phd scholar JSS College of pharmacy, Mysuru, India Mysuru, India, India
Background: The accelerated introduction and use of COVID-19 vaccines by passing all traditional clinical trails was an ice-breaking point in vaccinology. Today we are in the second year of the new vaccine, still, the delayed and long-term safety profile of the vaccines is a needful area to be explored. this study focuses on the safety surveillance of COVID-19 vaccines for a period of two years in a WHO recognized sentinel site in south India.
Objectives: To conduct COVID-19 vaccine safety surveillance and to detect the causality of each reported Adverse Events Following Immunization (AEFI).
Methods: This study was conducted in one of the World Health Organisation (WHO) recognized sentinel site in south India. The study includes two year of COVID-19 vaccine safety surveillance (16th January 2021 – 16th January 2023). Both spontaneous reports and active surveillance through direct telephone contact following the immunization were used for data collection. The causality assessment of each reported AEFI was determined through the WHO causality algorithm by the causality assessment team of the study site.
Results: A total of 15,869 doses of COVID-19 vaccine were administered at the study site during the study period, of which 12,600 doses were COVISHIELD™ and 3269 doses were COVAXIN™. A total of 1365 AEFIs were reported from 900 subjects with an incidence rate of 5.67%. Of which 1217 AEFIs were reported following COVISHELD and 115 AEFIs following COVAXIN. After the causality assessment, 1021 as vaccine product-related reactions followed by 202 events as coincidental events and 12 were immunization anxiety-related reactions. Another 15 events were categorized as intermediate, which can be potential new signals and may be considered for investigation.
Conclusions: This study was able to bring out many of the immediate as well as delayed adverse reactions following COVID-19 vaccinations. Apart from few serious events, these newly introduced COVID-19 vaccines are safe to use in human-beings.
