The release of the AAP statement is in response to the Food and Drug Administration approval in August of the first vaccine for the prevention of rotavirus gastroenteritis, and the recent vote by the Advisory Committee on Immunization Practices (ACIP) to add the vaccine to the routine childhood immunization schedule.
The oral, tetravalent vaccine (RotaShield, Wyeth-Lederle Vaccines and Pediatrics) is now available and is indicated for infants at 2, 4 and 6 months of age.
The first dose of the three-dose series may be given as early as 6 weeks of age and as late as 6 months of age. However, each subsequent dose should be given at intervals of at least three weeks, according to the package insert.
The AAP recommends special efforts be made to immunize infants prior to the anticipated annual onset of rotavirus infections in their local communities.
Because none of the clinical trial data extend beyond two years, duration of protection beyond this time is uncertain, but protection similar to that after natural infection is expected, according to the AAP statement.
Data are needed to establish the safety, immunogenicity, and, if possible, efficacy of the rotavirus vaccine and of future rotavirus vaccines in several populations, including premature infants and children with acute diarrhea, chronic gastrointestinal tract disease, immunosuppression, children in long-term care facilities, and children ages 1-3 years.
Studies also are needed to determine the efficacy of a two-dose immunization schedule as well as the effect of maternal rotavirus immunization on maternal milk and serum antibody titers and the protection afforded to nursing infants by these maternal antibodies.
Morbidity from rotavirus disease in the United States and cost to the health care system and society associated with rotavirus disease are substantial. These considerations in conjunction with vaccine safety and efficacy justify a nationwide immunization program for prevention or modification of rotavirus disease in infants and young children.
|American Academy of Pediatrics
Rotavirus Vaccine Recommendations
Specific AAP recommendations for use of rotavirus vaccine are as follows.