RotaTeq Safety
RotaTeq Safety
Abstract & Commentary
By Stan Deresinski, MD, FACP, Clinical Professor of Medicine, Stanford, Associate Chief of Infectious Diseases, Santa Clara Valley Medical Center, is Editor for Infectious Disease Alert.
Source: CDC. Postmarketing Monitoring of Intussusception After RotaTeq™ Vaccination — United States, February 1, 2006 - February 15, 2007. MMWR. 2007; 56(10):218-222.
Synopsis: Passive monitoring has failed to find evidence of an excessive risk of intussusception in infant recipients of RotaTeq.
Rotashield, a vaccine protective against rotavirus infection was withdrawn from the U.S. market because of an apparent excess risk of intussusception. The recent introduction of a new vaccine, RotaTeq, has inevitably led to concerns about an increased incidence of this complication in children receiving this vaccine, as well. Postmarketing surveillance of possible adverse effects of RotaTeq by the Vaccine Adverse Event Reporting System (VAERS) during the first year of its use, however, suggests an absence of increased risk of intussusception.
During February 1, 2006 - February 15, 2007, VAERS received 567 reports of adverse events after RotaTeq vaccination, including 35 reports of confirmed intussusception. One-half occurred within the first 21 days after vaccination with almost one-third occurring within the first 7 days. Fifty-nine percent of affected infants required surgery. When compared to background rates of intussusception in infants, however, the incidence in vaccine recipients was not excessive.
RotaTeq vaccine continues to be recommended for administration to all infants at ages 2, 4, and 6 months. Healthcare providers are reminded that the first dose should be administered to infants only between ages 6 and 12 weeks, and the full series should be completed before age 32 weeks. Monitoring by CDC and FDA will be continued. All persons are encouraged to report cases of intussusception or any adverse events after RotaTeq or any other vaccination to VAERS. Reports may be submitted securely online at www.vaers.hhs.gov or by fax at (877) 721-0366. Reporting forms and additional information are available by telephone at (800) 822-7967.
Rotashield, a vaccine protective against rotavirus infection was withdrawn from the U.S. market because of an apparent excess risk of intussusception. The recent introduction of a new vaccine, RotaTeq, has inevitably led to concerns about an increased incidence of this complication in children receiving this vaccine, as well.Subscribe Now for Access
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