Panel Recommends Universal Rotavirus Shots
An influential federal advisory panel recommended Tuesday that every U.S. infant be vaccinated against rotavirus, a common and potentially fatal cause of childhood diarrhea and vomiting.
Children should receive a three-dose vaccination series during roughly the first six months after birth, according to a unanimous vote by the Advisory Committee on Immunization Practices.
The panel's recommendation cannot become policy unless it is adopted by the federal Centers for Disease Control and Prevention. But the panel's recommendations commonly are adopted by the CDC, which issues vaccination guidelines to doctors and hospitals.
"This could have a substantial impact," potentially preventing tens of thousands of hospitalizations a year, said Dr. Jon Abramson, the panel's chairman.
The Food and Drug Administration on Feb. 3 licensed an oral rotavirus vaccine for infants, named RotaTeq. Manufactured by Merck & Co., the vaccine has a proposed sale price of $62.50 a dose.
Rotavirus is the leading cause of severe diarrhea in infants and children, according to the CDC. But what's of greatest concern is the vomiting and potentially fatal dehydration the disease causes, said Dr. Paul Offit, a vaccine specialist at the Children's Hospital of Philadelphia and a co-inventor of the Merck vaccine.
Worldwide, the virus causes millions of hospitalizations and an estimated 500,000 deaths each year in children under 5.
The disease's impact has been less severe in the United States, where severely ill children have better access to hospitals and intravenous rehydration.
In children under age 5 in the U.S., rotavirus causes more than 550,000 emergency department or outpatient visits and more than 50,000 hospitalizations each year, but only 20 to 60 deaths.
In the U.S., rotavirus cases occur in annual winter epidemics, with most moderate to severe cases occurring in children ages 6 months to 24 months.
"It's 'that winter vomiting thing.' And I think people don't know the name," Offit said.
According to the manufacturer, the first dose of the three-dose vaccine regimen should be administered to children between 6 weeks and 12 weeks old. The series should be completed by the time the child is 32 weeks old.
A recent study involving 72,000 infants mainly in the U.S. and Finland concluded the drug prevented 98 percent of severe cases of rotavirus gastroenteritis, and 74 percent of cases overall.
GlaxoSmithKline is developing another rotavirus vaccine, RotaRix, which is awaiting approval by European regulators. The company expects to apply for U.S. licensing by early next year, said Dr. Beatrice De Vos, the company's director of worldwide medical affairs.
An earlier vaccine, RotaShield, was licensed in the U.S. in 1998, but the manufacturer - Wyeth Laboratories - withdrew it from the market a year later after rare instances of infants developing a potentially fatal condition in which the small intestine folded in on itself, like a closing telescope.
The RotaShield side effect, called intussusception, was thought to be due to the strain of virus used by Wyeth to develop its vaccine. That virus came from a rhesus monkey. The vaccines developed by Merck and GlaxoSmithKline are based on bovine and human strains, and have not had the same reported side effect.
Because of RotaShield's U.S. problems, governments in developing countries declined to authorize it.
If the CDC adopts the panel's recommendation, there will be 15 illnesses for which U.S. children receive vaccination.
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