PCV1 Virus Detected in GSK's Rotarix Vaccine

March 22, 2010

The US Food and Drug Administration is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine, manufactured by GlaxoSmithKline (GSK) for rotavirus immunization in the US, while the agency learns more about components of an extraneous virus detected in the vaccine.

The US Food and Drug Administration is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine, manufactured by GlaxoSmithKline (GSK) for rotavirus immunization in the US, while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.

The agency recently became aware that an independent US academic research team has found DNA from porcine circovirus 1 (PCV1) in Rotarix. PCV1 is not known to cause illness in humans or other animals. In a media briefing today, FDA Commissioner Margaret Hamburg stressed the fact that PCV1 is a virus, and that this is not a food safety issue.

Hamburg stated that there currently is no evidence of a safety concern. The FDA is recommending that clinicians temporarily suspend use of Rotarix until it can learn more about the situation.

Follow-up tests by GSK and FDA scientists confirmed the academic team's findings that viral components have been present since the early stages of the vaccine's development, including during clinical studies. Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq (manufactured by Merck), has not detected components of PCV1.

Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease. The FDA licensed RotaTeq in 2006 and Rotarix in 2008. Most children vaccinated in the US received RotaTeq.