“There is no evidence at this time that this material poses a safety risk,” Food and Drug Administration Commissioner Dr. Margaret Hamburg told reporters in a conference call.
Dr. Hamberg went on to say that the Rotavirus disease kills more than 500,000 infants around the world each year, primarily in low- and middle-income countries. Before the vaccine became available, the disease was blamed for more than 50,000 hospitalizations and several dozen deaths per year in the United States.
The FDA learned about the contamination after an academic research team using a novel technique to look for viruses in a range of vaccines found the material in GlaxoSmithKline’s product and told the company, Dr. Hamburg said. The drug maker confirmed its presence in both the cell bank and the seed from which the vaccine is derived, suggesting its presence from the early stages of vaccine development, she said. The FDA then confirmed the drug maker’s findings.
GlaxoSmithKline emphasized today that the pig virus is not known to cause illness in humans, saying “it is found in everyday meat products and is frequently eaten with no resulting disease or illness.”
GSK’s Chief Medical Officer Thomas Breuer also issued a statement saying,
“No safety issue has been identified by external agencies or GSK. GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world.”
They also confirmed that the second vaccine approved for use against Rotavirus, RotaTeq, has not been affected. Both RotaTeq and Rotarix are given orally to infants to prevent rotavirus disease, which is marked by severe diarrhea and dehydration.
The FDA stressed that they’re not pulling the vaccine, just ‘taking a pause, to really ask the critical questions about what this material was doing in the vaccine, how it got there.’
The suspension applies only to the United States.
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