种剂量密切相关，但与年龄、年龄组及既往新冠病毒感染无关。在209,720剂疫苗中，84人（0.04%）在接种两剂mRNA疫苗后出现不良事件（总体发生率为每10万人40.1例（95%置信区间32.4 - 49.6））。女性的不良事件发生率也显著高于男性。与BNT162b2和mRNA - 1273疫苗相关的不良事件发生率较低，但BNT162b2疫苗接种者的不良事件发生率（每10万人58.3例，95%置信区间45.4 - 74.9）显著高于mRNA - 1273疫苗接种者（每10万人21.9例，95%置信区间14.6 - 32.8）。mRNA - 1273疫苗与较低的不良事件风险相关。
不良事件报告因年龄、性别、所用疫苗及接种剂量而异。未来应开展对不良事件进行随访和长期报告的研究。
