Centers for manufacturing emergency influenza vaccine ready in next few years


One of three organizations hired by the Health and Human Services Department for surge vaccine production in the event of a pandemic should be running at full capacity within three years, department officials say.

HHS in 2012 awarded contracts collectively worth nearly $400 million to Novartis, Emergent Manufacturing Operations, and Texas A&M University to establish centers capable of providing surge vaccine capacity by using methods allowing for quick production. For example, the centers might use disposable plastic bags to grow cell cultures rather than stainless steel tanks or resort to recombinant technologies rather than the traditional egg-based method.

HHS anticipates that one of the centers will be ready in 2017 to produce 50 million doses of pandemic influenza vaccine within four months of receiving the virus strain. All the centers should be ready to do the same by the end of 2020. Under the program, the public is scheduled to receive the first doses of surge vaccine within 12 weeks.

The 2009 H1N1 pandemic raised concerns about the United States' ability to rapidly manufacture medical countermeasures to infectious diseases, a concern that also extends to medical countermeasures against the effects of chemical, biological, radiological or nuclear attacks.

A HHS review of the pandemic concluded that the department should pay for manufacturing centers able to suddenly produce vast amounts of influenza vaccine.  The private sector on its own lacks the incentive to establish such capacity, dubbed a "warm base," the HHS concluded. Under the program, the centers are also set to engage in the development and production of CBRN medical countermeasures.

Congress directed the Government Accountability Office to review progress of the program, but in a March 31 report, concludes that it's too early to tell how helpful the contracts will be in support of CBRN countermeasure development.

The contracts are structured so that the centers first concentrate on developing vaccine surge capacity.

HHS officials stationed within the Biomedical Advanced Research and Development Authority told GAO auditors some of the centers may be ready to process CBRN countermeasure task orders this year, but that all should be definitively ready by the end of 2015.

Still, although the GAO says that "it is too early to tell how effective" the program is in CBRN countermeasures, the report says some in industry have "concerns about demand, availability of funding, and communication with BARDA."

Among their concerns was whether the task orders will be large enough to be effective; BARDA officials said they expect to have sufficient funding for task orders this fiscal year and the next.

For more:
- download the report, GAO-14-329 (.pdf)

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