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Recommendations

From the ACIP and the AAP
Important endorsements
The Advisory Committee on Immunization Practices (ACIP) to the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) recommend routine rotavirus vaccination for all eligible infants.
According to the ACIP and AAP, infants in the United States should routinely receive a 3-dose series of rotavirus vaccine orally at 2, 4, and 6 months of age.
To facilitate widespread rotavirus vaccination of all eligible children, the CDC has included RotaTeq in its Vaccines for Children program.
Learn more about the ACIP recommendations.
Learn more about the AAP recommendations.
Administration of RotaTeq
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RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks.
The first dose of RotaTeq should be administered between 6 and 12 weeks of age.
Select Safety Information

RotaTeq should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine.
No safety or efficacy data are available for the administration of RotaTeq to infants who are potentially immunocompromised, or with a history of gastrointestinal disorders.
Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.
Over 71,000 infants were evaluated in 3 placebo-controlled clinical trials. Serious adverse events occurred in 2.4% of recipients of RotaTeq when compared to 2.6% of placebo recipients within the 42-day period of a dose of RotaTeq. Hematochezia reported as a serious adverse event for RotaTeq compared to placebo was <0.1% vs <0.1%. The most frequently reported serious adverse events for RotaTeq compared to placebo were bronchiolitis (0.6% vs 0.7%), gastroenteritis (0.2% vs 0.3%), pneumonia (0.2% vs 0.2%), fever (0.1% vs 0.1%), and urinary tract infection (0.1% vs 0.1%).
In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6% vs 42.8%). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of RotaTeq as compared with placebo recipients were diarrhea (24.1% vs 21.3%), vomiting (15.2% vs 13.6%), otitis media (14.5% vs 13.0%), nasopharyngitis (6.9% vs 5.8%), and bronchospasm (1.1% vs 0.7%).
In post-marketing experience, cases of intussusception and Kawasaki disease have been reported in infants who have received RotaTeq.
RotaTeq may not protect all vaccine recipients against rotavirus.
Before administering RotaTeq, please read the Prescribing Information and Patient Product Information.
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