Second trials for the bird flu vaccine Fluvax set to begin

Published: 09/02/2009 05:00

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LookAtVietnam – Avian flu remains a threat to humans across the world. Viet Nam News spoke with Dr Nguyen Thu Van from the National Institute of Hygiene and Epidemiology about a project to develop a vaccine.

A newly-developed vaccine has to conduct trials on humans in many steps, on both small and large scales.

According to the World Health Organisation (WHO), a newly-developed vaccine has to conduct trials on humans in many steps, on both small and large scales. The first human trials, involving 30 volunteers, have achieved good results and now we are going to carry out a larger trial using 240 volunteers. The second test will be used to evaluate safety, the levels of antibodies and side effects and appropriate dose of the vaccine. If this larger trial has good results, the vaccine will be registered for mass production. However, we still have to research the effectiveness of the vaccine in post-marketing and post-licensing periods when it will be used by thousands of people or if an epidemic occurs.

The large-scale trial will be carried out in Thanh Hoa Province this month.

At the moment, I definitely think that the human trial will be successful.

How important is the vaccine?

If there is an epidemic of bird flu, all those at risk of catching it should be vaccinated. There are persistent outbreaks of bird flu every year across Southeast Asia.

The disease is not kept under control so it is particularly important to vaccinate people in good time to protect them against the virus. This is especially important for high-risk or vulnerable groups.

It has been five years since VABIOTECH started developing the vaccine. Is there a risk the vaccine will not be able to protect people against any new strains of the virus?

The WHO issues warnings about which strain of bird flu might occur each year. The virus can mutate seasonally and annually. It is important to administer the vaccine before an epidemic breaks out.

There are concerns that H5N1 will mutate, but to date all researches on virology and serotherapy show little mutation. At the moment H5N1 is more than 90 per cent the same as when it first appeared.

VABIOTECH, as well as other international companies, has used the original strain of the virus to develop the vaccine. I believe that the vaccine will still be effective in fighting bird flu.

One dose of Fluvax costs around US$2. Will the human vaccine project be profitable and of a comparable quality with vaccines developed by international groups like GlaxoSmith-kline or Sanofi Aventis ?

We haven’t thought about the profitable aspect of the project. When the vaccine is produced on a large scale we will need more financial investment.

A lot of people laugh when I tell them a dose of Fluvax costs only $2 when similar vaccines sometimes cost 10 times that in other countries.

We estimated that we would need about $10 million to invest in a new vaccine production facility. So the price of Fluvax may double or increase a little depending on the output contracts. However, the project is feasible and we will provide vaccines with a suitable price for Viet Nam and developing countries in the region.

I’m sure that the vaccine can compete with other companies’ vaccine in quality. The vaccine, developed from monkey kidney cells, employs the latest in world bio-technology. To date, there are VABIOTECH No 1 and BAXTER, an US company developing bird flu vaccine based on this kind of cell technology.

VietNamNet/Viet Nam News

Provide by Vietnam Travel

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