Merck & Co., Inc. updated the prescribing information for ROTATEQ? (rotavirus vaccine, live, oral pentavalent), the Company’s vaccine to help prevent rotavirus gastroenteritis in infants and children.
The labeling update includes post-marketing reports of intussusception and hematochezia to the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety surveillance program. A naturally occurring event in infants, intussusception is estimated to occur in the U.S. in approximately 1 in 2,000 infants during the first year of life. Cases of intussusception can occur when no vaccine has been given and the cause is usually unknown.
The U.S. Food and Drug Administration (FDA) reported that since the licensure of ROTATEQ on Feb. 3, 2006 until Jan. 31, 2007, 28 cases of intussusception in infants who received ROTATEQ have been reported in the U.S. to VAERS and that this number does not exceed the number of cases expected based on the background rate.
The FDA Public Health Notification on this label change is available at http://www.fda.gov/cber/safety/phnrota021307.htm.
ROTATEQ is approved for the prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3 and G4, and is administered as a three-dose series to infants between the ages of 6 to 32 weeks. Since approval, more than 3.5 million doses of ROTATEQ have been sold.
ROTATEQ was approved based on the results of the landmark Rotavirus Efficacy and Safety Trial (REST), which involved nearly 70,000 infants, about half receiving ROTATEQ and half receiving placebo. REST was specifically designed to evaluate vaccine safety with respect to intussusception. Intussusception occurs when the bowel folds in on itself causing an intestinal blockage. In REST, there was no increased risk of intussuception with ROTATEQ, compared to placebo.