Hospitalisation among vaccine breakthrough COVID-19 infections.
Hospitalisation among vaccine breakthrough COVID-19 infections.
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DOI：
10.1016/s1473-3099(21)00558-2
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发表时间：
2021-11
期刊：
影响因子：
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通讯作者：
Chun HJ
中科院分区：
文献类型：
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作者：
Juthani PV;Gupta A;Borges KA;Price CC;Lee AI;Won CH;Chun HJ
美国食品药品监督管理局对三种SARS-CoV-2疫苗的紧急使用授权是应对COVID-19大流行的重要里程碑。来自Shrotri及其同事的VIVALDI研究1和其他3期临床试验2 -4的数据显示，疫苗在预防严重症状性疾病方面具有强大的效力（> 85%）。虽然罕见，但新出现的报告描述了完全接种疫苗的个体中的突破性SARS-CoV-2感染。5我们使用耶鲁纽黑文卫生系统收集的真实数据描述了疫苗接种对确诊SARS-CoV-2感染患者入院的影响。我们对2021年3月23日至7月1日期间因SARS-CoV-2（入院时经PCR检测阳性证实）入院的患者进行了系统回顾。记录SARS-CoV-2疫苗接种状态，包括特定疫苗类型（mRNA-1273 [elasomeran; Moderna]，BNT 162 b2 [tozinameran; Pfizer-BioNTech]或Ad. 26. COV2。S [Janssen]）和接种日期。如果最终剂量（第二剂量的BNT 162 b2或mRNA-1273，或第一剂量的Ad. 26. COV2。S）在症状出现或SARS-CoV-2 PCR检测阳性前至少14天给药。总共，我们确定了969名被耶鲁纽黑文卫生系统医院收治的患者，他们证实了SARS-CoV-2的PCR检测阳性。COVID-19感染的严重程度根据既定指引厘定。969名患者中有6172名（18%）在入院时至少接种了一剂COVID-19疫苗。在这些患者中，103例接受了部分疫苗疗程（一剂BNT 162 b2或mRNA-1273），15例接受了完整疗程（两剂BNT 162 b2或mRNA-1273或一剂Ad. 26. COV2。S症状发作前14天内或PCR检测阳性），54人完全接种疫苗（附录第1-2页）。被认为有突破性SARS-CoV-2感染的患者，即54名完全接种疫苗的患者，被评估了疾病的严重程度。在这一队列中，我们发现25名（46%）患者无症状（因非COVID-19相关诊断而入院，但SARS-CoV-2 PCR检测偶然阳性），4名（7%）患者病情轻微，11名（20%）患者病情中度，14名（26%）患者病情严重或危重。在重度或危重病患者中，中位年龄为80· 5岁（IQR 76· 5-85· 0）; 14例患者中有4例需要重症监护，1例需要机械通气，3例死亡。14例重度或危重症患者的既存合并症包括超重（体重指数> 25 kg/m²; n= 9）、心血管疾病（n= 12）、肺部疾病（n= 7）、恶性肿瘤（n= 4）、2型糖尿病（n= 7）和使用免疫抑制剂（n= 4;附录第3页）。14例患者中有13例接受了BNT 162 b2（附录p 1-2）。SARS-CoV-2疫苗接种对预防SARS-CoV-2感染或COVID-19住院非常有效。在我们对SARS-CoV-2 PCR检测阳性的住院患者进行的真实评估中，我们发现近五分之一的患者至少接种了一剂疫苗，我们观察到许多患者没有完成完整的疫苗接种过程。这一发现表明，超过四分之一的完全接种疫苗的患者因COVID-19而严重或危重，这可能反映了许多因素，包括SARS-CoV-2变异体的出现，这些变异体可能会降低疫苗的有效性，并导致免疫反应无效。
Emergency use authorisations granted by the US Food and Drug Administration for three SARS-CoV-2 vaccines represent an important milestone in the response to the COVID-19 pandemic. Data presented from the VIVALDI study by Shrotri and colleagues1 and other phase 3 clinical trials2–4 have shown robust vaccine efficacies (> 85%) at preventing severe symptomatic disease. Although rare, emerging reports describe breakthrough SARS-CoV-2 infections in fully vaccinated individuals. 5 We describe the impact of vaccination on admission to hospital in patients with confirmed SARS-CoV-2 infection using real-world data collected by the Yale New Haven Health System. We did a systematic review of patients admitted to hospital with SARS-CoV-2 (confirmed by a positive PCR test at the time of admission) between March 23 and July 1, 2021. SARS-CoV-2 vaccination status was recorded, including the specific vaccine type (mRNA-1273 [elasomeran; Moderna], BNT162b2 [tozinameran; Pfizer–BioNTech], or Ad. 26. COV2. S [Janssen]) and vaccination dates. Patients were considered fully vaccinated if the final dose (either second dose of BNT162b2 or mRNA-1273, or first dose of Ad. 26. COV2. S) was administered at least 14 days before symptom onset or a positive PCR test for SARS-CoV-2. In total, we identified 969 patients who were admitted to a Yale New Haven Health System hospital with a confirmed positive PCR test for SARS-CoV-2. Severity of COVID-19 infection was determined on the basis of established guidelines. 6 172 (18%) of 969 patients had received at least one dose of a COVID-19 vaccine at the time of admission to hospital. Among these patients, 103 had received a partial vaccine course (one dose of BNT162b2 or mRNA-1273), 15 had received a complete course (two doses of BNT162b2 or mRNA-1273 or one dose of Ad. 26. COV2. S within 14 days before symptom onset or a positive PCR test), and 54 were fully vaccinated (appendix pp 1–2). Patients deemed to have a breakthrough SARS-CoV-2 infection—ie, the 54 patients who were fully vaccinated—were evaluated for illness severity. Among this cohort, we found that 25 (46%) patients were asymptomatic (admitted to hospital for a non-COVID-19-related diagnosis but with an incidental positive PCR test forSARS-CoV-2), four (7%) had mild disease, 11 (20%) had moderate disease, and 14 (26%) had severe or critical illness. Among those with severe or critical illness, the median age was 80· 5 years (IQR 76· 5–85· 0); four of 14 patients required intensive care, one required mechanical ventilation, and three died. Pre-existing comorbidities in the 14 patients with severe or critical illness included overweight (body–mass index> 25 kg/m²; n= 9), cardiovascular disease (n= 12), lung disease (n= 7), malignancy (n= 4), type 2 diabetes (n= 7), and use of an immunosuppressive agent (n= 4; appendix pp 3). 13 of 14 patients had received BNT162b2 (appendix p 1–2). Vaccination for SARS-CoV-2 is highly effective against infection with SARS-CoV-2 or hospitalisation with COVID-19. In our real-world assessment of patients admitted to hospital with a positive SARS-CoV-2 PCR test, we found that nearly a fifth of patients had received at least one dose of the vaccine, and we observed that many patients had not completed the full vaccine course. The finding that more than a quarter of fully vaccinated patients admitted to hospital with SARS-CoV-2 were severely or critically ill with COVID-19 could be reflective of numerous factors, including the emergence of SARS-CoV-2 variants that might confer decreased vaccine effectiveness and an ineffective immune response mounted against …