Eight U.S. Cities Line Up for Swine Flu Vaccine Test
August 11, 2009 - 5:08 AMAbout 2,800 people will participate in the government-led studies that will test the safety and effectiveness of vaccines developed by drug makers.
Sharon Frey, who is leading the government-funded testing at Saint Louis University, said scientists have been working late nights and weekends to organize the studies and recruit volunteers.
"Typically it takes a year to do this," said Frey, an infectious diseases expert. "I can tell you we're working at breakneck speed."
About 2,800 people will participate in the government-led studies. Saint Louis University will test 200 adults and 200 children. Also under way are separate studies by five flu vaccine manufacturers under contract with the government.
Health officials expect to have about 160 million doses available this fall, with the first batch sometime in September. The studies will test the safety and effectiveness of vaccines developed by drug makers and help determine dosage and whether it can be given with a seasonal flu shot.
Participants will be given different combinations of two swine flu vaccines made by drug makers Sanofi Pasteur and CSL Limited and a seasonal flu vaccine.
Frey said the data will be turned around quickly for review by the Food and Drug Administration.
It's possible the government will begin a public vaccination campaign before all of the work of the trials is complete, Dr. Anne Schuchat has said. She oversees the flu vaccination programs at the Centers for Disease Control and Prevention.
Health officials are haunted by the swine flu vaccine campaign in 1976, which was stopped after unexpectedly high numbers of patients suffered a paralyzing condition called Guillain-Barre Syndrome. While it's not clear the vaccine was to blame, the government wants to carefully monitor people who get the new vaccine for any problems.
Nicholas Sarakas, 25, of St. Peters, Mo., is among the vaccine volunteers. As a young adult, he's among the groups targeted for the swine flu vaccine; swine flu has been harder on younger people than their elders.
"I thought, 'I'll end up getting a flu shot anyway,'" he said. "Somebody has to be the first person to try it."
The other study sites are Baylor College of Medicine in Texas, Children's Hospital Medical Center in Cincinnati, Emory University, Group Health Cooperative in Seattle, University of Iowa, University of Maryland School of Medicine and Vanderbilt University.
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