EMERGENCY USE AUTHORIZATION TO RESUME ANTHRAX VACCINATIONS

RAAUZYUW RUEWMCS0000 1401855-UUUU--RUCRNAD.
ZNR UUUUU
R 201855Z MAY 05
FM CNO WASHINGTON DC
TO NAVADMIN
BT
UNCLAS //N02300//
NAVADMIN 110/05
MSGID/GENADMIN/CNO WASHINGTON DC/DNS/MAY//
SUBJ/EMERGENCY USE AUTHORIZATION TO RESUME ANTHRAX VACCINATIONS//

REF/A/DOC/DEPSECDEF/YMD:20040628//
REF/B/MSG/CNO (N09) WASHINGTON DC/010012ZSEP2004//
REF/C/DOC/ASD (FMP)/YMD:20010625//
REF/D/DOC/ASD (NS AND CP)/YMD:19931126//
REF/E/DOC/ASD (FMP)/YMD:19920410//
REF/F/DOC/ASD (FMP)/YMD:19960126//
REF/G/DOC/USD (P AND R)/YMD:20040922//
REF/H/DOC/USD (P AND R)/YMD:20020806//
REF/I/DOC/ASD (HA)/YMD:20020806//
REF/J/DOC/SECDEF/YMD:20041027//
REF/K/DOC/SECNAVINST 6230.4A/YMD:19980428//
REF/L/MSG/CNO (N09) WASHINGTON DC/290118ZOCT2004//
REF/M/DOC/FDA/YMD:20050202//
REF/N/DOC/DEPSECDEF/YMD:20050425//
REF/O/DOC/USD (P AND R)/YMD:20050429//
NARR/REF A IS DEPUTY SECRETARY OF DEFENSE (DEPSECDEF) MEMO DIRECTING
EXPANSION OF ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP) AND
SMALLPOX IMMUNIZATION PROGRAM (SVP) FOR DOD PERSONNEL.  REF B IS
NAVADMIN 201/04 DIRECTING EXPANSION OF AVIP AND SVP.  REF C IS
ASSISTANT SECRETARY OF DEFENSE, FORCE MANAGEMENT POLICY (ASD(FMP))
MEMO NOTIFYING EMERGENCY-ESSENTIAL EMPLOYEES REGARDING AVIP
REQUIREMENTS.  REF D IS DOD DIRECTIVE 6205.3, IMMUNIZATION PROGRAM
FOR BIOLOGICAL WARFARE DEFENSE.  REF E IS DOD DIRECTIVE 1404.10,
EMERGENCY-ESSENTIAL DOD CITIZEN CIVILIAN EMPLOYEES.  REF F IS THE
DOD INSTRUCTION 3020.37, CONTINUATION OF ESSENTIAL DOD CONTRACTOR
SERVICES DURING CRISIS.  REF G IS UNDER SECRETARY OF DEFENSE,
PERSONNEL AND READINESS (USD (P AND R)) MEMO DIRECTING EXPANSION OF
FORCE HEALTH PROTECTION ANTHRAX AND SMALLPOX IMMUNIZATION PROGRAMS
FOR EMERGENCY-ESSENTIAL AND EQUIVALENT DOD CIVILIAN EMPLOYEES.  REF
H IS USD (P AND R) POLICY MEMO ON ADMINISTRATIVE ISSUES RELATED TO
THE AVIP.  REF I IS ASSISTANT SECRETARY OF DEFENSE (HEALTH AFFAIRS)
(ASD(HA)) POLICY MEMO ON CLINICAL ISSUES RELATED TO ANTHRAX
VACCINATION.  REF J IS SECDEF MEMO DIRECTING TO TEMPORARILY STOP
GIVING ANTHRAX IMMUNIZATIONS TO ALL DOD PERSONNEL.  REF K IS
SECNAVINST 6230.4A, DEPARTMENT OF THE NAVY (DON) ANTHRAX VACCINATION
IMPLEMENTATION PROGRAM (AVIP).  REF L IS NAVADMIN 245/04 DIRECTING
ANTHRAX VACCINE IMMUNIZATION PROGRAM PAUSE.  REF M IS FOOD AND DRUG
ADMINISTRATION (FEDERAL REGISTER DOCKET NO. 2005N-0040, VOL 70)
AUTHORIZATION OF EMERGENCY USE OF ANTHRAX VACCINE ADSORBED (AVA) FOR
PREVENTION OF INHALATION ANTHRAX BY INDIVIDUALS AT HEIGHTENED RISK
OF EXPOSURE DUE TO ATTACK WITH ANTHRAX. REF N IS DEPSECDEF MEMO
DIRECTING RESUMPTION OF AVIP UNDER EMERGENCY USE AUTHORIZATION
(EUA). REF O IS USD (P AND R) MEMO DIRECTING IMPLEMENTATION OF
RESUMPTION OF THE AVIP UNDER EUA.//
POC/KARI BUCHANAN/LCDR/CNO N931D5/LOC:WASHINGTON DC/TEL:703-601-1716
/TEL:DSN 329-1716/EMAIL:KARI.BUCHANAN@NAVY.MIL//
RMKS/1.  BACKGROUND.  ON 10 DEC 04, THE DEPSECDEF DETERMINED THAT
THERE IS A SIGNIFICANT POTENTIAL FOR A MILITARY EMERGENCY INVOLVING
UNITED STATES MILITARY FORCES AND AN ATTACK WITH ANTHRAX. ON 22 DEC
04, THE ASD(HA) REQUESTED THAT THE FOOD AND DRUG ADMINISTRATION
(FDA) ISSUE AN EMERGENCY USE AUTHORIZATION (EUA) REGARDING AVA TO
PREVENT INHALATION ANTHRAX (REF L).  THE SECRETARY OF HEALTH AND
HUMAN SERVICES, ON 14 JAN 05, DECLARED AN EMERGENCY JUSTIFYING THE
EMERGENCY USE OF AVA.  FDA ISSUED THE EUA ON 27 JAN 05 (REF M). ON 1
APR 05, THE US DISTRICT COURT FOR THE DISTRICT OF COLUMBIA MODIFIED
ITS INJUNCTION AGAINST ANTHRAX IMMUNIZATIONS. THUS, IN ACCORDANCE
WITH REFS A-K, N AND O, DOD IS AUTHORIZED TO RESUME ANTHRAX
IMMUNIZATIONS, UNDER EUA RESTRICTIONS, FOR ALL PERSONNEL INCLUDED IN
REF O.  IMPORTANT NOTES:
A.  COURT ORDERED PAUSE ON THE "MANDATORY" AVIP REMAINS IN EFFECT.
B.  UNDER THE EUA, PERSONNEL MAY DECLINE ANTHRAX IMMUNIZATIONS
WITHOUT HARASSMENT, COERCION OR ADMINISTRATIVE PUNISHMENT.
C.  IMMUNIZATIONS UNDER EUA RESTRICTIONS ARE APPROVED FOR A SIX
MONTH PERIOD WHICH WILL EXPIRE NLT 27 JUL 05, UNLESS EXPLICITLY
EXTENDED.
D.  PER REF N, VOLUNTARY IMMUNIZATIONS OF LABORATORY RESEARCH
PERSONNEL AGAINST CUTANEOUS ANTHRAX ARE NOT SUBJECT TO COMPLIANCE
WITH THE EUA AVIP AND ARE AUTHORIZED TO CONTINUE.
2.  EUA AVIP.  AS DIRECTED BY DOD IN REF O, THE NAVY WILL INITIATE
THE EUA AVIP FOR MILITARY AND CIVILIAN PERSONNEL UNDER SPECIFIC
CONDITIONS OUTLINED IN REFERENCES M , N AND O, AS DELINEATED BELOW.
A.  THE EUA WAS GRANTED BY THE FDA WITH THE CONDITION THAT PERSONNEL
DESIGNATED TO RECEIVE THE ANTHRAX IMMUNIZATION MAY ACCEPT OR DECLINE
THE ANTHRAX IMMUNIZATION WITHOUT PUNISHMENT OR COERCION AND WILL
REMAIN DEPLOYABLE.
B.  EFFECTIVE 29 APRIL 05, ONLY ELIGIBLE COMMANDS WHO MEET THE
REQUIREMENTS CONTAINED IN THIS MESSAGE ARE AUTHORIZED TO BEGIN
THE EUA AVIP. THE US DISTRICT COURT IN WASHINGTON DC GRANTED
PERMISSION TO INITIATE THE EUA AVIP UNDER FDA GUIDELINES PROVIDED
THAT DOD STRICTLY COMPLY WITH ALL FDA AND LEGAL REQUIREMENTS.
NON-COMPLIANCE WITH THE EUA AVIP WILL NOT BE TOLERATED AND MAY
RESULT IN PUNITIVE AND/OR ADMINISTRATIVE ACTION.  VIOLATIONS OF THE
EUA WILL BE REPORTED TO SERVICE POC AS SOON AS RECOGNIZED.
C.  COMMANDING OFFICERS (CO) AND OFFICERS-IN-CHARGE (OIC) OF UNITS
TO BE IMMUNIZED AGAINST ANTHRAX MUST COMPLETE THE COMPLIANCE
AGREEMENT AVAILABLE AT WWW.ANTHRAX.MIL{FORWARD SLASH}EUA WEBSITE.
(1) THE COMPLIANCE AGREEMENT WILL BE SUBMITTED TO MILVAX AGENCY VIA
THE SERVICE POC.
(2) LOGISTICS COMMANDS WILL NOT SHIP ANTHRAX VACCINE TO UNITS UNTIL
THE COMPLIANCE AGREEMENT STATEMENT IS RECEIVED BY THE SERVICE POC.
(3) THE COMPLIANCE AGREEMENT STATEMENT HOLDS THE CO OR OIC
ACCOUNTABLE FOR STRICT COMPLIANCE WITH ALL EUA AVIP REQUIREMENTS.
3.  VACCINE ELIGIBILITY.  THOSE CURRENTLY ELIGIBLE TO RECEIVE EUA
ANTHRAX IMMUNIZATIONS ARE:
A.  MILITARY AND MILITARY SEALIFT (CIVILIAN AND CONTRACT MARINERS)
PERSONNEL WITHIN THE US CENTRAL COMMAND (USCENTCOM) AREA OF
RESPONSIBILITY (AOR) INCLUDING FORCES AFLOAT PER REF O FOR 15 OR
MORE CONSECUTIVE DAYS.
B.  US FORCES KOREA ASSIGNED TO THE KOREAN PENINSULA FOR 15 OR MORE
CONSECUTIVE DAYS.  THIS EXCLUDES, REPEAT EXCLUDES, C TO C+20 FORCES
AND USPACOM FORWARD DEPLOYED NAVAL FORCES PREVIOUSLY IDENTIFIED FOR
ANTHRAX IMMUNIZATIONS IN REF B.
C.  FAMILY MEMBERS (AGES 18 TO 65) OF CATEGORIES ABOVE WHO RESIDE IN
USCENTCOM AOR OR WITH US FORCES KOREA.
D.  UNIFORMED PERSONNEL ASSIGNED TO SPECIAL MISSION UNITS, UNITS
WITH BIOWARFARE OR BIOTERRORISM RELATED MISSIONS, AND OTHER
SPECIALLY DESIGNATED MISSIONS AS RECOMMENDED BY THE CHAIRMAN OF THE
JOINT CHIEFS OF STAFF (OR DESIGNEE) AND APPROVED BY USD (P AND R).
E.  PERSONNEL THAT ARE PERMANENT PARTY, OR ON TEMPORARY DUTY FOR 15
OR MORE CONSECUTIVE DAYS ASSIGNED TO LOCATIONS AND MISSIONS
SPECIFIED ABOVE MAY BEGIN ANTHRAX IMMUNIZATIONS UP TO 60 DAYS BEFORE
DEPARTURE EXCEPT AS INDICATED IN PARA 6 OF THIS MESSAGE.  PERSONNEL
MUST BE IN RECEIPT OF ORDERS TO RECEIVE EUA ANTHRAX IMMUNIZATIONS.
F.  PERSONNEL WILL ONLY RECEIVE ANTHRAX IMMUNIZATIONS WHILE ASSIGNED
TO SPECIFIED DUTIES AND OR GEOGRAPHIC LOCATIONS LISTED ABOVE. UPON
RETURN FROM LOCATIONS OR WITH CHANGE IN DUTY STATUS IDENTIFIED
ABOVE, PERSONNEL WILL NO LONGER RECEIVE ANTHRAX IMMUNIZATIONS.  THE
REQUIREMENT TO COMPLETE THE FDA APPROVED DOSING SCHEDULE IS
SUSPENDED UNDER THE EUA.
G.  DO NOT BEGIN EUA ANTHRAX IMMUNIZATIONS FOR DOD EMERGENCY
ESSENTIAL CIVILIANS AND OTHER MISSION ESSENTIAL CONTRACTORS SERVING
IN USCENTCOM AOR OR THE KOREAN PENINSULA UNTIL FURTHER GUIDANCE IS
ISSUED.
H.  THE EUA ANTHRAX IMMUNIZATIONS MAY BE PROVIDED IN OTHER VENUES
FOR DOD PERSONNEL (E.G., EMBASSIES AND MISSIONS OF THE DEPARTMENT OF
STATE), PROVIDED THAT THE REQUIREMENTS IN THIS MESSAGE AND REF O ARE
FULFILLED.
4.  EUA AVIP EDUCATION.  CO AND OICS ARE RESPONSIBLE FOR EDUCATING
THEIR PERSONNEL PRIOR TO RECEIVING EUA ANTHRAX IMMUNIZATIONS.
A.  CO AND OICS WILL ENSURE ALL PERSONNEL ELIGIBLE UNDER THE EUA
RECEIVE THE FOLLOWING SPECIFIC EDUCATION:
(1) FDA ISSUED THE EUA FOR PREVENTING INHALATIONAL ANTHRAX.
(2) MILITARY AND CIVILIAN LEADERSHIP STRONGLY RECOMMEND ANTHRAX
IMMUNIZATIONS AS A FORCE HEALTH PROTECTION MEASURE. IMMUNIZATIONS
PROTECT INDIVIDUALS, UNITS, AND THEIR MILITARY MISSION.
(3) THE SIGNIFICANT KNOWN AND POTENTIAL BENEFITS AND RISKS OF
ANTHRAX VACCINE.
(4) NO OTHER PRODUCT IS APPROVED BY FDA TO PREVENT ANTHRAX BEFORE
EXPOSURE.
(5) INDIVIDUALS HAVE THE OPTION TO ACCEPT OR DECLINE ANTHRAX
VACCINE.
(6) THE MEDICAL CONSEQUENCES OF REFUSING THE VACCINE (E.G.
VULNERABILITY TO LETHAL ANTHRAX INFECTION)
(7) ALTERNATIVE POST EXPOSURE TREATMENT OPTIONS, IF ANY.
B.  CO AND OIC'S WILL INFORM ALL INDIVIDUALS ELIGIBLE FOR EUA
ANTHRAX IMMUNIZATIONS "YOU MAY DECLINE ANTHRAX IMMUNIZATION UNDER
THE EUA, AND YOU WILL NOT BE PUNISHED.  NO DISCIPLINARY ACTION OR
ADVERSE PERSONNEL ACTION WILL BE TAKEN.  YOU WILL NOT BE PROCESSED
FOR SEPARATION, AND YOU WILL STILL BE DEPLOYABLE.  THERE WILL BE NO
PENALTY OR LOSS OF ENTITLEMENT FOR REFUSING ANTHRAX IMMUNIZATIONS."
C.  THE PRIMARY MODE OF EDUCATION IS THE EUA AVIP TRIFOLD DATED 5
APRIL 2005 OR LATER.  EACH INDIVIDUAL WILL BE PROVIDED A COPY OF THE
EUA AVIP TRIFOLD BROCHURE BEFORE EACH ANTHRAX IMMUNIZATION.  NO
ANTHRAX IMMUNIZATION WILL BE GIVEN UNLESS AN EUA AVIP TRIFOLD
BROCHURE IS DISTRIBUTED BEFORE EACH DOSE.
(1) ALL EARLIER VERSIONS OF THE AVIP TRIFOLD BROCHURES WILL BE
COLLECTED AND DISCARDED OR RECYCLED.  DO NOT RETAIN THEM FOR FUTURE
USE.  BE SURE TO REMOVE OBSOLETE AVIP TRIFOLD BROCHURES FROM
PAMPHLET RACKS IN WAITING ROOMS, ON BULLETIN BOARDS, INTRANETS, ETC.
(2) EUA AVIP TRIFOLD BROCHURES WILL BE MAILED TO UNITS ONCE THE
COMPLIANCE AGREEMENT IS SUBMITTED AND AN ANTHRAX VACCINE ORDER IS
APPROVED.
(3) EUA AVIP TRIFOLD BROCHURES CAN BE DOWNLOADED FROM THE MILVAX
WEBSITE LISTED IN PARA 4B AND REPRODUCED IF NECESSARY.
D.  CO AND OIC'S WILL SUPPLEMENT THE EUA AVIP TRIFOLD BROCHURE
WHENEVER POSSIBLE WITH A STANDARD EUA AVIP BRIEFING AVAILABLE ON THE
MILVAX WEBSITE (WWW.ANTHRAX.MIL{FORWARD SLASH}WHATSNEW{FORWARD
SLASH}EUA).  IF UNABLE TO ACCESS THIS BRIEF, OR IF YOU NEED THE
BRIEF SHIPPED TO YOU IN HARD COPY OR ON A CD-ROM, SEND AN EMAIL
REQUEST TO: ON NIPRNET VACCINES@OTSG.AMEDD.ARMY.MIL OR ON SIPRNET
OTSG.OPSCENTER21OPNS@HQDA-S.ARMY.SMIL.MIL (ON THE SUBJECT LINE
INDICATE "ATTENTION: MILVAX").
(1) CO AND OIC'S SHOULD DEVELOP TEAMS OF LOCAL HEALTHCARE PROVIDERS
AND OTHER SUBJECT MATTER EXPERTS (E.G., JUDGE ADVOCATE GENERAL,
PUBLIC AFFAIRS OFFICE) TO ASSIST WITH EUA AVIP BRIEFINGS.
(2) QUESTIONS SHOULD BE ANSWERED PROACTIVELY AND UPFRONT.
E.  CO AND OIC'S WILL KEEP A DATED ROSTER OF PERSONNEL PROVIDED AN
EUA AVIP TRIFOLD BROCHURE AND BRIEF.  THE ROSTER WILL BE ENTITLED "I
RECEIVED AN EUA TRIFOLD FOR ANTHRAX VACCINE".  THESE ROSTERS WILL BE
RETAINED AT THE COMMAND AND AVAILABLE TO VALIDATE COMPLIANCE.
(1) EUA AVIP TRIFOLD BROCHURES ARE INTENDED FOR PERSONAL ISSUE TO
VACCINE CANDIDATES.  DO NOT COLLECT SIGNATURES ON THESE BROCHURES.
(2) PERSONNEL DO NOT SIGN THAT THEY ACCEPT OR DECLINE ANTHRAX
IMMUNIZATIONS UNDER THE EUA.  THEY ARE SIGNING THAT THEY RECEIVED
THE EDUCATION.
(3) A COPY OF THE EDUCATION ROSTER SHALL BE SUBMITTED TO THE MEDICAL
ACTIVITY ADMINISTERING THE EUA ANTHRAX IMMUNIZATIONS.  THE MEDICAL
ACTIVITY SHALL VERIFY THAT ALL PERSONNEL HAVE RECEIVED APPROPRIATE
EDUCATION PRIOR TO ADMINISTERING EUA ANTHRAX IMMUNIZATIONS.
F.  HEALTHCARE PROVIDERS (E.G., PREVENTIVE MEDICINE AND PUBLIC
HEALTH STAFF, AMBULATORY CARE, ALLERGY-IMMUNOLOGY, FLIGHT MEDICINE,
AND EMERGENCY CARE) AND VACCINATORS WILL BE KNOWLEDGEABLE ON
THE FOLLOWING TOPICS:
(1) EUA AVIP HEALTHCARE PROVIDER BRIEF AT WWW.ANTHRAX.MIL{FORWARD
SLASH}EUA.
(2) BIOTHRAX PACKAGE INSERTS, AVAILABLE WITH EVERY VACCINE VIAL OR
AT WWW.BIOPORT.COM{FORWARD SLASH}ANTHRAXVACCINE{FORWARD
SLASH}INSERT{FORWARD SLASH}AVAINSERT.ASP.
(3) THE EUA AVIP TRIFOLD BROCHURE DATED 5 APR 2005 OR LATER.
(4) INFORMATION IN PARA 4 OF THIS MESSAGE.
(5) REPORTING PROCEDURES FOR VACCINE ADVERSE EVENTS REPORTING
SYSTEM(VAERS) AT WWW.VAERS.ORG.
(6) CONTRAINDICATIONS FOR ANTHRAX IMMUNIZATIONS AND INITIATING
MEDICAL EXEMPTION ASSESSMENTS PER REF I (E.G., PREVIOUS SERIOUS
ALLERGIC REACTIONS TO ANTHRAX IMMUNIZATIONS, PRESENCE OF CURRENT
MODERATE OR SEVERE ILLNESS, PREGNANCY, LATEX SENSITIVITY,
IMMUNE-SUPPRESSIVE CONDITIONS, GUILLIAN-BARRE SYNDROME, RECOVERED
FROM ANTHRAX INFECTION IN THE PAST).
(7) PROCEDURES TO IDENTIFY EARLY PREGNANCY TO INCLUDE OFFERING
PREGNANCY TESTING BEFORE ANY IMMUNIZATION.
G.  A COPY OF THE US DISTRICT COURT'S 27 OCT 04 "ORDER AND OPINION
OF INJUNCTION" MUST BE READILY AVAILABLE AT THE IMMUNIZATION SITES
FOR VACCINEES TO READ.  COPIES WILL BE SHIPPED WITH THE EUA AVIP
TRIFOLD BROCHURES FROM USAMMA.  THE DOCUMENT IS ALSO AVAILABLE AT
WWW.ANTHRAX.MIL{FORWARD SLASH}EUA.
5.  OPTION TO DECLINE.  THE FDA GRANTED THE EUA WITH THE CONDITION
THAT PERSONNEL DESIGNATED TO RECEIVE THE ANTHRAX IMMUNIZATION MAY
ACCEPT OR REFUSE THE IMMUNIZATION.  PERSONNEL CHOOSING TO DECLINE
THE ANTHRAX IMMUNIZATION WILL NOT BE PUNISHED, HARASSED OR COERCED.
COMMANDERS WILL RESPECT THE INDIVIDUAL'S DECISION TO DECLINE ANTHRAX
IMMUNIZATIONS DURING THE EUA.
A.  IF A SERVICEMEMBER EXPRESSES DOUBTS ABOUT RECEIVING THE ANTHRAX
IMMUNIZATION, THE CO OR OIC MAY OFFER ADDITIONAL EDUCATION ON THE
RISKS OF DECLINING THE VACCINE.  CO OR OIC WILL ENSURE SERVICEMEMBER
RECEIVES THE EUA AVIP TRIFOLD BROCHURE DATED 5 APR 05 OR LATER.  AT
A MINIMUM, THE ADDITIONAL EDUCATION SHOULD COVER THE FOLLOWING
POINTS:
(1) ANTHRAX SPORES ARE LETHAL.
(2) ANTHRAX SPORES CAN BE INHALED UNKNOWINGLY.
(3) ANTHRAX VACCINE IS 92.5 PERCENT EFFECTIVE IN PREVENTING ANTHRAX
INFECTION.
(4) ANTHRAX IMMUNIZATION MAY BE DECLINED UNDER THE EUA WITHOUT
RETRIBUTION, HARASSMENT OR PUNISHMENT.
(5) SERVICE MEMBER WILL REMAIN DEPLOYABLE IF ANTHRAX IMMUNIZATION IS
DECLINED UNDER THE EUA.
(6) DECLINING ANTHRAX IMMUNIZATIONS COULD RESULT IN MEMBER'S DEATH
AND IMPACT THE UNIT'S ABILITY TO ACCOMPLISH THE MISSION.
B.  IF A MEMBER CHOOSES TO EXERCISE THE OPTION TO DECLINE ANTHRAX
IMMUNIZATIONS DURING EUA, CO AND OICS WILL RESPECT THAT INDIVIDUAL'S
DECISION.  NO DISCIPLINARY ACTION WILL BE TAKEN BY THE CHAIN OF
COMMAND.  CO AND OICS WILL ENSURE THE MEMBER IS NOT HARASSED OR
COERCED TO RECEIVE ANTHRAX IMMUNIZATIONS.
(1) MEMBERS WHO DECLINE EUA ANTHRAX IMMUNIZATIONS WILL NOT BE
OFFERED ANTHRAX IMMUNIZATIONS AGAIN UNTIL A CHANGE OF CIRCUMSTANCES
OCCURS (E.G., CHANGE OF DUTY, CHANGE OF LOCATION, PASSAGE OF AT
LEAST 30 DAYS).
(2) MEMBERS MAY CHANGE THEIR DECISION AND REQUEST ANTHRAX
IMMUNIZATIONS AT ANY TIME PROVIDED THEY ARE STILL ELIGIBLE TO
RECEIVE THE ANTHRAX IMMUNIZATION UNDER THE EUA.  (NOTE THAT THE
BODY'S IMMUNE SYSTEM REQUIRES TIME TO DEVELOP IMMUNITY TO ANTHRAX).
(3) IF A MEMBER ACCEPTS AN ANTHRAX IMMUNIZATION, THE MEMBER MAY
ELECT NOT TO RECEIVE A SUBSEQUENT DOSE UNDER THE EUA AVIP.
6.  RESERVE COMPONENT (RC) PERSONNEL.   IN ADDITION TO PARA 3, RC
PERSONNEL MUST MEET THE FOLLOWING CONDITIONS IN ORDER TO RECEIVE EUA
ANTHRAX IMMUNIZATIONS.
A.  SPECIFIC CRITERIA FOR RC PERSONNEL ARE AS FOLLOWS:
(1) RC PERSONNEL IN RECEIPT FOR ORDERS OF LESS THAN 30 DAYS WILL
RECEIVE EUA ANTHRAX IMMUNIZATIONS AT SUPPORTED COMMAND IN THEATER.
SUPPORTED COMMAND CO OR OIC IS RESPONSIBLE FOR EUA ANTHRAX EDUCATION.
(2) RC INDIVIDUAL MOBILIZATION AUGMENTEES WILL RECEIVE EUA ANTHRAX
IMMUNIZATIONS AT NAVY MOBILIZATION PROCESSING SITES.  NMPS CO OR OIC
IS RESPONSIBLE FOR EUA ANTHRAX EDUCATION. RC MEMBERS WILL RECEIVE
THE INITIAL ANTHRAX IMMUNIZATION AT THE NMPS AND ANY SUBSEQUENT
IMMUNIZATIONS AT I-STOPS AND ULTDUSTA.  IT IS NOT REQUIRED THAT
PERSONNEL HAVE INITIAL SERIES OF THREE ANTHRAX IMMUNIZATIONS PRIOR
TO DEPLOYING TO THEATER.
(3) RC UNITS WITH ORDERS MEETING CRITERIA IN PARA 3 MUST COMPLY WITH
EUA AVIP REQUIREMENTS AND RECEIVE RC SERVICE POC APPROVAL BEFORE
ORDERING AND ADMINISTERING ANTHRAX VACCINE.  RC UNIT CO OR OIC IS
RESPONSIBLE FOR EUA ANTHRAX EDUCATION.
B.  RC MEMBERS MUST BE IN A DUTY STATUS WHEN RECEIVING ANY
DOD-DIRECTED IMMUNIZATION.
C.  AN ADVERSE REACTION TO A DOD-DIRECTED IMMUNIZATION IS A LINE OF
DUTY (LOD) CONDITION.
(1) RC MEMBERS WHO INCUR OR AGGRAVATE ANY INJURY, ILLNESS, OR
DISEASE WHILE PERFORMING ACTIVE DUTY FOR LESS THAN 30 DAYS, OR ON
INACTIVE DUTY TRAINING ARE ENTITLED TO MEDICAL CARE APPROPRIATE FOR
THE TREATMENT OF THE INJURY, ILLNESS, OR DISEASE.
(2) WHEN AN RC MEMBER PRESENTS FOR TREATMENT AT A MILITARY TREATMENT
FACILITY EXPRESSING A BELIEF THAT THE CONDITION FOR WHICH TREATMENT
IS SOUGHT IS RELATED TO RECEIVING AN IMMUNIZATION DURING A PERIOD OF
DUTY, THE MEMBER MUST BE EXAMINED AND PROVIDED NECESSARY MEDICAL
CARE.  SUBMIT REPORTS TO THE VACCINE ADVERSE EVENTS REPORTING
SYSTEM(VAERS) (WWW.VAERS.ORG).
(3) WHEN TREATMENT HAS BEEN RENDERED OR THE INDIVIDUAL'S EMERGENT
CONDITION IS STABILIZED, A LINE OF DUTY-NOTICE OF ELIGIBILITY WILL
BE DETERMINED AS SOON AS POSSIBLE.  FOR INJURIES, ILLNESSES, OR
DISEASE UNRELATED TO DUTY, RC MEMBERS SHOULD SEEK MEDICAL ATTENTION
FROM THEIR PERSONAL HEALTHCARE PROVIDERS.
(4) RESERVE MEDICAL DEPARTMENT REPRESENTATIVES WILL ENSURE ACCURATE
LOD DATA IS ENTERED IN MEDICAL READINESS REPORT SYSTEM (MRRS),
FORMERLY KNOWN AS RAMIS.
7.  DOSING SCHEDULE. UNDER THE EUA AVIP, THE DOSING SCHEDULE IS AS
FOLLOWS:
A.  PERSONNEL RESUMING ANTHRAX IMMUNIZATIONS UNDER THIS POLICY WILL
CONTINUE THE DOSING SCHEDULE WHERE THEY LEFT OFF.  THEY WILL NOT
NEED TO REPEAT ANY DOSES ALREADY RECEIVED IN THE SERIES OR RESTART
THE SERIES.  THIS IS CONSISTENT WITH GUIDANCE FROM THE CENTERS FOR
DISEASE CONTROL (CDC), ITS ADVISORY COMMITTEE ON IMMUNIZATION
PRACTICES (ACIP), AND THE FDA.  WHEN A DOSE CANNOT BE PROVIDED ON
THE SPECIFIC DATE SUGGESTED BY THE SCHEDULE, PROVIDE IT AS SOON
THEREAFTER AS PRACTICAL.
B.  DURING THE PERIOD OF THE EUA, THE POLICY OF CONTINUING THE
VACCINE DOSING SERIES (SIX SHOTS PLUS BOOSTERS) IS SUSPENDED FOR
PERSONNEL WITHOUT CONTINUING DUTY ASSIGNMENT INDICATED IN PARA 3,
ASSOCIATED WITH THE HEIGHTENED RISK OF EXPOSURE.
8.  ANTHRAX IMMUNIZATIONS TRACKING.  ALL IMMUNIZATION DATA WILL BE
ENTERED INTO THE MEMBER'S MEDICAL RECORD, THE YELLOW SHOT CARD (PHS
731), AND AN APPROVED ELECTRONIC TRACKING SYSTEM (ETS) THAT
TRANSMITS DATA TO DEERS.  CURRENTLY THOSE SYSTEMS ARE THE SHIPBOARD
NON-TACTICAL ADP PROGRAM (SNAP) AUTOMATED MEDICAL SYSTEM (SAMS), THE
MRRS, AND COMPOSITE HEALTH CARE SYSTEM VERSION II (CHCS II).  CHCS
VERSION I DOES NOT TRANSMIT IMMUNIZATION DATA TO DEERS AND THEREFORE
IS NOT AN APPROVED SYSTEM FOR IMMUNIZATION TRACKING.
A.  TO ENSURE ACCURACY OF ETS ENTRIES, THE DATE OF ANTHRAX
IMMUNIZATION AS RECORDED IN THE MEDICAL RECORD MUST BE THE SAME DATE
RECORDED IN THE ETS.  FOR ALL SYSTEMS, MANUALLY OVERRIDE TIME-DATE
DEFAULT TO ACCURATELY REFLECT THE CORRECT IMMUNIZATION
ADMINISTRATION DATE.
B.  ALL REFUSALS SHALL BE DOCUMENTED IN THE MEDICAL RECORD (SF 600).
SF 600 ENTRIES SHALL STATE: "MEMBER REFUSED EUA ANTHRAX
IMMUNIZATION."
C.  REFUSALS SHALL BE ENTERED INTO THE ETS UNDER THE CODE "MD" FOR
MEDICALLY DECLINED.
9.  REPORTING REQUIREMENTS. EUA AVIP ELIGIBLE UNIT CO AND OIC'S WILL
PROVIDE WEEKLY REPORTS.  THE FOLLOWING INFORMATION WILL BE ATTESTED
TO:  NO ONE RECEIVED ANTHRAX VACCINATION AGAINST HIS OR HER WILL, OR
WITHOUT BEING INFORMED OF THE OPTION TO DECLINE, OR OTHERWISE IN
VIOLATION OF THE OPTION TO DECLINE, AT THIS UNIT FOR THIS INTERVAL.
A.  IN EVERY CASE IN WHICH ANTHRAX IMMUNIZATIONS WERE GIVEN WITHOUT
BEING INFORMED OF THE OPTION TO DECLINE, OR OTHERWISE IN VIOLATION
OF THE OPTION TO DECLINE, A REASON MUST BE PROVIDED AS WELL AS STEPS
TAKEN TO PREVENT THIS FROM HAPPENING IN THE FUTURE.  REPORT FORMATS
ARE AVAILABLE AT WWW.ANTHRAX.ARMY.MIL WEBSITE AND WILL ALSO BE SENT
WITH EACH SHIPMENT OF VACCINE.
B.  ACTIVE AND RESERVE UNITS REPORTS WILL BE SUBMITTED TO THE
FOLLOWING
(1) MILITARY VACCINE AGENCY (MILVAX). CONTACT INFORMATION FOR MILVAX
IS BY NIPR VACCINES@OTSG.AMEDD.ARMY.MIL OR SIPR:
OTSG.OPSCENTER21OPNS@HQDA-S.ARMY.SMIL.MIL OR FAX (COMM)
703-681-4692, (DSN) 782-4692.
(2) NAVY AVIP OFFICE.  CONTACT INFO IS BY NIPR
EUA-AVIP@US.MED.NAVY.MIL OR FAX (COMM) 703-601-2010, (DSN) 329-2010.
SIPR ADDRESS IS: OPNAV_VACCINES_N931@CNO.NAVY.SMIL.MIL.
C.  REPORTS WILL BE SUBMITTED BY MONDAY OF EACH WEEK FOR THE
PREVIOUS WEEK'S ACTIVITY, NO LATER THAN 1600 EST (2100 ZULU).
NEGATIVE REPORTS REQUIRED.
D.  WEEKLY REPORTS ARE NOT REQUIRED ONCE A UNIT NO LONGER MEETS EUA
AVIP ELIGIBILITY REQUIREMENTS AS DELINEATED PARA 3.  THE UNIT'S
FINAL WEEKLY REPORT WILL SERVE AS A CLOSEOUT REPORT AND MUST
INDICATE THAT THE UNIT NO LONGER MEETS ELIGIBILITY REQUIREMENTS.
10.  EUA AVIP OVERSIGHT.  COMPLIANCE WITH EUA AVIP REQUIREMENTS WILL
BE INCORPORATED INTO CURRENT INSPECTION PROCESSES.  CO AND OICS
SHALL CONDUCT INTERNAL AUDITS OF THEIR COMPLIANCE UTILIZING NEUTRAL
PARTIES NOT ENGAGED IN EUA AVIP IMPLEMENTATION.
11.  VACCINE DISTRIBUTION.
A. DISTRIBUTION OF ANTHRAX VACCINE WILL BE LIMITED TO SITES WHERE
CO AND OIC'S HAVE SUBMITTED COMPLIANCE AGREEMENTS.
B.  UPON SERVICE POC APPROVAL, NAVAL MEDICAL LOGISTICS COMMAND
(NMLC) WILL LIAISON WITH THE U.S. ARMY MEDICAL MATERIEL AGENCY
(USAMMA) TO COORDINATE THE DISTRIBUTION OF ANTHRAX VACCINE PER REF
K.  APPROVED END-USERS WILL DIRECTLY REQUISITION VACCINE USING
USAMMA WEBSITE WWW.USAMMA.ARMY.MIL{FORWARD SLASH}VACCINES.
(1) EUA AVIP TRIFOLD BROCHURES WILL BE SHIPPED TO EACH REQUESTING
UNIT PRIOR TO VACCINE SHIPMENT.  NO VACCINE WILL BE SHIPPED UNTIL
USAMMA RECEIVES CONFIRMATION THAT BROCHURES HAVE BEEN RECEIVED.
RECEIVING COMMAND WILL CONFIRM WITH USAMMA THAT BROCHURES HAVE BEEN
RECEIVED.
(2) ALL SHIPMENTS OF ANTHRAX VACCINE WILL CONTAIN A COPY OF THE
PACKAGE INSERT AND THE US DISTRICT COURT'S 27 OCT 2004 OPINION.
C.  ACTIVITIES MUST HAVE SUFFICIENT REFRIGERATION CAPACITY TO
PRESERVE VACCINE INTEGRITY, INCLUDING TEMPERATURE ALARMS AND BACK UP
POWER CAPACITY.  ENSURE PERSONNEL HAVE BEEN TRAINED IN COLD CHAIN
MANAGEMENT PROCEDURES, INCLUDING PROMPT REFRIGERATION OF VACCINE
UPON RECEIPT.
12. SERVICE POCS ARE AS FOLLOWS:
A.  ACTIVE POC: LCDR K. BUCHANAN AVAILABLE AT NIPR
KARI.BUCHANAN@NAVY.MIL; SIPR BUCHANAN.KARI@CNO.NAVY.SMIL.MIL; OR
FAX(COMM) 703-601-2010, (DSN) 329-2010.
B.  RESERVE POC: CDR M. JACOBSEN AVAILABLE AT NIPR
MARY.JACOBSEN@NAVY.MIL; SIPR JACOBSEN.MARY@CNO.NAVY.SMIL.MIL; OR
FAX(COMM) 703-614-7746, (DSN) 224-7746.
13. THE ANTHRAX VACCINE IMMUNIZATION PROGRAM REMAINS A COMMANDER'S
FORCE PROTECTION RESPONSIBILITY. COMMANDERS WILL FOLLOW GUIDANCE
PROVIDED IN REFERENCES A-K, M, N AND O TO PROPERLY IDENTIFY AND
EDUCATE SERVICE MEMBERS AND DOD CIVILIANS TO BE IMMUNIZED, TRACK
IMMUNIZATIONS, AND ENSURE APPROPRIATE MEDICAL EVALUATION IF
VACCINEES EXPERIENCE SYMPTOMS FOLLOWING ANY VACCINATION. COMMANDERS
WILL RESPECT THE OPTION TO DECLINE ANTHRAX IMMUNIZATIONS DURING THE
EUA.
14.  MESSAGE WILL EXPIRE 27 JUL 05 UNLESS EXPLICITLY EXTENDED.
15.  RELEASED BY VADM A. T. CHURCH III, DIRECTOR, NAVY STAFF.
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