Abstract: Rotavirus vaccination (ROTAVAC®) was included in the rainbow of the Universal Immunization Program (UIP) of Punjab, India in 2019. This is a single centre observational prospective study conducted in Government Civil Hospital in Punjab, India.
Endpoints: This study has two endpoints; Primary, to detect and study the adverse events (AE) arising after ROTAVAC® vaccine administration to infants and Secondary, to create awareness to promote the reporting of adverse events following immunization (AEFI) by Health Care Practitioners (HCPs).
Results: In this study, 47% of the subjects receiving ROTAVAC® vaccine experienced AEFIs. Overall, most of the AEFIs reported were non-serious and resolved completely in less than a day. Most of the AEFIs were consistent with the known safety profile of ROTAVAC® vaccine. There was no statistically significant difference between the different demographics and AEFI incidence. All the 30 HCPs who were interviewed had limited knowledge regarding reporting of AEFI and had rarely reported any AEFI. The mean score prior to imparting health education was 4.07±1.17, and the score after educating them increased to 7.27±1.05, depicting a statistically significant difference (W=465.000, p<0.005).
Conclusion: ROTAVAC® vaccine was found to be safe in Punjab, India where the vaccine was launched recently. There were no new safety concerns identified with ROTAVAC®. The study also highlights the importance of conducting knowledge sharing sessions for HCPs at immunization clinics to improve adverse event detection and reporting.
Keywords: Rotavirus, Rotavac, intussusception, adverse events, adverse events following immunization, safety profile.
Title: Safety Profile of Rotavac: An Observational Prospective Study
Author: Malook Vir Singh, Sue Ann Costa Clemens, Puneet Vir Singh
International Journal of Healthcare Sciences
ISSN 2348-5728 (Online)
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