Coalition of AIDS Advocacy Groups Call for NIH Review of AIDSVAX Trial Results
A coalition of AIDS advocacy groups has called for NIH to conduct an independent review of the clinical trial results of VaxGen's experimental AIDS vaccine AIDSVAX, the San Francisco Chronicle reports (Tansey, San Francisco Chronicle, 3/31). VaxGen late last month announced that AIDSVAX reduced the rate of new HIV infections by 3.8% among people who received the vaccine, compared with clinical trial participants who received a placebo injection, but said that the vaccine was effective among African Americans, Asians and other non-white, non-Hispanic volunteers. In a subgroup of 498 non-white, non-Hispanic volunteers the vaccine appeared to provide protection in the range of 30% to 84%. According to the company, the analysis had less than a 1% chance of being random chance, making it statistically significant (Kaiser Daily HIV/AIDS Report, 3/11). In a letter to Dr. Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, the coalition said that VaxGen should release its AIDSVAX data to an outside NIH panel to clarify the company's claims about the potential benefits of the vaccine to certain racial groups. "If such effects are real, they need to be followed up on with further research," the letter said, adding, "If they are the result of an artifact, the public needs to be informed of this expeditiously so researchers and the affected communities can move on to explore more promising vaccine approaches." Fauci said that he plans to convene a panel that would honor the advocates' request for significant minority representation. VaxGen said that it would cooperate with an NIH review, according to the Chronicle. Further analysis of the company's AIDSVAX clinical trial data today will be released at the Keystone Symposia in Canada. The company also faces a series of shareholder lawsuits alleging that the company "puff[ed] up weak data" on the potential benefits to minority groups in an effort to "cushion the inevitable price drop" of its stock after announcing the trial results, the Chronicle reports. VaxGen denies those claims (San Francisco Chronicle, 3/31).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.