by Playfuls Staff |
4th February 2006
Merck & Co. announced that the U.S. Food and Drug Administration (FDA) approved ROTATEQ (rotavirus vaccine, live, oral, pentavalent), the only vaccine available in the U.S. to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young [more] children. ROTATEQ is an oral, three-dose vaccine given to infants between the ages of six to 32 weeks.
ROTATEQ can be given during the current routine well baby visits at two, four, and six months of age. It is ready-to-use without re-formulation or mixing and is the only oral vaccine approved for use in infants in the U. S. The Advisory Committee on Immunization Practices (ACIP) is expected to decide whether ROTATEQ should be added to the current pediatric immunization schedule of recommended vaccines later this month. ROTATEQ should not be used in infants that are allergic to any component of the vaccine.
ROTATEQ is a pentavalent vaccine that targets the strains of rotavirus responsible for more than 90 percent of rotavirus disease in the U.S. Among children under five in the United States, it is estimated that 2.7 million episodes of rotavirus gastroenteritis occur each year, leading to approximately 250,000 emergency room (ER) visits and up to 70,000 hospitalizations. In the U.S., children are at the greatest risk for severe rotavirus disease from six to 24 months of age. By the time they are five years old, approximately one out of every 17 children in the U.S. will visit the emergency room, and one out of every 65 will be hospitalized for rotavirus gastroenteritis in the U.S. Published surveys show that many pediatricians and family physicians believe rotavirus gastroenteritis is a significant disease for children and that 94 percent of physicians would use a rotavirus vaccine.
The FDA approval of ROTATEQ is based on data from Merck's Phase III clinical trials of more than 70,000 infants, including the Rotavirus Efficacy and Safety Trial (REST), one of the largest pre-licensure vaccine clinical trials ever conducted.
Among infants observed in Phase III clinical trials, ROTATEQ prevented 98 percent of severe cases of rotavirus gastroenteritis and prevented 74 percent of rotavirus gastroenteritis cases of any severity caused by serotypes targeted by the vaccine (G1, G2, G3, G4) compared to placebo through the first full rotavirus season after vaccination. In REST, ROTATEQ reduced hospitalizations by 96 percent and ER visits by 94 percent for rotavirus gastroenteritis caused by serotypes targeted by the vaccine through the first two years after the third dose. As with any vaccine, vaccination with RotaTeq may not result in complete protection in all recipients.
