H1N1 vaccine problems trigger review of public health emergency plans

The HHS secretary tells an AMA health system readiness summit that outdated technology affected vaccine production and distribution, and that changes are needed.

By Christine S. Moyer — Posted Dec. 1, 2009

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Reacting in large part to production delays of the influenza A(H1N1) vaccine, Health and Human Services Secretary Kathleen Sebelius is calling for a review of the federal government's system for handling public health emergencies.

The review will analyze vaccine development, production and distribution policies, and then determine the best plan for disaster preparedness, Sebelius told the AMA's National Congress on Health System Readiness in Washington, D.C., on Dec. 1. The move comes as the Centers for Disease Control and Prevention reports the country's H1N1 epidemic has started to wane.

"The ultimate goal of this review is a modernized countermeasure production process where we have more promising discoveries, more advanced development, more robust manufacturing, better stockpiling and more advanced distribution practices," Sebelius said.

"We want to create a system that can respond to any threat at any time. The kind of system that is so dependable and comprehensive that it deters our potential bioterrorism attacks and makes our enemies say, 'It's not worth the effort.' "

The unexpected delays of delivering the H1N1 vaccine in the fall, coupled with the virus' rapid spread, left Americans frantically searching for the vaccine and doctors scrambling to allocate limited supplies. The CDC fell short of its vaccine supply goals by millions of doses.

Hospitals were overwhelmed, as were vaccine distribution centers, where people waited in line for hours, only to be turned away when the supply fell short of the demand.

The root of the problem, according to the CDC and Sebelius, is outdated vaccine technology.

"We were working to squeeze every last bit of efficiency and dependability out of a safe but outdated technology," Sebelius said. "For us, the conclusion was clear: If we wanted to avoid these problems in the future, we needed to make some long-term investments in developing countermeasures that were just as safe and effective, but could be produced faster and more reliably."

Although the government has discussed updating vaccine technology for years, "what is new," Sebelius said, "is that we're backing up our talk with action and resources."

Sebelius said HHS supports Novartis' recent opening of America's first cell-based vaccine plant, which is scheduled to begin operation in 2011 in North Carolina.

She asked that the review, which will be done by the HHS Office of the Assistant Secretary for Preparedness and Response, be completed in the first quarter of 2010. But she stressed that improving the country's response to public health emergencies will be ongoing.

"We know this transformation won't happen overnight. But we're going to do everything we can to speed it along."

The text of Sebelius' remarks is online (link).

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