AUTHORIZATION TO BEGIN SMALLPOX VACCINATION PROGRAM (SVP)
Date Signed: 1/8/2003 | MARADMINS Number: 008/03
MARADMINS : 008/03

P 081821Z JAN 03
FM CMC WASHINGTON DC(n)
TO ML MARADMIN(n)
MARADMIN
BT
UNCLAS
MARADMIN 008/03
MSGID/GENADMIN/CMC WASHINGTON DC PPO//
SUBJ/AUTHORIZATION TO BEGIN SMALLPOX VACCINATION PROGRAM (SVP)//
REF/A/DOC/DEPSECDEF MEMO/-/30SEP02/-//
REF/B/DOC/DEPSECDEF MEMO/-/12DEC02/-//
REF/C/DOC/USECDEF PR MEMO/-/13DEC02/-//
REF/D/DOC/ASDHA MEMO/-/26NOV02/-//
REF/E/DOC/USECDEF PR MEMO/-/13DEC02/-//
REF/F/DOC/USECDEF PR MEMO/-/26DEC02/-//
REF/G/DOC/ASNMRA MEMO/-/31DEC02/-//
REF/H/MSG/HQMC PPO POC/181344ZOCT2002/-//
REF/I/MSG/SECDEF OASD-PA/131700ZDEC2002/-//
REF/J/DOC/TITLE 10 US CODE SECTION 1107/-/2002/-//
REF/K/DOC/21 CODE OF FED REGS 50.23/-/1999/-//
REF/L/DOC/EO 13139/-/30SEP99/-//
REF/M/DOC/DODD 6200.2/-/1AUG00/-//
NARR/REF A IS DEPSECDEF MEMO, DEPARTMENT OF DEFENSE SMALLPOX
RESPONSE PLAN. REF B IS DEPSECDEF CLASSIFIED MEMO, AUTHORIZATION
FOR SVP STAGE 2. REF C IS USECDEF PR CLASSIFIED MEMO, DEPARTMENT OF
DEFENSE SMALLPOX VACCINATION PROGRAM. REF D IS ASDHA MEMO, CLINICAL
EXECUTION GUIDANCE FOR SMALLPOX. REF E IS USECDEF PR MEMO, POLICY
ON ADMINISTRATIVE ISSUES RELATED TO SMALLPOX VACCINATION PROGRAM.
REF F IS USECDEF PR MEMO, APPROVAL OF SMALLPOX IMPLEMENTATION PLAN.
REF G IS ASNMRA MEMO, APPROVAL OF SMALLPOX IMPLEMENTATION PLAN. REF
H IS HQMC PPO POC PRIORITY MSG, WEEKLY REPORTING REQR FOR ANTHRAX
IMMUNIZATIONS AND FUTURE BIOLOGICAL WARFARE. REF I IS
SECDEF OASD-PA ROUTINE MSG, PART 1, PUBLIC AFFAIRS GUIDANCE (PAG) ON
THE SMALLPOX VACCINATION PROGRAM. PART 2 IS 131701Z DEC 02 AND PART
3 IS 131702Z DEC 02. REF J IS THE FEDERAL LAW ON NOTICE
REQUIREMENTS FOR USE OF AN INVESTIGATIONAL NEW DRUG. REF K IS A
FEDERAL REGULATION ON INFORMED CONSENT REQUIREMENTS AND PRESIDENTIAL
WAIVER FOR ADMINISTRATION OF INVESTIGATIONAL NEW DRUGS. REF L IS AN
EXECUTIVE ORDER ON IMPROVING HEALTH PROTECTION OF MILITARY PERSONNEL
PARTICIPATING IN PARTICULAR MILITARY OPERATIONS. REF M IS A DOD
DIRECTIVE ON THE USE OF INVESTIGATIONAL NEW DRUGS FOR FORCE HEALTH
PROTECTION.//
POC/MCGINNIS TD/LTCOL/HQMC PPO PLN/-/TEL:703 695 0221 DSN 225
/EMAIL:MCGINNISTD@HQMC.USMC.MIL//
POC/MORELAND D/MR/HQMC PPO PLN/-/TEL:703 695 0186 DSN 225
/EMAIL:MORELANDDK@HQMC.USMC.MIL//
POC/SCHOR K/CAPT (USN)/HQMC PREVENTIVE MEDICINE/-
/TEL:703 614 4477 DSN 224/EMAIL:SCHORKW@HQMC.USMC.MIL//
POC/STILWELL D/COL/HQMC PPO POC/-/TEL:703 614 2151 DSN 224
/EMAIL:STILWELLDM@HQMC.USMC.MIL//
POC/HASKELL K/LTCOL/HQMC PPO POC/-/TEL:703 614 2151 DSN 224
/EMAIL:HASKELLKJ@HQMC.USMC.MIL//
POC/READING M/CDR/HQMC IL LPC-4/-/TEL:703 695 8926 DSN 225
/EMAIL:READINGMJ@HQMC.USMC.MIL//
POC/LEPE F/HMC/HQMC IL LPC-4/-/TEL:703 695 8926 DSN 225
/EMAIL:LEPEFJ@HQMC.USMC.MIL//
POC/QUIVERS C/LCDR/CNO N931/-/TEL:703 601 1716
/EMAIL:QUIVERS.CELIA@HQ.NAVY.MIL//
POC/UPTON S/CAPT/HQMC PA/-/TEL:703 614 4309 DSN 224
/EMAIL:UPTONST@HQMC.USMC.MIL//
RMKS/1. READ THIS MESSAGE IN ITS ENTIRETY. THIS MESSAGE
CONSTITUTES AUTH TO BEGIN SMALLPOX VACCINATIONS FOR DESIGNATED USMC
ACTIVE DUTY AND RESERVE PERSONNEL (UPON ACTIVATION) PER PARA. 1A AND
ADVISES COMMANDERS ON THE ADMINISTRATIVE AND CLINICAL GUIDELINES
RELATED TO THE DOD SVP. GUIDANCE FOR VACCINATION OF AUTH
EMERGENCY-ESSENTIAL AND MISSION-ESSENTIAL CIVILIAN AND CONTRACTOR
PERSONNEL WILL BE ADDRESSED IN FUTURE CORRESPONDENCE.
A. DEPSECDEF HAS DIRECTED A SMALLPOX RESPONSE PLAN THAT INCLUDES
VACCINATION OF INITIAL MEDICAL RESPONDERS AND MEDICAL TREATMENT
PERSONNEL (REF A)(CBIRF AND SELECT USMC MEDICAL BN PERSONNEL).
DEPSECDEF HAS ALSO DIRECTED VACCINATION OF SELECT FORCES IN STAGE 2
(REF B)(ALL FORCES ASHORE AND AFLOAT IN THE CENTCOM AOR AND CENTCOM
CONTIGENCY DEPLOYERS). MARINE FORCES OPCON TO COMUSMARCENT WILL BE
SUPPORTED THROUGH COMUSCENTCOM COMPONENT PLANS. THE TIMELINE FOR
EXECUTING THE STAGES IS PUBLISHED IN REF C. USECDEF PR AND ASDHA
HAVE PUBLISHED SVP ADMINISTRATIVE AND CLINICAL EXECUTION POLICIES
(REFS D AND E). THESE POLICIES ESTABLISH ADMINISTRATIVE AND MEDICAL
EXEMPTIONS, AS WELL AS PROCEDURES AND APPROVAL AUTHORITY FOR
REQUESTS FOR EXCEPTIONS TO POLICY.
B. THE DEPARTMENT OF THE NAVY (DON) SVP IMPLEMENTATION PLAN HAS
BEEN COORDINATED WITH OPNAV N931 AND ASDHA, AND HAS BEEN APPROVED BY
USECDEF PR AND SECNAV FOR EXECUTION (REFS F AND G). A SECNAVINST IS
UNDER DEVELOPMENT THAT WILL SERVE AS THE DON SMALLPOX EXECUTION
GUIDANCE. UNTIL IT IS PUBLISHED, UTILIZE THIS MSG AS USMC INTERIM
SMALLPOX EXECUTION GUIDANCE. POLICY MEMOS AND THE 430-PAGE DOD
RESPONSE PLAN MAY BE VIEWED AT EITHER WWW.VACCINES.ARMY.MIL OR
WWW.HQMC.USMC.SMIL.MIL/PLN/PLN_HOME/HTM. REF H IS FOR WEEKLY
REPORTING.
C. CMC INTENT: IMPLEMENT THE DOD SVP AS SOON AS POSSIBLE IOT
PROTECT MARINE CORPS PERSONNEL AND PRESERVE COMBAT EFFECTIVENESS IN
THE EVENT OF A SMALLPOX ATTACK. WHILE THE THREAT OF A SMALLPOX
ATTACK CANNOT BE QUANTIFIED, THE EARLY VACCINATION OF OUR FORCES
REMAINS THE MOST EFFECTIVE COUNTERMEASURE. COMPREHENSIVE UNIT
EDUCATION IS THE CORNERSTONE OF A SAFE AND SUCCESSFUL SMALLPOX
IMPLEMENTATION PROGRAM. TO THE MAXIMUM EXTENT POSSIBLE, ENSURE
MARINE UNITS ARE VACCINATED FOR SMALLPOX PRIOR TO ARRIVAL IN CENTCOM
AOR. AS WITH ANY VACCINE, SOME INDIVIDUALS RECEIVING SMALLPOX
VACCINE WILL EXPERIENCE SIDE EFFECTS OR ADVERSE EVENTS MOST OFTEN ON
DAY EIGHT OR NINE AFTER VACCINATION. THIS ILLNESS MAY INTERFERE WITH
WORK. ADDITIONALLY, THE GREATEST CHANCE OF SPREADING THE VIRUS TO
ANOTHER AREA OF THE BODY OR TO ANOTHER PERSON BY INADVERTENT CONTACT
IS WITHIN 21 DAYS AFTER VACCINATION. THEREFORE, ALL DUE
CONSIDERATION SHOULD BE GIVEN TO ADMINISTERING VACCINE IMMUNIZATION
AT LEAST 21 DAYS PRIOR TO DEPLOYMENT/TRANSIT WHEN POSSIBLE DUE TO
THE INCREASED CHANCE FOR A VACCINE ADVERSE EVENT AS WELL AS LIMITED
AVAILABILITY OF CLINICAL SUPPORT PERSONNEL OR ACCESS TO APPROPRIATE
MEDICAL FACILITIES WHILE ENROUTE.
2. BACKGROUND:
A. SMALLPOX IS A CONTAGIOUS, SOMETIMES-FATAL INFECTION PREVENTED BY
VACCINATION WITH LIVE VACCINIA VIRUS. HISTORICALLY, SMALLPOX KILLED
30 PERCENT OF THOSE INFECTED. SURVIVORS OF SMALLPOX CAN BE SEVERELY
SCARRED, ESPECIALLY ON THE FACE. ON RARE OCCASIONS, IT CAN ALSO
CAUSE BLINDNESS.
B. THE DOD SMALLPOX RESPONSE PLAN DESCRIBES REQUIRED ACTIONS IN THE
EVENT OF A SMALLPOX ATTACK. IT IS IN CONCERT WITH DEPARTMENT OF
HEALTH AND HUMAN SERVICES (DHHS) AND OTHER NATIONAL INITIATIVES, AND
IS CONSISTENT WITH CLINICAL GUIDELINES ESTABLISHED BY THE CENTERS
FOR DISEASE CONTROL AND PREVENTION (CDC). A MAJOR TENET OF THE DOD
SMALLPOX RESPONSE PLAN REQUIRES THE IDENTIFICATION AND PREPARATION
OF MEDICAL PERSONNEL TO RESPOND TO A SMALLPOX ATTACK.
C. THE DOD SVP SUPPORTS THE RESPONSE PLAN BY INCLUDING PRE-EXPOSURE
(PREVENTIVE) SMALLPOX IMMUNIZATION OF SELECTED MEDICAL PERSONNEL,
AND EXPANDS PREVENTIVE SMALLPOX IMMUNIZATION TO OTHER DOD PERSONNEL.
3. SCOPE:
A. SMALLPOX PREPAREDNESS OF MARINE CORPS FORCES IS DIVIDED INTO
THREE STAGES USING MISSION, PRESERVATION OF OPERATIONAL CAPABILITY,
AND OCCUPATIONAL RESPONSIBILITIES AS PLANNING FACTORS. SPECIFIC
INFORMATION IS CLASSIFIED.
B. GO TO THE HQMC/PPO/PLN SIPR WEBSITE,
WWW.HQMC.USMC.SMIL.MIL/PLN/PLN_HOME.HTM, TO VIEW ALL APPLICABLE
REFERENCES, ALL SMALLPOX STAGES AND THE SCOPE OF EACH STAGE,
ASSOCIATED TIMELINES FOR EXECUTING EACH STAGE, AND THE
UNITS/PERSONNEL COVERED BY EACH STAGE FOR SMALLPOX VACCINATIONS.
4. EXECUTION:
A. PER REFS A AND B, VACCINATION IS MANDATORY FOR DESIGNATED
PERSONNEL, EXCEPT AS PROVIDED UNDER APPLICABLE MEDICAL AND
ADMINISTRATIVE EXEMPTION POLICIES CONTAINED IN REFS D AND E. THE
MARINE CORPS WILL BEGIN IMPLEMENTATION OF THIS SVP USING ONLY
EXISTING FDA-LICENSED VACCINE. IN THE EVENT THE FDA AND DOD
AUTHORIZE USE OF AN UNLICENSED VACCINE THROUGH THE INVESTIGATIONAL
NEW DRUG (IND) PROVISIONS OF THE FOOD DRUG AND COSMETIC ACT, THE
REQUIREMENTS IN REFS J THROUGH M WILL BE FOLLOWED. COMMANDERS WILL
ADDRESS VACCINATION REFUSALS AS THEY WOULD ADDRESS ANY REFUSAL TO
OBEY A LAWFUL ORDER, ENSURING THAT PERSONNEL HAVE RECEIVED
APPROPRIATE EDUCATION AND ADMINISTRATIVE/MEDICAL SCREENINGS.
B. PRE-VACCINATION:
(1) DETERMINE DOSE REQUIREMENTS AND OBTAIN SMALLPOX VACCINE PER
LOGISTICAL GUIDANCE IN PARA 7.
(2) ENSURE HIV SCREENING OF ALL PERSONNEL IS CURRENT. HIV SCREENING
MUST BE PROVIDED UPON REQUEST OF THE MEMBER AT SVP PRE-VACCINATION
SCREENING; SVP VACCINATION WILL BE WITHHELD UNTIL HIV RESULTS ARE
KNOWN.
(3) TRAIN SUPPORTING MEDICAL STAFFS WITH EMPHASIS ON SCREENING
PROCEDURES AND THE PROCESS OF VACCINATION.
(4) ESTABLISH POLICIES AND PROCEDURES TO PREVENT VACCINATING
PREGNANT WOMEN.
(5) ESTABLISH A VACCINATION SCHEDULE WHICH WILL ALLOW THE RECIPIENT
OF THE VACCINE TO RETURN 6-8 DAYS AFTER INOCULATION FOR OBSERVATION
(TO ENSURE "TAKE" OF THE VACCINE). THIS POST-VACCINATION MEDICAL
VISIT IS MANDATORY.
(6) INITIATE A ROBUST LOCAL PUBLIC AFFAIRS PLAN PER PARA 9. LOCAL
AND STATE HEALTH OFFICIALS MUST BE INFORMED OF SMALLPOX IMMUNIZATION
SCHEDULES BEFORE INITIATION OF LOCAL PLANS.
(7) COORDINATE WITH ALL TRAINING OFFICERS TO ENSURE THE UNIT
TRAINING SCHEDULE, 3-4 WEEKS AFTER VACCINATIONS, IS CONSISTENT WITH
GUIDANCE IN POST-VACCINATION PHASE (PARA 4.D.).
(8) OBTAIN EDUCATIONAL MATERIALS FOR UNIT TRAINING, TO INCLUDE
SMALLPOX TRI-FOLDS FOR DISTRIBUTION, AND IMPLEMENT EDUCATIONAL
TRAINING FOR ALL VACCINEES PRIOR TO VACCINATION. EDUCATIONAL
MATERIALS MAY BE VIEWED AND DOWNLOADED FROM WWW.VACCINES.ARMY.MIL OR
WWW.HQMC.USMC.SMIL.MIL/PLN/PLN_HOME/HTM. PROFESSIONAL QUALITY
TRI-FOLD BROCHURES MAY BE OBTAINED BY CONTACTING MR. HERMAN HARRIS
AT (703) 681-4262, DSN 761-4262, OR HERMAN.HARRIS@AMEDD.ARMY.MIL.
(9) COORDINATE WITH MEDICAL TREATMENT FACILITIES (MTF) FOR TRAINING,
SCREENING QUESTIONNAIRES, VACCINE RECEIPT AND DISTRIBUTION DATES,
INDIVIDUAL MEDICAL CONSULTATIONS, REPORT TRACKING IN SHIPBOARD
NON-TACTICAL ADP PROGRAM (SNAP) AUTOMATED MEDICAL SYSTEM (SAMS) AND
DEERS, AND PROCESSES/PROCEDURES FOR TREATING POSSIBLE SMALLPOX
VACCINE ADVERSE EVENTS. ALL ADVERSE EVENTS WILL BE TRACKED THROUGH
THE VACCINE ADVERSE EVENTS REPORTING SYSTEM (VAERS).
(10) ENSURE INFECTION CONTROL MEASURES AND SUPPLIES ARE ADEQUATE,
INCLUDING BANDAGES LARGE ENOUGH TO COVER VACCINATION SCAB.
(11) UNITS CONDUCTING SMALLPOX IMMUNIZATIONS SHALL DEVELOP POLICIES
AND PROCEDURES WITH SUPPORTING MTFS TO ASSURE TIMELY IDENTIFICATION
AND TREATMENT OF SMALLPOX VACCINE ADVERSE EVENTS, INCLUDING
TREATMENT WITH VACCINIA IMMUNE GLOBULIN (VIG) AND/OR CIDOFOVIR, BOTH
OF WHICH ARE INVESTIGATIONAL NEW DRUGS (IND). THE DIAGNOSIS OF A
PROBABLE SMALLPOX VACCINE ADVERSE EVENT FOR WHICH VIG OR CIDOFOVIR
IS INDICATED WILL BE MADE BY AN APPROPRIATELY QUALIFIED PROVIDER
(E.G., INFECTIOUS-DISEASE, DERMATOLOGY, ALLERGY-IMMUNOLOGY
PHYSICIAN). THIS ATTENDING PHYSICIAN MAY REQUEST USE OF VIG OR
CIDOFOVIR FOR A NAMED PATIENT BY TELEPHONING USAMRIID AT
1-888-USA-RIID OR 301-619-2257. ALTERNATELY, PAGE THE UASMRIID
STAFF DUTY OFFICER AT 301-631-4393 OR THE USAMRMC STAFF DUTY OFFICER
AT 301-619-6092. HEALTHCARE PROVIDERS FROM CIVILIAN INSTITUTIONS
SHOULD CONTACT THE CDC DRUG SERVICE FOR VIG AT 404-639-3670.
USAMRIID WILL COORDINATE WITH SPECIALIZED TREATMENT TEAMS, WHICH
WILL TRAVEL TO THE MTF CARING FOR THE DIAGNOSED PATIENT. THESE
TEAMS WILL BE RESPONSIBLE FOR THE TREATMENT OF PATIENTS WITH THE
INDICATED MEDICATIONS. IND-SPECIFIC PROCEDURES WILL BE FOLLOWED
CAREFULLY. ADDITIONAL INFORMATION ON VIG AND CIDOFOVIR MAY BE
OBTAINED FROM THE DOD SMALLPOX RESPONSE PLAN, ANNEXES E, H, AND I,
LOCATED AT EITHER WEBSITE LISTED IN PARA 4.B.(8). PER REF D, VIG IS
AVAILABLE ONLY UNDER IND PROTOCOL. REFS J THROUGH M MUST BE
FOLLOWED WHEN ADMINISTERING IND.
C. VACCINATION:
(1) CONDUCT PRE-VACCINATION SCREENING USING SF 600 OVERPRINT FORMS
DOWNLOADED FROM EITHER WWW.VACCINES.ARMY.MIL OR
WWW.HQMC.USMC.SMIL.MIL/PLN/SMALLPOX.HTM.
(2) REFER THOSE WITH POTENTIAL PERSONAL OR FAMILY CONTRAINDICATIONS
(SUCH AS IMMUNE DEFICIENCIES, CERTAIN SKIN CONDITIONS, ASSOCIATED
DRUG ALLERGIES, ETC.) TO APPROPRIATELY TRAINED HEALTH CARE PROVIDERS
FOR FURTHER SCREENING AND DISPOSITION. PERSONNEL RESIDING IN THE
SAME HOUSEHOLD WITH WOMEN WHO ARE PREGNANT AND/OR WITH CHILDREN LESS
THAN 1 YEAR OF AGE WILL NOT BE VACCINATED UNTIL DEPLOYED OR A 21-DAY
ISOLATION PERIOD CAN BE ASSURED.
(3) VACCINATE THOSE WITH NO PERSONAL OR FAMILY CONTRAINDICATIONS.
THOSE ADMINISTERING THE SMALLPOX VACCINE MUST THEMSELVES BE
VACCINATED. SUCH VACCINATION CAN IMMEDIATELY PRECEDE THEIR
INOCULATION OF OTHERS.
(4) COMMANDERS MAY VACCINATE THOSE WITH FAMILY CONTRAINDICATIONS
ONCE A RELIABLE MEANS IS ESTABLISHED TO SEGREGATE THOSE WITH FAMILY
CONTRAINDICATIONS FROM THEIR FAMILIES FOR AT LEAST 21 DAYS (OR UNTIL
VACCINATION SCAB FALLS OFF).
(5) PROVIDE BANDAGES TO HELP PROTECT THE VACCINATION SITE (BANDAGES
ARE CHANGED AT LEAST DAILY) WHILE REDUCING THE RISK FROM
AUTOINOCULATION (VACCINEE SPREADS TO OTHER SITES ON OWN BODY),
CROSS-INOCULATION (VACCINEE SPREADS TO OTHERS WHO MAY NOT BE
VACCINATED), AND SECONDARY BACTERIAL INFECTION (CELLULITIS). PAST
EXPERIENCE INDICATES KEEPING THE VACCINATION SITE DRY AND EXPOSED TO
AS MUCH AIR AS POSSIBLE, WITHIN THE CONSTRAINTS ABOVE, WILL SPEED
HEALING AND PREVENT INFECTION.
(6) COUNSEL VACCINATED FEMALES ABOUT AVOIDING PREGNANCY FOR 4 WEEKS
FOLLOWING VACCINATION.
(7) FULLY DOCUMENT ALL VACCINATIONS IN HEALTH RECORDS.
(8) REPORT VACCINATIONS ON SAMS, ENSURING DATA IS TRANSMITTED TO
DEERS, AND REPORT WEEKLY STATUS OF SVP EXECUTION PER REF H.
D. POST-VACCINATION:
(1) ASSESS AND DOCUMENT VACCINATIONS PER REF D, AND REPORT
VACCINATIONS PER REF H.
(2) ENSURE VACCINEES RETURN FOR TAKE ASSESSMENT AND DOCUMENTATION
6-8 DAYS AFTER INOCULATION. THIS ASSESSMENT IS MANDATORY.
INSUFFICIENT TAKE MAY REQUIRE RE-VACCINATION.
(3) ENCOURAGE AND ENFORCE FREQUENT HAND WASHING AND OTHER
APPROPRIATE MEASURES FOR PREVENTION OF AUTOINOCULATION AND
CROSS-INOCULATION. SPECIFIC GUIDANCE IS PROVIDED IN REF D (PAGES
5-6), CARE OF VACCINATION SITE.
(4) DO NOT SHARE TOWELS, BEDDING, OR PERSONAL HYGIENE ITEMS.
ENCOURAGE AND ENFORCE FREQUENT LAUNDERING OF CLOTHING AND TOWELS TO
PREVENT AUTOINOCULATION AND CROSS-INOCULATION. PERSONNEL WITH
PERSONAL CONTRAINDICATIONS TO SMALLPOX VACCINATION SHALL NOT HANDLE
OR OTHERWISE COME IN CONTACT WITH VACCINIA-CONTAMINATED CLOTHING AND
TOWELS.
(5) ENSURE TIMELY ACCESS TO MEDICAL CARE FOR DIAGNOSIS, TREATMENT,
AND REPORTING OF POTENTIAL VACCINE ADVERSE EVENTS.
(6) REPORT ALL VACCINE ADVERSE EVENTS VIA THE VAERS.
(7) ADHERE TO REF D (PAGE 11) GUIDANCE REGARDING BLOOD DONOR
DEFERRALS.
5. ADDITIONAL CLINICAL GUIDANCE:
A. UTILIZE REF D FOR ALL SPECIFIC CLINICAL GUIDANCE. ADDITIONAL
CLINICAL GUIDANCE FROM THE SURGEON GENERAL OF THE NAVY WILL BE
PROVIDED VIA SEP NAVAL MSG. MEDICAL PERSONNEL WILL THOROUGHLY
UNDERSTAND THE CLINICAL ASPECTS OF THIS VACCINE AND THE POTENTIAL
FOR ADVERSE EVENTS AFTER VACCINATION. MEDICAL PERSONNEL MUST KNOW
HOW TO MANAGE THE SPECTRUM OF ADVERSE EVENTS, INCLUDING THE
REQUIREMENT TO SUBMIT VAERS REPORTS.
B. MEDICAL PERSONNEL MUST CLEARLY UNDERSTAND THAT THEY WILL BE OUR
FRONT LINE FORCE IN RESPONDING TO QUESTIONS AND CONCERNS. THEY WILL
FAMILIARIZE THEMSELVES WITH ALL SMALLPOX WEBSITE RESOURCES,
ESPECIALLY WWW.VACCINES.ARMY.MIL.
C. ENSURE APPROPRIATE UNIT MEDICAL PERSONNEL ARE TRAINED IN SAMS
IMMUNIZATION TRACKING PROCEDURES AND HAVE A CURRENT PASSWORD TO
ACCESS DEERS IMMUNIZATION TRACKING WEBSITE.
D. IMMUNIZATION TRACKING IS VITAL FOR ALL ACTIVE AND RESERVE
FORCES. RECORD MEMBER DATA, UNIT DATA, VACCINE LOT NUMBER, AND
VACCINATION SITE IN SAMS, RECORD THIS SAME INFORMATION IN MEMBER S
HEALTH RECORD AND ON YELLOW SHOT CARD (PHS 731). INFORMATION FOR
IMMUNIZATION TRACKING CAN BE OBTAINED VIA THE WEBSITE AT
HTTPS://IMCENTER.MED.NAVY.MIL/ITS. IN ADDITION TO COMPLETING
APPLICABLE SECTIONS OF THE 2-PAGE SF-600 OVERPRINT FORM, "INITIAL
SMALLPOX VACCINE IMMUNIZATION NOTE" (AVAILABLE AT
WWW.VACCINES.ARMY.MIL/SMALLPOX/FORMS), SMALLPOX VACCINE
ADMINISTRATORS WILL COMPLETE ALL INFORMATION FIELDS CONTAINED IN
THIS FORM'S "VACCINE ADMINISTRATOR" SECTION.
E. MEDICAL EXEMPTION POLICY IS CONTAINED IN REF D. UNIT MEMBERS
CONSIDERED FOR MEDICAL EXEMPTION CODE "MR" (MEDICAL REACTIVE) SHALL
BE REFERRED PER CLINICAL MANAGEMENT OF ADVERSE EVENTS GUIDELINES IN
REF D FOR APPROPRIATE SPECIALTY EVALUATION PRIOR TO ASSIGNMENT OF
MEDICAL EXEMPTION CODE "MR". SIMILAR SPECIALTY EVALUATION WILL BE
SOUGHT PRIOR TO ASSIGNMENT OF MEDICAL EXEMPTION CODE "MP" (MEDICAL
PERMANENT). MEDICAL EXEMPTION CODE "MT" (MEDICAL TEMPORARY) MAY BE
ASSIGNED BY APPROPRIATE PRIVILEGED HEALTHCARE PROVIDERS.
F. ADVERSE EVENTS WILL BE MANAGED EXPEDITIOUSLY BY PRIVILEGED
HEALTHCARE PROVIDERS APPLYING RECOMMENDATIONS, AS INDICATED,
CONTAINED IN DOD GUIDELINES FOR MANAGEMENT OF ADVERSE EVENTS AFTER
VACCINATION, AVAILABLE AT WWW.VACCINES.ARMY.MIL AND AT THE VACCINE
HEALTHCARE CENTER WEBSITE, WWW.VHCINFO.ORG. SPECIFIC INFORMATION ON
THE USE OF VACCINE IMMUNE GLOBULIN (VIG) IS PROVIDED IN ANNEX H OF
THE DOD SMALLPOX RESPONSE PLAN, WITH CONTACT NUMBERS PROVIDED ABOVE
IN PARA 4.B.(11). DUE TO THE SERIOUSNESS OF THE INDICATIONS FOR VIG
AND THE CONSTRAINTS APPLYING TO INVESTIGATIONAL NEW DRUGS, EITHER A
SPECIALIZED TREATMENT TEAM WILL BRING VIG TO THE PATIENT AND
INITIATE THERAPY OR THE PATIENT WILL BE EVACUATED TO A DESIGNATED
MTF FOR TREATMENT.
G. VACCINE WILL BE ADMINISTERED ACCORDING TO FDA LABEL REQUIREMENTS.
6. ADMINISTRATIVE GUIDANCE:
A. ADMINISTRATIVE EXEMPTION POLICY IS CONTAINED IN REF E.
ADMINISTRATIVE EXEMPTIONS ARE ONLY FOR THOSE LEAVING MILITARY
SERVICE, WITHOUT RC OBLIGATIONS, WITH 30 DAYS OR LESS OF SERVICE OR
EMPLOYMENT REMAINING. THE ADMINISTRATIVE EXEMPTION DOES NOT APPLY
TO PERSONNEL WHO THE COMMANDER (FIRST GO/FO EXERCISING OPCON)
DETERMINES SHALL RECEIVE THE VACCINE BECAUSE OF OVERRIDING MISSION
REQUIREMENTS. EXCEPTIONS TO THIS EXEMPTION POLICY (E.G., A MARINE
RETIRING IN 60 DAYS) WILL BE SUBMITTED THROUGH THE CHAIN OF COMMAND
TO THE APPLICABLE COMBATANT COMMANDER. BASED UPON SUBSEQUENT
RECOMMENDATION OF THE COMBATANT COMMANDER, EXCEPTIONS WILL BE
DETERMINED BY THE ASDHA, IN CONSULTATION WITH THE CHAIRMAN OF THE
JOINT CHIEFS OF STAFF.
B. ADDITIONAL ADMINISTRATIVE EXCEPTION POLICY IS CONTAINED IN REF E
(APPLICABILITY AND SCOPE). THESE ADMINISTRATIVE EXCEPTIONS WOULD
APPLY TO THOSE PERSONNEL/UNITS NOT QUALIFYING AS STAGE 1 OR STAGE 2
VACCINE RECIPIENTS, BUT WHO WARRANT SPECIAL CONSIDERATION FOR
VACCINATION DUE TO EXTENUATING CIRCUMSTANCES. COMMANDERS WILL
SUBMIT REQUESTS FOR EXCEPTIONS THROUGH THEIR CHAIN OF COMMAND TO THE
APPLICABLE COMBATANT COMMANDER. BASED UPON SUBSEQUENT
RECOMMENDATION OF THE COMBATANT COMMANDER, EXCEPTIONS WILL BE
DETERMINED BY THE ASDHA, IN CONSULTATION WITH THE DIRECTOR, JOINT
STAFF AND THE EXECUTIVE AGENT.
C. DEPLOYABILITY. PER REF E, ELIGIBILITY FOR SMALLPOX VACCINATION,
INCLUDING INSTANCES WHERE A SERVICE MEMBER IS ADMINISTRATIVELY OR
MEDICALLY EXEMPT, WILL NOT IN ITSELF BE A FACTOR IN DETERMINING THE
SERVICE MEMBER'S DEPLOYABILITY. SERVICE MEMBERS MAY BE DEPLOYED
REGARDLESS OF THEIR SMALLPOX IMMUNIZATION STATUS. DEPLOYMENT
EXEMPTION AUTH RESTS WITH THE FIRST GO/FO EXERCISING ADMINISTRATIVE
CONTROL (ADCON). UPON DETERMINING TO DEPLOY A
NON-IMMUNE/NON-VACCINATED INDIVIDUAL, THE COMMANDER WILL COUNSEL THE
INDIVIDUAL THAT SHOULD AN OUTBREAK OF SMALLPOX OCCUR, REQUIRING
ACTIVATION OF THE DOD SMALLPOX RESPONSE PLAN, IT IS DOD'S INTENT TO
PROVIDE SMALLPOX VACCINE TO DEPLOYED UNIMMUNIZED INDIVIDUALS IN A
TIMELY MANNER.
D. VACCINATION OF RESERVE COMPONENT (RC) PERSONNEL WILL OCCUR UPON
ACTIVATION BUT NLT DATE OF ARRIVAL IN CENTCOM AOR.
7. LOGISTICAL GUIDANCE:
A. 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 APPROPRIATE MEDICAL PERSONNEL.
RECONSTITUTED SMALLPOX (DRYVAX) VACCINE MAY BE STORED AT ABOVE
TEMPERATURES AND ADMINISTERED FOR 60 DAYS BEFORE EXPIRING. RECORD
DATE OF RECONSTITUTION ON VIAL. STORE UNOPENED/UNRECONSTITUTED VIALS
AT MTFS; AID STATIONS WILL CHECKOUT VACCINE PRIOR TO UNIT 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.
B. EACH COMMARFOR AND MEF CG WILL DESIGNATE A SMALLPOX COORDINATOR,
WHO WILL PROCURE SMALLPOX VACCINE FOR ELIGIBLE SUPPORTED UNITS
UTILIZING USAMMA'S SECURE WEBSITE.
(1) COMMARFOR AND MEF CG SMALLPOX 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 SMALLPOX REQUIREMENTS. MEF CG SMALLPOX COORDINATORS WILL
SUBMIT REQUISITIONS ON THE USAMMA WEBSITE FOR THEIR SUPPORTED UNITS,
WHILE COMMARFOR SMALLPOX COORDINATORS WILL SUBMIT REQUISITIONS ONLY
FOR THOSE UNIQUE UNITS NOT ROUTINELY SUPPORTED BY THE MEF CG.
(3) COMMARFOR AND MEF CG SMALLPOX COORDINATORS WILL ENSURE THAT ALL
REQUISITIONS MEET STAGE 1A/1B/2.
(4) HQMC (I&L) WILL SCREEN SUBMITTED REQUISITIONS FOR APPROVAL.
NAVMEDLOGCOM WILL COORDINATE HQMC APPROVED REQUISITIONS WITH
(USAMMA) FOR VACCINE DISTRIBUTION.
(5) SMALLPOX VACCINE WILL BE PROVIDED AT NO COST TO UNITS.
(6) REFER TO THE USAMMA WEBSITE FOR MORE INFORMATION
(HTTP://WWW.ARMYMEDICINE.ARMY.MIL/USAMMA/SMALLPOX/INDEX.HTM).
8. LEGAL GUIDANCE:
A. SJAS SHOULD BE FAMILIAR WITH THE DOD SMALLPOX RESPONSE PLAN, TO
INCLUDE ANNEXES B, C, H, AND ALL APPLICABLE REFS.
B. ALL SVP LEGAL CASES SHALL BE REPORTED TO THE HQMC JAD (JAO/JAM).
C. IMPLEMENTATION OF SVP WILL CONSIDER AS REQUIRED STATUTORY AND
CONTRACTUAL LABOR RELATIONS RESPONSIBILITIES.
9. PUBLIC AFFAIRS GUIDANCE (PAG):
A. PUBLIC AFFAIRS POSTURE FOR THIS PROGRAM IS ACTIVE. USE REF I
FOR FURTHER GUIDANCE.
B. PUBLIC AFFAIRS OFFICERS ARE AUTHORIZED AND ENCOURAGED TO
WIDELY DISTRIBUTE INFORMATION CONTAINED HEREIN TO BOTH INTERNAL AND
EXTERNAL AUDIENCES.
C. PUBLIC AFFAIRS OFFICES ARE EXPECTED TO LOCALIZE SMALLPOX
STORIES. ENCOURAGE ARTICLES IN BASE NEWSPAPERS AND INSTALLATION
WEBSITES THAT LIST PLACES, POC'S AND PHONE NUMBERS WHERE MORE
INFORMATION MAY BE OBTAINED.
D. IMAGES/PHOTOGRAPHS OF INDIVIDUALS RECEIVING THE VACCINE ARE
AUTHORIZED ONLY IF ACCOMPLISHED IN A MANNER THAT PROTECTS THE
IDENTITY OF THE VACCINEES AND SPECIFIC UNITS BEING VACCINATED.
10. THIS MARADMIN IS APPLICABLE TO THE MARINE CORPS RESERVE.
11. EXPIRATION DATE CANNOT BE DETERMINED.//