Polinski Jennifer M, Weckstein Andrew R, Batech Michael, Kabelac Carly, Kamath Tripthi, Harvey Raymond, Jain Sid, Rassen Jeremy A, Khan Najat, Schneeweiss Sebastian
Department of Science, Aetion Inc, New York, New York.
Janssen Research and Development Data Science, Spring House, Pennsylvania.
JAMA Netw Open. 2022 Mar 1;5(3):e222959. doi: 10.1001/jamanetworkopen.2022.2959.
Vaccination against the SARS-CoV-2 virus is critical to control the pandemic. Randomized clinical trials demonstrated efficacy of the single-dose Ad26.COV2.S COVID-19 vaccine, but data on longer-term protection in clinical practice and effectiveness against variants are needed.
To assess the association between receiving the Ad26.COV2.S vaccine and COVID-19-related infections and hospitalizations before and during the Delta variant surge.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study included adults aged 18 years and older who were newly Ad26.COV2.S-vaccinated matched to as many as 10 unvaccinated individuals by date, location, age, sex, and comorbidity index. This was followed by 1:4 propensity score matching on COVID-19 risk factors. Data were collected from US insurance claims data from March 1, 2020, through August 31, 2021.
Vaccination with Ad26.COV2.S vs no vaccination.
Vaccine effectiveness (VE) was estimated for recorded COVID-19 infection and COVID-19-related hospitalization, nationwide and in subgroups by age, high-risk factors, calendar time, and states with high incidences of the Delta variant. VE estimates were corrected for underrecording of vaccinations in insurance data.
Among 422 034 vaccinated individuals (mean [SD] age, 54.7 [17.4] years; 236 437 [56.0%] women) and 1 645 397 matched unvaccinated individuals (mean [SD] age, 54.5 [17.5] years; 922 937 [56.1%] women), VE was 76% (95% CI, 75%-77%) for COVID-19 infections and 81% (95% CI, 78%-82%) for COVID-19-related hospitalizations. VE was stable for at least 180 days after vaccination and over calendar time. Among states with high Delta variant incidence, VE during June to August 2021 was 74% (95% CI, 71%-77%) for infections and 81% (95% CI, 75%-86%) for hospitalizations. VE for COVID-19 was higher in individuals younger than 65 years (78%; 95% CI, 77%-79%) and lower in immunocompromised patients (64%; 95% CI, 59%-68%). All estimates were corrected for vaccination underrecording; uncorrected VE, which served as a lower bound, was 66% (95% CI, 64%-67%) for any recorded COVID-19 infection and 72% (95% CI, 69%-74%) for COVID-19-related hospitalization.
This cohort study in US clinical practice showed stable VE of Ad26.COV2.S for at least 6 months before as well as during the time the Delta variant emerged and became dominant.
接种针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的疫苗对于控制疫情至关重要。随机临床试验证明了单剂量Ad26.COV2.S新冠疫苗的有效性，但仍需要临床实践中关于长期保护以及针对病毒变体有效性的数据。
评估接种Ad26.COV2.S疫苗与德尔塔变体激增之前及期间新冠病毒相关感染和住院之间的关联。
设计、设置和参与者：这项队列研究纳入了18岁及以上首次接种Ad26.COV2.S疫苗的成年人，并按日期、地点、年龄、性别和合并症指数与多达10名未接种疫苗的个体进行匹配。随后，根据新冠病毒风险因素进行1:4倾向得分匹配。数据收集自2020年3月1日至2021年8月31日的美国保险理赔数据。
接种Ad26.COV2.S疫苗与未接种疫苗。
针对记录的新冠病毒感染和新冠病毒相关住院情况，在全国范围内以及按年龄、高危因素、日历时间和德尔塔变体高发病率州的亚组中估计疫苗有效性（VE）。对保险数据中疫苗接种记录不全的情况进行了VE估计校正。
在422034名接种疫苗的个体（平均[标准差]年龄，54.7[17.4]岁；236437名[56.0%]为女性）和1645397名匹配的未接种疫苗个体（平均[标准差]年龄，54.5[17.5]岁；922937名[56.1%]为女性）中，新冠病毒感染的VE为76%（95%置信区间，75%-77%），新冠病毒相关住院的VE为81%（95%置信区间，78%-82%）。接种疫苗后至少180天以及在日历时间内，VE保持稳定。在德尔塔变体高发病率州中，2021年6月至8月期间感染的VE为74%（95%置信区间，71%-77%），住院的VE为81%（95%置信区间，75%-86%）。65岁以下个体新冠病毒的VE较高（78%；95%置信区间，77%-79%），免疫功能低下患者的VE较低（64%；95%置信区间，59%-68%）。所有估计值均针对疫苗接种记录不全进行了校正；未校正的VE作为下限，任何记录的新冠病毒感染的VE为66%（95%置信区间，64%-67%），新冠病毒相关住院的VE为72%（95%置信区间，69%-74%）。
这项在美国临床实践中的队列研究表明，在德尔塔变体出现并占主导地位之前以及期间，Ad26.COV2.S的VE至少6个月保持稳定。
