Swine flu vaccines are safe and time-tested, experts assert

The first testing of both vaccines was performed on 3,000 volunteer recipients in eight laboratories at Baylor University, Cincinnati Children’s Hospital, Emory University, Seattle Group Health Cooperative, St. Louis University, University of Iowa, University of Maryland and Vanderbilt University.

It also is being tested on volunteers by the five firms licensed to make up to 250 million doses of the vaccine by next spring for the U.S. market — CSL Limited, Novartis Vaccines, Sanofi-Pasteur Inc., GlaxoSmithKline and MedImmune. “It is tested to see if it produces the level of antibody production in the blood that reaches the FDA standard,” said William Schaffner, an infectious-disease specialist at Vanderbilt. “It is also tested for safety in the volunteers, something I know a little bit about since I was one of the volunteers for this vaccine.”

On its Web site last week, the FDA posted the contents of the vaccines produced by the five companies, including copies of the long, multipage ingredient lists included with the doses at clinics. Schaffner said that like many everyday foods and medicines, they contain a number of vital chemical substances that could be toxic in large volume but are included in harmless, trace amounts. “If we looked at acetylsalicylic acid, (the active ingredient) in aspirin, taken in the current dosage it is an effective product that can relieve headaches and reduce fevers. Taken by the handful, it can have serious adverse events,” Schaffner said.

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