On August 31, 1998, the first vaccine targeting rotavirus, RotaShield, received FDA approval for use in children. At this time, health officials estimated that 2.7 million children under the age of five developed the illness each year, which resulted in 50,000 hospitalizations and 500,000 physician appointments. The rates were reported to be much higher in developing countries, with public health officials estimating that the virus caused about 800,000 deaths each year.
The approved reassortant (mix of genetic material from different species) vaccine, a tetravalent rhesus-human reassortant rotavirus vaccine (RRV-TV) contained a rhesus monkey rotavirus with serotype G3 specificity and reassortant rhesus-human rotaviruses with G1, G2, and G4 specificity to target the four common serotypes of rotavirus. The vaccine was reported to be between 49 and 68 percent effective against any rotavirus diarrhea and between 61 and 100 percent effective against severe rotavirus diarrhea.
At the time of the vaccine’s recommendation by the CDC’s Advisory Committee on Immunization Practices (ACIP), it was noted that few cases of rotavirus occurred in infants younger than 3 months of age, while infants and children between four and 36 months were most affected. Rotavirus was rarely symptomatic in adults; however, it was still found at times to cause illness in parents of children with the infection, those with immunocompromising conditions, travelers to underdeveloped countries, and the elderly.
