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H1N1 Swine Flu Vaccine: Australia to Conduct First Human Trials
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by Scott Wu | July 21, 2009 at 03:16 pm
851 views | 4 Recommendations | 1 comment
The World Health Organization has confirmed that more than 700 deaths worldwide have been caused by the swine flu pandemic.
Australia will be the first to begin human trials of an H1N1 vaccine on Wednesday, July 22. The tests will be conducted on 240 volunteers between the ages of 18-64. Participants will undergo blood tests after receiving two vaccine shots three weeks apart.
"We appreciate that new influenza strains like the 'swine flu' can surprise us with properties that mean they might require higher dosing and two injections rather than one to provoke the desired level of immune response in humans," said Dr. Russell Basser, global director of clinical development for CSL.
As September approaches, officials and parents worry that a wide spread infection among young children might happen as school starts. Vaccine makers have been rushing the testing process. However, the expected distribution day is still mid-October, 6 weeks after the school term starts. Members of the National Biodefense Science Board expressed the need to push the distribution date to mid-September even if safety and effectiveness data is not yet available.
In a teleconference Monday, the members of the National Biodefense Science Board made clear they think the process should be accelerated. The board's members agreed that vaccine makers should be asked to begin the preliminary steps toward producing vaccine on Aug. 15, before safety and effectiveness data is available.
The risks of vaccination is well documented. In 1976, the decision to vaccinate 43 million Americans resulted in 500 people came down with a rare neurodegenerative condition, and 25 people died. The outbreak never materialized. Ironicly, the dangers of vaccination might be over-blown by its effectiveness.
"In 1976, we ended up having lots of people vaccinated and then having only a small number of people who got sick," said Lillibridge. "If there's no disease killing people or hurting people then the side effects of the vaccine dominate attention."
Lipsitch added: "If there had been a major flu epidemic with tens of thousands of deaths in 1976, I don't think there would have been much of a concern that the vaccine caused side effects."
No one can guarantee the safety of the 600 million doses of vaccine before they are given to the public. However, public health experts point out the even greater danger for not proceeding with vaccination.
If we talk about relatively rare side effects on safety, by probability they will not show up until more people get the vaccine. This speaks to the need for continued surveillance. But, as far as efficacy and immediate reactions, we will have good information on that with the round of trials planned for this summer
More on the H1N1 swine flu coverage in the swine flu channel.
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Most RecentMost Recommended Comments (1)
at 18:44 on July 21st, 2009
I would not be a test subject for this.