New Pandemic Influenza Vaccine Uses Next Generation Technology to Strengthen Health Security

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New Pandemic Influenza Vaccine Uses Next Generation Technology to Strengthen Health Security

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• FDA approved AUDENZ, (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. AUDENZ is approved for use in persons 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. This vaccine will be produced and distributed under contract to the U.S. Government as part of national pandemic preparedness initiatives. (January 31, 2020) Also see, from HHS/ASPR: New Pandemic Influenza Vaccine Uses Next Generation Technology to Strengthen Health Security
• FDA In Brief: FDA Updates Prioritization Policy for Original Abbreviated New Drug Applications, Amendments and Supplements to Maximize Impact on Public Health (January 30, 2020)
• From HHS/ASPR - The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Multiyear Budget Report for fiscal years (FY) 2018–2022 has been posted. This report includes the multiyear budgets for the following Department of Health and Human Services (HHS) entities involved in MCM development and stockpiling: the National Institutes of Health (NIH), ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and Strategic National Stockpile (SNS), and FDA. (January 29, 2020)