Vaccines In Reserve

America’s ability to respond to a biological threat was tested when terrorists sent deadly anthrax spores through the U.S. mail. The attack — which occurred three years ago — killed five people and sickened 17 more.

Now, lawmakers envision having enough new-generation anthrax vaccines to distribute to more than 25 million Americans, thanks to the almost unanimous Congressional approval of Project Bioshield — a $5.6 billion program to develop and keep on hand enough vaccines and treatments to combat massive biological attacks.

“Project BioShield is part of a broader strategy to defend America against the threat of weapons of mass destruction,” President Bush says. “Since Sept. 11, we’ve increased funding for the Strategic National Stockpile by a factor of five, increased funding for biodefense research by a factor of 30, secured enough smallpox vaccine for every American, worked with cities on plans to deliver antibiotics and chemical antidotes in an emergency, improved the safety of our food supply, and deployed advanced environmental detectors under the BioWatch program to provide the earliest possible warning of a biological attack.”

Under BioShield, The Department of Health and Human Services (HHS) will acquire a safer, second generation smallpox vaccine, an antidote to botulinum toxin, and better treatments for exposure to chemical and radiological weapons.

Bush says that private industry will play a vital role in biodefense efforts by taking risks to bring new treatments to the market.

Project BioShield gives the government new authority to expedite research and development on the most promising and time-sensitive medicines to defend against bioterror.

The bill will also change the way the government authorizes and deploys medical defenses in a crisis. The Food and Drug Administration will be able to permit rapid distribution of promising new drugs and antidotes in the most urgent circumstances, thus allowing patients to quickly receive the best available treatments in an emergency.

“This legislation is pro-active,” Senate Majority Leader Bill Frist (R-Tenn.) says. Frist was one of the Senators who received a package laced with the deadly toxin ricin in February, causing three Senate office buldings to be closed for a week.

“It will help ensure that our public health agencies can focus in a deliberate and comprehensive way on developing vaccines, drugs, devices, assays and other countermeasures against biological, chemical, radiological and nuclear agents,” Frist continues.

With no expected commercial market for the drugs, the companies that make the vaccines have only one real customer — the federal government. But some of the makers of anthrax-fighting drugs are divided on the issue of whether BioShield will help them as they spend millions of their own money on development.

Questions remain — whether the government will buy the drugs, how the companies will protect themselves from liability over problems that might arise from the largely untested drugs, and how many doses they would need to make.

“We look at Project BioShield and other government efforts as a good step,” Donald Drakeman, CEO of the Princeton, N.J.-based Medarex told The Associated Press. “But we would like to have all our questions answered.

“If you come up with a successful cancer drug, you know there is going to be a commercial marketplace,” he continued. “With biodefense, there is no clear marketplace and the cost of development can be significant.”

Over the next 10 years, the Department of Homeland Security and HHS have said they will buy 75 million doses of an anthrax vaccine, a new smallpox vaccine and medicines to treat the effects of radiation.

One of those medicines is potassium iodide — designed for use by children in the event of radiation exposure. Currently, the pills given to prevent thyroid cancer in a radiation incident are only approved for adult usage.

Later, the government plans to stock vaccines or antidotes to the plague, Ebola and Rift Valley fever.

The vaccines may not be subjected to many of the Food and Drug Administration’s strict testing for safety. In fact, Bioshield authorizes HHS to introduce a drug, biological product or device that has not been FDA-approved in emergency situations. The authorization is granted only if alternative treatments are not available, and it requires a finding by the Secretary of HHS that the benefits of such a treatment outweigh the risks.

The department will maintain the new stockpile of vaccines in coordination with the Department of Homeland Security.