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.
In only a week, the Office of the Gene Technology Regulator had received so many emails from troubled Aussie citizens that it added a post to its website assuring the public that it had not yet issued a license to the company.
But if history is any indicator, the Aussie gene regulator will probably grant the license to PaxVax, just as it approved a license, in 2003, to the Australian Commonwealth Serum Laboratory (CSL) to release its genetically modified cholera vaccine, Orochol, into commercial use. The gene regulator declared, in its risk assessment document, that the risk of releasing the live genetically engineered cholera organism was ‘very low’ or ‘negligible’, despite several public submissions the regulator had received objecting to the release of the GMO vaccine into the Australian population and environment.
The popular outcry fell on deaf bureaucratic ears since the Orochol vaccine had already been experimentally tested on Australian travelers and on children in third world countries after the Therapeutic Goods Administration had fast tracked and approved the GMO product for commercial use 2 years before  the Gene Regulator had conducted its risk assessment and issued a license. 
Apart from the strangely reversed methodologies used by Australian regulators, many pundits asked why the Australian Commonwealth Serum Laboratory would be acting on such an urgent need to produce millions of experimental GM cholera vaccines for the Australian population when it was not a pressing public health issue.
Cholera is endemic in third world countries and spread by water born bacteria to populations living in areas with poor sanitation. It causes a fever, explosive fluid diarrhea leading to rapid dehydration (with a fluid loss of up to 1 liter per hour) and if left untreated, the infection’s death rate is up to 40%.
Australia has not seen a home grown case of cholera for the past 35 years and according to the WA State Government website: ‘There has not been a case of cholera acquired in Australia since 1977’, with the only cases being ‘seen in travellers arriving from countries where the disease is still present, such as Africa, Asia, Latin America and Central Europe’.
In countries where the disease is still endemic, several safe and effective oral and injectable vaccines are available that have reduced the disease burden from many endemic areas. Cholera vaccines were among the first developed and used since the late 19th century, and until the cholera bacteria’s recent genetic laboratory manipulations, they have been derived from the wild cholera strains that occur in natural disease outbreaks. 
Since the Gene regulator’s announcement to test another experimental GM cholera vaccine, some Australian health practitioners are asking why yet another cholera vaccine is being developed when so many are already available and in common use, while others question the safety of a vaccine that is derived by genetically engineering the wild cholera bacteria into an entirely new ‘strain’ of the disease. Activists claim the key to that question is because biotech companies cannot easily patent a naturally occurring micro-organism, and can only financially exploit its properties when patents are in effect.
Whatever the case, genetically engineered vaccines have infiltrated global markets to claim an increasing market share through smart Madison Avenue marketing that has convinced governments to add them on to the already overflowing vaccination schedules for infants and children. An example of marketing efficiency is Recombivax HB, the first human vaccine produced by genetic engineering and approved by the FDA in 1986. Without a demonstrated need, this hepatitis B vaccine has been marketed to doctors for use in day old infants and children for a disease that is almost exclusively found in adults pursuing high risk sex or illicit drug lifestyles.
Since then, the big five biotech companies; Merck, Pfizer, Novartis, SGK, and Sanofi Pasteur have dozens more recombinant vaccinations under development pending regulatory approval, while a smaller bio-tech, PST, has released a GM influenza vaccine containing genetic material from the fall armyworm, scheduled for release in 2014.
The most notable GM vaccines already on the market include: Gardisil (Cervarix), licensed in 2006, prepared from virus-like particles and insect DNA. The Rotavirus vaccine was licensed in 2006 for infants and children, and is made from live human or human-animal hybrid rotavirus strains.
Meanwhile, studies are emerging that link Guillain-Barre Syndrome (ascending paralysis) and multiple sclerosis (MS) to genetically engineered hepatitis B vaccine, as well as reports of central nervous system demyelination (brain cells stripped of their insulation) following the GM vaccination. The Gardisil vaccination has also been associated with blood clots, at least 18 deaths from pulmonary embolism, fainting and pain syndromes in young women and girls, and has been taken off the list of recommended vaccines in Japan for girls 12-16 pending further safety data.  The genetically engineered rotavirus vaccination containing monkey and bovine DNA (Tetravalent Rhesus Rotavirus Vaccine) encountered trouble after its release when, after 1 million doses were given, it was linked with an increased rate of potentially fatal bowel obstruction (intussusception) and other gastrointestinal illnesses in children and infants, and withdrawn from the market. 
The office of the Gene Technology Regulator of the Australian Federal Department of Health is currently processing the PaxVax application for a license to release its GM cholera vaccine to Australian adults and children and it will be accepting submission from the public in January, 2014.
Anyone interested in making a submission can research the current issues underlying GM science here: http://www.i-sis.org.uk/GM_Science_Exposed.php
Full details of the PaxVax submission to the Gene Regulator here:
Address your submission to: Dr Joe Smith
Gene Technology Regulator
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: OGTR Website
 DIR 033 http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/DIR033-2002 (Page 23)
 On April 17, 2000
 DIR 033 http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/DIR033-2002 (Page 17)
 Hernán, M. A., Jick, S. S., Olek, M. J., & Jick, H. (2004). Recombinant hepatitis B vaccine and the risk of multiple sclerosis A prospective study.Neurology, 63(5), 838-842.
 Herroelen, L., De Keyser, J., & Ebinger, G. (1991). Central-nervous-system demyelination after immunisation with recombinant hepatitis B vaccine. The Lancet, 338(8776), 1174-1175.
Eve Hillary BHSc, MA. is a writer tracking past, present and future trends in health care. www.sarahs-last-wish.com