Merck & Co., Inc. today 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. Today, 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.
"It is common for post-marketing experience information with a vaccine to be reported to VAERS and for the prescribing information to be updated accordingly," said Mark Feinberg, M.D., Ph.D, vice president of policy, public health and medical affairs, Merck Vaccines. "Merck places public health and patient safety as our highest priorities, and we are very confident in the data supporting the safety profile of ROTATEQ from the placebo-controlled Rotavirus Efficacy and Safety Trial. Merck will continue to work with the FDA and the Centers for Disease Control and Prevention (CDC) to monitor post-marketing experience with ROTATEQ by collecting data from additional systems including active, controlled surveillance studies in addition to passive reporting systems such as VAERS."
The "Adverse Reactions" section of the label for ROTATEQ has also been updated to include information on hematochezia (bloody stools) from the pre-licensure clinical trials. In REST, the rate of hematochezia was comparable between the vaccine and placebo recipients within six weeks following any dose.
VAERS is a national vaccine safety surveillance program cosponsored by the FDA and the CDC. VAERS collects and analyzes information from voluntary reports of adverse events that occur after the administration of licensed vaccines. A report to VAERS does not mean that a causal relationship between an event and vaccination has been established - just that the event occurred after vaccination. Merck encourages healthcare providers and consumers to report any adverse experience associated with ROTATEQ to the Company and to VAERS.
ROTATEQ is recommended by the CDC's Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP). Among children under five in the United States, it is estimated that 2.7 million episodes of rotavirus gastroenteritis occur each year, with an estimated 250,000 emergency room visits and up to 70,000 hospitalizations.
Selected Safety Information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine. No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including those who have received blood products within 42 days of vaccination. Over 71,000 infants were evaluated in three placebo-controlled clinical trials. Serious adverse events occurred in 2.4% of recipients of ROTATEQ when compared to 2.6% of placebo recipients within the 42-day period of a dose of ROTATEQ. Hematochezia reported as a serious adverse event for ROTATEQ compared to placebo was <0.1% vs <0.1%. The most frequently reported serious adverse events for ROTATEQ compared to placebo were bronchiolitis (0.6% vs 0.7%), gastroenteritis (0.2% vs 0.3%), pneumonia (0.2% vs 0.2%), fever (0.1% vs 0.1%), and urinary tract infection (0.1% vs 0.1%).
In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6% vs 42.8%). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea (24.1% vs 21.3%), vomiting (15.2% vs 13.6%), otitis media (14.5% vs 13.0%), nasopharyngitis (6.9% vs 5.8%), and bronchospasm (1.1% vs 0.7%). In post-marketing experience, cases of intussusception have been reported in temporal association with ROTATEQ.
As with any vaccine, vaccination with ROTATEQ may not result in complete protection in all recipients.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.
source - Medical News Today