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The Food and Drug Administration (FDA) today announced the approval of RotaTeq™, a live, oral, vaccine for use in preventing rotavirus gastroenteritis in infants. It is the only vaccine approved in the United States that can help protect against rotavirus, a viral infection that may cause diarrhea, vomiting, fever, and dehydration.
"This vaccine gives health care providers an important new tool that can effectively prevent an illness that affects almost all children within the first few years of life," said Jesse L. Goodman, MD, MPH, director of FDA’s Center for Biologics Evaluation and Research.
Infection with rotavirus is a leading cause of severe diarrhea in infants and young children in the United States and worldwide. The Centers for Disease Control and Prevention (CDC) has estimated that rotavirus infection results in approximately 55,000 hospitalizations annually of infants and young children in this country. Death from rotavirus is rare in the United States. However, in developing countries, rotavirus gastroenteritis has been estimated to cause up to several hundred thousand deaths annually in infants and young children.
Overall, approximately 72,000 healthy infants were studied in the United States and other countries in randomized placebo-controlled studies to look at the safety of RotaTeq™. Of these infants, almost 7,000 from the United States and Finland were also studied for efficacy. In these studies, RotaTeq™ prevented 74 percent of all rotavirus gastroenteritis cases and 98 percent of the severe cases. In addition, RotaTeq™ prevented approximately 96 percent of hospitalizations due to rotavirus gastroenteritis.
In 1998, FDA approved a different live vaccine against rotavirus that was later withdrawn from the market because of its association with an increased risk of intussusception, a rare, life-threatening type of blockage or twisting of the intestine. Intussusception occurs spontaneously in approximately 1 in 2,000 healthy young infants and children per year, but occurred at an increased rate during the first week or two following vaccination with the previous rotavirus vaccine.
The risk of intussusception for RotaTeq™ was evaluated in a large-scale trial of over 70,000 children, of whom half received vaccine and the remaining half received placebo. In this study, RotaTeq™ was not associated with an increased risk of intussusception when compared to placebo. In addition, RotaTeq™ was not associated with an increased risk of other serious adverse events when compared to placebo.
"Although this large study did not show an increased risk of intussusception associated with RotaTeq™, given the experience with the previous vaccine, safety of this vaccine will be closely monitored in additional studies conducted after licensure," said Dr. Goodman. The manufacturer has committed to conducting a post-licensure study of approximately 44,000 children. CDC will also conduct a large study designed to rapidly detect any association of intussusception with RotaTeq™ through its Vaccine Safety Datalink Program, which evaluates vaccine safety in approximately 80,000 U.S. infants every year. In addition, for the first three years of licensure, the manufacturer will report cases of intussusception and all serious and unexpected adverse events to FDA within 15 days of receiving them, and all other side effects on a monthly basis.
RotaTeq™ is a liquid vaccine that is given by mouth in three doses, between the ages of 6 and 32 weeks. The following were reported more often in infants who received RotaTeq™ when compared to infants who received placebo; diarrhea (24.1 percent in vaccine recipients vs 21.3 percent in those receiving placebo), vomiting (15.2 percent in vaccine recipients vs 13.6 percent in those receiving placebo), ear infection (14.5 percent in vaccine recipients vs 13.0 percent in those receiving placebo), runny nose and sore throat (6.9 percent in vaccine recipients vs 5.8 percent in those receiving placebo), wheezing and coughing (1.1 percent in vaccine recipients vs 0.7 percent in those receiving placebo).
The vaccine is manufactured by Merck & Co., Inc.
Additional information regarding the approval of RotaTeq
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