In the United States, rotavirus is responsible for approximately 500,000 physician visits and 50,000 hospitalizations per year. It is also estimated to cause approximately twenty deaths per year in the United States. Children who are between three and twenty-four months of age have the highest rates of severe disease and hospitalization. Clinically, one can see a range of illness from asymptomatic shedding of the virus in the stool to life-threatening gastroenteritis with severe vomiting and diarrhea. The virus is highly infectious and is transmitted by the fecal-oral route.
Infections are usually seasonal with the vast majority of cases occurring in the winter months.
The vaccine is an oral vaccine, given as a series of three doses. The most common side effect to date has been fever. Further details regarding administration, indications and contraindications should be available in the very near future. Clinical studies in infants conducted under Investigational New Drug applications have demonstrated that using some combination vaccine products containing Hib vaccine may induce a suboptimal immune response to the Hib vaccine component. First, the two new strains in this year's vaccine have been responsible for some significant production problems.