Development and Availability of BW Vaccines
David Robinson
Battelle Memorial Institute
Columbus, Ohio.
Since the terrorist attacks of September 2001 and the subsequent mailing of letters containing weaponized anthrax spores, the US Government has revamped its strategy for the development and delivery of vaccines and other biologically based therapeutics intended to protect against exposure to agents of biological warfare (BW) interest. While the basic precepts of the Food and Drug Administration (FDA), the US regulatory agency for biologics and drugs, remain, the US Government has recognized that the products intended to protect against BW agents are unique from scientific, regulatory and economic standpoints. Of course, they have the liability concerns related to adverse events military population deployed to areas outside of the inherent with any vaccine. Additionally, the perceived at risk populations are not only the US but also the civilian population residing in the US. The combination of compliance with the FDA regulations, expansion of the perceived at risk populations, and the singular characteristics of the products intended to protect against intentional aerosol exposures, present unusual dilemmas for the developer and the government.
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Some very important CBW meetings:
1. CBMTS V - Spiez Laboratory Switzerland, 25-30 April 2004. This is the fifth international symposium in Spiez and the tenth meeting in the CBMTS series. Page 3
2. Eighth International Symposium on Protection Against CBW. This grandfather of all CBW meetings takes place in Gothenberg, Sweden from 2-6 June ‘04. Page 12
3. Development of International Collaboration in Infectious Disease Research, 8-10 September 2004, VECTOR, Novosibirsk, Russia. Second Announcement will be in the 23 June, 04-3 issue.
4. 4th SISPAT, Singapore, 4-10 December 2004. This 4th meeting in collaboration with the CBMTS, will be the most important meeting for CBW protection science and medical professionals ever held in the Pacific area. The Pharmaceutical Workshop, 4/5 Dec, is exceptionally important. Page 7
in association with the Chemical and Biological Medical Treatment Symposium (CBMTS) Series:
6th to 10th Dec 2004
Shangri-La Hotel
Singapore
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SISPAT 4 with CBMTS, 4-10 December 2004, will feature an exceptionally important pre-meeting Pharmaceutical / Medical Supply Workshop for medical and other professionals on 4 and 5 December 2004. The below article outlines several areas of coverage that are being prepared for this Workshop.
Establishing a Stockpile of Essential Medical Supplies: Actions and Issues
by Richard Nolan 1
Murray Hamilton 2
1 US Strategic National Stockpile (SNS), Atlanta
2 Rocky Mountain Center for Homeland Defense, Denver Research Center
Executive Summary
If a bioterrorism attack, a natural disaster, or a technological accident occurred today, would we, would you be ready? Would you have enough pharmaceuticals, vaccines, chemical antidotes, antitoxins, medical equipment, and other medical supplies to protect your citizens? Sadly, the answer is likely to be no. Today hospitals, manufacturers, and distributors hold just enough inventory to satisfy routine requirements. A large-scale national or regional emergency would quickly deplete their stocks.
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an inside look at ASA 04-2
| The Professional Library |
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| CBMTS V - The Technical Agenda |
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| CBMTS V - The Sponsors |
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| The 4th SISPAT |
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| CBW, a Chen Ji-Sheng Book - Tony Tu Review |
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| Eighth Symposium Protection Against CBWA |
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| WMD-CST Fielding Plan |
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| NATO ARW on Radiation Inact. of Bio Agents |
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| HHS selects Bio. Detect. Systems Contractors |
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| ON THE STREET |
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| Sophia Toxic gas Release |
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| Charles Duelfer’s Testimony to Congress |
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| GAO Reports |
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| Industry Spotlight: monica ®’ mk6 |
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| Industry Notes |
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| Recent Contracts |
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| BioScope ‘04 |
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ASA 04-3, Issue No. 102, 23 June 04
- Medical Preparedness. Hospitals - are our greatest asset also our weakest link?
- CBMTS V - A report and pictures of this tenth meeting of the CBMTS
- Eighth Intl Symposium on Protection Against CBWA - a report and pictures of this premier CBW Protection Symposium
- Second Announcement: Development of International Collaboration in Infectious Disease Research, 8-10 September 2004, VECTOR, Novosibirsk, Russia.
- The Second Announcement for the 4th SISPAT, Singapore, December 4-10. This meeting is a must for all professionals.
Note: Time constraints may delay articles
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