Joint Vaccine Acquisition Program Countering Emerging Threats Against the U.S.

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Biological warfare has long been an active potential threat against U.S.  forces internationally.  After the first Gulf War, for example, it became known that the Iraqis had filled 100 R-400 bombs with botulinum toxin, 50 with anthrax, and 16 with aflatoxin. In addition, 13 Al Hussein (SCUD) warheads were filled with botulinum toxin, 10 with anthrax, and 2 with aflatoxin. These weapons were reportedly deployed to four locations for use against Coalition forces.

While there haven’t been any documented cases of biological attacks against U.S. forces in recent history, there remains extensive evidence that nations have either developed  biological agents in the past, or are developing such capabilities now.

IDGA recently spoke with Lieutenant Colonel David P. Hammer, Medical Service, U.S. Army, who is the DoD Product Manager overseeing the Joint Vaccine Acquisition Program (JVAP).  JVAP develops, produces, and stockpiles U.S. Food and Drug Administration (FDA)–licensed vaccine systems to protect the warfighter against biological agents. JVAP consolidates the DoD’s efforts for advanced development, testing, FDA licensing, production, and storage of biological defense vaccines.

According to LTC Hammer, the mission of the JVAP is simple, but vitally important: to develop, produce and stockpile FDA-licensed vaccine systems to protect the war-fighter from biological agents. 

“We don't develop vaccines for infectious diseases, but for agents that have the potential to be weaponized and used in a biological attack,” he says. “This attack has the potential to come on the battlefield or in a terrorist scenario.”

LTC Hammer’s role in driving that mission is to ensure that the products within the portfolio he oversees are meeting specific cost, performance and schedule requirements.   The process of development, he says, is often an arduous one.

“FDA approved vaccine development is a very complicated and long process to navigate,” he says, “and the many uncertainties result in conflicts in funding, time and product performance.”

Budgeting Major Challenge

The biggest challenge facing JVAP, says LTC Hammer,  is not unique to that program but one that is likely consistent with all of DoD and other federal agencies: the unpredictable financial and budgeting outlook  all government departments face, driven by escalating deficits. 

“It can be extremely difficult to manage a biological development effort without consistent flow of funding to ensure the research and development continues,” says LTC Hammer.  “Gaps in funding stall efforts, and can, in some instances, force you to scale back or re-evaluate the scope of the R&D that will be conducted.”

Another potential pitfall that can be created by underfunding, he adds, is that viable vaccine candidates may be selected too early in the process, resulting in the wrong product being selected.

LTC Hammer explains that when advanced development of a biologic is initiated, there is generally more than one prototype to be considered, because there are a number of different ways to manufacture a vaccine. Each prototype is developed and tested to a point where a decision is made on which one will perform the best. 

That decision can be made at a number of different points throughout the process. “If it’s too early, you may choose the wrong prototype,” he says. “Too late and you waste money developing the candidate that ends up not being selected.”

The biological development process, says LTC Hammer, is an extremely complex one, which creates a great deal of uncertainty during research and development.

The process “isn't like a physical engineering process where we know the tensile strength of steel, or how much load a concrete wall can bear,” he says. “At the molecular level there is still much to be learned and even the best predictions about how a molecule will perform are inaccurate.”

Vaccines Managed

There are currently five vaccines being managed within the Joint Vaccine Acquisition Program, of which two are in sustainment, and three are in development.

The two vaccines in sustainment counter the threats of Anthrax and Smallpox.  The Smallpox vaccine was actually the first ever created, with a process discovered in 1796. The three in development are Recombinant Botulinum (rBV), Plague (rF1V) and a tri-valent Filo-firus vaccine (Marburg, Ebola Zaire and Ebola Sudan).  The rBV and RF1V are the most advanced and are entering phase III human trials in FY13.

In addition, two new “starts” are currently being explored, says LTC Hammer.   A Ricin vaccine advanced development program will being in FY13, followed by a Multi-valent Equine Encephalitis (Venezuelen, Western, Eastern Equine Encephalitis) advanced development program, which is scheduled to begin in FY14.

According to LTC Hammer, all JVAP products are coordinated within the federal and international communities.   For example, the filo-virus product is a partnership with the Department of Health and Human Services, and both the Plague and Botulinum products are international partnerships with the United Kingdom and Canada.  In all cases, he says, agreements are put into place to ensure all players are clear on their role and expectations can be appropriately managed.

JVAP is part of the Chemical Biological Medical Systems (CBMS) Joint Project Management Office, which is responsible for the research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA.

The CBMS product portfolio includes products spanning the entire acquisition life cycle. The CBMS comprises a headquarters and three supporting Joint Product Management Offices: JVAP, the Medical Identification and Treatment Systems (MITS), and the Biosurveillance (BSV-Provisional).

Lieutenant Colonel David P. Hammer, Medical Service, U.S. Army, is the DoD Product Manager overseeing the Joint Vaccine Acquisition Program (JVAP).  He will be speaking at IDGA's 7th Annual CNRNe Defense conference, to be held Jan. 30-Feb. 1, 2012 in Washington, DC.

Contributor:   Christopher Dauer

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