FDA Suspends Use of GlaxoSmithKline Rotavirus Vaccine Tainted with Pig Virus
The FDA has recomended the temporary suspension of GlaxoSmithKline's rotavirus vaccine called Rotarix, which is a direct competitor of Dr. Paul Offit's RotaTeq vaccine from Merck. AP medical news reported an "apparently benign pig virus" as the contaminant. Fortunately for patient safety, AP Medical News reported "A group of scientists testing a new way to detect viruses in a variety of products stumbled onto fragments of genetic material — broken pieces of DNA — from what's called porcine circovirus-1 in Rotarix and alerted Glaxo, which confirmed the findings and in turn alerted FDA, Hamburg said." The report stressed that the suspension of use has been recommended despite no evidence of harm.
From the FDA: On Monday, March 22, the Food and Drug Administration recommended that clinicians and public health professionals in the United States temporarily suspend the use of Rotarix, a rotavirus vaccine produced by GlaxoSmithKline.
FDA has learned that components of an extraneous virus are present in Rotarix. There is no evidence at this time that this finding poses a safety risk. However, the FDA asks that clinicians temporarily suspend use of the vaccine while the agency learns more about the situation. More information is available at: HERE.
From AP Medical News via Yahoo: WASHINGTON – U.S. health officials told pediatricians Monday to temporarily quit 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.
But vaccines are supposed to be sterile, and because there is a competing vaccine against diarrhea-causing rotavirus that has tested clean — Merck's RotaTeq — the FDA decided to err on the side of caution.
"We don't want to scare parents," Hamburg told reporters. "This was a difficult decision for us to make because there is no evidence at this time that there is a risk to patients who have received this vaccine, and we know there are real benefits for children to be vaccinated against rotavirus."
Rotavirus causes severe diarrhea and is a leading child killer in developing countries. In the U.S., with better health care, about 55,000 children a year were hospitalized for rotavirus infections and several dozen died each year before vaccination began — with Merck's vaccine in 2006 and Glaxo's in 2008.
Glaxo said Monday that regulators abroad have decided not to change how Rotarix is used while scientists probe the relevance of the discovery.
A group of scientists testing a new way to detect viruses in a variety of products stumbled onto fragments of genetic material — broken pieces of DNA — from what's called porcine circovirus-1 in Rotarix and alerted Glaxo, which confirmed the findings and in turn alerted FDA, Hamburg said.
Rotarix, an oral vaccine, is made from a weakened strain of human rotavirus that has to be grown inside living cells before being purified into a vaccine dose. Glaxo uses a line of monkey kidney cells, or vero cells. Hamburg said the pig virus DNA fragments have been found in Glaxo's cell bank, meaning they were present from the vaccine's earliest development. How the original contamination occurred is under investigation.
Merck's competing rotavirus vaccine RotaTeq is made by a very different process, and FDA's testing showed no sign of the pig virus in it.
It's not the first time unwanted viruses have been discovered in vaccines. Best known is a monkey virus that contaminated some polio vaccine in the 1950s; years later, scientists investigated if the SV40 virus might have increased vaccine recipients' risk of later-in-life cancer but concluded it didn't.
"We live in a world that's teeming with microbes," Hamburg said, but until now this particular pig virus is not one that FDA thought vaccine makers needed to check their products against.
Parents should switch to the Merck vaccine for now — it requires three doses instead of Glaxo's two — because rotavirus is too serious a disease to ignore, said Dr. William Schaffner, a vaccine specialist at Vanderbilt University who was briefed on FDA's decision.
He's bracing for calls from worried parents and will tell them that "this has been an extraordinarily safe vaccine," and that the discovery is "a consequence of our improved science and ability to detect things that we never could before."
I forgot Charlotte is a spider. I don't think she's delicious unless you're a bird.
Posted by: Carol | January 23, 2011 at 10:47 AM
I'm posting this here just because it's hilarious and by "hilarious" I mean "profoundly disturbing."
"....Could the gun be any more smoking? GlaxoSmithKline knew Avandia was causing heart attacks and strokes, and didn't say a word.
In one document, the company sought to quantify the lost sales that would result if Avandia’s cardiovascular safety risk 'intensifies.' The cost: $600 million from 2002 to 2004 alone, the document stated.
Which means if they can get away with this with a penalty of less than $600 million, they win.
And they have. An FDA advisory panel voted today to let GSK continue to sell this heart attack in a bottle.
Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, said that the company had not provided the results of its study because they 'did not contribute any significant new information.'
I think that's the part that pisses me off the most. They don't even care enough to come up with a line of bullshit that is even plausible. Your drug causes more people to die than its main competitor and that's not significant new information? Can you at least make a little effort when you lie to me?"
Posted by: Carol | July 22, 2010 at 10:06 AM
The irony is that most diseases which we are made to be paranoid about originate from the domestication of animals and our close contact with them - measles from cows, TB from goats, pertussis from pigs, thyphoid from chickens. So what do they do? they create an even closer contact between all kinds of animals and ourselves by actually using animal cells (from mice to monkeys, chickens to calves, pigs and dogs) to culture germs and viruses for vaccines, giving ample opportunity for other new diseases to emerge. And they dare call it science!
Posted by: GennyGC | March 24, 2010 at 01:11 PM
Even Offitt has no idea if vaccines cause harm
This is tragic what is happening and how it is happening.
For those victims of collateral damage in this "war against communicable disease" this is so sad.
Posted by: bensmyson | March 24, 2010 at 11:17 AM
Now the Emirates have also suspended the vaccine. 5 countries so far.
Not a single word yet about this in UK media...
Posted by: Natasa | March 24, 2010 at 09:01 AM
"... FDA will also seek input on the use of new techniques for identifying viruses in vaccines. The agency anticipates that following the advisory committee meeting, based on expert input and additional review, FDA will make further recommendations on the use of the two licensed rotavirus vaccines in the United States..."
Good to hear they will look into new techniques only WELL AFTER it has been used by a third party, ie University in question. To do the job of regulators, who probably had no idea that new technique was out there. Pharma probably did, but thought 'why bother'.
Posted by: Natasa | March 24, 2010 at 04:38 AM
Latest on the story:
Several countries have suspended use of the vaccine: Switzerland, Israel, Jordan.
Offit says nothing to worry about.
FDA recommends continued use in undeveloped countries.
Posted by: Natasa | March 24, 2010 at 04:31 AM
After the massive propaganda campaign about the supposed dangers of the swine flu virus, will Joe Q. Public think a pig virus in his 2-month-old's Rotarix vaccine is nothing to worry about? I doubt it. The public's confidence in vaccines will continue to erode.
Add that to the twenty million or so viewers of American Idol who heard the pertussis vaccine caused seizures and delayed language, and I'm sure we'll see a downtick in vaccine sales. (But the "anti-vaccinationists" will receive all the blame!)
Posted by: pass the popcorn | March 23, 2010 at 08:57 PM
Can you say "virus microarray", folks?
I hate it when we are right.
Posted by: TexasDad | March 23, 2010 at 08:48 PM
Cell cultures used in research and biological product production have rampant problems with contamination and outright misidentification.
Regarding SV40, there was an unusual cluster of pediatric brain cancers in the Chicago area when the contaminated polio vaccine was distributed. When this information was posted to a popular website, the CDC removed the link below.
(Poof! Page gone but the truth is not.)
“Have research studies looked at the risk of cancer in children whose mothers received SV40-contaminated polio vaccine?
Yes, two studies concerning maternal vaccination with SV40-contaminated vaccines and risk of cancer in offspring have been conducted. Each study reported an association.
* Heinonen et al. (1973) reported a higher incidence of neural malignancies in children born to mothers who received inactivated poliovirus during pregnancy. The prospective study of over 50,000 women who were pregnant between 1959–1965 identified 24 malignancies in their children during the first 4 years of life. The rate of malignancy was about two-fold greater in children born to mothers immunized during pregnancy when compared with children born to unimmunized mothers or mothers who received influenza or OPV vaccines. Neural tumors accounted for most of the difference.
* Farwell et al. (1979) found that of 15 cases of medulloblastoma in children born in Connecticut between 1956–1962, 10 were born to mothers exposed to SV40 contaminated polio vaccine while 5 were born to mothers unexposed. Interpretation of these results, however, is hampered by the low response rates and uncertain accuracy of vaccination histories by obstetricians (Strickler et al., 1998).
Additional studies are needed that focus on maternal vaccination with SV40-contaminated vaccines and risk of cancer and other health effects in offspring.”
Here is the Hilleman interview about that. His concerns about the virus were ignored.
Posted by: Anon | March 23, 2010 at 12:50 PM
Notice that only the US is going to stop using GSK...wonder if Bill Gates 10 billion dollar donation for vaccines (aka "investment" with an obviouslly REALLY BIG payoff---perhaps MS monopoly of government electronic medical records? ). Wasn't a great deal of the contributions to Mercks rotavirus vaccine for developing countries? Hmmm....Somebody's getting greedy...
Posted by: anonymous | March 23, 2010 at 11:49 AM
Theresa O - thank you for pointing out the SV40 quote in the article. They aren't just 'downplaying' the contamination of the polio vaccine, they are outright saying it didn't happen. outright lies. I pray everyday that more and more people are actually paying attention.
Posted by: Sorsha | March 23, 2010 at 11:26 AM
"But vaccines are suppossed to be sterile..." Name one that's sterile.
Vaccines are a disgusting sludge of contamination and poison.
Posted by: mary | March 23, 2010 at 11:08 AM
Sadly enough, after looking up PCV1 and 2, the one thing that stands out is just how many studies there are to look through. WOW! How in the world does a pig virus have so many more studies than the vaccines we give our children??? What parallel universe are we living in??
Posted by: kathleen | March 23, 2010 at 09:21 AM
I think in the biologics industry there is no more serious issue than this. Companies certainly take it seriously I can assure you. You wouldn't imagine how much money is spent to avoid this problem. A huge portion of the cost and it is huge push to eliminate all animal components in future products (at tremendous cost) for this reason. The FDA's effort to downplay it indicates to me that they know they have absolutely no handle on the issue. The one quote is correct, years ago we didn't have the technology to recognize this problem. The follow-up line is obvious: we have no idea now what else is out there and what the effects could be.
Posted by: Jack | March 23, 2010 at 08:45 AM
"This is exactly why my children and family will never get another vaccine, LIES AND IRRESPONSIBILITY. These people simply cannot take responsibility for their screw ups and therefore they can never be trusted again ever."
This statement is as true as it gets. I spend time everyday explainig to my children that the measure of a man/woman relies heavily on how they can face their mistakes in life. Do they hide, or handle it with grace? Even when said mistake carries with it profound shame or embarrassment associated. How in the world does one expect to teach these things when our own government fails to hold themselves to the same moral standard?
Posted by: kathleen | March 23, 2010 at 08:00 AM
[email protected] "So am I correct in assuming that the manufacturer and FDA have known ALL ALONG that this contaminant was in the vaccine, but they approved it anyway and only acted once an "independent U.S. research group" discovered it?"
They might have known all along, but more likely they didn't. More likely they never bothered to really check properly. And that regulatory agencies never really bothered to really make them really check properly.
I have recently been looking closely in how biologicals (including vaccines) are checked for contaminants. What the recommendations and regulatory requirements are, and what purification methods can be employed etc. I was astonished (even though half-expected to find them) at the sloppiness and ‘oh-well-it-should-be-fine’ attitudes. On the part of regulatory bodies!! I don’t have the time to post it all but if you are interested follow this thread here on another forum – it gets better and better as you move down the thread): http://tinyurl.com/ygapssf - or full link http://www.forums.aboutmecfs.org/showthread.php?3753-Mouse-retrovirus-present-in-cell-lines-used-for-production-of-biologicals.
Posted by: Natasa | March 23, 2010 at 07:41 AM
Oh, if ONLY that had been Paul Offit's vaccine...
Posted by: Jake Crosby | March 22, 2010 at 10:59 PM
God help me, my first thought was, the FDA takes care of its own. Suspension of the main competitor to Dr. Offit's RotaTeq vaccine would be nice compensation for his "False Prophet" authorship and testimony bashing Wakefield, Anti-Vax and those demanding solid research.
Find me a Pharm, FDA or CDC "expert" who does not qualify as a porcine contaminant and I'll admit that my suspicions are out of control.
I didn't think so.
Posted by: Sarah L'Heureux | March 22, 2010 at 10:49 PM
I'm waiting for the CDC to leverage this heretofore undetected virus as a value-added bonus, like the Thimerosal study that shows the mercury compound decreases autism rates.
Posted by: nhokkanen | March 22, 2010 at 10:31 PM
And just in time for "US Universal Healthcare" how convenient...
Posted by: Dannysvoice | March 22, 2010 at 09:43 PM
David Kirby may be able to add this conversation.
Posted by: bensmyson | March 22, 2010 at 09:43 PM
Naaa--aahhhh!!! I don't believe you. All vaccines are safe, even those tainted with pig virus. They're SAFE.
Geez, you people are hard to please.
I can hear the dollar signs going "cha-ching" in Proffit's eyeballs right now.
Posted by: JessicaF | March 22, 2010 at 09:40 PM
Note Shaffner's recommendation - and I doubt that he is alone in recommending this - that parents "switch to the Merck vaccine for now". Merck will get a large increase in vaccine profits. Offit is likely to be very happy right now.
Posted by: Carolyn M | March 22, 2010 at 09:31 PM
The FDA's reference to SV-40 is classic government bull****: "It's not the first time unwanted viruses have been discovered in vaccines. Best known is a monkey virus that contaminated some polio vaccine in the 1950s; years later, scientists investigated if the SV40 virus might have increased vaccine recipients' risk of later-in-life cancer but concluded it didn't."
Actually, the CDC is the only group that has not yet acknowledged that SV-40 from the contaminated polio vaccine *is* a cause of mesothelioma: http://www.theatlantic.com/past/docs/issues/2000/02/002bookchin.htm
And as far as when anybody knew that the Rotarix was contaminated, it's pretty clear that the FDA has been sitting on this information for a while. On Thursday (03/18), Reuters reported that the FDA had decided to require an expanded warning label on the carcinogenic Elidel. As preparation for the same meeting at which Elidel would be reviewed, the FDA looked at several other drugs, but decided that there were "no new safety concerns" related to these drugs. As noted in this article
(http://www.reuters.com/article/idUSTRE62H2NZ20100318), one of the drugs with "no new safety concerns" is Rotarix. It seems to me that information about Rotarix contamination had already been provided to the FDA prior to last Thursday--I suppose it's possible that the review of Rotarix was about some other safety concern about which the public shouldn't trouble itself, but what are the odds of that?
I guess we should watch the news carefully for reports of serious issues with the other drugs reviewed at that same FDA meeting (Sanofi-Aventis vaccines Pentacel and Daptacel, and GSK diphtheria, tetanus and pertussis vaccine Kinrix).
Posted by: Theresa O | March 22, 2010 at 09:29 PM
One word: Gross.
Posted by: Kristina | March 22, 2010 at 09:26 PM
"Parents should switch to the Merck vaccine for now — it requires three doses instead of Glaxo's two — because rotavirus is too serious a disease to ignore, said Dr. William Schaffner, a vaccine specialist at Vanderbilt University who was briefed on FDA's decision."
I'm picturing Offit jumping for joy, yelling: "OMG,OMG, IT'S LIKE WINNING THE LOTTERY TWICE!!!!!!!!"
Posted by: samaxtics | March 22, 2010 at 09:20 PM
"...scientists testing a new way to detect viruses in a variety of products STUMBLED onto..."
You mean to tell me, that if they had not "stumbled on to it" they would never have known? The FDA would not have cared???
What this tells me is that they found something they could not hide.
Were the concerns, well documented at the Simpsonwood Retreat, something that were "stumbled upon"? Why did (and still) the FDA not care about those concerns?
Not to downplay this issue, but I have to ask why the FDA is so quick to jump on this but the ignore aluminum and mercury toxicity that is glaring them in the face??????
Posted by: Mit Ledomesak (guess who?) | March 22, 2010 at 09:07 PM
Proffit will be ringing up the sales now and we'll surely see his mug on TV praising the safety of his vaccine. Crap.
Posted by: Cha-ching! | March 22, 2010 at 09:02 PM
Sure, no evidence of harm. Except for the studies that show that there probably is.
"Ultrastructural alterations in human blood leukocytes induced by porcine circovirus type 1 infection
CONCLUSIONS: These results suggest that PCV has the capability of infecting human leukocytes in vitro, and should be considered a potential risk of viral transmission during xenotransplantation."
"Xenotransplantation and the potential risk of xenogeneic transmission of porcine viruses.
A major concern, however, is the potential for xenogeneic transmission of viruses from animals to humans via organ, tissue, or cellular transplantation or via ex vivo exposure of humans to porcine biologic materials. Xenotransplantation allows viruses to bypass the normal immunological defense mechanisms of the recipient. Furthermore, the use of immunosuppressive drugs following transplantation may facilitate the xenogeneic transmission of zoonotic agents. Of porcine viruses, swine hepatitis E virus does not cause any clinical symptoms in the natural host but is a likely zoonotic agent that can infect humans and cause hepatitis. Porcine circovirus type 1 is prevalent in swine populations with no known association with clinical disease, while circovirus type 2 causes post-weaning multi-systemic wasting syndrome. Porcine endogenous retrovirus is integrated into the host chromosomes while porcine cytomegalovirus undergoes latent infection. Two additional porcine herpesviruses have recently been identified in swine and have been named porcine lymphotrophic herpesviruses. These herpesviruses can potentially become reactivated in human recipients after xenotransplantation. All in all, there are a number of viruses in swine that are of primary concern to screen and eliminate from xenotransplantation protocols. Epidemiology and the current knowledge on xenogeneic risk of these viruses are discussed."
"Infection studies on human cell lines with porcine circovirus type 1 and porcine circovirus type 2
CONCLUSION: Although PCV gene expression and replication took place in human cells, the infection is non-productive. Alteration of protein localization suggests that protein targeting may be disturbed in human cells."
Posted by: Garbo | March 22, 2010 at 08:20 PM
Gee benmyson the second type sounds like Kawasaki's????
Posted by: Benedetta | March 22, 2010 at 08:19 PM
These are the quotes from a different news account of the FDA call with reporters:
"The agency explained that an independent U.S. academic research group had identified the "extraneous virus" in the Rotarix vaccine using a novel molecular diagnostic method."
"Researchers at the FDA and the product's manufacturer, GlaxoSmithKline, have confirmed that PCV1 components have been present in the vaccine since the early stages of its development, including the registration trials."
So am I correct in assuming that the manufacturer and FDA have known ALL ALONG that this contaminant was in the vaccine, but they approved it anyway and only acted once an "independent U.S. research group" discovered it?
Anyone know who this independent research group is? And are they doing this for every vax? And is the novel molecular diagnostic method the same one that found XMRV?
Posted by: Garbo | March 22, 2010 at 08:05 PM
Wow, at first I thought this was maybe a joke but of course it isn't. Maybe they're downplaying this like the SV-40 thing. When they say "this discovery is a consequence of our improved science and our ability to detect things we never could before", it makes me wonder what other unintended shit is in there. I'm surprised that swine Offit's vaccine wasn't the infected one.
Posted by: jen | March 22, 2010 at 08:00 PM
We'd rather some harm be done then scare parents. After all, denial has worked and we have the vaccine court to stick up for us.
Posted by: Dr Dewey Cheatum | March 22, 2010 at 07:43 PM
Porcine Circovirus (PCV)
There are 2 strains: Type 1 PCV and Type 2 PCV.
Type 1 PCV (first identified in 1974) readily infects but is not known to cause disease in swine; it is the type 2 that has caused problems in recent years with the increasing occurrence of postweaning multisystemic wasting syndrome (PMWS) which over time results in significant depletion of lymphocytes; post mortem of diseased animals reveals enlarged lymph nodes and abnormal lung tissue.
It is still unclear whether type 2 PCV (first isolated in 1997) actually causes PMWS, as infection with the virus alone causes no clinical signs, it appears to work synergistically with parvovirus, perhaps with parvovirus activating a latent form of circovirus or weakening the immune system enough for PCV to take hold. PCV1 and PCV2 show a high degree of sequence homology and a similar genomic organisation; nevertheless, the basis of the distinct pathogenicity has not yet been unravelled.
Both PMWS (Postweaning multisystemic wasting syndrome)and PDNS (Porcine Dermatitis and Nephropathy Syndrome) are associated to PCV2. It seems that many pigs affected by the circovirus also tend to develop secondary bacterial infections, like Glässer disease (Haemophilus parasuis), Pulmonary Pasteurellosis, Colibacilosis and Salmonellosis and others. Dissected morbid pigs showed lesions in multiple organs, especially in lymphoid tissues, giving birth to the term "multisystemic"
Posted by: bensmyson | March 22, 2010 at 07:06 PM
PCV1 is harmless but PCV2 causes wasting disease?
Virus Res. 2009 Aug;143(2):177-83. Epub 2009 Feb 26.
Porcine circoviruses--small but powerful.
Finsterbusch T, Mankertz A.
Division of Viral Infections (FG12), Robert Koch-Institute, 13353 Berlin, Germany.
When porcine circovirus type 1 (PCV1) was isolated more than 40 years ago as a non-pathogenic contaminant of a porcine kidney cell line, enthusiasm and curiosity kept within reasonable limits. Virologists became more interested, when a second variant was isolated and termed PCV2, because PCV2 is linked to postweaning multisystemic wasting disease (PMWS), a new emerging multifactorial disease in swine. Both PCV1 and PCV2 are small and rather simply organized and express only few proteins. Therefore, it was expected that the factor(s) triggering PMWS should be easily identified, but more than one decade of PCV research has not yet singled out a molecule inducing the disease onset. Unravelling the molecular features of PCV and the channels through which the virus interacts with its host are key to manage, prevent and treat PMWS and other PCV-associated diseases. Since we have learned many aspects of the molecular biology of PCV in the last years, it is time for a résumé!
PMID: 19647885 [PubMed - indexed for MEDLINE]
Posted by: Porcine circovirus type 1 vs 2 - Swine wasting disease? | March 22, 2010 at 06:57 PM