Production of an (A)H1N1 flu vaccine will begin today and the vaccine will hit the market by mid-November if clinical trials and the certification process go as planned, state-sponsored Adimmune Corp said yesterday.
Adimmune, otherwise known as Kuo-kwang Biotechnology Co, won a bid tendered by the Centers for Disease Control (CDC) last month to produce 5 million doses of (A)H1N1 vaccine at NT$199 each.
Adimmune deputy chief executive officer and president Ignatius Wei (魏逸之) told reporters yesterday that the company would begin injecting chicken embryos with a strain of the type A flu virus created by New York Medical College, the first step toward mass production of type A (H1N1) vaccines.
Once mass production is underway, clinical trials can begin, Wei said
The trials will be conducted by Huang Li-min (黃立民), a professor at National Taiwan University Hospital and chief of the infectious diseases division in the pediatric department.
“We will conduct clinical trial with 200 adults — half of which will be under 60 years old, and half above,” Huang said.
Following the dosage used in seasonal flu vaccines, half of the tested shots will be 15mg and the other half will be 30mg, he said.
“We are quite certain that one of them, or both, will work,” he said.
As the principle investigator of the clinical trials he needs to maintain a neutral position in terms of the drug candidates, Huang said.
“I really hope it works ... Of course, the hospital will not be working on a vaccine that we think will not work,” he said.
Given that the world’s vaccine production capacity is 900 million doses annually, it would be difficult for everyone on earth — about 6 billion people — to be vaccinated, he said.
The bad news is that swine flu is already beginning to spread, Huang said, adding that he has seen many people in his outpatient practice with the virus.
Contrary to predictions that swine flu will not begin to spread widely until the weather cools down in the fall, Huang said: “When a virus is strong enough, it will spread regardless of the temperature.”
Depending on foreign companies for type A flu vaccines would be a long shot, so Taiwan must produce its own vaccines, he said.
Given the skepticism over Adimmune’s decision to begin mass production of its vaccine even before the clinical trials are complete, Wei said: “Mass production must begin as soon as possible. Time is not on our side.”
A 200-person trial is already a larger test than what the WHO deems necessary, because the WHO considers the type A flu a common flu virus, therefore tests for its vaccine do not need to follow procedures for brand new drugs, he said.
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