A New Vaccine to Protect Babies Against Diarrhea A New Vaccine to Protect Babies Against Diarrhea
International Institutes of Health

NIAID scientists have developed a successful vaccine against rotavirus diarrhea, a major killer of children, particularly in developing countries.

In a recently completed study of more than 2,000 infants in Venezuela, the new oral vaccine against rotavirus reduced severs diarrheal illness by 88 percent.

The vaccine consists of a mixture of four viruses that together protect against the four most important clinical strains of rotavirus. This is the largest and most successful trial to date of a rotavirus vaccine among children in a developing country.

A universal threat
Worldwide, rotavirus diarrhea affects 130 million infants and children each year. Despite the availability of oral rehydration therapy there are 18 million cases of moderate to severe disease and more than 870,000 deaths.

In the United States, rotavirus causes more than 3 million cases of childhood diarrhea during the cooler months of each year, leading to an estimated 500,000 doctor visits, 55,000 to 100,000 hospitalizations, and 20 to 100 deaths

The symptoms of rotavirus infection develop quickly and, in addition to diarrhea, include vomiting, fever, and dehydration. In severe cases, a child can experience 10 to 20 episodes of diarrhea and 10 to 15 vomiting episodes per day.

Dehydration can be reversed through oral rehydration therapy or, if more serious, through hospitalization and intravenous fluids. Although effective, these therapies are not readily available or widely used in many parts of the developing world.

Developing the vaccine
After identifying rotavirus in children in the United States in 1974, NIAID scientists developed a vaccine against one rotavirus strain. They later added three other strains when it appeared that one strain would not provide adequate protection against illness. The investigators patented the vaccine, which has been tested in nearly 18,000 people in the United States and abroad.

The vaccine was licensed to a pharmaceutical company, which has applied to the Food and Drug Administration for approval to market the vaccine