An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program (2003) / Chapter Skim
Currently Skimming:
2 Background
2 Background
Pages 23-32
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 23... ...
These limitations do not alter the committee's conclusion that the CDC research program as planned includes most of the studies needed to provide a strong and appropriate response to the congressional mandate. When considered in its entirety, however, the CDC anthrax vaccine research program also includes elements that the committee considers to be of lower priority and some that should not be earned out as planned.
|
From page 24... ...
The committee considers passive protection studies to be an essential component of a research program on AVA (see Chapter 4~. Recommendation: CDC should conduct passive protection studies as part of its anthrax vaccine safety and efficacy research program.
|
From page 25... ...
PROPOSED STUDIES ON TlIE SAFETY OF THE ANTHRAX VACCINE Human Clinical Trial The committee concluded that the human clinical trial should provide helpful information about the risk factors for common adverse reactions that occur soon after vaccination, including differences in reaction rates related to SQ versus IM administration of AVA. It should also be possible to examine differences between men and women in the occurrence of immediate-onset adverse events and to compare ~ ~ ~ A , ~ .
|
From page 26... ...
Finding: As described in the study protocol, the human clinical trial is generally responsive to the congressional mandate to evaluate the incidence of, risk factors for, and differences between men and women in local and systemic immediate-onset health effects associated with AVA and the effect of the route of vaccine administration on adverse events. The study win also provide a 42-month foBow-up period during which to monitor the occurrence of lateronset health effects.S Follow-up Study of Textile Mill Workers Vaccinated Against Anthrax The committee recommends against the retrospective cohort study intended to investigate potential chronic health effects or later-onset adverse events following anthrax vaccination.
|
From page 27... ...
. Enhanced Signal Detection and Hypothesis Testing for Adverse Events Following Anthrax Vaccination The committee is pleased to see that CDC has begun to give attention to the Defense Medical Surveillance System (DMSS)
|
From page 28... ...
The study population should include health care providers who may treat service members with adverse events following vaccination, as well as those who al nister vaccines. RESEARCH GAPS The gaps in the CDC research program that were noted in the preceding discussion of the individual research studies are summarized in Table ES-~.
|
From page 29... ...
87) Survey of civilian and military health care providers regarding vaccination and the reporting of possible vaccine-associated adverse events (modification of a study proposed by CDC, Chapter 6, p.
|
From page 30... ...
A NEED FOR A SINGLE PROGRAM LEAI) ER From its review, the committee sees evidence of a need for strong internal overall leadership of the CDC anthrax vaccine research plan to provide management and oversight.
|
From page 31... ...
EXECUTIVE SUMMARY 11 Boxes ES-2, ES-3, ES-4, and ES-5 provide a complete listing of the findings and recommendations :from this report. Subsequent chapters provide background for these findings and recommendations.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.