Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behavior

IF 2.3 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Clinical Epidemiology and Global Health Pub Date : 2025-05-30 DOI:10.1016/j.cegh.2025.102082

Sujoy Bose , Arpita Bhriguvanshi , Mehul Saxena

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引用次数: 0

Abstract

Background

India initiated COVID-19 vaccination for adolescents (aged 15–18 years) on January 3, 2022, exclusively using COVAXIN. Adolescent-specific safety data remain limited, and adverse event following immunization (AEFI) reporting is notably low. This study evaluated the frequency, characteristics, and predictors of adolescents' short-term, self-reported AEFI post-COVAXIN vaccination and assessed their awareness and practices regarding official AEFI reporting mechanisms.

Methods

A retrospective cohort study was conducted between May and September 2022 among 411 adolescents vaccinated with at least one dose of COVAXIN across schools in urban and rural Lucknow, Northern India. Data on demographics, vaccine doses, AEFI symptoms, onset, duration, management, prior SARS-CoV-2 infection, and awareness and reporting behaviors were collected via a validated questionnaire through face-to-face interviews.

Results

65.45 % reported AEFI after the first dose and 56 % after the second. The most common reactions included injection-site pain, fever, and headache, predominantly occurring within 12 h and resolving within three days. Females reported significantly higher AEFI frequency (Adjusted OR = 3.0; 95 %CI:1.23–7.37), and the first dose was associated with greater reactogenicity (Adjusted OR = 1.55; 95 %CI:1.14–2.09). Prior SARS-CoV-2 infections significantly influenced AEFI occurrence. Despite frequent mild, self-limiting symptoms, awareness of official AEFI reporting mechanisms was low (18 %), with only 1.2 % formally reporting their symptoms.

Conclusion

COVAXIN vaccination in adolescents demonstrated a favorable short-term safety profile with predominantly mild, transient reactions. However, critically low awareness and negligible formal reporting highlight an urgent need to strengthen vaccine safety monitoring and public education on reporting practices.

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印度北部青少年（15-18岁）接种COVAXIN后的短期不良事件：频率、预测因素和报告行为

印度于2022年1月3日开始为青少年（15-18岁）接种COVID-19疫苗，完全使用COVAXIN。青少年特异性安全性数据仍然有限，免疫接种后不良事件（AEFI）报告非常低。本研究评估了青少年在接种covaxin后短期自我报告的AEFI的频率、特征和预测因素，并评估了他们对官方AEFI报告机制的认识和做法。方法于2022年5月至9月对印度北部勒克瑙城乡学校411名至少接种过一剂COVAXIN的青少年进行回顾性队列研究。通过面对面访谈，收集人口统计学、疫苗剂量、AEFI症状、发病、持续时间、处理、既往SARS-CoV-2感染、意识和报告行为等数据。结果第一次接种后报告AEFI的比例为65.45%，第二次接种后报告AEFI的比例为56%。最常见的反应包括注射部位疼痛、发热和头痛，主要发生在12小时内，3天内消退。女性报告的AEFI频率显著高于女性(调整后OR = 3.0；95% CI: 1.23-7.37)，并且第一次剂量与更大的反应原性相关(调整OR = 1.55；95%置信区间:1.14—-2.09)。既往SARS-CoV-2感染显著影响AEFI的发生。尽管经常出现轻微的自限性症状，但对官方AEFI报告机制的了解程度很低（18%），只有1.2%的人正式报告了他们的症状。结论青少年接种covaxin具有较好的短期安全性，且反应以轻微、短暂性为主。然而，严重的低认识和忽略的正式报告突出了迫切需要加强疫苗安全监测和关于报告做法的公众教育。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Epidemiology and Global Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

CiteScore

4.60

自引率

7.70%

发文量

218

审稿时长

66 days

期刊介绍： Clinical Epidemiology and Global Health (CEGH) is a multidisciplinary journal and it is published four times (March, June, September, December) a year. The mandate of CEGH is to promote articles on clinical epidemiology with focus on developing countries in the context of global health. We also accept articles from other countries. It publishes original research work across all disciplines of medicine and allied sciences, related to clinical epidemiology and global health. The journal publishes Original articles, Review articles, Evidence Summaries, Letters to the Editor. All articles published in CEGH are peer-reviewed and published online for immediate access and citation.