curly

This is scary stuff, of which you would expect to see in films, however it's real.

Receipt of licence application (DIR 126) from PaxVax Australia Pty Ltd for a clinical trial of a GM cholera vaccine.

The Office of the Gene Technology Regulator (OGTR) has received a licence application from PaxVax Australia Pty Ltd (PaxVax) for the intentional release of a genetically modified (GM) bacterial vaccine into the environment (DIR 126), which qualifies as a limited and controlled release under section 50A of the Gene Technology Act 2000 (the Act).

PaxVax is seeking approval to conduct a clinical trial of a GM 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. The trial will involve the inoculation of approximately 1000 children and adults. The applicant has proposed a number of control measures to restrict the spread and persistence of the GM vaccine and its introduced genetic material.

PaxVax has indicated that a Clinical Trial Notification will be submitted to the Therapeutic Goods Administration, and that they will be applying to Department of Agriculture for a permit to import the vaccines.

http://realnewsaustralia.com/2013/11...-in-australia/
http://www.ogtr.gov.au/internet/ogtr...6ebnotific-htm

curly

Map of trial sites

http://www.ogtr.gov.au/internet/ogtr...sf/Content/map

curly

https://secure.avaaz.org/en/petition...ralia/?sRNKweb

curly

And these are the people responsible for unleashing cholera on places including Toowoomba, Moreton Bay, Cairns (QLD), Glenelg, Southern Grampians (Vic), ACT, Moree Plains, Narrabri (NSW), Marion (SA), Corrigin (WA) are just a few of the places. For the full list see here: http://www.ogtr.gov.au/internet/ogtr...sf/Content/map

These are the people responsible: http://www.health.gov.au/internet/ma.../gene-gtmc.htm

fish.01

More info from govt about trial for those interested:


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.


See: http://www.ogtr.gov.au/internet/ogtr...t/dir126qa-htm

northernbird

Why on earth do we need a cholera vaccine in Australia??

carolinephillips

It said it was for Australians who were going to travel overseas.

Japonica

My first question is then why test it here. Most of the large pharma companies have outsourced their testing and clinical trials to developing nations. Whatever you think of that practice, it strikes me as a bit odd that a vaccine meant for overseas travellers to places that have endemic cholera needs to be tested in Australia. Seems strange.

Also, control measures to limit spread? That worked so well for GM crops. It's a live virus vaccine, so I assume it can be potentially spread through sewage. Are current facilities equipped to deal with these types of issues?

michael_w

Why is it scary stuff? Genetically modified cholera vaccine has been around for a decade and there are no major safety concerns. The GM vaccine was evaluated in 2003 and found to have negligible risk. It's not going to introduce a mutated version of lethal cholera into Australia. The proposal is to carry out a clinical trial of a similar vaccine from a different manufacturer. Where is the scientific evidence that this poses any threat to human or animal health?

lesleys

Like the UK. When I was working I had to have a cholera jab every 6 months so I was always ready to travel. You couldn't get into a lot of countries without the vaccination certificate. Even if you were going to a non-cholera country and had recently been to a country with cholera you still needed the certificate.

I've no idea how long a cholera jab lasts these days as I'm no longer going to dodgy destinations.

Luma

It may do the opposite

spouse of scouse

What the....? If adults who have the capacity to made informed decisions want to put their hand up, great. But children???

Swerv-o

Because anything that is genetically modified is inevitably bad, in the same way that anything remotely nuclear is also bad. Get with the picture!


S

carolinephillips

IMO It is easier to test the vaccine in a developed country where cholera is not present, as it eradicates the chance that (if the subjects do develop cholera, or other symptoms,) they have caught it from being exposed to the real stuff outside the clinic.

lesleys

Don't forget the chemicals