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FDA Recommends US Allow Use of Rotavirus Vaccines While Safety Being Studied

Fda-approved From Jennifer Corbett-Dooren of the Wall Street Journal

(Dow Jones)--A Food and Drug Administration panel said Friday fragments of pig viruses found in vaccines used to protect infants against rotavirus didn't appear to cause health risks.

While the panel didn't take a vote on the products, several members of the agency's vaccine panel said the vaccines -- Merck & Co.'s (MRK) Rotateq and GlaxoSmithKline PLC's (GSK, GSK.LN) Rotarix -- should remain on the U.S. market while additional studies are conducted about the impact of pig viruses.

In the meantime, the panel said parents who are considering whether to vaccinate their infants need to be informed about the findings.

FDA panels are made up of non-FDA medical experts and are called upon to make nonbinding recommendations to the agency.

Karen Midthun, acting director of FDA's Center for Biologics and Research, said the agency would be "very expeditious" in making recommendations about whether either vaccine should be used. n March, the FDA recommended that doctors stop using Glaxo's vaccine after a team of researchers from the University of California in San Francisco found DNA of a porcine circovirus known as PCV1 in the vaccine. Those tests didn't find the same pig virus in Merck's Rotateq.

However, on Thursday the FDA said more sensitive tests subsequently conducted on Rotateq found a "low level" of the same PCV1 virus, as well as a related porcine circovirus known as PCV2. Both viruses are common in pigs -- and neither is known to cause illness in humans -- but PCV2 may cause illness in pigs.

The FDA said it wouldn't decide whether it would recommend that use of Merck's Rotateq be suspended or whether it would lift its suspension recommendation involving Glaxo's Rotarix in advance of the meeting. The panel meeting had originally scheduled to discuss Rotarix but also included Rotateq in light of similar findings about pig virus fragments discovered in the product.

"PCV is not infectious in humans," said Harry Greenberg, a panel member and medical professor at Stanford University. "The benefits far outweigh the risks."

Both the Glaxo and Merck vaccines are designed to protect infants from a gastrointestinal illness caused by rotavirus and have been given to millions of babies. While rotavirus is rarely fatal in the U.S., it contributed to about 70,000 infant hospitalizations annually before Merck's vaccine was approved in 2006 and Glaxo's in 2008.

Umesh Parashar, an epidemiologist at the Centers for Disease Control and Prevention, said the most recent agency data looking at the impact of the vaccines in the U.S. show "almost...a complete wipeout of rotavirus activity." Parashar deemed rotavirus "a major killer" of children in parts of the world that can't adequately treat dehydration from severe diarrhea.

One theory about how pig virus fragments got into the vaccine offered by both the FDA and the companies is that PCV fragments might be in trypsin, an enzyme derived from pigs that is used in the manufacturing process of the vaccine. The enzyme is used to grow viruses used in the vaccines.

Barbara Howe, a GlaxoSmithKline vice president in the company's vaccine division said, "all available data support PCV1 in Rotarix is a manufacturing quality issue, not a safety issue." She said the company is working on ways to remove PCV from the vaccine but that developing a new manufacturing process "is complex and will take time."



My son (now 7 months old) was perfectly normal before receiving rotateq. Now several months later we are struggling with frequent vomiting, blood in his diapers, and terrible stomach pain that wakes him throughout the night. Next week is yet another appointment caused by this with a pediatric GI specialist. His two older siblings contracted the rotavirus when they were toddlers. It lasted 3 or 4 days. I'd take that any day over this. Allowing more infants to be injected with this is criminal!


i would like to shed some light on this situation. my son is 9 months old. he was given the his first round of merck rotatech on december 1st, at 4 months old. he was perfectly healthy, thriving gainging weight and beautifully developing as were my other 3 kids. unfortunatly, from the vaccine, my son developed full blown rotavirus and was nearly hospitalized. in 12 days, he dropped from 13lbs, down to 10lbs. on december 12th, he was in to see the doctor who put him on enfamil nutramigen. he has not been the same. at 9 months old, he weighs only 14lbs, 4 oz. and is slowly losing weight. he is being tested for everything under the sun and nothing has come up yet. my husband and i are convinced whatever this cause is, is derived from the vaccine for rotavirus given in december. he is unable to gain weight and has been labeled with the diagnosis "failure to thrive". he also is not developing physically as far as progress with crawling, moving, etc. he has just "remastered" rolling over which he was doing very well at 3 1/2 months old. yet they are saying none of the situations are linked. we are now looking at a situation that seems unfavorable for all involved. doctors won't say it was the vaccine because of the ties it has with pharmacutical companie, meanwhile, my son is losing ounces every week, despite the appitite of a horse. his daily intake consists of 34-40 oz of formula, 2, 4 oz. jars of baby food and also rice cereal/oatmeal so we definitly know it isn't malnutrition on our part. is my case valid enough to take to the cdc to say "hey, your vaccine shouldn't be used!!"?? thanks for any input or light you can shed on our situation.


To Bob Moffit:

"To FDA .. Would you allow baby formula contaminated with pig virus to remain on the market? If not .. why are vaccines allowed to continue using pig contaminated vaccines?"

The obvious answer (from their perspective) is "herd immunity". Whether or not my baby eats contaminated baby food doesn't affect your baby.

Alison MacNeil

So, let me make sure I have this correct: tomorrow, Monday May 10,2010 any infants/toddlers who are vaccinated for Rotovirus will be vaccinated with vaccines that the FDA admitted on friday May 7, 2010 are infected with pig virus. All children vaccinated with RotaTeq and Rotarix from last friday forward are being given vaccine that the FDA knows is infected with pig virus. Beyond comprehension.


By all means, don't let your infants swallow contaminated Tylenol, as it might make them sick - BUT - please continue to have them injected with contimanated Rotavirus vaccines while we figure out whether the shot will or will not harm your child!

Your Friends at the FDA


The Rotavirus vaccine is becoming unpopular. First it was the injury claims, then its effectiveness questioned in healthy individuals, and now the contamination issues.
It reminds me of when the Pertussis vaccine supposedly was threatening to put the vaccine industry out of business because of injury claims.
Maybe they could turn this around too and combine Rotavirus with a couple other viruses we think we need (a couple swine flu strains perhaps) and triple the profits.


To Sheri:
"The source of porcine circovirus type 1 DNA in both Rotarix and RotaTeq is likely to be trypsin used during propagation of the cell cultures necessary for vaccine production. The enzyme is produced from porcine pancreas."

michael framson

I just reread Chapter 7 and 8 in "A Shot in The Dark" 1991 edition.

Nothing has changed. That book is as current today as it was when first published.

On second thought, things have changed for the worse. More vaccines, more scandals, more bad science, same egregious behaviors of those closest to the vaccine industry.


Recalling the PCV1, PCV2 containing vaccine made at least in part by the most vocal go-to guy for propping up the vaccine program? And after saying they weren't too worried about PCV1..., it's probably safer than PCV2, so no worries..., but since they have alternate version which "tested clean," they would suspend Rotarix temporarily just in case....

Is there anything they can do here that doesn't look bad? How about recalling both and maybe providing some evidence of safety oversight?


Dr. Offit is working on a vaccine for the pig virus this weekend. He had some leftover Thimerosal on hand, so no need to fear.

He will be seeking volunteers for testing early next week at CHOPs. Dr. Nancy will be on hand to shoot em up...

They want to "save the children again..."

3-4 doses will be needed to provide full immunity...


@Robin Rowlands - protecting the market share of the US vaccine company perhaps? Or maybe that want at least 1 Rotavirus vaccine in operation at all times. I don't know, just speculating, they invite speculation with the assinine stuff like this they do.

Thoeore M. Van Oosbree

Just when you think the FDA couldn't get any lower!

Sheri Nakken, RN, MA, Homeopath

how does a pig virus get into a vaccine produced on monkey tissue?


Porcine circovirus. I mistakenly read that as "Porcine Circus".

Viruses trade DNA, which how the recent swine flu virus was created. Who's to say whether PCV isn't interacting with live vaccine viruses (or other as-yet undiscovered rogue animal viruses in these vaccines)?

Wouldn't it be sci fi if it turned out that one of these animal viruses was designed to, say, make a monkey flap its hands and develop an overwhelming fascination for water because this somehow benefitted the virus? I remember someone at AOA wrote a post a while ago on how certain viruses can induce incredibly specific behavior. One virus can make an ant, for instance, climb up and down a blade of grass to increase the chances it will be eaten by a grazing cow-- the virus's real target.

I doubt that's the exact case with autism but do these regulatory authorities have any idea if something of this nature (viral crossover to humans impacting specific behaviors) is possible? I don't think so.

Robin Rowlands

hmmn, that's interesting

Suspend one but not the other?

Glaxo's Rotarex, English company = suspended
Merk's Rotatech, American co., same virus found = not suspended

Anab --- what do you think ???

Robin Rowlands ( vigilant & virtuous )


Qualifier:"wasting conditions that confound their doctors and specialists"

It is easy to diagnose a wasting condition, just look at the person who is dying. Finding the source or cause and an appropriate treatment is the problem. Doctors and specialists who are confounded by all treatments that do not stop the progression have now been afforded the opportunity to research another avenue on behalf of their patients - the incorporation of porcine wasting viral DNA into humans.

How many of our children with autism are considered "non-responders" to gut and nutritional therapies, continuing to suffer from failure to thrive, functional malnutrition and chronic illness? Perhaps the issue here is not whether wasting conditions exist, but that the treatments are targeted to known human viral/bacterial/pathogenic conditions when in fact, for some, it needs to be targeted to chimeric epigentic changes.

How Stupid Do They Think We Are?

Beyond belief. They have no idea what the effect of these viruses are, and would not know true effects for decades. Viruses can increase the risk of cancers and other diseases either acutely or years/decades down the road. When drugs are found to be contaminated, the only logical action is to recall and discard them and make sure the new lots are not contaminated. And it is irrational to use a cost/benefit argument to defend continued use of the vaccines when no one knows the true "cost" (the analysis simply cannot be done).

David M.

So Mercury, aluminum, formaldehyde and now pig viruses are fine to shoot into babies. I am so proud of the FDA, the CDC and our medical establishment. (Being ironical.)

Also cannot wait for Paul Offit and the vaccine cheerleaders new defense of Rotateq: "A baby's immune system can handle up to 100,000 pig viruses at the same time."


PCV2 replicated and was associated with apoptosis in spleens, lymph nodes abd Peyer's patches of infected BALB/c mice. Upregulation of caspase 1, 2, 3, 6, 8, 11 and 12 abd upregulation for the transcripts of apoptosis inhibitors bcl-2, bcl-w and btl-X and apoptosis promoters' bax, bak, and bad was detected in spleens of sPCV and mPCV mice,but not control mice. Apoptosis was further confirmed by light and electron microscopic morphology as well as by positive TUNEL assay and detection of activated caspase 3. PCV2 nucleic acid was detected by in-situ hybridization in the nuclei and cytoplasm of such apoptotic cells.

None of this sounds like I wasnt any child to be the guinea pig to determine if this is safe in humans.
So let me get this straight. It is unethical to perform a vaccinated vs unvaccinated study, but it is ethical to conduct a study on the unknown potential of PCV2 while administering a vaccine containing PCV2. And the vaccine that contained only the PCV1 contaminate is suspended and the vaccine contaminated with both PCV1 and 2 is ok while testing is ongoing???


grammaknows: wasting conditions have been around us forever. we are just better at diagnosing it now. no apology letter needed.


Bastards!! A stupid vaccine, useless for the U.S. anyways, has foreign ingredients in it that most certainly aren't good and they just say, "yeah, keep going." They are nuts.

kathy blanco

hmm..people who have chrohns have often been tested to have a cow bacteria in their stomachs called paratuberculosis. Interestingly, if you look at the lining of a cow infected, it exactly matches that of a human. It's not weeded out with the pasteurization process. And before people had Chrohns, they drank milk. Who's to say, an unknown pig virus, surpassing the mucousal lining and directly going in the blood stream doesn't create all sorts of unknown havoc, brain attack, seizures? It's time to drop the antigens over ten thousand theory. That's all well fine and good if you have a great immune system, and it's not injected directly into your bloodstream? Even when you have one exposure to an agent, it's enough for our children to have tipped balances. I am sorry but protecting our kids at ALL COSTS has gone a little too far. I only hope parents get real selfish, real soon, or realize our kids are guinee pigs and lab rats. And my kids survived fine without a diahrreah vaccine. GEEZ.


@Alison - yes! It smells like rotting bacon. :(

Leslie Eaton

I have a Autistic 3yr old son, who had a severe reaction following his MMR and totally regressed. I have been trying to educate myself on all vaccines and the issues out there.

I listened to the entire meeting via webcast yesterday, and at the end of the meeting, there was no actual "yes" or "no" about allowing the vaccs to be used while contaminated. There were Dr's on the panel that had some serious concerns about long term effects that could not be seen yet, and there were Dr's who questioned the fact that PCV2 had not been discussed in enough detail that they felt comfortable about it, and then there were Dr's on the panel who said the all famous "Benefits far outweigh the Risks". After the meeting, I went online, and the Journalists for many websites (even WSJ) had already immediately posted articles saying there was no eveidence of harm, etc... But the decision was not made at the meeting. The panel said they had serious issues to figure out before any decision would be made.
(for example, how to notify the public about the situation either way on the outcome without further causing "distrust" in vaccines) Some of the Dr's on the panel even went as far as to say they did not feel really comfortable telling a parent that "yes, this vaccine contains PCV1, and short term effects show no harm in humans, but we do not know about the long term effects". Barbara Loe Fisher was also allowed to make statements, and they were extremely good, and I believe made the panel think about what she said, as that was some of their concerns in the end.

Did they make the decision overnight lastnight to go ahead and continue use of the Rotarix and Rotateq vaccines?


In Parasitology class that I took many - many years ago - the professor said that the more benign the parasite (bacteria), virus, worm, fungus is a true indication that it has been around a very long time.

Because if it kills it's host - it too will die out.

It is the new stuff that moves into new territory (host) that is deadly.

So a pig virus that causes a wasting disease in pigs in injected directly into the blood stream of an infant and there is no indication of any problems here?

And I use to think I was not smart enough to be a government agent and work for all those big government agency like FDD, CDC.

Hmmmm, maybe it was not my brain that was the problem but my heart --- I actually had one.

Alison MacNeil

Just the PCV scented candle available now from Autism Speaks?

Bob Moffitt

All of the comments posted here on AOA raised immediate, common sense questions .. that should have been asked by the fearless WSJ reporter who wrote this article:

To prof Harry Stevens .. How do you know "PCV is not infectious in humans? If you don't know for certain .. how do you know if the "benefits outweigh the risks"?

To FDA .. What is the scientific rationale that caused you to withdraw suspension of Glaxo's pig contaminated vaccine after the same pig virus was found in Merck's? Did Merck's pig virus somehow make Glaxo's pig virus a more acceptable risk?

To FDA .. Shouldn't testing for pig virus be done FIRST .. before you allow these vaccines to proceed .. thereby making children unwitting guinea pigs for Merck and Glaxo?

To FDA .. Why haven't you adopted the "better safe than sorry" position taken by public health officials in Hong Kong?

To FDA .. Would you allow baby formula contaminated with pig virus to remain on the market? If not .. why are vaccines allowed to continue using pig contaminated vaccines?

Raymond Gallup

Per, Beth Clay's comment..............

"Those who want the nation's children to continue taking this vaccine while they continue to study its safety ought to roll up their sleeves and take the vaccine publicly."

I agree 1,000,000 percent.

Those like Paul Offit who push the pus (vaccines) should take these poisons adjusted upwards for their body weight.

On another subject, now that we do not take Eric out when we see him at the residential center, aggressions seem to have dissipated and we were told that recently they have seen Eric with a smile on his face. Eric has a structured environment there and when we took him out it probably added to his confusion.

If people face aggressions with their child/adults with autism they should consider getting a lawyer to place their child/adult with an appropriate residential center. As in our case, we could not cope with the situation and when the time comes that we are no longer around, we know he will be taken care of in a good place where he will be safe (especially where doors are locked). Also, they won't be calling us to say we have to take him home because they can't cope with him like they did at his school in NJ.


guess we never met a vaccine that we didnt like


Are these the same people who say the SV40 virus doesn't affect anyone?
With decisions like these is it any surprise that 39 percent of parent now delay or spread out vaccines?
Interesting about the comment of how the vaccine helps in areas of the world where they can't adequately treat dehydration. I just read yesterday the opposite opinion that these vaccines don't even protect against the type of germ that causes the majority of diarrhea in the developing countries.

Beth Clay

Those who want to the nation's children to continue taking this vaccine while they continue to study its safety ought to roll up their sleeves and take the vaccine publicly.

It is counter to everything the FDA is supposed to do in protecting the public to know a product is contaminated and to keep it in the marketplace with a recommendation to give it to small children. If infant formula was contaminated with pig viruses you bet it would be in a product recall. If spinach or aspirin or baby food, or a vitamin were contaminated with a pig virus the product would be recalled and the company attacked by the agency and the media...and Congress would introduce a vast new 'pig virus protections' legislation.


No surprise there. But Hong Kong recalled it. Better safe than sorry (not in USA though).


This is just sick. Keep using it while we evaluate it for safety. How about you do the safety testing FIRST. After all, rotavirus is RARELY FATAL as the article clearly states.


"The FDA said it wouldn't decide whether it would recommend that use of Merck's Rotateq be suspended or whether it would lift its suspension recommendation involving Glaxo's Rotarix in advance of the meeting."

hmmn, that's interesting

Suspend one but not the other?

Glaxo's Rotarex, English company = suspended
Merk's Rotatech, American co., same virus found = not suspended

I'm just sayin'


Not surprising...

"PCV is not infectious in humans," said Harry Greenberg, a panel member and medical professor at Stanford University. "The benefits far outweigh the risks."


Assignment for the FDA panel members:
Scenario - the viral contamination incites autoimmune responses and causes a wasting away condition in children through molecular mimicry, and is discovered to do so exactly 10 years from the date the viral contamination was discovered.

The assignment is to compose an apology letter to the children and their parents.

when your assignment is complete, the committee will reconvene and discuss the current decision in terms more appropriate than suggesting the use of these products continue on the basis of not knowing if they cause long term consequences. Hell, you didn't even know the contamination existed, and until there is extensive study done to determine what foreign DNA of a mammal virus will do in an infant and not an adult, get over the mind shock that it exists and do the right thing to protect more children from exposure.

...and sharpen those letter writing skills because there are children who have wasting conditions that confound their doctors and specialists. Next step is doing tests on the children for presence or incorporation of the viral DNA. Tread carefully on your assurances.

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