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Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India

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Abstract

Background and Objective

Evidence on the long-term safety of COVID-19 vaccines is scarce. Here, in continuation of our previously published results on short-term safety, we provide data on the long-term safety of the BBV152 vaccine in adolescents and adults.

Methods

This was a prospective observational study conducted from January 2022 to August 2023. Adolescents and adults receiving the BBV152 vaccine were interviewed telephonically about long-term adverse events of special interest (AESIs) after 1 year of vaccination. Risk factors of AESIs and AESIs persistent for at least 1 month were identified.

Results

Out of 1024 individuals enrolled, 635 adolescents and 291 adults could be contacted during the 1-year follow-up. Viral upper respiratory tract infections were reported by 304 (47.9%) adolescents and 124 (42.6%) adults in this period. New-onset skin and subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%) were the common AESIs in adolescents. General disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%) were the common AESIs in adults. Menstrual abnormalities were noticed in 4.6% of female participants. Ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% of participants, respectively. Among serious AESIs (1%), stroke and Guillain–Barre syndrome were identified in 0.3% and 0.1% of participants, respectively. Among adolescents, female individuals, those with a history of allergy and post-vaccination typhoid were respectively at 1.6, 2.8, and 2.8 times higher risk of AESIs. The majority of the AESIs persisted at the 1-year follow-up. Female individuals, adolescents with pre-vaccination COVID-19, those with co-morbidities, and those with post-vaccination typhoid had respectively 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs. Adults with co-morbidities had more than 2 times higher odds of AESIs and persistent AESIs.

Conclusions

The patterns of AESIs developing after BBV152 differed from those reported with other COVID-19 vaccines as well as between adolescents and adults. With the majority of AESIs persisting for a significant period, extended surveillance of COVID-19-vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs. Serious AESIs might not be uncommon and necessitate enhanced awareness and larger studies to understand the incidence of immune-mediated phenomena post-COVID-19 vaccination. The relationship of AESIs with sex, co-morbidities, pre-vaccination COVID-19, and non-COVID illnesses should be explored in future studies.

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Acknowledgments

Upinder Kaur and Sankha Shubhra Chakrabarti thank the Institutions of Eminence Scheme in the Banaras Hindu University for research support. Sankha Shubhra Chakrabarti thanks the Indian Council of Medical Research for research support.

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Corresponding authors

Correspondence to Upinder Kaur, Vaibhav Jaisawal or Sankha Shubhra Chakrabarti.

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Funding

No funding was received for the conduct of this study or the preparation of this article.

Conflicts of Interest/Competing Interests

Upinder Kaur, Aakanksha Jaiswal, Ayushi Jaiswal, Kunal Singh, Aditi Pandey, Mayank Chauhan, Mahek Rai, Sangeeta Kansal, Kishor Patwardhan, Vaibhav Jaisawal, and Sankha Shubhra Chakrabarti have no conflicts of interest that are directly relevant to the content of this article.

Ethics Approval

The study was conducted after permission from the Institute Ethics Committee of the Institute of Medical Sciences, Banaras Hindu University. No human experimentation was performed. All procedures were performed as per the Declaration of Helsinki and its subsequent modifications (Ethical Approval number: Dean/2022/EC/3210 and Dean/2021/EC/2526).

Consent to Participate

Written informed consent/assent to participate was obtained from each participant in the study.

Consent for Publication

Written informed consent/assent for publication was obtained from all participants.

Availability of Data and Material

All data produced in the present study are available upon reasonable request to the corresponding authors, as per institutional and national legal norms and procedures.

Code Availability

Not applicable.

Authors’ Contributions

Conceptualization: UK, SSC, SK, VJ, KP. Methodology: UK, SSC, VJ. Formal analysis and investigation: UK, VJ, AJ, AJ, KS, AP, MC, MR. Writing, original draft preparation: UK, AJ AJ, KS, MR. Writing, review and editing: UK, SSC. Funding acquisition: none. Resources: none. Supervision: UK, VJ. All authors read and approved the final version. 

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Kaur, U., Jaiswal, A., Jaiswal, A. et al. Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India. Drug Saf (2024). https://doi.org/10.1007/s40264-024-01432-6

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