Wilson Amanda, Rahai Neloufar, Beck Ekkehard, Beebe Elisha, Conroy Brian, Esposito Daina, Govil Priya, Kopel Hagit, Lu Tianyi, Mansi James, Marks Morgan A, Mues Katherine E, Shah Rohan, Skornicki Michelle, Sun Tianyu, Toyip Astra, Yousefi Mitra, Martin David, Araujo Andre B
Moderna, Inc., 325 Binney St., Cambridge, MA, 02142, USA.
Aetion, New York, NY, USA.
Infect Dis Ther. 2025 Jan;14(1):199-216. doi: 10.1007/s40121-024-01091-1. Epub 2024 Dec 21.
In September 2023 the Food and Drug Administration (FDA) approved an updated mRNA COVID-19 vaccine targeting the XBB.1.5 sublineage. This study evaluates the effectiveness of mRNA-1273.815, a 2023-2024 Omicron XBB.1.5-containing mRNA COVID-19 vaccine in preventing COVID-19-related hospitalizations and medically attended COVID-19 in US adults aged ≥ 18 years.
This observational, matched cohort study used medical and pharmacy claims data from HealthVerity. Adults vaccinated with mRNA-1273.815 between September 12, 2023, and December 31, 2023, were followed through January 26, 2024. Vaccinated individuals were matched with individuals unvaccinated with any 2023-2024 COVID-19 vaccine on demographic and clinical characteristics. The primary and secondary outcomes were COVID-19 hospitalization and medically attended COVID-19, respectively. Inverse probability of treatment weighting and Cox proportional hazards regression were utilized to estimate vaccine effectiveness (VE).
The study included 1,272,161 vaccinated individuals matched 1:1 with unvaccinated individuals, with a maximum follow-up of 128 (median 84) days. The VE against COVID-19 hospitalization was 51% (95% confidence interval [CI]: 48-54%). Subgroup analyses showed a VE of 56% (95% CI 51-61%) among adults ≥ 65 years and 46% (95% CI 39-52%) in immunocompromised adults. For medically attended COVID-19, the VE was 25% (95% CI 24-27%). Time-varying analyses showed that while VE declined over time, VE remained significant.
During the 2023-2024 respiratory season, the mRNA-1273.815 vaccine significantly protected against COVID-19-related hospitalizations and medically attended COVID-19 across diverse adult populations and demonstrated durability of the effect. These results support the continued use of updated COVID-19 vaccines to mitigate severe outcomes and maintain public health safety.
2023年9月，美国食品药品监督管理局（FDA）批准了一种针对XBB.1.5亚谱系的新型mRNA新冠疫苗。本研究评估了mRNA-1273.815（一种含2023-2024年奥密克戎XBB.1.5的mRNA新冠疫苗）在预防≥18岁美国成年人新冠相关住院治疗和需就医的新冠感染方面的有效性。
这项观察性匹配队列研究使用了来自HealthVerity的医疗和药房理赔数据。对2023年9月12日至2023年12月31日期间接种mRNA-1273.815的成年人进行随访，直至2024年1月26日。根据人口统计学和临床特征，将接种疫苗的个体与未接种任何2023-2024年新冠疫苗的个体进行匹配。主要和次要结局分别是新冠住院治疗和需就医的新冠感染。采用治疗权重的逆概率法和Cox比例风险回归来估计疫苗有效性（VE）。
该研究纳入了1,272,161名接种疫苗个体，与未接种疫苗个体按1:1匹配，最长随访时间为128天（中位数84天）。预防新冠住院治疗的疫苗有效性为51%（95%置信区间[CI]：48-54%）。亚组分析显示，≥65岁成年人的疫苗有效性为56%（95%CI 51-61%），免疫功能低下成年人的疫苗有效性为46%（95%CI 39-52%）。对于需就医的新冠感染，疫苗有效性为25%（95%CI 24-27%）。随时间变化的分析表明，虽然疫苗有效性随时间下降，但仍具有显著性。
在2023-2024年呼吸道疾病流行季，mRNA-1273.815疫苗在不同成年人群体中显著预防了新冠相关住院治疗和需就医的新冠感染，并显示出效果的持久性。这些结果支持继续使用新型新冠疫苗以减轻严重后果并维护公众健康安全。
