Background: COVID-19 pandemic is a major public health problem worldwide with limited success in treatment regimes. Vaccination has been an important tool for prevention and control of COVID-19. Health-care professionals (HCPs) as frontline warriors in health-care setups were given priority for getting the vaccination. Data generated from clinical trials in the controlled study participants will be limited. This study was planned to document and analyze data regarding vaccine safety in our hospital.
Aims and Objectives: The aims of this study were to identify determine the severity and compare the Adverse Events Following Immunization (AEFI) in HCPs vaccinated for COVID-19.
Materials and Methods: After taking ethics committee approval (IEC/ASR APPROVAL/033/2021) and obtaining informed consent from 422 study participants, pre-validated questionnaires were administered for all the participants and data were analyzed for comparing the incidence, severity of AEFI’s. Categorical variables will be calculated in Percentages. Chi-square test was done to correlate the AEFI’s in COVISHIELD versus COVAXIN groups.
Results: In this study, about 80.5% were below 40 years of age with female predominance in gender distribution. COVISHIELD was administered in 88.1% and COVAXIN in 11.8%. After COVISHIELD 1st dose, myalgia was the most common mild AEFI reported with 79.8% and in 2nd dose, fever was the most common mild AEFI reported with 51.1%. After COVAXIN, feeling tired was the common AEFI in mild (50%) and moderate grades in both doses. AEFIs’ were significantly greater (P < 0.001) in COVISHIELD 1st dose as compared to COVAXIN 1st dose in injection site reaction, feeling feverish, headache, myalgia, nausea and vomiting, flu-like symptoms, and feeling dizzy. Fever was not significantly different in COVISHIELD 1st dose as compared to COVAXIN 1st dose. There is no significant difference between 2nd dose of COVISHIELD and 2nd dose of COVAXIN for injection site reaction, myalgia, nausea, and vomiting. Serious AEFIs’ were not observed in both vaccine groups.
Conclusions: The majority of the AEFI’s in this study are mild-to-moderate in nature and associated after the 1st dose of vaccine. None of the participants had serious AEFI’s with both vaccines in the study. The better safety profile of vaccines allows building public faith in a successful vaccine program for our nation.
Key words: Adverse Events Following Immunization; COVAXIN; COVISHIELD; Pharmacovigilance
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