AZD1222 初级系列疫苗接种对未接种加强针个体预防 COVID-19 住院的作用：欧洲 COVIDRIVE 研究的首个疫苗有效性结果及元回归分析
Protection against COVID-19 hospitalisation conferred by primary-series vaccination with AZD1222 in non-boosted individuals: first vaccine effectiveness results of the European COVIDRIVE study and meta-regression analysis.
作者信息
Meeraus Wilhelmine, de Munter Leonie, Gray Christen M, Dwivedi Akshat, Wyndham-Thomas Chloé, Ouwens Mario, Hartig-Merkel Wendy, Drikite Laura, Rebry Griet, Carmona Antonio, Stuurman Anke L, Chi Nguyen Thi Yen, Mena Guillermo, Mira-Iglesias Ainara, Icardi Giancarlo, Otero-Romero Susana, Baumgartner Sebastian, Martin Charlotte, Taylor Sylvia, Bollaerts Kaatje
机构信息
Medical Evidence, Vaccines & Immune Therapies, AstraZeneca, Cambridge, UK.
P95 Pharmacovigilance and Epidemiology, Leuven, Belgium.
出版信息
Lancet Reg Health Eur. 2023 Jul 1;31:100675. doi: 10.1016/j.lanepe.2023.100675. eCollection 2023 Aug.
BACKGROUND
Vaccine effectiveness (VE) studies with long-term follow-up are needed to understand durability of protection against severe COVID-19 outcomes conferred by primary-series vaccination in individuals not receiving boosters. COVIDRIVE is a European public-private partnership evaluating brand-specific vaccine effectiveness (VE). We report a prespecified interim analysis of primary-series AZD1222 (ChAdOx1 nCoV-19) VE.
METHODS
Seven Study Contributors in Europe collected data on individuals aged ≥18 years who were hospitalised with severe acute respiratory infection (June 1st, 2021-September 5th, 2022) and eligible for COVID-19 vaccination prior to hospitalisation. In this test-negative case-control study, individuals were defined as test-positive cases or test-negative controls (SARS-CoV-2 RT-PCR) and were either fully vaccinated (two AZD1222 doses, 4-12 weeks apart, completed ≥14 days prior to symptom onset; no booster doses) or unvaccinated (no COVID-19 vaccine prior to hospitalisation). The primary objective was to estimate AZD1222 VE against COVID-19 hospitalisation. A literature review and meta-regression were conducted to contextualise findings on durability of protection.
FINDINGS
761 individuals were included during the 15-month analysis period. Overall AZD1222 VE estimate was 72.8% (95% CI, 53.4-84.1). VE was 93.8% (48.6-99.3) in participants who received second AZD1222 doses ≤8 weeks prior to hospitalisation, with spline-based VE estimates demonstrating protection (VE ≥ 50%) 30 weeks post-second dose. Meta-regression analysis (data from seven publications) showed consistent results, with ≥80% protection against COVID-19 hospitalisation through ∼43 weeks post-second dose, with some degree of waning.
INTERPRETATION
Primary-series AZD1222 vaccination confers protection against COVID-19 hospitalisation with enduring levels of VE through ≥6 months.
FUNDING
AstraZeneca.
背景
需要开展长期随访的疫苗效力（VE）研究，以了解未接种加强针的个体在接种初始系列疫苗后对重症 COVID-19 结局的保护持续时间。COVIDRIVE 是一项欧洲公私合作项目，旨在评估特定品牌疫苗的效力（VE）。我们报告了对初始系列 AZD1222（ChAdOx1 nCoV-19）疫苗效力的预先指定的中期分析。
方法
欧洲的七个研究贡献者收集了年龄≥18 岁、因严重急性呼吸道感染住院（2021 年 6 月 1 日至 2022 年 9 月 5 日）且在住院前符合 COVID-19 疫苗接种条件的个体的数据。在这项检测阴性的病例对照研究中，个体被定义为检测阳性病例或检测阴性对照（SARS-CoV-2 RT-PCR），且要么已完全接种疫苗（两剂 AZD1222，间隔 4 - 12 周，在症状出现前≥14 天完成接种；未接种加强针），要么未接种疫苗（住院前未接种 COVID-19 疫苗）。主要目标是估计 AZD1222 对 COVID-19 住院的疫苗效力。进行了文献综述和荟萃回归，以将关于保护持续时间的研究结果置于背景中。
结果
在 15 个月的分析期内纳入了 761 名个体。总体 AZD1222 疫苗效力估计值为 72.8%（95%CI，53.4 - 84.1）。在住院前≤8 周接受第二剂 AZD1222 的参与者中，疫苗效力为 93.8%（48.6 - 99.3），基于样条的疫苗效力估计显示在第二剂后 30 周仍有保护作用（疫苗效力≥50%）。荟萃回归分析（来自七篇出版物的数据）显示了一致的结果，即第二剂后约 43 周内对 COVID-19 住院的保护率≥80%，且有一定程度的下降。
解读
初始系列 AZD1222 疫苗接种可提供针对 COVID-19 住院的保护，疫苗效力在≥6 个月内保持持久水平。
资助
阿斯利康。
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