比较ChAdOx1 nCoV-19冠状病毒疫苗（重组）（Covishield）和BBV152；巴拉特生物技术公司的COVID-19疫苗（Covaxin）用于预防COVID-19：印度人群接种疫苗后不良事件报告

Comparing ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (Covishield) and BBV152; Bharat Biotech COVID-19 Vaccine (Covaxin) for COVID-19: Reports of Adverse Events Following Vaccination among the Indian Population.

作者信息

Kaur Sukhpal, Rohilla Latika, Kayina Choro Athiphro, Kaur Jasvir, Kaur Gurpreet, Walia Anjani, Kumar Pramod, Singh Ajay, Saini Sushma, Soni Shiv Lal, Malhotra Pankaj

机构信息

Associate Professor, Department of National Institute of Nursing Education, PGIMER, Chandigarh, India.

Public Health Nursing Officer, Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh, India.

出版信息

Indian J Public Health. 2025 Jan 1;69(1):27-32. doi: 10.4103/ijph.ijph_505_23. Epub 2025 Mar 21.

DOI:10.4103/ijph.ijph_505_23

PMID:40214314

Abstract

BACKGROUND

COVID-19 is declared a global pandemic by the WHO; vaccines were the need of the hour to reduce mortality and return to some form of normal life. The Indian government provides two vaccines as per the program; ChAdOx1 nCoV-19 and BBV152; Bharat Biotech COVID-19 vaccine. However, vaccine hesitancy is a major public health concern.

OBJECTIVE

To evaluate the adverse events following immunization (AEFIs) after COVID-19 vaccination. The safety profile of ChAdOx1 nCoV-19 and BBV152 vaccine was also studied.

MATERIALS AND METHODS

This was a large-scale, cross-sectional survey. Beneficiaries who had their vaccination in the past 2 weeks were sent an online survey performa regarding AEFIs after COVID-19 vaccine.

RESULTS

Out of 2311 participants, 58% received ChAdOx1-nCoV-19 and 42% received BBV152 COVID-19 vaccine, with the mean ± standard deviation age (years) of 36.3 ± 14.5 and 16.9 ± 4.07, respectively. The previous history of COVID-19 infection was reported in 7% of the participants. In the ChAdOx1-nCoV-19 group, 85.3% participants reported at least one adverse reaction, with pain at site being the most common, followed by fever, fatigue, and feeling of unwellness. In the BBV152 group, 17% reported adverse reaction, with pain site being the most common, followed by tenderness, fatigue, and feeling of unwellness. In the BBV152 group, a significant positive association was observed between AEFIs and age. In the ChAdOx1-nCoV-19 group, age was marginally associated with AEFIs. AEFIs were more after first dose (121 vs. 43, P < 0.001, adjusted odds ratio (OR) =3.39 [95% confidence interval [CI]: 2.24-5.11], P < 0.001) among elderly (adjusted OR = 0.60, 95% CI: 0.36-0.99, P = 0.047) and women (721 vs. 423, P = 0.001, adjusted OR = 1.68 [95% CI: 1.24-2.29], P = 0.001).

CONCLUSION

Our study observed that both ChAdOx1 nCoV-19 and BBV152 have a favorable safety profile without serious AEFIs in any of the beneficiaries.

摘要

背景

世界卫生组织宣布新冠病毒病（COVID-19）为全球大流行；疫苗是降低死亡率并回归某种正常生活形式的当务之急。印度政府按计划提供两种疫苗；牛津大学/阿斯利康新冠病毒疫苗（ChAdOx1 nCoV-19）和BBV152；巴拉特生物技术公司新冠病毒疫苗。然而，疫苗犹豫是一个主要的公共卫生问题。

目的

评估新冠病毒疫苗接种后的免疫接种后不良事件（AEFI）。还研究了ChAdOx1 nCoV-19和BBV152疫苗的安全性。

材料与方法

这是一项大规模横断面调查。向在过去2周内接种过疫苗的受益者发送了一份关于新冠病毒疫苗接种后AEFI的在线调查问卷。

结果

在2311名参与者中，58%接种了ChAdOx1-nCoV-19疫苗，42%接种了BBV152新冠病毒疫苗，平均年龄±标准差（岁）分别为36.3±14.5和16.9±4.07。7%的参与者报告有新冠病毒感染既往史。在ChAdOx1-nCoV-19组中，85.3%的参与者报告至少有一种不良反应，其中接种部位疼痛最常见，其次是发热、疲劳和不适。在BBV152组中，17%的参与者报告有不良反应，接种部位疼痛最常见，其次是压痛、疲劳和不适。在BBV152组中，观察到AEFI与年龄之间存在显著正相关。在ChAdOx1-nCoV-19组中，年龄与AEFI的相关性较弱。在老年人（调整后的比值比（OR）=0.60，95%置信区间[CI]：0.36-0.99，P=0.047）和女性（721例对423例，P=0.001，调整后的OR=1.68[95%CI：1.24-2.29]，P=0.001）中，首剂接种后AEFI更多（121例对43例，P<0.001，调整后的OR=3.39[95%CI：2.24-5.11]，P<0.001）。