rotavirus vaccine contaminated with pig virus

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Rotarix rotavirus vaccine contaminated, officials say
By Tom Watkins, CNN
March 22, 2010 4:22 p.m. EDT

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
GlaxoSmithKline, maker of Rotarix, says the contamination is not harmful
RELATED TOPICS
Rotavirus
GlaxoSmithKline 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 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.
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 GlaxoSmithKline'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.
GlaxoSmithKline 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," Thomas 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. Anthony 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.
 

natasa778

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Wow, thanks so much for posting this. There is another similar thread I started on possible animal retrovirus (including xmrv) contamination of vaccines and other biologicals. See under XMRV forum. But this is something!

GlaxoSmithKline 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."
Yes but fresh pig blood is not frequently shot up our veins now is it?
 

JillBohr

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O.K., you have got me googling now. This was one of the first hits when googling porcine circoviruses.

http://www.virologyj.com/content/6/1/60

The members of the Circovirus genus in the Circoviridae family are animal viruses, most of which affect birds although type 1 and type 2 porcine circoviruses (PCV-1 and PCV-2) affect swine and wild boars. All circoviruses known at present, except PCV-1, are associated with immuno-suppressive or immuno-depressive diseases.
Although they did say it was contaminated with type 1 porcine circovirus but I am going to keep an eye out on this. I would love to know which university was researching this. I hope all the vaccinations are being examined now and under much better scrutiny.
 

Frickly

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Thanks OutofStep! I agree with Natasa when she said, "Yes but fresh pig blood is not frequently shot up our veins now is it?" What else makes it into our vaccines?
 
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Fauci

I totally agree w/ you guys and wonder if the virochip is being used to identify the viruses.

Something interesting about this article is that it quotes Dr. Anthony Fauci, and per Osler's Web Fauci was totally clueless about CFS. He supported the view that CFS is a psych disorder and it was said that he couldn't understand why people with CFS resented being labelled as mentally ill.
 

flybro

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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, Hamburg said.
was this standard testing of new techniques, or was this an accidental find wjile looking for something else, what were the intitial reasons to carry out the tests?
 

acer2000

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Rotavirus vaccine pulled due to potential pig virus contamination

WASHINGTON U.S. health officials urged pediatricians Monday to temporarily stop using one of two vaccines against a leading cause of diarrhea in babies, after discovering that doses of GlaxoSmithKline's Rotarix were contaminated with bits of an apparently benign pig virus.
Glaxo's vaccine has been used in millions of children worldwide, including 1 million in the U.S., with no signs of safety problems and the pig virus isn't known to cause any kind of illness in people or animals, said Dr. Margaret Hamburg, commissioner of the Food and Drug Administration.

Full article:

http://news.yahoo.com/s/ap/20100322/ap_on_he_me/us_med_vaccine_warning

Not sure how often this happens, but it at least shows the possibility that human vaccines can be delivered to Drs offices contaminated with animal viruses. Not sure whether this particular pig virus causes disease.