A prospective observational safety study on ChAdOx1 nCoV-19 corona virus vaccine (recombinant) use in healthcare workers- first results from India

Abstract

Vaccines are an important public health measure for tiding over the COVID-19 pandemic. Several vaccines have been approved in different countries for emergency use. In India, two vaccines have been currently approved- COVISHIELD (Serum Institute of India (SII)) which is a recombinant simian adenovirus-based vaccine and COVAXIN (Bharat Biotech) which is an inactivated SARS-CoV-2 vaccine. Our current study provides the first post approval safety data on ChAdOx1 nCoV- 19 corona virus vaccine (recombinant) use in healthcare workers in northern India (n=804). Around one half of vaccinees developed adverse events at any time post vaccination with majority of reactions being mild to moderate in severity. AEFIs were seen in 40% participants after first dose and around 16% participants after second dose. This observed reactogenicity is much less compared to 60-88% reactogenicity rate observed with Oxford-AstraZenecas ChAdOx1 vaccine in the UK based population. Individually, fever, injection site pain and headache were the commonly observed AEFIs. Overall, the frequency of systemic events of severity grade 3 was only 0.5% and is much less than the reported rates for other recombinant adenoviral vaccines. The rate of serious AEFIs in our study was only 0.1% (n=1). There was a possibility of this AEFI being an immunization stress related response. No deaths were reported in the vaccinees in our study during the study period. Reactogenicity rate was observed to decrease with age and was higher in females. On the basis of interim findings of this safety study, it may be interpreted that the ChAdOx1 nCoV-19 corona virus vaccine (recombinant) (COVISHIELD, Serum Institute of India) carries a good safety profile overall.

Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India

“…The incidence rate of AEFIs reported within 30 min was 0.66%, and a similar result of 0.9% incidence was observed in a recent Indian study. 20 However, the overall incidence in this study 20 was as high as 40%, which is much higher than the incidence observed in the current study (3.48%). This might be due to the difference in the study method as the refereed study had followed up their beneficiaries in fixed time intervals for identifying the AEs, and they enrolled a smaller study population compared with our study.…”

Occurrence of COVID‐19 in priority groups receiving ChAdOx1 nCoV‐19 coronavirus vaccine (recombinant): A preliminary analysis from north India

“…Baseline demographic details of each participant were collected in a pre-designed case report form. 1 Enrollment was continued till the target sample size (n = 1650) was reached. As part of the ongoing prospective observational study, each participant is being monitored telephonically at specific intervals following the second dose, for a total duration of 1 year (study duration).…”

“…The authors recently demonstrated a favorable safety profile of COVISHIELD when assessed up to 7 days after the second dose. 1 Here, we report the preliminary findings regarding our secondary outcome measure of postvaccination SARS-CoV-2 infections. The data are based on at least 2 months of follow-up since the second dose of vaccine in enrolled participants who could be successfully contacted telephonically.…”

Adverse events following immunization after COVISHIELD vaccination among Nepali population of eastern Nepal

“…The female participants were more because more nursing professionals were vaccinated in the first phase. Other studies reported 85.04%, 12 91.6% 14 , 57.24% 15 and 40% 13 AEFI after COVISHIELD vaccination. These findings vary in the higher and lower range compared to what we found.…”

“…14 Further another study found fever, headache, and dizziness were the commonly reported AEFIs, seen respectively in 15.2%, 6.2%, and 3.7% individuals. 13 Other studies found feeling unwell (19%), headache (17.4%), fever (12.5%), fatigue (12.3%), and muscle ache (11.2%). 17,18 Solicited injection-site pain was the most common local reaction, and fatigue and headache were the most common systemic reactions.…”