>> I THINK WE HAVE SUFFICIENT
MEMBERSHIP AROUND THE TABLE HERE
TO GET STARED ON HPV VACCINE.
AND DR. BOCCHINI.
>> I HAVE THE FINAL
PRESENTATION, WHICH IS HPV
VACCINE.
THIS IS A SUMMARY OF THE RECENT
ACTIVITIES.
ON THE LAST FEW MONTHS, WE HAVE
REVIEWED THE MORE RECENT DATA IN
PREGNANCY REGISTRY.
WE HAD SOME DISCUSSIONS
INCLUDING HPV INFECTION RISK,
AND HPV INFECTION RISK FOR
SELECTED HEALTH CARE WORKERS AS
WELL.
WE HAVE BEEN WORKING ON PLANNING
FOR UPDATING OUR ACIP HPV
VACCINE STATEMENT.
THE PLANS FOR THE STATEMENT GO
BACK TO WHAT WE HAVE OUT THERE
CURRENTLY.
IN 2007, THERE IS OUR STATEMENT
ON USE OF HPV VACCINE IN WOMEN.
2009 THERE WAS A POLICY NOTE
WITH THE LICENSURE, AND THEN IN
2011, WE UPDATED THE 2009
STATEMENT ON USE OF HPV VACCINE
IN MALES THROUGH A POLICY NOTE.
SO THE UPDATED STATEMENT WILL
NEED TO INCLUDE PUTTING THE --
ALL OF OUR RECOMMENDATIONS FOR
MEN AND WOMEN AND BOYS AND GIRLS
IN ONE DOCUMENT, AND RECONCILING
A NUMBER OF WORDING DIFFERENCES
WITH THE DOCUMENTS.
IN ADDITION ADDING UPDATES ON
THE BURDEN OF INFECTION AND
CANCE
CANCERS, AND CHANGING IN
SCREENI
SCREENING RECOMMENDATIONS, AND
THEN ADDRESSING ISSUES RELATED
TO THE RESEARCH LABORATORY
WORKERS AND CERTAIN HEALTH CARE
WORKERS AS WELL.
ADDITIONAL FUTURE WORK GROUP
PLANS, WE WILL LOOK AT AN
ALTERNATIVE VACCINE SCHEDULE.
THE DATA PRESENTED PROXIMATELY A
YEAR AGO ON THE STUDY BY DR.
DOTSON AND ASSOCIATES WAS
PRESENTED ON TWO ACIP IN JUNE OF
LAST YEAR.
IT IS NOW PUBLISHED.
THERE ARE OTHER ONGOING STUDIES
ON ALTERNATIVE SCHEDULES AND WE
WILL LOOK TO THOSE FOR FUTURE
PRESENTATION FOR ACIP.
OUR PLANS ARE TO REVIEW NEW DATA
WHEN IT BECOMES AVAILABLE FOR ON
GOING TRIALS OF CURRENT AND
SECOND GENERATION HPV VACCINES.
THIS SESSION IS REALLY AN
INFORMATIONAL SESSION.
WE WANT TO UPDATE THE ACIP ON A
NUMBER OF ISSUES.
FIRST OF ALL, THE VACCINE AND
PREGNANCY REGISTRY, MERCK
RECEIVED NOTIFICATION FROM THE
FDA THEY MET THEIR POST
LICENSURE.
WE ARE GOING TO HEAR FURTHER
DETAILS ABOUT OUR PLANS FOR THE
UPDATED ACIP STATEMENT, AND WE
WILL PROVIDE INFORMATION ABOUT
THE HPV VACCINE PROGRAM, AND
SOME IMPACT MONITORING WITH DATA
THAT SHE CURRENTLY HAS FROM THIS
COUNTRY AND ELSEWHERE.
SO I WILL TURN THIS PODIUM TO .
D.LIEVANO.
DR. LIEVANO.
>>> GOOD AFTERNOON.
I APT PRESENTED THE HPV VACCINE.
FROM JUNE 2006 TO MAY 31, 2012.
IT IS NOT RECOMMENDED FOR USE
DURING PREGNANCY.
THERE WERE CONTROLLED STUDIES
FOR PREGNANT WOMEN.
ACCIDENTAL EXPOSURES MAY OCCUR.
WHEN CONSIDERED IN THE PREGNANCY
REGISTRY THEY WERE MONITORED
CLOSELY.
IT WAS PART OF A MULTIFACETED
PLAN TO MONITOR THE SAFETY IN
PREGNANCY SINCE 2006.
IT WAS PART OF OUR PROGRAM.
THE MAIN GOALS OF THE REGISTRY
WERE TO GATHER INFORMATION ON
PREGNANCY EXPOSURES AND
OUTCOMES, IDENTIFY SAFETY
SIGNALS, AND PROVIDE INFORMATION
TO ADVISORS, REGULATORS, AND
PATIENTS, FOR THE EFFECTS OF HPV
VACCINE.
WITH THE PREGNANCY EXPOSURE IT
IS REPORTED TO THE COMPANY TO
REDEEM.
PATIENTS WHEN CONSIDERED ON THE
PREGNANCY REGISTRY, ALL OF THE
FOLLOWING CIRCUMSTANCES EXIST.
IT WAS IMPORTED FROM THE U.S.,
CANADA, OR FRANCE.
THERE WAS A UNIQUE PATIENT
IDENTIFIER.
A HEALTH CARE PROVIDER WAS
IDENTIFIED.
THE EXPOSURE WAS UINCURED WITHI
ONE MONTH.
INSTRUCTIONS ABOUT HOW TO MAKE A
REPORT IN THE PREGNANCY REGULAR
INDUSTRY WERE DESCRIBED ON THE
LABEL AND THE WEBSITE.
THEY ALSO DESCRIBED ENROLLMENT.
IN SUMMARY, THE PREGNANCY
EXPOSURES WERE REPORTED TO
MERCK.
THEY WERE RECEIVED FROM HEALTH
CARE PROFESSIONALS.
THEY WERE MONITORED AS THEY WERE
RECEIVED.
THE REPORT WAS ON THE
PERSPECTIVE AND RETROSPECTIVE.
PROSPECTIVE REPORTS ARE THOSE
THAT ARE BEFORE THE OUTCOME OF
THE PREGNANCY ARE
KNOWN.
RETROSPECTIVE IS AFTER IT IS
KNOW.
IT IS RETROSPECTIVE IF AN
INITIAL REPORT IS RECEIVED OF AN
ABNORMALITY.
THE RESPECTED REPORTS --
[ INAUDIBLE ]
-- THE PRIMARY OUT COME OF
INTERESTS ARE BIRTH DEFECTS AND
PREGNANCY OUT COMES INCLUDING
ABORTIONS PRIOR TO WEEK 20.
FETAL DEATH AFTER WEEK 20 AND
LIVE BIRTHS.
IF AN OUTCOME INCLUDING
CONGENITAL ANOMALIES OF THE
PREGNANCY, PEDIATRIC MEDICAL
RECORDS WERE REQUESTED FOR UP TO
THREE YEARS AFTER THE BIRTH FOR
ALL NEWBORNS THAT HAVE IT ON
FILE.
BIRTH DEFECTS FREQUENCY WERE
CALCULATED ON PERSPECTIVE
REPORTS USING IT AND A NUMBER OF
CASES INCLUDES LIVE BORN, FETAL
DEATH OR TERMINATION AFTER 20
WEEKS.
FINALLY, THERE ARE NO REPORTS ON
SELECTIVE CASES WHERE REVIEW OF
A NATURAL BASE WERE NEEDED AND
RESULTS WERE AS OF MAY 31st,
2012.
REPORTS OF EXPOSURE TO HPV
VACCINE DURING PREGNANCY WERE
RECEIVED BY THE COMPANY THROUGH
MAY 31st, 2012.
1,865 CASES DID NOT MEET THE
CRITERIA AND WERE NOT INVOLVED.
2,802 PATIENTS WITH REPORTED OF
EXPOSURE TO HPV VACCINE DURING
PREGNANCY WAS ONLY THE PREGNANCY
REGISTRY.
HOWEVER, 73 IS ESTIMATED THE
DATA IS CORRUPT.
OF THE 2,802 INVOLVED REPORTS
INCLUDING THIS ANALYSIS, 96%
FROM THE U.S., 1% FROM CANADA
AND 3% FROM FRANCE.
THEY WERE 2,440 PROSPECKIVE
REPORTS AND INVOLVED CASES.
25 OR 30% FOLLOWED UP.
OF THE 1,573 PREGNANCY OUTCOMES
FIVE WERE EPTOPIC PREGNANCY.
1,460 NEWBORNS.
THERE WERE 8 SETS OF TWINS.
150 WERE ABORTIONS AND 12 WERE
FETAL DEATH.
IN REGARD TO REPORTS, 362 TOOK
HPV VACCINE DURING PREGNANCY.
29 WERE ELECTIVE ABORTION, 318
PREGNANCY OUTCOMES AND 13
[ INAUDIBLE ]
>> 8 WERE EPTOPIC.
242 LIVE BIRTHS.
61 RESULTING IN ABORTIONS AND 8
WERE FETAL DEATHS.
THESE ARE PERSPECTIVE REPORTS BY
THE PRIMARY ANALYSIS POPULATION.
I SAID THIS BEFORE, IN REGARD TO
THE 2,440 REPORTS, 30% WOULD
DESPITE MULTIPLE ATTEMPTS TO
INVOLVE THESE CASES IN THE
REGISTRY.
LESS THAN 2% ARE PENDING FOLLOW
UP AND LESS THAN 2% HAVE
OUTCOMES UNAVAILABLE.
91% OF EXPOSURE OF THE
PERCENTAGE THEY WERE 102
ELECTIVE ABORTIONS AND 105 OTHER
ABORTIONS.
1,460 NEWBORNS.
1,381 OR 95% FOR NORMAL
INCIDENTS.
34 HAD MAJOR CONGENITAL ANOMALY
AND 45 HAD MINOR CONGENITAL
ANOMALIES.
ALL ARE CALCULATED TO BE 6.5
WITH A CONFIDENCE OF ABOUT 5.5
TO 8.2.
THE CLINICALLY RECOGNIZED --
[ INAUDIBLE ]
-- FETAL DEATH WAS CALCULATED TO
BE 0.8.
0.8.
100 OUTCOMES WITH 95% RATE.
0.4 TO 1.4.
IN THE GENERAL POPULATION, IT
INDICATED THAT THE MORTALITY
RATE IS 0.62.
THOSE RATE OF MAJOR CONGENITAL
ANOMALIES WAS 2.5 FOR 100 LIVE
BORN INFANTS 1.7
S ON PERSPECTIVE
REPORTS 15GNANCY IS KNOWN.
INVOLVED ISOLATE ADD
LEE.
CONGENITAL
ANOMALIE IN A VARIETY OF SISTER]
-- ALL OF THE ABNORMALITIES WERE
REPORTED JUST ONCE.
THERE WERE 362 RETROSPECTIVE
REPORTS RECEIVED AFTER THE
OUTCOME OF PREGNANCY WAS KNOWN.
AND AMONG THE 25 REPORTS OF
MAJOR BIRTH DEFECTS 15 INCLUDE
AN ISOLATED CONGENITAL ANOMALY
THAT INCLUDE KIDNEYS --
[ INAUDIBLE ]
--
>> FOUR HAD ABNORMAL SPEECH,
THREE HAD MULTIPLE ANOMALIES AND
THREE HAD MULTIPLE ANOMALIES BY
CHROMOZONAL ABNORMALITIES.
>> IT'S A REGULATORY OBLIGATION
OF COLLECTING INFORMATION.
REGARDLESS IN PREGNANCIES, TO
DATE, WITH NEARLY 5,000 REPORTS
AND 2,800 INVOLVED SUBJECTS
SINCE THE 31st OF MAY, 2012.
AS I SAID BEFORE, THE DATA AND
INFORMATION IS SPECIFIC.
IN ADDITION, IDENTIFY THE
PATTERN WITH BIRTH DEFECTS.
THEY ARE INCLUDED IN ABORTIONS
AND AT OR BELOW BACKGROUND RATE.
THE CONTINUATION OF THE REGISTRY
WILL NOT BE SIGNIFICANTLY
INCREASED OF BETTER PREGNANCY
OUTCOMES.
NOW ON GOING AND FUTURE --
[ INAUDIBLE ]
-- THE ACTIVITIES WILL
CONTINUE -- AND FOLLOW UP
ATTEMPTS IN ALL CASES WILL
CONTINUE.
AND THE ANALYSIS WILL CONTINUE
BEING TAKEN TO REGULATORY
AGENCIES.
6,000 OF THESE CONTINUATION
THE REGISTRY AND A COMPANY
CONTINUE INTEREST IN THE REPORTS
OF EXPOSURE DURING PREGNANCY.
IN ADDITION, A SUMMARY OF THE
RESULT OF THE PREGNANCY REGISTRY
WILL BE ADDED TO THE LABEL.
PUBLISH THE FLY BALL DATA IN A
PEER REVIEWED JOURNAL.
IN SUMMARY, THE DATA FROM THE
REGISTRY, REGARDING THE RATE OF
THE SPONTANEOUS ABORTIONS.
FAVORABLY THE BACKGROUND RATES.
THEY HAVE BEEN CONSISTENT WITH
THE GROUND RATES OTHER THAN THE
RESULT OF VACCINE EXPOSURE AND
INDICATES THAT THE ANOMALIES ARE
IN EXPOSURE.
IT'S THE VACCINE AND THE BIRTH
DEFECT REPORTED TO THE REGISTRY.
[ INAUDIBLE ]
-- INCLUDING THE REPORTS OF
EXPOSURE DURING PREGNANCY AND
FINALLY, FDA, AND HEALTHCANADA,
FULFILLED THE REGULATORY
COMMITTEE.
THEY HAVE ENOUGH INFORMATION TO
UPDATE THE LABEL.
THANK YOU.
>> WHY DON'T WE GO AHEAD WITH
ANY QUESTIONS REGARDING THE
REGISTRY AT THIS POINT IN TIME?
>> CAN YOU EXPLAIN WHAT THE
DIFFERENCE IS BETWEEN REGISTRY
AND WHAT YOU PLAN TO DO IN THE
FUTURE IF YOU'RE STILL GOING TO
SUBMIT EACH CASE AND DO
ANALYSIS.
>> ABSOLUTELY.
WHEN WE HAD THE REGISTRY WE MADE
SEVERAL CALLING THE PHYSICIAN
AND REALLY TRACKING DOWN ON
THESE PERSPECTIVE REPORTS AND
FOR TWO YEARS WE WERE ASKING TO
MAKE SURE THAT WE GET ALL OF THE
INFORMATION.
HOWEVER, NOW, WITH THE FUTURE
ACTIVITIES WE ARE GOING TO SEND
LETTERS TO PROVIDERS, TO REQUEST
MORE INFORMATION, AND WE ARE
GOING TO CONTINUE WRITING IN THE
PERIODIC SAFETY UPDATES THE
REPORT THAT WE RECEIVE.
>> DO YOU HAPPEN TO HAVE THE
BACKGROUND RATE FOR ELECTIVE
ABORTION IN THE GENERAL
POPULATION.
?
I THINK IN YOUR REGISTRY YOU HAD
102 OUT OF 2,440 PERSPECTIVE
CASES.
>> YEAH, CAN I MOVE TO THAT
SLIDE?
I THINK IT'S NUMBER SIX.
NUMBER SIX.
YEAH, IT'S SLIDE NUMBER SIX.
AND THAT NUMBER -- I ELECTIVE
ABORTIONS.
>> I'M JUST CURIOUS IF A WOMAN
FINDING OUT SHE WAS VACCINATED
WOULD BE MORE LIKELY TO
TERMINATE THE PREGNANCY.
>> I DON'T HAVE THAT RATE AT
THIS MOMENT.
>> IN THE UNITED STATES YOU'RE
ASKING FOR HOW MANY WOMEN
TERMINATE PREGNANCY IN GENERAL.
>> JUST THE BACKGROUND RATE.
>> ABOUT A THIRD.
>> SO THIS IS LOWER THAN
EXPECTED.
THANK YOU.
>> I HAVE A QUESTION, IN THE
CONGENITAL ANOMALIES, DID YOU
LOOK AT WHETHER MOST OF THEM
WERE FIRST DOSE OR SECOND DOSE
OF VACCINE?
THERE'S FEW CASES BUT --
>> 91% AND THEY HAVE THAT
INFORMATION.
>> SO WERE THEY FIRST DOSE
RECIPIENTS.
>> YES, 76%.
>> OTHER QUESTIONS OR COMMENT?
OKAY.
THEN I THINK WE MOVE ON TO DR.
DUNNE.
>> GOOD AFTERNOON, I'LL BE
DISCUSSING ISSUES FOR
CONSIDERATION IN THE UPDATED HPV
VACCINE STATEMENT.
AS HIGHLIGHTED BY THE DOCTOR, I
WANTED TO HIGHLIGHT THE
INFORMATION FOR THE STATEMENTS
AND IT WILL INCLUDE UPDATES TO
HPV VACCINE DATA AND SAFETY DATA
AS WELL AS IMPACT AND
COST-EFFECTIVENESS.
SINCE THE STATEMENT FROM 2007,
THERE'S BEEN MANY CHANGES THAT
NEEDED TO BE INCORPORATED.
ALSO IN THE UPDATED ACIP
STATEMENT THERE WILL BE NO
WORDING CHANGES IN PREGNANCY BUT
WE'LL BE MAKING A CHANGE IN
INFORMATION ABOUT THE PREGNANCY
REGISTRY REPORTING, AS YOU HEARD
EARLIER, THE QUADRIVALENT IS NO
LONGER IN EXISTENCE.
THE REPORTING REMAINS THE NAME.
ALSO FOR EVALUATIONS OF CHILD
SEXUAL ABUSE THE RECOMMENDATION
WILL BE TO START THE SERIES AT
AGE 9 YEARS.
SO I'LL BE ADJUSTING THE FOLLOW
ISSUES TODAY FOR THE UPDATED
ACIP STATEMENT INCLUDING UPDATED
INFORMATION ON IMMUNO
COMPROMISED PERSONS AND MALES
THROUGH 26 YEARS FOR THE END
STAGE RENAL DISEASE AND
INCLUDING INFORMATION ABOUT
SELECT HEALTHCARE WORKERS AND
HPV LABORATORY WORKERS.
THE NEW DATA ON HPV VACCINE AND
HIV INFECTED PERSONS PUBLISHED
AND NOW ONE CLINICAL TRIAL IN
MEN, TWO IN WOMEN AND TWO IN
CHILDREN AND THESE STUDIES
DEMONSTRATED AN ACCEPTABLE
SAFETY PROFILE AND NEW RESPONSE
TO VACCINES AND SOME STUDIES
HAVE FOUND DIFFERENCES IN THE
ANTIBODY 2 HPVS COMPARED TO
HISTORIC CONTROLS HOWEVER IT'S
UNCLEAR IF THIS FINDING HAS
CLINICAL SIGNIFICANCE.
AND FOR OTHER IMMUNO COMPROMISED
POPULATIONS, PERSONS WITH
TRANSPLANTS OR AUTO IMMUNE
DISORDERS THERE'S ON GOING
EVALUATIONS.
WE PROPROSE INCLUDING THESE
UPDATES IN THE REVISED STATEMENT
AND MALE AND FEMALE
RECOMMENDATIONS.
SO I'D LIKE TO NEXT DISCUSS THE
PROEASY POSED CHANGES FOR THE
CURRENT ADULT SCHEDULE FOR HPV
VACCINE.
I WANTED TO HIGHLIGHT THE
CURRENT SCHEDULE FOR VARIOUS
MEDICATIONS AND FOCUS YOUR
ATTENTION ON HP VACCINATIONS FOR
MALE AND FEMALE WHICH IS IS
NOTED AS THE 4th AND 5th LISTED
VACCINE HERE.
FOR MALES, IT'S RECOMMENDED
THROUGH 26 YEARS FOR INFECTIONS
AND IMMUNO COMPROMISED
CONDITIONS AND MEN THAT HAVE SEX
WITH MEN.
FOR CHRONIC LIVER DISEASE,
KIDNEY FAILURE, DIABETES AND
HEALTHCARE PERSONNEL, THE
RECOMMENDATIONS ARE THE SAME AS
FOR THE GENERAL RECS FOR MALES
THROUGH 21 YEARS.
WHEN WE CONDUCTED A REVIEW OF
THE LITERATURE AND HPV DISEASE
AND CANCER, THERE WAS A HIGHER
VERSION OF HPV IN CANCER FOR
ONLY ONE WHICH IS KIDNEY
FAILURE.
WE PROPOSED EXTENDING
VACCINATIONS FOR MALES THROUGH
AGE 26 YEARS FOR THIS MEDICAL
INDICATION.
THIS WOULD MEAN INCLUSION OF
THIS INFORMATION IN THE UPDATED
STATEMENT AS WELL AS A CHANGE IN
THE MEDICAL INDICATIONS
SCHEDULE.
THE REASONS TO EXTEND TO AGE
26-YEAR-OLD MALES FOR THE
SPECIFIC INDICATIONS ARE THAT
DATAS SHOW A HIGHER BURDEN OF
HPV ASSOCIATED DISEASES
INCLUDING ANAL GENITAL WARTS AND
CERVICAL DYSPLASIA FOR BOTH END
STAGE PATIENTS AS WELL AS THE
POST RENAL TRANSPLANTS.
AND THERE'S NO DATA ON
EFFICACIES SPECIFIC TO THIS.
AND THEN A POINT IS THERE IS
LIKELY TO BE A BENEFIT TO
VACCINATION EARLY, ESPECIALLY
SINCE MANY YOUNG PERSONS WITH
END-STAGE RENAL DISEASE WILL
EVENTUALLY RECEIVE RENAL
TRANSPLANT.
AS A NOTE, WE ALREADY RECOMMEND
VACCINATIONS FOR PERSONS
POSTTRANSPLANT THROUGH AGE 26
YEARS.
SO AS -- NEXT I'D LIKE TO
DISCUSS THE QUESTION OF HPV
LABORATORY WORKERS AND SELECT
HEALTHCARE WORKERS.
WE POSE THESE QUESTIONS LISTED
HERE INCLUDING, IS THERE A RISK
TO HPV LABORATORY WORKERS IF
AKIE
ACQUIRING HPV AND ALSO THE RISK
TO HEALTHCARE WORKERS OF AKWIERG
HPV SECONDARY.
THE SECOND ISSUE WAS ALSO
CONSIDERED FOR THE STD TREATMENT
GUIDELINES MEANING IN APRIL OF
2013.
SO FOR THE FIRST QUESTION ABOUT
LABORATORY WORKERS, IT'S
IMPORTANT TO NOTE THAT HPV IS
DIFFICULT TO CULTURE AND PCR FOR
DNA IS USED TO EVALUATE FOR
INFECTION.
SOME RESEARCH LABORATORIES ARE
WORKING WITH WILD TYPE HPV AS
WELL AS NEW OR SYNTHESIZED TO
CHARACTERIZED THE NATURAL
HISTORY AND IMMUNITY TO HPV.
THERE'S OVER SIX U.S.
LABORATORIES AND OTHER GLOBAL
LABORATORIES IN WHICH THE LAB
GENERATED ONES ARE BEING
PRODUCED.
THERE'S TWO TYPES TO USE IN THE
LAB.
THERE'S WILD TYPE HPV WHICH ARE
GENERATED IN THE LAB AND GROWN
IN IMMUNO COMPROMISED ANIMALS OR
IN CULTURES.
IN A GENERATION OF THESE IS TIME
CONSUMING AND PRODUCES VERY LOW
VIRUS YIELDS.
BUT SOME NEWER TECHNIQUES
RECENTLY INTRODUCED ALLOW
DEVELOPMENT OF LAB GENERATED
ONES CALLED PSUEDOVERIONS.
THEY HAVE NO GENES AND ARE NOT
BELIEVED TO BE INFECTIOUS.
FOR THE PURPOSES OF THIS
DISCUSSION I WON'T TALK ABOUT
THEM FURTHER.
HOWEVER, ANOTHER SYNTHESIZED ONE
IS LAB GENERATED AND SYNTHESIZED
IN A 293 CELL SYSTEM AND THEY
CONSIST OF THE PROTEINS WHICH
INC
INCAPSULATE THE COMPLETE VIRUS.
AND ARE DIFFERENT FROM THE WILD
TYPE PAPILLOMAVIRUS.
THEY HAVE THE PROTEINS IN THE
29223 CELL SYSTEM AND WITHIN 72
HOURS THEY'RE PRODUCED AND
PURIFIED AND THE SYNTHESIS OF
THESE PRODUCES 1,000 TIMES MORE
INFECTIOUS VIRUS PER CELL
CULTURE THAN ORGANIC CULTURE
SYSTEMS.
WHILE THEY'RE INFECTIOUS AND
THIS IS TO DEMONSTRATE USING
ANIMAL MODELS IN WHICH RABID
PAPILLOMAS WERE SPPRODUCED.
THEY INCLUDE ELEMENTS ASSOCIATED
WITH DISEASE AND CANCER
DEVELOPMENT.
THE CELL SYSTEM PRODUCES VIRUS,
OVER 1,000 TIMES MORE THAN THE
WILD TYPE SYSTEM AND UP TO 10
UNITS FROM A SINGLE FLASK.
IT'S IMPORTANT TO NOTE THAT THE
MINIMAL INFECTIOUS DOSE IS NOT
KNOWN.
SOME OF THE POTENTIAL EXPOSURES
THAT CAN HAPPEN IN THE
LABORATORY INCLUDE EXPOSURE
THROUGH RESPIRATORY ROUTES.
THERE ARE KNOWN ONES IN THE LAB
THAT POTENTIAL RISK TO LAB
WORKERS IS REALLY NOT BEING
CHARACTERIZED.
THERE'S NO EVIDENCE OF PREVIOUS
EXPOSURE, INFECTION AND DISEASE
IN THE LABORATORY ALTHOUGH THIS
IS SOME WHAT DIFFICULT TO
ASSESS.
THERE'S BEEN INOCULATOIN IN
RABBITS THAT DID DEMONSTRATE
DISEASE AS I NOTED EARLIER.
THERE'S A POTENTIAL RISK TO
RESEARCH HPV LAB WORKERS WORKING
WITH THESE.
HOWEVER THERE ARE LIMITED DATA
ON RISK AND NO TRANSMISSION OR
VACCINE ETH KA SI FOR THESE
EXPOSURES.
WE PROPOSE ADDING LANGUAGE FOR
THE UPDATED STATEMENT AND I'LL
DISCUSS THIS LANGUAGE AT THE END
OF THE PRESENTATION.
SO FOR THE SECOND QUESTION, IS
THERE A RISK TO HEALTHCARE
WORKERS OF ACQUIRING HPV DURING
TREATMENT OF AAL GENERAL TIITAL
DEMONSTRATED INTACT HP DNA
AND ONE ALSO LOOKED AT THAT.
THERE'S EVIDENCE FROM AN ANIMAL
MODEL THAT THESE FROM THE SMOKE
PLUME ARE INFECTIOUS AND FINALLY
THERE'S TWO CASE REPORTS OF
PAPILLOMAS REPORTED IN
HEALTHCARE WORKERS THAT TREATED
PERSONS WITH ANAL GENITAL WARTS.
IT'S UNCLEAR IF RP WAS A RESULT
OF THIS EXPOSURE.
THE ONE STUDY EVALUATED SMOKE
PLUMES GENERATED FROM LASER OF
PAPILLOMAS IN COWS AND IT WAS
REINNOCULATED IN THE COWS AND
ALL OF THEM DEVELOPED PAPILLOMAS
AT THE SITE.
IMPORTANT TO NOTE, THERE'S
CURRENT INFECTION CONTROL
PRACTICE RECOMMENDATIONS.
THEY ISSUED DPIE DANCE ON LOCAL
EXHAUST VENTILATION OR A SMOKE
SO IN SUMMARY, SMOKE PLUMES
GENERATED BY ELECTROCAUTERY AND
CO 2, AND USE OF A SMOKE
EVACUATOR.
IT'S UNCLEAR IF IT LEAD TO THE
DISEASE AND WE PROPOSE LANGUAGE
FOR INCLUSION IN THE YOU WANT
DATED ACIP STATEMENT.
I'D LIKE TO SHARE THAT DRAFT
LANGUAGE WITH YOU AND READ IT TO
YOU.
RESEARCH HP LABORATORY AND
SELECT HEALTHCARE WORKERS MIGHT
HAVE AN INCREASED RISK OF
ACQUIRING HPV FROM OCCUPATIONAL
EXPOSURES.
THESE PERSONS INCLUDE THOSE
WORKING IN LABORATORIES AND
HANDLING WILD TYPE VIRUS IN
HEALTHCARE WORKERS TREATING
GENITAL WARTS WITH LASER CO 2 OR
ELECTROCAUTERY.
IT SHOULD BE INSTITUTED
INCLUDING A MINIMUM OF BS 2.
THOSE TREATING AAL GENITAL WARTS
SHOULD HAVE VACUUM VENTILATION
AND THE NEED FOR ANY ADDITIONAL
INVESTIGATED.
IT'S UNCLEAR THERE THERE WOULD
BE A BENEFIT ANY SETTINGS SINCE
THERE'S NO INDICATION OF RISK OR
VACCINE ETHICACY.
I'D LIKE TO THANK THOSE THAT
CONTRIBUTED TO THE ASSESSMENT.
>> THANK YOU.
>> I HAVE A QUESTION ABOUT THE
SURGICAL SMOKE.
I WOULD LIKE THERE TO AT LEAST
BE SOME CONSIDERATION OF
LANGUAGE FOR RESPIRATORY HELP
FOR THOSE DOING THOSE
PROCEDURES.
IT SEEMS REASONABLE WITH 95 OR
HIGHER RESPIRATORY PROTECTION.
BUT I JUST WONDERED IF YOU WOULD
DISCUSS THAT.
>> THAT'S A GREAT POINT.
WE HAVE BEEN DISCUSSING
POTENTIALLY OTHER INFECTION
CONTROL PRACTICES SUCH AS
PERSONAL PROTECTIVE EQUIPMENT
WITH OUR DIVISION OF HEALTHCARE
QUALITY AND WE ARE HAVING SORT
OF ACTIVE CONVERSATIONS ABOUT
OTHER STEPS THAT MAY OR MAY NOT
BE NEEDED.
AT THIS POINT, THERE'S -- SO
THAT'S UNDER CONSIDERATION.
>> THANK YOU.
>> TWO QUESTIONS RELATED TO THE
HEALTHCARE WORKER
RECOMMENDATION.
FIRST, DO YOU PROPOSE ANY AGE
RESTRICTION ON IT?
I WOULD ASSUME NOT.
AND SECONDLY, I'M WONDERING
ABOUT THE RECOMMENDATION THAT
ONLY HEALTHCARE WORKERS DOING
THESE SPECIFIC TYPES OF SURGERY
ARE INCLUDED.
I WOULD IMAGINE PEOPLE COULD BE
A-SYMPTOM ATTICLY INFECTED AND
PEOPLE DOING CAUTERY IN THE ANAL
GENITAL REGION IN GENERAL COULD
BE AT RISK.
>> LET ME GO TO THE SECOND
QUESTION ABOUT OTHER KINDS OF
EXPOSURES TO SMOKE PLUME.
>> YEAH FROM ANY SURGERY IN THE
ANAL GENITAL REGION.
NOT JUST ON GENITAL WARTS.
>> THAT'S A GOOD POINT.
MOST OF THE CASES AS A
DESCRIBED, THE KIND OF
EVALUATIONS PRIMARILY OCCUR WITH
ANAL GENITAL WARTS AND CIN AND
THERE COULD BE OTHER AREAS THAT
ALSO USE THE TECHNIQUES.
THAT'S A GOOD POINT.
WHAT WAS THE FIRST QUESTION
AGAIN.
>> WHETHER THERE WOULD BE ANY
AGE RESTRICTION.
>> SO IT'S PRIMARILY FOR
INFORMATIONAL PURPOSES AND IT
WOULD BE INCLUDED IN THE DRAFT
STATEMENT BUT THERE WOULD BE NO
SPECIFIC VACCINE
RECOMMENDATIONS.
>> WOULD YOU CONSIDER EXTENDING
THIS TO ORAL CANCERS OR OTHER
CANCERS THAT ARE PROBABLY HPV
RELATED IN TERMS OF HEALTHCARE
WORKER EXPOSURES?
>> THAT'S A GREAT QUESTION ABOUT
OTHER KINDS OF TREATMENTS OF
OTHER TYPES OF CONDITIONS.
I GUESS THE QUESTION I WOULD
NEED TO ADDRESS IS WHETHER THESE
KINDS OF PROCEDURES ARE BEING
USED FOR ORAL CANCERS.
I'M NOT CLEAR ABOUT THAT SO WE
CAN ADDRESS THAT IN FOLLOW UP.
>> PARTICULARLY FOR ABLATION OF
LESIONS.
I'M SURE THAT CAUSES SMOKE.
>> YEAH.
I'LL FOLLOW THAT UP WITH THE
GROUP THAT WORKS WITH CANCERS
AND WE CAN CONSIDER THAT AS
WELL.
>> WHAT IS BEING PROPOSED ON
MALES FOR THOSE WITH KIDNEY
FAILURE AND END STAGE RENAL
DISEASE?
BECAUSE I DON'T SEE ANY WORDING
ON THAT.
ARE WE VOTING ON THAT?
NOT TODAY?
THAT'S GOING TO BE CONSIDERED?
>> WHAT WE'RE PROPOSING IS
EXTENDING JUST THE MEDICAL
INDICATIONS FOR KIDNEY FAILURE
THROUGH AGE 26 YEARS FOR MALES
FOR THAT SPECIFIC MEDICAL
INDICATION.
BUT NO, WE DON'T HAVE A VOTE AT
THIS MEET
>> SO IS THAT A PLAN FOR THE
FUTURE?
IS THAT A DECISION THAT'S BEEN
MADE OR IS THAT A DECISION
THAT'S PENDING?
>> THIS SESSION WAS PRIMARILY TO
DESIGNED FOR OUR INFORMATION
ABOUT WHAT WE'RE PROPOSING.
I THINK IT WILL BE UP TO OTHERS
TO CONSIDER WHETHER A FORMAL
VOTE WILL NEED TO BE CONSIDERED
FOR THAT INDICATION.
>> AT THIS POINT I THINK IT'S
INFORMATIONAL.
THE QUESTION IS WHETHER OR NOT
THIS IS AN EXPANSION TO THE
LEVEL OF WHICH REQUIRES A VOTE
FOR RECOMMENDATION OR NOT.
AND I THINK THAT IS SOMETHING WE
MAY WANT TO DISCUSS.
>> I CAN ASSURE YOU IT WILL BE
SOMETHING THE ADULT
IMMUNEIZATION GROUP WILL
DISCUSS.
>> I WAS GOING TO SAY THE SAME
THING.
THAT WOULD COME BEFORE THE
COMMITTEE FOR CONSIDERATION.
AS THE STATEMENT IS UPDATED.
>> PROCEDURALLY I'M CONFUSED.
>> IT'S TO GET FEEDBACK AND ANY
AREAS THAT SHOULD BE FURTHER
INVESTIGATED.
>> THANK YOU.
>> SO I THINK TECHNICALLY IF IT
IS A RECOMMENDATION WE MAKE, WE
PROBABLY SHOULD HAVE IT AS
EMOTION AND SECONDED AND VOTED
UPON IF, INDEED THAT IS -- IF
YOU CAN INFORM US.
>> YEAH, MY UNDERSTANDING WAS --
CAN YOU TURN YOURS OFF -- I
THINK TODAY WAS -- SOMEBODY
NEEDS TO TURN THAT ONE OFF.
>>> I UNDERSTAND THAT I THINK
THE GROUP WAS TRYING TO CATCH
THE COMMITTEE UP ON ALL OF THE
ISSUES THEY HAVE BEEN TALKING
ABOUT SO IT'S A GOOD TIME IF YOU
HAVE QUESTIONS ABOUT THE BEST
WAYS THEY SHOULD BE THINKING OR
CONSIDERING THE RENAL --
END-STAGE RENAL DISEASE BUT IT
WOULD BE AT A FUTURE MEETING
WHERE DECISIONS ABOUT ANY
SUBSTANTIVE CHANGES COULD GET
VOTED ON.
THIS ISN'T TO SAY WE'LL NEVER
VOTE.
IT'S TO SAY THAT THE COMMITTEE
IS WORKING ON A LOT OF ISSUE.
>> I SEE THIS AS SIMILAR TO THE
MMR GROUP THAT LOOKED AT NEW
DATA REGARDING, FOR EXAMPLE, HIV
INFECTED INDIVIDUALS.
IT WAS PRESENTED ONCE OR TWICE
PRIOR TO THE TIME THAT IT WAS
ALL PUT INTO A PACKAGE AND EACH
OF THOSE COMPONENTS WERE VOTED
UPON.
SO HOPEFULLY THIS IS GOING TO
BE -- I THINK IT'S HEADED IN THE
SAME DIRECTION.
>> SO PRESUMABLY BEFORE IT CAME
TO A VOTE, MANY WOULD BE BRIEFED
ON THE RISK OF HOW HIGH THE
INCREASED RISK IS, WHETHER THERE
ARE CERTAIN SUBGROUPS OF END
STAGE RENAL DISEASE.
DID THEY HAVE OTHER RISK FACTORS
THAT PREDISPOSE THEM TO THESE
DISEASES, SO ON AND SO FORTH.
>> BEFORE THEY WOULD VOTE.
>> THE COMMITTEE WOULD CERTAINLY
BRING FORWARD THE EVIDENCE AND
SPECIFIC RECOMMENDATIONS AT THE
APPROPRIATE TIME.
>> I HAVE A QUESTION GETTING
BACK TO THE PREGNANCY ISSUE.
YOU MENTIONED THAT YOU'RE NOT
GOING TO CHANGE THE LANGUAGE BUT
WOULD YOU CONSIDER, GIVEN THE
POSITIVE NEWS WE HEARD ABOUT
GARDASIL, WOULD YOU CONSIDER IF
THERE ISN'T INADVERTENT
PREGNANCY THEN NOT DO AN
ELECTIVE TERMINATION.
SORT OF ALONG THE LANGUAGE OF
MMR.
>> THAT'S ALREADY INCLUDED.
>> OKAY.
>> I'M WONDERING IF WE COULD GET
A GUESSTIMATE OF THE LABORATORY
PERSONNEL INVOLVED?
THE PEOPLE INVOLVED ARE EXPOSED
TO SMOKE IS NOT UNCOMMON BUT THE
NUMBER OF PEOPLE WORKING IN THE
LABORATORIES I WOULD GUESS COULD
BE COUNTED ON A COUPLE OF HANDS.
>>> YES, THAT'S CORRECT.
ONE OTHER FOLLOW UP POINT IS THE
MBL IS ALSO GOING TO BE
EVALUATING THE -- THIS IS A NEW
TECHNIQUE, THE SYNTHESIS SO
THEY'RE ALSO GOING TO BE
CONSIDERING THIS IN THE FUTURE.
>>> IN TERMS OF THE END STAGE
RENAL DISEASE IS THE BURDEN THE
ANAL GENITAL WARTS OR MORE
SURGICAL DYSPLASIA?
BECAUSE THERE'S IMPLICATIONS OF
WHICH VACCINE IS LIKELY TO BE
MORE EFFECTIVE FOR PREVENTION OF
THOSE.
>> THAT'S A GOOD QUESTION.
MOST OF THE DATA IS DESCRIPTIVE
DATA OF ANAL GENITAL LESIONS BUT
ONE DISKRIPGS OF CERVICAL
DYSPLASIA.
THERE'S NO INFORMATION OR RATES
OR INCIDENTS AND THERE'S NO DATA
ON VACCINE EFFICACY IN THIS
PARTICULAR GROUP ALTHOUGH THERE
ARE ON GOING STUDIES I BELIEVE
THAT ARE BEING CONDUCTED IN THIS
POPULATION.
>>> WE HEARD DATA ABOUT THE
DURABILITY OF NOT BEING WHAT WE
THOUGHT IT WAS.
CAN YOU GIVE US THE LATEST ON
THE DURABILITY OF HPV
ANTIBODIES.
>> YEAH, I THINK WE HAVE DATA
THAT HAS BEEN PRESENTED BEFORE
THE WORK GROUP THROUGH ABOUT 6
TO 10 YEARS DEPENDING ON THE
VACCINES THAT SHOW IMMUNE
RESPONSE TO THE VACCINATION.
IS THAT WHAT YOU WERE REFERRING
TO?
>> ANY ADDITIONAL QUESTIONS?
THEN I THINK, DR. MARKOWITZ.
>> SO TO CLOSE THE SESSION, I'M
GOING TO REVIEW THE HP
VACCINATION PROGRAM AND IMPACT
MONITORING AND I WILL REVIEW A
VARIETY OF TOPICS BRIEFLY.
SOME OF THE DATA HAVE BEEN
UPDATED.
FIRST OF ALL THE VACCINATION
PROGRAM VERY BRIEFLY I'LL REVIEW
A BRIEF UPDATE ON VACCINE SAFETY
AND THEN TALK ABOUT VACCINE
IMPACT MONITORING.
SO THIS IS A REVIEW OF OUR
RECOMMENDATIONS IN THE U.S.
WHICH I THINK YOU ALL KNOW THAT
ACIP FOR AGES 11 TO 12 AND UP TO
26 FOR THOSE NOT PREVIOUSLY
VACCINATED AND THEN 2009 AFTER
IT WAS LICENSED THEY ADVISED
RECOMMENDATIONS TO STATE THAT
EITHER VACCINE COULD BE USED.
IN 2009 IT WAS LICENSED FOR USE
IN MALES AND A ROUTINE
RECOMMENDATION WAS NOT MADE BUT
IN 2011 THEY RECOMMEND THE
VACCINE NOR MAFOR MALES 11 AND
YEARS AND THROUGH AGE 21.
AND THIS SLIDE ARE DATA FROM THE
NATIONAL IMMUNIZATION SURVEY
TEAM FROM 2006 AND 2011 FOR ALL
ADOLESCENT VACCINES.
AS OF 2011, 78% OF ADOLESCENTS
RECEIVED TDAP, 76% RECEIVED THE
VACCINE AND 53% OF GIRLS
RECEIVED ONE OR MORE DOSES OF
HPV VACCINE AND 35% RECEIVED ALL
THREE DOSES AND AS ALSO, YOU CAN
SEE HERE EACH YEAR THERE IS
ABOUT A 10 PERCENTAGE POINT
INCREASE IN COVERAGE FOR TDAP
BUT IN THE PAST THREE YEARS WE
HAVE SEEN VERY LITTLE INCREASE
IN COVERAGE FOR HPV VACCINE.
VACCINATION STATUS AMONG PARENTS
OF UNVACCINATED GIRLS ARE ALSO
AVAILABLE FROM THE NIS SURVEYS.
AND SHOWN HERE IS THE TOTAL
POPULATION OF GIRLS FOR IS
SURVEY YEARS 2008 TO 2011 AND
EACH YEAR THE PROPORTION OF
VACCINATED GIRLS HAS INCREASED
SHOWN IN PINK AND SUBSEQUENTLY
DECREASING THE REPORT THERE SOME
WHAT ARE VERY LIKELY TO HAVE
THEIR DAUGHTER VACCINATED AND
THE PROPORTION OF PARENTS TO
REPORT THAT THEY ARE NOT LIKELY
TO RECEIVE -- FOR THEIR DAUGHTER
TO RECEIVE VACCINE IN THE NEXT
12 MONTHS REMAINED CONSTANT AT
ABOUT 25% SHOWN IN BLUE.
WE DON'T KNOW IF THIS MEANS THAT
THEY ARE NEVER INTENDED TO
VACCINATE THEIR DAUGHTER OR THEY
ARE WAITING FOR SOME TIME IN THE
FUTURE.
>> IN 2011, THE TOP FIVE REASONS
FOR NOT VACCINATING THEIR
DAUGHTER AMONG PARENTS THAT SAID
THEY HAD NO INTENTION TO
VACCINATE IN THE NEXT 12 MONTHS
WERE FEELING THE VACCINE IS NOT
NEEDED OR NECESSARY.
THEIR DAUGHTER IS NOT SEXUALLY
ACTIVE.
THEY HAD SAFETY CONCERNS.
LACK OF KNOWLEDGE ABOUT THE
VACCINE AND NO RECOMMENDATION BY
A PROVIDER.
WHILE NIS TEEN SURVEY COLLECTS
DATA ON 13 TO 17 YEAR OLDS THE
NATIONAL HEALTH INTERVIEW SURVEY
COLLECTS DATA ON OLDER
INDIVIDUALS AND IN CONTRAST THE
NATIONAL IMMUNIZATION SURVEY,
NHIS VACCINATION HISTORY ARE
FROM SELF-REPORT WHERE NIS DATA
ARE FROM PROVIDER RECORDS.
YOU CAN SEE 2010-2011 IT
INCREASED FROM 29.7 TO 29.5 AND
THE LARGEST INCREASE WAS WHEN IT
INCREASED FROM 43.2% TO 43.1%.
IT IS NOT COLLECTED IN THE
SURVEY TO IT'S UNCLEAR IF THE
VACCINATION OCCURRED AS AN ADULT
AND THEN OR NOT THEY WERE PART
AGED INTO IT.
>> NOW A BRIEF UPDATE ON VACCINE
SAFETY.
EVERYONE KNOWS HERE THAT UPDATES
ON VACCINE SAFETY HAVE BEEN
PROVIDED PERIODICALLY.
AS FOR OTHER VACCINES, THE
IMMUNIZATION SAFETY OFFICE,
SAFETY MONITORING INFRASTRUCTURE
HAS THREE COMPONENTS WHICH IS
THE SYSTEM OF ADVERSE EVENTS
REPORTING.
THE VACCINE SAFETY DATA LINK AND
JUST BRIEF DESCRIPTION OF EACH
OF THESE IS ON THE SLIDE.
>> ABOUT 56 MILLION DOSES OF
QUADRIVALENT VACCINE WERE
DISTRIBUTED IN THE U.S. BETWEEN
JUNE 2006 AND MARCH 2013.
NO NEW SAFETY CONCERNS HAVE BEEN
IDENTIFIED IN RECENT ANALYSES OF
THE POST LICENSURE SAFETY DATA
AMONG MALES OR FEMALES.
AMONG THE 7.9% OF REPORTS THEIRS
WERE CODED AS SERIOUS AND THOSE
FREQUENTLY CITED EVENTS ARE
HEADACHES, NAZ I CAN'T,
VOMITING, FATIGUE AND
GENERALIZED WEAKNESS AND THE
PATTERN OF THE REPORTS, SERIOUS
AND NONSERIOUS AND THE FIRST
THREE AND A HALF YEARS OF THE
DATA.
AND IT CONTINUES TO BE A
REPORTED EVENT IN ADOLESCENTS.
NOW OF NOTE, IN THIS SLIDE, WE
SHOW THE ADVERSE EVENTS
REPORTING TO QUADRIVALENT
VACCINES ADMINISTERS TO FAMILIES
AND IT DECREASES AFTER 2008 AND
ALSO SHOWN HERE ARE THE
PROPORTION OF ALL EVENTS THAT
WERE SERIOUS EVENTS AND THESE
ALSO DECLINED FROM THE PEAK IN
2009 WHERE THEY ACCOUNTED FOR
12.8% OF ALL EVENTS TO 7.4% IN
2013.
IN TERMS OF THE VACCINE SAFETY
DATA LINK, TO DATE, MORE THAN 1
MILLION DOSES HAVE BEEN GIVEN TO
THOSE WITHIN THE NETWORK.
ABOUT 270,000 TO MALES AND THE
IMMUNIZATION SAFETY OFFICE IS
WAITED UNTIL A LARGE ENOUGH
NUMBER WAS ADMINISTERED TO MALES
TO START THEIR RAPID CYCLE AND
THAT WILL BEGIN THIS YEAR.
AS PREVIOUSLY PUBLISHED CARRIED
OUT IN 7 HMOS AMONG 600,000
DOSES, FEMALES 9 TO 26 YEARS OF
CONDUCT AND PUBLIC INTOXICATION,
THERE WAS NO SIGNIFICANT
INCREASE RISK FOR ANY OF THE
PRESPECIFIED ADVERSE EVENTS
WHICH I LIST ON THE SLIDE AND
THE LONGER TERM SURVEILLANCE OF
STROKE AMONG FEMALES 9 TO 26
YEARS OLD FOLLOWING QUADRIVALENT
VACCINE WAS EVALUATED AND NO
INCREASED RISK WAS OBSERVED.
THEY'RE AT THE PROCESS OF BEING
WRITTEN UP AT THE PRESENT TIME
AND WILL BE AVAILABLE IN A
PUBLICATION.
AS YOU HEARD EARLIER TODAY THERE
WERE NO SAFETY CONCERNS RAISED
BY THE VACCINE AND PREGNANCY
REGISTRY FOR THE QUADRIVALENT
VACCINE.
THEY'LL CONTINUE TO MONITOR THE
SAFETY INCLUDING REPORTS IN
PREGNANT WOMEN AND WE ALSO
THAT MERK WILL CONTINUE TO
COLLECT THIS INFORMATION AS
WELL.
A RETROSPECTIVE ANALYSIS OF
REPORTS IN 85%
OF REPORTS ARE SUBMITTED THROUGH
THE MERK VACCINE REGISTRY,
PREGNANCY REGISTRY, IT'S
ANTICIPATED THERE WILL BE A
SIMILAR SAFETY PROFILE AS WAS
REPORTED BY THE MERK PREGNANCY
REGISTRY.
AND FOR 'S A
DESCRIPTIVE STUDY LOOKING AT
ADVERSE EVENTS FOLLOWING
INADVERTENT EXPOSURE DURING
PREGNANCY AND THOSE DATA WILL BE
AVAILABLE BY 2015.HPV
VACCINE IMPACT MONITORING.
FOR IMPACT MONITORING, IT'S VERY
HELPFUL TO CONSIDER EARLY, MID
AND LATE OUTCOMES BASED ON WHEN
WE WOULD EXPECT TO SEE OUTCOMES
BASED ON THE HISTORY OF
OUTCOMES, EARLY WOULD BE GENITAL
WARTS AND MID OUTCOMES WOULD BE
PRECANCER LESIONS AND THE LATE
OUTCOMES WHICH WILL BE THE
IMPACT ON CANCER.
IMPACT MONITORING IS OCCURRING
IN A VARIETY OF COUNTRIES AND
DATA ARE AVAILABLE FROM
COUNTRIES THAT WERE EARLY
ADOPTERS OF HPV VACCINE.
BEFORE I TALK ABOUT DATA FROM
THE U.S., I'D LIKE TO SHOW DATA
FROM A FEW OTHER COUNTRIES.
SPECIFICALLY I'LL FOCUS ON
AUSTRALIA AND DENMARK BUT
THERE'S DATA FROM OTHER
COUNTRIES AVAILABLE AN SOME OF
WHICH HAVE BEEN PUBLISHED.
AUSTRALIA INTRODUCED THEIR
VACCINATION PROGRAM IN 2007 AS A
SCHOOL BASED PROGRAM.
THIS WAS PUBLICLY FUNDED USING
QUADRIVAL
QUADRIVALENT VACCINE.
THE TARGET AGE GROUP WAS 12 TO
13-YEAR-OLD GIRLS.
THEY HAD A PROGRAM THAT LASTED
FOR A WOMAN STANDING YEAR
PERIOD.
ONE WAS 14 YEAR OLDS IN SCHOOL
AND ADMINISTERED BY PRIMARY CARE
PROVIDE OERS.
THEY RECEIVED COVERAGE FOR THREE
DOSES AND 51% ONE DOSE COVERAGE
IN 20 TO 26 YEAR OLDS.
LOWER CFO RACK IN SOME OF THE
OTHER CATCH UP AGE GROUPS.
WE PRESENTED THIS DATA BEFORE
AND THIS IS AN UPDATE OF THIS
BUT AUSTRALIA WAS THE FIRST
COUNTRY TO PUBLISH DATA SHOWING
AN IMPACT OF THE VACCINATION
PROGRAM LOOKING AT GENITAL WARTS
IN SIX SEXUAL HEALTH CENTERS
ACROSS THE COUNTRY AND THESE
DATA WHICH I'M SHOWING YOU TODAY
ARE FROM A MORE RECENT
PUBLICATION FROM THIS YEAR AND
SHOWN HERE IS THE PROPORTION OF
FEMALES DIAGNOSED AS HAVING
GENITAL WARTS AT THEIR FIRST
VISIT BY AGE -- AND YOU CAN SEE
HERE ON THE SOLID GREEN LINE
WHICH ARE THOSE UNDER AGE 21
THAT THERE WAS A FAIRLY DRAMATIC
AND EARLY DECREASE IN GENITAL
WARTS AND THROUGH 2011, THERE'S
BEEN A 96% DECREASE COMPARED TO
THE PREVACCINE ERA.
AMONG THOSE 21 TO 30 THERE WAS A
73% DECREASE IN THE DOTTED RED
LINE AND NO DECREASE SEEN IN
THOSE OVER AGE 30.
DATA FROM AUSTRALIA DEMONSTRATED
A DECLINE AMONG MALES ALTHOUGH
THEY WERE NOT INCLUDED IN THE
VACCINATION PROGRAM.
YOU CAN SEE HERE THE MOST
DRAMATIC DECREASE WAS IN THOSE
UNDER 21 SHOWN ON THE SOLID
GREEN LINE AND THIS WAS A STRONG
DEMONSTRATION OF HURT IMMUNITY
FROM THEIR VACCINATION PROGRAM.
AUSTRALIA HAS ALSO DEMONSTRATED
DECLINES IN VACCINE TYPE
PROBLEMS AMONG 18 TO 24-YEAR-OLD
WOMEN AND THIS SLIDE SHOWS FROM
LEFT TO RIGHT, ANY HPV PROBLEMS,
HIGH RISK TYPES OVERALL,
NONVACCINE HIGH RISK TYPES AND
ON THE FAR RIGHT, VACCINE TYPE
HPV PROBLEMS AND THERE WAS ABOUT
AN 80% DECLINE IN THE PREVALENCE
OF VACCINE TYPES WITHIN 3 TO 4
YEARS AFTER INTRODUCTION OF THE
VACCINATION PROGRAM.
NOW A BRIEF REVIEW OF THE DATA
OUT OF DENMARK.
DENMARK INTRODUCED VACCINE IN
2009.
VACCINE WAS DELIVERED BY GENERAL
PRACTITIONERS.
THIS WAS ALSO PUBLICLY FUNDING
USING QUADRIVALENT VACCINE AND
THE AGE GROUP WAS 12-YEAR-OLD
GIRLS.
THEY HAD A LIMITED CATCH UP
PROGRAM, 13 TO 15-YEAR-OLD GIRLS
AND IT STARTED BEFORE THEIR
REDUCTION IN LATE 2008.
AND THROUGH THIS GENERAL
PRACTITIONER ORGANIZED PROGRAM,
THEY ACHIEVED BETTER THAN 80%
THREE DOSE COVERAGE IN BOTH THE
TARGET AGE AND THE CATCH UP AGE
GROUP.
THESE ARE THE DATA PUBLISHED
THIS YEAR FROM DENMARK.
THESE ARE DATA ON GENERAL WARTS
FROM THE DANISH NATIONAL PATIENT
REGISTRY.
IT SHOWS NATIONAL DATA BY SIX
MONTH INTERVAL FROM 2006 TO 2011
FOR 12 TO 21-YEAR-OLD GIRLS AND
BOYS.
MEN AND WOMEN I SHOULD SAY.
THE INCIDENCE WAS LOW FOR THOSE
12 TO 15.
AMONG THOSE 16 TO 17 YEARS,
INCIDENTS PEAKED IN THE SECOND
HALF OF 2008 AND THAT WAS
FOLLOWED BY SHARP DECLINE.
DECLINE WENT FROM 381 FOR 40,000
TO 40 PER 100,000 IN THE FIRST
SIX MONTHS OF 2011.
THERE WERE ALSO MORE GRADUATE
AND SIGNIFICANT DECLINE IN WOMEN
IN THE OLDER AGE GROUP.
AND AMONG MEN AS YOU CAN SEE,
THERE WAS NO CSIGNIFICANT DECLIE
IN GENITAL WARTS BUT THERE'S A
TENDENCY FOR DECLINE FOR MEN IN
THE OLDER AGE GROUP WHICH I HAVE
NOT SHOWN ON THIS SLIDE.
THE ANNUAL -- AVERAGE ANNUAL
PERCENTAGE CHANGE WAS 45% FOR
THOSE 16 TO 45 YEARS OF AGE
AMONG WOMEN.
NOW TURNING TO THE U.S., WE HAVE
A VARIETY OF EFFORTS ON GOING TO
MONITOR TIM PACT OF HP
VACCINATION.
THIS INCLUDES TYPE SPECIFIC
PROBLEMS, GENITAL WARTS,
CERVICAL PRE-CANCERS AND HPV
ASSOCIATED CANCERS AND I'LL SHOW
SOME OF THIS DATA.
THE FIRST DATA IS THE NATIONAL
HEALTH AND NUTRITION EXAMINATION
SURVEYS.
THIS IS A SURVEY OF THE U.S.
POPULATION.
THERE'S HOME INTERVIEWS AND
EXAMINATION IN THE MOBILE EXAM
CENTER.
HPV COMPONENT OF THIS INCLUDES
WOMEN, MEN AS WELL, 14 TO 59
YEARS OF AGE.
HPV DNA TESTING AND
SELF-COLLECTED CERVICAL VAGINAL
SWABS WAS ADDED IN 2002.
SEXUAL BEHAVIORS COLLECTED AS
WELL.
HPV VACCINE QUESTIONS WERE ADDED
IN 2007 AND THIS YEAR WE ADDED
HPV DNA TESTING FOR MALES.
WE WON'T HAVE THOSE DATA UNTIL
2015.
THIS SLIDE SHOWS THE PREVALENCE
OF VACCINE TYPE HPV IN FEMALES
BY AGE GROUP IN THE PRE-VACCINE
AREAS SHOWN IN ORANGE AND
VACCINE SHOWN IN GREEN.
THERE WAS A DECLINE IN 14 TO 19
YEAR OLDS AND THIS IS THE AGE
GROUP IN WHICH WE WOULD FIRST
EXPECT TO OBSERVE A CHANGE AND
THERE WERE NO SIGNIFICANT
DIFFERENCES IN HPV VACCINE TYPE
PREVALENCE IN THE OTHER AGE
GROUPS.
AMONG 14 TO 19 YEAR OLDS THERE
WAS NO CHANGES IN THE POPULATION
CHARACTERISTICS THAT COULD HAVE
CONTRIBUTED TO THIS DECLINE SUCH
AS THE PERCENT SEXUALLY ACTIVE
OR THE NUMBER OF LIFETIME SEX
PARTNERS OR RACE ETHNICITY.
OF COURSE THIS POINT ESTIMATE
DECLINE IS GREATER THAN EXPECTED
PACED ON THREE DOSE VACCINE
COVERAGE IN THE U.S.
NOW, THIS DECLINE COULD BE DUE
TO SOME CHANGES IN BEHAVIOR THAT
WE WERE NOT ABLE TO MEASURE.
BUT THE DATA LIKELY DEMONSTRATES
EARLY IMPACT TO VACCINATIONS AND
IMPACT FROM IMMUNITY AND
EFFICACY FROM LESS THAN A
COMPLETE THREE DOSE SCHEDULE.
EARLY IMPACT OF THE VACCINATIONS
ARE ALSO SUGGESTED BY SOME DATA
WE HAVE IS ON GENITAL WARTS.
WE HAVE A PRAYERTY OF PROJECTS
LOOKING AT GENITAL WARTS AND THE
ONE I'LL PRESENT TODAY IS THE
ADMINISTRATIVE DATA THAT WE HAVE
FROM THE MARKET SCAN DATA.
THIS ANALYSIS THAT I'M GOING TO
SHOW YOU NOW IS FROM THE MARKET
STAND OF COMMERCIAL CLAIMS AND
ENCOUNTERS DATA BASE FROM 2003
TO 2010.
WE SHOWED EARLIER, PREVIOUSLY,
THE OBJECTIVE WAS TO ESTIMATE
THE PROBLEMS OF ANAL GENITAL
WART FROM 2003 TO 2010.
THIS INCLUDES 64 MILLION CASES
OF DATA AND CASES WERE DEFINED
BY IC-9 CODES AS INDICATED HERE
ON THE SLIDE.
SO THESE ARE THE DATA FOR
FEMALES AND YOU CAN SEE HERE ON
THE VERY BOTTOM, THE LOWEST
PREVALENCE WAS IN 10 TO 14 YEAR
OLDS AND THE HIGHEST WAS 20 TO
24 YEAR OLDS CONSISTENT WITH
OTHER STUDIES LOOKING AT GENITAL
WART PROBLEMS AND IN RED YOU CAN
SEE THE LINE FOR THE PREVALENCE
IN FEMALES AGE 15 TO 19 AND
THERE WAS A SIGNIFICANT DECLINE
FROM 2.9 PER THOUSAND TO 1.8 IN
2010.
WOMEN AGE 20 TO 24 PROBLEMS IB
CREASED FROM 4 TO 5.5 IN 2007
AND REMAINED LEVEL THROUGH 2009
AND YOU CAN SEE THERE'S STARTING
TO BE A DECREASE IN 2010.
THERE'S ALSO MAYBE A SUGGESTION
OF A DECREASE AS WELL IN 25 TO
29 YEAR OLDS.
THESE ARE THE DATA FOR MALES.
HERE YOU CAN SEE THAT IN
CONTRAST TO THE FEMALES
PREVALENCE INCREASE WAS STABLE
DURING THIS TIME AND NO DECREASE
SEEN IN THE 15 TO 19 YEAR OLDS.
AMONG 20 TO 24 YEAR OLDS
PROBLEMS DECREASE IN 2009 AND
THERE WAS A SMALL DECREASE.
THESE DATA WILL BE FURTHER
EVALUATED BUT THE EARLY DECREASE
IN 15 TO 19-YEAR-OLD FEMALES AS
WELL AS TRENDS IN SOME OF THE
OTHER AGE GROUPS YOU SUGGEST AN
EARLY IMPACT OF VACCINATION.
SEVERAL EVALUATIONS ARE ON GOING
TO EVALUATE MID OUTCOMES OR
CERVICAL PREREKANSERS AND TODAY
I'LL SHOW YOU DAY FROM FROM OUR
POPULATION BASED ASSESSMENTS IN
OUR SITES AND SINCE PRECANCER
LESIONS ARE DETECTED BY CERVICAL
CANCER SCREENING, CHANGES IN
RECOMMENDATIONS WILL IMPACT OUR
ABILITY TO INTERRUPT THESE
FINDINGS.
THIS IS PARTICULARLY AN ISSUE
FOR THE YOUNGEST AGE GROUP SINCE
RECOMMENDATIONS HAVE CHANGE SOD
THAT SCREENING IS NOT
RECOMMENDED BEFORE AGE 21.
SO OUR HPV IMPACT PROJECT WHICH
IS CONDUCTED IN THE EMERGING
INFECTIONS PROGRAM IS MONITORING
THE IMPACT ON HIGH GRADE
CERVICAL LESIONS IS ON FIVE
SITES AND HPV TYPING IS BEING
CONDUCTED AT CDC AND VACCINATION
HISTORY IS ACTIVELY BEING
COLLECTED FROM A VARIETY OF
SOURCES.
WE'RE STILL ANALYZING DATA ON
RACE BECAUSE WE NEEDED TO
COLLECT INFORMATION ON CERVICAL
CANCER SCREENINGS TO ADEQUATELY
INTERRUPT THESE.
WHAT I'D LIKE TO SHOW YOU TODAY
IS PREVIOUSLY PUBLISHED DATA
LOOKING AT THE EARLY IMPACT OF
VACCINATION AND WE'RE LOOKING AT
THE% OF CIN-2 LESIONS.
ANALYZED BY TIME THAT LEAD TO
THE BIOPSY FOR THAT DIAGNOSIS
AND TIME BETWEEN PAP AND
VACCINATION REFLECTS THE
LIKELIHOOD OF BEING VACCINATED
BEFORE EXPOSURE TO THE TYPE THAT
WAS RESPONSIBLE FOR THE
PRE-CANCER LESION.
AND AS EXPECTED THOSE VACCINATED
IN THE RESECENT PAST WERE NOT ME
LIKELY.
HOWEVER FOR THOSE VACCINATED
MORE THAN 24 MONTHS BEFORE THE
PAP, THEY WERE SIGNIFICANTLY
LESS LIKELY TO HAVE HPV 16, 18
RELATED LESIONS COMPARED TO
THOSE UNVACCINATED.
FINALLY, WE WILL BE ABLE TO LOOK
AT CANCER, WE HAVE CANCER
REGISTRIES IN ALLSTATES BUT
COVER VIRTUALLY 100% OF THE
POPULATION.
OUR REGULAR UPDATES ON HPV
ASSOCIATED CANCER OVERALL AND BY
STATE WILL BE REPORTED AND THE
FIRST REPORT WAS PUBLISHED LAST
YEAR.
TYPING OF THESE CANCERS HAS BEEN
DONE IN SELECT REGISTRIES AS A
BASELINE AND THESE WILL ALSO BE
REPORTED TO LOOK AT
TYPE-SPECIFIC CANCERS.
SO IN SUMMARY, VACCINATION
COVERAGE HAS INCREASED SINCE
2007 BUT VERY LIMITED INCREASE
HAS BEEN OBSERVED IN RECENT
YEARS.
POST-LICENSURE MONITORING DATA
CONTINUE TO SHOW A GOOD VACCINE
SAFETY PROFILE.
A VARIETY OF EARLY, MID, AND
LATE OUTCOMES ARE BEING
MONITORED AND DATA SUGGESTED
IMPACT ON EARLY AND MID OUTCOMES
IN THE UNITED STATES.
I WANTED TO END WITH MENTIONING
SOME PLANS THAT CDC HAS.
FIRST OF ALL, WE HAVE AN HPV
SPECIFIC THAT'S SCHEDULED TO
COME OUT IN JULY.
THIS WILL HAVE DATA FROM THE NIS
TEAM FROM 2007 TO 2012 AND ALSO
SUMMARIZE VACCINE SAFETY DATA.
THE ANNUAL 20 -- THE ANNUAL MMWR
WILL COME OUT AT THE END OF
AUGUST.
THIS WILL HAVE 2012 DATA ON
COVERAGE.
THERE'S WORK GOING ON TO UTILIZE
THE INFORMATION IMMUNIZATION
SYSTEMS TO CONDUCT REMINDER
RECALL AND VACCINATION COVERAGE
ASSESSMENT OF PROVIDERS
ACCORDING TO IIS.
A VARIETY OF TOOLS ARE DEVELOPED
FOR PROVIDERS INCLUDING A TIP
SHEET FOR TALKING WITH PATIENTS
ABOUT HPV VACCINES.
THERE'S A SPEAKERS BUREAU BEING
DEVELOPED AND THERE'S CONTINUED
EFFORT TO EVALUATE BARRIERS TO
VACCINATION, UNDERSTANDING WHAT
SAFETY CONCERNS TRULY MEAN SINCE
THIS HAS BEEN REPORTED AS ONE OF
THE REASONS FOR NONINTENT TO BE
VACCINATED AND FURTHER
COMMUNICATION OF SAFETY DATA TO
PROVIDERS AND
I WANT TO THANK A LARGE VARIETY
OF PEOPLE WHO CONTRIBUTED DATA
FOR THIS PRESENTATION.
>> THANK YOU, WE'RE OPEN FOR ANY
QUESTIONS.
COMMENTS?
>> I THINK YOU KNOW, SOMETIMES
WE ALL GET LOST IN THE DETAILS.
I HAD A QUESTION ABOUT MEN AND
THE INCREASE IN CANCER AND WHAT
THE DISCUSSION IS IN THE WORKING
GROUP ON LOOKING AT VACCINATING
MEN OVER AGE 26.
DID I MISS THAT EARLIER?
OR WAS IT JUST NOT MENTIONED?
>> WE HAVE NOT HAD ANY
DISCUSSIONS ABOUT VACCINATING
MEN OVER AGE 26.
>> THANK YOU LAURI.
YOU EXPRESSED SOME SURPRISE AT
THE IMPACT ON GENITAL WARTS
BEING GREATER THAN THE COVERAGE
MIGHT HAVE PREDICTED LOOKING AT
THREE-DOSE COVERAGE AND I
WONDERED IF YOU ANALYZED IT BY
ONE-DOSE AND TWO-DOSE COVERAGE
BECAUSE YOU MAY ONLY NEED TWO
DOSES?
>> WELL, THE DATA THAT I SHOWED
FROM THE MARKET SCAN DATA, WE DO
NOT HAVE RIGHT NOW.
THERE'S NO VACCINE DATA
ASSOCIATED WITH THAT.
THAT WAS JUST AN ECOLOGIC
ANALYSIS.
WE DO HAVE SELF-REPORTED HISTORY
OF VACCINATION BUT OUR NUMBERS
RIGHT NOW WERE TOO SMALL.
WE DID NOT WANT TO BREAK IT DOWN
BY INDIVIDUAL NUMBER OF DOSES
BUT THAT IS SOMETHING WE'LL BE
LOOKING AT.
>> JUST A COMMENT.
THANKS, LAURI, FOR A REALLY NICE
SUMMARY.
WE SPENT A LOT OF THE DAY
TALKING ABOUT TEENAGE VACCINE
WHICH HAS PERFORMANCE THAT IS
DISAPPOINTING AT THIS POINT BUT
WE'VE HAD VERY GOOD UPTAKE AND
ARE REALLY ON TRACK, IN FACT,
HAVE ACHIEVED THE HEALTHY PEOPLE
2020 OBJECTIVE FOR THE
VACCINATION OF TEENAGERS AND
HERE WE'RE FINDING OUT ABOUT A
VACCINE THAT HAS GREATER THAN
EXPECTED PERFORMANCE EVEN WITH
OUR PATHETIC COVERAGE AND I
THINK THAT THIS AUDIENCE OF
HIGHLY MOTIVATED IMMUNIZATION
EXPERTS AND CLINICIANS AND
PROGRAM STAFF, I HOPE SEE THIS
AS A WAKE UP CALL FOR US TO DO
MUCH, MUCH BETTER.
BECAUSE, LAURI, IF YOU COULD GO
BACK TO THE COVERAGE SLIDE, I'M
STRUCK WITH THE FACT THAT IN
2008, THE THREE VACCINES
FIRST-DOSE COVERAGE WERE NECK
AND NECK.
WE HAD A REALLY GOOD INITIAL
PROGRAM FOR HPV.
I THINK IT'S SLIDE FOUR.
REALLY EXPECTING PRETTY GOOD
THINGS AND SINCE 2008, THEY HAVE
DIVERGED IN A MAJOR WAY AND I
THINK THIS IS A POINT WHERE
THESE VACCINES ARE WORKING
BETTER THAN WE THOUGHT.
THEY'RE SAFE.
THEY APPEAR TO BE EXTREMELY
EFFECTIVE.
AND AS CLINICIANS, PARENTS, AND
COMMUNITY MEMBERS, I REALLY
THINK WE NEED TO DO BETTER IN
GETTING THEM TO PREVENT THE
CANCERS THAT WILL BE OCCURRING
IF WE DON'T DO BETTER.
>> I'M WONDERING IF YOUR
COVERAGE RATES MAYBE A SLIGHT
UNDERESTIMATE.
IN CALIFORNIA WE HAVE A NEW LAW
THAT ALLOWS MINORS TO CONSENT
FOR PREVENTION SERVICES FOR STDS
WHICH INCLUDES HPV VACCINE.
THAT MAY LEAD THEM TO GET THE
VACCINE AT SOMEONE OTHER THAN
THEIR PRIMARY CARE PROVIDER AND
MAYBE NOT REPORT IT OR HAVE IT
NOT AS EASILY REPORTED.
DO YOU HAVE ANY IDEA OF THE
IMPACT?
>> LET ME REFER THAT TO -- I
GUESS SHE IS SAYING WE DON'T.
>> IF I RECALL
LAW WAS JUST RECENTLY PASSED OR
IT WAS WITHIN THE LASTst PAST
YEAR.
>> THAT'S TRUE IN CALIFORNIA.
I ASSUME THERE'S OTHER STATES
THAT HAVE SIMILAR LAWS.
>> VERY FEW STATES HAVE THAT
SPECIFIC LAW.
YOU HAVE TO HAVE THE WORD
PREVENT STD IN THE LAW AND
THAT'S USUALLY THE KEY.
BUT AS YOU SAID, IF TEENS ARE
GETTING VACCINES OUTSIDE OF
THEIR ROUTINE MEDICAL PROVIDER
AND NOT LETTING THE PARENTS
KNOW.
THE SURVEYS ARE WITH THE PARENTS
SO THE PARENT HAS TO INDICATE
WHERE THE CHILD GOT THE VACCINE
FOR US TO VALIDATE IMMUNIZATION.
SO IF THAT IS ASSUMED WE WOULD
BE UNDERESTIMATING.
SO I REALLY CAN'T SAY HOW
FREQUENTLY THAT'S OCCURRING.
BUT I IMAGINE WITH HPV -- I
DON'T THINK OUR RATES WOULD BE
DRAMATICALLY HIGHER IF WE HAD
THAT.
>> YES.
IT SEEMED TO ME, I THINK WE ALL
RECOGNIZED THAT SOME OF THIS IS
PROBABLY A HESITANCY OF PROBABLY
TOO SOON AT AGE 11, 12.
BUT I'M WONDERING -- I THINK
ABOUT REASONS TO MOTIVATE
PARENTS AND PROVIDERS THAT AGE
11-12 IS A GOOD TIME TO GET THIS
VACCINE DONE.
THERE WAS DATA PRESENTED IN THE
PREVIOUS MEETING THAT YOUNGER
ADOLESCENTS RESPOND BETTER TO
THE VACCINE THAN THE OLDER
ADOLESCENTS.
HAS THAT INFORMATION AND MAYBE
IT'S PREMATURE, MAYBE WE DON'T
KNOW EXACTLY WHAT THAT MEANS,
BUT IS THERE A WAY TO TURN THAT
INTO A MESSAGE OF WHY IT'S
BETTER TO VACCINATE YOUNGER
ADOLESCENTS?
>> WE HAVE BEEN DISCUSSING THAT.
THAT IS INCLUDED IN A LOT OF OUR
COMMUNICATION MESSAGES, THE
RESPONSE TO VACCINATION IS
BETTER AT THE YOUNGER AGES.
SO WE HAVE INCLUDED THAT IN SOME
OF OUR COMMUNICATION MESSAGES.
MAYBE WE NEED TO EVALUATE IF THE
PROVIDERS UNDERSTAND THAT AND IF
THAT'S COMMUNICATED.
THAT'S SOMETHING WE COULD LOOK
AT.
>> I HAD ANOTHER QUESTION BUT
I'LL ASK THIS ONE INSTEAD.
LAURI, COULD YOU TALK A LITTLE
BIT ABOUT HOW WE ARE GOING TO
DEAL WITH THE DECREASING RATES
OF SCREENING AND THEIR IMPACT ON
LOOKING AT THE INTERMEDIATE
OUTCOME?
>> WELL, WE ARE DOING THE
MONITORING FOR THE PRECANCER
LESIONS.
WE ARE TRYING TO GET ESTIMATES
OF SCREEN RATES.
THIS IS DIFFICULT IN THE U.S.
BECAUSE WE DON'T HAVE NATIONAL
REGISTRIES.
THERE'S ONLY ONE STATE WITH A
STATE REGISTRY SO WE'RE BEING
CREATIVE IN TRYING TO COLLECT
DATA FROM A VARIETY OF SOURCES.
THIS IS VERY CHALLENGING.
WE DON'T HAVE COMPLETE VACCINE
REGISTRIES BUT I THINK WE'RE
GOING TO BE TRYING TO DO THAT
AND WE HAVE INCORPORATED IT IN
SOME OF THE ANALYSIS BUT IT'S
ONE OF THE CHALLENGES ASPECTS OF
LOOKING AT THE PRECANCER
LESIONS.
THAT'S WHY HAVING THE
TYPE-SPECIFIC DATA WILL BE
HELPFUL.
>> DR. TURNER.
>> JIM TURNER, AMERICAN COLLEGE
HEALTH.
IN ANSWER TO MARK SAWYER'S
QUESTION, IN 2011, WE HAD THREE
SCHOOLS REPRESENTING THE STATES
OF WISCONSIN, PENNSYLVANIA, AND
VIRGINIA LOOK AT IMMUNIZATION
RATES AMONG FEMALES WHO HAD
MATRICULATED OUR SCHOOLS AND WE
WERE AT 46% UPTAKE OF LTHREE
SHOTS AMONG FEMALES IN COLLEGE.
OBVIOUSLY DIFFERENT
SOCIOECONOMIC CLIMATE IN EACH
STATE WITH DIFFERENT RULES BUT
IN VIRGINIA WE HAVE A PERMISSIVE
RECOMMENDATION FOR 6th GRADERS
TO GET IT AND I BELIEVE MINORS
CAN SIGN FOR IT AND GET IT IF
THEY HAVE A WAY OF PAYING FOR
IT.
REGARDING THE AGE OF UPTAKE --
AND BY THE WAY, I THINK COST FOR
A LOT OF PEOPLE REMAINS A BIG
ISSUE AND HOPEFULLY WITH THE
AFFORDABLE CARE ACT THAT WILL
BECOME LESS OF A BURDEN -- BUT
WE GOT A NETWORK OF COLLEGES
CONTRIBUTING DATA TO US AND
AMONG 20,000 VACCINES GIVEN FOR
OUR NETWORK OF 22 SCHOOLS, ABOUT
A QUARTER OF THEM ARE STILL
BEING GIVEN TO MALES AND 60% OF
THE MALES RECEIVING THE VACCINE
ARE ACTUALLY OVER THE AGE OF 21.
SO THERE REMAINS A -- AND THIS
IS WITH NO MARKETING BY THE WAY
AND NO RECOMMENDATION.
SO THERE REMAINS A FAIRLY ROBUST
DEMAND AMONG MEN TO RECEIVE THE
VACCINE OVER THE AGE OF THE
RECOMMENDATION.
THANK YOU.
>> COULD YOU PLEASE REMIND ME
HOW MUCH MORE EFFECTIVE THE
VACCINE IS WHEN GIVEN TO
YOUNGER -- LIKE 11 OR 12 YEAR
OLDS VERSUS OLDER ADOLESCENTS?
I'D LIKE TO PASS THAT ON.
>> FIRST OF ALL, THE EFFICACY
TRIALS WERE ONLY DONE IN 15 TO
26 YEARS OF AGE.
SO THE EFFICACY DATA COMES FROM
THAT AGE GROUP AND THE BRIDGING
STUDIES WERE DONE IN THE 9 TO 15
YEAR OLDS.
SO WHAT WAS REFERRED TO EARLIER
IS THE DATA SHOWING THAT THE
ANTIBODIES ARE HIGHER IN THE
YOUNGER AGE GROUP AS PREPARED TO
THE ANTIBODIES IN WOMEN WHO WERE
IN THE EFFICACY TRIALS.
SO IF SOMEONE IS NAIVE TO A
VACCINE TYPE, THE EFFICACY WAS
CLOSE TO 100% IN THOSE OLDER
WOMEN.
SO THE EFFICACY WAS VERY GOOD
AND WE DON'T THINK THE EFFICACY
IS GOING TO BE DIFFERENT.
WE'RE TALKING ABOUT THE IMMUNE
RESPONSE TO VACCINATION IN THE
HIGHER AND YOUNGER AGE GROUP.
>> OTHER QUESTIONS OR COMMENTS?
>> HE WANTS THE LAST WORD SO MS.
HAYES.
>> I GAVE YOU AN ERRONEOUS
STATISTIC EARLIER, THE ABORTION
RATE HAS FALLEN TO 26%.
DR. BENNETT.
>> YOU CAN HAVE THE LAST WORD.
HAS THERE BEEN ANY CONSIDERATION
OF SCHOOL BASED STRATEGIES FOR
DELIVERING THIS VACCINE?
>> YEAH.
A COUPLE OF COMMENTS.
THERE ARE SOME PROGRAMS THAT ARE
OFFERING, YOU KNOW, SCHOOL
ASSOCIATED VACCINATION FOR A
VARIETY OF VACCINES, BUT ONE
THING THAT'S REALLY STRUCK US IN
LOOKING AT THE DATA OVER THE
LAST FEW YEARS IS THAT THE VERY
HIGH COVERAGE WITH TDAP HAS NOT
BEEN DELIVERED THROUGH SCHOOLS.
THAT'S BEEN DELIVERED PRIMARILY
THROUGH THE MEDICAL HOME AND SO
WHEN WE ANALYZE OUR DATA FOR
MISSED OPPORTUNITIES, IF EVERY
TIME A TEEN WAS GETTING A TDAP
OR VACCINE THEY WERE OFFERED AN
ACCEPTED AN HPV VACCINE OUR
COVERAGE COULD BE 90%.
SO THE QUESTION OF WHETHER
SCHOOL STRATEGIES ARE NEEDED OR
EVEN COST EFFECTIVE HERE IN THE
U.S. NOW THAT WE HAVE A PRETTY
STRONG ADOLESCENT PLATFORM TO
BUILD ON WE THINK WE CAN DO THIS
WITH THE MEDICAL HOME IF THE
CLINICIANS WILL MAKE STRONG
RECOMMENDATIONS.
WE ALSO HAD SOME DISAPPOINTING
RESULTS IN SOME OF THE SCHOOL
PROGRAMS FOR FLU AND OTHER
VACCINES SO WHILE THAT IS A WAY
TO REACH SOME PEOPLE WE THINK
THE MEDICAL HOME IS PROBABLY THE
WAY TO GO FOR THIS.
>> ALSO ACROSS MY STATE WE HAVE
ONE SCHOOL NURSE PER 1950
STUDENTS.
AND THEY SPEND ALL OF THEIR TIME
PUSHING MEDICATION AND GOING ON
FIELD TRIPS WITH DIABETICS AND
THERE'S JUST NO TIME FOR
ANYTHING ELSE AT THIS POINT IN
TIME.
>> I JUST WANT TO RECOGNIZE DR.
MARKOWITZ WHO HAS BEEN THE
DESIGNATED FEDERAL OFFICIAL FOR
THE HPV WORK GROUP SINCE IT'S
CONCEPTION AND ALL THE
CONTRIBUTIONS SHE HAS MADE TO
THE COMMITTEE AND ALSO WANT TO
THANK THE COMMITTEE MEMBERS THAT
WORKED HARD OVER THE YEARS TO
BRING US TO THIS POINT.
CONTINUE TO DO SO.
[ APPLAUSE ]
>> I HAVE BOTH GOOD NEWS AND --
ACTUALLY, TWO PIECES OF GOOD
NEWS.
NUMBER ONE, WE ARE CLOSE TO
FINISHING.
BUT THE OTHER PIECE OF GOOD NEWS
IS, THEY ARE HERE AND ARE ABLE
TO GIVE AGENCY UPDATES AND THEY
ASSURED ME THESE WOULD BE BRIEF.
WE ALSO, AS OF THIS POINT IN
TIME HAVE NO PUBLIC COMMENTS SO
WE'LL LET THEM HAVE THE LAST
WORD.
>> WOULD SOMEBODY BRING UP WA
WALT'S SLIDE SET PLEASE?
WE CAN START WITH SLIDE 30.
JUNE 11th AND 12th AND WAS THE
26th ANNIVERSARY, THE FIRST
MEETING WAS IN JUNE OF 1988 AND
UNFORTUNATELY A FEW OF US WERE
THERE AT THAT TIME.
AND OF AGE.
THE MAJOR FOCUS WAS ON ADULT
IMMUNIZATION AND TWO ACTION
ITEMS REALLY CAME OUT.
ONE, THE NATIONAL ADULT
IMMUNIZATION SUMMIT PROPOSED A
MAJOR REVISION IN THE STANDARDS
FOR ADULT IMMUNIZATION
PRACTICES.
SOMETHING ISSUED IN 2003 AND WE
HAVE THAT ZRAFT AND WE'LL BE
REVIEWING IT AND HOPEFULLY
SUPPORTING A NEW VERSION WHICH I
THINK IS MUCH MORE COMPREHENSIVE
AND AUDIENCE BASED THAN THE
CURRENT VERSION.
THE SECOND ISSUE IS WE HAVE
HEARD A LOT ABOUT ADULT
IMMUNIZATION IN THE SENSE OF THE
STATE OF AFFAIRS WITH REGARD TO
IMPLEMENTATION AND WE ASKED THE
NATIONAL VACCINE PROGRAM OFFICE
AS TO HOW WE CAN BE HELPFUL.
PUBLISHED IN 2012 A
COMPREHENSIVE SET OF
RECOMMENDATIONS AND DETERMINED
WHAT ELSE WE MIGHT DO TO MOVE
THINGS ALONG.
A THIRD ISSUE IS WHAT WAS
REPORTED, I GUESS AT THE
IMMUNIZATION SUMMIT IS CMS HAS
RECOMMENDED WITHDRAWAL OF A
REQUIREMENT FOR A PERFORMANCE
MEASURE WITH VACCINATION.
WE WILL BE HAVING AN URGENT
MEETING BY TELEPHONE ON FRIDAY
TO DISCUSS THE PROPOSED VMS RULE
TO REMOVE THAT MEASURE AND
WHETHER THEY SHOULD OR SHOULD
NOT MAKE ANY RECOMMENDATIONS
WITH REGARD TO THAT.
THE OTHER BIG ISSUE IS WE HAVE A
NUMBER OF WORKING GROUPS.
I THINK ANN AND OTHERS HAVE
GOTTEN THE MESSAGE ACROSS
CLEARLY.
WE'RE NOT DOING WELL ON HPV
VACCINE IMPLEMENTATION AND WE
HAVE FALLEN TO WORKING GROUP
SHARED BY SARAH AND WAYNE
ROLLINS AND CHARGED BY THE
SECRETARY OF HEALTH WILL LOOK AT
WHAT ELSE CAN BE DONE OR SHOULD
BE DONE TO IMPROVE
IMPLEMENTATION.
WE ALSO FORMED A VACCINE
CONFIDENCE OR HESITANCY.
WE HAVEN'T COME OUT WITH THE
RIGHT NAME FOR IT, WORKING GROUP
TO TRY AND DEAL WITH IMPROVING
ACCEPTANCE OF VACCINATIONS THAT
ARE RECOMMENDED.
WE HAVE A GLOBAL IMMUNIZATION
WORKING GROUP THAT PROPOSED THE
COMPREHENSIVE SET OF
RECOMMENDATIONS FOR WHY IT'S
HUMANITARIAN INTERESTS AND IN
OUR OWN INTERESTS TO IMPROVE
GLOBAL IMMUNIZATION RANGING FROM
USE OF CURRENT VACCINES,ULATION
NEW VACCINES TO DEAL WITH GLOBAL
INFECTIOUS DISEASE PROBLEMS AND
WE ALSO, AS WAS MENTIONED
EARLIER HAVE A SET OF
RECOMMENDATIONS WE'RE COMMENTING
ON FOR OUR INTERNAL IMMUNIZATION
COVERAGE GROUP AND OUR HOPE IS
TO FINALIZE THE RECOMMENDATIONS
OR VOTE AT THE SEPTEMBER
MEETING.
>>> THANK YOU.
SO THE THEMES ARE OFTEN
OVERLAPPED WITH THE THEME OF THE
NATIONAL VACCINE PROGRAM OFFICE
UNDER THE UMBRELLA OF THE
NATIONAL VACCINE PLAN I THINK
ONE OF THE MAJOR THEMES IS ADULT
IMMUNIZATIONS WHICH HE MENTIONED
IS AND TRANSFORMING INTO AN
ADULT SUMMIT WITH THE HELP OF
PARTNERSHIPS OF CDC AND
IMMUNIZATION ACTION COALITION.
PICKED UP BY THE ASSISTANT
SECRETARY FOR HEALTH, THERE'S A
TASK FORCE FOCUSSING ON ADULT
IMMUNIZATION.
IN THE FUTURE WE'RE HOPING TO
DEVELOP A FREE STANDING
IMMUNIZATION PLAN OR STRATEGY IN
A MAPS ACROSS THE GOAL OF THE
NATIONAL VACCINE PLAN.
SO A LOT OF THINGS RELATED TO
ADULT VACCINE AND FINALLY T
COMMITTEE HERE HAS SEEN THE
PRESENTATION IN THE PAST IN THE
INSTITUTE OF MEDICINE LOOKING AT
THE VACCINE DECISION -- VACCINE
PRIORIZATION CALLED SMART
VACCINES.
THEY'RE IN ANOTHER PHASE AND THE
REPORT IS SCHEDULED TO BE
RELEASED AT THE END OF SEPTEMBER
WHETHER YOU WANT TO HEAR FROM
THEM AGAIN IN OCTOBER, WE'LL
SEE.
BUT THAT WILL BE PUBLIC AT THE
END OF SEPTEMBER.
THAT'S IT FOR ME.
>> THANK YOU VERY MUCH.
IS THERE ANY FINAL COMMENT FROM
ANYONE?
LAST THING WE NEED TO MENTION IS
WE START PROMPTLY AT 8:00
TOMORROW MORNING.
WE HAVE NO UNFINISHED BUSINESS
AND WE WILL GET STARTED WITH
ROTO VIRUS AT THAT POINT AND
TIME AND WE ARE FINISHING UP A
GOOD 10 MINUTES AHEAD OF
SCHEDULE.
THANKS EVERYBODY.