CONTINUATION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)

RAAUZYUW RUENAAA0008 0192219-UUUU--RHMFIUU.
ZNR UUUUU ZUI RUEWMCF1015 0192224
R 192219Z JAN 06 ZYB MIN ZYW
FM CNO WASHINGTON DC//DNS//
TO NAVADMIN
RHMFIUU/CNO WASHINGTON DC
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UNCLAS
NAVADMIN 034/06
MSGID/GENADMIN/CNO WASHINGTON DC/DNS/JAN//
SUBJ/CONTINUATION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
//


REF/A/LTR/ASD (HA)/YMD:20051222//
REF/B/DOC/DHHS FDA/YMD:20051219//
REF/C/DOC/DHHS FDA/YMD:20040105//
REF/D/MSG/CNO/201855ZMAY2005//
REF/E/MSG/CNO/042202ZAUG2005//
REF/F/MSG/CNO/242245ZOCT2005//
NARR/REF A IS ASSISTANCE SECRETARY OF DEFENSE (HEALTH AFFAIRS)
(ASD(HA))POLICY MEMO ON THE CONTINUATION OF THE ANTHRAX VACCINE
IMMUNIZATION PROGRAM (AVIP). REF B IS DEPARTMENT OF HEALTH AND HUMAN
SERVICES FOOD AND DRUG ADMINISTRATION DOCKET NO. 1980N-0208
BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS; IMPLEMENTATION
OF EFFICACY REVIEW; ANTHRAX VACCINE ADSORBED; FINAL ORDER; FEDERAL
REGISTER 19DEC05 VOL.70 NO. 242 PAGES 75180-751298.  REF C IS DHHS
FDA DOCKET NO. 1980N-0208 BIOLOGICAL PRODUCTS; BACTERIAL VACCINES
AND TOXOIDS; IMPLEMENTATION OF EFFICACY REVIEW; FINAL ORDER; FEDERAL
REGISTER 5JAN04 VOL.69 NO. 2 PAGES 255-266.  REF D IS NAVADMIN
110/05, EMERGENCY USE AUTHORIZATION TO RESUME ANTHRAX VACCINATIONS.
REF E IS NAVADMIN 188/05, EXTENSION OF EMERGENCY USE AUTHORIZATION
TO RESUME ANTHRAX IMMUNIZATIONS.  REF F IS NAVADMIN 280/05 APPROVAL
OF EXCEPTION TO POLICY TO PROVIDE ANTHRAX VACCINATIONS FOR FORWARD
DEPLOYED NAVAL FORCES AND III MARINE EXPEDITIONARY FORCE UNDER
EMERGENCY USE AUTHORIZATION FOR THE ANTHRAX VACCINE IMMUNIZATION
PROGRAM.//
POC/CATHLEEN DONOHUE/LCDR/CNO N931D5/LOC:WASHINGTON DC
/TEL:(703) 601-1716/TEL:DSN 329-1716/EMAIL:CATHLEEN.DONOHUE@NAVY.MIL
//
RMKS/1.  ON 22 DEC 05, THE ASSISTANT SECRETARY OF DEFENSE (HEALTH
AFFAIRS) NOTIFIED THE SERVICE SURGEONS GENERAL (REF A) THAT THE FOOD
AND DRUG ADMINISTRATION (FDA) ISSUED A FINAL ORDER FINDING ANTHRAX
VACCINE PROTECTS AGAINST ALL ROUTES OF EXPOSURE TO ANTHRAX SPORES,
INCLUDING INHALATION (REF B).  FDA REAFFIRMED ITS PREVIOUS
CONCLUSION (REF C) AFTER EVALUATING THE FULL SCIENTIFIC LITERATURE
AND ASSESSMENT OF PUBLIC COMMENTS.  SINCE REF B ELIMINATES THE BASIS
FOR THE EMERGENCY USE AUTHORIZATION (EUA) DOD HAS FOLLOWED SINCE
APRIL 2005, IT WILL NOT BE NECESSARY FOR DOD TO SEEK RENEWAL OF THE
EUA.  THE CURRENT EUA EXPIRES 14 JAN 06.
2.  EFFECTIVE WITH THIS MESSAGE, DOD WILL CONTINUE WITH VOLUNTARY
ANTHRAX VACCINATIONS UNTIL SENIOR CIVILIAN LEADERS CAN COMPLETE A
POLICY REVIEW AND ISSUE NEW GUIDANCE.  PROGRAM REQUIREMENTS AND
ELIGIBILITY WILL REMAIN AS IDENTIFIED IN REFS D THROUGH F.  NOTE:
REF A REQUIRES THE USE OF A NEW AVIP TRIFOLD BROCHURE DATED 16 DEC
05 AND REVISED EDUCATIONAL MATERIAL AVAILABLE AT DOD'S AVIP WEBSITE:
WWW.ANTHRAX.MIL.
3.  THE AVIP REMAINS A COMMANDER'S FORCE HEALTH PROTECTION
RESPONSIBILITY.  UNTIL OTHERWISE DIRECTED COMMANDERS WILL CONTINUE
TO IMPLEMENT THE AVIP IN ACCORDANCE WITH REFS D THROUGH F, USING THE
NEW AVIP TRIFOLD AND REVISED EDUCATIONAL MATERIAL.
4.  SERVICE POCS FOR THIS MESSAGE ARE:
A.  ACTIVE:  LCDR C. M. DONOHUE, COMM:  (703) 601-1716; DSN
329-1716; E-MAIL: NIPR CATHLEEN.DONOHUE@NAVY.MIL; SIPR
DONOHUE.CATHLEEN@CNO.NAVY.SMIL.MIL
B.  RESERVE:  CDR M. K. JACOBSEN, COMM:  (703) 703-614-4830; DSN
224-4830; E-MAIL:  NIPR MARY.JACOBSEN@NAVY.MIL; SIPR
JACOBSEN.MARY@CNO.NAVY.SMIL.MIL
5.  THIS NAVADMIN IS EFFECTIVE IMMEDIATELY UPON RECEIPT.
6.  RELEASED BY VADM A. E. RONDEAU, DIRECTOR, NAVY STAFF.//
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