Testing for H1N1 flu vaccine under way in Utah
By Ed Yeates
SALT LAKE CITY — An advisor to the Centers for Disease Control and Prevention says protecting the public against the new swine flu later this year could potentially involve “the largest mass-vaccination program in human history.”
Manufacturers are racing to meet the deadline, including testing volunteers here in Utah, to make sure the vaccine works safely.
The H1N1 virus has already hit hard, making ready for a return visit this flu season. In fact, the World Health Organization projects 2 billion people–one-third of the earth’s population–could be infected within two years.
That’s why testing clinics, like Jean Brown Research in Salt Lake, are moving rapidly to test the new swine flu vaccine on volunteers.
“It’s pivotal, it’s crucial that we get this information back to the drug companies so they can submit it to the FDA,” said Matt Longson, with Jean Brown Research.
Volunteers sign informed-consent documents, go through extensive screening–including physicals and blood draws–then each participant gets a shot. The process involves not just the initial first-day, three-hour session, but a 25-day follow-up as well.
“After they’ve had the vaccine, we’ll do another blood draw to see whether they’re getting antibodies in their system,” Longson explained.
The clinic will also stay in contact with these initial test participants throughout the flu season.
Because of research protocol, KSL News could not use names or show dosages of the volunteers; most will get the new vaccine, but some will not. Again, this is an experimental trial, meaning the volunteers do not know whether they’re being injected with the real vaccine or just a placebo.
Right now, for H1N1, testing clinics are conducting double-blind studies. Does the vaccine work effectively? What about side effects?
One volunteer said, “They want to know if you have a fever, if you have extreme swelling around the site of the injection.”
“Any side effects of a normal flu,” added another volunteer.
Most of the people we talked to believe they’re sort of setting the stage in these trials–a stage that awaits the really big production.
A third volunteer told us, “I think pandemic in a word scares us all, so I think it’s important to realize we can be helped. We don’t need to panic.”
H1N1 has certainly changed the landscape. If there’s enough vaccine to go around, some may need three shots for full protection: the new H1N1 shot, a booster NS the regular seasonal flu shot.
Jean Brown Research begins pediatric clinical trials for the new vaccine this Wednesday for kids 6 months to 9 years of age; adult clinical trials continue for those 18 years and older.
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