« Home | Effectiveness of Safer Smallpox Vaccine Demonstrat... » | The New Pentagon Papers » | Criticism, skepticism surround anthrax vaccine -- ... » | GI Denied Health Care After Speaking Out » | BioPort to sell anthrax vaccine to Taiwanese gover... » | Military Vaccine Flattens GI, 17 » | SCANDAL OF THE ANTHRAX BABIES » | Army Proposal to use U.S. Soldiers as Human Test S... » | Anthrax shots made AU troops sick » | U.S. Army Assigns Soldiers Who Refused Anthrax Vac... »

U.S. to Buy Anthrax Vaccine - Stockpile Would Permit Mass Inoculations

By Justin Gillis
Washington Post Staff Writer

The government is preparing to buy enough experimental anthrax vaccine for 25 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 citizen of the United States. 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 California and in Britain, have won contracts to make an early stockpile of the unlicensed vaccine sufficient to inoculate 2 million people, according to bidding documents released yesterday, 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 will soon have developed 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 T. 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. He said a large-scale attack "would still be a tragic situation, but compared to what we had available two years ago, we have come a long, long way."

Government scientists are still discussing how the anthrax vaccine might be used, and how it compares with other drugs under development, such as artificial antibodies given over the short term to prevent or treat anthrax infection. But the documents released yesterday 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, as much as 9 percent of the country's population would be covered.

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, Calif., and Avecia Ltd. of Manchester, England, are racing to scale up their factories for rapid vaccine production.

The most likely use of the vaccine, experts said, would be to inoculate the entire population of a city immediately after a terrorist attack. People might need to take antibiotics for several weeks to prevent disease until the vaccine kicked in, but after that they would be immune even if anthrax spores lingered in the city for years, as the germs are believed capable of doing.

While preventive vaccination of entire cities isn't likely any time soon, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, inoculations may be considered for some high-risk occupational groups, including the hazardous-materials teams that would respond to an anthrax attack.

"If the safety profile of this vaccine is as good as we think it's going to be, I think there's going to be at least a discussion among some of the unions of postal workers," he said. Two postal workers in Washington died in 2001 after letters containing anthrax spores were sent through the mail.

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 terrorist attacks of 2001 to help biotechnology companies develop alternatives.

Many postal workers who were offered the old vaccine after the 2001 attacks declined it, preferring to stay on antibiotics. Among numerous disadvantages, the old vaccine requires six doses over 18 months to induce immunity. The new vaccine is likely to require three or fewer doses over several weeks, and it's expected to contain far less of an additive that some suspect of causing side effects. The experimental vaccine has undergone initial tests in people and caused few problems, but bigger tests are planned and the full extent of any side effects or other safety concerns is not yet known.

The Pentagon has made no public statement about switching to the new vaccine, but most experts believe the military is likely to do so once it is licensed by the FDA. That could happen as soon as 2006.

The prime ingredient in the new vaccine is a protein vital to the life cycle of the anthrax germ. Research by U.S. Army scientists over many years has shown that the protein, when administered to animals by injection, causes the immune system to mount a powerful defense. When the animals were later exposed to large amounts of anthrax germs, they did not become ill.

Preliminary tests have already shown that the vaccine induces the same kind of immunity in people as in other animals, and broader tests are underway. Definitive proof of the vaccine's effectiveness in people is likely to come only with another anthrax attack, since exposing people to anthrax germs deliberately would be unethical. But the FDA has rules allowing it to license bioterror vaccines on the basis of animal tests.

It's unusual for the government to buy such a large amount of vaccine while it's still experimental, but it's not unprecedented. The Department of Health and Human Services bought millions of doses of a smallpox vaccine that had not been licensed. The theory is that in a large-scale attack, people will want access to vaccines even if they are experimental.

Smallpox, eradicated in the 1970s by worldwide vaccination campaigns, was able to spread from person to person. There is no proof that terrorists possess the smallpox germ, but many people suspect it. That is why the government bought enough vaccine for everyone in the country: A worst-case attack with smallpox weapons could produce a national epidemic.

Anthrax, by contrast, does not spread from person to person, but the spores can float through the air. The worst-case scenario is that terrorists would make enough anthrax to spray it over cities from airplanes.

The germ causes a lung disease that kills 30 percent to 50 percent of people who get it even if they receive medical care.

Anthrax spores can apparently hide in the lungs for long periods before germinating and causing disease. In the absence of a vaccine stockpile, people living in -- or possibly just visiting -- a city that had been attacked with anthrax might need to take powerful antibiotics for six months or longer. With a vaccine, doctors could inoculate a person and then, once immunity kicks in, discontinue the antibiotics. As a safeguard, the government has stockpiled enough antibiotics to treat 20 million people for 60 days.