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HHS Calls for New Emergency Countermeasures

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The Department of Health and Human Services has unveiled a new multi-point plan aimed at better preparing the US to combat health emergencies such as the H1N1 flu, including development of nucleic acid-based technologies, new centers for medical research, partnerships with industry, enhancing manufacturing capabilities, and other approaches.

The plan stemmed from a review of US medical countermeasure (MCM) capabilities that HHS Secretary Kathleen Sebelius called for in late 2009 – as a response to the H1N1 flu pandemic – that led to a new report loaded with recommendations for several US agencies, Sebelius said late last week.

“Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it’s a threat we know about today or a new one,” Sebelius said in a statement accompanying the release of the report.

“By moving towards a 21st century countermeasures enterprise with a strong base of discovery, a clear regulatory pathway, and agile manufacturing, we will be able to respond faster and more effectively to public health threats,” she added.

The review found that the US needs to: upgrade science and regulatory capacity at the Food and Drug Administration; develop manufacturing processes that can be used to produce more than one type of countermeasure; and that “some of the most promising research and development on countermeasures is done by small, emerging biotech companies with little experience in large-scale manufacturing,” according to HHS.

In response to those points, HHS plans to “make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market,” HHS said.

HHS also plans to release a solicitation in the coming weeks to fund one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) will support new manufacturing platforms to develop a range of countermeasures and would help meet demand for such facilities in the US.

Another response will be to use the center(s) as a resource for new companies by helping to bring MCM products to market.

HHS also said that the government must be better at nurturing new discoveries in their early phases, and so it will create new teams at the National Institutes of Health to identify promising research and to help move it forward.

One other finding in the report was that private companies have a hard time luring investors into the MCM market, where there is not much market for new products.

“As a result of this finding, HHS will explore ways to help small companies attract investors to develop promising countermeasures that have multi-use potential,” HHS said.

Sebelius said that the report, The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs, included other findings.

“We found that our contracting processes were often too rigid, for example," she explained. "We realized we needed to do a better job talking to the private sector throughout the product development process rather than just when we want to license a product. And we saw that we needed better coordination, not just within our department, but across government.”

“We incorporated some of these lessons into our response to the H1N1 pandemic last year, and we’re going to keep working to make sure we’re doing our part to strengthen our response,” she continued.

The MCM development strategy is aimed at supporting technologies that can be applicable for “multiple and diverse threats,” according to the report.

These technologies include those that support rapid and safe development of a drug, vaccine, or diagnostic based on nucleic acid sequences from the pathogen, which does not require that an organism be isolated, as well as tools that have the potential to be scaled up rapidly and used on the large scale.

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