Asare Amma Frempomaa, Sabblah George Tsey, Buabeng Richard Osei, Alhassan Yakubu, Asamoa-Amoakohene Abena, Amponsa-Achiano Kwame, Mohammed Naziru Tanko, Darko Delese Mimi, Bonful Harriet Affran
Food and Drugs Authority, Accra, Ghana.
Department of Biostatistics, School of Public Health, University of Ghana, Legon, Accra, Ghana.
PLOS Glob Public Health. 2024 Sep 27;4(9):e0003770. doi: 10.1371/journal.pgph.0003770. eCollection 2024.
Vaccines are important public health tools and formed part of the fight against the COVID-19 pandemic. Five COVID-19 vaccines were given Emergency Use Authorization in Ghana and deployed during the pandemic. Early phase trials of the vaccines were mostly not conducted in Africans. This study examines safety data during their deployment under real-life conditions in Ghana. This study analysed secondary data on COVID-19 vaccine-related adverse events following immunization (AEFI) reported to the Ghana Food and Drugs Authority (GFDA) between March 2021 and June 2022 using STATA. AEFIs were coded with their Preferred Terms using the Medical Dictionary for Regulatory Activities, version 24.0. Statistical tests examined associations between demographic characteristics, vaccine types, seriousness, and AEFI outcomes. Binary logistic regression model assessed factors associated with serious AEFIs, while the GFDA's Joint COVID-19 Vaccine Safety Review Committee provided causality assessments of serious AEFIs. Overall cumulative incidence of AEFIs was about 25 per 100,000 persons vaccinated. Across the five vaccines, majority of the AEFIs reported were not serious (98.7%) with higher incidences in those below 50 years (74.0%) and females (51.2%). The most common AEFIs recorded were headache (52.9%), pains (44.4%), pyrexia (35.1%), chills (16.7%) and injection site pain (15.6%). Relative to those 50 years and above, the odds of serious AEFI were 60% less among those aged <30 years (aOR = 0.40, CI: [0.19, 0.86], p = 0.019). However, a causality assessment of the 57 serious AEFIs indicated only 8 (14%) were vaccine product-related. There was a low incidence of AEFIs following deployment of the vaccines in Ghana with a much lower incidence of serious AEFIs. Informing the public about the safety of the vaccines and potential side effects may increase trust and acceptance, decreasing hesitancy in current and future vaccination programmes.
疫苗是重要的公共卫生工具，也是抗击新冠疫情的一部分。五种新冠疫苗在加纳获得了紧急使用授权，并在疫情期间进行了部署。这些疫苗的早期试验大多不是在非洲人身上进行的。本研究考察了它们在加纳现实生活条件下部署期间的安全性数据。本研究使用STATA分析了2021年3月至2022年6月期间向加纳食品药品管理局（GFDA）报告的与新冠疫苗相关的免疫后不良事件（AEFI）的二手数据。使用《药物监管活动医学词典》第24.0版对AEFI进行首选术语编码。统计检验考察了人口统计学特征、疫苗类型、严重程度和AEFI结果之间的关联。二元逻辑回归模型评估了与严重AEFI相关的因素，而GFDA的新冠疫苗联合安全审查委员会对严重AEFI进行了因果关系评估。AEFI的总体累积发病率约为每10万人接种疫苗中有25例。在这五种疫苗中，报告的大多数AEFI并不严重（98.7%），50岁以下人群（74.0%）和女性（51.2%）的发病率较高。记录到的最常见AEFI是头痛（52.9%）、疼痛（44.4%）、发热（35.1%）、寒战（16.7%）和注射部位疼痛（15.6%）。与50岁及以上人群相比，年龄<30岁的人群发生严重AEFI的几率低60%（调整后比值比=0.40，置信区间：[0.19, 0.86]，p=0.019）。然而，对57例严重AEFI的因果关系评估表明，只有8例（14%）与疫苗产品相关。在加纳部署疫苗后，AEFI的发病率较低，严重AEFI的发病率更低。向公众宣传疫苗的安全性和潜在副作用可能会增加信任和接受度，减少当前和未来疫苗接种计划中的犹豫情绪。
