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FDA Sees Bowel Risk In Rotavirus Vaccine Data

Intussusception Rotavirus vaccines have been plagued with this side effect called intussusception - where one portion of the bowel slides into another like a telescope (HERE) causing great pain and leading to the point where the infant can die from bowel obstruction. Dr. Paul Offit is a patent holder on Merck's RotaTeq virus. This article from Reuters is about the Glaxo version of the vaccine.

WASHINGTON | Wed Sep 22, 2010 9:11pm IST

WASHINGTON (Reuters) - GlaxoSmithKline Plc's rotavirus vaccine may be linked to a small increase in a life-threatening type of bowel obstruction, U.S. health officials said on Wednesday.

Early data from a study in Mexico suggested infants given the Rotarix vaccine may face a higher chance of an intestinal problem known as intussusception in the 31 days after their first dose, the Food and Drug Administration said on its website.

"Although the results are preliminary and will require further evaluation, FDA approved revised labeling to inform healthcare providers of this finding," the agency said.

Rotavirus is the world's leading cause of severe diarrhea and dehydration in young infants. The benefits of rotavirus vaccines continue to outweigh risks, the FDA said.

Glaxo's rotavirus vaccine sales in 2009 were $440 million globally, including $118 million in the United States.

The British drug company's shares slipped 0.7 percent to $40.06 in morning trading on the New York Stock Exchange.

(Reporting by Lisa Richwine; Editing by Maureen Bavdek)



Breastfed, unvaccinated babies get neither rotavirus nor intusseception...


Alisyn Camerota Is how you spell her name.
Her name as I said before is worth learning spelling it correctly.
I have been over at Fox and as always I cannot find anything.

Where are these Youtubes or these segments found?

The show on Fox News is "Foxs and Friends" and it is on the weekend - segments???? don't know.


Pattrons99 Yes I did watch the entire thing.
I never can find these things. I go to the Fox News web site and look and look. I just am not good at it
But I sure would not mind seeing it again.
Alysn Camarata was a tiger!


My son was never vacced for rotavirus and never got rotavirus. He never got diarreah either for that matter. He was very much a constipation kid.

Isaacs Grandma

They are pushing this Rotavirus crap so much that when a child goes to the E.R. with fever and diarreah, they just assume this is what it is if a child has not been vaccinated! I know first hand. My 11 month old Granddaughter was so horribly ill in August with 104 temp and bloody diarreah that she spent a few days in the hospital. The Dr. at the hospital assumed it was Rotavirus because my Grandaughter had not been vaccinated. That Dr. gave my daughter such a hard time about it and tried to tell her that it could have all be prevented if she had been vaccinated, and....get this...that she was just looking out for the child! my daughter wasn't?? All they did was give her I.V. fluids and "watch" her. They finally sent her home after 3 days because she was improving. That Dr. called my daughter a day later to tell her that the test results showed that my Granddaughter had Salmonella Poisoning! I'm hoping that Dr. felt like crap when she realized that there wasn't anything my daughter did to "cause" this by not vaccinating her baby, but..I doubt it. And the medical establishments wonder why we parents are losing trust in them?


Revise the label, get 10 more years of profits off a dangerous pharma product, meanwhile hope for a newer safer version to emerge from R&D, and when that doesn't happen a decade later, then ultimately pull the product off the shelves.

Leaving a trail of lots of twisted bowels...and damaged babes.



Benedetta - I think that I saw part of the FOX news blurb this morning by Allison Camarata that you refer to.

I didn't hear the entire segment, but what I did hear was about the omnibus autism proceeding victims being sent a mass mailing of a "too bad, so sad" letter or letters which effectively say that you are SOL. I only caught a brief snippet of Allison Camarata talking with one of the Omnibus autism victim's parents. The legalese in the letters that were mailed out would certainly be of interest. I wish I had recorded the spot with TIVO. Did you watch the entire segment? Maybe we can find it on youtube or at the FOX news website. A link to the segment would be helpful.


Theresa O;
Well I guess that answers my question!
what we need is a big stick!
What could we possibly use as a big stick?
Maybe a sure enough court system instead of the vaccine court.
And more than 18 million will be coming out of thier pocket when a virus gets in their vaccines??? Maybe???
Speaking of vaccine court and all ----
Alysn Camrotoa (oh shoot forgot how to spell it and she is worth me remembering her) she is a news reporter on Fox News did another segment on the vaccine court again this morning. Can you believe that? She very much is trying to show the unfairness of this system.

She said this morning that the vaccine court was suppose to be an administration type of agency but instead they have turned into this sure enough federal court from hell.

Cherry Sperlin Misra

I would like to know this: Does any child whose immune system has not been damaged by mercury actually get rotavirus disease - or if he gets it, is it just a mild case? Im guessing that this is another disease that vanished or decreased along with the decrease in mercury in vaccines. Can anyone weigh in on this- for example, parents who have unvaccinated kids.
We can certainly expect that the CDC wants kids to receive rotavirus vaccine so that they can claim that they eliminated it with vaccines.


Arrrgh! Typo alert - "To date, systemic, robust, scientifically-valid studies of this type have not been done for any vaccine." "Systemic" should be amended to "systematic".

I should know better than posting such a long-winded comment! Sorry.

RN Mommy

I swear my kids had this (maybe vaccine induced even?) and I kept them hydrated. Yes, it was a bit scary as all the did was lay around. I kept full sippy cups in their cribs at all times and hydrated them while awake. The diarrhea was awful but they survived!! Hydration is key. Surgery on the bowel is a very serious side effect to me. Is the bowel ever the same? At least once you get over rotavirus you are not left with any long term issues that I know of.


“Pharmacodynamics is the study of the physiological effects of drugs on the body or on microorganisms or parasites within or on the body and the mechanisms of drug action and the relationship between drug concentration and effect.”

The world has an urgent need for formal pharmacodynamic study of the physiological effects of vaccines on the body. These studies must be performed because there is likely to be more than one mechanism of vaccine toxicity, operating in parallel and synergistically. The kinetics with which these mechanisms of vaccine toxicity take place is different, depending on which vaccine is being considered. For example, the rate at which PCV-2 ends up in the lymph glands and thymus of the lab mice is likely to be VERY different than the rate at which blood clots form, both silent clots and symptomatic, after Gardasil and Anthrax inoculations.

While we are ALL vulnerable to vaccine-induced diseases, we probably ALL have a variable degree of pre-existing environmental risk, based on how much mercury amalgam dentistry, fluoridated water, and dietary aluminum we have been exposed to. To circumvent such potentially confounding variables as pre-existing toxic environmental exposures, we need a prospective, placebo-controlled, double-blinded comparison of fully vaccinated versus unvaccinated human subjects. It is unethical to force the vaccine schedules on the public without conducting these studies. Our government could conduct these studies if they were truly serving the public. Either government should conduct these studies or government should “get the hell out” of healthcare, altogether.

To date, systemic, robust, scientifically-valid studies of this type have not been done for any vaccine. The FDA does not require studies of this type as conditions for “approval”. Political and financial expediency for their client - pharma - has really become the only prerequisite for “expedited” market approvals of new vaccines. The currently marketed vaccines are grandfathered-in, thus new studies validating their safety are unlikely to ever be performed. The approval process for any new vaccine is virtually “jet-propelled” by FDA for their pharma clients. Quite often, there is not a true placebo arm. Under the “non-inferiority” threshold for safety, as long as a new biological is no more acutely toxic than currently marketed biologicals in the same class, it gets “approval”. Antibody titers are often used as surrogate markers of alleged efficacy. Quite often, another marketed vaccine and aluminum adjuvants are “allowed” by FDA in the “placebo” arms of “placebo-controlled” pivotal studies upon which expedited market approvals are based. See the pivotal studies upon which the market “approval” of Gardasil was based. I strongly suspect that even these minimal hurdles for gaining market approvals of new biologicals will be circumvented by pharma and FDA. The sole threshold for market approvals by FDA in the future will be political expediency. There is now a 23 valent pneumococcal vaccine. Pharma wants to put vaccines into the food supply.

Whatever pharma wants, pharma gets. There will be no end to vaccine madness. Damn the torpedoes, full speed ahead!


Bob Moffit - "It is also comforting to know the FDA now sees itself as a "marketing tool" of the vaccine industry"

The FDA is utterly pathetic and disgusting. The FDA has sunk to just being an all-purpose pharma "tool", much like a Swiss Army knife. Don't forget the pharma-endorsed FDA "seal of approval".

Theresa O

This development kind of shoots the CDC's whole argument of "American kids should risk intussusception, because they will be helping to save kids in developing nations." Oops! Kids in developing nations are at risk for intussusception, too. I have to think it's easier (even in developing nations--heck, maybe more so there) to re-hydrate a child than to perform bowel surgery on him.

Regarding the pig viruses, I went to a Labor Day picnic and ran into my old classmate (I've mentioned him before) who works for Merck. I asked him whether Merck would be screening for PCV1 and PCV2, now that the technology is available. Now, he's not a decision-maker (I think he's a vial-filler), but he said that the company's attitude was basically, Should we really spend $18 million to screen for these viruses, or should we just say, the benefit outweighs the risk, and move on? (Benefit to whom? one is tempted to ask...)

Julie Leonardo

I just love the fact that with all of these diseases and vaccines that in order to save 45 people from dying of a disease, they kill 45 (and maim 95)with the vaccine. I guess the only ones worth saving are those who have the disease.


You know it is the pig viruses that has caused this! Why have they just not recalled it and cleaned it up if it is such an important vaccine to save third world children. The viruses were right there, they were caught red handed this spring.

I now understand Tom Insel when he first spoke to Congress has it been a year now if not two?? He said the antigens in the vaccines were now were reduced to very small numbers. I mis-took that to mean then - all that was left was just enough protein for the immune system to react and the rest was adjuvants like aluminum or perservatives like mercury. So, if they decrease the antigens they must be having to increase the adjuvants to get the immune system to react.

No,, that was not what Tom Insel was saying what he was saying was "OH, we have reduced the number of antigens and thus possibly reduced the possibility of given the children a retrovirus that will give them cancer or some other God awful immune disfunction for the rest of these children's lives. Because really folks - given the population a virus is a real possibility. and what we have been doing is crossing our fingers for a very long time.

It has been viruses all along that was worring him. Oh, how silly of me to worry about the adjuvants.

So, now, what happens when you start stacking up generations of infected people with even more virus contaminated vaccines?

Why, Bill Gates gets to have all his money is a pristine world with just his family and friends around, would be my guess.

Bob Moffitt

"Early data from a study in Mexico suggested infants given the Rotarix vaccine may face a higher chance of an intestinal problem known as intussusception in the 31 days after their first dose, the Food and Drug Administration said on its website."

It is real comforting to know the FDA has absolutely NO DATA OF THEIR OWN .. to prove or disprove .. a study done in MEXICO .. that suggests infants given Rotarix vaccine face higher chance of intussusception within 31 days after their first dose.

I mean how hard should it be for the FDA to confirm or deny this study's serious implications?

It is also comforting to know the FDA now sees itself as a "marketing tool" of the vaccine industry .. happily applying warning labels on dangerous products rather than DOING THE DAMN STUDIES THEMSELVES!!!!!!

God help us .. because our federal protection bureaucracies sure as hell won't.

Donna L.

My son was lucky enough (not!) to get this wretched vaccine shortly before they took it off the market in 1999. Within days, he had GI bleeding and bowel obstruction, which was the beginning of the end for him. I hope their 'revised labeling' includes "illness, disability, and death" as possible outcomes. Science has proven that cranberry concentrate will effectively inhibit rotavirus. But I guess using cranberries, rather than a toxic vaccine, would be too cheap...and too safe.


Not that it has 2 different PIG VIRUSES in BOTH brands....
Muscle wasting PIG VIRUS too. Paul Offit, your days as the go to guy for vaccine authority are numbered. Bitch boy.


I agree with the post by kerboblog on September 24. Wyeth's vaccine was finally pulled off the market in 1999 after the same situation developed. You'd think the FDA brainiacs would "get it." Maybe they're all working with Julie at Merck counting stock options instead of "doing no harm."


So now it's a tossup between Rotarix and RotaTeq.
Rotarix--intussusception. RotaTeq--pig wasting virus PCV2.

Hmm, choices, choices. I think I'll take neither.


I second Autodad. Since when are IV fluids dangerous?
Offit, once again, is criminal in his money making 'experiments'.


Offit Disease or iv fluids. I'd rather have rotavirus and take the iv. Offit can keep his diarrhea drug. Wish we had a vaccine for his diarrhea of the mouth!


Revise labeling? How about pulling it like they did the first time?

It never should have been allowed to be put back on the market.

Enough is enough.


"Rotavirus is the world's leading cause of severe diarrhea and dehydration in young infants. The benefits of rotavirus vaccines continue to outweigh risks, the FDA said."

Offit's Disease notwithstanding, the jury is still out on whether the benefits of rotavirus vaccines continue to outweigh risks. Shouldn't the millions of rotavirus vaccine inoculated kids worldwide be screened NOW for the presence of PCV2 viruses in their lymph nodes and thymus? Is there risk of multisystemic wasting syndrome in humans? Dare we assume there is ZERO risk? What about the Precautionary Principle?

What about providing clean water and sewage facilities for the Third World? Might that be a safer and more cost-effective approach?


Offit's Disease is fairly well documented whereever rotavirus vacine is dispensed.

You wonder if these people believe in vaccine fairies or something odd? They keep re-trying these shots, each time expecting different results.

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