Defense Vaccines: Force Protection Or False Security? - Congressional Hearing
Witnesses: Sue Bailey, Assist. Sec. for Health Aff., DoD; Randall West, Spec. Assist. to the Sec. of Def. for Biol. Warfare and Anthrax, DoD; Randy Randolph, Anthrax Vaccine Immun. Prog. Agency, DoD; Cedric Dumont, Off. of Med. Serv., U.S. Dept. of State; Kathryn Zoon, Ctr. for Biologics, Eval. and Res., FDA; Kwai-Cheung Chan, Spec. Stud. and Eval., GAO, accomp. by Dr. Charla; William Crowe, Jr. (USN Ret.); Jack Melling, biol. dev't. center, the Salk Inst.; Milton Leitenberg, Center for Internat. and Security Stud., Univ. of Maryland; John Classen; Sonnie Bates, Pilot, USAF; Thomas Rempfer, Pilot, USAF Reserves; and Neal Halsey, dir., Inst. for Vaccine Safety, Johns Hopkins Univ.
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Page 48 - Mr. Chairman and members of the committee, thank you very much for the opportunity to...
Page 79 - ... 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.
Page 69 - ... five inhalation cases, two individuals had received the placebo, while three individuals were in the observational group. Four of the five people who developed inhalation anthrax died. No cases of inhalation anthrax occurred in anthrax vaccine recipients. Of the 21 cutaneous cases, 15 individuals had received the placebo, three individuals were in the observational group, two individuals were partially immunized and one individual was fully immunized. Based upon a comparison between the populations...
Page 42 - ... since administering the first doses in March 1998. The Tri-fold explains the threat of biological weapons, the benefits of anthrax vaccination and the known risks from the vaccine. The Tri-fold is currently under revision to become a Quad-fold to include RC specific information on accessing care.
Page 63 - ... clinical study and the names and qualifications of each clinical investigator. Once the sponsor submits the IND, FDA has 30 days to review the application to determine whether or not the study may proceed. FDA may prohibit a sponsor from conducting a study for a number of reasons, including when the study volunteers will be exposed to unwarranted risks, by putting the IND on "Clinical Hold.
Page 1 - I ask unanimous consent that all Members' and witnesses' written opening statements be included in the record. Without objection, so ordered. I ask unanimous consent that all articles, exhibits, and extraneous or tabular material referred to be included in the record.
Page 43 - DOD is currently collaborating with CDC to array this information in the format of Vaccine Information Statements (VIS) that civilian health care providers around the country give America's children, adolescents, and adults during routine vaccinations. • Clinical Guidelines were drafted in May 1999, based on a consensus panel of civilian and military physicians experienced both in immunology and the general provision of health care. After a synchronized staffing with the Services, Federal Agencies...
Page 79 - Evidence for the efficacy of the licensed AVA is based on data from both humans and animal models. The only clinical study conducted in humans to evaluate efficacy used a...
Page 78 - None of these events, except for the injection site reactions, can be attributed to the vaccine with a high level of confidence, nor can contribution of the vaccine to the event reported be entirely ruled out. With the exception of injection site reactions, all of the adverse events noted above occur in the absence of immunization.