RotaTeq regulatory update

FDA approved updated labeling for Merck's RotaTeq rotavirus vaccine based on safety data from the agency's Mini-Sentinel Post-licensure Rapid Immunization Safety Monitoring (PRISM) study evaluating the risk of intussusception after vaccination with RotaTeq and Rotarix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.). PRISM identified an increased risk of intussusception in the 21 days after the first dose of RotaTeq, with the majority of cases occurring in the first 7 days. No increased risk was found after the second or third doses. Based on the results, about 1-1.5 additional cases of intussusception would occur per 100,000 first doses of RotaTeq. Data from PRISM on the risk of intussusception following Rotarix were inconclusive, and no changes were made to the prescribing information or patient information for Rotarix. PRISM evaluated more than 1.2 million RotaTeq vaccinations (507,000 first doses) and 103,000 Rotarix vaccinations (53,000 first doses) in infants 5-36 weeks of age. FDA required that new information be added to the highlights, the existing intussusception subsection of the warnings and precautions section, the postmarketing experience section of the prescribing information and the patient information. ...