Evans Alison, Roy Debabrata, Davies Miranda, Dhanda Sandeep, Morris Denise, Aurelius Taylor, Lane Samantha, Fry Catherine, Shakir Saad
Drug Safety Research Unit, Southampton, UK
University of Portsmouth, Portsmouth, UK.
BMJ Open. 2025 May 2;15(5):e093366. doi: 10.1136/bmjopen-2024-093366.
To monitor the safety and utilisation of AZD1222 under real-world use in the UK.
A non-interventional post-authorisation active surveillance study.
Vaccination sites in the UK.
A total of 17 945 participants were eligible and provided consent to participate in the study between 1 March 2021 and 6 April 2023. Participants were followed up at weeks 1, 4 and 14 and at months 6, 9, 12 and 18 after the first dose of AZD1222 vaccination and prompted to complete electronic data capture forms. A total of 11 219 participants submitted a Follow-Up 1 form and 5189 participants submitted a Follow-Up 7 form (at 18 months).
The safety of AZD1222, including the identification, assessment and quantification of serious adverse events (SAEs) and adverse events of special interest (AESI), was examined. The utilisation of AZD1222 was described and characterised, including populations with missing information.
The majority of participants were women (n=10 845; 60.4%) and the median age (IQR) was 50 (43, 62) years. Most participants were from white ethnic groups (n=13 112; 73.1%). Headache and fatigue had the highest reported incidence rate (421.28 cases per 1000 person years and 386.00 cases per 1000 person years, respectively). The most frequently reported AESI was anosmia (6.25 cases per 1000 person years). An increased Observed versus Expected (O:E) ratio was seen for anaphylaxis (O:E 7.38 (95% CI 2.80 to 11.95); based on 10 observed cases (expected cases: 1.36)) and anosmia and/or ageusia (O:E 39.23 (95% CI 29.13 to 49.32), based on 58 observed cases (expected cases: 1.48)).
The most frequent vaccinee-reported adverse events (AEs) were headache and fatigue. An increased O:E ratio was seen for the AEs of anaphylaxis and anosmia and/or ageusia. No safety signals were identified throughout the course of this study.
This study is registered with the HMA-EMA Catalogue of RWD studies (EUPAS44035).
监测AZD1222在英国实际使用中的安全性和使用情况。
一项非干预性的上市后主动监测研究。
英国的疫苗接种点。
共有17945名参与者符合条件，并在2021年3月1日至2023年4月6日期间同意参与该研究。在接种第一剂AZD1222疫苗后的第1、4和14周以及第6、9、12和18个月对参与者进行随访，并促使他们填写电子数据采集表。共有11219名参与者提交了随访1表，5189名参与者提交了随访7表（在18个月时）。
检查了AZD1222的安全性，包括严重不良事件（SAE）和特殊关注不良事件（AESI）的识别、评估和量化。描述并分析了AZD1222的使用情况，包括信息缺失的人群。
大多数参与者为女性（n = 10845；60.4%），年龄中位数（IQR）为50（43，62）岁。大多数参与者来自白人种族（n = 13112；73.1%）。报告发病率最高的是头痛和疲劳（分别为每1000人年421.28例和386.00例）。最常报告的AESI是嗅觉丧失（每1000人年6.25例）。过敏反应（观察值与预期值（O:E）比值为7.38（95%CI 2.80至11.95）；基于10例观察到的病例（预期病例：1.36））以及嗅觉丧失和/或味觉丧失（O:E 39.23（95%CI 29.13至49.32），基于58例观察到的病例（预期病例：1.48））的O:E比值有所升高。
疫苗接种者报告最多的不良事件（AE）是头痛和疲劳。过敏反应以及嗅觉丧失和/或味觉丧失的AE的O:E比值有所升高。在本研究过程中未发现安全信号。
本研究已在HMA - EMA真实世界数据研究目录（EUPAS44035）中注册。
