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 Rotarix Approved
The Food and Drug Administration (FDA) has approved Rotarix, the second oral vaccine approved for preventing infection by rotavirus (strains G1, G3, G4, and G9). Rotarix is a liquid given in a two-dose series to infants ages 6 weeks to 24 weeks.
Clinical trials including more than 24,000 infants showed that Rotarix prevented mild and severe cases of rotavirus gastroenteritis in children age 2 and younger. Its most common adverse effects included fussiness, irritability, cough, runny nose, fever, loss of appetite, and vomiting.
To help make sure Rotarix doesn't raise the risk of intussusception, which prompted removal of an earlier rotavirus vaccine from the market, the drug maker studied more than 63,000 infants. Although intussusception wasn't a concern, the study turned up higher rates of seizures and pneumonia-related deaths. They may be unrelated to Rotarix administration, but the FDA asked the drug maker to study another 40,000 infants to gather additional safety information.
A virus, rotavirus causes gastroenteritis in about 2.7 million infants and children each year in the United States. Although usually self-limiting, the infection sends more than 50,000 American children to the hospital each year and causes about 20 to 60 deaths. Without vaccination, nearly every child in the United States would be infected at least once by age 5.
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