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December 18, 2002
U.S. IMMUNIZATION NEWS
"FDA Grants 'Fast Track' Status to VaxGen's Vaccine for HIV" Wall Street Journal (www.wsj.com) (12/16/02); Wetzel, Kara
VaxGen edged closer to its goal of marketing an HIV vaccine, as the Food and Drug Administration issued fast-track designations to the AIDSVAX B/B and AIDSVAX B/E vaccines on Monday, expediting the review process for final approval. The status is meant to address unmet medical needs for the treatment or prevention of life-threatening conditions and allows VaxGen to submit its biologics license application (BLA) as it is completed. Company spokesman Jim Key says VaxGen anticipates submitting a BLA application by late 2004, before which, however, the firm must have completed analyzing and processing Phase III trial data and completed the manufacturing facilities for licensing purposes as well. Early results of the AIDSVAX B/B trial--which involved 5,400 volunteers in the United States, Canada, the Netherlands, and Puerto Rico--will be released in the first quarter of 2003. Results of the AIDSVAX B/E trial in Thailand are anticipated for the second quarter of 2003.
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