HHS plans include expansion of BioThrax
HHS expects two novel influenza vaccines and possibly a next-generation anthrax vaccine will be on the market within the next five years, according to CIDRAP News.
The department's 2012 Public Health Emergency Medical Countermeasures Implementation plan includes an outline for the development of medical countermeasures to counter anthrax, smallpox, pandemic influenza, botulism and other dangerous biological threats.
The plan says that the U.S. Biomedical Advanced Research Development Agency, which is part of HHS, will offer its support to the development of at least two novel drugs through the completion of their phase III clinical studies between 2015 and 2017, CIDRAP News reports.
BARDA predicts that a next-generation anthrax vaccine will become available sometime in the same timeframe. Several of the candidates in the pipeline are recombinant protective antigen vaccines.
The agency also plans to support the expansion of the domestic manufacturing capacity of the current anthrax vaccine, BioThrax, which is produced by Emergent BioSolutions, Inc. The expansion effort includes the validation of new manufacturing processes, conducting additional studies and pursuing the licensure of a new facility. BARDA is also hoping to expand the indications for BioThrax so that they include postexposure prophylaxis and an extended shelf life.
The U.S. National Institutes of Health, also part of HHS, is also supporting the continued development of anthrax countermeasures. NIH wants to improve the existing vaccine by developing and testing adjuvants to improve efficacy and performance.
BioThrax, the only anthrax vaccine approved by the U.S. Food and Drug Administration, is currently given to members of the U.S. military who serve in areas of the world considered high-risk.