Project Bioshield Act
Encyclopedia
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 these agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated. In these cases efficacy testing follows the FDA
Animal Rule for pivotal animal efficacy.
Since the 2001 terrorist attacks, the United States government has allocated nearly $50 billion to address the threat of biological weapons. U.S. funding for bioweapons-related activities focuses primarily on research for and acquisition of medicines for defense. Biodefense funding also goes toward stockpiling protective equipment, increased surveillance and detection of biological agents, and improving state and hospital preparedness. The increase in this type of funding is mainly for this Project BioShield. Significant funding also goes to BARDA (Advanced Research and Development Authority), part of HHS. Funding for activities aimed at prevention has more than doubled 2007 and is distributed to 11 federal agencies. Efforts toward cooperative international action are part of the project.
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
in 2004
2004 in the United States
Events from the year 2004 in the United States.-Incumbents:* President: George W. Bush * Vice President: Dick Cheney * Chief Justice: William Rehnquist* Speaker of the House of Representatives: Dennis Hastert...
calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist
Bioterrorism
Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, or toxins, and may be in a naturally occurring or a human-modified form. For the use of this method in warfare, see biological warfare.-Definition:According to the...
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
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
, due to ethical concerns. Efficacy of these agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated. In these cases efficacy testing follows the FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
Animal Rule for pivotal animal efficacy.
Since the 2001 terrorist attacks, the United States government has allocated nearly $50 billion to address the threat of biological weapons. U.S. funding for bioweapons-related activities focuses primarily on research for and acquisition of medicines for defense. Biodefense funding also goes toward stockpiling protective equipment, increased surveillance and detection of biological agents, and improving state and hospital preparedness. The increase in this type of funding is mainly for this Project BioShield. Significant funding also goes to BARDA (Advanced Research and Development Authority), part of HHS. Funding for activities aimed at prevention has more than doubled 2007 and is distributed to 11 federal agencies. Efforts toward cooperative international action are part of the project.
See also
- Biodefense and Pandemic Vaccine and Drug Development Act of 2005Biodefense and Pandemic Vaccine and Drug Development Act of 2005The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 , nicknamed "Bioshield Two" and sponsored by Senator Richard Burr , aims shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical...
, nicknamed "Bioshield Two" - Biomedical Advanced Research and Development AuthorityBiomedical Advanced Research and Development AuthorityThe Biomedical Advanced Research and Development Authority , within the Office of the Assistant Secretary for Preparedness and Response in the U.S...
(BARDA) - Vaccines for the New Millennium ActVaccines for the New Millennium ActVaccines for the New Millennium Act was a bill introduced by Senator John Kerry and Rep. Nancy Pelosi . The bill would have provided tax credits to private sector companies working on vaccines for some of the world's most deadly infectious agents...