Kaur Upinder, Bala Sapna, Joshi Aditi, Reddy Noti Taruni Srija, Japur Chetan, Chauhan Mayank, Pedapanga Nikitha, Kumar Shubham, Mukherjee Anurup, Mishra Vaibhav, Talda Dolly, Singh Rohit, Gupta Rohit Kumar, Yadav Ashish Kumar, Rana Poonam Jyoti, Srivastava Jyoti, Bhat K Shobha, Singh Anup, P G Naveen Kumar, Pandey Manoj, Patwardhan Kishor, Kansal Sangeeta, Chakrabarti Sankha Shubhra
Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005, UP, India.
Department of Geriatric Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005, UP, India.
Vaccines (Basel). 2022 Jul 20;10(7):1153. doi: 10.3390/vaccines10071153.
There is paucity of real-world data on COVID-19 vaccine effectiveness from cohort designs. Variable vaccine performance has been observed in test-negative case-control designs. There is also scarce real-world data of health issues in individuals receiving vaccines after prior COVID-19, and of adverse events of significant concern (AESCs) in the vaccinated. : A cohort study was conducted from July 2021 to December 2021 in a tertiary hospital of North India. The primary outcome was vaccine effectiveness against COVID-19 during the second wave in India. Secondary outcomes were AESCs, and persistent health issues in those receiving COVID-19 vaccines. Regression analyses were performed to determine risk factors of COVID-19 outcomes and persistent health issues. : Of the 2760 health care workers included, 2544 had received COVID-19 vaccines, with COVISHIELD (rChAdOx1-nCoV-19 vaccine) received by 2476 (97.3%) and COVAXIN (inactivated SARS-CoV-2 vaccine) by 64 (2.5%). A total of 2691 HCWs were included in the vaccine effectiveness analysis, and 973 COVID-19 events were reported during the period of analysis. Maximum effectiveness of two doses of vaccine in preventing COVID-19 occurrence was 17% across three different strategies of analysis adopted for robustness of data. One-dose recipients were at 1.27-times increased risk of COVID-19. Prior SARS-CoV-2 infection was a strong independent protective factor against COVID-19 (aOR 0.66). Full vaccination reduced moderate-severe COVID-19 by 57%. Those with lung disease were at 2.54-times increased risk of moderate-severe COVID-19, independent of vaccination status. AESCs were observed in 33/2544 (1.3%) vaccinees, including one case each of myocarditis and severe hypersensitivity. Individuals with hypothyroidism were at 5-times higher risk and those receiving a vaccine after recovery from COVID-19 were at 3-times higher risk of persistent health issues. : COVID-19 vaccination reduced COVID-19 severity but offered marginal protection against occurrence. The possible relationship of asthma and hypothyroidism with COVID-19 outcomes necessitates focused research. With independent protection of SARS-CoV-2 infection, and high-risk of persistent health issues in individuals receiving vaccine after recovery from SARS-CoV-2 infection, the recommendation of vaccinating those with prior SARS-CoV-2 infection needs reconsideration.
关于队列设计中新冠病毒疫苗有效性的真实世界数据匮乏。在检测呈阴性的病例对照设计中观察到疫苗表现存在差异。关于既往感染过新冠病毒的个体接种疫苗后的健康问题以及接种疫苗者中重大关注不良事件（AESCs）的真实世界数据也很稀少。：2021年7月至2021年12月在印度北部的一家三级医院进行了一项队列研究。主要结局是印度第二波疫情期间疫苗对新冠病毒的有效性。次要结局是AESCs以及接种新冠病毒疫苗者的持续性健康问题。进行回归分析以确定新冠病毒结局和持续性健康问题的风险因素。：在纳入的2760名医护人员中，2544人接种了新冠病毒疫苗，其中2476人（97.3%）接种了COVISHIELD（重组腺病毒载体新冠病毒疫苗），64人（2.5%）接种了COVAXIN（灭活新冠病毒疫苗）。共有2691名医护人员纳入疫苗有效性分析，分析期间报告了973例新冠病毒感染事件。在为确保数据稳健性而采用的三种不同分析策略中，两剂疫苗预防新冠病毒感染的最大有效性为17%。接种一剂疫苗的人感染新冠病毒的风险增加1.27倍。既往感染过严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是预防新冠病毒感染的强有力独立保护因素（调整后比值比为0.66）。全程接种疫苗可使中度至重度新冠病毒感染减少57%。患有肺部疾病的人发生中度至重度新冠病毒感染的风险增加2.54倍，与疫苗接种状态无关。在2544名接种疫苗者中有33人（1.3%）出现了AESCs，包括1例心肌炎和1例严重过敏反应。甲状腺功能减退者出现持续性健康问题的风险高5倍，既往感染过新冠病毒后康复再接种疫苗的人出现持续性健康问题的风险高3倍。：新冠病毒疫苗接种降低了新冠病毒感染的严重程度，但对感染发生的预防作用有限。哮喘和甲状腺功能减退与新冠病毒结局之间可能存在的关系需要重点研究。鉴于既往感染SARS-CoV-2具有独立保护作用，且既往感染SARS-CoV-2后康复再接种疫苗的个体出现持续性健康问题风险高，对于既往感染过SARS-CoV-2的人接种疫苗的建议需要重新考虑。
