California Company to Make New Anthrax Vaccine

VaxGen Inc. will make a new and improved version of the anthrax vaccine for use in case of a biological attack, the U.S. government said on Thursday.

Under an $877 million contract, the Brisbane, California, based biotechnology company will supply 75 million doses of vaccine — meant to protect 25 million civilians — within three years.The new vaccine is designed to be purer and more effective than the current vaccine, which must be given in six doses. A few of the 1 million or so U.S. troops vaccinated with the older vaccine have complained of side-effects.The contract is the first announced under the “Project Bioshield” law enacted in July, providing $5.6 billion over 10 years for private sector research and guaranteed government purchases of defenses against biological weapons.”It is a critical use of Project Bioshield,” Health and Human Services Secretary Tommy Thompson told reporters in a telephone briefing.”Without Project BioShield, we would likely still be years away from a new anthrax vaccine and today’s announcement might never have been possible,” added National Institute of Allergy and Infectious Diseases Director Dr. Tony Fauci.Anthrax is considered the No. 1 biological weapon threat. It can be transmitted in three ways — through inhalation of the spores, into a cut in the skin, or by eating contaminated meat.Inhaled anthrax is by far the deadliest form. In 2001, five Americans died from anthrax inhaled from contaminated mail.The infection is easily cured with antibiotics, but in cases of the inhaled form, by the time symptoms appear it is often too late to treat the patient.The older vaccine uses material from the anthrax bacteria grown in cell culture, said Fauci.The new vaccine uses one specific protein from the bacteria, called protective antigen. “This is just a highly efficient and purified way of getting it,” Fauci said.It is more controlled and predictable, added VaxGen president Lance Gordon. “We know exactly what is in the product,” he said.The vaccine, to be available in about 2007, will have to undergo Food and Drug Administration approval. Because deadly agents cannot be tested in humans, two different species of animals will be given the vaccine and exposed to anthrax.Then human volunteers will get the shots and have immune system proteins called antibodies measured.Thompson said the Department of Defense will make its own decision on a new anthrax vaccine.On Wednesday, a federal judge barred the U.S. military from forcing troops to be vaccinated for anthrax without either getting their informed consent or obtaining a special order from President Bush.U.S. District Judge Emmet Sullivan set aside a final rule and order by the FDA that late last year declared the anthrax vaccine safe and effective to protect troops.Some troops have complained of inflammation in the area of the vaccination. Others have reported extreme fatigue, joint pain and temporary memory loss.Hundreds of U.S. service members have refused the vaccinations and many have been punished, including being discharged.Other U.S. biotechnology companies are working to develop vaccines against potential biological agents, including Cerus Corp., which has a $3.8 million contract to develop a different anthrax vaccine. (Source: Reuters, Nov 2004)