The FDA has asked the nation’s physicians to stop giving their patients Rotarix, a vaccine used to protect against rotavirus.
The recommendation came after the FDA became aware of an independent U.S. research team finding an unauthorized substance, porcine cirovirus 1, or PCB-1 DNA, in multiple samples of Rotarix.
According to CNN: "Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said 'a substantial amount' of the DNA was found in the vaccine. But, he stressed, 'there is no evidence that it causes any disease. ... There is no evidence that it ever does anything.”
According to the New York Times: “For now, the decision is unlikely to disrupt routine immunizations in children since a second vaccine, this one made by Merck and called RotaTeq, remains available. RotaTeq was approved for use in the United States in 2006 and is still the more popular vaccine. Rotarix was approved in 2008 and has been used to vaccinate about one million children.”
The discovery of this virus, hastens the need for more robust Quality Control testing at all lengths of the supply chain, raw materials, manufacturer, distribution and the point of dispense to properly protect the healthcare of the global consumer.
A variety of news sources are reporting on the story including the New York Times, CNN, Wall Street Journal, Washington Post and USA Today.
To view the New York Times story, link to: http://www.nytimes.com/2010/03/23/health/policy/23fda.html.
To learn more about supply chain protections against contamination, adulteration, fraud or counterfeiting, visit: http://www.xstreamsystems.net/.
The recommendation came after the FDA became aware of an independent U.S. research team finding an unauthorized substance, porcine cirovirus 1, or PCB-1 DNA, in multiple samples of Rotarix.
According to CNN: "Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said 'a substantial amount' of the DNA was found in the vaccine. But, he stressed, 'there is no evidence that it causes any disease. ... There is no evidence that it ever does anything.”
According to the New York Times: “For now, the decision is unlikely to disrupt routine immunizations in children since a second vaccine, this one made by Merck and called RotaTeq, remains available. RotaTeq was approved for use in the United States in 2006 and is still the more popular vaccine. Rotarix was approved in 2008 and has been used to vaccinate about one million children.”
The discovery of this virus, hastens the need for more robust Quality Control testing at all lengths of the supply chain, raw materials, manufacturer, distribution and the point of dispense to properly protect the healthcare of the global consumer.
A variety of news sources are reporting on the story including the New York Times, CNN, Wall Street Journal, Washington Post and USA Today.
To view the New York Times story, link to: http://www.nytimes.com/2010/03/23/health/policy/23fda.html.
To learn more about supply chain protections against contamination, adulteration, fraud or counterfeiting, visit: http://www.xstreamsystems.net/.
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