Indian J Community Med. 2025 Oct;50(Suppl 2):S228-S234. doi: 10.4103/ijcm.ijcm_86_24. Epub 2025 Feb 27.
ABSTRACT
BACKGROUND: The mankind has been fighting the pandemic of COVID-19 for the last few years and vaccines came in as a real game changer by the end of 2020. World’s biggest COVID-19 vaccination drive was started in India on January 16, 2021. A year later, vaccines were introduced for the adolescent population. The concern over Adverse Events Following Immunization (AEFI) surfaced and dampened vaccine uptake with increasing fear and misinformation toward vaccination. AEFI is any untoward medical occurrence that follows immunization, and not necessarily have a causal relationship with the usage of the vaccine. Although technical and toll-free numbers are available for the reporting of the AEFI, there is a high chance of under-reporting of the same. There were only very limited number of studies assessing the AEFI after Covaxin vaccination in the adolescent age group and hence this study was performed to assess the adverse reaction following immunization and the factors associated with it among the adolescent age group. Further, this study assessed perception, and ideas regarding acceptance of COVID-19 vaccination services among adolescent beneficiaries.
METHODOLOGY: A mixed methods study was conducted at AIIMS Bhubaneswar for adolescent beneficiaries aged 15-18 years between January 3rd and March 31st, 2022. A prospective longitudinal study was conducted with a sample size of 250. Study participants were selected by simple random sampling from the beneficiary list in CoWin app. Ten beneficiaries per day were selected for the telephonic interview regarding AEFI, 7 to 10 days following immunization. Data were collected using the tool based on the document for toxicity grading in healthy volunteers in preventive vaccine trials given by the US FDA. In-depth interview was conducted among adolescent beneficiaries using predesigned interview schedule. Analysis was performed using SPSS version 25.0 and Anthropac software for quantitative and qualitative data, respectively.
RESULTS: AEFI was assessed after first dose among participants, among which 84 (36.52%) had some kind of AEFI. Pain at the injection site was the most common AEFI reported. One-third participants (32.1%) had developed only one AEFI. More than one AEFI was reported in 10 participants. Among the 50 participants followed up in their second dose, 10 (20.83%) developed any AEFI in our study. Five participants reported having AEFI in the first and second doses. There was no statistical difference in the number of AEFI reported after the first and second doses. Majority of the adolescents seemed self-motivated to avail COVID-19 vaccine. According to the beneficiaries, vaccination certificate was the felt need to enter schools and sit for exams.
CONCLUSION: Covaxin (BBV152) has good safety profile among adolescent age group. The AEFI reported are less in comparison with other mRNA vaccines as well. Although AEFI is common after BBV152 among adolescent, majority are mild in nature. Still, further studies with larger cohort are warranted to study the long-term effects of vaccination as well. It’s encouraging that the adolescents were optimistic about availing vaccine.
PMID:41200685 | PMC:PMC12588121 | DOI:10.4103/ijcm.ijcm_86_24
