DoD Vaccine Report Proposes Interdepartmental Group To Work With Industry

The Department of Defense is recommending the development of an interdepartmental "executive council" that would advise the federal government on vaccine planning and serve as the primary point of contact with vaccine manufacturers on procurement.

The council would consist of representatives from DoD, HHS and the proposed Department of Homeland Security, as well as the President's science advisor. An executive director and a small full-time staff would support the council.

The council would "serve as a focus of communications with private industry," DoD says in a report on its long-range plan for the production and acquisition of vaccines against biological agents.

Other responsibilities of the council would include defining vaccine requirements, setting priorities, recommending budget requirements, monitoring progress, establishing streamlined processes, providing regular reports to Congress and making annual recommendations to DoD, HHS and the White House.

The DoD report to Congress, originally due Feb. 1, was required under the National Defense Authorization Act for Fiscal Year 2002 (PL 107-107) (¹ (Also see "Bioterrorism Vaccines: Liability Limits, Federalization Under Consideration" - Pink Sheet, 8 Oct, 2001.), p. 13). The report is understood to have been delayed due to the proposal to create the Department of Homeland Security.

DoD, HHS and U.S. Department of Agriculture staff have been meeting since January to coordinate and develop long-range plans to address vaccine needs highlighted by the terrorist attacks. The executive council is one idea on which the departments have reached consensus, the report says.

The departments also recommend that an "enhanced" DoD vaccine procurement program is still required. As part of this program, "a dedicated vaccine development and production facility is needed for those vaccines that industry will not take on," DoD said.

Office of Homeland Security Director Tom Ridge told a Senate Health Committee hearing that the Department of Homeland Security should collaborate with HHS and DoD to establish a government-owned, contractor-operated vaccine production facility (² (Also see "Vaccine Facility Should Be Considered By Homeland Security Dept. – Ridge" - Pink Sheet, 22 Jul, 2002.), p. 24). Sen. Tim Hutchinson (R-Ark.) introduced legislation last fall that would direct DoD to build a GOCO vaccine facility (³ , p. 22).

The primary source of vaccine production should be industry, the report says. "The established pharmaceutical and biotechnology industry should be approached to undertake and support development, FDA licensure and production of vaccines needed by DoD."

DoD, HHS and USDA note that "federal procurement rules and processes need to be simplified and streamlined."

The report also suggests that disincentives to vaccine manufacturing need to be addressed. "The government and industry need to resolve hurdles that mitigate industry support (e.g. FDA regulatory issues, product liability, and indemnification)," the report says.

DoD is focused on the development and acquisition of seven biological warfare defense vaccines: anthrax vaccine adsorbed; smallpox; recombinant botulinum, bivalent vaccine; next generation anthrax vaccine; plague and Venezuelan equine encephalitis.

BioPort has been providing anthrax vaccine to DoD since licensure of BioThrax (anthrax vaccine adsorbed) in January under a production contract. The company says it is interested in a long-term, multiple-year contract. DoD and HHS plan to set aside half of the Bioport output to increase emergency civilian stockpiles (⁴ (Also see "Anthrax Vaccine Stockpile For Civilians Created From Half Of BioPort Output" - Pink Sheet, 8 Jul, 2002.), p. 14).

The National Institute of Allergy & Infectious Diseases is collaborating with DoD to develop a next generation anthrax recombinant protective antigen vaccine. DynPort is expected to manufacture a next generation anthrax vaccine under a contract with DoD.

DoD estimates that 70% of its planned funding of $1 bil. over fiscal years 2003 to 2007 for medical countermeasures against biological agents will be directed to vaccine R&D and acquisition activities.

The Defense Science Board plans to meet in closed sessions beginning Aug. 19 to assess DoD's activities regarding biological warfare, including the availability of sufficient vaccine and drug manufacturing capacity and the logistical adequacy of the supply chain.