All rotavirus vaccines contaminated worldwide - FDA suspends its use

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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.
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You are so right my love it is very mucvh an emotive and personal issue. I think a large number of parents make very loving and thought out choices for their children. As you rightly say it's a personal decision for each child.

However, for me it is one of the many things that have reinforced that for me the decision was the correct one. As for meds that were contaminated. For me it would stop me taking my medications & that again would be an outrage.

As health care consumers we have to demand the best possible. Yes, errors occur but for the level of contamination that is evident here to occur this shows to me severe misconduct.

This is certainly not the first time vacc's have been contaminated. It's another reason I stopped vaccing DD17 when she was little and searched a little deeper. It's just not good enough.

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?

check the vacc info threads, there are several thread in which members give their reasoning.

10 Reasons Why Parents Choose Not To Vaccinate

With the Chicken Pox vaccination they have found it to be too ineffective and are currently talking of introducing an additional shot to make it work better. Of all the kids at my son's kinder last year, those who were vaccinated were the ones who got it.

Statement on Rotarix® (Rotavirus vaccine)

From the Australian Therapeutic Goods Adminsitration; The FDA is a US Government Agency and has no say whasoever on what happens with drugs, medications and therpeteutic goods in this country. Its important when discussing topics as important as this to use the accredited sources. The FDA hasn't suspended the use of Rotarix only asked Drs to withold it's administration until further investigations are complete. http://www.tga.gov.au/alerts/medicines/rotarix.htm

24 March 2010
On 17 March 2010 GlaxoSmithKline (GSK) notified the Therapeutic Goods Administration (TGA) and other regulatory agencies around the world of a manufacturing quality issue concerning its rotavirus vaccine Rotarix.
The company advised the TGA that DNA fragments of a virus identified as porcine circovirus type 1 (PCV1), had been found in batches of the product. PCV1 is common in pigs but does not cause illness in pigs or any other animals, nor has it been shown to cause illness or replicate in humans. The risk of any illness from ingesting such material is remote.
Two oral vaccines (Rotarix and RotaTeq) are currently approved for use in Australia and included in the National Immunisation Program (NIP) for babies aged 2 to 6 months of age for the prevention of rotavirus, a form of gastroenteritis which can be severe. Rotarix was added to the NIP in 2007.
The TGA is working closely with other regulatory agencies overseas and the company, GSK, to obtain information and expert advice to ensure that the vaccine is safe and effective. In addition, the TGA is convening an expert panel to provide further advice on the matter.
The European Medicines Agency (EMA) has taken no regulatory action, but is continuing to gather information pending a meeting of its Committee for Human Medical Products Vaccine Working Group scheduled for 24 March 2010.
The US FDA has not taken any regulatory action, but has requested US medical practitioners not to use Rotarix for the next 4 to 6 weeks while the matter is further investigated.
Clinical trials data and extensive experience to date have demonstrated that Rotarix is effective in preventing infection with rotavirus and is well tolerated in babies. Individual vaccination programs that have commenced should continue, and parents should contact their doctor if they have concerns about immunisation of their baby with Rotarix.
The TGA will provide additional advice regarding its careful scientific risk assessment as soon as it is completed. Based on current evidence and pending further expert review the TGA does not consider this constitutes a threat to public health.
A comprehensive list of Frequently Asked Questions follows.

Frequently asked questions

What is rotavirus?

Rotavirus is named after its characteristic wheel-like appearance when viewed under an electron microscope. Rotavirus is the leading cause of severe diarrhoea and dehydration in young infants worldwide. It is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries.
In Australia, prior to the introduction of rotavirus vaccination, it was estimated that there were approximately 10,000 hospitalisations due to rotavirus in children less than 5 years of age each year. In addition to hospitalised children, an estimated 5,000 children under 5 years of age visited a GP, and 22,000 children required an emergency department visit due to rotavirus illness each year. On average, there was one death due to rotavirus each year in Australia.

What are the symptoms of rotavirus infection?


Rotavirus infects the intestines. The disease usually starts with fever, an upset stomach, and vomiting, followed by diarrhoea. The disease generally lasts 3-8 days.

How is rotavirus infection treated?

There is no specific treatment for the rotavirus infection. The most serious problem caused by the disease is dehydration, so symptoms are treated mostly by oral rehydration. Severe cases require administration of intravenous fluids in a hospital. Rotavirus disease can be prevented with vaccination.

How does rotavirus spread?

Rotavirus is usually spread when children touch or place in their mouths small, usually invisible amounts of faecal matter found on surfaces such as toys, books and clothing, or on the hands of caregivers. The virus can also be transmitted through contaminated water or food, and possibly by respiratory droplets in a sneeze, cough, or exhalation. The virus is very contagious. Nearly all children are exposed to rotavirus at some point before the age of 5 years.

Rotavirus vaccines

After evaluating data from extensive clinical and non-clinical tests, TGA registered GlaxoSmithKline's Rotarix vaccine in March 2006. A second rotavirus vaccine RotaTeq is also marketed in Australia by Merck, Sharp & Dohme (Australia) Pty Ltd. TGA registered RotaTeq in May 2006. Pre- and post-market studies have shown both vaccines to be highly effective at preventing serious gastrointestinal disease caused by rotavirus. No serious or unexpected safety concerns have been identified in postmarket surveillance of either vaccine.

What is Rotarix?

Rotarix is a live-attenuated human rotavirus vaccine. It causes a slight infection that typically produces no symptoms, but creates immunity against rotavirus.
Rotarix is available in Australia as an oral liquid suspension and is administered by mouth in a two-dose schedule on the National Immunisation Program between six and fourteen weeks of age. The first dose can be given beginning at six weeks of age and the second at least four weeks after the first dose, but before the child reaches 24 weeks of age.


What countries currently use Rotarix?

In addition to Australia, Rotarix is licensed in the United States, the European Union and nearly 100 other countries.

How many doses of Rotarix have been sold?

Current data indicate that between July and December 2009, 91331 doses of Rotarix were used in Australia. Rotarix is predominantly used in NSW, ACT, NT and Tasmania. It was previously used in WA during 2007 to 2009. To date it is estimated that 68 million doses of the vaccine have been distributed worldwide, and more than 70000 children have participated in clinical trials. No unexpected pattern of adverse reactions to the vaccine has been reported in any country.

What other rotavirus vaccines are currently available?

The other licensed rotavirus vaccine is Merck, Sharp & Dohme's RotaTeq, also a live-attenuated viral vaccine taken by mouth. It was tested in more than 70,000 children, primarily in the United States and Finland, and registered in Australia in May 2006. The vaccination is administered in a three dose schedule starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals; the third dose should be given by 32 weeks of age. During the period July and December 2009, more than 304,000 doses of RotaTeq were administered in Australia. RotaTeq is currently used in Victoria, Queensland, SA and WA.

Background on PCV1
Porcine circovirus 1 (PCV1) is a small, circular virus composed of a single strand of DNA that is very common in pigs but is not known to cause disease in animals or humans. It was first identified in 1974. PCV1 may be acquired from eating pork and from exposure to farm animals. It has not been shown to cause disease in pigs, humans or any other animals. PCV1 is found in many meat products.
PCV1 should not be confused with PCV2. PCV2 is a circovirus that causes illness in pigs, but not humans.


Is PCV1 a pig material?

No. PCV1 is a virus. It is not animal material.
Detection of DNA from PCV1 in Rotarix
The presence of components of PCV1 in Rotarix was discovered when an independent US academic research team applied a new technology for detecting viral genetic material. The researchers detected DNA fragments of PCV1 in two lots of Rotarix vaccine.

The researchers notified GlaxoSmithKline of their findings on 9 February 2010. The company then initiated extensive experiments to confirm the results and undertake further investigations. These included a series of assessments on the same two lots of the finished vaccine, as well as on vaccine materials at different stages of the production process.
These follow-up tests confirmed the presence of many copies of DNA from PCV1 in the two finished vaccine lots that had previously been tested, as well as in intermediates in the production process, and in the working cell bank and viral "seed" from which the vaccine was derived.
The firm notified TGA of its findings on 17 March 2010. TGA staff then began to review the evidence, consult with experts, contact other public health officials in Australia, and communicate with international regulatory counterparts.


Has DNA from PCV1 been found in other lots of Rotarix?

In its follow-up assessments, GlaxoSmithKline detected the presence of DNA from PCV1 in the working cell bank and viral "seed" used to produce Rotarix, confirming that the material has been present since the early stages of product development, including during clinical studies.

Why wasn't the presence of DNA from PCV1 detected in previous reviews of Rotarix?
Circoviruses such as PCV1 have not been associated with illnesses in humans, and the identification of DNA fragments by the academic researchers has only recently become possible due to technological developments. No regulatory agency has required testing for the presence of the virus or any components as this has not been possible previously.

How did DNA from PCV1 come to be present in Rotarix?
At this time, TGA does not know how DNA from PCV1 came to be present in Rotarix. TGA, other regulatory agencies and GlaxoSmithKline are investigating this issue as a matter of urgency.

Does the detection of DNA from PCV1 indicate that the virus is present in Rotarix?
Although DNA fragments from PCV1 have been detected in Rotarix, it is not yet known whether this means that intact virus is present. Additional studies are currently being conducted to establish whether or not intact PCV1 is present in Rotarix.

Does the detection of DNA from PCV1 in Rotarix raise special concerns for influenza vaccines?
No. The manufacturing process for Rotarix is very different from the manufacturing process for influenza vaccines. Unlike Rotarix, a cell-based vaccine, the influenza vaccines currently on the market are egg-based vaccines. The cell-based influenza vaccine currently in development uses materials that are different from the one used to develop Rotarix.

TGA actions
After learning of the detection of PCV1 DNA in Rotarix on 17 March 2010, TGA began reviewing the available evidence, and consulting with relevant clinical and scientific experts, conferring with public health officials, and exchanging information with regulatory counterparts in other countries to establish a better understanding of the extent, if any, of possible risk. The TGA has urgently requested further and complete information from the manufacturer, GSK.
In the United States, the FDA also tested lots of RotaTeq for evidence of PCV1. The agency’s preliminary studies have not found DNA from PCV1 in Rotateq.


Are follow-up assessments being conducted?
The TGA's investigations are ongoing. Both TGA and GlaxoSmithKline are reviewing all available evidence and additional tests are being conducted to obtain more information about the presence of PCV1 DNA in Rotarix, including whether intact virus (as opposed to DNA fragments) is present.

Information for parents and caregivers
Rotavirus causes severe diarrhoea and dehydration in young infants. There are two licensed vaccines for rotavirus in Australia: RotaTeq and Rotarix. Each of these vaccines is given by mouth in a series of doses during the first year of life.

My child has received or is due to receive the Rotarix vaccine. Should I be worried?
All available evidence, including clinical studies involving tens of thousands of children, supports the safety of the vaccine. PCV1 is not known to cause disease in humans. Children who received Rotarix need no additional medical follow-up. Scheduled vaccination with Rotarix should proceed as normal.
Information for healthcare providers and public health professionals

Is there any medical follow-up needed for children who have received the Rotarix vaccine?
No. The risk of any illness from ingesting any such material is unlikely. TGA does not believe special medical follow-up is warranted for children who have been vaccinated with Rotarix. Extensive pre- and post-market clinical studies involving tens of thousands of vaccine recipients support the safety and effectiveness of the vaccine.
If a child has received one dose of Rotarix, what should I do for the next dose?
For children who have received one dose of Rotarix, it is recommended that the vaccination course be completed according to the usual timetable for the second dose.

You guys really have to be joking, lovingly made your decision? Yes to make the Drug companies richer on the back of your children's health and long term well being and at worst, DEATH.
You sound like some sort of commercial for ultra soft toilet tissues, this is your children's lives, not yours, theirs.

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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?

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try looking up these information sheets (hopefully I can post the link), they are the best I have seen.

NCIRS fact sheets - NCIRS - National Centre for Immunisation Research and Surveillance

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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.

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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.

This thread is for discussion of the Rotavirus vaccine. Please stay on-topic.

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