The U.S. Food and Drug Administration has approved changes to the application of the only government-approved anthrax vaccine, its maker announced Friday (see GSN, Oct. 1).
BioThrax can now be administered in five doses over 18 months through the muscle, rather than in six doses under the skin over the same time period.
The agency based its decision on an interim analysis of a Centers for Disease Control and Prevention study that began six years ago. The ultimate goal of the study is to determine whether sufficient immunity to anthrax can be produced through three shots over six months, with booster doses applied up to every three years afterward.
The data analysis is due for completion next year, after which Maryland-based Emergent BioSolutions might request that the government authorize further reductions in the minimum mandatory number of anthrax vaccine doses (Emergent BioSolutions release, Dec. 19).