All rotavirus vaccines contaminated worldwide - FDA suspends its use
And people think those of us who don't support such vaccinations are taking risks.... here's why we think like we do. The things we do and say are safe today, may not be tomorrow, especially when these things are pushed out to market without adequate long-term testing, in order to get the $$. This is rife in this industry, as in obstetrics...
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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.
FDA Suspends Use of GlaxoSmithKline Rotavirus Vaccine Tainted with Pig Virus - AGE OF AUTISM
March 22, 2010
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."
Re: All rotavirus vaccines contaminated worldwide - FDA suspends its use
So can I just check I have it right as DD is having her 6 month jabs this week...
It's the one that's given in 2 doses that there's been the problem with?
Also, as I've seen it come up here as well as in several other threads, what is the reason behind those who chose to vax opting to decline the cp vax? And where do you all get your info from to decide whether to vax or not? I've decided not to get swine flu vaccine for DD based on easily accessible info, but where can I read up on others in more depth?
"what could happen if they arent vaccinated"
:
my son has had it he had the rotateq, 3 doses.
I think the decision to vaccinate or not is very personal amd emotional.
I do worry about whats in them, but also about what could happen if they arent vaccinated, and at the end of the day its a really difficult choise to make.
You should be extremely concerned about what will happen, if not now, but in years to come.
The term “immunization” (US, Canada) or "immunisation" (UK, Australia, NZ), often substituted for the term "vaccination", is false and should not be used in place of "vaccination", because it is well documented in medical research that vaccination, the direct injection of foreign proteins and other toxic material (particularly known immune-sensitising poisons such as mercury and aluminium compounds, formaldehyde and phenol) sensitises, meaning makes the recipient more, not less, susceptible,
i.e. more easily affected, by what he/she encounters in the future
This means that vaccines do the opposite of immunise, commonly even preventing immunity from developing after natural exposure, in which cases vaccine recipients have gone on to contract the disease not even just once, but several times. (Vaccines "de-immunize".) New, more serious forms of the diseases (e.g. atypical measles) are also now appearing, only in the vaccinated.
Yes, you should worry what's in them.
Isn't this the whole reason to not vaccinate your kids is because you love them.
All you need to know about the great vaccination scam is in the Medical research if you care to read it.
To give an example Polio has never been erradicated by vaccines.
The polio virus is a very small RNA virus, categorized as an enterovirus, meaning that it multiplies primarily in the intestinal tract.
Polio had declined from its peak in 1950 by 80-90% by the time the polio vaccine was introduced in 1956, so the vaccine was not responsible for its decline. Indeed after the vaccine was introduced, the incidence and deaths from polio increased, which was a
major problem.
In 1958 the definition of polio was changed to make the diagnostic criteria so restrictive that it became almost impossible to call an illness polio even when the person suffers paralysis and the polio virus is present.
Immediately this change occurred the number of cases of “polio” crashed, and the number of cases skyrocketed of “other” diseases, such as “viral meningitis” and “cerebral palsy” (up to 75% of these cases are actually polio). All the vaccines - for DPT, MMR, Hib, polio etc are still provoking polio to this day, but the word “polio” is very rarely used. When paralysis occurs it usually does not last more than a couple of days in which cases usually no diagnosis is given when they occur these days.
That'sit in a nutshell. and that is only the tip of the vaccination iceberg.
Rotarix Update from US Ferderal Drug Administration
This is about the US standpoint. The Therapeutic Goods Administration (Australia) may comment soon.
Rotarix Vaccine: Update to Clinicians and Public Health Professionals
Rotarix Vaccine: Update to Clinicians and Public Health Professionals
Audience: Pediatric and family practice healthcare professionals, public health professionals
[UPDATED 05/16/2010] 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. Based on a careful evaluation of laboratory results from the manufacturers and its own laboratories, 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 also determined that RotaTeq vaccine should remain in use.
In its decision, FDA considered that 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 porcine circovirus (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 United States and of death in other parts of the world. he benefits outweigh the risk, which is theoretical. FDA and the manufacturers will continue to investigate the findings of PCV in rotavirus vaccines and will evaluate information from ongoing testing by FDA and the manufacturers
