March 12, 2004-The federal government is preparing to buy enough experimental anthrax vaccine for 27 million people, a stockpile that would permit mass inoculations in numerous U.S. cities if terrorists launched a broad assault with the deadly germ.

The new vaccine would be the most significant addition to the national anti-terrorism stockpile since the Bush administration fulfilled a pledge to buy enough smallpox vaccine for every U.S. citizen.

Up to now, there has been little commercial incentive for companies to develop a modern anthrax vaccine, but the new plan would change that, creating a reserve big enough in a year or two to immunize everyone in the New York and Washington metropolitan areas -- or in other cities that might be targeted in an anthrax attack.

Two biotechnology companies, in the Bay Area and in Britain, already have won contracts to make an early stockpile of the unlicensed vaccine sufficient to inoculate 2 million people, and they are likely to bid soon on larger contracts. Coupled with the government's successes in stockpiling smallpox vaccine and antibiotics, the anthrax purchases mean the United States soon will have a wide array of defenses against the two most important biological weapons.

"The colleagues that I work with in this business would tell you that smallpox and anthrax are the two most feared agents, and we've done a lot to take those off the table," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, who has advised the federal government on combating bioterrorism.

Bidding documents released Thursday show the government has decided to order an additional 75 million doses, enough to vaccinate at least 25 million people. Added to the 2 million doses already on order, they would provide enough to cover 9 percent of the country's population.

The stockpile is projected to cost at least $700 million on top of nearly $200 million already spent, a congressional report said. The two companies involved, VaxGen Inc. of Brisbane and Avecia Ltd. of Manchester, England, are racing to scale up their factories for rapid vaccine production.

The most likely use for the vaccine, experts said, would be to inoculate the entire population of a city immediately after a terrorist attack.

The new vaccine is designed to be a potent, highly purified replacement for an existing anthrax vaccine, a product developed in the 1950s that is used mostly by the Pentagon to inoculate troops.

The old vaccine, which contains a complex and poorly understood mix of substances, has been the subject of broad controversy and an ongoing court fight, with thousands of military personnel resisting vaccination and others attributing various health problems to the vaccine.

The Food and Drug Administration has ruled it safe and effective, but another arm of the government, the National Institutes of Health, is intent on replacing it, awarding grants totaling nearly $200 million since the 2001 terrorist attacks to help biotechnology companies develop alternatives.

The experimental vaccine has undergone initial tests in people and caused few problems, but bigger tests are planned. The full extent of any side effects or other safety concerns is not yet known.

http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/03/12/MNGP65JAI61.DTL