The Government Accountability Office released a progress report on the production of a safe effective vaccine against anthrax. We have posted copies of the May 9th report and the highlights on the FAS website.

The report, like their past reports on this issue, cites continued disorganization on the part of the government. Namely, they note that there has been little progress in the area of testing of the current vaccine for safety, effectiveness and reliability. The GAO had previously noted that there has been no long-term safety data, no studies on the optimum number of doses, and inadequate human clinical data. The GAO called upon the Director of Homeland Security to form a strategic plan for the development and safety testing of the vaccine including interagency cooperation.

In 2004, the Department of Health and Human Services awarded a contract for $877.5M for 75 million doses of anthrax vaccine to VaxGen, Inc, a company that had not previously developed and marketed any drugs or vaccines. The contract was noteworthy because it was the first award for bioterrorism countermeasure production under the Project Bioshield.

The GAO noted that the biotech community is watching the anthrax vaccine development and production carefully and warned that if it fails, companies will be less than eager to get involved with government contracts to produce future countermeasures.

We have just posted a recent report from CRS on Dual Use Biological research and the role and activities of the National Science Advisory Board on Biosecurity (NSABB). The report is a summary of the history and role of the NSABB and outlines some of their activities.

View the report at /sgp/crs/natsec/RL33342.pdf

Yesterday, the Senate passed a whopping $107 billion Emergency Supplemental Appropriations bill to fund the war in Iraq. Attached to the bill was an amendment by Senator Tom Harkin (D-Iowa) that adds $2.3 billion to prepare for an influenza pandemic. Such money will also prepare the country for other public health emergencies and is a strong indication that Congress is starting to take the threat of Avian Influenza seriously. The bulk of the bill consists of $67.8 billion for the Pentagon to support the war in Iraq and $27 billion in hurricane relief.

The whole amendment can be found in the extended comments section:

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FAS has just released our internet resource for biosecurity policy, bioterrorism information, and biodefense research. The site includes an interactive map that provides the locations of both operational and planned laboratories in the U.S. The organizations linked on the site present a wide array of perspectives on what actions individual scientists, research institutions, science journals, the public, and government can do to minimize the threat of bioterrorism while maximizing the benefits of life science research. They also provide important information on select agents, the Biological and Toxic Weapons Convention and new approaches to biosecurity. We will be adding to the site over the coming years and welcome feedback on its design and content. You can visit the site at /biosecurity/resource/

On February 15th, Senator Edward Kennedy introduced S.2291, The <a href=”http://thomas.loc.gov/cgi-bin/bdquery/z?d109:s.02291:”Responsible Public Readiness and Emergency Preparedness Act, which aims to expand compensation and clarify liability issues that will arise if untested vaccines and countermeasures need to be distributed in the event of a pandemic disease outbreak.

The move is clearly designed to revise the sweeping liability protection inserted as part of the Public Readiness and Emergency Preparedness Act in the Defense spending bill conference report. That bill is widely regarded as incomplete since it does not provide for funding for a vaccine injury compensation program. It has also been widely criticized for providing overly zealous liability coverage of drug and vaccine companies as well as those delivering countermeasures to patients. In fact, it requires that for any injured person to get around the liability protection, they have to prove that a drug company or medical professional administering the drug or vaccine engaged in “willful misconduct.” This is, of course, next to impossible.

The new bill

Senator Kennedy’s bill repeals the measures from the defense spending bill and takes a more balanced approach.

First, the bill provides more limited liability for drug companies and those delivering medications and defines a narrow scope of products that it would apply to. They specifically design it so that drugs that have already been FDA approved are not covered since they have already been thoroughly tested. Liability coverage is only extended to products that are not FDA approved and have been designated by the Secretary of the Department of Health and Human Services to be necessary to fight an epidemic.

Second, the bill defines a real compensation program that is modeled after the existing Vaccine Injury Compensation program. Therefore, no money needs to be appropriated for a fund that might never be used. This approach has been pushed by several advocacy groups.

Third, the bill provides a way for the government to sue a vaccine or drug manufacturer or medical professional to recover payments made through the vaccine compensation program for negligence.

Now all we need is for the partisanship in the Senate to disappear so bills like this have a fighting chance.

Here I detail the two major pieces of biosecurity legislation up for consideration by Congress this year, S.1873, The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 and S.1880, The National Biodefense and Pandemic Preparedness Act of 2005. They both address similar issues relating to the nation’s ability to develop countermeasures against emerging public health threats including bioterrorism agents and avian influenza. However, there are fairly significant differences between them. My understanding is that the Republicans and Democrats have not gotten together to discuss these two bills yet. Please feel free to get in touch with me directly if you have any questions. mstebbins@fas.org

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FAS hopes the President will take the opportunity to send the right message to the American public and ditch political rhetoric in his State of the Union.

FAS is deeply concerned that the nation is headed in the wrong direction on critical science issues that affect our health, national security, environment and economic future. The President has an opportunity to change that starting with his State of the Union address on January 31st. Specifically, we would like the President to take scientific research funding, science education funding, and biosecurity more seriously then he has in the past.

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I’m Michael Stebbins; my group focuses on biosecurity issues and national policy as it relates to health and biological sciences. These two areas have melded together in a number of ways since the anthrax attacks in 2001. First, there was a dramatic increase in research on bioterrorism threat agents including anthrax, tularemia, and plague. With this increase came the daunting fact that we have also dramatically increased the number of scientists who have access to and the knowledge of how to handle these agents. Second, what we have not seen is a serious commitment to increasing our nation’s public health infrastructure to handle emergencies, including the threat of a pandemic outbreak of influenza. This is absolutely essential, not just for the nation’s national security as it pertains to bioterrorism, but for all public health emergencies.

We have several active projects that address these important issues and will update you on them here. Please visit our main page for more information on the biosecurity group. Our bios can be found here.