------------------------------------------------------------------------------------------------------------------------
From:
MFR MDSADMIN
Sent: Saturday, September 21, 2002 2:23 AM
MEMO,
SUBJ: APPROVAL OF IMPLEMENTATION PLAN TO RESUME ANTHRAX VACCINE
IMMUNIZATIONS
SUBJ: GUIDANCE FOR IMMEDIATE RESUMPTION OF THE
ANTHRAX VACCINE
IMMUNIZATION PROGRAM (AVIP) IN ELIGIBLE MARINE CORPS FORCES
1. READ THIS MESSAGE IN ITS ENTIRETY. THIS MESSAGE HAS BEEN
COORDINATED WITH
OPNAV N931 AND ASDHA, AND HAS BEEN APPROVED BY PAGE 03
RUEOMFB0585
UNCLAS ASDFMP (REF E) AND SECNAV (REF G). PURPOSE IS TO
ADVISE
COMMANDERS:
A. DEPSECDEF HAS ORDERED A THREAT-BASED
RESUMPTION OF THE AVIP VIA
POLICY MEMOS DATED 28 JUN 2002 (REF A) AND 6 AUG
2002 (REF B). POLICY
MEMOS MAY BE VIEWED ON AVIP WEBSITE AT WWW.ANTHRAX.MIL.
B. REF C IS CURRENTLY UNDER REVISION AND, WHEN SIGNED, PROVIDES DON
EXECUTION
GUIDANCE. THIS ALMAR AUTHORIZES IMMEDIATE RESUMPTION OF
ANTHRAX VACCINE
ADSORBED (AVA) TO INDIVIDUALS ATTACHED TO USMC UNITS
CURRENTLY MEETING
DEFINITION OF PRIORITY GROUP 2 (SEE PARAGRAPHS 3B AND 4) OR
WILL MEET
PRIORITY GROUP 2 DEFINITION BASED UPON VALID UNIT EMPLOYMENT PLAN
PER
MCBUL 3120 CONSOLIDATED DEPLOYMENT SCHEDULE FY 02-04.
2.
BACKGROUND:
A. ON 31 JAN 02 THE FOOD AND DRUG ADMINISTRATION (FDA) GAVE
BIOPORT
CORPORATION FINAL APPROVAL TO RESUME THE MANUFACTURE AND DISTRIBUTION
OF THE US-LICENSED ANTHRAX VACCINE (AVA) AND RELEASED ADDITIONAL VACCINE
FOR
USE. THIS RESTORES THE AVAILABILITY OF FDA RELEASED AVA TO DOD. B.
THE
NATIONAL ACADEMY OF SCIENCES' INSTITUTE OF MEDICINE PAGE 04
RUEOMFB0585
UNCLAS REAFFIRMED AVA SAFETY AND EFFECTIVENESS IN MAR 02 BY
PUBLISHING THE
FINDINGS OF THEIR TWO YEAR STUDY OF AVA. C. CURRENT
INTELLIGENCE
ASSESSMENTS INDICATE THE ANTHRAX THREAT REMAINS REAL.
3.THE INITIAL
SCOPE OF AVIP RESUMPTION IS: A. PRIORITY GROUP 1: CONTINUE
ANTHRAX
VACCINATIONS TO DESIGNATED SPECIAL MISSION UNITS, AND PERSONNEL
INVOLVED IN
RESEARCH AND AVA MANUFACTURING. B. PRIORITY GROUP 2:
EXPAND
VACCINATIONS TO PERSONNEL ASSIGNED TO OR DEPLOYED IN THE HIGHER
THREAT
AREAS OF SOUTHWEST ASIA (SWA) FOR MORE THAN 15 CONSECUTIVE DAYS.
MARINE
FORCES AFLOAT ON CONTIGUOUS WATERS IN VICINITY OF ARABIAN
PENINSULA
(ARABIAN GULF, GULF OF OMAN, GULF OF ADEN, RED SEA) ARE ELIGIBLE,
WHILE
MOST NAVY FORCES AFLOAT ARE EXCLUDED. PERSONNEL FLYING IN THE
AIRSPACE
OVER THE HTA SHALL NOT BE VACCINATED UNLESS THEY WILL BE BASED
ASHORE
FOR 15 OR MORE CONSECUTIVE DAYS. C. ACTIVE DUTY AND RESERVE
COMPONENT
MEMBERS, CIVILIAN PERSONNEL CLASSIFIED AS EMERGENCY-ESSENTIAL,
AND
CONTRACTOR PERSONNEL CARRYING OUT MISSION ESSENTIAL SERVICES ARE SUBJECT
TO THIS POLICY PAGE 05 RUEOMFB0585 UNCLAS PER REF B. NEAR TERM AVIP
IMPLEMENTATION MAY ALSO INCLUDE OTHER PERSONNEL DETERMINED BY THE
ASSISTANT
SECRETARY OF DEFENSE FOR HEALTH AFFAIRS, IN CONSULTATION WITH
THE CHAIRMAN OF
THE JOINT CHIEFS OF STAFF, TO BE AT HIGHER RISK FOR
EXPOSURE TO ANTHRAX. FOR
THOSE PERSONNEL ALREADY DEPLOYED AT THE
ISSUANCE OF THIS MARADMIN, WHO WILL
ROTATE OUT OF ASSIGNMENT OR
RE-DEPLOY FROM HIGHER THREAT AREAS IN 90 DAYS OR
LESS, WILL NOT BE
REQUIRED TO START VACCINATION AT THIS TIME.
4. THE FOUR PRIORITY GROUPS AND THIRTEEN COUNTRIES COMPRISING THE
HIGHER THREAT AREAS MAY BE OBTAINED ON SIPRNET VIA THE HQMC/PPO
HOMEPAGE
WWW.HQMC.USMC.SMIL.MIL/PLN/PLN_HOME.HTM.
5. LEADERSHIP
GUIDANCE:
THE AVIP REMAINS A COMMANDER'S RESPONSIBILITY. IT IS A
CRITICAL PART OF
THE MARINE CORPS FORCE PROTECTION PROGRAM. A.
COMMANDERS SHALL ENSURE THAT ALL PERSONNEL UNDER THEIR COMMAND ARE BRIEFED,
COVERING TOPICS IN THE MEMBER'S BRIEF, LEADER'S BRIEF, AND TRIFOLD FOUND AT DOD
WEBSITE WWW.ANTHRAX.MIL. THE AVIP WEBSITE SHOULD BE PROMOTED AS A VALUABLE
RESOURCE TO ALL MEMBERS AND THEIR FAMILIES. LEADERS SHOULD ALSO REVIEW THE
COMMANDER'S EDUCATION TOOLKIT AND THE QUESTIONS AND ANSWERS POSTED ON THE
WEBSITE, SINCE PAGE 06 RUEOMFB0585 UNCLAS THESE ARE THE MOST FREQUENTLY ASKED
QUESTIONS BY OUR PERSONNEL AND THEIR FAMILIES; REF F MAY ALSO BE UTILIZED FOR
THIS PURPOSE. UNIT-WIDE EDUCATION CAMPAIGNS SHOULD OCCUR IN PROXIMITY (DAYS) TO
INITIAL UNIT VACCINE ADMINISTRATION. PROFESSIONAL QUALITY TRIFOLD BROCHURES HAVE
BEEN DESIGNED ESPECIALLY FOR THIS PURPOSE. THEY MAY BE VIEWED ONLINE UNDER THE
POPULAR RESOURCES SECTION OF THE AVIP WEBSITE
(WWW.ANTHRAX.MIL/MEDIA/PDF/BROCHURE.PDF).
UNIT COMMANDERS, AT THEIR
DISCRETION, MAY CONTACT MR. HERMAN HARRIS AT
(703) 681-4262, DSN 761-4262, OR
HERMAN.HARRIS@AMEDD.ARMY.MIL TO ARRANGE
PURCHASE OF QUANTITIES OF THE
BROCHURES FOR UNIT EDUCATION. B.
ADMINISTRATIVE EXEMPTIONS POLICY IS
CONTAINED IN REF B. EXEMPTION
AUTHORIZATION RESTS WITH THE FIRST GO/FO
EXERCISING ADMINISTRATIVE
CONTROL (ADCON).
COMMANDERS WILL MANAGE
IMMUNIZATION REFUSALS AS THEY WOULD ADDRESS ANY REFUSAL TO OBEY A LAWFUL
ORDER.
6. MEDICAL GUIDANCE:
A. MEDICAL PERSONNEL WILL
THOROUGHLY UNDERSTAND THE CLINICAL ASPECTS OF THIS VACCINE AND THE POTENTIAL FOR
ADVERSE EVENTS AFTER VACCINATION QQQQ (REF B). MEDICAL PERSONNEL
MUST KNOW HOW TO MANAGE THE SPECTRUM OF ADVERSE EVENTS, INCLUDING THE
REQUIREMENT TO SUBMIT VACCINE ADVERSE
EVENT REPORTS. ASSISTANT
SECRETARY OF DEFENSE FOR HEALTH AFFAIRS, DR.
WILLIAM WINKENWERDER, WANTS
MEDICAL PERSONNEL TO CLEARLY UNDERSTAND THEY WILL NOT ONLY ADMINISTER THE
VACCINE, BUT WILL BE OUR FRONT LINE
RESPONDING TO QUESTIONS AND CONCERNS.
THEREFORE, MEDICAL PERSONNEL WILL FAMILIARIZE THEMSELVES WITH ALL AVIP WEBSITE
RESOURCES, ESPECIALLY THE CLINICIAN'S TOOLKIT AT PAGE 02 RUEOMFB0586
UNCLAS
HTTP://WWW.ANTHRAX.MIL/EDUCATION/CLINICIAN/CLINICIANS.ASP.
THE
RECENT COMPREHENSIVE REPORT ON ANTHRAX VACCINE SAFETY AND
EFFECTIVENESS FROM
THE NATIONAL ACADEMY OF SCIENCES' INSTITUTE OF
MEDICINE IS OF PARTICULAR NOTE
TO MEDICAL PERSONNEL, AND CAN BE READ
ONLINE AT
HTTP://WWW.NAP.EDU/HTML/ANTHRAX/INDEX.HTML.
B. ENSURE APPROPRIATE
UNIT MEDICAL PERSONNEL ARE TRAINED IN STANDARD
AUTOMATED MEDICAL SYSTEM
(SAMS) IMMUNIZATION TRACKING PROCEDURES AND
HAVE A CURRENT PASSWORD TO
ACCESS DEERS IMMUNIZATION TRACKING WEBSITE.
DESIGNATED MEDICAL PERSONNEL MUST
HAVE ACCESS TO A COMPUTER, A USMC.MIL EMAIL ACCOUNT, AND WORLDWIDE WEB
ACCESS.
IMMUNIZATION TRACKING IS VITAL FOR ALL ACTIVE AND RESERVE FORCES; IN
ADDITION TO RECORDING MEMBER DATA, UNIT DATA, VACCINE LOT NUMBER, AND INJECTION
SITE/ROUTE/NUMBER IN SAMS, RECORD THIS SAME INFORMATION IN MEMBER'S HEALTH
RECORD AND ON YELLOW SHOT CARD (PHS 731).
DOCUMENT PROVISION OF PATIENT
EDUCATION IN MEMBER'S HEALTH RECORD. INFORMATION FOR IMMUNIZATION TRACKING
CAN BE OBTAINED VIA THE WEBSITE AT HTTPS://IMCENTER.MED.NAVY.MIL/ITS. PAGE 03
RUEOMFB0586 UNCLAS
C. PERSONNEL ELIGIBLE FOR VACCINE WITHIN THIS
INITIAL PROGRAM SCOPE AND
WHO ALREADY HAVE RECEIVED AT LEAST ONE DOSE OF AVA,
WILL SIMPLY BEGIN
WITH THE NEXT DOSE IN SERIES PER FDA-APPROVED
SCHEDULE. THERE IS NO
NEED TO RE-START INDIVIDUALS WITH DOSE NUMBER
ONE. DOSES WILL NOT BE
GIVEN ON A COMPRESSED OR SHORTENED SCHEDULE AS THIS
DECREASES
EFFECTIVENESS. THESE REQUIREMENTS ARE CONSISTENT WITH FDA
REGULATIONS
AND GUIDANCE FROM THE CENTERS FOR DISEASE CONTROL AND
PREVENTION'S (CDC)
ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP).
D. ADDITIONALDETAILED CLINICAL GUIDANCE IS AVAILABLE IN REF B.
THIS GUIDANCE INCLUDES DISCUSSION OF DOSAGE SCHEDULE, MEDICAL SCREENING BEFORE
IMMUNIZATION
(PROVIDES SAMPLE SCREENING QUESTIONAIRE THAT MAY BE
CONSIDERED AND
MODIFIED FOR USE), PREGNANCY SCREENING (REF D APPLIES),
INJECTION-SITE
SELECTION, MEDICAL EXEMPTIONS, AND ADVERSE EVENTS MANAGEMENT.
E. UNIT MEMBERS CONSIDERED FOR MEDICAL EXEMPTION CODE (MR)
(MEDICAL
REACTIVE) SHALL BE REFERRED PER CLINICAL MANAGEMENT OF ADVERSE
EVENTS
PAGE 04 RUEOMFB0586 UNCLAS GUIDELINES IN REF B FOR APPROPRIATE
SPECIALTY
EVALUATION PRIOR TO ASSIGNMENT OF MEDICAL EXEMPTION CODE (MR).
F. VACCINE WILL BE ADMINISTERED ACCORDING TO FDA LABEL REQUIREMENTS.
7.
LOGISTICAL GUIDANCE:
A. MARINE FORCES OPCON TO COMUSMARCENT
WILL BE SUPPORTED THROUGH COMUSCENTCOM COMPONENT PLANS. INTENT IS TO ENSURE
MARINE UNITS ARE UP TO DATE ON AVA STATUS PRIOR TO DEPLOYMENT, INCLUDING
PROVISION OF FIRST 3 AVA DOSES TO THOSE CURRENTLY UNIMMUNIZED. AVA WILL BE
PROVIDED TO DEPLOYING MARINE CORPS UNITS NO LESS THAN 45 DAYS AND NO MORE THAN
90 DAYS PRIOR TO DEPLOYMENT TO A HIGHER THREAT AREA.
B. ENSURE LOGISTICS
SUPPORT HAS SUFFICIENT REFRIGERATION CAPACITY TO
PRESERVE VACCINE INTEGRITY
WITHIN FDA LABEL TEMPERATURE RANGE OF 2-8
DEGREES CENTIGRADE/36-46 DEGREES
FAHRENHEIT (DO NOT PUT VACCINE IN
DIRECT CONTACT WITH ICE). SUPPORT
INCLUDES TWICE DAILY MONITORING OF
TEMPERATURE AND BACK-UP POWER SUPPLY.
IDEALLY, A 24 X 7 ALARM SYSTEM
SHOULD NOTIFY APROPRIATE MEDICAL PERSONNEL.
STORE UNOPENED VIALS AT
MTFS; AID STATIONS WILL CHECKOUT VACCINE PRIOR TO
UNIT PAGE 05
RUEOMFB0586 UNCLAS SHOTEXS AND RETURN UNOPENED VIALS TO THE
MTF
PRESERVING COLD CHAIN REQUIREMENTS AND VIAL ACCOUNTABILITY.
TRANSPORT
VACCINES IN VAXI-PACK OR VAXI-COOL CONTAINERS, PREVIOUSLY PROVIDED
BY
U.S. ARMY MEDICAL MATERIEL AGENCY (USAMMA) FOR MARINE FORCES USE
AND
CURRENTLY STORED AT MTFS AND CLINICS.
C. EACH COMMARFOR AND
CG MEF WILL DESIGNATE AN AVIP COORDINATOR, WHO WILL PROCURE AVA FOR ELIGIBLE
SUPPORTED UNITS UTILIZING USAMMA'S SECURE WEBSITE.
1) COMMARFOR AND CG
MEF AVIP COORDINATORS MUST FIRST LOG INTO WEBSITE
GIVEN BELOW, AND COMPLETE
THE REGISTRATION PROCESS. A USER ACCOUNT IS
ESTABLISHED ON A SECURE WEBSITE,
AND A PASSWORD AND CONFIRMATION WILL BE
SENT BACK AFTER APPROVAL FROM NAVAL
MEDICAL LOGISTICS COMMAND
(NAVMEDLOGCOM) AND HQMC/I&L/LPC-4.
(2)
THE OVERALL GOAL IS TO EXPEDITE THE REQUISITION AND APPROVAL CHAIN
FOR AVA
REQUIREMENTS. CG MEF AVA COORDINATORS WILL SUBMIT PAGE 06
RUEOMFB0586
UNCLAS REQUISITIONS ON THE USAMMA WEBSITE FOR THEIR
SUPPORTED UNITS, WHILE
COMMARFOR AVA COORDINATORS WILL SUBMIT
REQUISITIONS ONLY FOR THOSE UNIQUE
UNITS NOT ROUTINELY SUPPORTED BY THE
CG MEF.
(3) IOT ENSURE THAT
SUPPLY MEETS DEMAND IN THE EARLY PHASES OF
RESUMPTION, COMMARFOR AND CG MEF
COORDINATORS WILL ENSURE THAT ALL
REQUISITIONS MEET PRIORITY 2 CRITERIA AND
FALL WITHIN THE PROVISION
WINDOW DESCRIBED IN PARAGRAPH 7A.
(4) HQMC
WILL SCREEN SUBMITTED REQUISITIONS FOR APPROVAL. NAVMEDLOGCOM
WILL COORDINATE
HQMC APPROVED REQUISITIONS WITH (USAMMA) FOR VACCINE
DISTRIBUTION.
(5)
ANTHRAX VACCINE WILL BE PROVIDED AT NO COST TO UNITS.
ANCILLARY
SUPPLIES ARE THE RESPONSIBILITY OF THE RECEIVING
ACTIVITY.
(6) REFER TO THE USAMMA WEBSITE FOR MORE
INFORMATION
(HTTP://WWW.ARMYMEDICINE.ARMY.MIL/USAMMA/ANTHRAX/ANTXHOME.HTM).
8.
PUBLIC AFFAIRS GUIDANCE (PAG)
A. PUBLIC AFFAIRS OFFICES ARE EXPECTED TO
LOCALIZE AVA STORIES.
ENCOURAGE ARTICLES IN BASE NEWSPAPERS AND INSTALLATION
WEBSITES THAT
LIST PLACES, POC'S AND PHONE NUMBERS WHERE MORE INFORMATION AND
BE QQQQ
OBTAINED.
(1) GENERAL PUBLIC WEBSITE FOR MORE INFORMATION ABOUT
ANTHRAX
(HTTP://WWW.ANTHRAX.OSD.MIL/)
(2) OASD PA PRESS
RELEASE
(HTTP://WWW.DEFENSELINK.MIL/NEWS/JUN2002/B06282002_BT338-02.HTML)
(3)
AFIS NEWS
ARTICLE
(HTTP://WWW.DEFENSELINK.MIL/NEWS/JUN2002/N06282002_200206283.HTML)
(4)
NAVY & MARINE CORPS MEDICAL
NEWS
(HTTP://NAVYMEDICINE.MED.NAVY.MIL/MEDNEWS/)
(5) SPECIAL BRIEFING ON
THE ANTHRAX VACCINE
PROGRAM
(HTTP://WWW.DEFENSELINK.MIL/NEWS/JUN2002/T06292002_T0628WW.HTML)
B.
PUBLIC AFFAIRS OFFICES CAN OBTAIN THE LATEST PUBLIC AFFAIRS PAGE
02
RUEOMFB0587 UNCLAS GUIDANCE BY ACCESSING THE SECURE BUMED PUBLIC
AFFAIRS
WEBSITE
(HTTPS://BUMED.MED.NAVY.MIL/ANTHRAXINFO.HTM)
C.
INSTALLATION AND OPERATIONAL COMMANDS WILL NORMALLY RESPOND TO LOCAL
MEDIA
QUERIES. HQMC PA SHOULD BE CONSULTED ON MEDIA QUERIES THAT
MAY
GARNER NATIONAL INTEREST.
9. HQMC POCS FOR THIS MESSAGE
ARE: LTCOL TOM
MCGINNIS OR MR DENNIS MORELAND, PPO, (703) 695-0221/0186
(DSN 225); CAPT
KEN SCHOR (USN), HQMC PREVENTIVE MEDICINE OFFICER,
(703) 614-4478 (DSN
224); CDR READING OR HMC LEPE, I&L (LPC-4),
(703) 695-8926 (DSN 225);
LCDR CELIA QUIVERS, CNO N931,
(703)
601-1716; CAPT STU UPTON, HQMC PUBLIC AFFAIRS, (703) 614-4309
(DSN 224).
9. EXPIRATION DATE CANNOT BE DETERMINED.// PAGE 03
RUEOMFB0587 UNCLAS
BT #0585 NNNN
RTD:000-000/COPIES: