Advisory Committee on Immunization Practices (ACIP) recommendations for use of rotavirus vaccines are available at www.cdc.gov/mmwr/PDF/rr/rr5802.pdf.
Two rotavirus vaccines are available in the United States. RotaTeq (RV5; Merck) is recommended for routine oral administration for all infants as a 3-dose series. The usual schedule is at ages 2, 4, and 6 months. Rotarix (RV1; GlaxoSmithKline) is recommended as a 2-dose series at ages 2 and 4 months.
The minimum interval between doses of rotavirus vaccine is 4 weeks. The minimum age for the first dose is 6 weeks and the maximum age for dose #1 is 14 weeks 6 days. Vaccination should not be initiated for infants age 15 weeks 0 days or older because there are insufficient data on the safety of dose #1 in older infants. The maximum age for the last dose of rotavirus vaccine is 8 months and 0 days.
The two rotavirus vaccine products differ in composition and schedule of administration. RotaTeq was approved by the Food and Drug Administration (FDA) in 2006. It contains five reassortant rotaviruses developed from human and bovine parent rotavirus strains; 3 doses are given in the series. Rotarix was approved by the FDA in 2008 and contains an attenuated human rotavirus strain; 2 doses are given in the series.
ACIP recommendations and package inserts do not always match. Occasionally, ACIP may use different data to formulate its recommendations, or try to add flexibility to its recommendations (as was the case in this situation), which results in a recommendation different than the package insert. Published recommendations of national advisory groups (such as ACIP or AAP’s Committee on Infectious Diseases) should be considered equally as authoritative as those on the package insert. You should consider 8 months 0 days as the maximum age for a dose of rotavirus vaccine.
ACIP recommends that the rotavirus vaccine series be completed with the same product whenever possible. However, vaccination should not be deferred because the product used for a previous dose is not available or is unknown. In these situations, the provider should continue or complete the series with the product available. If any dose in the series was RotaTeq, or the vaccine product is unknown for any dose in the series, a total of 3 doses of rotavirus vaccine should be administered. The minimum interval between doses of rotavirus vaccine is 4 weeks. All doses should be administered by age 8 months and 0 days.
ACIP recommends that infants who have had rotavirus gastroenteritis before receiving the full series of rotavirus vaccination should still start or complete the schedule according to the age and interval recommendations because the initial rotavirus infection might provide only partial protection against subsequent rotavirus disease.
ACIP supports vaccination of preterm infants according to the same schedule and precautions as full-term infants and under the following conditions: if the infant’s chronological age meets the age requirements for rotavirus vaccine (for example, age 6 weeks to 14 weeks 6 days for dose #1), the infant is clinically stable, and the vaccine is administered at the time of discharge from the hospital or after discharge from the hospital.
ACIP recommends vaccination of preterm infants according to the same schedule and precautions as full-term infants. In preterm infants (as in full-term infants), the maximum chronological age for the first dose is 14 weeks 6 days. Vaccination should not be initiated for infants aged 15 weeks 0 days or older because of insufficient data on safety of dose 1 of rotavirus vaccine in older infants. For more information, see page 19 of ACIP’s recommendations on rotavirus vaccination, available at www.cdc.gov/mmwr/PDF/rr/rr5802.pdf.