The Food and Drug Administration recommended Monday that doctors temporarily stop using GlaxoSmithKline PLC's (GSK) Rotarix child vaccine after a virus was found in the product.
Jennifer Corbett, Wall Street Journal, Mar 22, 2010
WASHINGTON (Dow Jones)--The Food and Drug Administration recommended Monday that doctors temporarily stop using GlaxoSmithKline PLC's (GSK) Rotarix child vaccine after a virus was found in the product.
The agency said it needed to learn more about parts of an extraneous virus that was found in the vaccine. The FDA said there's currently no evidence of a safety risk associated with the vaccine.
"There is no evidence...that this poses any health risk," FDA Commissioner Margaret Hamburg said in a conference call with reporters. "We're simply asking that there be a pause in its use."
She also said Rotarix has a significant track record of being safe.
Rotarix, approved for use in the U.S. in 2008, is typically given to babies at two and four months of age and is designed to help protect infants from a gastrointestinal illness caused by rotavirus.
The FDA said it recently became aware that an independent U.S. academic research team has found DNA from porcine circovirus 1, or PCV-1, in Rotarix. PCV-1 is not known to cause illness in humans or other animals. The agency said follow-up testing has found that DNA from the PCV-1 virus has been in the product since early in development.
In a statement, GlaxoSmithKline said PCV-1 does not multiply or cause illness in humans. The company said the virus is found in everyday meat products and is frequently eaten with no resulting disease or illness.
The company said the material was first detected following work done by a research team in the U.S. using a novel technique for looking for viruses. It was then confirmed by additional tests conducted by GlaxoSmithKline.
Hamburg said the FDA is convening a panel of outside medical experts in four to six weeks to look at the issue more closely, which suggests it could be several weeks before FDA lifts its recommendation on Rotarix.
The FDA's recommendations apply only to the U.S.
GlaxoSmithKline said European regulatory authorities haven't recommended any changes in how health-care professionals use Rotarix.
Rotarix had global sales of $440 million last year, up 50% from 2008. Those sales figures include $118 million worth of U.S. sales last year.
The product competes with Merck & Co.'s (MRK) RotaTeq, a similar vaccine, which was approved in 1996. That product had worldwide sales of $564.2 million including $468 million in the U.S. last year. There's no evidence the virus is in RotaTeq, the FDA said.
Before the vaccines were approved, the FDA had estimated that up to 70,000 infants and toddlers in the U.S. were hospitalized annually for dehydration and other complications from rotavirus; about two dozen babies died. Rotavirus affects most children before age five.
Rotavirus is the leading cause of severe childhood diarrhea and causes more than 500,000 deaths from dehydration among young children worldwide, mostly in countries where vaccination isn't common.
The vaccines are designed to offer protection against rotavirus for two years. After that, most children are old enough to withstand rotavirus illnesses with few complications.
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