Vaccine and Other Medical Countermeasures
Medical countermeasures (MCMs) are central to the public health response to mitigate the impact of influenza pandemics. Pandemic influenza MCM planning efforts are a part of the Public Health Emergency Medical Countermeasures EnterpriseExternal (PHEMCE) process to increase public health preparedness. HHS leads the PHEMCE, the coordinating body for the federal agencies involved in the effort to protect the civilian population through the use of MCMs. Safe, effective, and readily available MCMs, including vaccines, antiviral drugs, therapeutics, diagnostics, ventilators, and respiratory protection devices, are central to HHS’s goal to significantly reduce morbidity and mortality during an influenza pandemic. An effective influenza pandemic response includes developing, manufacturing, distributing, and administering MCMs in the shortest time possible, and monitoring their impact when used in the context of a public health emergency.
Vaccination is the most cost-effective medical intervention for mitigating the potentially devastating impact of an evolving influenza pandemic. This requires developing a well-matched, safe, and effective vaccine in the shortest time possible; determining the proper dose and dosage; and administering it promptly. If a severe influenza pandemic emerges, a well-coordinated vaccination campaign would need to be implemented immediately to reduce morbidity and mortality.
The following are a collection of federal resources designed to guide influenza pandemic planning related to vaccines and other MCMs.
- 2015 Public Health Emergency Medical Countermeasures (PHEMCE) Strategy and Implementation PlanExternal
- HHS Biomedical Advanced Research and Development Authority (BARDA) Influenza DivisionExternal is charged with the advanced development and procurement of medical and non-pharmaceutical countermeasures for pandemic influenza preparedness and response.
- BARDA Strategic Plan 2011-2016External emphasizes five goals BARDA will use to accomplish its mission
- BARDA’s Influenza Vaccines, Stockpiling, Antivirals, Diagnostics, and Devices External
- CDC’s Strategic National Stockpile
- United States Government Vaccine Stockpile H5N1
- Making a Candidate Vaccine Virus (CVV) for a Highly Pathogenic Avian Influenza (Bird Flu) Virus
- National Institute of Allergy and Infectious Disease Influenza VaccinesExternal
- FDA Medical Countermeasure (MCM) Legal, Regulatory and Policy Framework External
- FDA Emergency Use Authorities External
- FDA PAPHRA Q&A for Public Health Preparedness and Response Stakeholders External
- FDA Emergency Use Authority of Medical Products and Related Authorities (April 2016) External
- FDA Emergency use of an Investigational Drug or Biologic External
- WHO’s summary report on the antigenic and genetic characteristics of zoonotic influenza viruses and candidate vaccine viruses developed for potential use in human vaccinesExternal