Panel evaluates implementation of Project BioShield, procurement of vaccines

WASHINGTON, D.C. — At the National Press Club on Dec. 8, 2005, a panel of three internationally known biodefense and vaccine experts discussed the implementation of Project BioShield, the procurement process for biodefense vaccines.

They also discussed 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 that 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 policymakers advise and guide government policy on medical countermeasures,” Meyerhoff said. “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 AVA).

“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 adviser 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,” Melling said.

Efforts are under way 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,” Melling continued, “That is the only way to ensure that an experimental vaccine is not inferior to the current FDA-licensed vaccine. ... 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 policymakers 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 professor at the Erasmus Medical Centre of Rotterdam University in the Netherlands. “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.”