Re: Rotavirus Rotarix vaccine contaminated with pig virus!

[Guest guest]

My favorite part is they actually try to justify this by saying it is in pork

meat, but I cook my pork; vaccines are not *cooked* and most have weakened live

virus in them.

Yuck!

We do not have to worry about this because we do not vaccinate.

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> Rotarix rotavirus vaccine contaminated, officials say

> By Tom Watkins, CNN

> March 22, 2010 4:22 p.m. EDT

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> About 1 million children in the United States and about 30 million

> worldwide have gotten Rotarix vaccine, the FDA says.

> STORY HIGHLIGHTS

> Doctors have been advised to suspend use of Rotarix rotavirus vaccine

> Another vaccine, RotaTeq, is still OK to use, officials say

> GlaxoKline, maker of Rotarix, says the contamination is not harmful

> RELATED TOPICS

> Rotavirus

> GlaxoKline plc

> Contagious and Infectious Diseases

> (CNN) -- Federal health authorities recommended Monday that doctors

> suspend using Rotarix, one of two vaccines licensed in the United States

> against rotavirus, saying the vaccine is contaminated with material from a

> pig virus.

> " 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 GlaxoKline, 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.

> About 1 million children in the United States and about 30 million

> worldwide have gotten Rotarix vaccine, she said.

> Rotavirus disease kills more than 500,000 infants around the world each

> year, primarily in low- and middle-income countries, she said. Before

> rotavirus vaccine became available, the disease was blamed for more than

> 50,000 hospitalizations and several dozen deaths per year in the United

> States, she said.

> 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 GlaxoKline's product and told the company, 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.

> GlaxoKline emphasized Monday 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. "

> " No safety issue has been identified by external agencies or GSK, "

> Breuer, the drug maker's chief medical officer, said in a written

> statement. " 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. "

> Another vaccine, RotaTeq, is made by Merck and was approved in 2006.

> There is no evidence that the Merck product is affected, Hamburg said. Both

> vaccines are given by mouth to infants to prevent rotavirus disease, which

> is marked by severe diarrhea and dehydration.

> Asked whether Merck would be able to meet the nation's demand, Merck

> spokeswoman Pam Eisele said, " Obviously, we will work with the ... FDA to

> evaluate supply needs. "

> In the next four to six weeks, the drug agency will convene an advisory

> committee to make recommendations and seek input on the use of new

> techniques for identifying viruses in vaccine, Hamburg said.

> " We're not pulling it from the market, we're just suspending its use

> during this period while we're collecting more information, " she said. " It

> should not be in this vaccine product and we want to understand how it got

> there. It's not an easy call and we spent many long hours debating the pros

> and cons but, because we have an alternative product and because the

> background rates of this disease are not so severe in this country, we felt

> that the judicious thing to do was to take a pause, to really ask the

> critical questions about what this material was doing in the vaccine, how it

> got there. "

> Dr. 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. "

> The research group that discovered the contamination has asked not to be

> identified pending its paper's publication in a scientific journal, Hamburg

> said.

> Anyone who has already received a dose of Rotarix should switch to the

> Merck product for the next two doses, Hamburg said. Preliminary testing of

> the Merck product has found no evidence of the porcine circovirus 1 DNA, she

> said. Doctors should be able to tell parents which of the two products their

> children received, she said.

> Hamburg stressed that the suspension applies only to the United States.

> Public health officials in countries where the incidence of rotavirus is

> more severe may decide that the benefits of continuing to use the vaccine

> outweigh any concerns raised by the contamination, she said. " Such a

> decision would be very understandable, " she added.

> A similar virus, porcine circovirus 2, also does not cause disease in

> humans, but it does cause disease in its pig host, Hamburg said.

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