CDC Backs New Kids' Diarrhea Vaccine

Feb. 22, 2006 -- The CDC's Advisory Committee on Immunization Practices (ACIP) has voted to recommend a newly licensed vaccine to protect against rotavirus.

Rotavirus is a viral infection that can cause severe diarrhea, vomiting, fever, and dehydration (gastroenteritis) in infants and young children. While rotavirus isn't responsible for all cases of diarrhea, it's the No. 1 cause of kids' severe diarrhea.

The new vaccine, RotaTeq, is the only vaccinevaccine approved in the U.S. for prevention of rotavirus gastroenteritis. It was licensed by the FDA in early February.

A previous rotavirus vaccine was withdrawn from the market in 1999 due to risk of intussusception, a rare cause of intestinal obstruction. The new vaccine hasn't shown a higher risk of intussusception in studies and will be closely monitored by the CDC and FDA.

Vaccine Recommendations

The ACIP recommends that infants receive three doses of the oral vaccine at 2, 4, and 6 months of age. Children should receive the first dose of the vaccine by 12 weeks of age and should receive all doses of the vaccine by 32 weeks of age.

"There is insufficient data on safety and efficacy outside of these age ranges," states a CDC news release.

The ACIP's recommendations become the CDC's recommendations once they are accepted by the CDC director and the U.S. secretary of Health and Human Services, and they are published in the CDC's Morbidity and Mortality Weekly Report.

CDC's Comments

In a news release, Anne Schuchat, MD, director of the CDC's National Immunization Program, commented on rotavirus and the new vaccine.

"Rotavirus is the leading cause of severe gastroenteritis in infants and young children worldwide," Schuchat says.

"Nearly every child in the United States is infected with rotavirus by age 5 and most will develop gastroenteritis, leading to a large number of physician visits, emergency room visits, and hospitalizations, with a few deaths," she continues.

"Therefore, this vaccine will help reduce one of our most common and potentially severe childhood illnesses."

In the U.S., rotavirus annually causes:

• More than 400,000 doctor visits
• More than 200,000 emergency room visits
• 55,000 to 70,000 hospitalizations
• 20-60 deaths in children younger than 5 years, leading to about $300 million in direct medical costs and $900 million in total societal costs

In developing countries, rotavirus is a major cause of childhood deaths, with an annual death toll of more than half a million children younger than 5 years.

The new rotavirus vaccine will not prevent gastroenteritis caused by other viruses, but it's "very effective against rotavirus disease," states the CDC.

Studies indicate the vaccine will prevent about 74% of all rotavirus cases and about 98% of the most severe cases, including 96% of rotavirus cases requiring hospitalization. In trials, the vaccine prevented 59% of all causes of gastroenteritis hospitalizations, which highlights the important role of rotavirus in severe childhood gastroenteritis, according to the CDC.