Department of Defense Anthrax Vaccine Immunization Program: Hearings Before the Committee on Armed Services, United States Senate, One Hundred Sixth Congress, Second Session, April 13 and July 12, 2000, Volumen4U.S. Government Printing Office, 2001 - 244 páginas |
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Administration Admiral CLINTON Adverse Event Reporting adverse events aerosol Anthrax Vaccine Expert Anthrax Vaccine Immunization assessed AVIP Bacillus anthracis Biological Defense biological warfare biological warfare agent BioPort BioPort Corporation BLANCK Chairman WARNER civilian clinical concerns continue contract Department of Defense disease doses evaluated Event Reporting System FDA approval force Fort Detrick Go-Co going hearing high threat areas inhalation anthrax injection inspection issue license manufacturing MBPI Michigan military OLIVER percent personnel potency protection question received recommended renovated renovated production Rudy de Leon schedule Secretary DE LEON Secretary of Defense Senator ALLARD Senator HUTCHINSON Senator LEVIN Senator SESSIONS Senator SMITH Senator SNOWE Senator WARNER service members spores stockpile symptoms Thank thrax tion vaccination program Vaccine Adverse Event Vaccine Expert Committee Vaccine Immunization Program vaccine recipients VAERS reports weapons West ZOON
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Página 233 - Health screening programs are popular, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC...
Página 234 - Memorandum for Secretaries of the Military Departments, Chairman of the Joint Chiefs of Staff, Under Secretaries of Defense Director, Defense Research and Engineering, Assistant Secretaries of Defense, General Counsel of the Department of Defense.
Página 32 - Identifying potential problems, the reports on anthrax vaccine received thus far do not raise any specific- concerns about -the safety of the vaccine. As more people receive the vaccine, the numbers of adverse events reported will increase. .FDA continues to view the anthrax vaccine as safe and effective for individuals at risk of exposure to anthrax. LOT RELEASE As mentioned above, because of the complex manufacturing processes for most biological products, each product lot undergoes thorough testing...
Página 101 - The available studies are of insufficient quality, consistency or statistical power to permit a conclusion regarding the presence or absence of a causal association, or no data on cancer in humans are available.
Página 30 - Standards issued a product license to MDPH to manufacture anthrax vaccine. Approved labeling for the anthrax vaccine states that immunization with this product is recommended for individuals who may come in contact with animal products that may be contaminated with Bacillus anthracis spores; and for individuals engaged in diagnostic or investigational activities which may bring them in contact with Bacillus anthracis spores. It is also recommended for persons at high risk, such as veterinarians and...
Página 60 - Anthrax is an infectious disease caused by the bacterium Bacillus anthracis and is spread by contact with infected animals, handling infected products, eating infected meat, or inhaling weapon-dispersed anthrax spores. Of all known biological warfare agents, anthrax spores are the top choice in biological weapons for "germ warfare.
Página 181 - While the data gathered from the VAERS system can serve as a useful tool in identifying potential problems, the reports on anthrax vaccine received thus far do not raise any specific concerns about the safety of the vaccine. With all vaccines, as the number of people that receive the vaccine increases, so will the number of adverse events reported to FDA. Thus, our knowledge of the vaccine will grow accordingly. FDA continues to view the anthrax vaccine as safe and effective for individuals at high...
Página 102 - The committee's findings are best regarded as an early step in the complex process of understanding the vaccine's safety, which began with the vaccine's licensure in 1970 and the 1985 FDA advisory pane!
Página 181 - ... imminent or substantial hazard to the public health, ordering a recall of the product. Because of the complex manufacturing processes for most biological products, each product undergoes thorough laboratory testing for purity, potency, identity, and sterility.
Página 29 - ... vaccine lot and the results if their own tests for potency, safety, and sterility to the Agency before release of each lot of the licensed product, because of the complex manufacturing processes for most biological products. In addition, licensed establishments are inspected regularly by FDA. Let us now turn to anthrax.