Global Security Newswire

In December, the U.S. Health and Human Services Department retracted its call for specific proposals for a new and improved anthrax vaccine, complicating work already done by two Maryland biotechnology firms, the Gazette reported Friday (see GSN, Dec. 8, 2009).

Emergent BioSolutions in Rockville and PharmAthene in Annapolis have spent years developing their second-generation vaccine candidates with the hope of being awarded a federal contract from the HHS Biomedical Advanced Research and Development Authority. However, agency officials canceled their call for new vaccine proposals after determining that firms would be unlikely to have a vaccine ready for product licensing within eight years.

Health and Human Services instead said it would request new vaccine development outlines. At the end of December, the government said it would consider working with PharmAthene to develop SparVax. The next-generation vaccine candidate has already been tested on 700 people in two clinical trials.

"We look forward to working closely with BARDA to meet their needs and the critical needs of the Strategic National Stockpile as quickly as possible," PharmAthene CEO David Wright said in a statement last week.

A federal contract would cover production work efforts such as safety testing, according to the BARDA notice.

The only anthrax vaccine licensed by the Food and Drug Administration is BioThrax, developed by Emergent BioSolutions. It takes five doses spread over 18 months for the vaccine to deliver immunity. Emergent has previously said that its new candidate is in a good position to win a federal contract.

Washington wants an improved vaccine that does not require refrigeration and does not need as many doses as BioThrax to work (Gazette, Jan. 8).