Continuation of the Anthrax Vaccine Immunization Program (AVIP)
This MARADMIN announces the continuation of the Anthrax Vaccine Immunization Program (AVIP) following FDA's final order confirming the vaccine's effectiveness against all routes of anthrax exposure, including inhalation. The program will continue on a voluntary basis for eligible personnel while courts complete judicial review and DOD leadership completes policy review, maintaining the same educational briefings, option to refuse, and reporting requirements previously established under the Emergency Use Authorization (EUA).
Issued: January 23, 2006
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.