IF WE CAN HAVE DR. HARRISON
COME UP TO INTRODUCE THE SMALL
POX VACCINE SESSION.
>> I WANT TO GIVE AN UPDATE
WHERE WE ARE WITH THIS SMALL POX
VACCINE WORK GROUP.
JUST TO GIVE YOU A LITTLE BIT OF
A BACKGROUND THERE'S NUMEROUS
OCCURRENCES WHICH BRETT PETERSEN
WILL BE TALKING ABOUT.
SMALL POX VACCINE IS USED TO
PROTECT CLINICAL AND RESEARCH LA
R BRAER TO WORKERS AGAINST THESE
VIRUSS.
THESE REMEMBER SLIDES I SHOWED
LAST YEAR BASICALLY SHOWING YOU
SOME OF THESE LABORATORY
TRANSMISSIONS OF MOSTLY VACCINIA
VIRUS.
THIS IS AN AUTO INOCULATION AND
THIS IS THE POSTULE ON THE NOSE
AND EAR.
SO, FURTHER BACKGROUND, ACIP
RECOMMENDATIONS FOR SMALL BOX
VACCINE WERE INITIATED AND
PUBLISHED IN 2001 AND THEN A
SUPPLEMENT IN 2003.
SINCE THEN THERE'S BEEN A NEW
SMALL POX VACCINE ACAM2000 WHICH
HAS BEEN REPLACED BY DRYVAX
WHICH IS NO LONGER WITH US.
SO THE WORK GROUP WAS
ESTABLISHED LAST YEAR.
WE HAD MONTHLY MEETINGS SINCE
THAT TIME.
THIS IS THE WORK GROUP,
UNANIMOUS BENNETTE -- NAN BENNE
THE LIST.
WE WELCOME HER TO THE WORK
GROUP.
BRETT IS OUR DFO AND HAS DONE A
GREAT JOB OF DRIVING AND
DIRECTING THE WORK GROUP,
KEEPING US IN LINE AND WE HAVE A
VERY ROBUST GROUP OF MEMBERS WHO
REALLY ADD A SUBSTANTIAL AMOUNT
OF EXPERTISE AS WE TALK ABOUT
THE VARIOUS ISSUES RELATED TO
VACCINE STRAINS AS WELL AS THE
VACCINES.
SO THE IDEA IS TO REVIEW
RECOMMENDATIONS, DID I MENTION
THAT WERE ISSUED IN 2001 AND
THEN 2003.
VIA THE CURRENT REQUIREMENTS FOR
WORKING WITH ORTHOPOXVIRUSS AND
THEN LABORATORY TRANSMISSIONS.
WE'RE ALSO GOING TO SPEND MOST
OF THE DAY TODAY TALKING ABOUT
ACAM2000.
THIS IS A DERIVATIVE OF DRYVAX.
WE'LL ALSO BE REVIEWING
PUBLICATIONS ON THE PRE-EVENT
PROGRAM OF 2002-2004 THAT YOU'RE
ALL AWARE OF.
AND THEN THERE'S ANOTHER VACCINE
THAT'S NOT LICENSED IT'S IN THE
NATIONAL STRATEGIC NATIONAL
STOCKPILE.
UMVAMUNE.
THIS IS INFORMATIONAL.
INTEREST IN THIS VACCINE IS THAT
IT'S MADE FROM, THE NAME IMVA
DOES NOT MEAN A MILLION CELLS.
WE'LL REVIEW THAT DATA.
THAT'S INFORMATIONAL BECAUSE OF
THE LICENSURE STATUS OF THIS
VACCINE.
THEN WE'LL LOOK AT THE
RECOMBINANT VIRUSS.
THIS IS INTERESTING BECAUSE OF
VARYING DEGREES OF ATTENUATION.
THE BOTTOM LINE IS WE WANT TO
TAKE THE EXISTING STATEMENT AND
SO THANK YOU.
>> GOOD MORNING.
I'LL START BY THANKING HARRISON
FOR THAT INTRODUCTION AND REALLY
THE GOAL OF MY PRESENTATION
TODAY IS TO PROVIDE GENERAL
OVERVIEW OF SOME OF THE TOPICS
AND ISSUES THAT OUR WORK GROUP
HAS DISCUSSED TO DATE.
AS WELL AS SOME OF THE DATA THAT
WE HAVE REVIEWED AND ASSESSED
AND WE REALLY HOPE THIS
INFORMATION CAN SERVE AS A
FOUNDATION FOR REVISING AND
UPDATING THE SMALL BOX VACCINE
RECOMMENDATIONS FOR LABORATORY
WORKERS.
LET'S START WITH A LITTLE BIT OF
BACKGROUND.
ORTHOPOKE VIRUSS ARE WITHIN THE
POXVIRIDAE FAMILY.
ORTHOPOXVIRUS PROVIDES KPROS
TEXAS AND IT'S THIS PROPERTY
THAT HAS ALLOWED THE DEVELOPMENT
OF VACCINIA AS A VACCINE FOR
SMALL BOX AND ULTIMATELY THE
EEEE
EEM
ERADICATION OF SMALL POX.
IT'S COMMONLY USED IN LABORATORY
RESEARCH.
MANY HISTORIC VACCINES, A NUMBER
OF WHICH ARE LISTED HERE.
DIFFERENT VACCINIA VIRUSS HAVE
DIFFERENT PROFILES.
RECOMBINANT VACCINIA VIRUSS ARE
U
USED FOR VIRAL VECTOR FOR
EXPRESSION OF FOREIGN GENES.
GIVEN THE RISKS LABORATORY
WORKERS USING THESE VIRUS THE
ACIP DID PRODUCE RECOMMENDATIONS
FOR VACCINIA VACCINE IN 2001.
THE ACIP RECOMMENDED VACCINIA
VACCINE FOR LABORATORY WORKERS
THAT HANDLE CULTURES OR ANIMALS,
CONTAMINATED OR INFECTED WITH
HIGHLY LLY ATTENUATED VACCINIA
VIRUS.
THEY RECOMMENDED VACCINATION CAN
BE OFFERED TO HEALTH CARE
WORKERS WITH DRESSINGS OR OTHER
INFECTIOUS MATERIAL FROM
VOLUNTEERS IN CLINICAL STUDIES
WHERE NONHIGHLY ATTENUATEDE
ATTENUATED VACCINIA VIRUSS ARE
USED.
PERSONS WORKING WITH VACCINIA
VIRUS, RECOMBINANT VACCINIA
VIRUSS OR OTHER NONVARIOL
NONVARIOLA ORTHOPOXVIRUSS SHOULD
BE RE-VACCINATED AT LEAST EVERY
10 YEARS.
THEY RECOMMENDED LABORATORY AND
HEALTH CARE PERSONNEL WORKING
WITH HIGHLY ATTENUATED POXVIRUS
STRAINS DO NOT REQUIRE ROUTINE
VACCINIA VACCINATION.
NOW WHEN DEVELOPING
RECOMMENDATIONS AS CLEARLY
IMPORTANT TO CONSIDER BOTH THE
POPULATION AT RISK AS WELL AS
THE RISK ITSELF.
AND BOTH OF THESE PRESENT
CHALLENGES WHEN YOU CONSIDERED
VACCINATION FOR LABORATORY
WORKS.
THE POPULATION AT RISK IS
DIFFICULT TO ESTIMATE.
THERE'S NO REGISTRY OF PERSONS
WHO WORK WITH ORTHOPOXVIRUSS.
A SIMPLE SEARCH REVEALED 431
ORTHOPOXVIRUS RELATED
PUBLICATIONS WAS RELEASED IN
2013.
THERE'S 185 ACTIVE PROJECTS
LISTED RELATING TO THE VACCINIA
VIRUS WORK.
CLINICAL TRIALS.GOV LISTED 25
OPEN CLINICAL TRIALS INVOLVING
THE VACCINIA VIRUS.
LASTLY WE KNOW VACCINATION OF
LABORATORY WORKERS CONTINUES AS
LAST YEAR IN 2013 THIS WERE 31
DIFFERENT SITES THAT RECEIVED 80
SHIPMENTS OF SMALL POX CDC.
OVER THE LAST FIVE YEARS THERE'S
ECHBT 3W DIFFERENT SITES
RECEIVING 523 SHIPMENTS.
WE DON'T HAVE A COMPREHENSIVE
LIST OF ALL POTENTIAL DISS.
ORTHOPOXVIRUS IS NOT ALWAYS
REPORTED.
LASTLY THE VIRUS MAY NOT BE WELL
CHARACTERIZED AND THAT'S
PARTICULARLY TRUE WITH
RECOMBITANT VIRUSS.
HOWEVER THE CDC HAS MAINTAINED A
DATABASE OF LABORATORY RELATED
ORTHOPOXVIRUS EXPOS THURSDURES
THESE ARE SUMMARIZED IN THE
TABLES IN THE FOLLOWING TWO
SLIDES.
THIS NEXT SLIDE SUMMARIZES SOME
OF THESE CASES.
SO 26 EXPOSURE INCIDENTS WERE
REPORTED OF WHICH 69% INVOLVED
RECOMBINAN VIRUSS.
OF THESE 26, 54% RESULTED IN
INFECTIONS.
86% OF THE INFECTIONS INVOLVED
RECOMBINANT VARIOUSES.
THE VIRUSS INVOLVED IN THE
INFECTIONS WERE PRIMARILY
VACCINIA REPRESENTING 86% OF THE
INFECTIONS ALTHOUGH TWO WERE
REPORTED.
OF NOTE FOUR OF THE 14
INFECTIONS ACTUALLY REQUIRED
HOSPITALIZATION.
THAT'S 29% OF TOTAL INFECTIONS.
ALSO OF NOTE, ANOTHER 25% OF THE
INFECTIONS, IT WAS ACTUALLY
FOUND THAT THE STRAIN INFECTING
WAS A STRAIN OTHER THAN THAT
WHICH RESEARCHER THOUGHT THEY
WERE WORKING WITH.
WHICH SHOWS THAT SOME OF THE
UNCERTAINTY IN THESE, THE RISK
OF THESE LABORATORY WORKERS.
LASTLY, 7 OF THE 26 EXPOSURE
INCIDENTS INVOLVED LABORATORY
WORKERS WHO MET THE ACIP
VACCINATION RECOMMENDATION.
AND OF THESE ONLY ONE RESULTED
IN INFECTION.
THERE WAS ONE OTHER INFECTION
THAT OCCURRED IN AN INDIVIDUAL
WHO WAS VACCINATED BEYOND TEN
YEARS AND WAS NOT MEETING THE
ACIP RECOMMENDATION.
SWITCHING GEARS JUST A LITTLE
BIT.
WE'LL START BY GIVING AN
OVERVIEW OF THE SMALL POX
VACCINE.
ACAM2000 IS CURRENTLY THE ONLY
SMALL POX VACCINE LICENSED AND
AVAILABLE IN THE UNITED STATES.
IT WAS LICENSED IN 2007 AND
REPLACED THE PREVIOUSLY USED
SMALL POX VACCINE DRYVAX WHICH
IS NO LONGER AVAILABLE.
THIS VACCINE ACAM2000 HAS BEEN
USED IN LABORATORY AND HEALTH
CARE WORKERS AS WELL AS SELECT
DEPARTMENT OF DEFENSE PERSONNEL.
THE VACCINE ITSELF IS A LIVE
VACCINIA VIRUS THAT'S PRODUCED
IN VERO CELLS.
THE VACCINE IS DERIVED, IS A
CLONAL DERIVATIVE OF DRYVAX.
AND ACAM2000 IS EXPECTED TO
SHARE MANY OF THE PROPERTIES OF
THIS VIRUS.
THE VACCINE IS ADMINISTERED IN A
SINGLE DOSE VIA MULTIPLE
PUNCTURE WITH A BIFURCATED
NEEDLE WHICH IS PICTURED HERE.
FOLLOWING VACCINE
ADMINISTRATION, A LESION
DEVELOPED AT THE SITE OF
VACCINATION OF THE PROGRESSION
OF WHICH IS DEPICTED IN THESE
PICTURES.
DURING THIS TIME THE LESION DOES
CONTAIN INFECTIOUS VIRUS THAT
CAN BE TRANSMITTED TO OTHERS BY
INADVERTENT INOCULATION.
THIS RESPONSE IS REFERRED TO AS
A TAKE AND CONSIDERED AS A
MARKER OF SUCCESSFUL
VACCINATION.
HISTORICALLY SMALL POX VACCINES
HAVE BEEN ASSOCIATED WITH A
NUMBER O EVENTS SOME OF
WHICH CAN BE SEVERE
THREATENING.
SOME OF THOSE ARE ENARECEPHALIT.
THE DATD WAS PRODUCED FROM A
STUDY THAT WAS PERFORMED IN 1968
DURING THE TIME OF ROW INTO THE
IMMUNIZATIO SMALL POX
VACCINE.
OF NOTE THE RATES ARE DESCRIBED
AS CASES PER MILLION
VACCINATIONS AND THE RATES RANGE
FOR SERIOUS ADVERSE EVENTS OF
PROGRESSIVE VACCINIA AND
VACCINATUM AND ENCEPHALITIS.
RATES FOR DEATH WERE ALSO
REPORTED AS APPROXIMATELY ONE
DEATH PER MILLION VACCINATION.
THIS TABLE IS RESULTING FROM THE
SAME STUDY, BUT GIVING THE RATES
FOR REVACCINATION AND CLEARLY
THE RATES FOR REVACCINATION ARE
MUCH LOWER THAN THOSE FOR
PRIMARY VACCINATION.
IN DATA FROM A MORE
RECENT STUDY LUATING,
VACCINATION PROGRAMS IN 2002 AND
2005 GIVE US THESE RATES.
FIRST POINT MUCH NOTE IS THEABS
ECZEMA AND THIS IS
DUE TO SCREENING OF PERSONS AT
SECOND POINT MUCH NOTE IS THE
OF MYOPARICARDITIS.
WE USED THE GRADING AND
RECOMMENDATIONS ASSESSMENT
DEVELOPMENT AND EVALUATION
METHOD TO ASSESS THE USE OF
ACAM2000 IN LAB WORKERS
OUTLINED, AS OUTLINED IN THE
FOLLOWING STEPS.
FIRST STARTING WITH DEVELOPING A
POLICY QUESTION, IDENTIFYING AND
ASSESSING THE IMPORTANCE MUCH
OUTCOMES, PERFORMING A
LITERATURE REVIEW, SUMMARIZING
THE EVIDENCE FOR CRITICAL OUT
COMES AND LASTLY EVALUATING
QUALITY OF EVIDENCE FOR
OUTCOMES.
THE POLE QUESTION FORMULATED BY
WORK GROUP SHOULD ADMINISTRATION
OF ACAM2000 BE RECOMMENDED
ROUTINELY TO PERSONS AT RISK FOR
ORTHOPOKEVIRAL DISEASE?
PERSONS AT RISK FOR EXPOSURE TO
ORTHOPOXVIRUSES.
INTERVENTION IS VACCINATION WITH
ACAM2000.
COMPARISON IS VACCINATION WITH
DRYVAX PREVIOUSLY RECOMMENDED
VACCINE.
WE USED A MODIFIED METHOD TO
SOLICIT OUTCOMES ASSESSMENT FROM
OUR WORKING GROUP MEMBERS.
THE OUT COMES IDENTIFIED IS
BENEFITS AND HARMS.
AMONG THE BENEFITS WERE VACCINE
EFFICACY TO PREVENTS
ORTHOPOXVIRAL DISEASE.
AMONG THE HARMS
MYO/PERICARDITIS.
ALL OF THE OUTCOMES WERE
INCLUDED IN THE PROEINCLUDE
ED EVIDENCE PROFILE.
AS SUCH CUTANEOUS RESPONSE WAS
USED AS A SURROGATE FOR THIS
BENEFIT OUTCOME.
WE PERFORMED SYSTEMATIC
LITERATURE REVIEW TO IDENTIFY
STUDIES THAT MET OUR CRITERIA,
AND ADDRESSED THE OUTCOMES
IDENTIFIED BY THE WORKING GROUP.
WE IDENTIFIED A TOTAL OF FIVE
RANDOMIZED TRILTS WHICH
ADDRESSED THE BENEFIT OUTCOMES
AND FOUR ADDRESSED THE HARM
OUTCOME.
THE FOLLOWING SLIDES WILL GIVE A
PREVIOUS SUMMARY OF THESE
CRITICAL OUTCOMES.
THE FIRST BEING THE CUTANEOUS
RESPONSE.
THE CUTANEOUS RESPONSE WAS BESED
ASSESSED IN VACCINIA NAIVE.
YOU CAN SEE THAT 96% OF VACCINIA
SUBJECTS DEMONSTRATED
VACCINATION SUCCESS AND ACAM2000
WAS FOUND TO BE NON-INFERIOR TO
THE DRYVAX AMONG THIS
POPULATION.
FOR PREVIOUSLY VACCINATED
SUBJECTS.
STATISTICAL ANALYSIS REVEALED
THAT ACAM2000 DID NOT NEED
PREDEFINED CRITERIA FOR
NON-INFERIORITY TO DRYVAX AMONG
THIS POPULATION.
WHEN LOOKING AT THE NEUTRALIZING
ANTI-VIRUS RESPONSE THESE SAME
STUDIES EVALUATED THE RESPONSE
IN BOTH, AGAIN, VACCINIA
SUBJECTS.
BOTH GEOMETRIC MEAN WERE
COMPARABLE TO THE DRYVAX BUT BY
THE SLIGHTEST OF MARGINS
ACAM2000 DIDN'T NEED CRITERIA
FOR NON-INFERIORITY VACCINE.
IN CONTRAST AMONG FREFLY
VACCINATED SUBJECTS, THE
ANTI-BODIES WERE SIMILAR AND DID
MEET CRITERIA FOR
NON-INFERIORITY.
IN LOOKING AT THE CRITICAL HARMS
OUTCOMES THERE WERE ACTUALLY NO
SERIOUS ADVERSE EVENTS REPORTED
IN THE RANDOMIZED CONTROLLED
TRIALS.
THAT INCLUDED NO INCIDENTS OF
DEATH, ECZEMA OR VACCINIA.
WITH RESPECT TO MYOPARICARDITIS
THERE WERE SIX CASES REPORTED.
THE BEST ESTIMATE OF RISK BASED
ON PROTECTION OF FIVE CASES
AMONG 873 VACCINEES GIVES A RATE
OF 5.7 CASES PER 1,000
VACCINEES.
WE FOUND ONE CASE AMONG THESE
REPORTED MYO/PERICARD ITIS DID
HAVE SEQUILLAE THAT WAS
ABNORMAL.
WE USED GRADE METHODOLOGY.
THE SUMMARY IS PRESENTED HERE IN
THIS TABLE.
THROUGHOUT FOR ALL THE OUTCOMES
WE DID NOT FIND ANY CONCERNS FOR
RISK OF BIAS OR INCONSISTENCY.
HOWEVER, THERE WERE CONCERNS
ABOUT INDIRECTNESS IN THE
CUTANEOUS RESPONSE AND
NEUTRALIZING ANTIBODY RESPONSE.
WITH RESPECT TO IMPRECISION
THERE WERE CONCERNS WITH REGARDS
TO THE SERIOUS ADVERSE EVENTS
AND INADVERTENT INOCULATION OUT
COMES WHICH I'LL DESCRIBE IN THE
FOLLOWING SLIDES.
GIVEN THESE CONCERNS THE
EVIDENCE TYPE WAS DOWNGRADED FOR
THOSE OUTCOMES AS YOU CAN SEE IN
THE EVIDENCE TYPE COLUMN.
WITH RESPECT TO INDIRECTNESS
THERE WAS CONCERNS THAT THE
OUTCOME THAT WAS ASSESSED IN THE
RANDOMIZED CLINICAL TRIALS MAY
HAVE BEEN DIFFERENT THAN THE
PRIMARY INTEREST.
THE CUTANEOUS RESPONSE WERE
SURROGATES FOR THE OUTCOME OF
PRIMARY INTEREST IS THAT VACCINE
EFFICACY TO PREVENT
ORTHOPOXVIRAL DISEASE.
MYO/PERICARDITIS RESOLVED
WITHOUT SEQUELAE IS UNCLEAR.
AND THESE INCLUDED MONITORING OF
EKGs AS WELL AS CARDIAC ENZYMES.
SOME WERE EKG CHANGES OR CARDIAC
ENZYMES THAT HAD NO SYMPTOMS
WHATSOEVER.
BASED ON THIS, IT WAS CLOUDED
THAT MYO/PERICARDITIS WOULD BE
RESOLVED.
IN TERMS OF IMPRECISION, WE
FOUND THAT THE CLINICAL TRIALS
WERE NOT ADEQUATELY POWERED TO
DETECT SERIOUS ADVERSE EVENTS.
IT WAS NOT FORWARD DETECT
INADVERTENT INOCULAT OVARIAN N.
CALCULATIONS BELOW INDICATE THE
PROBABILITY YOU WOULDN'T SEE
THESE ADVERSE EVENTS AS WELL AS
THE SAMPLE SIZE THAT YOU WOULD
NEED DETECT THESE EVENTS AND
THESE CALCULATIONS SUPPORT THE
IMPRECISION IN THESE CASES.
SO FWHINSD GRADE ASSESSMENT THE
OVERALL LEVEL OF EVIDENCE WAS
DETERMINED TO BE TWO AS THE
STUDIES EVALUATED WERE ALL
RANDOMIZED CONTROLLED TRIALS
THOUGH THEY DID HAVE IMPORTANT
LIMITATIONS.
SO IN TERMS OF NEXT STEPS, THE
WORK GROUP WILL BEGIN UPDATING
AND REVISING THE RECOMMENDATIONS
USING THE DATA THAT WE'VE
REVIEWED AND DISCUSSED TO DATE.
OUR HOPE IS TO PRESENT THESE
RECOMMENDATIONS TO THE ACIP AT A
FUTURE MEETING, AND ULTIMATELY
AS INDICATED BY DR. HARRISON TO
PUBLISH THESE RECOMMENDATIONS IN
AN ACIP POLICY NOTE.
SO I'LL CONCLUDE BY AGAIN
THANKING OUR WORK GROUP MEMBERS
WHO HAVE BEEN VERY ENTHUSIASTIC
AND CONTRIBUTED GREATLY AND SO
WITH THAT I WILL OPEN IT UP TO
QUESTIONS.
>> I HAVE ONE QUICK QUESTION,
IT'S MORE IN TERMS OF
NOMENCLATURE.
SHOULD WE NOT BE REFERRING TO
THIS AS AN ORTHOPOXVIRUS VERSUS
SMALLPOX VACCINE.
I'M CURIOUS ABOUT THAT.
IT'S MORE OF A THOUGHT QUESTION.
DR. KEMP?
YES.
ON SLIDE 24 WHEN YOU'RE TALKING
ABOUT THE SEQUELLAE IT LOOKS
LIKE YOU'RE JUST REPORTING --
YOU'RE NOT GIVING THE
COMPARATOR.
WHAT'S THE HARM THAT YOU'RE
COMPARING THESE TO?
WHAT WERE THE HARMS FOR DRYVAX.
>> IN TERMS OF MYO/PERICARDITIS
AND DRYVAX WAS LOWER.
I CAN PROVIDE THAT INFORMATION
TO YOU.
I CAN TELL YOU THERE WERE SEVEN
CASES REPORTED AMONG THE
ACAM2000 GROUP AND THREE CASES
REPORTED AMONG THE DRYVAX GROUP.
THE DENOMINATOR DATA I DON'T
HAVE OFF THE TOP OF MY HEAD BUT
I CAN GET THAT FOR YOU.
YES.
>> THAT'S A PRETTY HIGH THE RATE
OF MYO/PERICARDITIS.
1 FOR 180.
WHAT'S THE RATE OF
AUTOINOCULATION AND OTHER
COMPLICATIONS FROM LABORATORY
WORKERS THAT GET EXPOSURE.
WE HAVE TO WEIGH IT, RATE ONE
OUT OF 180 I WOULD LIKE TO
COMPARE THAT TO TRAITS OF
AUTOINOCULATION AND GETTING THE
VACCINE EXPOSURE IN THE LAB.
>> SURE.
WE CAN INVESTIGATE THAT AND SEE
IF WE CAN DETERMINE THE RATE OF
AUTOINOCULATION WITH LABORATORY
WORKERS.
THAT CAN BE DONE.
>> DR. KEMP?
I GUESS MY ORIGINAL QUESTION
GOES TO THAT POINT.
WHY ARE YOUR NOT DOING THE GRADE
AGAINST NOTHING VERSUS THE
DRYVAX.
>> THE PREVIOUSLY RECOMMENDED
VACCINE WAS DRYVAX THAT'S HOW WE
APPROACHED OUR GRADE ASSESSMENT.
IF WE WERE TO GO BACK AND TRY TO
DO A COMPARISON WITH NOTHING
THERE'S NO RANDOMIZED CLINICAL
TRIALS AND VERY LITTLE DATA TO
EVALUATE THAT QUESTION.
IT'S REALLY SINCE SMALLPOX
VACCINE WAS THE FIRST VACCINE
INVENTED AND IN SOME SENSE BEEN
GRAND FATHERED IN IT'S NOT
ROBUST STUDIES TO EVALUATE ITS
EFFICACY AGAINST
ORTHOPOXVIRUSES.
DR. HERMAN.
>> IF I REMEMBER CORRECTLY IN
THE PRE-EVENT DRYVAX
VACCINATION PROGRAM PEOPLE WHO
GOT MYO/PERICARDITIS I THINK AND
OFTEN MALE.
IS THERE ANY INDICATION THAT
THERE ARE CERTAIN PEOPLE WHO ARE
TO GET MYO/PERICARDITIS IN THIS
GROUP?
YOU ARE CORRECT, THE PEOPLE
WERE OLDER BUT OVERALL THE
POPULATION BEING VACCINATED AS
WELL.
THERE'S NO RISK FACTORS TO
PREDICT WHO IS AT RISK OF
SUFFERING THIS ADVERSE EFFECT.
>> DR. DECKER.
I THINK I MIGHT BE ABLE TO
OFFER INSIGHT ABOUT MOST OF THE
SKES THAT HAVE BEEN ASKED SO FAR
BY TELLING YOU ABOUT ONE OF THE
TRIALS WE'RE CONDUCTING.
WHEN IT WAS LICENSED, AS A
NATIONAL IMPERATIVE AT THE TIME,
BUT LICENSED IN RECOGNITION OF
THE DATA THAT DR. PIERCE
DESCRIBED AND IN ASSOCIATION
WITH A FAMILY OF COORDINATED
TRIALS AS I DID FURTHER
ASSESSMENTS FOR SAFETY ALL OF
WHICH ARE STILL UNDER WAY.
AT ONE OF THESE TRIALS WHICH
I'LL CALL BY THE NAME WE USED
THE -- ALL THE STUDIES ARE
CONDUCTED WITH THE DEPARTMENT OF
DEFENSE BECAUSE THAT'S WHERE YOU
FIND PEOPLE GETTING THE VACCINE.
AND ONE OF THESE STUDIES
CONDAKTD MOANING TROOPS
DEPLOYING, BEING DEPLOYED TO
OVERSEAS WHO ARE BEING PROCESSED
WITH THE ACAM2000 VACCINE.
WE HAVE STUDY SITES AT SIX MAJOR
MILITARY BASES IN THE UNITED
STATES THAT SOLICITATE
PARTICIPATION.
A CLOSE CONTACT WHO IS PREGNANT
COULD NOT RECEIVE THE VACCINE.
THIS STUDY POPULATION DIFFERS
FROM THE STUDY POPULATION OF
LABORATORY WORKERS AND THESE ARE
GENERALLY MORE FIT PEOPLE AND
RECEIVE A VACCINATION IN A
HIGHLY STRUCTURED ORGANIZED DOD
PROGRAM THAT HAS A RIGOROUS
CONTRA INDICATION.
IT PUTS YOU AT HIGHER RISK.
CLEARLY THINGS THAT PUT YOU AT
HIGHER RISK.
ANYBODY WITH MORE THAN FOUR
CARDIAC OR CARDIAC RESPIRATORY
INFECTIONS IS NOT QUALIFIED FOR
THESE.
OF THE STUDIES STILL UNDER WAY
THEREFORE I DON'T HAVE THE
DETAILED RESULTS BUT FROM OUR
ADMINISTRATIVE MANAGEMENT STUDY
I CAN TELL YOU THAT
APPROXIMATELY 3 PER 1,000
VACCINEES DEVELOPED SIGNS OR
SYMPTOMS SUGGESTS
MYO/PERICARDITIS WHICH REFERS
THEM TO A COMMITTEE TO WHETHER
OR NOT THEY HAVE DEFINITE,
PROBABLE, POSSIBLE OR NO
MYO/PERICARDITIS.
SO FAR 30 OUT OF THE 10,500
SOME-ODD HAVE BEEN AS POSSIBLE
OR DEFINITE MYO/PERICARDITIS.
NONE OF THESE PEOPLE HAVE BEEN
SYMPTOMATIC.
THERE'S AN ATTEMPT TO FOLLOW THE
LONG TERM CLINICAL COURSE AS YOU
JUST HEARD AND ALMOST NO ONE
SOLICITATED IN THAT STUDY.
THAT'S CONJECTURE.
>> THANK YOU FOR THAT
INFORMATION, DR. DECKER.
>> ANY OTHER QUESTIONS,
DISCUSSION?
OKAY.
I DO NOT BELIEVE WE HAVE ANY
PUBLIC COMMENT SIGNED UP, SO
IF -- IF ANYONE WANTS TO GET A
LAST COMMENT IN THIS IS THE TIME
OTHERWISE WE'LL CLOSE THE
MEETING AND WISH YOU
HAPPY TRAVELS.
THANK YOU.