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Vaccine Contamination: Pig Virus DNA Found in Rotarix

Pig_virus_446935 By Barbara Loe Fisher

On March 22, 2010, Food and Drug Administration (FDA) officials adhering to the precautionary principle advised American doctors to suspend use of Rotarix vaccine until the agency finds out why DNA from a swine virus (porcine circovirus 1 or PCV1) was found in the live rotavirus vaccine. The FDA said there is "no evidence at this time" that the vaccine manufactured by GlaxoSmithKline and given to babies at 2,4 and 6 months of age to prevent diarrhea poses any safety risk.

Independent Lab Using New Technology Found Contamination

The discovery that viral DNA is contaminating Rotarix vaccine was made by a team of scientists at an independent research lab in San Fransisco, California, where they used new technology to detect fragments of viral genetic material in vaccines using genetic sequencing.

More testing confirmed that many copies of DNA from the pig virus were present in all Rotarix vaccine lots released since the vaccine was licensed in 2008 because the pig virus DNA also contaminated the working cell bank and the original viral "seed" stock, from which Rotarix vaccine was first produced.

Two Other Live Virus Vaccines Contaminated

The surprising discovery reportedly was made after the independent lab used new technology to evaluate the purity of eight live virus vaccines for polio, rubella, measles, yellow fever, human herpes 3 (varicella or chicken pox), rotavirus (Rotarix and RotaTeq) and MMR. In addition to pig viral DNA found in Rotarix vaccine, low levels of DNA fragments from avian (bird) leukosis virus (a retrovirus) was found in measles vaccine and DNA fragments of a virus similar to simian (monkey) retrovirus was found in RotaTeq vaccine.

FDA Looking For Answers

After the team double checked their findings, researchers notified GlaxoSmithKline (GSK) on February 9, 2010 and GSK notified the FDA on March 15, 2010, which prompted the FDA's action on March 22, 2010 to suspend use of Rotarix. The FDA says it "does not know how DNA from PCV1 came to be present in Rotarix" or whether "this means that intact virus is present. Additional studies are being conducted."

Rotavirus Vaccines Use Monkey, Cow, Pig Materials for Production

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.

RotaTeq is a genetically engineered vaccine containing five human-cow reassortment strains of rotavirus that were created at the Children's Hospital of Pennsylvania (CHOP), where strains of rotavirus that give cows diarrhea were combined with strains of rotavirus that cause diarrhea in humans. The reassortment viruses were transported to Merck, where master seeds were produced using African Green Monkey kidney cell cultures. Fetal bovine (cow) serum and porcine trypsin was used to make the "seed" stock. There are small amounts of bovine serum and cell culture media (monkey viral DNA) that remain in RotaTeq vaccine....to read the entire commentary and watch a video, click here. HERE.

Comments

patrons99

Every vaccine in the marketplace today needs to be rigorously screened for the presence of adventitious biologic recombinants.

Are we inadvertently transfecting ourselves with non-human DNA with every jab? How certain are we that cancer is less a problem with gene mutation than it is a problem with gene transfer between species, e.g. SV-40?

With the stupendous number of vaccines in the current pediatric and adult vaccination schedules, and hundreds more in the pipeline, has some of our DNA inadvertently become human-animal chimeras (hybrids)?

This is certainly not the first time that the risk of uncertain biologic recombinants has been raised. Is anyone listening?

"The truth that vaccine policy is not about science or safety but about money and politics is finally seeing the light of day." K. Paul Stoller, MD, FACHM, on January 13th, 2009.

"The history of vaccine in littered with horrible mistakes and skulduggery - from the SV40 virus given to millions in the polio vaccine to the continued use of mercury and other heavy metals. The fact is even the best MMR vaccine is contaminated with avian retro virus and reverse transcriptase. This is criminal!" K. Paul Stoller, MD, FACHM, on January 13th, 2009.

Just in case there is anyone at this website who has not yet seen this, here’s the link to a series of video clips titled

“Merk drug company vaccines admits injecting cancer. AIDS/HIV/Virus Information.”

http://www.godlikeproductions.com/forum1/message470057/pg1

Mercola's New Post with  BLF Interview

Thanks to Dr. Mercola for posting this important info. Mercola has a large readership. Thanks again, BLF! You rock!

http://articles.mercola.com/sites/articles/archive/2010/04/17/major-vaccine-suspended-due-to-contamination-with-pig-virus.aspx

Natasa

Business as usual....

In an April 14 advisory, the Food and Drug Administration (FDA) cited findings by the manufacturer and other regulatory agencies that the virus does not pose any public health risk. http://www.gmanews.tv/story/188485/rp-fda-no-need-for-ban-on-rotarix-vaccine


I wonder WHAT it would take for them do say “wait a minute, maybe better not give THIS to babies”. Maybe seeing green aliens dancing under the microscope? Or not? After all there is no proof that dancing aliens pose public health risk! Only a speculation on the part of anti-alien nutters.

Garbo

Good grief, what is wrong with these people?! 10-20x more contaminant than antigen, but it's all fine, nothing to see here, move along and line up for those shots...

Natasa

Just as a side note, European Health Agency has looked into this and decided, without going into details, that this contamination of rotavirus vaccine poses no risk to human health and that there is no reason to pull it off the market. Nothing to do with GSK influence in Europe one might guess...

Louise Kuo Habakus

Three thoughts:

INADEQUATE OVERSIGHT BY THE FDA!
It took an independent research lab to find this out. The FDA does no independent testing. It relies upon the vaccine makers. How odd that GSK's research folks didn't suss this out themselves.

LUCK OF THE DRAW?
Now, how about those kids who received the Rotarix vaccine on March 21? And the ones whose scheduled appointments were moved, for various reasons, to March 23. Sort of like the WTC dads whose alarm clocks were accidentally turned off the morning of 9/11.

VACCINATION IS A RIGHTS ISSUE
Our federal government "recommends" 69 doses of 16 different vaccines. Taking their lead, state governments mandate up to 45 doses of 14 vaccines for school. Only 19 states offer the philosophical exemption. Whether you turn to the US Constitution, the Declaration of Human Rights, customary international law (legal standard of informed consent), or religious law, there are universal principles and inalienable rights that all human beings possess. These are rights to protect our personal security, autonomy, and of course life and liberty. Come to Chicago and rally with us. It's about choice and an affirmation of our rights. In the greatest country in the world.

Garbo

Perhaps the most interesting thing (or most frightening) is one of the comments on the virology blog asking a very pertinent question: What about the other 60% of what they found? The question seems to assert that the pig virus was 40% of what they found that was unexpected, but the other 60% was other DNA stuff that wasn't in the Genome project database to which the researchers compared their findings. Other stuff was there but since nobody ever identified it before nobody knows what it is? Incomplete fragments or whole? File it under miscellaneous?

michael framson

Whats the harm of a few DNA fragments?

"The smallpox crust is then scraped form each sore with a blunt lancet, and the remaining contents of blood, skin, lymph, and pus are drawn from each sore and transferred to a heat-resistant pot. Glycernine is added to the poisonous swill, and the entire contents are mixed with an electric motor. They are then passed through a sieve to remove the coarse materials (rotten flesh, hair etc.) and homogenized again by remixing the witch's brew. The mixture is then poured into tubes and sold throughout the country as pure calf lymph, commonly known as smallpox
vaccine." This was injected into millions of children and adults from 1880 - 1940.

I wonder what diseases of man are the result incredibly contaminated smallpox vaccines?

Theresa O

Garbo, thank you for that link.

It does not surprise me that there is little discussion about HERK, given that even the paper you linked to parrots the old lie about there being no link between SV40 and human cancers. (Did no one at this journal read about Michele Carbone's work?) I guess it is not in the interest of the vaccine program to make people nervous about contaminants.

This is likely just the tip of the iceberg...

Maurine Meleck

I can just hear Paul Offit now saying" No need to worry about the pig DNA being in your children unless they start to oink and grow short, curly tails.
Disgusting, I might add.
Maurine

Garbo

The whole journal article is here:
http://jvi.asm.org/cgi/reprint/JVI.02690-09v1

A couple of questions I have:
First, there seems to be little discussion of the fact that they also found HERK (human endogenous retrovirus K) in the MMRII and Varivax vaccines. Here's a discussion of HERK re: possible activity in cancers:

http://jvi.asm.org/cgi/content/full/79/19/12507

Second is the differentiation between the PCV1 and PCV2 viruses. They've been careful to state that what they found was PCV1 which they assume to be non-infectious to humans, and in table 1 they list what they found by PCR to be PCV1, but in table 2 they list what they found in Rotarix via Pan Microbial Microarray as PCV2. Is this a typo mistake? Or did they find BOTH types of porcine circovirus, PCV1 AND PCV2, each one using a different technique?

Natasa

Garbo or anyone if interested in more details on this study and general discussion on its implications by 3 virologists listen to this podcast, titled TWiV 77: Non-nuclear proliferation here http://www.virology.ws/

I'm going to frame one of the comments there: "Circovirus DNA is a new way of looking into vaccines"."

"We told you so" indeed LOL

Discussion on these findings is followed by a very interesting discussion on polio vaccine, which was also looked at by the same paper. On how attenuated viruses REVERT to virulence in your gut, so throwing down the drain previous claims that getting infected by polio from vaccines is due to sloppy manufacturing and that careful manufacture would eliminate that risk. Not.

Kristina

jen, that's my feeling--GROSS. Even though most of the public doesn't understand the specifics of all this, I hope "GROSS" is the take home message. It might get them to start second guessing.

Personally, I always thought an oral, live virus diarrhea vaccine was gross in itself.

Benedetta

Well Gee --- It is a lot more complicated than injecting a weaken or dead pathogen into our bodies - like they teach in school with pictures in text books of Jenner and Salk complete with halos on their heads.

Garbo

From the virology blog: "Significant levels of porcine cirovirus 1 were found in Rotarix. The entire viral genome sequence was deduced from 6344 sequence reads, comprising over 40% of the reads done for that vaccine. Over 100,000 porcine circovirus 1 DNA molecules were detected in each vaccine dose, fully 10 times higher than the amount of rotavirus present. However, it’s not known if the porcine circovirus present is infectious."

Sandy Gottstein

This is so not news. It's a huge ongoing problem. Here are a couple of relevant literature searches for those of you who are subscribers to Vaccination News - http://www.vaccinationnews.com:

http://www.vaccinationnews.com/Scandals/2004/Jan_2/contamination_of_cell_cultures.htm

http://www.vaccinationnews.com/Scandals/2004/Jan_2/re_detection_of_contamination.htm

And a column I wrote concerning this issue:
On "mad cows" and sick monkeys: From the people who brought you SV40 in vaccines....
http://www.vaccinationnews.com/Scandals/2004/Jan_2/Scandal69.htm

Garbo

It's my understanding that the rotarix contamination was much more severe than the others, either in the amount of the viral DNA found or in the completeness of that DNA vs. "fragments" found in the others.

FDA and HHS know this has been an issue in the field of xenotransplantation for some time; there are many published papers about the issue, particularly pertaining to monkey and pig parts used for transplant and the risk of fomenting a global outbreak of some reassorted disease. The notion that various animal viral DNA (pig, bird, monkey) is being injected along with human viruses ought to be alarming in the extreme, not only in terms of individual health but also in terms of raising risks of a reassortment leading to global public health hazard.

The researchers and manufacturers should be FLOGGED in front of Congress and the media for the inexcusable delay in reporting this, and investigated to find out how much they knew and when they knew it. The FDA ought to be hauled in for not catching this in the first place, or for knowing but letting it slide. I can't help but wonder if this isn't part of the reason why GSK/Elsevier put the kibosh on the Neurotoxicology monkey/vax study article. Is it related? SHOW ME THE MONKEYS!

(blink)

I'm waiting.

Bob Moffitt

Am I missing something here?

Rotarix - made by GSK - suspended for pig virus contamination.

Rotateq - made by Merck - NOT suspended .. contaminated with monkey virus.

Measles - manufacturer unknown - NOT suspended .. contaminated with bird virus.

Is it just a coincidence the ONLY vaccine suspended by US FDA for being contaminated was made in Great Britain? Why didn't the bird and monkey virus contaminations warrant suspension?

Natasa

Offit has already been in the media on this issue, saying that pig virus in vaccines is not such a big deal!! Because we are exposed to it every day through eating pork. He forgot to say that destroying pathogens is one of reasons we humans tend to cook meat before eating. Or could be that Paulie does drink fresh pig blood on a daily basis?

He didn’t comment on his vaccine contamination with retroviral DNA. Not a word.

The irony of this is that the study was intended the prove the purity of vaccines. The researcher behind it is clearly a friend of pharma: “for now it is my hope that people will not interpret this study as putting vaccines in a bad light (!!), but rather as relfecting the intense attention placed on vaccine safety … people should not be alarmed or over-react to every virus detection…”. http://www.virology.ws/

Hillarious or what?

cmo

Is Dr. Offit to issue a public statement on this vaccine issue with Dr. Nancy shortly ??

It would be great to see them together on NBC.

He needs to calm fears once again.

sorsha

"low levels of DNA fragments from avian (bird) leukosis virus (a retrovirus) was found in measles vaccine"

not that super-safe, definitively not connected to regressive autism, bowel problems, immune destruction, measles vaccine? why, we've never had any indication that the measles vaccine might cause harm in some individuals.

jen

I have to say that this is not surprising but GROSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSS!!!!!! I hope Dr. Offit and all of them are squirming!!!

Sylvia

Jim: They are well paid and watching alright, just not for the consumer!

kerbob1

and DNA fragments of a virus similar to simian (monkey) retrovirus was found in RotaTeq vaccine.

--------------------

Oink. Oink. Oink......Oink

http://kerboblog.blogspot.com/2010/04/ego-rotateq-no-mo.html

Anne McElroy Dachel

It is outrageous that it took an independent lab to find the contamination.
It is outrageous that this lab first notified the vaccine maker,not the FDA.
It is outrageous that it took GSK more than a month to contact the FDA.
And it is outrageous that this is not an isolated incident.
Obviously, the health and safety of children isn't a priority for anyone.
Anne Dachel
Media

Jim Thompson

Thank you Barbara. Where are the well paid watchdogs in our government?

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