Please join the upcoming Engelberg Center for Health Care Reform webinar, “Findings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception,” Tuesday, July 23, 2013, from 2:00 PM to 3:00 PM EDT. RotaTeq (Merck and Co., Inc.) and Rotarix (GlaxoSmithKline Biologicals) are vaccines for the prevention of rotavirus gastroenteritis in infants 6 weeks to 32 weeks of age (RotaTeq) and infants 6 weeks to 24 weeks of age (Rotarix). Intussusception, a form of bowel obstruction, has been an outcome of interest since an older rotavirus vaccine, RotaShield, was voluntarily withdrawn from the market by the manufacturer after studies suggested an elevated risk of intussusception, estimated at approximately 1 case per 10,000 vaccine recipients. RotaShield was the first licensed vaccine for the prevention of rotavirus infection in infants. Prior to licensing RotaTeq and Rotarix, the risk of intussusception was assessed in large clinical trials of more than 60,000 children for each vaccine. No increased risk for intussusception was observed for either vaccine. However, several postlicensure studies conducted in other countries subsequently suggested potential increased risk of intussusception after vaccination with both Rotarix and RotaTeq. In 2010, the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) initiated a study to quantify this possible risk among U.S. infants. The recently completed study was conducted through the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, a component of the Mini-Sentinel pilot developed to conduct active surveillance for medical product safety. Investigators found an increased risk of intussusception after vaccination with the first dose of RotaTeq; the data regarding the risk after Rotarix vaccination were inconclusive.In response, FDA approved required revisions to the Prescribing Information for RotaTeq that describe the new findings from this Mini-Sentinel PRISM study. New information was added to the Highlights, the existing intussusception subsection of the Warnings and Precautions section, and the Post-Marketing Experience section of the Full Prescribing Information.Michael Nguyen, Deputy Director in the Division of Epidemiology at CBER, will provide a brief description of the rationale for conducting this study, along with Katherine Yih, epidemiologist and lecturer at Harvard Pilgrim Health Care Institute and Harvard Medical School, who will present an overview of findings from the medical product assessment. For a full webinar agenda, please view the "Agenda" tab above, and to register, click "Register" below. Please note: Webinar log in and teleconference information can be found in your registration confirmation email or in the downloadable Outlook calendar hold once you register. Due to the interest in this topic, you must register to obtain this information!
Tuesday, July 23, 2013 2:00 PM - 3:00 PMEastern Time
Webinar / Teleconference
Engelberg Center for Health Care Reform
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