ALCOAST 010/09
COMDTNOTE 6230
SUBJ: ANTHRAX VACCINE - CHANGE IN ROUTE OF ADMINISTRATION AND IN
DOSING SCHEDULE.
A. CG ANTHRAX VACCINATION IMMUNIZATION PROGRAM (AVIP), COMDTINST
M6230.3(SERIES)
1. THE FOOD AND DRUG ADMINISTRATION (FDA) HAS APPROVED A CHANGE IN
THE ROUTE OF ADMINISTRATION FOR THE ANTHRAX VACCINE FROM A
SUBCUTANEOUS (SC) INJECTION TO AN INTRAMUSCULAR (IM) INJECTION. THE
FDA HAS ALSO APPROVED A CHANGE IN THE VACCINATION SERIES BY
REMOVING THE REQUIREMENT FOR THE 2-WEEK DOSE. RESEARCH HAS
DETERMINED THAT A REDUCTION FROM 6 DOSES TO 5 DOSES PROVIDED THE
SAME BENEFIT OF PROTECTION AGAINST ANTHRAX. ADDITIONALLY,
RESEARCHERS DETERMINED THAT THE IM ADMINISTRATION SIGNIFICANTLY
REDUCED THE OCCURRENCE OF LOCAL ADVERSE EVENTS AT THE INJECTION
SITE.
2. THE ANTHRAX VACCINATION WILL NOW BE GIVEN AS A SERIES OF FIVE
0.5 ML IM DOSES AT 0, 4 WEEK, 6 MONTH, 12 MONTH AND 18 MONTH, WITH
BOOSTERS GIVEN ANNUALLY TO MAINTAIN IMMUNITY. FOR MISSED OR LATE
DOSES, RESUME THE PRIMARY SERIES WITH ADMINISTRATION OF THE NEXT
DOSE IN THE SERIES. ADMINISTER SUBSEQUENT DOSES OF VACCINE AT
INTERVALS BASED ON THE DATE THE LAST DOSE WAS GIVEN NOT WHEN IT WAS
ORIGINALLY SCHEDULED. THE ANTHRAX VACCINE SERIES DOES NOT NEED TO
BE RESTARTED REGARDLESS OF THE TIME ELAPSED SINCE LAST DOSE.
3. THE NEW ROUTE AND SCHEDULE IS A CLINICAL CHANGE AND DOES NOT
ALTER THE POPULATION BEING VACCINATED OR THE PREVIOUS REQUIREMENTS
OF THE CG AVIP.
4. PRIOR TO THE ADMINISTRATION OF ANY ANTHRAX VACCINE, THE PATIENT
MUST RECEIVE A COPY OF THE VACCINE INFORMATION STATEMENT (VIS) AND
THE DOD ANTHRAX INDIVIDUAL INFORMATION TRIFOLD BROCHURE. THESE ARE
SHIPPED TO CG CLINICS/SICKBAYS AT NO COST IN THE SAME QUANTITY AS
THE ORDERED VACCINE. THESE PRODUCTS ARE ALSO AVAILABLE ON-LINE FOR
DOWNLOADING AT HTTP://WWW.ANTHRAX.MIL/AVIP2008 OR
HTTP://WWW.VACCINES.MIL/ANTHRAX.
5. THE ORDERING PROCESS FOR ANTHRAX VACCINE WILL REMAIN THE SAME.
DESIGNATED PERSONNEL WILL CONTINUE TO ORDER FROM THE USAMMA
WEBSITE.
6. THE MEDICAL READINESS REPORTING SYSTEM (MRRS) WILL BE UPDATED
OVER THE NEXT 30 DAYS TO REFLECT THE DOSING AND ROUTE OF
ADMINISTRATION CHANGE. IN THE INTERIM, HEALTH SERVICES PERSONNEL
MUST DOCUMENT ANTHRAX VACCINATIONS IN THE PAPER HEALTH RECORD AND
MUST MAINTAIN A LIST OF PERSONNEL WHO HAVE RECEIVED THE ANTHRAX
VACCINE DURING THIS INTERIM PERIOD. WHEN MRRS HAS BEEN UPDATED,
HEALTH SERVICES PERSONNEL MUST ENSURE THAT THEY ENTER THE MEMBER'S
ANTHRAX VACCINATION INFORMATION INTO MRRS.
7. THESE CHANGES WILL BE REFLECTED IN THE NEXT UPDATE TO REFERENCE
A.
8. FOR QUESTIONS REGARDING THIS UPDATE PLEASE CONTACT CAPT ANITA
ARNOLD BY E-MAIL AT ANITA.F.ARNOLD(AT)USCG.MIL OR (202) 475-5171.
FOR CLINICAL QUESTIONS REGARDING THIS UPDATE, CONTACT CDR ERICA
SCHWARTZ BY E-MAIL AT ERICA.G.SCHWARTZ(AT)USCG.MIL OR (202) 475-
5172.
9. RADM MARK J. TEDESCO, DIRECTOR OF HEALTH, SAFETY AND WORK-LIFE
SENDS.
10. INTERNET RELEASE AUTHORIZED.