International Journal of Healthcare Sciences ISSN 2348-5728 (Online) Vol. 9, Issue 1, pp: (152-158), Month: April 2021 - September 2021, Available at: www.researchpublish.com
Safety Profile of Rotavac: An Observational Prospective Study Malook Vir Singh1, Sue Ann Costa Clemens2, Puneet Vir Singh3 1
MBBS, Masters in Vaccinology and Drug Development, Department of Molecular Medicine, University of Siena, Italy 2
Head, Department of Molecular Medicine, University of Siena, Italy 3
MBBS, SERM Physician, GSK, Siena, Italy
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.
I. INTRODUCTION Diarrheal disease is one of the leading cause of child mortality in the world [1]. Infectious diarrhoea is caused by a variety of agents like bacteria, parasites, and viruses [1]. Among these, Rotavirus is the most important cause of severe diarrhea among children. The World Health Organization (WHO) estimates that globally 527,000 deaths occur each year among children as a result of rotavirus infection [2]. In India, diarrheal diseases are the third most common cause of death among infants and young children, after pneumonia followed by prematurity & low birth weight. It is responsible for 13% of deaths in children less than 5 years of age and approximately 34% of these deaths are due to rotavirus infection [3]. Thus, Rotavirus infection is a heavy burden on the healthcare system of a country because of its associated high mortality. While there are effective antibacterial and antiparasitic drugs available for treating some intestinal infections, there is no approved pharmacotherapy for rotavirus infection. The management of rotavirus infection is symptomatic with an emphasis on the treatment of dehydration [4]. If untreated, the dehydration can be fatal for children [4]. In most of the cases, treatment involves the use of oral rehydration therapy. If the infection is serious enough to warrant hospitalization, then fluids are given by parenteral route, intravenous therapy or nasogastric intubation.
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