ADR Profile of Covishield and Covaxin among Young Adults (18-45 Year) in a District in Northern India: A Comparative Study

ABSTRACT

Background: The Covid-19 vaccines Covishield and Covaxin have been approved by the Govt. of India for emergency use against SARS COV-2 virus. The vaccination drive was initiated on 16 Jan 2021 among healthcare workers. Following this, age groups above 45 years and people with co-morbidities were covered. On 1st May 2021, the vaccination drive was extended to cover young adults (18-45 years). Objective: To evaluate Adverse Drug Reaction (ADR) profile of Covishield and Covaxin among young adults (18-45 years) in Karnal district, Haryana. Methods: A descriptive cross-sectional study was performed for 2 months at the ADR Monitoring Centre located at Kalpana Chawla Government Medical College (KCGMC), Karnal, Haryana, India. ADRs of both vaccines (Covishield and Covaxin) among young adults (18-45 years) voluntarily reported at the ADR-monitoring centre from various vaccination centres of Karnal District, by healthcare workers or beneficiaries were recorded and selected for the study. Results: One hundred and eleven ADRs were reported amongst 51 beneficiaries (85 ADRs among 38 Covishield vaccinated beneficiaries and 26 ADRs among 13 Covaxin vaccinated beneficiaries). There was no significant difference in the numbers of ADRs reported among males and females in both vaccine groups during the study period. The common ADRs reported in both vaccine groups were fever followed by body ache. One serious ADR was reported, which required admission in the hospital but was discharged on the same day. The majority of the suspected ADRs were classified as ‘Probable’ as per the WHO-UMC scale. Conclusion: Among both the vaccine beneficiaries, no event of death or disability was reported. Common ADRs observed were fever, body ache, and weakness. There was no significant difference in the number of ADRs reported in the two vaccine groups.