Department of Physician Affairs, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
JAMA. 2021 Jun 22;325(24):2457-2465. doi: 10.1001/jama.2021.7152.
Randomized clinical trials have provided estimates of the effectiveness of the BNT162b2 vaccine against symptomatic SARS-CoV-2 infection, but its effect on asymptomatic infections remains unclear.
To estimate the association of vaccination with the Pfizer-BioNTech BNT162b2 vaccine with symptomatic and asymptomatic SARS-CoV-2 infections among health care workers.
DESIGN, SETTING, AND PARTICIPANTS: This was a single-center, retrospective cohort study conducted at a tertiary medical center in Tel Aviv, Israel. Data were collected on symptomatic and asymptomatic SARS-CoV-2 infections confirmed via polymerase chain reaction (PCR) tests in health care workers undergoing regular screening with nasopharyngeal swabs between December 20, 2020, and February 25, 2021. Logistic regression was used to calculate incidence rate ratios (IRRs) comparing the incidence of infection between fully vaccinated and unvaccinated participants, controlling for demographics and the number of PCR tests performed.
Vaccination with the BNT162b2 vaccine vs unvaccinated status was ascertained from the employee health database. Full vaccination was defined as more than 7 days after receipt of the second vaccine dose.
The primary outcome was the regression-adjusted IRR for symptomatic and asymptomatic SARS-CoV-2 infection of fully vaccinated vs unvaccinated health care workers. The secondary outcomes included IRRs for partially vaccinated health care workers (days 7-28 after first dose) and for those considered as late fully vaccinated (>21 days after second dose).
A total of 6710 health care workers (mean [SD] age, 44.3 [12.5] years; 4465 [66.5%] women) were followed up for a median period of 63 days; 5953 health care workers (88.7%) received at least 1 dose of the BNT162b2 vaccine, 5517 (82.2%) received 2 doses, and 757 (11.3%) were not vaccinated. Vaccination was associated with older age compared with those who were not vaccinated (mean age, 44.8 vs 40.7 years, respectively) and male sex (31.4% vs 17.7%). Symptomatic SARS-CoV-2 infection occurred in 8 fully vaccinated health care workers and 38 unvaccinated health care workers (incidence rate, 4.7 vs 149.8 per 100 000 person-days, respectively, adjusted IRR, 0.03 [95% CI, 0.01-0.06]). Asymptomatic SARS-CoV-2 infection occurred in 19 fully vaccinated health care workers and 17 unvaccinated health care workers (incidence rate, 11.3 vs 67.0 per 100 000 person-days, respectively, adjusted IRR, 0.14 [95% CI, 0.07-0.31]). The results were qualitatively unchanged by the propensity score sensitivity analysis.
Among health care workers at a single center in Tel Aviv, Israel, receipt of the BNT162b2 vaccine compared with no vaccine was associated with a significantly lower incidence of symptomatic and asymptomatic SARS-CoV-2 infection more than 7 days after the second dose. Findings are limited by the observational design.
重要性:随机临床试验已经提供了 BNT162b2 疫苗对有症状的 SARS-CoV-2 感染的有效性估计,但它对无症状感染的影响仍不清楚。
目的:估计接种辉瑞-生物技术公司的 BNT162b2 疫苗与医护人员中 SARS-CoV-2 有症状和无症状感染之间的关联。
设计、地点和参与者:这是一项在以色列特拉维夫的一家三级医疗中心进行的单中心、回顾性队列研究。数据来自于在接受定期鼻咽拭子筛查的医护人员中,通过聚合酶链反应(PCR)检测确诊的 SARS-CoV-2 有症状和无症状感染。研究时间为 2020 年 12 月 20 日至 2021 年 2 月 25 日。使用逻辑回归计算比较完全接种和未接种参与者之间感染发生率的发病率比(IRR),控制了人口统计学和进行的 PCR 检测数量。
暴露:通过员工健康数据库确定 BNT162b2 疫苗接种和未接种状态。完全接种定义为第二剂疫苗接种后超过 7 天。
主要结果和措施:主要结果是完全接种和未接种医护人员中 SARS-CoV-2 有症状和无症状感染的回归调整 IRR。次要结果包括部分接种(第一剂后 7-28 天)和被认为是迟完全接种(第二剂后超过 21 天)的医护人员的 IRR。
结果:共有 6710 名医护人员(平均[标准差]年龄为 44.3[12.5]岁;4465[66.5%]名女性)的中位随访期为 63 天;5953 名医护人员(88.7%)至少接种了一剂 BNT162b2 疫苗,5517 名(82.2%)接种了两剂,757 名(11.3%)未接种。与未接种者相比,接种者年龄较大(平均年龄分别为 44.8 岁和 40.7 岁),且为男性(分别为 31.4%和 17.7%)。8 名完全接种者和 38 名未接种者发生有症状 SARS-CoV-2 感染(发病率分别为每 100000 人天 4.7 和 149.8,调整后的 IRR 为 0.03[95%CI,0.01-0.06])。19 名完全接种者和 17 名未接种者发生无症状 SARS-CoV-2 感染(发病率分别为每 100000 人天 11.3 和 67.0,调整后的 IRR 为 0.14[95%CI,0.07-0.31])。倾向评分敏感性分析的结果定性上没有变化。
结论:在以色列特拉维夫的一家单一中心,与未接种疫苗相比,接受 BNT162b2 疫苗接种与第二剂后 7 天以上 SARS-CoV-2 有症状和无症状感染的发生率显著降低有关。研究结果受到观察性设计的限制。