PaxVax applies to have GM cholera vaccine tested in Australia - But "Genethics" objects to Australia testing Solutions for Third World Disasters

Original ABC post by medical reporter Sophie Scott and Alison Branley Posted Mon 23 Dec 2013, 11:59am AEDT
Original nwes clip here: http://www.abc.net.au/news/2013-12-23/gm-cholera-vaccine-trial-draws-criticism/5172118

Australia could join a global trial of a new genetically-modified cholera vaccine which could save thousands of lives in the developing world.

United States-based vaccine company PaxVax is running a trial of the oral vaccine, and has applied to the Federal Government to run part of the trial in Queensland, South Australia, Victoria and Western Australia.

PaxVax says the single-dose vaccine has been genetically-modified to remove the part of the cholera bacteria that makes people sick.

It wants to use Australia as a trial site to test the vaccine on about 1,000 adults, and potentially children, planning to travel overseas to cholera-affected areas.

PaxVax chief executive Nima Farzan says the plan is to then expand the vaccine's use to developing countries.

Cholera is a worldwide health problem with 3 to 5 million cases and up to 130,000 deaths a year.

"Cholera is endemic in sub-Saharan Africa, cholera is endemic in parts of south Asia and even parts of Latin America," Mr Farzan said.

"Outbreaks can come quite rapidly. Cholera, if not treated, can be a fatal disease."

Mr Farzan says the vaccine is safe because it has been genetically-modified, meaning it cannot produce toxins or reproduce the cholera bacteria.

"The study in Australia will only be looking at the immune response or the antibody levels and the safety from taking this vaccine," he said.

"What we are measuring in the vaccine is anything that could come about local or systemic reaction that could come from the vaccine."

First World Worries First. Third World Realities Last
 -- "Genethical" approach to Third World Problems. 

However, anti-genetic modification campaigner Bob Phelps from the Gene Ethics Network says as cholera is rare in Australia, there is no justification for a mass vaccination program.

He is also concerned that people taking part in the trial will only be monitored for one hour.

"In the [company] application, there is no follow-up monitoring or proper surveillance," he said.
Doctors say 'no risk' vaccine will spread cholera in Australia

Victoria is one of the potential trial states. Its chief health officer Dr Rosemary Lester says there is a rigorous process to assess anything which is genetically modified, not just vaccines.

"The risk would be carefully assessed before the trial is allowed to go ahead," she said.

There's really no risk to people living in Australia.
Our sanitation and hygiene systems are so good. I would be very comfortable with that sort of trial going on.Victorian chief health officer Dr Rosemary Lester

Dr Lester says there is no risk of the vaccine spreading cholera to Australia.

"There's really no risk to people living in Australia," she said.

"Our sanitation and hygiene systems are so good. I would be very comfortable with that sort of trial going on."

Over the past five years, there have been 22 cases of cholera reported in Australia. Most of these were acquired in South-East Asia.

"In Australia, fortunately cholera is a very rare disease," Dr Lester said.

"It's almost always seen in returned travellers. We typically see about three to six cases per year in returned travellers," Dr Lester said.
Adverse reactions to vaccine infrequent, mild

Results of a phase one trial into the PaxVax vaccine found that a single dose created an immune response in almost 90 per cent of patients.

The company says the vaccine was well-tolerated, adverse events were infrequent, and generally mild.

Of 3,000 volunteers worldwide, 1,000 would be from Australia and the remainder from North America.

Cholera is a gut infection caused by consuming of food or water contaminated with the bacterium vibrio cholerae.

It usually presents quickly after infection and in extreme causes large amounts of painless, watery diarrhoea that can quickly lead to severe dehydration and death.

Most episodes are mild or moderate and similar to other stomach flus.

In Australia there is an existing travel vaccine which can prevent cholera that is typically given to health-vulnerable travellers, but it is a double dose regime which takes longer to complete.

The Federal Government's Office of the Gene Technology Regulator will seek public comment on the PaxVax trial after a risk assessment and risk management plan is released in late January.

The trial is expected to last 12 months.

@ PaxVax applies to have GM cholera vaccine tested in Australia - ABC News (Australian Broadcasting Corporation):