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FDA Sees Possible Risk of Fatal Bowel Problem With GSK Vaccine

October 16, 2010 | 43,848 views
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gsk vaccineThe Food and Drug Administration said preliminary results from a study in Mexico involving GlaxoSmithKline's Rotarix vaccine suggest an increased risk of a serious bowel problem that could be fatal.

A statement posted to the FDA's website said the study showed an increased risk of intussusception in the 31-day period following the first dose of Rotarix. Intussusception is a twisting or obstruction of the intestine that can be fatal.

The safety of Rotarix and RotaTeq, a similar vaccine made by Merck, have carefully been tracked by regulators since another vaccine by then drug-maker Wyeth was pulled off the market in 1999 after it was linked to an increased rate of intussusception.

 

Dr. Mercola's Comments:

GlaxoSmithKline's Rotarix vaccine has been plagued with problems since its approval in 2008, not the least of which is this alarming link to intussusception, a potentially fatal problem with the intestine in which one portion of the bowel slides into the next.

Preliminary results from a Mexican study found an increased risk of intussusception within 31 days following vaccination with Rotarix, with most cases occurring within the first seven days. Unfortunately, the vaccine will still remain on the market until the U.S. Food and Drug Administration (FDA) has a chance to review the final study results sometime next year.

Yet you only need to look at the past history of rotavirus vaccines to know that this is a disaster in progress …

Similar Rotavirus Vaccine Pulled From Market for This Very Same Problem

Rotarix is intended to prevent rotavirus disease, which causes diarrhea and dehydration. A similar oral rotavirus vaccine was actually pulled from the market in 1999 after nine reports of intussusception occurred within the first 7 months of vaccine use, more than double the cases reported in the previous seven years.

Meanwhile, in 2007, the FDA also issued an advisory warning about RotaTeq (a rotavirus vaccine made by Merck). For what? The risk of intussusception, in which 16 of the 28 reported cases required surgery to repair a baby's intestinal tract.

Given this track record with rotavirus vaccines, it is appalling that the FDA is not taking urgent action to protect the children, but then this is the same agency that approved Rotarix in the first place -- even though there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies.

It's also the same agency that only "recommended" physicians temporarily suspend their use of Rotarix earlier this year after a serious contamination risk was uncovered …

Rotarix Contaminated by Pig Virus

As though the risks of intussusception are not bad enough, a research team revealed that Rotarix was contaminated with "a substantial amount" of DNA from a pig virus

Somewhat by accident, Dr. Eric Delwart and colleagues, who were intending to "show that live attenuated vaccine only contained the expected viral genomes and no other," discovered that Rotarix contained "significant levels" of porcine cirovirus 1. Rotateq, Merck's rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus.

Both the FDA and GlaxoSmithKline spokespeople continue to state that no safety risk has been uncovered from the contamination, at least not yet. But what are they going to say? The vaccine has already been given to 1 million U.S. children, and about 30 million worldwide, who must now live with the consequences of this contaminated vaccine, whatever they may be.

Carefully Research before Getting Your Kids Vaccinated for Rotavirus

Clearly these vaccines, including the two still on the market, are causing a disturbance serious enough that a typically rare bowel problem is becoming all too common.

Before taking this potential risk with your child, you must get informed on the risks of rotavirus … the disease the vaccine is intended to prevent.

Rotavirus is very contagious and does cause more than 500,000 deaths in young children each year, but this is mostly in developing countries. In the United States, rotavirus is responsible for only "several dozen" deaths a year, according to FDA Commissioner Dr. Margaret Hamburg.

Typically, when a child in the United States contracts rotavirus, and most do, only rest and fluids are required to recover. This infection also provides natural immunity that will protect your child for life.

As the National Vaccine Information Center writes:

"The CDC estimates that, by age 3, almost every US child has had a case of rotavirus. Once a child has been infected with a strain of rotavirus, he or she develops antibodies and is either immune for life or has a milder case if infected with that same strain in the future.

Most healthy children, who are infected with several strains of rotavirus in the first few years of life, develop lifelong natural immunity to rotavirus infection."

So in most cases, if you live in a developed country there is absolutely no need to get the vaccine in the first place. And even now that vaccination is widespread, the vaccine appears to be having virtually NO effect on rotavirus rates. According to NVIC:

"Today, even though almost all US infants receive vaccines for rotavirus, and despite efforts to improve the management of childhood rotavirus-associated diarrhea, hospitalizations of children in the U.S. with the disease have not significantly declined in the past two decades."

It even states right on GSK's Web site that "Vaccination with ROTARIX may not provide 100% protection to all recipients." The site also reveals the fact that safety has not been established for all infants:

"Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated."

So with this particular vaccine, children are taking on serious risks with little to no benefit.

The question U.S. parents need to ask is, would I rather risk my child getting a mild disease that requires rest and fluids for recovery -- and then affords them lifelong immunity -- or risk getting them vaccinated and having them suffer from a potentially fatal intestinal blockage or some other unknown side effect?

With this and all vaccines, it's necessary to always weigh the risks versus the benefits, as often you'll find that the risks come out on top.

My Appeal to You

Don’t sit this one out! We’ve got them “on the run.”

Tell everyone. Tell your friends, your family. With a little bit of effort, you can make significant strides toward preserving your freedom to make voluntary health decisions affecting your and your children’s future.

One of the top goals for the National Vaccine Information Center (NVIC) is preserving your freedom of choice about if and when to use vaccines. As part of that mission, this non-profit charity has been fighting for your right to make informed VOLUNTARY vaccine choices since 1982.

During the upcoming Vaccine Awareness Week, NVIC is launching the online NVIC State Advocacy Portal that will give you the tools you need to take action to protect legal medical, religious and conscientious belief exemptions to vaccination in YOUR state.

Mercola.com & NVIC Dedicating November 1-6 Vaccine Awareness Week

In a long-scheduled joint effort to raise public awareness about important vaccination issues during the week of November 1-6, 2010, Mercola.com and NVIC will publish a series of articles and interviews on vaccine topics of interest to Mercola.com newsletter subscribers and NVIC Vaccine E-newsletter readers.

The week-long public awareness program will also raise funds for NVIC, a non-profit charity that has been working for more than two decades to prevent vaccine injuries and deaths through public education and protecting informed consent to vaccination.

The November 1-6 Vaccine Awareness Week hosted by Mercola.com and NVIC will follow a month-long vaccine awareness effort in October that was recently announced on Facebook by parents highlighting Gardasil vaccine risks.

The six-week-long focus this fall on vaccine issues will help raise the consciousness of many more Americans, who may be unaware that they can take an active role in helping to prevent vaccine injuries and deaths and defend the legal right to make voluntary vaccination choices.

And remember, you can always visit Vaccines.Mercola.com and NVIC.org for the latest vaccine news updates and other important vaccine information.


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