US Withdraws Rotarix Vaccine After Virus Threat

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Rotarix, a vaccine that is used to prevent rotavirus infection, has been advised by FDA officials to be temporarily stopped by physicians.

Rotavirus Infections Pipeline Drugs Marketis concerned that GlaxoSmithKline's vaccine may contain PCV-1, a second virus that is known to infect pigs and other species but not humans or any other animals.

There is no evidence that this finding poses a safety risk, so it is assumed that the virus came from the cell cultures used to make Rotarix.
Patients who have received the Rotarix vaccine do not require a medical follow-up because the evidence that is available supports its safety.

Rotavirus is responsible for approximately 500,000 deaths annually in infants and children due to vomiting and diarrhea.

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In the United States, there are two licensed rotavirus vaccines: Rotarix and RotaTeq

While the FDA gathers additional information, the precaution has been recommended.

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