It took BioPort several years to receive FDA approval, and during that time supplies of the vaccine ran low, necessitating suspension of the military’s vaccination program. With the newly validated manufacturing process being used in a renovated facility, AVA will be produced under strict controls that are in accord with current FDA requirements. The report states that the newly produced vaccine is expected to have greater assurance of consistency than the vaccine produced at the time of its original licensure.

The committee emphasized the importance of continued and improved monitoring efforts to detect any adverse health effects caused by AVA and other vaccines. In addition, studies are needed to quantify and correlate protective levels of antibodies in animals with antibody levels in humans after full immunization. Direct tests of the efficacy of AVA are neither feasible nor ethical in humans. However, correlates of protection can be derived from studies that use animal models to test the efficacy of AVA, as well as new vaccines against anthrax. Both passive and active protection studies have important roles. The report stressed that production, testing, and licensure of a new vaccine requiring fewer doses and producing fewer local reactions is needed. The findings and recommendations of the report are presented in Appendix G. The full report can be found on the Internet at http://www.nap.edu/catalog/10310.html.

ORGANIZATION OF THE REPORT

CDC has organized its Anthrax Vaccine Safety and Efficacy Research Plan into components of efficacy, safety, and acceptability. Accordingly, this report follows that structure to some extent. Chapter 2 provides background material about the disease known as anthrax, the licensed anthrax vaccine, and the questions regarding the efficacy and safety of AVA that prompted the congressional request for the CDC research program. Chapter 3 summarizes CDC’s plan for the anthrax vaccine research program. In Chapter 4, the CDC research regarding the efficacy of AVA is described and the committee’s findings and recommendations regarding this aspect of the research plan are presented. Chapter 5 describes the CDC research that is to address the safety of the anthrax vaccine, followed by the committee’s discussion and evaluation. Chapter 6 reviews the research planned by CDC to address the acceptability of AVA and the committee’s findings and recommendations about this research. In Chapter 7, the committee discusses and evaluates the completeness and appropriateness of the research plan as a whole.

REFERENCES

CDC (Centers for Disease Control and Prevention). 2000. Use of anthrax vaccine in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR (Morbidity and Mortality Weekly Report) 49(RR-15):1–20.


IOM (Institute of Medicine). 2001. CDC Anthrax Vaccine Safety and Efficacy Research Program. Interim Report. Washington, D.C.: National Academy Press.

IOM. 2002. Joellenbeck LM, Zwanziger LL, Durch JS, Strom BL, eds. The Anthrax Vaccine: Is It Safe? Does It Work? Washington, D.C.: National Academy Press.



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