Vaccine Safety and Efficacy in Preventing Rotavirus Infection

Abstract

The rotavirus infection causes acute gastroenteritis and is a major cause of lethal severe dehydrating diarrhoea in children under 5 years of age worldwide. Live attenuated rotavirus vaccines are the only means of preventing severe forms of the disease. The aim of the study was to analyse the twenty-year international experience of prophylactic immunisation against rotavirus infection. The paper summarises safety and efficacy data on the long-term use of Rotarix® (Belgium) and RotaTeq® (USA) for the prevention of rotavirus infection in the WHO European Region, the European Union and other countries. It addresses the development of correlates of immune protection for vaccines as well as evaluation of efficacy and safety of the new vaccines Rotavac® and Rotasiil® (India) in clinical trials. The authors analysed international experience of using the vaccines in countries that do not keep records of infant mortality from diarrhoea. The study summarises the results of clinical studies on the use of new vaccines prequalified by WHO in 2018 in regions with high rates of infant mortality from diarrhoea. It was demonstrated that vaccination not only reduces the rates of hospital admission of immunised children, but also contributes to the development of herd immunity. Rotarix® and RotaTeq® vaccines are authorised or included in the national immunisation schedules of many countries, but this type of vaccination is not mandatory in most of these countries. Vaccination coverage in the EU countries is about 24 %. Alternative vaccination schemes using live attenuated vaccines based on strains derived from newborn children, and parenteral rotavirus vaccines which do not replicate in the intestine may help reduce existing risks. It was concluded that the introduction of live rotavirus vaccines in immunisation schedules should be accompanied by the analysis of incidence of intussusception of the small intestine before and after the introduction of mass immunisation, and by active pharmacovigilance.