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.
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.