Administration Seeks to Modernize Vaccine Production - Pharmaceutical Technology

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Administration Seeks to Modernize Vaccine Production
President Obama and HHS eye innovation and countermeasures to protect public health.


Pharmaceutical Technology
Volume 10, Issue 34, pp. 32-38


Jill Wechsler
To better tackle future biological threats and global pandemics, public-health experts are urging a more efficient approach to producing vaccines and medical treatments. Officials at the US Department of Health and Human Services (HHS), along with research scientists and drug manufacturers, have acknowledged the shortcomings of traditional influenza-vaccine production methods for years, as demonstrated last year during the H1N1 influenza pandemic. The Obama administration is proposing a $2-billion strategy to create a more "nimble and flexible" system that can respond quickly to new pathogens and provide surge capacity for influenza-vaccine production, explained HHS Secretary Kathleen Sebelius at an August press briefing in Washington, DC.

A new HHS report, The Public Health Emergency Medical Countermeasures Enterprise Review, outlines how researchers and biopharmaceutical companies can work with government agencies to produce vaccines and medical countermeasures (MCMs) to meet emergency public-health needs. The plan proposes to strengthen science at the US Food and Drug Administration, finance multi-use manufacturing operations, provide more assistance to innovative researchers, encourage investment in start-up biotechnology firms, and modernize influenza-vaccine development and production.


In Washington this month
The plan appears to be part of continued efforts to apply lessons learned during the 2009 H1N1 influenza pandemic response to expand the nation's arsenal against bioterrorism and infectious disease. There have been multiple conferences and presentations on what worked, and what went wrong, in the race to produce sufficient quantities of vaccine to combat last year's influenza strain (see the February 2010 Washington Report, "Manufacturers Look to Vaccines for Growth and Innovation").

Dealing with a global health emergency requires a broad spectrum of activities, from early detection of an outbreak to building a health infrastructure able to provide care. Creating a "21st century countermeasures enterprise," as Secretary Sebelius called the new HHS project, will require even more work.

Faster influenza-vaccine production

The HHS proposals for improving influenza-vaccine production parallel a more detailed plan prepared by the President's Council of Advisors on Science and Technology (PCAST) called "Reengineering the Influenza Vaccine Production Enterprise." This advisory body to the White House Office on Science and Technology Policy assessed the nation's preparedness for the looming H1N1 influenza pandemic in August 2009 and offered recommendations for improvement in May 2010. The final report reiterates the group's proposals for bolstering influenza-vaccine development and production and emphasizes how the proposed changes could serve as a "relevant pathfinder" for modernizing countermeasure production more broadly.

The PCAST review notes that it took 26 weeks to produce pandemic-influenza vaccine after government agencies officially requested it last year, and that most of the US population did not have access to the vaccine for 38 weeks. The pandemic claimed 13,000 American lives and sickened more than 60 million people, including a disproportionate number of children and young adults.

Fortunately, the H1N1 virus proved to be less lethal than anticipated, and vaccine manufacturers ended up with unsold product and cancelled government orders that diminished profits. Even so, some entities charged that the pharmaceutical industry hyped the pandemic to sell more vaccines and drugs at high prices. US and international public health officials rejected those accusations, and HHS hopes that improved forecasting and more efficient vaccine production will avoid delays and waste and improve treatment in the future.


Presidential council aims to streamline influenza-vaccine production
Such gains require major improvements in influenza-vaccine production methods, says PCAST. It proposes spending $1 billion a year for three years to shift from egg-based to more modern vaccine-manufacturing methods that use cell-culture and recombinant DNA processes. PCAST also outlines specific strategies that can cut vaccine production by several weeks and can be implemented quickly (see sidebar, "Presidential council aims to streamline influenza-vaccine production").


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