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The FDA Shuts Down Common Infant Vaccine After Startling Discovery

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posted on Apr, 19 2010 @ 11:37 PM
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“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 sequences”:

1.

A measles vaccine was found to contain low levels of the retrovirus avian leukosis virus
2.

Rotateq, Merck’s rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus
3.

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?”




posted on Apr, 19 2010 @ 11:38 PM
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You should know that it is very common for vaccine manufacturers to use cells from animals and birds in their manufacturing process.

To put this in perspective, Barbara Loe Fisher has explained what animal material is par for the course in manufacturing the Rotarix vaccine for your children:

“Rotarix is a genetically engineered vaccine that GSK created by isolating human rotavirus strain infecting a child in Cincinnati and using African Green monkey kidney cells to produce the original viral seed stock from which all Rotarix vaccine has been made.

In the FDA licensing process, Rotarix had to meet certain FDA standards, that included demonstrating the vaccine was not contaminated with, for example TSE (Transmissable Spongiform Encephalopathy or “mad cow” disease, a brain wasting disease) or with cow viruses because bovine (cow) serum was used to prepare the original viral seed stock.

Porcine trypsin, an enzyme in the pancreatic juice of a pig, was also used to make the viral seed stock.”

So the fact that Rotarix contains animal material is not a surprise … it’s the type of animal material, an unexpected variety, that has even the FDA raising their eyebrows.



posted on Apr, 19 2010 @ 11:55 PM
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