By Institute of Medicine, Medical Follow-Up Agency, Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program
In 1998, the dep. of security (DoD) begun a software of crucial immunization opposed to anthrax for all army group of workers. because the application proceeded, although, a few army team of workers and their households raised matters concerning the security and efficacy of the anthrax vaccine. Acknowledging either the necessity to shield army group of workers and the worries concerning the anthrax vaccine, congress directed the facilities for affliction keep watch over and Prevention (CDC) to hold out a examine software on its protection and efficacy. to help within the improvement of this application, CDC asked the Institute of medication (IOM) to convene a committee to check the completeness and appropriateness of the examine application. In An evaluate of the CDC Anthrax Vaccine security and Efficacy study Program, the committee makes an total overview of the CDD study plan and studies the explicit reports proposed through CDC within the 3 components of efficacy, protection and acceptability. The committee additionally notes extra study wishes that grew to become obtrusive following the bioterrorist occasions of 2001 and makes concepts in regards to the management of the examine program.
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Extra info for An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program
The new rule amends the regulations governing new drugs and biological products to allow for the use in certain cases of appropriate studies in animals to provide evidence of the efficacy of products to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances, when traditional efficacy studies in humans are not feasible and cannot be ethically conducted. Key provisions of the rule are stated as follows: . . FDA can rely on the evidence from animal studies to provide substantial evidence of the effectiveness of these products when: 1) There is a reasonably well understood pathophysiological mechanism for the toxicity of the chemical, biological, radiological, or nuclear substance and its amelioration or prevention by the product; 2) the effect is demonstrated in more than one animal species expected to react with a response predictive for humans, unless the effect is demonstrated in a single animal species that represents a sufficiently well-characterized animal model (meaning the model has been adequately evaluated for its responsiveness) for predicting the response in humans; 3) the animal study endpoint is clearly related to the desired benefit in humans, which is generally the enhancement of survival or prevention of major morbidity; and 4) the data or information on the pharmacokinetics and pharmacodynamics of the product or other relevant data or information in animals and humans is sufficiently well understood to allow selection of an effective dose in humans, and it is therefore reasonable to expect the effectiveness of the product in animals to be a reliable indicator of its efficacy in humans.
The research program will also be affected by other circumstances beyond CDC’s control, such as the timing and extent of the resumption by the Department of Defense (DoD) of its anthrax vaccination program for the military. Similarly, the timeline for the availability of a new licensed vaccine is uncertain. Bearing in mind these uncertainties, the committee strove to focus on addressing the research questions that stand regardless of these circumstances. S. military, in December 1997 DoD announced a program to vaccinate all service personnel against anthrax using the li- 18 INTRODUCTION 19 censed product AVA.
These bioterrorist events led to 11 cases of inhalational anthrax, 5 of which were fatal, and to 8 confirmed and 4 suspected cutaneous anthrax infections (CDC, 2001b, 2002). More than 30,000 people may have been exposed to anthrax spores (CDC, 2001a,b). Anthrax vaccines for use in animals were first developed in 1881 (Turnbull, 1991). Work on vaccines suitable for human use gained urgency in the 1940s because of fears that anthrax would be used as a biological warfare agent. A human vaccine was developed in the 1950s by the Army Chemical Corps and produced by a pharmaceutical company under contract with the Army.