MARADMINS : 033/06
R 230010Z JAN 06
FM CMC WASHINGTON DC(UC)
TO AL MARADMIN(UC)
UNCLASSIFIED//
MARADMIN 033/06
MSGID/GENADMIN/CMC WASHINGTON DC PPO//
SUBJ/CONTINUATION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)//
REF/A/DOC/FDA/191344ZDEC2005//
REF/B/DOC/ASD (HA)/221344ZDEC2005//
REF/C/MSG/CMC/161700ZMAY2005//
REF/D/MSG/CMC/281800ZJUL2005//
POC/BETHEL D.A./LTCOL/HQMC PPO POC/-/TEL:(703) 692-4369
/EMAIL:BETHELDA@HQMC.USMC.MIL//
NARR/REF A IS FDA DOCKET NO. 1980-0208, BIOLOGICAL PRODUCTS;
BACTERIAL VACCINES AND TOXOIDS; IMPLEMENTATION OF EFFICACY REVIEW;
ANTHRAX VACCINE ADSORBED; FINAL ORDER. FEDERAL REGISTER 2005; VOLUME
70 (DEC 19). WWW.FDA.GOV/CBER/RULES/BVACTOXANTH.HTM
REF B IS ASD (HA) MEMO, CONTINUATION OF THE ANTHRAX VACCINE
IMMUNIZATION PROGRAM (AVIP)
REF C IS MARADMIN 230/05, RESUMPTION OF THE ANTHRAX VACCINE
IMMUNIZATION PROGRAM (AVIP) UNDER THE EUA.
REF D IS MARADMIN 342/05, EMERGENCY USE AUTHORIZATION (EUA) FOR
ANTHRAX IMMUNIZATIONS /EXTENDED//
GENTEXT/REMARKS/REMARKS/1. ON 19 DEC 05, OFFICIALS FROM THE FOOD
AND DRUG ADMINISTRATION (FDA) ISSUED A FINAL ORDER (REF A), FINDING
THAT THE ANTHRAX VACCINE PROTECTS AGAINST ALL ROUTES OF EXPOSURE TO
ANTHRAX SPORES, INCLUDING INHALATION. AFTER EVALUATION OF THE FULL
SCIENTIFIC LITERATURE AND ASSESSING COMMENTS FROM THE PUBLIC, WHICH
WERE SUBMITTED IN EARLY 2005, THE FDA REAFFIRMED ITS PREVIOUS
CONCLUSIONS. AS THIS REGULATORY ACTION REMOVED THE BASIS AND NEED
FOR THE EMERGENCY USE AUTHORIZATION (EUA) THAT DOD HAS FOLLOWED
SINCE APRIL 2005, IT WILL NOT BE NECESSARY FOR DOD TO SEEK RENEWAL
OF THE EUA FOR USE OF ANTHRAX VACCINE TO PREVENT INHALATION ANTHRAX.
THE CURRENT EUA EXPIRED JANUARY 14, 2006.
2. THE PERIODIC REPORTING REQUIREMENTS (NOW MONTHLY) REMAIN IN
EFFECT. UNTIL THE COURTS COMPLETE THEIR JUDICIAL REVIEW AND WHILE
OUR SENIOR CIVILIAN LEADERS COMPLETE A POLICY REVIEW, DOD WILL
CONTINUE VOLUNTARY ANTHRAX VACCINATIONS (REF B) FOR THOSE SAME
PERSONNEL THAT WERE ELIGIBLE UNDER THE EUA, UTILIZING THOSE
REQUIREMENTS STIPULATED IN REFERENCES C AND D. THIS INTERIM APPROACH
WILL CONTINUE TO INCLUDE EDUCATIONAL BRIEFINGS, AN OPTION TO REFUSE,
AND REPORTING REQUIREMENTS (REF C AND D). THE REQUIREMENT FOR AN
"EUA COMPLIANCE OFFICER" (REF C AND D) REMAINS WITH THE DUTY RENAMED
"AVIP COMPLIANCE OFFICER". ADDITIONALLY, THE CURRENT AVIP TRIFOLD
BROCHURE, DATED 16 DEC 05, WILL BE DISTRIBUTED TO ALL PERSONNEL
RECEIVING THE ANTHRAX BRIEFING PRIOR TO THEIR DECISION TO ACCEPT OR
DECLINE THE VACCINE (REF C AND D). TRIFOLDS WILL BE SHIPPED WITH
VACCINE ORDERS TO REQUESTING COMMANDS, OR MAY BE DOWNLOADED AT
WWW.ANTHRAX.MIL, OR ORDERED VIA EMAIL MESSAGE TO
USAMMADOC@DET.AMEDD.ARMY.MIL
3. POCS FOR THIS MESSAGE ARE:
A. HQMC (PP&O); LTCOL D. A. BETHEL, SERVICE POC (703) 692-4369
(DSN 222) AND
MR. F. J. LEPE, ASST SERVICE POC (703) 614-5157 (DSN 224).
B. HQMC (HS); CDR D. L. MCMILLAN (USN), PMO, (703) 614-4478 (DSN
224).
C. HQMC (I&L/LPCD); LCDR SCOTT M SPRATT AND HMC (FMF/SW)
PALMARES, MEDICAL LOGISTICS (703) 695-8926 (DSN 225).
4. COMMAND AND SIGNAL. THIS MARADMIN IS EFFECTIVE IMMEDIATELY UPON
RECEIPT AND APPLIES TO THE MARINE CORPS TOTAL FORCE. THERE IS NO
EXPIRATION DATE AT THIS TIME.//