Trials of a new GE vaccine must be fully contained. The experiments must not be used as an excuse to weaken regulation of GE or to push through environmental release of other GMOs in New Zealand.
The Environmental Protection Agency�s new Chief Executive, Dr. Allan Freeth, has just approved the release of a genetically modified (GMO) live vaccinia (smallpox) virus, Pexa-Vec, for clinical phase III trials. [1] This drug has yet to receive Medsafe approval, which includes consideration by a committee of the Health Research Council and an ethics committee, before it can be used in New Zealand.
Jennerex, the developer of Pexa-Vec [2] states that the experimental GM virus is �engineered to activate the white blood cells to produce a systemic immune response to kill tumor cells throughout the body. It uses the vaccinia (smallpox) stealth extracellular envelope form, allowing the virus to survive in the bloodstream in the presence of neutralizing antibodies.�
GE Free NZ has concerns over how Medsafe effectively contain the trials to prevent potential harm from viral shedding or transfer to the families of patients or the wider community.
There is also concern that the government, to justify release of GE animal, crops and trees in New Zealand, is cynically exploiting this contained GE drug trial.
"It would be cynical for the government to use the vaccine trial to promote the release of GE in New Zealand�, said Jon Carapiet, spokesman for GE-Free NZ
�Preservation of our GE-Free growing environment continues to advantage our farmers and food and beverage exporters".
The smallpox-derived trial drug�s adverse effects include - flu like symptoms; pustules, lesions, and breathing difficulties that show a heightened immune response. Containment is vital to prevent symptoms like cough, cold and fevers that spread the virus. The Small pox virus killed over 300 million people world wide in the 20th century.[3]
Public safety demands good quarantine of subjects for the time they are undergoing these trials. It is important to prevent any escape of the virus to the community at large, as the potential effects are unknown.
References: [1] http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/APP202601_APP202601_Decision.pdf [2] http://www.marketwired.com/press-release/jennerex-announces-completion-enrollment-phase-2b-clinical-trial-pexa-vec-treatment-1793251.htm
[3] Epidemics: small pox http://www.infoplease.com/cig/dangerous-diseases-epidemics/smallpox-12000-years-terror.html
ENDS: Jon Carapiet 0210507681 Claire Bleakley 027 348 6731 / 06 3089842 |