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Anthrax: U.S. Company Receives FDA Approval to Begin Testing New Vaccine A U.S. company has received Food and Drug Administration approval to begin testing a new anthrax vaccine (see GSN, Oct. 4, 2002). VaxGen plans to conduct Phase I human clinical testing of its vaccine on 100 volunteers beginning next month, according to the company. The trials will be carried out at four medical centers — Baylor College of Medicine, Emory University School of Medicine, Johns Hopkins University and St. Louis University Health Sciences Center. The tests will compare the safety of VaxGen’s new vaccine with that of the existing anthrax vaccine. The tests are also intended to evaluate the efficacy of the new vaccine by comparing human immune responses with those immune responses shown to protect animals from inhalation anthrax, company officials said. “The ability to begin Phase I clinical trials advances our ultimate goal of supplying the next-generation anthrax vaccine to the U.S. and foreign governments, as well as private markets,” company Chief Executive Officer Lance Gordon said in a statement (VaxGen release, May 27).
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