PaxVax releasing GMO cholera vaccine into 'the environment'.

Pete Tar

Senior Member.
People in Australia are freaking out about the proposed trail of a GMO cholera vaccine, mainly due to misunderstanding the language used.


http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir126appsumm-htm
An application has been made under the Gene Technology Act 2000 (the Act) for Dealings involving the Intentional Release (DIR) of genetically modified organisms (GMOs) into the Australian environment.

...
This proposed trial would form part of three international clinical trials covering different age groups. The trial would involve the inoculation of children and adults in Australia via oral ingestion of the GMOs. The purpose of the trial is to verify the effectiveness of the vaccine in producing an immune response against cholera.
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The 'environment' just means the human organisms being monitored and their possible interaction with their surroundings. It does not mean putting it into the air or water supply.

They are trying to develop a single-dose cholera treatment.

The single dose and rapid onset of protection demonstrated by CVD 103-HgR makes it ideal for travelers to cholera endemic areas. Additionally, rapid onset of protection is potentially invaluable in epidemic outbreaks where the spread of the disease needs to be controlled quickly. CVD 103-HgR was studied extensively in clinical trials, including in a field efficacy study conducted in Micronesia by the WHO1.

An initial clinical trial conducted by PaxVax with PXVX0200 has shown safety and immunogenicity. In the Phase 1 study, PXVX0200 was well tolerated and 89% of vaccine recipients seroconverted for vibriocidal antibodies vs 0% of the placebo recipients. The vaccine was well tolerated; vaccine-related solicited adverse events were infrequent and generally mild.The Phase III studies planned for licensure of PXVX0200 are being conducted in North America and Australia and will be comprised of cholera challenge, safety and immunogenicity studies.
http://www.paxvax.com/cholera
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The initial reaction to this was outrage that they were going to aerially spray the population,

eg...
More GMO Nightmares: Australia to Trial Forcible Vaccination Through the Release of Aerosol GMO Vaccine
The article by
Dave Mihalovic is a Naturopathic Doctor who specializes in vaccine research, cancer prevention and a natural approach to treatment.

goes on to talk about West Nile virus spraying and the history of other aerosoled releases despite the Paxvax trial mentioning no such thing. It seems to be the main source of the initial misunderstanding.


Now that has mostly reduced to being offended about Aussies being 'experimented' on...


http://www.activistpost.com/2013/12/biotech-wants-to-experiment-on-aussies.html
Many Australians were outraged last week to find out that the California based company, PaxVax, had applied to the Australian government for a licence to use 1000 Australian adults and children as guinea pigs to test its experimental, genetically modified, live bacterial cholera vaccine.
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which, whether misguided or not, is at least not misrepresenting the initial proposal anymore.

It still has the fear buzzwords 'GMO', 'cholera', and 'vaccine', so people will be easily riled.
 

David Fraser

Senior Member.
Your definition of environment is slightly incorrect. It does mean environment in the wider sense due to the possiblity of some of the vaccine been excreted.
 

Pete Tar

Senior Member.
Thanks, I meant to ask anyone that knows for the proper definition in this context.

Mine was just a basic guess.
 

Pete Tar

Senior Member.

The applicant has proposed a number of control measures to restrict the spread and persistence of the GMOs and their introduced genetic material that will be considered in the assessment of this application, including:
  • Inoculating a maximum of 1000 individuals in Australia with the GM vaccine
  • Requiring that inoculations be performed by trained nurses and/or physicians at health care facilities in accordance with standard universal precautions and ICH-GCP2
  • Storage and transport of all GM vaccines, including any waste or samples containing the GM vaccines, in accordance with relevant regulations
  • Monitoring vaccinated individuals for at least one hour after ingestion to ensure the vaccine solution is not expelled orally
  • Disposing of all waste in accordance with standard clinical waste disposal practices as required by the relevant local and state legislation
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MikeC

Closed Account
The trial request document for Australia is here - it doesn't seem to be cut-and-paste-able, but the actual GM's carried out are listed.

-mercury resistant
-toxin suppression (x 2)
 

Pete Tar

Senior Member.
The link to the sensationilist article has been changed to a more sane one (unless I pasted the wrong link in the first place), though the objections still seem based on imisunderstanding the trial...
.

But what of the risks involved in this proposed environmental release of this genetically modified bacteria in Australia? Control measures are set to be in place for the trial by PaxVax, but what if they fail? At a minimum wildlife and ecosystems will become infected, and a possible pandemic is the worst case scenario.
...
Just to be clear, as there has been much fear and speculation over this GM vaccine trial, this is not an aerosol vaccine to be sprayed on the public. This vaccine trial will be administered orally to 1000 volunteer test subjects.
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Here are two links to the original article


http://beforeitsnews.com/eu/2013/11...heir-own-government-from-the-air-2541604.html
http://beforeitsnews.com/eu/2013/11...heir-own-government-from-the-air-2541604.html
http://www.bibliotecapleyades.net/salud/salud_vacunas172.htm


And here is a Q/A which I missed
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir126qa-htm
Questions & Answers on licence application DIR 126 for a clinical trial of genetically modified (GM) live bacterial vaccine
November 2013

What is this application for?
PaxVax Australia Pty Ltd (PaxVax) is seeking approval to conduct a clinical trial with a genetically modified live bacterial vaccine against Cholera. The trial is proposed to take place in clinical facilities in QLD, SA, VIC and WA. Once underway the trial is expected to be completed within one year.

What is the purpose of the clinical trial?
The purpose of the trial is to verify the effectiveness of the vaccine for preventing cholera. It is being developed for travellers proposing to visit areas outside of Australia where cholera is endemic. The proposed trial would form part of three international clinical trials covering different age groups. A maximum of 1000 volunteers would be given the GM vaccine in Australia.

Note: Clinical trials involving the use of therapeutic products also require approval from Therapeutic Goods Administration (TGA).

Who will be vaccinated and how will they be vaccinated?
PaxVax will seek healthy volunteers to participate in this clinical trial. All volunteers will be given extensive information about the GM vaccine, prior to consenting to participate in the trial.

Clinical trial participants will be given the vaccine as a drink. It will not be injected or sprayed into the air.

Has this GM vaccine been tested or used in any other country?
This same vaccine was previously approved and marketed in several different countries, including Australia, under the brand name “Orochol” or “Mutacol”. Orochol® was registered as a prescription medicine by the Therapeutic Goods Administration, after undergoing extensive evaluation of its safety, quality and efficacy and it was licensed by the Gene Technology Regulator in 2003. Since the manufacturer of Orochol ceased production of this vaccine, they voluntarily surrendered the licence in 2010.

If same GM vaccine was commercially available why is this clinical trial going to be conducted?
PaxVax is developing this GM vaccine as a new commercial product as the previously available vaccine (Orochol®) is no longer available. Although it is the same vaccine strain, it is manufactured in different facilities Therefore clinical trials are required to confirm that the newly manufactured product has a similar safety and efficacy profile as the previously manufactured product.

How have the GM live bacterial vaccine been modified?
The GM vaccine contains live genetically modified cholera bacteria, V. cholerae. Unmodified cholera bacteria produce a toxin and a protein (haemolysin) which can break open blood cells. The vaccine strain has been produced by deleting a part of the toxin gene and disrupting the haemolysin gene. As a result of the genetic modification, the bacteria cannot produce the cholera toxin molecule or the protein which breaks open red blood cells. The GM vaccine will not produce toxins or disease.

How can I comment on this application?
The Regulator will seek public comment after a risk assessment and risk management plan (RARMP) has been prepared for the application. At this stage, the RARMP is expected to be released for comment in late January 2014. The public will be invited to provide submissions on the RARMP via advertisements in the media and direct mail to anyone registered on the OGTR mailing list. The RARMP and other related documents will be available on the OGTR website, or in hard copy from the OGTR.

Matters raised in submissions relating to the protection of people or the environment will be taken into account in finalising the RARMP, which then forms the basis of the Regulator’s decision on whether or not to issue a licence.





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http://www.bibliotecapleyades.net/salud/salud_vacunas172.htm
 
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Lisa P

Active Member
The vaccine was approved and a license issued on 10th April 2014.
http://www.ogtr.gov.au/internet/ogt...10ECBCA257CD1000D2AD1/$File/dir126notific.pdf

However there are some rubbish news articles doing the rounds again.

The fact is the Vaccine was to be given as a drink not sprayed from a plane as the article below suggests.

In this case the author appears to be Tami Canal from March Against Monsanto.
The article provides this link to the government website it is a shame Tami didn't read it.
DIR 126 is down in the lower right hand corner where it may be missed.
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/home-1


GMO Cholera Vaccine to be Released Via Aerosol Spray
By Tami Canal On February 23, 2016
The Office of the Gene Technology Regulator (OGTR) is on its way to approving a licence application from PaxVax Australia (PaxVax) for the intentional release of a GMO vaccine consisting of live bacteria into the environment in Queensland, South Australia, Western Australia and Victoria.
According to the regulator, it qualifies as a limited and controlled release under section 50A of the Gene Technology Act 2000 (the Act).
PaxVax is seeking approval to conduct the clinical trial of a genetically modified live bacterial vaccine against cholera. Once underway the trial is expected to be completed within one year, with trial sites selected from local government areas (LGAs) in Queensland, South Australia, Victoria and Western Australia. PaxVax has proposed a number of control measures they say will restrict the spread and persistence of the GM vaccine and its introduced genetic material, however there is always a possibility of these restrictions failing and infecting wildlife and ecosystems.
http://www.march-against-monsanto.com/gmo-cholera-vaccine-to-be-released-via-aerosol-spray/
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I thought it might be good to bump this post as I am feeling very frustrated seeing this hoax popping up in lots of different places. There is a March scheduled for late May 2016 so that could be a possible reason for the regurgitation.
 

Hofnarr

Member
The word Environment is a pretty bad choice. No wonder CT's are jumping on this, its just too easy to misunderstand, especially without further reading.

It still has the fear buzzwords 'GMO', 'cholera', and 'vaccine', so people will be easily riled.

not to mention "guinea pigs"...
 

Dan Wilson

Senior Member.
How have the GM live bacterial vaccine been modified?
The GM vaccine contains live genetically modified cholera bacteria, V. cholerae. Unmodified cholera bacteria produce a toxin and a protein (haemolysin) which can break open blood cells. The vaccine strain has been produced by deleting a part of the toxin gene and disrupting the haemolysin gene. As a result of the genetic modification, the bacteria cannot produce the cholera toxin molecule or the protein which breaks open red blood cells. The GM vaccine will not produce toxins or disease.
Content from External Source

Even if this bacteria were to get out into the environment, what would be the concern? A bacteria like this likely would not hold any advantage over wild type cholera species meaning it would be out-competed pretty fast and it is not even harmful to humans. Am I missing something in the objections?
 

Trailblazer

Moderator
Staff member
Even if this bacteria were to get out into the environment, what would be the concern? A bacteria like this likely would not hold any advantage over wild type cholera species meaning it would be out-competed pretty fast and it is not even harmful to humans. Am I missing something in the objections?
The phrase "genetic modification". Two words that extinguish rational thought.
 
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