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Rotavirus Vaccination For Health Professionals: Questions about Rotashieldand Intussusception General Questions about Intussusception Related Resources
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Monitoring of Intussusception after RotaTeq Vaccine Statement Regarding Rotarix and RotaTeq Rotavirus Vaccines and Intussusception Rotavirus Rotavirus Vaccination
The U.S. Advisory Committee on Immunization Practices (ACIP) voted on October 22, 1999 to no longer recommend use of the RotaShieldvaccine for infants because of an association between the vaccine and intussusception.
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For immunization information, call the CDCINFO Contact Center at: English and Spanish (800) CDC-INFO (800) 232-4636 TTY: (888) 232-6348 Contact info: Vaccines Questions Vaccines Webmaster
Is RotaShieldvaccine still available in the United States? RotaShieldvaccine is no longer available for use in the United States.
What action did CDC take when cases of intussusception were reported to VAERS? CDC, in collaboration with the Food and Drug Administration (FDA), and state and local health departments throughout the United States, conducted two large investigations. One was a multi-state investigation which evaluated whether or not rotavirus vaccine was associated with intussusception. Based on the results of the investigation, CDC estimated that RotaShieldvaccine increased the risk for intussusception by one or two cases of intussusception among each 10,000 infants vaccinated. The other was a similar investigation in children vaccinated at large managed care organizations. When the results of these investigations became available, the Advisory Committee on Immunization Practices (ACIP) withdrew its recommendation to vaccinate infants with RotaShieldvaccine, and the manufacturer voluntarily withdrew RotaShieldfrom the market in October 1999. Why did CDC take this action? The decision to stop recommending use RotaShieldvaccine in the United States was made by the Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) because intussusception is a serious condition and because of the perception that most of the severe complications of rotavirus gastroenteritis in the United States can be prevented by oral rehydration. A primary goal of CDC is to protect the health and safety of the general public in the United States. One of the most effective ways to prevent disease is through vaccination. However, when a vaccine is discovered to have a serious side effect, a recommendation to continue using the vaccine will be reconsidered and the vaccine may be withdrawn, in spite of the beneficial effect of the vaccine to prevent disease. The vaccine safety monitoring systems worked to detect an uncommon side effect. Rotavirus vaccination was promptly suspended and new cases of intussusception were prevented. How did parents report intussusception to CDC during that time? If a child developed intussusception or any serious reaction after a vaccine, whether or not it is thought to be related to the vaccine, the child should have received prompt medical attention and the reaction should have reported to VAERS (See What is VAERS?). VAERS reporting forms and information can be requested 24 hours a day by calling (800) 822-7967 or online. What is VAERS? VAERS is the Vaccine Adverse Event Reporting System . It is a passive surveillance system jointly operated by the FDA and CDC. VAERS receives reports from manufacturers, physicians and other healthcare providers, patients and their parents or guardians, and anyone else who wants to report a suspected adverse reaction following vaccination. Many adverse events that follow vaccination are not caused by the vaccine, so VAERS data should be interpreted with caution. Nonetheless, VAERS reports can provide the first clue that a problem exists. Additional studies can then be conducted to answer the questions raised by VAERS reports, as was done in response to the reported cases of intussusception following administration of RotaShield vaccine.
Related Resources
CDC. Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR February 6, 2009 / 58(RR02);1-25 CDC. Withdrawal of Rotavirus Vaccine Recommendation MMWR. November 05, 1999 / 48(43);1007 CDC. Intussusception Among Recipients of Rotavirus Vaccine - - United States, 1998-1999 MMWR. July 16, 1999 / 48(27);577-581 Patel MM, Haber P, Baggs J, Zuber P, Bines JE, Parashar UD. Intussusception and rotavirus vaccination: a review of the available evidence. Expert Rev Vaccines, 2009 : 8(11), 1555-1564. Tate JE, Simonsen L, Viboud C, Steiner C, Patel MM, Curns AT, Parashar UD. Trends in Intussusception Hospitalizations among US Infants, 1993-2004: Implications for Monitoring the Safety of the New Rotavirus Vaccination Program. Pediatrics. 2008: 121(5), e1125-1132. Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, Zanardi LR, Setia S, Fair E, LeBaron CW, Wharton M, Livengood JR; Rotavirus Intussusception Investigation Team. Intussusception among infants given an oral rotavirus vaccine. New England Journal of Medicine. 2001;344(8):564572 Zanardi LR, Haber P, Mootrey GT, Niu MT, Wharton M. Intussusception among recipients of rotavirus vaccine: reports to the Vaccine Adverse Event Reporting System. Pediatrics. 2001;107(6):E97. Kramarz P, France EK, Destefano F, Black SB, Shinefield H, Ward JI, Chang EJ, Chen RT, Shatin D, Hill J, Lieu T, Ogren JM. Population-based study of rotavirus vaccination and intussusception. Pediatric Infectious Disease Journal. 2001;20(4):410416. Rennels MB. The rotavirus vaccine story: a clinical investigator's view. Pediatrics 2000;106:123-5. Ein SH, Alton D, Padler SB, Shandling B, Stringer D. Intussusception in the 1990s: has 25 years made a difference? Pediatric Surgery International.1997;12:374-376. Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus diarrhea in the United States: surveillance and estimates of disease burden. Journal of Infectious Diseases 1996;174:Suppl 1:S5-S11. Stringer MD, Pablot SM, Brereton RJ. Paediatric intussusception. British Journal of Surgery 1992;79:867-876.
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