AFBB (15-la) 2002-06 MIarch I,2002 MEM0RANDm

DEPARTMENT
OF DEFENSE
ARMED FORCES EPIDEMKWX#CAL SOARD
SM9 LEESWAd PIKE
FALLS CHUt?CH VA 22Wt42S8
AFBB (15-la) 2002-06
MEM0RANDm
MIarch I,2002
FOR The Assistant Secretaryof Defense(Health Affairs)
The SurgeonGeneral,Departmentof The Army
The SurgeonGeneral,Departmentof The Navy
The SurgeonGeneral,Department of The Air Force
SUBEKT: Vaccination Program to Protect Against Anthrax
1. During its Winter 2002 meeting, the Armed Forces
Board (AFRB)
was askedby the Assistant Secretaryof Defensefor
comment on the
possible reintroduction of the Anthrax Vaccine ~~~z~o~
Pro
(AVIP) to protect
Armed Forcespersonnel,now that additional Food and Drug A~~s~ti~
(FDA)
approvedlots of the vaccine have becomeavailable, The Board-hashad a longstanding
interest in force protection againstbiowarfare agentssuch as anthrax, and in recent years
has issued a number of statementsconcerninguse of the vaccine. These previous AFEB
statementshave supportedthe use of the vaccine when indicated to protect individuals
being deployed to areaswhere analysishas determinedthat there is a credible risk of
exposureto anthrax.
2. Since these statementswere issued,a significant amount of new information has been
collected basedon the previous experienceof the AVR?, which in&&s studiesof shortand long-term safety and side effects associatedwith vaccination and both basic and
applied researchstudies. The vaccine has also undergoneintense scrutiny and review by
severalindependentscientific bodies, including the Institute of Medicine of the National
Academy of Sciences. The Board is cognizant of the issuesassociatedwith
implementation of the total force anthrax immunization program including lack of
consensusregarding the risk-benefit ratio, concernsabout vaccine safety and efficacy,
difficulties tracking vaccine receipt and delivery, and ultimately an inadequatesupply of
the vaccine that led to a slow-down of the AVlP,
3. The Board is impressedwith the degreeof diligence that has been ven to addressing
the concernsand sharing publicly the findings of researchefforts, regardlessof whether
they were supportive of the program. We have seenno data that leads us to conclude that
the vaccine is unsafe when administeredaccording to the packztgeinsert. The range of
reported side effects experiencedby recipientsof the anthrax vaccine are in line with
previously published reports and compatible with similar vaccines. There are no
recipients of anthrax
convincing data demonstratinglong-term adverse
ng efficacy, particularly
vaccine, although additional studiesare in progress.
againstchallengewith aerosolizedanthrax spores,are less complete becausethey rely on
APBB (U-la) 2002-06
SUBJBCT: Vaccination Program to Protect Against Anthrax
animal surrogatesand very limited human studies,but there is no reasonto believe that
the vaccine doesnot offer valuable addedprotection to personsfrom any form of anthrax
exposure.
4. The eventsof Autumn 2001 showedthat the intentional use of anthrax can cause
significant morbidity, mortality, and disruption of activities. This recentexperienceis
likely to overcome some of the previous opposition to the pro
should a decision be
reachedto resumevaccination for personnelin settingswhere them is a significant risk of
exposureto anthrax.
5. The Board recommendsthe following stepsas a meansof enhancingthe anthrax
immunization program:
*
DEVELOP ENHANCED PROGRAMS TO EDIJCATE ALL ARMED
FORCES PERSONNEL AND T5 GENERAL PUBLIC
RISES AND BENEFITS OF THE VACCINE AND THE REASONS FOR
THE PROGRAM.
.
MAINTAIN THE CURRENT VACCINE TRACKING SYSTEMS AND
CONTINUE TO MONITOR FOR ACUTE AND LATENT VACCINERELATED MORBIDITY AMONG PERSONNEL WHO RECEIVE THIS
VACCINE.
*
DEVELOP A PROGRAM TO VALIDATE OR AUDIT THE CURRENT
VACCINE TRACEING SYSTEMS SIJCII THAT ~C~~~G
ERRORS
ARE MINIMIZED.
.
ASSURE THAT MEASURES ARE IN PLACE SO ‘IBAT PERSONNEL IN
WHOM THE VACCINE IS NOT INDICATED9
IALLY WOMAN
WHO ARE PREGNANT OR POTENTIALLY PREGNANT, DO NOT
RECEIVE IT.
l
.
ASSURE A STEADY AND UNINTERRUPTED SUPPLY ,OF LICENSED
VACCINE TO MEET PROGRAM NEEDS AND
ZEANY
FUTURE DISRUPTION OF PROGRAM ACTIVITIES AND CONTINUE
EFFORTS TO DEVELOP ALTERNATE SOIJRCES FOR VACCINE
PROCIJREMBNT.
THE BOARD STRONGLY ENDORSES ONGOING E~O~TS TO
DEVELOP NEW GENERATION ANTHRAX VACCINES THAT ARE
POTENTIALLY LI%S REACTOGENIC AND COULD REQUIRE LESS
2
AFEB (X5-la) 2002-06
SUBJECT: Vaccination Progmm to ProtectAgainst Ar&rax
FREQUENT DOSING TO AFFORD PROTECTfoN. WE ALSO
SUPPORT EFFCJRTSwITHIN DOD AND TEE DRF~~~
OF
HEALTH AM) liWM.AN SERWCES TO EX?!LORzEALTERNATIVE
DOSING SCHEDtJLES AND ~~~TiO~R~~S
TO
‘MINIMIZE LOCXLmD REAGTLONS
AVAILABLE VACXXNE. S4X.R STUD
TO SIMPLER DOSIRG SCHEDULES
VACCINE MORE ACCEPTABLE TO
HIGHLY MORILE PQPULATION.
These activities should be part of the criteria usedin
of the authrax immuuization program.
decisionsabout resmnption
6. The Board is pleasedto continue to assistthe DoD as it moves forward to develop
policies regarding anthrax vachation and other measuresto protect Armed Forces
personnelagainstthe threat of biologic weaponsof massdestruction.
FOR THE ARMJZD FORCES EPID$3~U
STEPHEN M. OSTROFF, M.D.
AFEB President
Lt Cal, USAF, BSC
AFEIB Executive Secretary
CF:
Board Members and Consukauts
USD (AT&L)
J4-MRD
USAMRMC
USAMRllD
SAAA-PPO
Library of Congress
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