Summaries of health policy coverage from major news organizations
VaxGen Officials Say AIDSVAX Trial Results ‘Accurate’
VaxGen officials yesterday said that their analysis of their AIDSVAX vaccine trials is "accurate as stated," the San Jose Mercury News reports. The company released the statement amid controversy over their interpretation of data released Monday, which said that the new vaccine may be more effective in blacks and Asians than in others (Jacobs, San Jose Mercury News, 2/28). The company said that the vaccine reduced the rate of new HIV infections by only 3.8% overall, but said that 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. But the analysis has been criticized by outside scientists because it is based on only 29 HIV infections among vaccinated participants in that subgroup and those who received a placebo. Although the company originally said that it made adjustments to reduce the statistical significance of results obtained from parsing out a large set of data, Lance Ignon, vice president for communications at VaxGen, said on Wednesday that the company did not take such penalties (Kaiser Daily Reproductive Health Report, 2/27). However, in a press release issued last night, company officials said that VaxGen's analysis was based on FDA requirements that had been agreed on in advance. Within these parameters, the number of adjustments required for analyses of subgroups, such as ethnic and racial subgroups, is "subject to interpretation," according to Dow Jones Business News. In addition, a "variety of methods" exist to calculate such adjustments under the FDA statistical analysis plan (Dow Jones Business News, 2/27). VaxGen said that it will continue to analyze the data in order to determine the vaccine's efficacy in preventing HIV transmission in the various subgroups (VaxGen release, 2/27).
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