Sebelius report re-states need for vax-making makeover

Expect HHS to complete a draft solicitation for vaccine manufacturing and development "centers of innovation" in the coming weeks. Secretary Kathleen Sebelius, staying on message since the beginning of this year, released last week The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs.

The report assesses the government's system to produce medications, vaccines, equipment and supplies for health emergencies. Then it makes recommendations for fixes.

Sebelius said in February that the current limitations of vaccine-manufacturing technology are among the biggest lessons learned from the 2009 H1N1 flu. The current report is the culmination of a fast-track review of the existing "safe but outdated" processes that she initiated then.

Recommendations include development of "agile manufacturing" of medical countermeasures for faster and more effective responses to public health threats. Along these lines, she's looking for manufacturing processes that can be used for multiple medications or vaccines rather than those developed for just one.

She expressed also the need for "a modernized countermeasure production process," spanning the research, development and FDA approval steps of such products. And she finds a need to" upgrade science and regulatory capacity at the FDA" to complement the manufacturing and development upgrades. She promises significant government investment.

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