Thursday, December 25, 2014

The U.S. Strategic National Stockpile: Ensuring rapid bio-defence during conflict

"A number of agents to counter biological threats are included in the Strategic National Stockpile (SNS), such as smallpox and anthrax vaccines. The U.S. Department of Health and Human Services and the CDC consider many factors, such as current biological threats, the availability of medical material, and the ease of dissemination of pharmaceuticals. One of the most significant factors in determining SNS composition, however, is the medical vulnerability of the U.S. civilian population." See: https://www.medicalcountermeasures.gov/phemce/cdc.aspx



According to The Association of State and Territorial Health Officials, "The U.S. Strategic National Stockpile (SNS) program is designed to supplement and resupply state and local inventories of medicines and supplies during emergencies severe enough to exhaust local supplies (3). Decisions about what medicines and materials should be included in the SNS are made by the HHS Assistant Secretary of Preparedness and Response (ASPR), the HHS, the Department of Homeland Security (DHS) and the CDC, in consultation with state and local public health officials and private sector organizations and entities. In determining and reviewing the composition of SNS assets, the HHS and the CDC look at multiple factors, including the medical vulnerability of the U.S. population (and of at risk populations such as children and other vulnerable populations), currently biological/chemical threats, the availability of medicines and medical supplies, and the ease of disseminating specific medicines.(4) See: http://www.astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Strategic-National-Stockpile-Fact-Sheet/ 

But what effect does or should, conflict play in the composition of the SNS and to what extent are these issues sufficient to merit an increase specifically in vaccines and anti-toxins in the event of a biological accident or deliberate event?

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While conflict, specifically in states which are suspected of conducting offensive biological weapon research, is worrisome, other factors such as rapid production  of and use of licensed and non-licensed products is a compelling topic. In a recent paper entitled "Making Vaccines 'on demand': A potential solution for emerging pathogens and biodefence? (See: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=90891468), the authors note:

"The integrated US Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has made great strides in strategic preparedness and response capabilities. There have been numerous advances in planning, bio-threat countermeasure development, licensing, manufacturing, stockpiling and deployment. Increased biodefense surveillance capability has dramatically improved, while new tools and increased awareness have fostered rapid identification of new potential public health pathogens. Unfortunately, structural delays in vaccine design, development, manufacture, clinical testing and licensing processes remain significant obstacles to an effective national biodefense rapid response capability. This is particularly true fro the very real threat of 'novel pathogens' such as the avian-origin influenzas H7N9 and H5N1, and new coronoaviruses such as hCoV-EMC. Conventional approaches to vaccine development, production, clinical testing and licensing are compatible with the prompt deployment needed for an effective public health response. An alternative approach, proposed here, is to apply computational vaccine design tools and rapid production technologies that now make it possible to engineer vaccines for novel emerging pathogens and WMD biowarfare agent countermeasures in record time. These new tools have the potential to significantly reduce the time needed to design string of epitope vaccines for previously unknown pathogens. The design process--from genome to gene sequence, ready to insert in a DNA plasmid-can now be accomplished in less than 24 hours." Syria's use of chemical weapons detailed in a UN Report (http://www.securitycouncilreport.org/un-documents/syria/) confirms what had been suspected for over two decades. It is suspected as well that Syria has an agile BW program. Given the current and on-going conflict in Syria, review of the composition of the US SNS as well as the push for advanced vaccine manufacturing is timely. If we compare the previous composition, from a 2011 report by MedFrontiers they detailed several contracts which included: 
  • 691 million USD for 29 million doses of the current approved anthrax vaccine (anthrax vaccine absorbed or AVA) from Emergent BioSolutions, Inc.
  • 334 million for 65,000 doses of Raxibacumab (ABthrax), a treatment for anthrax from Human Genome Sciences Inc.,
  • 144 million for 10,000 doses of Anthrax Immune Globulin, a treatment for anthrax from Cangene Corporation
  • 505 million for 20 million doses of a smallpox vaccine (Modified Vaccinia Ankara or MVA) from Bavaria Nordic, Inc.
  • 433 million for 1.7 million doses of ST-246, an antiviral treatment for smallpox from SIGA Technologies Inc.
  • 414 million for 200,000 doses of botulinum antitoxin, a treatment for botulinum toxin exposure, from Cangene Corp.
  • 18 million for 5 million doses of a pediatric form of potassium iodide, a treatment for radioactive iodine exposure from Fleming Pharmaceuticals
  • 22 million fro 395 doses of  pentetate calcium trisodium (also known as CA-DTPA) and 80,000 doses of pentetate zinc trisodium (also known as Zn-DTPA), two treatments for internal radioactive particle contamination from Akorn Inc. See: http://www.medfrontiers.com/news197.html 

How agile is the US Strategic National Stockpile at rapid procurement for bio-defence vaccines and counter-measures during conflict and crisis in states which could posses a BW complex and which could loose command and control over that complex? Are we able to swiftly acquire vaccines for example for synthetic agents? Global BioDefence notes in an article entitled, 'Biodefence Contracts Feed US Stockpile of Anthrax Anti-toxin," that Under Bio-Shield contracts "HHS will order approximately 196 million in antitoxin from GlaxoSmithKline. In addition, HHS will purchase materials to manufacture antitoxin. The materials include blood plasma from Cangene for approximately 63 million and a total of 1.6 million in cells from GlaxoSmithKline, PharmAthene, and Emergent. PharmAthene and Emergent have antitoxin at earlier stages of development than the GlaxoSmithKline and Cangene products. Today's actions build on efforts by all five companies and the federal government to develop anthrax antitoxins. Human Genome Sciences, acquired by GlaxoSmithKline, and Cangene began delivering to the stockpile in 2009 and 2007, respectively." For full article see: http://globalbiodefense.com/2013/09/20/biodefense-contracts-feed-us-stockpile-of-anthrax-antitoxin/#more-5277
Jill Bellamy is an internationally recognized expert on biological warfare and defence. She has formerly advised NATO and for the past seventeen years has represented a number of bio-pharmaceutical and government clients working on procurement strategy between NATO MS and Washington DC. Her articles have appeared in the National Review, The Wall Street Journal, The Washington Post, The Sunday Times of London, Le Temps, Le Monde and the Jerusalem Post among other publications. She is a CBRN SME with the U.S. Department of Defence, Chemical, Biological, Radiological and Nuclear Defence Information Analysis Center and CEO of Warfare Technology Analytics, a private consultancy based in the Netherlands.

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