Link-Gelles Ruth, Rowley Elizabeth A K, Irving Stephanie A, Klein Nicola P, Grannis Shaun J, Ong Toan C, Ball Sarah W, DeSilva Malini B, Dascomb Kristin, Naleway Allison L, Koppolu Padma, Zerbo Ousseny, Fireman Bruce, Hansen John, Timbol Julius, Block Lawrence, Dixon Brian E, Duszynski Thomas J, Allen Katie S, Mayer David, Chavez Catia, Barron Michelle, Reese Sarah E, Chickery Sean, Davis Jonathan M, Ciesla Allison Avrich, Mak Josephine, Najdowski Morgan, Akinsete Omobosola O, McEvoy Charlene E, Essien Inih J, Sheffield Tamara, Bride Daniel, Arndorfer Julie, Van Otterloo Joshua, Natarajan Karthik, Tenforde Mark W, DeCuir Jennifer, Payne Amanda B
National Center for Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Public Health Service Commissioned Corps, Rockville, Maryland.
JAMA Netw Open. 2025 Jun 2;8(6):e2517402. doi: 10.1001/jamanetworkopen.2025.17402.
SARS-CoV-2 continues to evolve, population immunity changes, and COVID-19 vaccine formulas have been updated, necessitating ongoing COVID-19 vaccine effectiveness (VE) monitoring.
To evaluate the VE of 2023-2024 COVID-19 vaccines against COVID-19-associated emergency department (ED) and urgent care (UC) encounters, hospitalizations, and critical illness, including during XBB- and JN.1-predominant periods.
DESIGN, SETTING, AND PARTICIPANTS: This test-negative design VE case-control study was conducted using data from September 21, 2023, to August 22, 2024, from EDs, UC centers, and hospitals in 6 US health care systems. Eligible adults 18 years or older with COVID-19-like illness and molecular or antigen testing for SARS-CoV-2 were studied. Case patients were those with a positive molecular or antigen test result; control patients were those with a negative molecular test result.
Receipt of 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination with products approved or authorized for use in the US.
Main outcomes were COVID-19-associated ED and UC encounters, hospitalizations, and critical illness (admission to the intensive care unit or in-hospital death). VE was estimated comparing the odds of receipt of the 2023-2024 COVID-19 vaccine with no receipt among case and control patients.
Among 345 639 eligible ED and UC encounters in immunocompetent adults 18 years or older with COVID-19-like illness and available test results (median [IQR] age, 53 [34-71] years; 209 087 [60%] female), 37 096 (11%) had a positive SARS-CoV-2 test result. VE against COVID-19-associated ED and UC encounters was 24% (95% CI, 21%-26%) during 7 to 299 days after vaccination. Among 111 931 eligible hospitalizations in immunocompetent adults 18 years or older with COVID-19-like illness and available test results (median [IQR] age, 71 [58-81] years), 10 380 (9%) had a positive SARS-CoV-2 test result. During 7 to 299 days after vaccination, VE was 29% (95% CI, 25%-33%) against COVID-19-associated hospitalization and 48% (95% CI, 40%-55%) against COVID-19-associated critical illness. VE was highest 7 to 59 days after vaccination (VE against ED and UC encounters 49%; 95% CI, 46%-52%; hospitalization, 51%; 95% CI, 46%-56%; critical illness, 68%; 95% CI, 56%-76%) and then waned (VE 180-299 days after vaccination against ED and UC encounters, -7% [95% CI, -13% to -2%]; hospitalization, -4% [95% CI, -14% to 5%]; and critical illness, 16% [95% CI, -6 to 34%]).
In this case-control study of VE, 2023-2024 COVID-19 vaccines were estimated to provide additional effectiveness against medically attended COVID-19, with the highest and most sustained estimates against critical illness. These results highlight the importance of receiving recommended COVID-19 vaccination for adults 18 years or older.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）持续演变，人群免疫力发生变化，且2019冠状病毒病（COVID-19）疫苗配方已更新，因此有必要持续监测COVID-19疫苗的有效性（VE）。
评估2023 - 2024年COVID-19疫苗针对与COVID-19相关的急诊科（ED）就诊、紧急护理（UC）就诊、住院和危重症的有效性，包括在XBB和JN.1为主的时期。
设计、设置和参与者：这项检测阴性设计的VE病例对照研究使用了2023年9月21日至2024年8月22日来自美国6个医疗系统的急诊科、UC中心和医院的数据。研究对象为18岁及以上患有COVID-19样疾病且进行了SARS-CoV-2分子或抗原检测的符合条件的成年人。病例患者为分子或抗原检测结果呈阳性者；对照患者为分子检测结果呈阴性者。
接种2023 - 2024年（单价XBB.1.5）经美国批准或授权使用的COVID-19疫苗。
主要结局为与COVID-19相关的ED和UC就诊、住院和危重症（入住重症监护病房或院内死亡）。通过比较病例和对照患者中接种2023 - 2024年COVID-19疫苗与未接种疫苗的几率来估计VE。
在18岁及以上患有COVID-19样疾病且有可用检测结果的免疫功能正常成年人中，有345639次符合条件的ED和UC就诊（年龄中位数[四分位间距]为53[34 - 71]岁；209087[60%]为女性），其中37096例（11%）SARS-CoV-2检测结果呈阳性。接种疫苗后7至299天内，针对与COVID-19相关的ED和UC就诊的VE为24%（95%置信区间[CI]，21% - 26%）。在18岁及以上患有COVID-19样疾病且有可用检测结果的免疫功能正常成年人中，有111931次符合条件的住院（年龄中位数[四分位间距]为71[58 - 81]岁），其中10380例（9%）SARS-CoV-2检测结果呈阳性。接种疫苗后7至299天内，针对与COVID-19相关住院的VE为
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