Panel Recommends Approval Of Vaccine For Juvenile Diarrhea Virus Kill 1 Million Children A Year Around World

The first vaccine against the leading cause of childhood diarrhea - a virus that hospitalizes 55,000 American children a year and kills 1 million in other countries - is safe and works, government advisers said Friday.

The Food and Drug Administration panel’s unanimous conclusion moves Wyeth-Ayerst Laboratories’ RotaShield vaccine a step closer to U.S. sales.

The FDA is not bound by the panel’s advice but typically follows it. If the FDA agrees, the vaccine would be given to infants to swallow in three doses, at ages 2, 4 and 6 months.

The vaccine promises to cut by up to 80 percent the most severe illnesses caused by the infection called rotavirus, but it won’t wipe out the intestinal virus altogether, the panel cautioned. Vaccinated children who do get sick have milder cases.

“It blunts severe disease,” explained adviser Dr. David Karzon of Vanderbilt University.

Rotavirus is the leading cause of severe diarrhea among children, attacking the lining of the small intestine. The constant diarrhea can cause severe dehydration, and children often suffer vomiting as well. About 75 percent of children are infected before age 5, with the youngest infants often the sickest.

In the United States, 3 million children are sickened each year, 500,000 need a doctor’s care and 55,000 are hospitalized with severe illness, the government says. There is no cure. But good care, especially replacing lost fluids, limits deaths here to no more than 40 a year. The medical bills total about $400 million.

In developing countries with poorer health care, rotavirus is much more deadly, killing about 1 million children worldwide every year.

“This is an endemic disease and all children are at risk,” said Dr. Roger Glass of the Centers for Disease Control and Prevention. “Clearly a vaccine would be of use.”

Alarmed by the toll, the National Institutes of Health began developing a vaccine in the 1980s and licensed its discovery to Wyeth. Today, RotaShield has been tested on about 16,000 children around the world.

On Friday, Wyeth presented three of those studies - in 24 U.S. cities, in Indians living in Arizona and New Mexico, and in Finland. RotaShield cut the number of rotavirus cases between 49 percent and 68 percent, depending on the study.

It was most effective against severe diarrhea, cutting those cases by some 80 percent. No vaccinated child suffered the dehydration that is rotavirus’ biggest danger.

The vaccine cut the need for doctor or hospital care by 73 percent, the studies showed. And the children who still got sick suffered milder disease and were well about a day sooner than unvaccinated children.

RotaShield is a live vaccine, made of one monkey strain of rotavirus - one that doesn’t sicken people but that primes their immune system to fight the disease - plus proteins from four human rotavirus strains.

The vaccine itself did not cause diarrheal disease, said Wyeth’s Dr. Peter Paradiso.

The main side-effect was a low fever a day or so after children swallowed the first two doses. A few children were hospitalized for fever. That side-effect is in line with other vaccines, the FDA advisers said, but urged the FDA to closely examine those cases to be sure.

Smaller studies found that giving RotaShield at the same time as vaccines against polio, diphtheria, whooping cough, tetanus and a form of meningitis did not alter those standard vaccines’ effectiveness. The FDA panel agreed, but cautioned that Wyeth didn’t know for sure whether those older vaccines in turn affected RotaShield’s effectiveness.

Friday’s decision puts RotaShield in line to be sold first in this country, although applications are pending in Europe and Latin America.

The company has not set a price. But a government analysis estimated that even if each dose cost $30, RotaShield would be cost-effective, saving the United States about $79 million in health-care costs.