Corchado-Garcia Juan, Zemmour David, Hughes Travis, Bandi Hari, Cristea-Platon Tudor, Lenehan Patrick, Pawlowski Colin, Bade Sairam, O'Horo John C, Gores Gregory J, Williams Amy W, Badley Andrew D, Halamka John, Virk Abinash, Swift Melanie D, Wagner Tyler, Soundararajan Venky
nference, Cambridge, Massachusetts.
nference Labs, Murgesh Pallya, Bengaluru, Karnataka, India.
JAMA Netw Open. 2021 Nov 1;4(11):e2132540. doi: 10.1001/jamanetworkopen.2021.32540.
Continuous assessment of the effectiveness and safety of the US Food and Drug Administration-authorized SARS-CoV-2 vaccines is critical to amplify transparency, build public trust, and ultimately improve overall health outcomes.
To evaluate the effectiveness of the Johnson & Johnson Ad26.COV2.S vaccine for preventing SARS-CoV-2 infection.
DESIGN, SETTING, AND PARTICIPANTS: This comparative effectiveness research study used large-scale longitudinal curation of electronic health records from the multistate Mayo Clinic Health System (Minnesota, Arizona, Florida, Wisconsin, and Iowa) to identify vaccinated and unvaccinated adults between February 27 and July 22, 2021. The unvaccinated cohort was matched on a propensity score derived from age, sex, zip code, race, ethnicity, and previous number of SARS-CoV-2 polymerase chain reaction tests. The final study cohort consisted of 8889 patients in the vaccinated group and 88 898 unvaccinated matched patients.
Single dose of the Ad26.COV2.S vaccine.
The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts, measured by SARS-CoV-2 polymerase chain reaction testing.
The study was composed of 8889 vaccinated patients (4491 men [50.5%]; mean [SD] age, 52.4 [16.9] years) and 88 898 unvaccinated patients (44 748 men [50.3%]; mean [SD] age, 51.7 [16.7] years). The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts was 0.26 (95% CI, 0.20-0.34) (60 of 8889 vaccinated patients vs 2236 of 88 898 unvaccinated individuals), which corresponds to an effectiveness of 73.6% (95% CI, 65.9%-79.9%) and a 3.73-fold reduction in SARS-CoV-2 infections.
This study's findings are consistent with the clinical trial-reported efficacy of Ad26.COV2.S and the first retrospective analysis, suggesting that the vaccine is effective at reducing SARS-CoV-2 infection, even with the spread of variants such as Alpha or Delta that were not present in the original studies, and reaffirm the urgent need to continue mass vaccination efforts globally.
持续评估美国食品药品监督管理局授权的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗的有效性和安全性对于提高透明度、建立公众信任并最终改善整体健康结果至关重要。
评估强生公司的Ad26.COV2.S疫苗预防SARS-CoV-2感染的有效性。
设计、地点和参与者：这项比较有效性研究使用了多州梅奥诊所医疗系统（明尼苏达州、亚利桑那州、佛罗里达州、威斯康星州和爱荷华州）电子健康记录的大规模纵向整理，以识别2021年2月27日至7月22日期间接种疫苗和未接种疫苗的成年人。未接种疫苗的队列根据年龄、性别、邮政编码、种族、族裔和先前的SARS-CoV-2聚合酶链反应检测次数得出的倾向评分进行匹配。最终研究队列包括8889名接种疫苗组患者和88898名匹配的未接种疫苗患者。
单剂Ad26.COV2.S疫苗。
通过SARS-CoV-2聚合酶链反应检测测量接种疫苗组与未接种疫苗对照组中SARS-CoV-2感染的发病率比。
该研究由8889名接种疫苗的患者（4491名男性[50.5%]；平均[标准差]年龄52.4[16.9]岁）和88898名未接种疫苗的患者（44748名男性[50.3%]；平均[标准差]年龄51.7[16.7]岁）组成。接种疫苗组与未接种疫苗对照组中SARS-CoV-2感染的发病率比为0.26（95%置信区间，0.20 - 0.34）（8889名接种疫苗的患者中有60例，88898名未接种疫苗的个体中有2236例），这相当于有效性为73.6%（95%置信区间，65.9% - 79.9%），SARS-CoV-2感染减少了3.73倍。
本研究结果与Ad26.COV2.S临床试验报告的疗效以及首次回顾性分析一致，表明即使存在原始研究中未出现的如阿尔法或德尔塔等变体的传播，该疫苗在减少SARS-CoV-2感染方面仍然有效，并再次强调全球持续大规模接种疫苗努力的迫切需求。
