FDA seeks collaborator on oral anthrax vaccine project

The U.S. Food and Drug Administration Center for Biologics Evaluation and Research recently announced that it is looking for a partner to collaborate on the further development, evaluation or commercialization of an oral anthrax vaccine.

Currently, the only FDA-approved, licensed vaccine for use against anthrax is AVA BioThrax. BioThrax is considered effective, but also carries several limitations. The vaccine requires an 18-month period and six injections before conferring protective immunity. It also must be kept cold at all times and has been known to cause side effects.

The Department of Health and Human Service characterizes the vaccine, which is currently in pre-clinical development, as having a well defined vector. The vaccine can be manufactured relatively easily and potentially at a low cost. It is temperature-stable throughout the manufacturing process and can be distributed without a cold chain. In addition, as an oral vaccine, is can be administered rapidly and in emergencies.

The vaccine has been tested successfully on animals. Vaccinated mice have shown a 100 percent protection rate when challenged with aerosolized spores of Bacillus anthracism the bacteria that causes anthrax.

The HHS announcement was published in the Federal Register. Interested parties are asked to contact the FDA about the collaborative opportunity.