A study from the Journal of Infectious Diseases released Friday reported that vaccines against the rotavirus had nearly cut in half hospitalizations of children in the U.S. in just two years.
Also on Friday, the U.S. Food and Drug Administration reversed course and said that pediatricians and other clinicians should use GlaxoSmithKline’s Rotarix vaccine to immunize infants against rotavirus. The agency also reaffirmed its position that Merck & Co.’s RotaTeq vaccine should remain in use.
Rotavirus often starts with a fever and can be followed by a week or more of watery diarrhea and vomiting. The infection is one of the most common causes of death in young children worldwide.
The FDA’s decision on the vaccines followed a controversy on the vaccines, which are both given by mouth, after researchers discovered fragments of a pig virus in the Rotarix vaccine. And then Merck announced in early May that its scientists found fragments of two pig viruses in RotaTeq. In Saturday's Inquirer my colleague Marie McCullough examined the FDA decision and controversy surrounding the discovery of DNA in the vaccines.
The FDA based its decision on an evaluation of all available information and on the recommendations of its Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss the rotavirus vaccines.
Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients. The FDA has no evidence that the pig viruses _ PCV1 or PCV2 _ pose a safety risk in humans, and neither is known to cause infection or illness in humans.
The vaccines’ benefits are substantial; they prevent thousands of deaths in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical. In fact, a study in the June 1 issue of the Journal of Infectious Diseases found a significant reduction in the hospitalizations of children for acute gastroenteritis, or acute diarrhea in the two years after RotaTeq was approved for use in the United States.
Using hospital billing data from 18 states, researchers from the Centers for Disease Control and Prevention and the federal Agency for Healthcare Research and Quality examined hospitalizations for “acute gastroenteritis” in children. The rate went from a median of 101.1 per 10,000 children in 2006 to 55.5 per 10,000 in 2008. That was a 46 percent decline.
The researchers concluded that the “vaccine was associated with a dramatic reduction in hospitalizations from acute gastroenteritis among U.S. children.