Public Health Emergency - Leading a Nation Prepared
Seasonal influenza epidemics occur every year, but periodically a novel influenza virus strain, for which there is little human immunity, emerges and can cause a global pandemic like the 2009 H1N1 pandemic, or even a more severe one like the pandemic of 1918. Influenza and other emerging viruses with pandemic potential continue to mutate, evolve, and infect animals and people, posing significant threats to global public health and to the United States.
ASPR coordinates across HHS and government-wide on pandemic preparedness and response. The agency drives strategies and action plans that complement seasonal influenza activities that are managed by the HHS National Vaccine Program Office. Together with federal and industry partners, ASPR has made great strides toward pandemic preparedness.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) has made available or stockpiled 18 influenza medical countermeasures – vaccines, drugs, diagnostics or medical devices – for pandemic influenza. As part of the overall National Strategy for Pandemic Influenza, BARDA has worked to ensure that the nation has stockpiles of pandemic influenza medical countermeasures to protect the public from influenza viruses with pandemic potential.
Because of these efforts, federal and state stockpiles now have enough influenza antiviral drugs to treat 25% of the U.S. population in a pandemic. Vaccine manufacturers have access to a year-round supply of eggs needed to make influenza vaccine in the traditional way. Manufacturers also are ready with new, innovative technology to make vaccines faster than ever in a pandemic.
Based on lessons from the 2009 H1N1 pandemic, ASPR has established services to fill gaps and save time for vaccine developers in a public health emergency. These services include networks of organizations with experience in conducting nonclinical and clinical studies; three Centers of Innovation for Advanced Development and Manufacturing that pair large and small companies to develop and manufacture vaccines; and a fill finish manufacturing network make up of companies with facilities that can fill and finish vials with vaccine and prepare them for shipping. BARDA also worked with companies to build new manufacturing facilities in the United States or retrofit existing U.S. facilities to make flu vaccine in a pandemic. These efforts created a 5-fold increase in the domestic capacity to make flu vaccines in a pandemic.
ASPR/BARDA is pursuing antiviral drugs to treat influenza and supported development of the first safe and effective antiviral treatment for influenza approved by the FDA in 15 years. The agency also is sponsoring the development of diagnostic tests that are faster and more accurate than ever so that doctors and patients have test results within hours rather than days. Knowing whether the patient is sick from a flu virus or has a different illness helps doctors determine the best treatment.
ASPR/BARDA will continue to develop and improve drugs, vaccines, and diagnostic tests and to maximize domestic and international manufacturing so that our nation is as ready as possible for the next pandemic.
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Assistant Secretary for Preparedness and Response (ASPR), 200 Independence Ave., SW, Washington, DC 20201
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