Emergency Use Authorization (EUA) for Anthrax Immunizations Extended
This MARADMIN extends the Emergency Use Authorization (EUA) for the Anthrax Vaccine Immunization Program (AVIP) until January 14, 2006, following FDA approval on July 22, 2005. The message clarifies reporting requirements for Emergency Use Compliance Officers (ECOs) and reinforces that personnel must be provided the "option to refuse" the anthrax vaccine before administration.
Issued: July 28, 2005
1. ON 22 JUL 05, THE FOOD AND DRUG ADMINISTRATION EXTENDED THE EUA FOR USE OF ANTHRAX VACCINE ADSORBED (AVA) TO PREVENT INHALATION ANTHRAX; SEE REF A. PREVIOUS DOD AND MARINE CORPS POLICY SET FORTH IN THE REF CONTINUES IN FORCE. THE ONLY CHANGE TO REF A IS IN THE EXPIRATION DATE OF THE EUA, NOW EXTENDED TO 14 JAN 06 IOT CONTINUE THE AVIP UNDER THE EUA. 2. CLARIFYING ESTABLISHED REPORTING REQUIREMENTS. A. THE COMMAND "EMERGENCY USE COMPLIANCE OFFICER" (ECO) WILL SUBMIT WEEKLY REPORTS, TO INCLUDE NEGATIVE REPORTS. (1) REPORTS WILL BE SUBMITTED VIA THE MEF/MARFOR COORDINATOR IN ORDER TO REACH HQMC EACH MONDAY NLT 1800 LOCAL TIME (LOCAL TO THE IMMUNIZATION SITE). (2) REPORTS MAY BE SUBMITTED VIA EMAIL BY ATTACHING SCANNED PDF DOCUMENTS, OR BY TYPING THE REPORT TEMPLATE INTO THE BODY OF AN EMAIL MSG, OR VIA FAX. EMAIL REPORTS MUST ORIGINATE FROM THE EMAIL ACCOUNT OF THE ECO. (3) SUBMIT REPORTS TO HQMC (HS) MCMILLANDL@HQMC.USMC.MIL, WITH COPY TO HQMC (PPO) LEPEFJ@HQMC.USMC.MIL; OR FAXED TO HQMC (HS) AT 703 614-1499 (DSN 224) AND HQMC (PPO) AT 703 693-5350 (DSN 224). (4) FAILURE TO SEND TIMELY REQUIRED WEEKLY REPORTS TO HQMC, MAY RESULT IN A COMMAND HAVING ITS COMPLIANCE AGREEMENT AND ANTHRAX IMMUNIZATION AUTHORITY VOIDED. B. IF AN INDIVIDUAL IS ADMINISTERED AN ANTHRAX IMMUNIZATION WITHOUT FIRST BEING PROVIDED THE "OPTION TO REFUSE", A DETAILED REPORT MUST BE IMMEDIATELY REPORTED TO HQMC (HS)/(PPO), VIA THE CHAIN OF COMMAND. 3. CLINIC OPERATIONS. CLINICS THAT OFFER SEVERAL IMMUNIZATIONS MUST EXERCISE SPECIAL CARE TO CONFIRM, BEFORE INJECTION, THAT THE INDIVIDUAL ELECTS TO RECEIVE ANTHRAX IMMUNIZATION AFTER BEING PROVIDED THE "OPTION TO REFUSE." 4. 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), PREVENTIVE MEDICINE OFFICER, (703) 614-4478 (DSN 224). C. HQMC (I&L/LPCD); LCDR SCOTT M SPRATT AND HMC (FMF/SW) JOE PALMARES, MEDICAL LOGISTICS (703) 695-8926 (DSN 225). 5. COMMAND AND SIGNAL. THIS MARADMIN IS EFFECTIVE IMMEDIATELY UPON RECEIPT, APPLIES TO THE MARINE CORPS TOTAL FORCE, AND EXPIRES 14 JAN 06.