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June 12, 2002

U.S. IMMUNIZATION NEWS

"Bioterror Defense: Drugmakers Seek More Incentives to Develop Vaccines" Montreal Gazette (www.canada.com/montreal) (06/12/02) P. D3; Dixon, Kim

Drugmakers said Tuesday that the United States needs to offer greater incentives if it hopes to get drugmakers to develop products that would protect against potential bioterrorism.  A shortage or lack of vaccines for potential bioterrorism weapons, such as anthrax or plague, has led to the U.S. Food and Drug Administration (FDA) speeding up the approval process for such drugs by eliminating the need for human testing in certain situations.  Now, however, drug companies are asking for protection from litigation stemming from possible side effects, according to Avant Immunotherapeutics president Una Ryan.  Recent setbacks have further delayed bioterrorism vaccines from reaching the market, including the FDA's demands that Avant's potential anthrax vaccine be tested on humans; production problems at BioPort's manufacturing facility for the anthrax vaccine; and lengthy negotiations between Acambis, Baxter International, and the U.S. government about who would be responsible for possible side effects from the smallpox vaccine.

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