| dbo:abstract |
The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for 5billionforpurchasingvaccinesthatwouldbeusedintheeventofabioterroristattack.Thiswasaten−yearprogramtoacquiremedicalcountermeasurestobiological,chemical,radiological,andnuclearagentsforcivilianuse.AkeyelementoftheActwastoallowstockpilinganddistributionofvaccineswhichhadnotbeentestedforsafetyorefficacyinhumans,duetoethicalconcerns.Efficacyofsuchagentscannotbedirectlytestedinhumanswithoutalsoexposinghumanstothechemical,biological,orradioactivethreatbeingtreated,sotestingfollowstheFDAforpivotalanimalefficacy.Sincethe2001terroristattacks,theUnitedStatesgovernmenthasallocatednearly5 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 for pivotal animal efficacy. Since the 2001 terrorist attacks, the United States government has allocated nearly 5billionforpurchasingvaccinesthatwouldbeusedintheeventofabioterroristattack.Thiswasaten−yearprogramtoacquiremedicalcountermeasurestobiological,chemical,radiological,andnuclearagentsforcivilianuse.AkeyelementoftheActwastoallowstockpilinganddistributionofvaccineswhichhadnotbeentestedforsafetyorefficacyinhumans,duetoethicalconcerns.Efficacyofsuchagentscannotbedirectlytestedinhumanswithoutalsoexposinghumanstothechemical,biological,orradioactivethreatbeingtreated,sotestingfollowstheFDAforpivotalanimalefficacy.Sincethe2001terroristattacks,theUnitedStatesgovernmenthasallocatednearly50 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. 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 Project BioShield. Significant funding also goes to Biomedical Advanced Research and Development Authority (BARDA), 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. (en) |
| rdfs:comment |
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 for pivotal animal efficacy. (en) |
