HHS establishes medical disaster response centers

At least one vaccine expert questions how effective the centers will be in preparing countermeasures for multiple types of emergencies.

By — Posted July 2, 2012

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The Dept. of Health and Human Services, in partnership with private sector drug companies and health care organizations, has established three new centers that aim to accelerate development and production of medical countermeasures such as influenza vaccine, while also taking steps to train a biopharmaceutical work force that may be needed for future medical emergencies.

“Establishing these centers represents a dramatic step forward in ensuring that the United States can produce lifesaving countermeasures quickly and nimbly,” HHS Secretary Kathleen Sebelius said in a statement. “They will improve our ability to protect Americans’ health in an emergency and help fill gaps in preparedness so that our nation can respond to known or unknown threats.”

HHS estimates that the centers will be capable of producing a quarter of the nation’s pandemic influenza vaccine domestically within four months of the onset of a pandemic.

Texas A&M University, which received a contract worth about $176 million over the first five years, plans to provide therapies in the event of chemical, biological, radiological and nuclear threats, as well as develop and manufacture vaccines to protect against pandemic influenza.

According to a statement from the university, the center also plans to accelerate the production of vaccines and other biosecurity products through pre-clinical and clinical development, and to train professionals in areas required to sustain this capability, “including process engineering, pharmaceutical manufacturing, veterinary sciences, quality, and regulatory affairs.”

The centers undoubtedly will enhance the national capability to respond to the emergence of new influenza strains, said Maj. Gen. Philip K. Russell, MD, founding president of the Sabin Vaccine Institute, a Washington-based nonprofit that develops and helps distribute vaccines to fight global health threats. However, they will do little for biodefense preparedness, he said.

“We really need only one facility for advanced development and manufacturing of biodefense vaccines,” Dr. Russell said. “I think HHS made a serious mistake in attempting to solve two very different problems — biodefense countermeasures and influenza vaccine supply — with a single solution.”

HHS plans to invest about $400 million in the initial phases of the effort through contracts with the lead member of each collaboration, the department stated. The private partners in these centers will pay about 35% of the total cost of the initial building phase, with HHS supporting operations and maintenance costs for the centers in subsequent years. The contracts can be renewed for up to 25 years. Each of the centers will be run by a consortium led by an organization that has experience in developing or manufacturing medical countermeasures.

A 2010 governmentwide review had recommended creating such centers. Sebelius asked for the review after HHS faced challenges developing various biodefense medical countermeasures, including the 2009 H1N1 pandemic flu vaccine. Only one company had manufacturing facilities located solely within the U.S. to produce H1N1 vaccine, and primary care physicians reported being overwhelmed by patients who were demanding the vaccine.

Dr. Russell said most primary care doctors have some awareness of the threat of bioterrorism and are capable of recognizing the major threats and responding. But as the memory of the Sept. 11, 2001, terrorist attacks and the subsequent anthrax attacks recedes, “it will be difficult to keep up the level of awareness and the ability to recognize an emergent situation. It is best addressed through continuing medical education,” he said.

The bigger problem is the limitations of the capacity of health care facilities to take on a major increase in patient load during an emergency, especially if many of those patients are critically ill, Dr. Russell said.

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Private sector to aid in preparing for emergencies

The Dept. of Health and Human Services has established three centers to bring medical countermeasures to the market more quickly and to help train the biopharmaceutical work force needed to respond to medical emergencies.

  • Emergent Manufacturing Operations Baltimore LLC, with facilities in Baltimore and Gaithersburg, Md., working with Michigan State University, Kettering University of Flint, Mich., and the University of Maryland, Baltimore. The contract is for about $163 million over the first eight years.
  • Novartis, with facilities in Holly Springs, N.C., working with North Carolina State University and Duke University in Durham, N.C. The contract is for about $60 million over the first four years.
  • The Texas A&M University System, working with GlaxoSmithKline Vaccines of Marietta, Pa., Lonza of Houston, and Kalon Biotherapeutics of College Station, Texas. The contract is for about $176 million over the first five years.

Source: Dept. of Health and Human Services

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