posted on Apr, 19 2010 @ 11:37 PM
“U.S. federal health authorities recommended … that doctors suspend using Rotarix, one of two vaccines licensed in the U.S. against rotavirus,
saying the vaccine is contaminated with material from a pig virus,” CNN reports.
The Rotarix vaccine, which is made by GlaxoSmithKline and was approved by the FDA in 2008, has already been given to about 1 million U.S. children
along with 30 million worldwide. The vaccine was found to contain DNA from porcine circovirus 1.
“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,” FDA Commissioner Dr. Margaret Hamburg told CNN.
Dr. Eric Delwart is the researcher who, along with colleagues, made the discovery of contamination in Rotarix. Their intent was reportedly to “show
that live attenuated vaccine only contained the expected viral genomes and no other,” but what they found told a different story.
Using new technology to test eight infectious attenuated viral vaccines, the results showed three of the vaccines contained “unexpected viral
A measles vaccine was found to contain low levels of the retrovirus avian leukosis virus
Rotateq, Merck’s rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus
Rotarix (GlaxoSmithKine’s rotavirus vaccine) was found to contain “significant levels” of porcine cirovirus 1
So in their tests, nearly 40 percent of the vaccines they tested contained viral contaminants. The implications of these findings on the alleged
safety of the vaccine supply remains to be seen, but clearly there is contamination occurring that was a complete surprise to researchers, health
officials and vaccine manufacturers alike.
“There are lots of questions about how the manufacturer of Rotarix vaccine and the FDA both missed the pig virus DNA contaminating the original
seed stock and all doses of Rotarix vaccine given to more than one million American children in the past few years.
Is there state-of-the-art technology that is being used by private laboratories but not by drug companies and the FDA?
Why did the independent team of scientists, who found the contamination, notify the vaccine manufacturer first rather than also immediately
reporting their finding directly to the FDA?
What about the significance of finding bird viral DNA in measles vaccine and the monkey viral DNA in RotaTeq vaccine?”