"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.
Rotarix, made by GlaxoSmithKline, was approved by the FDA in 2008. The contaminant material is DNA from porcine circovirus 1, a virus from pigs that is not known to cause disease in humans or animals, Hamburg said.
Learn more about Porcine circovirus 1
Pig Virus DNA Found in Rotavirus Vaccine
March 22, 2010 -- GlaxoSmithKline's Rotarix rotavirus vaccine contains DNA from an apparently harmless pig virus, the company and the FDA today announced.
The FDA estimates that 1 million U.S. kids have received the Rotarix vaccine.
The contamination was discovered by researchers developing a new technique for detecting viral material. GlaxoSmithKline confirmed that the pig virus, porcine circovirus type 1 or PCV-1, has been in the vaccine since it was developed.
This means that pig virus DNA was in the vaccine throughout clinical trials. No safety issues emerged from these international studies with 90,000 participants or, GlaxoSmithKline says, in post-marketing surveillance covering more than 69 million doses of the vaccine. READ FULL REPORT HERE
" No safety issue" Yeah Right.... I don't TRUST them one bit!
