Meeting today in Atlanta, the Advisory Committee on Immunization Practices (ACIP), an expert panel selected by the U.S. Department of Health and Human Services, added the new RotaTeq vaccine, manufactured by Merck & Co., Inc., to its list of routinely recommended childhood immunizations. Today's decision follows the vaccine's approval for licensing earlier this month by the U.S. Food and Drug Administration.
Rotavirus affects nearly all children at some point, often with mild symptoms, but in other cases with severe and potentially life-threatening diarrhea and dehydration. It causes tens of thousands of hospitalizations in the U.S. each year, and throughout the world, hundreds of thousands of child deaths.
The new vaccine was invented by three Philadelphia scientists: H. Fred Clark, D.V.M., Ph.D.; Paul A. Offit, M.D.; and Stanley A. Plotkin, M.D., all of whom led laboratory studies of the vaccine at The Children's Hospital of Philadelphia and The Wistar Institute between 1980 and 1991. Since 1991, the vaccine has been developed for commercial use by Merck, which conducted extensive clinical trials.
Dr. Offit is currently chief of Infectious Diseases, Maurice R. Hilleman Endowed Chair in Vaccinology, and director of the Vaccine Education Center at The Children's Hospital of Philadelphia. Dr. Clark is a research professor of Pediatrics at Children's Hospital. Dr. Plotkin, an emeritus professor at Wistar and a former director of Infectious Diseases at Children's Hospital, developed a number of previous vaccines, includ ing the vaccine that has eradicated rubella (German measles) in the United States.
"This vaccine against a major childhood killer will impact the lives of children around the world," said Steven M. Altschuler, M.D., president and chief executive officer of The Children's Hospital of Philadelphia. "The addition of this vaccine to the roster of childhood immunizations is the culmination of decades of work and represents a significant milestone in public health. It brings us a step closer to our ultimate goal of eliminating childhood disease."
Nearly every child experiences infection with rotavirus, usually as gastroenteritis. In the United States, children under age five experience an estimated 2.7 million episodes of rotavirus gastroenteritis each year, resulting in 250,000 emergency room visits and an estimated 70,000 hospitalizations. In developing countries, where appropriate medical care may be unavailable, rotavirus kills as many as 600,000 children annually.
Merck conducted clinical trials of RotaTeq in more than 70,000 infants in 11 countries--one of the largest clinical trials to be performed by a pharmaceutical company. The company's data showed that the vaccine prevented 98 percent of severe cases of rotavirus gastroenteritis and 74 percent of routine cases, compared to a placebo. Furthermore, the vaccine showed no increased risk of intussusception, a telescoping of the bowel that had been associated with a previous, discontinued rotavirus vaccine produced by another manufacturer in the 1990s.
Currently the only vaccine available in the U.S. to prevent rotavirus gastroenteritis, the new vaccine will be delivered by mouth, in three doses, at well-baby visits at ages two, four and six months. Merck has expressed a commitment to working with the global public health community to make the Rotateq vaccine available to infants and children worldwide.