FIRM TO DO HUMAN TESTS OF NEW ANTHRAX VACCINE



about Epidemiology & the department

Epidemiology academic information

Epidemiology faculty

Epidemilogy resources

sites of interest to Epidemiology professionals



Last Updated

16 Oct 2002

Source:  Washington Post, October 16, 2002.

Firm to Do Human Tests Of New Anthrax Vaccine

By Renae Merle, Washington Post Staff Writer

DynPort Vaccine Co. said yesterday that it will begin human testing of an anthrax vaccine that it hopes will prove safer than the current alternative.

Early clinical testing with 70 volunteers at the Walter Reed Army Institute of Research in Rockville should begin within a few weeks, company officials said. The company doesn't expect to receive approval from the Food and Drug Administration to market the vaccine until 2010.

"Protection against potential future biological attacks continues to be a key concern of our nation's leaders," DynPort President Terry R. Irgens said in a prepared statement. DynPort, based in Frederick, Md., is a joint venture of Reston-based DynCorp and Porton International Inc., whose U.S. headquarters is in Washington.

DynPort's proposed vaccine attempts to improve on the version produced by BioPort Corp. of Lansing, Mich. That vaccine has been criticized by the scientific community for years, and some who have taken the vaccine have complained of severe side effects. During last year's anthrax exposures, the vaccine, which was licensed to be given before someone is exposed to anthrax, was offered to congressional staffers and postal employees already exposed, who were also taking antibiotics.

The current vaccine is made from a strain of the non-lethal form of anthrax, which some doctors believe includes contaminants that could cause side effects. DynPort officials said the company is employing a process used widely in the biotechnology industry that should impede contamination.

The early testing will begin with low doses of the vaccine given to human subjects to prove its safety, said Robert Hopkins, director of clinical research at DynPort. Tests of the vaccine's effectiveness for warding off anthrax will begin later, he said.

DynPort's efforts began in 1997 after the company was awarded a Defense Department contract to develop six vaccines against biological agents, including anthrax. Under the contract, the company is also testing a smallpox vaccine.

Separately, the Department of Health and Human Services this month awarded contracts to develop a new anthrax vaccine to two companies: Avecia Ltd. of Manchester, England, and VaxGen Inc. of Brisbane, Calif. The National Institute of Allergy and Infectious Diseases wants to maintain an emergency stockpile of 25 million doses of the improved vaccine.