BW VACCINE USAMRIID 6 DEC 90

File: 120396_sep96_decls64_0001.txt
Page: 0001
Total Pages: 2

Subject: BW VACCINE  USAMRIID  6 DEC 90                                  

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003203

Folder Title: BW VACCINE-USAMRID                                                                              

Document Number:          1

Folder SEQ  #:         16






                                               UNCLASSIFIED


                                                              DFC lgge,

         DASG-PSZ


         MEMORANDUM FOR RECORD


         SUBJECT: BW VACCINE - USAMRIID

         1. A follow up meeting to the one of 3 December was held
         to specifically discuss vaccine and antitoxin production at
         USAMRIID. The meeting was attended by representatives from the
         Office of the Surgeon General and Medical Research and
         Development Command. A lists of attendees is at Enclosure 1.

         2. MRDC reiterated their position that they can begin producing
         one or two botulinum serotypes in 30 plus days without meeting
         the GMP or GLP standards. Furthermore, it was felt that to meet
         these standards it would take six to seven months or longer. The
         problems have to do with cleaning steam, purifying water and
         filtering air. Reference was made to difficulties with
         incubators and autoclaves as well. The group concurred that
         since the quickest production would have no output for six or
         more (the process takes 159 days or longer( that there was no
         reason to ignore standards. So the first criterion was that, if
         USAMRIID were to produce vaccine, the appropriate standards would
         be met and FDA approval obtained.

         3. Once it was decided that standards would be met, there was
         considerable discussion as to the time required to using existing
         containment areas to meet those standards. A report submitted by
         representative of the Salk Institute and the Michigan Department
         of Public Health was reviewed.   This report was based on a visit
         to USAMRIID on 28 November 1990 where the possibility of
         producing botulinum toxoids was evaluated. This report is at
         Enclosure 2. Recommendations were for the location of the

         rinse and steam be immediately evaluated. Furthermore,
         deficiencies should be thoroughly discussed with appropriate FDA
         officials for determination of facility acceptance. on the basis
         of this report and not knowing how long it would take to meet the
         appropriate air, water and steam requirements, USAMRIID was
         directed to proceed as rapidly as possible getting the evaluation
         and the proceeding with corrective measures so that vaccine
         production can begin as soon as feasible.

         DECLASSIFIED
         ON: 15 NOV 96
         BY: SEC ARMY (DAMH) UNDER SEC 3.4 EO 12958





                                            UNCLASSIFIED

Document 2 f:/Week-36/BX003203/BW VACCINE-USAMRID/bw vaccine usamriid 6 dec 90:1125961012474
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = BW VACCINE-USAMRID
Folder Seq # = 16
Subject = BW VACCINE USAMRIID 6 DEC 90
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