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

Abstract

INTRODUCTION: Evidence on 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 long term safety of the BBV152 vaccine in adolescents and adults. METHODOLOGY: This was a prospective observational study conducted from January 2022 to August 2023. Adolescents and adults receiving BBV152 vaccine were interviewed telephonically about long-term adverse events of special interest (AESIs) after one year of vaccination. Risk factors of AESIs and AESIs persistent for at least one month were identified. RESULTS: Out of 1024 individuals enrolled, 635 adolescents and 291 adults could be contacted on one year follow-up. Viral upper respiratory tract infections (URTIs) 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% females. Ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% participants respectively. Serious AESIs including stroke and Guillain-Barre syndrome were identified in around 1% participants. Among adolescents, females, those with history of allergy and post-vaccination typhoid were respectively at 1.6-, 2.8- and 2.8-times higher risk of AESIs. Majority of the AESIs were persisting at one year follow-up. Females, adolescents with pre-vaccination COVID-19, those with co-morbidities, and 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 two 2 times higher odds of AESIs and persistent AESIs.  CONCLUSION: 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. Relationship of AESIs with sex, co-morbidities, pre-vaccination COVID-19 and non-COVID illnesses should be explored in future studies.