TO   NAVADMIN
     NAVADMIN @ AL NAVADMIN(UC)

INFO CNO CNO


RAAUZYUW RUEWFMU4429 3030118-UUUU--RUCRNAD.
ZNR UUUUU
R 290118Z OCT 04 PSN 443046J21
FM CNO WASHINGTON DC
TO NAVADMIN
ZEN/NAVADMIN @ AL NAVADMIN(UC)
INFO ZEN/CNO CNO
BT
UNCLAS
SUBJ: ANTHRAX VACCINE IMMUNIZATION PROGRAM PAUSE
PASS TO OFFICE CODES:
FM CNO WASHINGTON DC//DNS//
TO NAVADMIN
UNCLAS
NAVADMIN 245/04
MSGID/GENADMIN/CNO WASHINGTON DC/DNS/OCT//
SUBJ/ANTHRAX VACCINE IMMUNIZATION PROGRAM PAUSE//
REF/A/DOC/DEPSECDEF/YMD:20020628//
REF/B/MSG/CNO (N09) WASHINGTON DC/211314ZOCT2002//
REF/C/MSG/CNO (N09) WASHINGTON DC/010012ZSEP2004//
REF/D/MSG/CNO (N09) WASHINGTON DC/272005ZOCT2004//
REF/E/DOC/SECDEF/YMD:20041027//
PAGE 02 RUEWMFU4429 UNCLAS
REF/F/MSG/CNO (N09) WASHINGTON DC/092315ZJAN2003//
REF/G/MSG/CNO (N09) WASHINGTON DC/241523ZDEC2003//
REF/H/MSG/CNO (N09) WASHINGTON DC/091306ZJAN2004//
NARR/REF A IS DEPSECDEF POLICY STATEMENT ANNOUNCING THE
REINTRODUCTION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP).
REF B IS NAVADMIN 351/02 ON RESUMPTION OF AVIP.  REF C IS NAVADMIN
201/04 DIRECTING EXPANSION OF AVIP AND SMALLPOX VACCINATION PROGRAM
(SVP).  REF D IS NAVADMIN 239/04 DIRECTING RESUMPTION OF AVIP FOR
DEFERRED PERSONNEL.  REF E IS SECDEF LETTER DIRECTING AVIP PAUSE.
REF F IS NAVADMIN 007/03 ISSUING SVP GUIDANCE.  REF G IS NAVADMIN
329/03 DIRECTING TEMPORARY STOPPAGE OF AVIP FOR ALL DOD PERSONNEL.
REF H IS NAVAMIN 003/04 DIRECTING RESUMPTION OF AVIP.//
POC/KARI BUCHANAN/LCDR/CNO N931D5/LOC:WASHINGTON DC/TEL:703-601-1716
/TEL: DSN 329-1716/EMAIL: KARI.BUCHANAN@NAVY.MIL//
RMKS/1.  REF A THROUGH D DIRECTED ANTHRAX VACCINE IMMUNIZATIONS
BASED ON THREAT ANALYSIS AND AVAILABILITY OF A SAFE, FOOD AND DRUG
ADMINISTRATION (FDA) APPROVED ANTHRAX VACCINE.  SINCE 1998, DOD HAS
SAFELY VACCINATED OVER 1 MILLION MILITARY, EMERGENCY-ESSENTIAL
CIVILIAN, AND MISSION-ESSENTIAL CONTRACTOR PERSONNEL TO PROVIDE
VITAL PROTECTION AGAINST ALL FORMS OF ANTHRAX DISEASE.
PAGE 03 RUEWMFU4429 UNCLAS
2.  ON 27 OCTOBER 2004, THE UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF COLUMBIA ISSUED A NEW INJUNCTION AGAINST THE DOD AVIP.
PER REF E, EFFECTIVE IMMEDIATELY, DOD WILL STOP ADMINISTERING
ANTHRAX IMMUNIZATIONS UNTIL FURTHER NOTICE.
3.  THE NEW INJUNCTION IS SIMILAR TO THE ONE ISSUED IN REF G, AT
WHICH TIME, DOD PAUSED AVIP PENDING CLARIFICATION OF LEGAL ISSUES.
THE DECEMBER INJUNCTION WAS LIFTED APPROXIMATELY 2 WEEKS LATER PER
REF H.  PER REF E, THE NEW INJUNCTION AGAIN REQUIRES FDA TO COMPLETE
REQUIRED PROCEDURES BEFORE ISSUING A FINAL RULE THAT THE ANTHRAX
VACCINE IS SAFE AND EFFECTIVE FOR PROTECTION AGAINST INHALATION
ANTHRAX.
4.  ADDITIONAL ACTIONS:
A.  PER REF F, SVP WILL CONTINUE AND IS NOT IMPACTED BY THE
INJUNCTION NOR THIS NAVADMIN.
B.  PER REF D PARA 3, CONTINUE TO SCREEN ALL ACTIVE AND RESERVE
MEDICAL RECORDS FOR COMPLIANCE WITH ALL IMMUNIZATIONS, ENSURING
IMMUNIZATION DATA IS CAPTURED IN THE MEDICAL RECORD, ON THE PHS-731
(YELLOW SHOT CARD) AND INTO AN APPROVED ELECTRONIC DATA SYSTEM THAT
TRANSMITS TO DEERS.
C.  FOR ANY PENDING MILITARY JUSTICE ISSUES, CONSULT WITH A STAFF
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JUDGE ADVOCATE IN YOUR CHAIN OF COMMAND.
D.  UNOPENED VIALS OF ANTHRAX VACCINE WILL BE STORED IN PLACE UNTIL
FURTHER INSTRUCTIONS ARE ISSUED.
E.  ALL ACTIVITIES WILL CONSOLIDATE AND REPORT THE INVENTORY OF ALL
UNOPENED VIALS OF ANTHRAX VACCINE BY LOT NUMBER TO NAVMEDLOGCOM.
INVENTORIES SHALL BE SUBMITTED BY 5 NOV 2004 VIA EMAIL TO LOUISE
MCLUCAS, EMAIL ADDRESS: SLMCLUCAS@NMLC.MED.NAVY.MIL, TELEPHONE: COMM
(301)619-8054.
F.  IMPLEMENT PUBLIC AFFAIRS ACTIONS THAT INFORM PERSONNEL OF THE
NECESSITY OF THIS TEMPORARY SUSPENSION PENDING THE CLARIFICATION OF
THE LEGAL SITUATION.
5.  DOD REMAINS CONFIDENT THAT THE ANTHRAX VACCINE COMPLIES WITH ALL
LEGAL REQUIREMENTS AND THAT THE VACCINE IS SAFE AND EFFECTIVE.
6.  AVIP RESUMPTION DATE CANNOT BE DETERMINED AT THIS TIME.
7.  RELEASED BY VICE ADMIRAL A. T. CHURCH, DIRECTOR, NAVY STAFF.//
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