Delhi School of Public Health, IoE & Dr. B.R. Ambedkar Center for Biomedical Research, University of Delhi, New Delhi, India.
Department of Zoology, Daulat Ram College, University of Delhi, New Delhi, India.
J Med Virol. 2022 Jul;94(7):3147-3154. doi: 10.1002/jmv.27708. Epub 2022 Mar 21.
Vaccines against COVID-19 provide immunity to deter severe morbidities associated with the infection. However, it does not prevent infection altogether in all exposed individuals. Furthermore, emerging variants of SARS-CoV-2 impose a threat concerning the competency of the vaccines in combating the infection. This study aims to determine the variability in adverse events and the extent of breakthrough infections in the Indian population. A retrospective study was conducted using a pre-validated questionnaire encompassing social, demographic, general health, the status of SARS-CoV-2 infection, vaccination, associated adverse events, and breakthrough infections in the Indian population. Informed consent and ethical approval were obtained as per Indian Council of Medical Research (ICMR) guidelines. Participants, who provided the complete information, were Indian citizens, above 18 years, and if vaccinated, administered with either Covishield or Covaxin, were considered for the study. Data have been compiled in Microsoft Excel and analyzed for statistical differences using STATA 11. The responses from 2051 individuals fulfilling the inclusion criteria were analyzed. Among 2051, 1119 respondents were vaccinated and 932 respondents were non-vaccinated. Among 1119 vaccinated respondents, 7 were excluded because of missing data. Therefore, out of 1112 vaccinated, 413 experienced adverse events with a major fraction of younger individuals, age 18-40 years, getting affected (74.82%; 309/413). Furthermore, considerably more females than males encountered adverse consequences to vaccination (p < 0.05). Among vaccinated participants, breakthrough infections were observed in 7.91% (88/1112; 57.96% males and 42.04% females) with the older age group, 61 years and above (odds ratio, 3.25 [1.32-8.03]; p = 0.011), and males were found to be at higher risk. Further research is needed to find the age and sex-related factors in determining vaccine effectiveness and adverse events.
新冠疫苗可提供针对感染相关严重疾病的免疫力，但不能完全防止所有暴露个体感染。此外，SARS-CoV-2 的新兴变异株对疫苗抗击感染的能力构成威胁。本研究旨在确定印度人群中不良反应和突破性感染的变化。使用经过预先验证的问卷进行回顾性研究，该问卷包括社会、人口统计学、一般健康状况、SARS-CoV-2 感染状况、疫苗接种、相关不良反应和印度人群中的突破性感染。根据印度医学研究理事会（ICMR）的指南，获得了知情同意和伦理批准。提供完整信息的参与者为印度公民，年龄在 18 岁以上，如果接种疫苗，则接种 Covishield 或 Covaxin，则被认为符合研究条件。数据已在 Microsoft Excel 中汇总，并使用 STATA 11 进行统计差异分析。对符合纳入标准的 2051 名个体的应答进行了分析。在 2051 名个体中，有 1119 名接种了疫苗，932 名未接种疫苗。在 1119 名接种疫苗的应答者中，有 7 人因数据缺失而被排除。因此，在 1112 名接种疫苗的个体中，有 413 人出现不良反应，其中大部分为 18-40 岁的年轻人（74.82%；309/413）。此外，女性比男性更容易因接种疫苗而产生不良反应（p<0.05）。在接种疫苗的参与者中，观察到 7.91%（88/1112；57.96%为男性，42.04%为女性）出现突破性感染，年龄在 61 岁及以上（比值比，3.25 [1.32-8.03]；p=0.011），男性感染风险更高。需要进一步研究以确定年龄和性别相关因素在确定疫苗效力和不良反应中的作用。
