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.
Emergent BioSolutions Inc. is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg,Maryland. It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses,and it provides medical devices for biodefense purposes.
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.
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to develop treatments for disease indications with limited profitability.
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.
BioCryst Pharmaceuticals,Inc. is an American pharmaceutical company headquartered in Durham,North Carolina. The company is a late stage biotech company that focuses on oral drugs for rare and serious diseases. BioCryst's antiviral drug peramivir (Rapivab) was approved by FDA in December 2014. It has also been approved in Japan,Korea,and China.
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 Biological Defense Program—in recent years also called the National Biodefense Strategy—refers to the collective effort by all levels of government,along with private enterprise and other stakeholders,in the United States to carry out biodefense activities.
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).
Dougbeh Chris Nyan is a Liberian medical doctor,a biomedical research scientist,social activist and inventor. He specializes in infectious disease research.
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.
Dr. Daniel R. Lucey is an American physician,researcher,clinical professor of medicine of infectious diseases at Geisel School of Medicine at Dartmouth,and a research associate in anthropology at the Smithsonian National Museum of Natural History,where he has co-organised an exhibition on eight viral outbreaks.
Richard Hatchett is an American oncologist and epidemiologist who has been serving as chief executive officer of the Coalition for Epidemic Preparedness Innovations (CEPI) in Oslo and London since 2017. He was awarded the Secretary of Health and Human Services's Award for Distinguished Service.
Syra Madad is an American pathogen preparedness expert and infectious disease epidemiologist. Madad is the Senior Director of the System-wide Special Pathogens Program at NYC Health + Hospitals where she is part of the executive leadership team which oversees New York City's response to the Coronavirus disease 2019 pandemic in the city's 11 public hospitals. She was featured in the Netflix documentary series Pandemic:How to Prevent an Outbreak and the Discovery Channel documentary The Vaccine:Conquering COVID.
Crystal Watson is a senior scholar at the Johns Hopkins Center for Health Security and an associate professor in the Department of Environmental Health and Engineering. She is an expert in health security,biodefense,and risk assessment and preparedness for emerging infectious diseases. She is currently working on the public health response to the COVID-19 pandemic.
Hilary D. Marston is an American physician-scientist and global health policy advisor specializing in pandemic preparedness. She is the Chief Medical Officer of the Food and Drug Administration.
