The nation’s only human vaccine manufacturer said it is conducting clinical trials to establish a databank on the efficacy and safety of locally produced seasonal influenza vaccines.
“Clinical trials will involve about 350 people in various age brackets to assess the effectiveness and side effects of our influenza vaccine,” Adimmune Corp spokeswoman Shen Ya-hui (沈雅慧) said.
Taiwan usually imports its flu vaccine from abroad, but few foreign vaccine manufacturers have ever conducted clinical tests on Taiwanese people to evaluate their response to the products, Shen said.
As a result, she said, there is no data or information about the level of protection the imported flu vaccines provide Taiwanese people.
Taking influenza A(H1N1) as an example, foreign studies have shown that older people might have immunity rates of about 30 percent because of the greater chance that they were infected with a less virulent form of the virus in the past, she said.
However, Shen said, clinical studies conducted by Adimmune have shown that only 3 percent of Taiwanese are immune to H1N1.
The company’s new vaccine will be able to protect local people against the virulent and sometimes fatal H1N1 form of the virus because it contains one of the virus strains that was prevalent in Taiwan last year, she said.
Shen said that Adimmune is conducting the clinical trials among both adults and children, with tests on 120 adults in two age brackets — those aged 18 to 60 and those older than 60. The trial began on Aug. 9.
The pediatric clinical trials, which will be conducted among children in three age brackets — those aged between six months and three years; those aged between three and nine; and those aged between nine and 18 — are scheduled to start later this month.
Shen added the company will also conduct trials on those aged between six months and one year in order to establish an extensive information databank on vaccine efficacy and safety.
Since the publicly financed influenza immunization program will be launched in mid-October, Shen said the Adimmune will complete a mid-term report on the results of the clinical trials before the program’s launch.
Afterward, the company will continue to monitor the sustainability of its vaccine’s effectiveness and track any possible side effects.
“We will come up with final reports in February, June and August next year,” she said, adding the company hopes its clinical research will help enhance people’s confidence in its product.
The Department of Health has already placed an order for a total of 3 million doses of influenza vaccines from three companies — Sanofi-Aventis, Novartis and Adimmune — for the free immunization program.
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