Wed, Jan 13, 2010 - Page 8 News List

Time for Adimmune to show data

By Mayo Kuo 郭明裕

While Adimmune Corp’s production of vaccines is the concern of the company and the Food and Drug Administration, vaccination policy is jointly managed by the Department of Health (DOH) and the Centers for Disease Control (CDC). The government departments that oversee production and use of vaccines are on an equal footing, neither being subordinate to the other, and the relationship between the vaccine maker and the government being one of buyer and seller.

Former health ministers have voiced their support for the government’s swine flu vaccination program — Chen Chien-jen (陳建仁) by volunteering for a flu jab and Twu Shiing-jer (涂醒哲) by saying that he hoped everyone would get vaccinated. The vaccines are supplied by two companies — Adimmune and Novartis — and they do not have the right to be partial to one or the other.

Adimmune chairman Steve Chan (詹啟賢), also a former health minister, has criticized Minister of Health Yaung Chih-liang (楊志良) for being unwilling to publish vaccine test data. This is a question of government and business taking a different approach.

When Novartis was having difficulty supplying enough vaccines to meet demand, the DOH and the CDC had no choice but to approach Adimmune as the only other possible supplier.

Now that both Novartis and Adimmune are able to supply adequate amounts of the vaccine, it is time to shore up public confidence by publishing clinical test data on the two companies’ vaccines. Novartis’ A(H1N1) vaccine test report can be found in the Sept. 11, 2009 and Dec. 31, 2009 issues of the New England Journal of Medicine.

Any adverse reactions following administration of the vaccine should be announced in a timely manner, and statistics should be compiled of mild and severe reactions.

The occurrence of severe reactions should be weighed against the death rate for A(H1N1) in the whole population (six in 100,000). If the disadvantages of immunization outweigh the advantages by a statistically significant margin, then the newly established Food and Drug Administration (FDA) should intervene and investigate. If the FDA finds this task to be beyond its limited capabilities, then it should invite experts from overseas drug administrations to help out.

In 1976, when the US instituted a program for the whole population to be vaccinated against swine flu, there were 743 cases of severe adverse reactions, including 67 deaths. The vaccination program started on Oct. 1 of that year. As severe reactions were reported one after another, and given the fact that the human mortality rate from swine flu was not as high as expected, the program was terminated on Dec. 16. A New York Times opinion piece described the affair as a “sorry debacle.”

Although science and technology are more advanced today than they were then, Adimmune should take what happened 34 years ago as a warning. The company must face the risk of allergic and autoimmune reactions such as death, semiplegia, rheumatoid arthritis and acute facial palsy and publish data about severe reactions so they can be compared with equivalent figures from the US and figures for severe reactions to the Novartis vaccine in Taiwan.

Since 1998, when I was involved in the CDC’s establishment and promotion of the flu vaccination program for people aged 65 and over, I have watched the CDC gradually mature in its efforts to prevent enterovirus and influenza.

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