Australian Gov to Begin GMO Cholera Vaccine Trials on Citizens
by Susanne Posel
November 18, 2013
PaxVax Australia has applied to the Australian Department of Health Office of the Gene Technology Regulator (DHO-GTR) to use a “genetically modified live bacterial” anti-cholera vaccine.
The genetically modified Cholera bacterium would be part of a vaccination initiative for trials to be conducted for 1 year “from date of approval”.
PaxVax claims that “a number of control measures to restrict the spread and persistence of the GM vaccine and its introduced genetic material.”
The application explains that “the parent organism Vibrio cholera is the causative agent of the gastroenteritis disease known as cholera, which is typically linked to the ingestion of contaminated water. Cholera is found in aquatic environments in tropical areas and has been isolated in some parts of Northern Australia.”
The locations chosen for the “clinical sites” are Queensland, South Australia, Victoria and Western Australia.
According to the DHO website: “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.”
To test the efficiency of the vaccine, “1000 individuals in Australian” children and adults will be inoculated with the GM Cholera.
The Australian government will employ “trained nurses and/or physicians at health care facilities” to conduct the vaccinations.
The current Cholera vaccine called Dukoral , is an oral vaccine that “contains a mixture of inactivated Vibrio cholerae bacteria (the bacteria that cause cholera) and a non-toxic component of the toxin that these bacteria produce.”
Dukoral “does not provide 100 per cent protection against cholera.”
It is recommended not to use Dukoral if the patient has:
• Allergy to formaldehyde
• Acute feverish illness
• Acute stomach or intestinal illness
• Not recommended for children under two years of age, as its effectiveness has not been studied in this age group
Known effects of Dukoral include:
• Abdominal pain
• Blocked nose passages
The Army Medical Research Institute of Infectious Diseases at Fort Detrick accessed the viability of genetically engineered vaccines; stating that “it is unlikely that a recombinant vaccine will be developed to replace an existing licensed human vaccine with a proven record of safety and efficacy.”
The report published by the IID explained: “Although recombinant subunit vaccines hold great promise, they do present some potential limitations. In addition to being less reactogenic, recombinant subunit vaccines have a tendency to be less immunogenic than their conventional counterparts.”
To combat this problem, the report suggests using “one of the many new types of adjuvants that are becoming available for use in humans.”
It is concluded that: “In lesser developed countries, where the prevalence of disease and the need for effective vaccines outweighs the risk associated with their administration, live vaccines may play an important role in human health.”
PaxVax “is a privately held” vaccine manufacturer that was “established in 2007, in response to the global threat of the H5N1 pandemic.”
The corporation is “committed to providing both attractive financial returns and social returns . . . in terms of return on equity . . . [and] access to our vaccines globally, particularly to the poor and otherwise disenfranchised.”
Financial contributions to PaxVax have been provided by:
• Ignition Ventures
• Ignition Growth
• The Wellcome Trust
• National Institutes of Health (NIH)
• NIH of Allergy and Infectious Diseases (NIAID)
• NIH Division of AIDS (DAIDS)
• Bill & Melinda Gates Foundation (BMGF)
Seven years ago, the BMGF sponsored a clinical trial of an oral Cholera vaccine in India that affected an estimated 14 million people in 30 vaccination centers.
During the trial, 52,212 Indians received the vaccine and 55,562 were given a placebo.
Dukoral was used by the World Health Organization (WHO) and internationally licensed; however not in India.
With coordination by the International Vaccine Institute (IVI) and the Cholera Vaccine Institute (CVI), the BMGF began an “international drive to make cholera vaccines more widely available.”