The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of the U.S. people and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW).
The Strategic National Stockpile (SNS), originally called the National Pharmaceutical Stockpile (NPS), is the United States' national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. Its website states:
"The Strategic National Stockpile's role is to supplement state and local supplies during public health emergencies. Many states have products stockpiled, as well. The supplies, medicines, and devices for life-saving care contained in the stockpile can be used as a short-term stopgap buffer when the immediate supply of adequate amounts of these materials may not be immediately available."
Influenza A virus subtype H5N1 (A/H5N1) is a subtype of the influenza A virus, which causes influenza (flu), predominantly in birds. It is enzootic in many bird populations, and also panzootic. A/H5N1 virus can also infect mammals that have been exposed to infected birds; in these cases, symptoms are frequently severe or fatal.
An influenza pandemic is an epidemic of an influenza virus that spreads across a large region and infects a large proportion of the population. There have been six major influenza epidemics in the last 140 years, with the 1918 flu pandemic being the most severe; this is estimated to have been responsible for the deaths of 50–100 million people. The 2009 swine flu pandemic resulted in under 300,000 deaths and is considered relatively mild. These pandemics occur irregularly.
Alex Michael Azar II is an American attorney, businessman, lobbyist, and former pharmaceutical executive who served as the U.S. Secretary of Health and Human Services from 2018 to 2021. Azar was nominated to his post by President Donald Trump on November 13, 2017, and confirmed by the United States Senate on January 24, 2018. He was also chairman of the White House Coronavirus Task Force from its inception in January 2020 to February 2020, when he was replaced by Vice President Mike Pence.
Under United States law, Biological select agents or toxins (BSATs)—or simply select agents for short—are bio-agents which have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety". The agents are divided into (1) HHS select agents and toxins affecting humans; (2) USDA select agents and toxins affecting agriculture; and (3) overlap select agents and toxins affecting both.
The pandemic severity index (PSI) was a proposed classification scale for reporting the severity of influenza pandemics in the United States. The PSI was accompanied by a set of guidelines intended to help communicate appropriate actions for communities to follow in potential pandemic situations. Released by the United States Department of Health and Human Services (HHS) on February 1, 2007, the PSI was designed to resemble the Saffir-Simpson Hurricane Scale classification scheme. The index was replaced by the Pandemic Severity Assessment Framework in 2014, which uses quadrants based on transmissibility and clinical severity rather than a linear scale.
H5N1 influenza virus is a type of influenza A virus which mostly infects birds. H5N1 flu is a concern due to the its global spread that may constitute a pandemic threat. The yardstick for human mortality from H5N1 is the case-fatality rate (CFR); the ratio of the number of confirmed human deaths resulting from infection of H5N1 to the number of those confirmed cases of infection with the virus. For example, if there are 100 confirmed cases of a disease and 50 die as a consequence, then the CFR is 50%. The case fatality rate does not take into account cases of a disease which are unconfirmed or undiagnosed, perhaps because symptoms were mild and unremarkable or because of a lack of diagnostic facilities. The Infection Fatality Rate (IFR) is adjusted to allow for undiagnosed cases.
The Biomedical Advanced Research and Development Authority (BARDA)' is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases. BARDA was established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA) and reports to the Office of the Assistant Secretary for Preparedness and Response (ASPR). The office manages Project BioShield, which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (CBRN) attacks.
On December 19, 2006, the Pandemic and All-Hazards Preparedness Act (PAHPA), Public Law No. 109-417, was signed into law by President George W. Bush. First introduced in the House by Rep. Mike Rogers (R-MI) and Rep. Anna Eshoo (D-CA), PAHPA had broad implications for the United States Department of Health and Human Services's (HHS) preparedness and response activities. Among other things, the act amended the Public Health Service Act to establish within the department a new Assistant Secretary for Preparedness and Response (ASPR); provided new authorities for a number of programs, including the advanced development and acquisitions of medical countermeasures; and called for the establishment of a quadrennial National Health Security Strategy.
The 2009 flu pandemic in the United States was caused by a novel strain of the Influenza A/H1N1 virus, commonly referred to as "swine flu", that was first detected on 15 April 2009. While the 2009 H1N1 virus strain was commonly referred to as "swine flu", there is no evidence that it is endemic to pigs or of transmission from pigs to people; instead, the virus spreads from person to person. On April 25, the World Health Organization declared a public health emergency, followed concurringly by the Obama administration on April 26.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.
James M. Galloway is an American medical doctor and public health physician. Galloway served as the Regional Health Administrator for the United States Department of Health and Human Services for the six eastern states that comprise Region V under Presidents George W. Bush and Barack Obama. He also served as the Senior Federal Official for Health for Pandemic Influenza and Bioterrorism for the Department of Homeland Security's Region C, which includes an additional six states. Galloway was the lead for one of CDC's lead efforts as the Director of the Office of Health System Collaboration, integrating clinical care and public health at a national level.
Operation Dark Winter was the code name for a senior-level bio-terrorist attack simulation conducted on June 22–23, 2001. It was designed to carry out a mock version of a covert and widespread smallpox attack on the United States. Tara O'Toole and Tom Inglesby of the Johns Hopkins Center for Civilian Biodefense Strategies (CCBS) / Center for Strategic and International Studies (CSIS), and Randy Larsen and Mark DeMier of Analytic Services were the principal designers, authors, and controllers of the Dark Winter project.
Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.
A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.
In the United States, the National Biodefense Strategy is a White House-issued policy document laying out the federal government's approach to biodefense and biosecurity.
Exercise Cygnus was a three-day simulation exercise carried out by the UK Government, in October 2016, to estimate the impact of a hypothetical H2N2 influenza pandemic on the United Kingdom. It was aimed at identifying strengths and weaknesses within the United Kingdom health system and emergency response chain by putting it under significant strain, providing insight on the country's resilience and any future ameliorations required. It was conducted by Public Health England representing the Department of Health and Social Care, as part of a project led by the "Emergency Preparedness, Resilience and Response Partnership Group". Twelve government departments across Scotland, Wales and Northern Ireland, as well as local resilience forums (LRFs) participated. More than 950 workers from those organisations, prisons and local or central government were involved during the three-day simulation, and their ability to cope under situations of high medical stress was tested.
Planning and preparing for pandemics has happened in countries and international organizations. The World Health Organization writes recommendations and guidelines, though there is no sustained mechanism to review countries' preparedness for epidemics and their rapid response abilities. National action depends on national governments. In 2005–2006, before the 2009 swine flu pandemic and during the decade following it, the governments in the United States, France, UK, and others managed strategic health equipment stocks, but they often reduced stocks after the 2009 pandemic in order to reduce costs.
Rick Arthur Bright is an American immunologist, vaccine researcher, and public health official. He was the director of the Biomedical Advanced Research and Development Authority (BARDA) from 2016 to 2020. In May 2020, he filed a whistleblower complaint, alleging that the Trump administration ignored his early warnings about the COVID-19 pandemic and illegally retaliated against him by ousting him from his role and demoting him to a position at the National Institutes of Health. On October 6, 2020, Bright resigned from the government. On November 9 he was named a member of President-elect Joe Biden's coronavirus advisory board.
