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Paul Offit and Rotavirus Vaccine: Deaths on VAERS

OffitBy John Stone

In the developed world rotavirus infection does not seem to be associated with mortality: this is not quite so with rotavirus vaccines, including Merck's RotaTeq vaccine in which Professor Offit had a share.

A table of cases of rotavirus reported by the UK National Health Service between 2000 and 2012 listed a remarkably consistent figure of around 15,000 annually  (approximately 200,000 cases): no deaths are mentioned. It was evident that when a vaccine, GSK’s Rotarix, was introduced to the British schedule last year it was to prevent diarrhoea not death.

The original rotavirus vaccine RotaShield, marketed by Lederle, was withdrawn after a year because Intussusseption of an association with a serious gastric condition intussusception in which the bowel folds in on itself causing a blockage. Intussusception can kill. Reports on VAERS (Vaccine Adverse Event Reporting System)  for Lederle’s RotaShield lists 124 reported cases of intussusception in one of which the patient died  (1 in 124). The newer products, Merck’s RotaTeq, which Paul Offit helped to develop and profitted from, and GSKs Rotarix are both associated with an elevated level of intussusception. Reports on VAERS (9 February 2015) for the Offit/Merck Rotateq vaccine introduced in 2006 list 1,068 cases of intussusception with 10 accompanying deaths  (1 in 107) while Rotarix (introduced in 2008?) has 553 cases of intussusception  and 11 deaths  (a very disturbing rate of 1 in 50). It is not known how many doses of the respective vaccines this represents.

RotaTeq Chart

Intussusception is a symptom specifically associated with rotavirus vaccines. It should be borne in mind that these vaccines have seldom been administered separately from other vaccines, however reports of total outcomes on VAERS in which the patient died are alarmingly high:

Rotashield 10

Rotateq 303

Rotarix 106

Unspecified 16

One of the evident problems is that exposure to multiple toxicities in one go might not just increase the overall risk of death it also makes it difficult to disentangle which vaccines are doing what. However, as a point of comparison there have been 425 deaths associated on VAERS with rotavirus vaccines since 2006 compared with a mere 329 for MMR since 1989.

While listing on VAERS does not mean a vaccine injury report is confirmed it is also as a passive reporting database likely to under-report by many times and may represent numerically no more than 1 or 2% of cases.

On March 22, 2010 the FDA suspended the use of GSK’s Rotarix vaccine after it was found to be contaminated with porcine circovirus type 1 (PCV-1). Then on May 6 the Offit/Merck version Rotateq was found to be contaminated not only by PCV-1  but another related virus, porcine circovirus type 2 (PCV-2).  On May 7, according to information on the FDA website a meeting was swiftly convened:

to discuss the findings of PCV and PCV DNA in rotavirus vaccines.  Based on a careful evaluation of this information, a thorough review of the scientific literature, and input from scientific and public health experts, the Agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine.  FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

Evidently the system had to patch itself up rapidly when a product patented by its most prominent advocate was determined to be faulty.  Buried now in the product insert for Rotateq is the elliptical statement:

In the manufacturing process for RotaTeq, a porcine-derived material is used. DNA from porcine circoviruses (PCV) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 are not known to cause disease in humans.

But presumably not known not to cause disease in humans either. And it seems likely few  pediatricians or nurses draw the attention of parents to this matter in obtaining consent.

According to an article by Dan Olmsted and Mark Blaxill written in 2009 Offit made at least $29m from his stake in Rotateq vaccine and took part in votes as a member of the Advisory Committee on Immunisation Practices to his own ultimate financial benefit.

…………………………………………………………………………………………

From FDA: Update on Recommendations for the Use of Rotavirus Vaccines, May 14, 2010

Background

On March 22, 2010, FDA provided an early communication regarding Rotarix, manufactured by GlaxoSmithKline Biologicals (GSK)  At that time, FDA recommended that clinicians and public health professionals in the United States temporarily suspend the use of Rotarix while the agency and manufacturer investigated the finding of DNA from porcine circovirus type 1 (PCV1) in the vaccine.  Since that time, both FDA and GSK have confirmed the presence of PCV1 in the vaccine.

On May 6, 2010, FDA provided information about RotaTeq, manufactured by Merck & Co, Inc. FDA indicated that preliminary studies conducted by Merck identified fragments of DNA from PCV1 and from a related porcine circovirus type 2 (PCV2) in RotaTeq.  FDA noted that it would seek input from its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and provide updates in the near future.

Updated Recommendations

FDA has evaluated laboratory results from the manufacturers and its own laboratories.  In addition, FDA’s VRBPAC convened on May 7, 2010 to discuss the findings of PCV and PCV DNA in rotavirus vaccines.  Based on a careful evaluation of this information, a thorough review of the scientific literature, and input from scientific and public health experts, the Agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine.  FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

FDA considered the following information in its decision:

*Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients.  FDA has no evidence that either PCV1 or PCV2 poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans.

 *The benefits of the vaccines are substantial, and include prevention of hospitalization for severe rotavirus disease in the U.S. and of death in other parts of the world.  The benefits of the vaccines, which are known, outweigh the risk, which is theoretical.

Comments

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flahute

Seems the PCV1-2, circovirus, and viral contaminants in several vaccines are emerging issue(s).

http://vir.sgmjournals.org/content/92/4/768.full
study on Circovirus genomic diversity & cross species transfer.

http://jvi.asm.org/content/84/4/1674.full
same lead author & group as above but showing PCV1-2 found in chimp/human feces, some of whom were suffering from diarrhea.

There seems to be a considerable number of identified adventitious virus in a number of vaccines- OPV, mumps, chickenpox being outlined here. http://jvi.asm.org/content/84/12/6033.short

Noted somewhere that PCV were contaminants of heparin and insulin (both derived from swine). I did find one PhD dissertation that had PCV2 infection & mentioned intussusception. Most curious and suggesting that it's a bigger problem than the rotavirus vaccines.

Linda1

Even the country had to deal with rotavirus in every infant...If that illness is treatable, not fatal, and resolves without incident...even if it costs millions or even billions of dollars, it is better than losing even ONE CHILD to adverse effects from the rotavirus vaccine.

There is no moral justification for the trade-off. In the developed world, it is choosing to save dollars over lives.

Benedetta

Bob Moffit; It is amazing - we would not have the imagination ot make this up if we were writing a fictional book - could we.

Everything that is wrong with the vaccine industry could come to light just by describing the ins and outs of the vaccine allllll by it itself and alone.

Just using this vaccine's example Congress should stop protecting the vaccine industry.

Benedetta

It says in the vaccine insert Kawasaki's disease.

So do you suppose that most of these vaccines are causing blood clots in the small veins and ischemia to different parts of the body.

This one is causing ischemia to the GI track more than most and it telescopes??

Offit is a piece of work. As we all know. But in spite of us all knowing - he just carries on like we don't exist.

Weird but not an unusual response for those in the wrong and know it.

Bob Moffitt

Let's see if I got this right.

On March 22, 2010 .. FDA recommended GlaxoSmithKline's Rotarix vaccine be suspended because it was found to contain "porcine circovirus type 1" (a pig virus).

Less than two full months later .. on May 6, 2010, preliminary studies identified fragments of DNA from PCV1 and from a related porcine circovirus type 2 (PCV2) in Merck's RotaTeq vaccine.

(What to do? Both GlaxoSmithKline and Merck vaccines contain "pig viruses"? Well that made it easy on the FDA .. approve BOTH. And so ...)

The FDA sought "input" from its Vaccines and Related Biological Products Avisory Committee .. to discuss findings of PCV and PVC DNA

(Pig DNA? First time I heard of pig DNA in addition pig viruses found in the vaccines? In any event ..not to worry you stupid parents .. because)

After a careful evaluation, thorough review of the scientific literature, with input from scientific and public health experts, the FDA resumed recommending BOTH vaccines for general use .. because .. "BOTH vaccines have strong safety records .. and .. the FDA has "no evidence" that either PCV1 or PCV2 poses a risk to humans.

(You silly parents .. pig DNA was not even mentioned)

In any event .. as parents we should be greatly relieved ... the VAST STORE of "scientific literature" on the long term consequences of injecting our children with pig viruses revealed there is "no evidence" that pig viruses pose a risk to humans.

Isn't it amazing .. vaccines are true miracles .. no matter what they inject into innocent toddlers .. mercury, formaldehyde, aluminum, pig viruses and pig DNA .. its all good.

It must be the shoes the manufacturers are wearing that makes it all happen.

Angus Files

Why isn't Offit in jail along with all his merry men Thorsen etc?the list goes on and gets bigger daily...

Superb article John thanks for all the research


MMR RIP

Jeannette Bishop

These researchers posit that rotavirus infection may be part of a group of factors leading to intussusception, but I wonder if that association existed prior to the vaccination (most generalized discussions of rotavirus risks I've read do not mention it)? Maybe something about the vaccine virus (or a combination of vaccine ingredients) disrupts appropriate immune function in the gut?

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1676276/

Jenny

How much of the risk for rotavirus could be prevented with probiotics to begin with? How many cases of rotavirus happens AFTER someone has had a course of antibiotics but before their gut has rebalanced? That would be an interesting topic of research. Do antibiotics increase the risk of a bout of rotavirus? If yes, then when we do a vaccine for diarrhea, we are performing an unnecessary invasive medical procedure in response to a manmade, preventable, possible non-issue. What if probiotics prevented rotavirus 100% of the time AND caused 0 deaths? Will the vaccine and judicial system take into account the leap in knowledge in the field of gut microbiome science?

Seems like Offit got his product approved just in time, because with what we know now about the gut biome and how to keep it healthy and resilient, nobody would have seen the need for his dangerous vaccine in the U.S.

Jeannette Bishop

Something like this was posted in a previous discussion, regarding the Postweaning Multisystemic Wasting Syndrome in pigs:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1562531/

"Gross pathological changes characteristic of PMWS were observed in all 5 groups. In order of decreasing frequency (Table II) the lesions included mild to moderate wasting, various degrees of gastric ulceration (pars esophagea), generalized skin pallor, mild to moderate mesenteric lymphadenopathy, and partially collapsed, rubbery lungs with or without cranioventral consolidation. Other gross findings, not characteristic of PMWS but occurring as primary or secondary disease processes in some pigs from all experimental groups, included bronchopneumonia (in 7 pigs), valvular endocarditis (in 5), fibrinous pericarditis (in 3), suppurative meningitis (in 3), proliferative enteropathy (in 3), mesenteric torsion (in 2), and fibrinous peritonitis, intestinal intussusception, fibrinosuppurative arthritis, ventricular septal defect, or umbilical hernia (in 1 each)."

cia parker

Dr. Sears recommended that the rotavirus vaccine be given as recommended to young infants, on the basis that infant diarrhea could be serious and deadly even in the U.S. I disagree with him, of course, also on his recommendation that infants be given the DTaP series starting at two months (no mention of the Manitoba study), Hib, and Prevnar, as per schedule. The really hard thing to face is that there is no course of action in the case of any vaccine or VPD that will save all people from often horrible consequences. If no infants got the rotavirus vaccine, then a very few would die of rotavirus. If any infants get the vaccine, they probably won't die of the types of rotavirus covered in the vaccine (which is by no means all of them), but they may die of intussusception or another severe reaction. Making a decision based on the odds and personal circumstances increases the chances of making a wise decision, but doesn't guarantee it, and we haven't even scratched the surface of all the reactions and far-reaching consequences vaccines cause. I was about to say that ultimately the decision has to come from a religious position of trust or doubt, whether in the immune system's innate powers and available treatments for disease, or in the pharma cartel (just blew my attempts at objectivity). I realized the limitations of either such global position, and now just have to go back to insisting that everyone contemplating any vaccine conduct voracious research on the disease, the vaccine, and individual location and circumstances. As for the rotavirus vaccine, that's easy. Anyone in a First World country with access to a hospital in the worst-case scenario should not get it. I had it once as an adult when I flew to Mexico, and got it so soon after arrival in Mexico City that I think it was from lettuce I ate on the plane that had been inadequately cleaned or handled with dirty hands. And it lasted for two weeks, a long duration that is a hallmark of rotavirus. Not fun, and definitely wouldn't be good for a baby, but then neither would intussception be. Breast feeding helps both prevent and treat it, and any infant with signs of dehydration should be taken to a hospital for rehydration by IV, and I think that would take care of the problem in nearly all cases without resorting to the vaccine.

Laura Hayes

Thank you, John, for this excellent explanation of why parents should say NO to rotavirus vaccines, and why they should say NO to vaccine mandates and NO to restricted exemptions if we're going to continue to have mandates.

If parents don't think the rotavirus vaccine will be one of the scores of vaccines that their child will be forced to get as our exemptions are being eliminated across the nation, they had better think again...and fast.

Shawn Siegel

Not only is intussusception sometimes deadly, but it can be excruciatingly painful even for an adult, and often requires surgery - and we're now giving it to infants. Four of the top five most frequently reported reactions to the rotavirus vaccines mirror the disease, including bloody stool; intussusception is number four.

The rotavirus vaccine isn't a medical procedure, it's a cruelty.

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