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

Abstract

Background: We provide the first post-approval safety analysis of COVISHIELD in health care workers (HCWs) in northern India. Methods: This continuing prospective observational study (February 2021 to May 2022) enrolled participants 18 years receiving COVISHIELD vaccination. Primary outcome was safety and reactogenicity. Categories (FDA toxicity grading) and outcomes of adverse events following immunization (AEFIs) were recorded, causality assessment performed, and risk factors analysed. Findings: We present the results of an interim analysis of 804 participants. AEFIs following first dose were reported in 321 (40%; systemic involvement in 248). Among 730 participants who completed a 7-day followup post second dose, AEFIs occurred in 115 (15.7%; systemic in 99). Majority of AEFIs were mild-moderate and resolved spontaneously. Serious AEFIs, leading to hospitalization was noticed in 1 (0.1%) participant with suspicion of immunization stress related response (ISRR). AEFIs of grade 3 severity (FDA) were recorded in 4 participants (0.5%). No deaths were recorded. Regression analysis showed increased risk of AEFIs in younger individuals, a two times higher odds in females, those with hypertension or with history of allergy; and three times higher odds in individuals with hypothyroidism. Interpretation: COVISHIELD carries an overall favourable safety profile with AEFI rates much less than reported for other adenoviral vaccines. Females, those with hypertension, individuals with history of allergy and hypothyroidism may need watchful vaccine administration. This being an interim analysis and based on healthcare workers who may not reflect the general population demographics, larger inclusive studies are warranted for confirming the findings.

Adverse Events Following Immunization of ChAdOx1 nCoV- 19 Vaccine Among Health Care Workers of a Tertiary Care Hospital of North India

“…We have found no signi cant association between age and AEFI, whereas some studies found age to be signi cantly associated with AEFI (24,25). Mohakuda (29). We have found signi cant association between gender and AEFI and number of females have reported more AEFI after both the doses as compared to males which is corroborated with some other studies (27,30).…”

“…In the study conducted by Raches Ella et al(34),22.2% had at least one comorbid condition. Whereas there was statistically insigni cant association between the development of AEFI and comorbidity in studies byMohakuda et al (26) and Kaur et al(29).In our study, subjects with allergy reported more AEFI. Similar results were found by Kaur et al(29).…”

“…Whereas there was statistically insigni cant association between the development of AEFI and comorbidity in studies byMohakuda et al (26) and Kaur et al(29).In our study, subjects with allergy reported more AEFI. Similar results were found by Kaur et al(29). We did not nd any association between past COVID-19 infection and AEFI, which was also shown by the study conducted byMohakuda et al (26) where as it was signi cant in study by Shrestha et al(32).…”

“…Whereas, study conducted by Mohakuda et al found that the odds of men developing systemic AEFI to the Covishield vaccine were 2.08 times that of women (26). Some studies found no signi cant association of AEFI with gender (25,32), but the prevalence was more among females (25,29,33). However, some studies found the prevalence of AEFI to be more among males (34,35).…”

“…On March 11, 2020, COVID-19, caused by SARS-CoV-2, was o cially declared a pandemic by World Health Organization (WHO). Con rmed COVID-19 cases and deaths reported till June 21, 2021 globally were 178.20 & 3.86 million (1) respectively, whereas, in India, were 29.94 and 0.39 million (2), respectively.…”