Expert Panel Evaluates Implementation of Project BioShield and Procurement of Biodefense Vaccines

WASHINGTON, Dec. 8 /PRNewswire/ -- At the National Press Club today, a panel of three internationally known biodefense experts and vaccine thought- leaders discussed the implementation of Project BioShield, the procurement process for biodefense vaccines, and recommendations regarding the need for a science-driven, systematic and impartial process for comparing the risks and benefits of current and new medical countermeasures to protect America from biological threats.

The panel recommended the adoption of an independent advisory oversight board be included in the decision making process for government-funded biodefense programs because federal policy and planning, rather than traditional market forces, drive the development of public health countermeasures.

"Decisions regarding biodefense preparedness have critical consequences to public health," said Dr. Andrea Meyerhoff, principal of GexGroup and former Director of WMD Defense for the Department of Defense and former Director of Counterterrorism, U.S. Food and Drug Administration.

"Because of this, it is crucial that a multidisciplinary panel of government, academic and industry scientists, lawyers and public policy makers advise and guide government policy on medical countermeasures. Currently, the government is developer, regulator and procurer of biodefense countermeasures, which presents the very real potential for conflict of interest.

"We must take steps to avoid the potential for flawed decisions because unproven countermeasures can be a waste of taxpayers' money, and worse, may not be safe and effective. Without oversight by an independent advisory oversight board, there is a real risk that an experimental, unproven countermeasure may be used in a bioterror attack, potentially resulting in unexpected side effects and failure to protect the public."

As a case study, the expert panel focused on the procurement under Project BioShield of an experimental, unproven and unlicensed anthrax vaccine for the near complete fulfillment of the anthrax vaccine allotment in the Strategic National Stockpile, despite the existence of a proven, safe and effective FDA- licensed anthrax vaccine (BioThrax(R) AVA). BioThrax has been approved since 1970, evaluated in over 20 clinical trials and judged to be both safe and effective by the prestigious Institute of Medicine. To date, more than 5 million doses of BioThrax have been administered to over 1.3 million people. It has also been shown to be effective, in combination with antibiotic therapy in the post-exposure setting, for preventing inhalation anthrax in two animal models after Bacillus anthracis exposure.

"This procurement raises all sorts of questions and very few answers," said Dr. Jack Melling, consultant to the U.S. Government Accountability Office and senior scientific advisor to the International AIDS Vaccine Initiative in New York.

"A proven, FDA-approved countermeasure is currently available, so why spend the effort and taxpayers' money on an untested, experimental vaccine -- which can't be studied in humans -- especially when there is no evidence that it will improve the protection of the public from a potentially fatal disease? Recombinant DNA technology is only one of many techniques available to vaccine producers and its application does not confer special status or advantage to a vaccine for meeting public health requirements."

Efforts are currently underway to develop a recombinant protective antigen anthrax vaccine candidate (rPA) for the intended indications of pre-exposure and post-exposure prophylaxis of inhalational anthrax. Recombinant technology, despite being available for more than 25 years, has not produced new vaccines to replace vaccines developed by established proven technologies.

Given the special circumstances of the use of any anthrax vaccine, the expert panel advocated a head-to-head comparison of AVA and rPA.

"The purpose of head to head comparison is to ensure that the public is being protected by the best available product," continued Dr. Melling. "That is the only way to ensure that an experimental vaccine is not inferior to the current FDA-licensed vaccine. Non-inferiority is a concept well accepted and understood in regulatory reviews of new drugs. This is a critical principle because the vaccine will be stored in the Strategic National Stockpile, rather than used routinely, and its first mass use could be in many millions of people put at risk in the event of a bioterrorist attack."

"Anthrax is the first of many biothreats for which policy makers need to evaluate the relative risk and benefit of FDA-approved versus experimental products before committing public funds to protect the public health," said Dr. Eric Claassen, board-certified immunologist and a full professor at the Erasmus Medical Centre of Rotterdam University. "A process based on science, systematic evaluation, and impartial review will build public trust and encourage the participation of industry in any public health effort."

  Presenters

  Andrea Meyerhoff, MD, MSc, DTMH

Dr. Meyerhoff, principal of GexGroup, is a consultant in biodefense and drug development. She has served the federal government as a policy advisor for both military and civilian populations on medical countermeasures for weapons of mass destruction (WMD) as part of the BioShield initiative. From 2003-2004, Dr. Meyerhoff was the Pentagon's Director of Medical WMD Defense. Prior to her tenure at the Defense Department, Dr. Meyerhoff was Director of Counterterrorism, U.S. Food and Drug Administration. She served in this position during the terrorist attacks of September 11 and the anthrax attack on the U.S. Postal Service. Dr. Meyerhoff is board certified in infectious diseases and internal medicine and an Associate Professor of Clinical Medicine at Georgetown University.

Jack Melling, PhD, FRCPath

Dr. Melling is a consultant to the U.S. Government Accountability Office and Senior Scientific Advisor to the International AIDS Vaccine Initiative in New York. Dr. Melling was a Senior Project Manager at the Battelle Memorial Institute in Ohio, served as Chief Executive of the Microbiological Research Authority of the UK Ministry of Health. He also served as Director of Vaccine Research and Production, and Head of the Division of Biologics at the Center for Applied Microbiology and Research (CAMR), Porton Down, UK. He directed the Salk Institute Biologicals Development Center in Pennsylvania and the Karl Landsteiner Institute for Vaccine Development in Vienna, Austria. He also served on several governmental advisory committees including the UK Committee on Safety of Medicines subcommittee on Biologicals and the Defense Scientific Advisory Council.

Eric Claassen, PhD

Dr. Claassen is a board-certified immunologist and a full professor at the Erasmus Medical Centre of Rotterdam University. He also holds a full professorship at the Athena Institute (Management and Policy Analysis in Health and Life Sciences) of the Vrije Universiteit in Amsterdam. He is a visiting professor for the Immunology courses at Institut Pasteur/University of Paris. He holds board positions in a number of biotech companies. He is a member of several prestigious governmental advisory groups and committees, including the Dutch Health Council, and has held positions such as secretary general of the Dutch Society for Immunology, chairman of NATO PG 32 on handheld detection devices for biological weapons defense, and director of research and deputy CEO of the Dutch Institute for Animal Science and Health.

About Emergent BioSolutions

Emergent BioSolutions Inc. is dedicated to the research, development and manufacture of novel products which harness the immune system to treat and prevent disease. These include products for prophylactic and therapeutic use against common infectious diseases and biological weapons of mass destruction. The company currently employs more than 400 people with facilities in Gaithersburg and Frederick, Maryland, Lansing, Michigan, Berkshire, U.K. and Munich Germany. More information about Emergent BioSolutions and its subsidiaries can be found at http://www.ebsi.com/ .