All rotavirus vaccines contaminated worldwide - FDA suspends its use

[BellyBelly]

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...

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."

[squidipa]

what ages do kids get this?

[Inanna]

Thanks Kelly it's bloody frightening and yes the reason why there is such fear about vaccination. Because it seems this happens all too frequently. Thankyou for sharing this info...

[Fleur]

what ages do kids get this?

The schedule in DD's book is for 2, 4 & 6mths.

I would take this to mean that they are given the Merck vaccine (3 does instead of 2).

Deosn't make me feel a lot better about it though although DD has had hers, too late now.

Thanks for sharing Kelly, I wish this info was more 'out there'.

[skybie]

have just printed this off to hand to MCHN when she gives me the 3rd degree about our decision to not vaccinate again! thanks Kelly

[Curly]

Yes the RotaTeq is 3 doses and this is the one on the schedule.

Before it was on the schedule it was an optional extra vax that you had to pay for yourself at the GP and then claim back, which is what I did for DS. Some GPs had RotaTeq, others had Rotarix, which was only 2 doses.

I am, generally speaking, pro-vax, but I can't deny that I am feeling a little like I've dodged a bullet on this one and only because my own GP had done their due diligence, decided that RotaTeq was the better vaccine and chose to administer it over the Rotarix.

[2CheekyMonkeys]

ok, i admit i only skimmed that.. but didnt it say although it showed up there was the virus in there it hasnt harmed anyone?

[Heaven]

I thought in QLD there was only 2 doses, so maybe they use that one?

Glad I didn't get it anyway.

[BellyBelly]

But aren't you concerned this is supposed to be a sterile vaccination made by one of the massive pharma companies and it's contaminated? What else could get in there? If a pig virus could contaminate an entire vaccine, firstly thats a massive error in part of the maker, but who knows what else could have gotten in there... which is why I would rather not take risks. My daughter had the virus, it was horrible... my son never got it... but I still would not put in a russian roulette of who knows what in their little bodies. Someone posted on FB too that their child had a bad reaction to the vaccine and ended up in hospital for 2 days...

[alioops]

Heaven DDs 2&3 had the 3 dose one. I think Australia uses Rotateq

[BellyBelly]

Two rotavirus vaccines are licensed for use in Australia: Rotarix® (GlaxoSmithKline); and; RotaTeq® (CSL Limited/Merck and Co, Inc).

[Eenee]

But aren't you concerned this is supposed to be a sterile vaccination made by one of the massive pharma companies and it's contaminated? What else could get in there? If a pig virus could contaminate an entire vaccine, firstly thats a massive error in part of the maker, but who knows what else could have gotten in there... which is why I would rather not take risks. My daughter had the virus, it was horrible... my son never got it... but I still would not put in a russian roulette of who knows what in their little bodies. Someone posted on FB too that their child had a bad reaction to the vaccine and ended up in hospital for 2 days...

Which is why i'm glad I have educated myself on the dangers of vaccines before I had kids and got them vaccinated. I used to be very pro-vaccine but now i'm the total opposite- it's a shame though unless you educate yourself on the dangers you'd otherwise never no.

[Pandora]

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.

[Matryoshka]

Things get contaminated all the time, people make mistakes... a can of bakes beans in your cupboard could be contaminated right now.

Yes its scarey for a vaxer, but i'd be just as scared if my medication was contaminated. But it wouldn't make me suddenly decide it wasn't worth the risk to take my medication anymore!

People who decide to vax don't take the decision lightly and i know i genuinely believe the benefits outweigh the risks.

Yes its great to educate and warn people of the dangers of vaxing, but i hope non-vaxers are just breathing a sigh of relief rather than trying to re-inforce that their decision not to vax was the right one....... because its a personal choice to vax, there is no right or wrong.

[BellyBelly]

I don't want to turn this into a pro vs against vax thing... i just stated this as it's why some people choose not to vax, because the number 1 thing you hear as a non-vax'er is that we're being dangerous and risky. I am not saying you're irresponsible to vax or not, but this is one side to the story. I think when people say, 'oh well its not hurt anyone,' there's so much more too it. We don't care because no-one got hurt. But this is a massive error... we can't be sheep and get second rate care... we need to hold them accountable and make sure they pick up their act.

This is also in the vaccination information forum, and I am simply providing info, which I believe is shocking and everyone should be made aware. Not looking to change anyone's mind but give info in an info forum. If you want to debate the topic, thats fine, but it needs a specific thread on its own.

[Matryoshka]

I don't believe in debating, just sharing my point of view as others have

[Eenee]

This is also in the vaccination information forum, and I am simply providing info, which I believe is shocking and everyone should be made aware. Not looking to change anyone's mind but give info in an info forum. If you want to debate the topic, thats fine, but it needs a specific thread on its own.

:yeahthat:

And I wasn't saying it was wrong for people to vaccinate i'm just saying that if it wasn't for people like Kelly we would only here one side of the story. where as I prefer to get all info and make my inforemd decision from there. And of course no one makes there decisions litely. But it is nice to know the facts, and of course it is personal choice no-one's debating that.

[Fleur]

And I wasn't saying it was wrong for people to vaccinate i'm just saying that if it wasn't for people like Kelly we would only here one side of the story.

:yeahthat:

I really value that I can come to BB for these viewpoints & this information.

DD is vaccinated & we will continue on with the schedule (mostly - I don't think we will get the CP vax) BUT I do wish I had had a little more info before we started.
I - once upon a time - put my faith in the medical system & didn't question. I wish this stuff had been more out there as I said before.

Still tossing up on the swine flu vax for DS2, he suffers asthma - but whatever way we go, I want to hear how & why other people have reached their decisions.