BiodefenseBioShield projects sees vaccine, treatments successes

As required by congress, the latest annual report on Project BioShield has been published by the U. S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response. The report covers activities and efforts to diversify the medical countermeasures (MCM) enterprise from January 2009-December 2009.

Efforts on behalf of the HHS to ensure that the country has medical countermeasures (MCMs) available for responding to a chemical, biological, radiological, or nuclear (CBRN) event have been successful in developing the first human vaccine for avian flu, as well as delivering treatments for anthrax (vaccines and therapeutics), radiation exposure, and botulism to the Strategic National Stockpile (SNS).

R&D efforts for a smallpox vaccine and additional countermeasures for the SNS are underway.

Despite advances made since the program’s inception in 2004, Project BioShield still needs “adaptable distribution plans in place to deliver countermeasures to every American quickly,” according to Nicole Lurie, MD, assistant secretary for preparedness and response, HHS.

Throughout 2009, antitoxins to anthrax and botulinum were delivered to the SNS through existing contracts administered by the Biomedical Advanced Research and Development Authority (BARDA), a department within HHS. In March 2009 a solicitation was successfully issued to support the procurement of 1.7 million treatment courses of smallpox antiviral drugs.

The project has run into considerable difficulty in developing and procuring a next generation anthrax vaccine. BioShield officials are hoping that the termination of a solicitation in December 2009 to support late-stage development of 20 million doses of vaccine will result in a more mature and reliable product being developed.

The annual report describes streamlining procedures in awarding grants, contracts, and cooperative agreements in developing countermeasures. Section Four of the Project BioShield Act allows the Secretary of HHS to declare the use of unapproved products (also known as Emergency Use Authorization [EUA]) in an event determined to be an emergency by DHS or Defense.

EUA has been used by the FDA in response to the 2009 H1N1 flu virus. In the event that an emergency is declared by the HHS secretary, the FDA commissioner must consult with the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to ascertain the correct plan of action.

Of the $5.6 billion in the Special Reserve Fund for Project BioShield, $2.4 billion remains as of December 2009.

Contracts awarded using the Special Reserve Fund are primarily of the fixed priced variety. BARDA has awarded 9 contracts for development and acquisition of CBRN medical countermeasures valued at over $2 billion, and has successfully stockpiled seventeen medical products against six CBRN threats.

The 2009 report details the status of several acquisition contracts, its recipients, total funding, and reasons specific authority use and terminated contracts.

Human Genome Sciences (HGS) was awarded $326 to develop Raxibacumab (an antitoxin used to treat Anthrax)

Cangene was awarded $558 million to develop and procure Anthrax Immune Globulin (AIG, an antitoxin also used to treat Anthrax) as well as Botulinum Antitoxin (hBAT) therapeutic. The deliveries of treatments as specified by the contracts are still ongoing.

Emergent, a global biopharmaceutical company focused on the development, manufacturing, and commercialization of vaccines and antibody therapies (formerly BioPort), received $691 million to procure 28.75 million doses of AVA (BioThrax, Anthrax vaccine absorbed).

A $2 million contract for rPA (Recombinant Protective Antigen), an Anthrax vaccine treatment, was terminated between VaxGen in December of 2006 for failing to meet contract requirements. This termination of this contract was thought to have been a premature decision according to top scientists in the field (“Conversation with Randall Larsen, executive director of the WMD Commission,” 11 January 2010 HSNW). On 28 July 2010, VaxGen completed a merger transaction with diaDexus, Inc., a diagnostics company that focuses on the development and commercialization of patent-protected in vitro diagnostic products.

Denmark-based Bavarian Nordic, an industrial biotechnology company that develops and produces vaccines for the treatment and prevention of life-threatening diseases, was awarded $505 million for their Imvamune (MVA, Modified Vaccinia Ankara) Smallpox vaccine. 1.15 million doses of the 10 million doses contract have been delivered as of 2009.

Based in the greater St. Louis area, Fleming, a pharmaceutical company that specializes in the discovery, development, and manufacture of innovative prescription and over-the-counter (OTC) therapies, was awarded $18 million for providing 4.8 million bottles of Potassium Iodide (Thyroshield), a pediatric treatment.

Illinois-based Akorn was awarded $22 million for close to 500,000 doses of IV Calcium/Zinc DTPA (Diethylene triamine pentaacetic acid), a treatment for internalized radionuclides.