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Resuming Production of the Anthrax Vaccine as Quickly as Possible: Analysis of Alternative Business Arrangements, Volume 1: Main Report

Author: Thomas P FrazierMaria BorgaJohn W BaileyAlec W SalernoJohn J CloosAll authors
Publisher: Ft. Belvoir Defense Technical Information Center OCT 2000.
Edition/Format:   eBook : English
Database:WorldCat
Summary:
A series of technical problems has delayed FDA approval for BioPort Corporation to deliver anthrax vaccine adsorbed (AVA) to the DoD. BioPort is preparing for a new FDA review, and the DoD is providing both financial relief and technical assistance to augment BioPort's efforts. Under this strategy, the earliest BioPort could gain FDA approval and resume AVA delivery is late May 2001. A more realistic expectation is  Read more...
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Material Type: Internet resource
Document Type: Internet Resource
All Authors / Contributors: Thomas P Frazier; Maria Borga; John W Bailey; Alec W Salerno; John J Cloos; INSTITUTE FOR DEFENSE ANALYSES ALEXANDRIA VA.
OCLC Number: 227952060
Notes: Prepared in cooperation with Rand Corporation.
Description: 43 pages

Abstract:

A series of technical problems has delayed FDA approval for BioPort Corporation to deliver anthrax vaccine adsorbed (AVA) to the DoD. BioPort is preparing for a new FDA review, and the DoD is providing both financial relief and technical assistance to augment BioPort's efforts. Under this strategy, the earliest BioPort could gain FDA approval and resume AVA delivery is late May 2001. A more realistic expectation is delivery in the first half of 2002. IDA and the RAND Corporation studied the advantages and disadvantages of the DoD purchasing BioPort's Lansing, Michigan, AVA-production facility and converting it to a government-owned, contractor-operated (GOCO) operation. In one scenario, the DoD would select a new company to run the facility; in another, the DoD would have BioPort run the facility. We found that neither Option would result in vaccine being delivered faster than under the current strategy. Under the first GOCO scenario, the earliest AVA could be delivered would be 2003 (more probably late 2004). Under the second scenario, the earliest delivery date would be August 2001 (more probably late 2002). This report is the first of two volumes.

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