Lab to produce 7.5 mil. vaccine doses by Oct.

TAIPEI, Taiwan -- A newly-built vaccine plant is set to make available 7.5 million doses of a vaccine against the influenza A(H1N1) virus, better known as swine flu, before Oct. 10 this year, the chairman of the biopharmaceutical firm Adimmune Corp. said yesterday.

Specialists at Adimmune Corp.'s vaccine processing plant in Tanzih township, central Taiwan are currently experimenting with a virus strain that was provided by four World Health Organization (WHO)-authorized labs in Australia, Britain and the United States, Steve Chan told the CNA in an exclusive interview.

Adimmune, the only human vaccine manufacturer in Taiwan, is scheduled to complete the experimental process and decide on a vaccine strain for mass domestic production by the end of August, said Chan. This would pave the way for animal and human trials of the A(H1N1) vaccine in September, he added. Chan, who served as Taiwan's health minister between 1997 and 2000, said the human clinical trials are scheduled to be completed by the end of September, giving the vaccine producer enough time to begin mass producing the A(H1N1) vaccine around Double Ten National Day on Oct. 10.

If all goes according to plan, Taiwan will become the 12th country in the world capable of producing A(H1N1) vaccines, he said.

Adimmune's Tanzih plant, in working toward this goal, will advance its original launch schedule by 18 months, as it had planned to begin mass production of vaccines against normal influenza in 2011 for export, he added.

The Tanzih plant, inaugurated in mid-June, is ready to ramp up production of the A(H1N1) vaccine to fill the orders placed by the Department of Health, as the WHO has declared the A(H1N1) swine flu a pandemic, which portends a growing demand for the swine flu vaccine worldwide, Chan said. He quoted international health specialists' estimates that in case of a global outbreak of swine flu, about 400 million to 800 million people around the world will become infected.

Chan said he is confident that Adimmune — the largest vaccine producing company in Asia with a maximum annual capacity of 30 million doses of vaccine — is capable of meeting the deadline. "The company is actually working as a national lab to produce the vaccine in an emergency mission," Chan said.

Adimmune is partly controlled by the government and 20 percent of its founding capital was contributed by the National Development Fund, which is supervised by the Executive Yuan.

With Adimmune's rush to produce the A(H1N1) vaccine on schedule, it cannot spare the time it would take to acquire the chicken eggs in which vaccines are usually produced, as the eggs have to meet specific local and international standards, Chan explained. Instead, Adimmune will produce the vaccine based on the cells of chicken embryos.

According to Chan, the National Laboratories of Foods and Drugs will begin inspections of Adimmune's Tanzih plant from Monday to check whether it conforms to Taiwan's Good Manufacturing Practice (GMP) standards.

WHO representatives are also expected to visit Taiwan soon to inspect the plant's facilities and its operations, he added.

Chan brushed off doubts in some quarters that the plant may not be able to produce quality A(H1N1) swine flu vaccines because of the rush. Adimmune Deputy CEO and President Ignatius Wei has said that he will volunteer to receive the first vaccine that the company's lab produces, Chan said.

Liao Chi-chou, director of the Bureau of Pharmaceutical Affairs under the Department of Health, has also volunteered to be inoculated first once the Adimmune swine flu vaccine is approved by the bureau, Chan added.

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Comments
July 1, 2009    thunderthunder@
Very interesting; this plant that has no experience whatsoever in producing cell cultured vaccines is as the first plant in the entire world to produce the vaccine based on cells from chicken embryos?! That is one hell of an experiment with the people of Taiwan! And the plant is not even GMP certified, not to speak of FDA or EMEA approved. Steve Chan is so driven and guess who is to be the test animals? We are!
Before I even consider taking this vaccine I want Steve Chan and his entire family to take it first, then the entire Executive Yuan with family members, then the Legislative Yuan - and then wait for 4 weeks before I even consider taking it.
Let not camaraderie and politics rule in such an important case. Please, someone - listen up! This is madness!
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 Lab to produce 7.5 mil. vaccine doses by Oct. 
Steve Chan, chairman of Adimmune Corp., says his firm is set to make available 7.5 million doses of a vaccine for the A(H1N1) virus before Oct. 10. (CNA)

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