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.
The document's most recent version was published in October 2022 by the Biden Administration as the "National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health." [1] It aims "to create a world free from catastrophic biological incidents, laying out a set of objectives to effectively counter the spectrum of biological threats." [1] The 2022 strategy updates the prior 2018 strategy [2] published by the Trump Administration, which the federal government was directed to adopt by the National Defense Authorization Act for Fiscal Year 2017. [3]
Prior to the 2018 congressional directive, previous U.S. government biodefense strategies existed, including the George W. Bush administration's 2004 Homeland Security Presidential Directive-10 ("Biodefense for the 21st Century"), which was one of many laws and executive actions enacted following the 2001 anthrax attacks. [3] The push for increased federal funding in biodefense began during Bush's term in office. For example, in 2006, Bush, in his annual budget request, asked for a total of $5.1 billion for civilian biodefense. This number was a decrease of $2.5 billion from the previous year's budget. The drop was primarily attributed to the absence of Project BioShield money in 2006; the money for that year was already allocated the previous year. Overall, the 2006 request contained incremental increases for all agencies involved in biodefense. [4] Homeland Security Presidential Directive-10's primary focus was on preventing, detecting, and responding to potential intentional attacks using biological weapons, and set forth the role of the nascent U.S. Department of Homeland Security and other institutions. [3]
During the Obama administration, the 2009 National Strategy for Countering Biological Threats and the 2012 National Strategy for Biosurveillance built on the Bush administration's work, and expanded biodefense strategy to emphasis global health security and other public health crises, whether of "natural, accidental, or deliberate origin." [3] The Obama administration biodefense strategies encompass "human, animal, and plant health" and included roles for "federal, state, local, and tribal governments, the private sector, nongovernmental organizations, and international partners." [3]
The bipartisan Blue Ribbon Study Panel on Biodefense, a privately sponsored group examining biodefense issues, convened in 2014 and issued a report in 2015. [5] [3] The panel, co-chaired by former governor of Pennsylvania Tom Ridge, warned "that the U.S. is dangerously vulnerable to a large-scale biological attack and has urged Washington to develop a more comprehensive strategy." [5] The panel specifically found that the U.S. had not adopted a comprehensive biodefense strategy over "a decade of profusion of policy directives," and noted that there was a fracturing of responsibility for biodefense across multiple agencies and levels of government. [3] These concerns prompted the U.S. Congress to include a provision in the National Defense Authorization Act for Fiscal Year 2017 that required the secretaries of Defense, Health and Human Services, Homeland Security, and Agriculture to coordinate to produce a comprehensive strategy for countering biological warfare threats and other biological threats. [3]
Following the congressional directive, in September 2018, President Trump announced and issued the strategy. The strategy placed the U.S. Department of Health and Human Services in charge of leading the federal government's biodefense efforts, and designated HHS to lead a committee of high-level officials from the Defense Department, Agriculture Department, and Homeland Security Departments, to review the biodefense capabilities of the United States Intelligence Community and 15 other executive branch agencies—i.e., the agencies' capacity to counter naturally occurring and human-caused biological threats. [6] Trump's National Security Adviser John Bolton said that the National Security Council would assist in the development of policy, and the interagency committee led by HHS would implement policy changes. [6] Trump said that the strategy drew lessons from the 2014 West African Ebola virus epidemic. [5] The policy was the work product of the reorganized NSC under Bolton. [7] [2]
According to Politico , "Senior administration officials later said threats could be better addressed by streamlining processes for biotech companies to work with the HHS's Biomedical Advanced Research and Development Authority, which supports private sector development of vaccines and drugs." [6]
One official from the Trump Administration said that the government's accounting requirements have made it difficult and undesirable for many companies to participate. [6]
HHS Assistant Secretary Robert Kadlec said that one of his top priorities was to get a decade-long extension of the Project BioShield Special Reserve Fund. The government can use that fund to buy countermeasures like vaccines, medication, and diagnostic tools. The fund was first authorized under President George W. Bush in 2004. [6]
Later, the Donald Trump administration announced they would siphon funds from medical programs to supplement fundings for the strategy. When questioned about this, it was reported that the Obama administration provided the plans for the strategy.
The Biden Administration's October 2022 National Biodefense Strategy and Implementation Plan has five goals with associated objectives for strengthening US biodefense, including (objectives for each goal are listed in the document): [1]
The document also lays out a number of assumptions behind its strategic approach, including (full explanations in the document): [1]
Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents include bacteria, viruses, insects, fungi, and/or their toxins, and may be in a naturally occurring or a human-modified form, in much the same way as in biological warfare. Further, modern agribusiness is vulnerable to anti-agricultural attacks by terrorists, and such attacks can seriously damage economy as well as consumer confidence. The latter destructive activity is called agrobioterrorism and is a subtype of agro-terrorism.
Biodefense refers to measures to counter biological threats, reduce biological risks, and prepare for, respond to, and recover from bioincidents, whether naturally occurring, accidental, or deliberate in origin and whether impacting human, animal, plant, or environmental health. Biodefense measures often aim to improve biosecurity or biosafety. Biodefense is frequently discussed in the context of biological warfare or bioterrorism, and is generally considered a military or emergency response term.
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 National Biodefense Analysis and Countermeasures Center (NBACC) is a government biodefense research laboratory created by the U.S. Department of Homeland Security (DHS) and located at the sprawling biodefense campus at Fort Detrick in Frederick, MD, USA. The NBACC is the principal U.S. biodefense research institution engaged in laboratory-based threat assessment and bioforensics. NBACC is an important part of the National Interagency Biodefense Campus (NIBC) also located at Fort Detrick for the US Army, National Institutes of Health and the US Department of Agriculture.
The Johns Hopkins Center for Health Security is an independent, nonprofit organization of the Johns Hopkins Bloomberg School of Public Health. The center works to protect people's health from epidemics and pandemics and ensures that communities are resilient to major challenges. The center is also concerned with biological weapons and the biosecurity implications of emerging biotechnology.
The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.
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.
The Administration for Strategic Preparedness and Response (ASPR) is an operating agency of the U.S. Public Health Service within the Department of Health and Human Services that focuses preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters. Its functions include preparedness planning and response; building federal emergency medical operational capabilities; countermeasures research, advance development, and procurement; and grants to strengthen the capabilities of hospitals and health care systems in public health emergencies and medical disasters. The office provides federal support, including medical professionals through ASPR’s National Disaster Medical System, to augment state and local capabilities during an emergency or disaster.
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.
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.
Brett P. Giroir is an American pediatrician. He was formerly the U.S. assistant secretary for health, a four-star admiral in the U.S. Public Health Service Commissioned Corps and an acting Food and Drug Administration commissioner.
The United States National Biosurveillance Strategy is the plan to implement a biosurveillance system that will monitor and interpret data that might relate to disease activity and threats to human or animal health – whether infectious, toxic, metabolic, and regardless of intentional or natural origin – in order to achieve early warning of health threats, early detection of health events and overall situational awareness of disease activity.
The Bipartisan Commission on Biodefense, formerly known as the Blue Ribbon Study Panel on Biodefense, is an organization of former high-ranking government officials that analyzes US capabilities and capacity to defend against biological threats. According to the Commission's mission statement, the organization was formed to "provide for a comprehensive assessment of the state of U.S. biodefense efforts, and to issue recommendations that will foster change."
The Strengthening Public Health Emergency Response Act of 2015, H.R. 3299, is a bill introduced in the U.S. House of Representatives that would streamline government decisions and provide incentives for vaccines and treatment of dangerous pathogens and diseases. The bill was introduced by Representatives Susan Brooks (R-IN) and Anna Eshoo (D-CA).
The First Responder Anthrax Preparedness Act is a law introduced in the United States Senate by U.S. Senator Kelly Ayotte. The law will set up a pilot program that provides anthrax vaccines from the U.S. Strategic National Stockpile to first responders, the Department of Homeland Security (DHS) would create a tracking system for those who receive the vaccine, and the government would prioritize vaccines close to the end of their labeled dates. The Congressional Budget Office estimated that implementing the law would cost about $4 million over the 2016-2020 period.
The Alliance for Biosecurity is a consortium of companies that develop products to respond to national security threats, including bioterrorism pathogens and emerging infectious diseases. It is headquartered in Washington DC.
Robert Peter Kadlec is an American physician and career officer in the United States Air Force who served as Assistant Secretary of Health and Human Services from August 2017 until January 2021. He is responsible for the creation of the COVID-19 vaccine development program Operation Warp Speed.
Rear Admiral Kenneth Bernard is an American public health physician and expert on biodefense and health security policy. He served at the George W. Bush White House from 2002-2005 as Special Assistant to the President for Biodefense and as Assistant Surgeon General.
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.
Elizabeth Cameron is an American national security expert specializing in biosecurity, biodefense, and bioterrorism. She is a professor at the Pandemic Center of the Brown University School of Public Health. Previously, she served as Senior Director for Global Health Security and Biodefense on the White House National Security Council staff.