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Observational Study
. 2022 Oct;45(10):1099-1109.
doi: 10.1007/s40264-022-01226-8. Epub 2022 Aug 27.

A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis

Upinder Kaur  1 , Anju K L  2 , Mayank Chauhan  3 , Aditi Joshi  4 , Agniva Das  1 , Sangeeta Kansal  5 , Vaibhav Jaisawal  6 , Kishor Patwardhan  7 , Sankha Shubhra Chakrabarti  8
Affiliations
Observational Study

A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis

Upinder Kaur et al. Drug Saf. 2022 Oct.

Abstract

Introduction: The BBV152 coronavirus disease 2019 (COVID-19) vaccine (COVAXIN) has recently been approved for adolescents.

Objective: We provide the first real-world safety data of COVAXIN use in adolescents and compare with adults.

Methods: A prospective observational study was initiated in January 2022. Enrolled adolescents and adults were contacted by telephone after 14 days of receiving the BBV152 vaccine. The primary outcome was vaccine safety assessed as rate of adverse events following immunization (AEFIs). Severity grading of AEFIs was done using the Food and Drug Administration (FDA) scale. Interim results are presented.

Results: A total of 698 adolescents and 326 adults were enrolled. AEFIs after the first dose developed in 243 out of 670 adolescents (36.3%), with 21% reporting only local AEFIs and 15.2% reporting systemic AEFIs. Among 340 adolescents who had received the second dose of vaccine, 129 (37.9%) developed AEFIs, with only local involvement in 20.3% and systemic involvement in 17.6%. Injection site pain and fever were the common AEFIs. The majority of AEFIs were mild-moderate. Nearly 0.9% of adolescents receiving the first dose reported severe AEFIs. Atypical AEFIs were observed in 0.6-0.9% of adolescents. The majority of the AEFIs resolved in 1-2 days. AEFIs were persistent in > 2% of adolescents at day 14 after the second dose, and also in 3.7% of adults overall at follow-up. No difference was observed in AEFI incidence and patterns between adolescents and adults. Regression analysis showed females and those with a history of allergy to be, respectively, at 1.6 times and 3 times increased risk of AEFIs among adolescents.

Conclusions: COVAXIN carries an overall favorable short-term safety profile in adolescents. The observed AEFI rates in adolescents are much lower than that reported with mRNA vaccines, but head-head comparisons in the same population are required to generate relative vaccine safety data. Female adolescents and those with a history of allergy need watchfulness for severe and persistent AEFIs. With some AEFIs persisting at 14 days, a longer follow-up is recommended to strengthen the safety data of COVAXIN.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
STROBE flowchart showing enrolment of adolescents and adults in the study. AEFI adverse event following immunization, STROBE STrengthening the Reporting of OBservational studies in Epidemiology
Figure 2
Figure 2
MedDRA SOCs of AEFIs following first dose of BBV152 in adolescents (percentages are out of total AEFI SOCs; in the case of development of more than one AEFI from the same SOC in an individual vaccinee, the SOC has been counted once). AEFI adverse event following immunization, MedDRA Medical Dictionary for Regulatory Activities, SOC system organ class
Figure 3
Figure 3
MedDRA SOCs of AEFIs following second dose of BBV152 in adolescents (percentages are out of total AEFI SOCs; in the case of development of more than one AEFI from the same SOC in an individual vaccinee, the SOC has been counted once). AEFI adverse event following immunization, MedDRA Medical Dictionary for Regulatory Activities, SOC system organ class
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