de Munter Leonie, Meeraus Wilhelmine, Dwivedi Akshat, Mitratza Marianna, Wyndham-Thomas Chloé, Carty Lucy, Ouwens Mario, Hartig-Merkel Wendy, Drikite Laura, Rebry Griet, Casas Irma, Mira-Iglesias Ainara, Icardi Giancarlo, Otero-Romero Susana, Baumgartner Sebastian, Martin Charlotte, Holemans Xavier, Ten Kate Gerrit Luit, Bollaerts Kaatje, Taylor Sylvia
P95 Epidemiology and Pharmacovigilance, Leuven, Belgium.
Medical Evidence, Vaccines & Immune Therapies, BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom.
Eur J Public Health. 2025 Apr 1;35(2):373-378. doi: 10.1093/eurpub/ckae219.
Marketing authorization holders of vaccines typically need to report brand-specific vaccine effectiveness (VE) to the regulatory authorities as part of their regulatory obligations. COVIDRIVE (now id. DRIVE) is a European public-private partnership for respiratory pathogen surveillance and studies of brand-specific VE with long-term follow-up. We report the final VE results from a two-dose primary series AZD1222 (ChAdOx1 nCoV-19) vaccine schedule in ≥18-year-old individuals not receiving boosters. Patients (N = 1,333) hospitalized with severe acute respiratory infection at 14 hospitals in Austria, Belgium, Italy, and Spain were included in the test-negative case-control study in 2021-2023. Absolute VE was calculated using generalized additive model (GAM), generalized estimating equation (GEE), and spline-based area under the curve (AUC, measuring VE up to 6 months after the last dose of AZD1222). Overall VE (against coronavirus disease 2019 [COVID-19] hospitalization) of an AZD1222 primary series was estimated as 65% using GEE (95% confidence interval [CI]: 52.9-74.5), and 69% using GAM (95% CI: 50.1-80.9) over the 22-month study period (comparator group: unvaccinated patients). The AUC of the spline-based VE estimate was 74.1% (95% CI: 60.0-88.3). VE against hospitalization in study participants who received their second AZD1222 dose 2 months or less before hospitalization was 86% using GEE (95% CI: 77.8-91.4), 93% using GAM (95% CI: 67.2-98.6). During this study period, where mainly the severe acute respiratory syndrome coronavirus 2 Omicron variant was circulating, a two-dose primary series AZD1222 vaccination conferred protection against COVID-19 hospitalization up to at least 6 months after the last dose.
疫苗的营销授权持有人通常需要向监管机构报告特定品牌疫苗的有效性（VE），这是其监管义务的一部分。COVIDRIVE（现为id. DRIVE）是一个欧洲的公私合作项目，用于呼吸道病原体监测以及对特定品牌VE进行长期随访研究。我们报告了≥18岁未接种加强针的个体中两剂次AZD1222（ChAdOx1 nCoV-19）疫苗基础免疫程序的最终VE结果。2021年至2023年，在奥地利、比利时、意大利和西班牙的14家医院中，因严重急性呼吸道感染住院的患者（N = 1333）被纳入了阴性对照病例对照研究。使用广义相加模型（GAM）、广义估计方程（GEE）以及基于样条的曲线下面积（AUC，测量最后一剂AZD1222后长达6个月的VE）来计算绝对VE。在22个月的研究期间，使用GEE估计AZD1222基础免疫程序的总体VE（针对2019冠状病毒病[COVID-19]住院）为65%（95%置信区间[CI]：52.9 - 74.5），使用GAM估计为69%（95% CI：50.1 - 80.9）（对照人群：未接种疫苗的患者）。基于样条的VE估计的AUC为74.1%（95% CI：60.0 - 88.3）。对于在住院前2个月或更短时间内接种第二剂AZD1222的研究参与者，使用GEE得出的针对住院的VE为86%（95% CI：77.8 - 91.4），使用GAM为93%（95% CI：67.2 - 98.6）。在本研究期间，主要是严重急性呼吸综合征冠状病毒2奥密克戎变异株在传播，两剂次AZD1222基础免疫程序接种在最后一剂后至少6个月内可提供针对COVID-19住院的保护。
