Tip:
Highlight text to annotate it
X
>> 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
*** 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
*** 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 *** 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 *** 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 *** 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 *** 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 *** 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, ***
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
*** 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 *** 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 *** 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. *** 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 *** 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.