Biodefense experts: vaccines 'at a crossroads'.

• Author: Davidson, Margaret
• Position: GERM WARFARE

A budding U.S. biodefense industry--working largely without the major pharmaceutical companies--is working on medical countermeasures intended to treat deadly agents. But many of the companies seeking government funds for biodefense work are small firms with no experience in bringing a drug to market. They face a significant challenge.

"I see an emerging new industry, new capabilities" in the medical biodefense field, says Vidadi M. Yusibov, executive director of the Fraunhofer USA Center for Molecular Biotechnology in Newark, Del., who oversees work on vaccines and therapeutics administered in edible plants.

Ninety-five U.S. companies are working on vaccines or therapeutics to combat bioweapons, according to a 2005 report by BioAbility, a provider of biotechnology- related information services located in Research Triangle Park, N.C. However, a large portion of those biodefense products are still just in the pre-clinical stage of development.

Since the 9/11 attacks, the federal government has dramatically increased funding to help create such products. For instance, funding for biodefense by the National Institute of Allergy and Infectious Diseases (NIAID) increased from $3.2 million in fiscal year 2001 to an estimated $ 561.51 million in fiscal year 2005. Project Bioshield legislation enacted last year provided $5.6 billion over the next 10 years to help generate medical countermeasures.

The president's requested fiscal year 2006 budget calls for $4.77 billion for civilian biodefense for the Departments of Homeland Security and Health and Human Services, in addition to funds for biodefense provided under Project Bioshield.

Experts say at least 50 biological agents are potential bioweapons. The development of a medical response to protect against them is an expensive and slow process. The estimated cost of creating a new vaccine is about $800 million, and takes typically about 10 years or more.

Government officials have created priority lists of pathogens of greatest concern, and further assessment of threats is under way. The only licensed biodefense vaccines being manufactured in the United States are against anthrax and smallpox, and each of those has shortcomings that companies are working to overcome in new vaccines.

Only a few companies are working on biodefense countermeasures as their only product. Instead, they frequently are drawing upon work on their other products. For some, government funds available for biodefense have helped ensure their survival after recent years of bad economic times.

"I'm not yet convinced there is a sustainable industry only in biodefense," says Una S. Ryan, president and chief executive officer of Avant Immunotherapeutics...