Prevention of Rotavirus Disease: Guidelines for Use of Rotavirus Vaccine

On February 3, 2006, a bovine-based pentavalent rotavirus vaccine (RotaTeq, Merck & Co Inc, Whitehouse Station, NJ) was licensed by the US Food and Drug Administration for use in infants in the United States. The American Academy of Pediatrics recommends routine immunization of infants with 3 doses of pentavalent rotavirus vaccine administered orally at 2, 4, and 6 months of age. The first dose should be administered between 6 and 12 weeks of age; immunization should not be initiated for infants older than 12 weeks of age. Subsequent doses should be administered at 4to 10-week intervals, and all 3 doses of vaccine should be administered by 32 weeks of age. Pentavalent rotavirus vaccine can be coadministered with other childhood vaccines. Pentavalent rotavirus vaccine is contraindicated for infants with a serious allergic reaction to any vaccine component or to a previous dose of vaccine. PURPOSE OF RECOMMENDATIONS AND RATIONALE The purpose of this statement is to provide the rationale and recommendations for use of a bovine-based pentavalent rotavirus vaccine (RotaTeq) in US infants. The rationale for using rotavirus immunization for prevention or modification of rotavirus disease is based on several considerations. First, rates of rotavirus illness among children in industrialized and less developed countries are similar, indicating that clean water supplies and good hygiene have little effect on virus transmission, so further improvements in water or hygiene are unlikely to prevent the disease.1–5 Second, in the United States, a high level of rotavirus morbidity continues to occur despite currently available therapies. For example, the rate of hospitalizations for gastroenteritis in young children declined only 16% from 1979 to 19956,7 despite the widespread recommendation by experts, including the American Academy of Pediatrics (AAP) and Centers for Disease Control and Prevention (CDC),8,9 for the use of oral rehydration solutions in the treatment of dehydrating gastroenteritis. Third, studies of natural rotavirus infection indicate that initial infection protects against subsequent severe gastroenteritis, although subsequent asymptomatic infections and mild disease might still occur.1,10,11 Finally, trials of pentavalent rotavirus vaccine in the United States and 10 other countries show efficacy rates of 98% for prevention of severe illness and 74% for prevention of rotavirus-induced diarrheal episodes of any severity.12 These results are similar to the protection observed after natural rotavirus infection. Thus, immunization early in life, which mimics a child’s first natural infection, will not prevent all subsequent disease but should prevent most cases of severe rotavirus www.pediatrics.org/cgi/doi/10.1542/ peds.2006-3134 doi:10.1542/peds.2006-3134 All policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.