FDA to give accelerated review to AIDSVAX

By Advocate.com Editors

Originally published on Advocate.com December 18 2002 1:00 AM ET

The Food and Drug Administration announced Monday that it has granted fast-track review status to VaxGen's experimental HIV vaccine AIDSVAX, currently wrapping up two Phase III clinical trials. The vaccine is being studied in the United States among men who have sex with men and in Thailand among injection-drug users. Nearly 8,000 people are participating in the clinical trials. VaxGen officials say the trials will be completed before the end of the year and that the company will have completed an examination of the trial data by the end of the first quarter of 2003.

"Once we have the data, we can seek a six-month priority review," said VaxGen spokesman Jim Key. If trial results are successful, AIDSVAX could be available for use by 2005. Early data has shown that the vaccine does convey some protection against HIV infection but that it is not 100% effective. Industry analysts have said that because of this, the vaccine will be useful only for groups at high risk for HIV infection, including residents of developing countries.