Nguyen Jennifer L, Mitratza Marianna, Volkman Hannah R, de Munter Leonie, Tran Thao Mai Phuong, Marques Catia, Mustapha Mustapha, Valluri Srinivas, Yang Jingyan, Antón Andrés, Casas Irma, Conde-Sousa Eduardo, Drikite Laura, Grüner Beate, Icardi Giancarlo, Ten Kate Gerrit Luit, Martin Charlotte, Mira-Iglesias Ainara, Orrico-Sánchez Alejandro, Otero-Romero Susana, Rohde Gernot, Jodar Luis, McLaughlin John M, Bollaerts Kaatje
Pfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United States.
P95 Epidemiology and Pharmacovigilance, Koning Leopold III Laan 1, Leuven 3001, Belgium.
EClinicalMedicine. 2024 Dec 9;79:102995. doi: 10.1016/j.eclinm.2024.102995. eCollection 2025 Jan.
Prior studies have reported lower effectiveness of XBB.1.5-adapted vaccines against hospitalization related to the Omicron JN.1 variant than the XBB variant. This study evaluated the effectiveness and durability of the BNT162b2 XBB.1.5-adapted vaccine against JN.1-related hospitalization during the 2023-2024 season in Europe.
A test-negative case-control study was carried out in adults (≥18 y) hospitalized between 2 October 2023 and 2 April 2024 with severe acute respiratory infection (SARI) within the id.DRIVE partnership. This study included nine sites across Belgium, Germany, Italy, and Spain. Cases had a laboratory-confirmed JN.1 infection or a positive SARS-CoV-2 test with symptom onset during JN.1 predominance; controls had a negative SARS-CoV-2 test and symptom onset during JN.1 predominance. The primary objective was to estimate BNT162b2 XBB.1.5-adapted vaccine effectiveness (VE) against COVID-19 hospitalization. One case was matched with up to four controls, according to symptom onset date and site. Multivariable analyses were adjusted for symptom onset date, age, sex, and number of chronic conditions.
Among 308 test-positive cases and 1117 test-negative controls, BNT162b2 XBB.1.5-adapted VE against hospitalization compared to no vaccination this season was 53.8% (95% CI 38.4-65.4) after a median of 63 days following vaccination. Protection was sustained through five months; VE was 52.2% (95% CI 41.3-61.1) 2 to <4 weeks after vaccination, 48.9% (95% CI 17.9-68.2) at 4 to <8 weeks, and ranged from 54.6% to 59.5% at 4-week intervals from 8 to <22 weeks.
BNT162b2 XBB.1.5-adapted vaccine provided protection against JN.1-related hospitalization, regardless of prior vaccination history, with no evidence of waning through five months. These data support yearly vaccination against COVID-19 to prevent severe illness during the respiratory virus season.
Pfizer.
先前的研究报告称，与XBB变体相比，针对奥密克戎JN.1变体相关住院的XBB.1.5适配疫苗有效性较低。本研究评估了2023 - 2024年欧洲流感季节期间，BNT162b2 XBB.1.5适配疫苗针对JN.1相关住院的有效性和持久性。
在id.DRIVE合作项目中，对2023年10月2日至2024年4月2日期间因严重急性呼吸道感染（SARI）住院的成年人（≥18岁）开展了一项检测阴性病例对照研究。该研究涵盖了比利时、德国、意大利和西班牙的9个地点。病例为实验室确诊的JN.1感染，或在JN.1占主导期间出现症状且SARS-CoV-2检测呈阳性；对照为SARS-CoV-2检测阴性且在JN.1占主导期间出现症状。主要目标是评估BNT162b2 XBB.1.5适配疫苗预防新冠住院的有效性（VE）。根据症状出现日期和地点，1例病例最多匹配4例对照。多变量分析对症状出现日期、年龄、性别和慢性病数量进行了校正。
在308例检测呈阳性的病例和1117例检测呈阴性的对照中，接种疫苗后中位63天，与本季节未接种疫苗相比，BNT162b2 XBB.1.5适配疫苗预防住院的有效性为53.8%（95%置信区间38.4 - 65.4）。保护作用持续了5个月；接种疫苗后2至<4周，有效性为52.2%（95%置信区间41.3 - 61.1），4至<8周为48.9%（95%置信区间17.9 - 68.2），8至<22周期间每4周的有效性在54.6%至59.5%之间。
无论既往疫苗接种史如何，BNT162b2 XBB.1.5适配疫苗均可预防JN.1相关住院，且在5个月内无减弱迹象。这些数据支持每年接种新冠疫苗以预防呼吸道病毒季节的严重疾病。
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