Detection of PCV1 Virus Caused Temporary Suspension of Rotarix Vaccine

• Date: March 23, 2010
• Source: Admin

Recently, an independent U.S. academic research team found the presence of DNA from porcine circovirus 1 (PCV1) in Rotarix which can cause diarrhea as it is contaminated with an apparently harmless pig virus. Although it has been proved by several tests that PCV1 does not cause illness in humans or other animals, still FDA wants to learn more about PCV1 in order to ensure a better safety of the patients. Clearing the air of safety issue, in a media briefing, FDA Commissioner Margaret Hamburg stressed the fact that PCV1 is a virus, and certainly not a food safety issue.

Follow-up tests done by GSK and FDA scientists confirmed the presence of the viral since the early stages of development of the vaccine. However, preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, 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.

FDA will inform health practitioners, patients and providers as soon as it gets any update on the vaccine and will also continue to communicate with the World Health Organization and counterpart regulatory agencies in other countries.

Source:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm

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