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File: 120396_sep96_decls82_0009.txt
Page: 0009
Total Pages: 13

Subject: PLAN FOR PROTECTION OF THE ARMY FORCE AGAINST ENDEMIC           

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003203

Folder Title: PLAN FOR PROTECTION OF THE ARMY FORCE AGAINST ENDEMIC DISEASES                                  

Document Number:          1

Folder SEQ  #:         96











                 (1) Storage, security, and QA checks shall be-performed by
         the manufacturer. The vaccines will be maintained in bulk storage
         under highly stable conditions. A prescribed number of doses of
         the vaccines will be pre-packaged in vials ready to be deployed.
         The bulk and packaged vaccines will undergo periodic QA checks.
         The vaccines are considered effective as long as the QA data shows
         vaccine potency.

                 (2) IND vaccines which transition beyond Milestone III in
         process review (IPR) will be placed in the contingency vaccine
         category. The cost to store and perform contingent vaccine QA
         checks will be borne by MDEP HSCB for-Army stocks. Other services
         will bear a proportion of the annual storage and QA costs.

                 (3) The vaccines will be decentralized at two or more
         sites to avoid catastrophic loss. Vaccine storage and QA checks
         will be performed by the manufacturer or his representative as
         approved by the FDA.

             e. Management of Vaccines - USAMMDA will manage the contingent
         vaccines in terms of accounting and maintaining an inventory and
         use data base, QA test results, issuance of annual QA contracts,
         and periodic on-site inspection of the manufacturer and on-site
         storage facilities. This information will be provided annually to
         the SGVPRC Working Group. A vaccine list and funds required for
         maintenance and storage will be provided to the SGVPRC WG by
         1 October annually.

             f. Indemnification - The U.S. Government will indemnify all
         manufacturers it has contracted for production of vaccines. If
         soldiers are adversely affected by the vaccines/toxoids/immune
         globulin, they will be treated and cared for in the Army Medical
         System.

             g. Duty Roster Notification - Designated members of the
Group, and representatives of other MACOMs
         and Army Agencies will be listed in the OTSG Duty Office-rls
         Instructions with explicit notification instructions in case of an
         emergency requiring a draw on the contingency vaccine stockpile.

             h. Decision to Vaccinate - Will be made by the TSG based upon
         recommendations from the SGVPRC. The SGVPRC will base it
         recommendation on the operations plans, threat scenario, crises,
         mobilization preparation, mobilization, declaration of war, input
         from MACOMs and Army Agencies, and/or test results of field
         samples.





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Document 13 f:/Week-36/BX003203/PLAN FOR PROTECTION OF THE ARMY FORCE AGAINST ENDEMIC DISEASES/plan for protection of the army force against en:11259610132722
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = PLAN FOR PROTECTION OF THE ARMY FORCE AGAINST ENDEMIC DISEASES
Folder Seq # = 96
Subject = PLAN FOR PROTECTION OF THE ARMY FORCE AGAINST EN
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 25-NOV-1996