February 2015 ACIP- Human Papillomavirus (HPV) Vaccine

February 2015 ACIP- Human Papillomavirus (HPV) Vaccine


>>SO LET’S MOVE ALONG TO THE
HUMAN PAPILLOMA VACCINE SESSION, PLEASE.
>>THANK YOU, JOHN. I WANT TO ADD MY THANKS TO
DR. PICKERING FOR HIS YEARS OF LEADERSHIP AND ACCOMPLISHMENTS
AS SECRETARY OF THE ACIP. WE’VE SHORTENED THE PRESENTATION
FOR HPV BASED ON THE TIME LIMITS AND ARE TRYING TO PROVIDE YOU
WITH THE ESSENTIAL INFORMATION WHICH WOULD LEAD TO A VOTE.
AS YOU KNOW, THE NONVALENT HPV VACCINE WAS LICENSED IN DECEMBER
FOR FEMALES 9 THROUGH 26 YEARS OF AGE AND MALES 9 THROUGH 15
YEARS OF AGE AND TRIALS WERE CONDUCTED WITH THE THREE-DOSE
SCHEDULE. THIS IS AN 01 PARTICLE VACCINE
SIMILAR TO THE QUADRIVALENT VACCINE WHICH TARGETS FIVE
ADDITIONAL HIGH-RISK TYPES WHICH ARE LISTED HERE.
IN THE UNITED STATES, THESE ARE ESTIMATED TO CAUSE 14% OF
HPV-RELATED CANCERS IN WOMEN AND APPROXIMATELY 5% OF HPV-RELATED
CANCERS IN MALES. MALES 16 TO 26 YEARS OF AGE WERE
NOT PART OF THE BLA SUBMITTED IN 2013.
WE DID SEE DATA FROM THE TRIAL ON 16 TO 26-YEAR-OLD MALES FOR
VACCINE SAFETY AND CONVERSION RATE.
THIS WAS PRESENTED TO ACIP IN OCTOBER AND NOW SUPPLEMENTAL BLA
HAS BEEN SUBMITTED FOR THIS AGE GROUP TO THE FDA.
THE CURRENT RECOMMENDATIONS ARE FOR ROUTINE VACCINATION.
IT CAN BE GIVEN AS EARLY AS 9. VACCINE IS RECOMMENDED FOR —
THROUGH AGE 26 FOR FEMALES AND THROUGH AGE 21 FOR MALES WHO
HAVE NOT BEEN PREVIOUSLY VACCINATED OR WHO HAVE NOT
COMPLETED THE SERIES. AND VACCINATION IS RECOMMENDED
FOR IMMUNOCOMPROMISED PERSONS INCLUDING PERSONS WHO ARE HIV
INFECTED AND FOR MEN WHO HAVE SEX WITH MEN THROUGH AGE 26.
THOSE ARE MALE RECOMMENDATIONS, AND IT’S A THREE-DOSE SCHEDULE
GIVEN AT ZERO, 1 TO 2 AND 6 MONTHS OF AGE.
SO THE NONVALENT VACCINE — WHOOPS, GOING BACKWARDS — SO
NOW WE HAVE THREE AVAILABLE HPV VACCINES WHICH YOU’RE FAMILIAR
WITH, NONVALENT ADDED TO THE LIST OF LICENSED VACCINES.
IN PREPARATION FOR THIS VOTE, WE HAVE PROVIDED A NUMBER OF
PRESENTATIONS OVER THE PAST YEAR AND INCLUDING IN OCTOBER A
REVIEW OF THE GRADE FOR THE NONVALENT VACCINE, HEALTH
ECONOMICS ANALYSIS, AND WE DISCUSSED POLICY OPTIONS FOR
WHICH WE GOT SIGNIFICANT FEEDBACK FROM ACIP MEMBERS.
TODAY — ACTUALLY PRESENTATIONS HAVE BEEN MODIFIED.
DR. HAROLD CHESSEN WILL PROVIDE SOME INFORMATION ON VACCINE
IMPACT AND COST EFFECTIVENESS. DR. MARKOWITZ WILL THEN PROVIDE
CONSIDERATIONS FOR RECOMMENDATIONS WHICH WILL LEAD
TO ACIP DISCUSSION AND VOTE. AND THEN RESOLUTION WILL FOLLOW.
I WANT TO THANK THE WORK GROUP MEMBERS.
WE’VE HAD CONSIDERABLE NUMBER OF DISCUSSIONS AND CALLS OVER THE
PAST NUMBER OF MONTHS, AND ESPECIALLY RECOGNIZE LAURIE
MARKOWITZ FOR HER LEADERSHIP AS THE ACIP CDC LEAD.
>>GOOD MORNING. OR GOOD AFTERNOON, I SHOULD SAY.
I’M THE OFFICER WHO’S BEEN WORKING WITH LAURIE MARKOWITZ
AND I’D LIKE TO THANK THE WORK GROUP AS WELL.
OKAY. I WAS ADVISED TO SPEAK SLOWLY.
SO THIS IS AN OUTLINE OF MY PRESENTATION.
IN THE INTEREST OF TIME, I’M GOING TO KEEP THIS VERY BRIEF.
LISTED HERE ARE THE NINE VALENT VACCINE STUDIES WHICH HAVE BEEN
PREVIOUSLY PRESENTED TO THE ACIP.
AS A REMINDER, PROTOCOL ONE IS THE PIVOTAL EFFICACY STUDY THAT
COMPARES THE VACCINES TO THE QUADRIVALENT VACCINE IN ADULT
FEMALES. THERE WERE ALSO IMMUNOBRIDGING
STUDIES AND USE STUDIES. IN ONE ASSESSING THE PRIOR
QUADRIVALENT RECIPIENTS. I’M ONLY GOING TO PRESENT THE
DATA FROM PROTOCOL ONE AS THIS WAS THE PIVOTAL EFFICACY STUDY
AND WILL THEN SUMMARIZE THE RESULTS AND SAFETY FINDINGS FROM
THE OTHER STUDIES. FOR THE FIVE ADDITIONAL TYPES,
THE NINE VALENT VACCINES DEMONSTRATED GREATER THAN 96%
EFFICACY IN PREVENTING HIGH-GRADE CERVICAL, VULVAR, AND
VAGINAL DISEASE AND SIX-MONTHS RESISTANT TO INFECTIONS.
FOR OUTCOMES FROM THE FOUR ORIGINAL TYPES THE INCIDENCE OF
DISEASE IN EITHER VACCINE GROUP WAS VERY LOW AND THE NINE VALENT
VACCINES DEMONSTRATED COMPARABLE PROTECTION IN PREVENTING
HIGH-GRADE CONSERVATIVE VALUE DISEASE AND ANAL GENITAL WARTS.
BOTH THE NINE VALENT AND QUADRIVALENT VACCINE INDUCED
GREATER THAN 99% SEROCONVERSION, AND THE
NONINFERIORITY CRITERION WAS MET FOR THE FOUR ORIGINAL TYPES AS
SHOWN HERE. I’LL NOW SUMMARIZE THE FINDINGS
FOR THE NINE VALENT VACCINE STUDIES.
AS I JUST SHOWED, THE NINE VALENT DEMONSTRATED CLOSE TO 97%
PROTECTION AGAINST OUTCOMES DUE TO THE FIVE ADDITIONAL TYPES.
AND SIMILAR AGAINST THE FOUR ORIGINAL TYPES.
THERE WAS SIMILAR USE AGAINST THE 9-VALENT AND QUADRIVALENT
COHORTS. 9-VALENT ALSO DEMONSTRATED NON INFERIOR IMMUNOGENICITY COMPARED TO THE QUADRIVALENT VACCINES FOR
THE FOUR ORIGINAL TYPES. ALTHOUGH I DO NOT SHOW THIS
DATA, THE VACCINE ALSO DEMONSTRATED NON-INFERIOR IMMUNOGENICITY FOR ALL NINE TYPES IN ADOLESCENT FEMALES AND MALES
COMPARED TO ADULT FEMALES AND IN ADULT MALES COMPARED TO ADULT
FEMALES SUPPORTING THE BRIDGING OF EFFICACY FINDINGS IN ADULT
FEMALES TO THESE OTHER GROUPS. FINALLY, THE CONTINUE CULL MY
GNAT USE STUDIES SHOWED THAT 9-VALENT CAN BE ADMINISTERED
WITH THE OTHERS LISTED HERE. REGARDING SAFETY, THE 9-VALENT
WAS GENERALLY WELL TOLERATED IN OVER 15,000 RECIPIENTS AND HAD
AN ADVERSE EVENT PROFILE SIMILAR TO THE QUADRIVALENT VACCINES
ACROSS AGE, GENDER, RACE, AND ETHNICITY.
WITH THE EXCEPTION OF A HIGHER FREQUENCY OF INJECTION SITE
SWELLING IN FEMALES. MALES HAD A LOWER FREQUENCY OF
ADVERSE EVENTS COMPARED TO FEMALES, WHICH IS SIMILAR TOLL
WHAT WE’RE SEEING IN THE QUADRIVALENT VACCINE PROGRAM.
I’LL NOW REVIEW GRADE OF THE 9-VALENT THAT WAS PRESENTED TO
THE ACIP LAST OCTOBER. AS A REMINDER, THE POLICY
QUESTIONS DEVELOPED BY THE WORK GROUP WERE SHOULD THE 9-VALENT
VACCINE BE RECOMMENDED ROUTINELY FOR 11- OR 12-YEAR-OLDS AND
SHOULD THE 9-VALENT VACCINE BE RECOMMENDED FOR FEMALES — FOR
MALES, I’M SORRY, FOR FEMALES AGE 13 TO 26 YEARS AND MALES AGE
13 TO 21 YEARS WHO HAVE NOT BEEN PREVIOUSLY VACCINATED, WHICH I
WILL REFER TO AS CATCH-UP VACCINATIONS.
THIS SLIDE SHOWS A GRADE SUMMARY TABLE FOR ROUTINE 9-VALENT
VACCINATION IN FEMALES. I WILL NOT GO OVER THIS TABLE IN
DETAIL AS THIS IS ALREADY PRESENTED TO THE ACIP.
IF YOU’LL RECALL, THE WORK GROUP GAVE THE OVERALL EVIDENCE TYPES
FOR ROUTINE VACCINATION IN FEMALES A RANKING OF TWO,
INDICATING THAT THE DATA REFLECTED A MODERATE LEVEL OF
EVIDENCE. FOR CATCH-UP VACCINATION IN
FEMALES, THE WORK GROUP ALSO GAVE THIS A RANKING OF TWO.
FOR ROUTINE VACCINATION IN MALES, THE WORK GROUP GAVE THIS
AN OVERALL EVIDENCE-TYPE RANKING OF THREE INDICATING A LOW LEVEL
OF EVIDENCE. AND THIS WAS THE SAME FOR
CATCH-UP VACCINATIONS IN MALES. I’LL NOW PRESENT THE
CONSIDERATIONS FOR FORMULATING 9-VALENT VACCINE RECOMMENDATION,
SEVERAL OF WHICH I JUST REVIEWED.
REGARDING THE EVIDENCE TYPE FOR BENEFITS AND HARM, THE DATA FOR
THE 9-VALENT VACCINE ARE FROM RANDOMIZED CONTROLLED TRIALS AND
IMMUNOBRIDGING STUDIES. WORK GROUP GAVE AN OVERALL OF 2
FOR FEMALES AND 3 FOR MALES. THE WORK GROUP FELT THAT THE
BENEFITS OF 9-VALENT VACCINATION OUTWEIGH THE HARMS AND PLACED A
HIGH VALUE ON THE PREVENTION OF OUTCOMES DUE TO THE 9 HPV
VACCINE TIMES. THE 9-VALENT VACCINE IS EXPECTED
TO BE COST SAVINGS COMPARED TO THE QUADRIVALENT VACCINE.
AND-IN THE NEXT PRESENTATION, DR. CHESSEN WILL PROVIDE FOR
INFORMATION REGARDING COST EFFECTIVENESS.
IN CONCLUSION, THE WORK GROUP PROPOSES A CATEGORY A
RECOMMENDATION FOR THE 9-VALENT VACCINE.
DR. MARKOWITZ WILL BE GOING OVER THE SPECIFIC RECOMMENDATIONS FOR
VACCINE DURING HER PRESENTATION TODAY.
THANK YOU. THANKS VERY MUCH FOR A VERY
NICE, SUCCINCT PRESENTATION. DR. CHESSEN.
>>GOOD AFTERNOON. TODAY I WILL SUMMARIZE THE THREE
MODELS WE HAVE AVAILABLE OF 9-VALENT VACCINATION IN THE
UNITED STATES AND THEN I WILL SUMMARIZE THE UNPUBLISHED
RESULTS REGARDING THE IMPACT AND COST EFFECTIVENESS OF 9-VALENT
VACCINATION. AT THE OCTOBER MEETING THERE WAS
A PRESENTATION OF THE U.S. HPV ADVICE MODEL BASED ON A
PUBLISHED 18-TYPE CANADIAN MODEL WHICH HAS BEEN FITTED TO U.S.
DATA. THE MERCK MODEL AND OUR
SIMPLIFIED MODEL HAVE BASED ON FORMER MODELS THAT HAVE BEEN
EXPANDED TO INCLUDE THE ADDITIONAL TYPES OF 9-VALENT
VACCINES. ALL THREE OF THESE MODELS ARE
DYNAMIC, MEANING THAT EFFECTS ARE INCLUDED IN THE RESULTS I’LL
BE SHOWING AND ALL MODELS INCLUDE A WIDE RANGE OF HEALTH
OUTCOMES THAT COULD POTENTIALLY BE AVERTED THROUGH VACCINATION
INCLUDING CONSERVATIVE CAL CANCER AND OTHER HPV-ASSOCIATED
CANCERS. IN THE INTEREST OF TIME, I WON’T
GO OVER ALL THESE CHARACTERISTICS AND I WON’T
THROW MODELING JARGON AT YOU BUT JUST POINT TO THE SECOND ROW
HERE AND SAY IN THE TERMS OF DEGREE OF COMPLEXITY AND
COMPREHENSIVENESS THE HPV ADVISED MODEL RANKS HIGHEST, OUR
SIMPLIFIED MODEL LOWEST AND THE MERCK MODEL FALLS BETWEEN.
AND I WON’T GO OVER ALL THESE MODEL ASSUMPTIONS AS WELL, BUT I
WILL POINT OUT ALL THE MODELS ASSUME THE HIGH MODEL EFFICACY
FOR THE 9-VALENT AND 4-VALENT VACCINES AND ASSUME A LIFETIME
OF PROTECTION AND ALL USE THE SAME COST ASSUMPTION SUCH AS THE
9-VALENT WAS ASSUMED TO COST $13 MORE PER DOSE THAN THE 4-VALENT
VACCINE. SO NOW I’LL MOVE ON TO THE
IMPACT AND COST EFFECTIVENESS RESULTS.
BUT BEFORE SHOWING THOSE RESULTS I JUST WANTED TO POINT OUT IN
ABSOLUTE TERMS THE POTENTIAL FOR ADDITIONAL CANCER PREVENTION IN
THE U.S. THIS IS A SLIDE FROM
DR. BASONE’S PRESENTATION. THE MAJORITY SHOWN IN GRAY 16 TO
18 FROM THE QUADRIVALENT VACCINE, AND THIS-IN BLUE WE SEE
THE ADDITIONAL REDUCTION. SO THE GREATEST GAIN FROM THE
9-VALENT VACCINE ARE IN TERMS OF CERVICAL CANCER PREVENTION.
THIS GRAPH SHOWS THE ESTIMATED EFFECTIVENESS OF THE 4-VALENT
AND 9-VALENT VACCINES IN A SCENARIO IN WHICH NO CROSS
PROTECTION IS ASSUMED FOR THE 4-VALENT VACCINE.
THE RED LINE SHOWS THE SCENARIO IN WHICH THE 4-VALENT VACCINE IS
PROVIDED TO BOYS AND GIRLS AND THE BLUE LINE SHOWS THE SCENARIO
IN WHICH THE 9-VALENT VACCINE IS PROVIDED TO BOYS AND GIRLS.
FOR CERVICAL CANCER IN THE LONG TERM THERE IS A 65% REDUCTION.
WITH THE 4-VALENT VACCINE AND IF BOTH SEXES WERE SWITCHED TO A
9-VALENT VACCINE THERE WOULD BE AN ADDITIONAL 14 PERCENTAGE
POINT DECREASE IN CERVICAL CANCER.
THIS IS FOR THE NO CROSS PROTECTION SCENARIO.
IF WE ASSUMED CROSS PROTECTION FOR THE 4-VALENT VACCINE, IT
WOULD HAVE A BIGGER IMPACT AND THE MARGINAL OF THE 9-VALENT
VACCINE WOULD BE REDUCED SLIGHTLY.
THIS GRAPH LOOKS AT SEX SPECIFIC 9-VALENT VACCINE STRATEGIES AND
TO TWO OUTCOMES ARE CERVICAL CANCER AND THE RED LINE SHOWS
THE SNARE KNOW IN WHICH THE 4-VALENT IS PROVIDED TO BOTH
SEXES. DOTTED BLUE LINE SHOWS THE
SCENARIO IN WHICH THE GIRLS ARE GIVEN THE 9-VALENT AND BOYS ARE
GIVEN THE 4-VALENT. THEN THE SOLID BLUE LINE SHOWS
THE SCENARIO IN WHICH GIRLS AND BOYS BOTH GET THE 9-VALENT
VACCINE. SO FOR THESE OUTCOMES THE
MAJORITY OF THE BENEFIT OF SWITCHING TO 9-VALENT
VACCINATION IS ACHIEVED THROUGH SWITCHING FEMALES TO THE
9-VALENT VACCINE. THIS TABLE SHOWS THE COST
EFFECTIVENESS RESULT FROM THE ADVISE MODEL UNDER THE SCENARIO
OF NO CROSS PROTECTION FOR 4-VALENT HPV VACCINE.
THE TOP ROW COMPARES A STRATEGY OF 9-VALENT VACCINATION FOR
FEMALES AND 4-VALENT FOR MALES TO A STRATEGY OF 4-VALENT
VACCINE FOR BOTH SEXES. WHAT THIS COMPARISON TELLS US
WHAT IS THE INCREMENTAL COST EFFECTIVENESS OF SWITCHING
FEMALES FROM THE 4-VALENT TO THE 9-VALENT.
AND THE MODEL INDICATES THIS IS COST SAVING, INDICATING THAT THE
ADDITIONAL COST OF THE 9-VALENT ARE OFFSET BY THE AVERTED
MEDICAL COSTS DUE TO THE ADDITIONAL BENEFITS OF THE
9-VALENT VACCINE. THE NEXT ROW SHOWS THE
COMPARISON OF A STRATEGY OF 9-VALENT VACCINE FOR BOTH SEXES
TO THE STRATEGY OF 9-VALENT VACCINE FOR FEMALES AND 4-VALENT
VACCINE FOR MALES. WHAT THIS TELLS US IS THE
INCREMENTAL COST EFFECTIVENESS OF SWITCHING MALES FROM 4-VALENT
TO 9-VALENT AND THE MODEL CAME IN AT $31,000 PER QUALITY
ADJUSTED LIFE YEAR. THE BOTTOM ROW SHOWS US THE
SCENARIO COMPARING 9-VALENT VACCINATION FOR BOTH SEXES TO
4-VALENT VACCINATION FOR BOTH SEXES.
SO WHAT THIS COMPARISON TELLS US IS WHAT IF WE SIMULTANEOUSLY SWITCHED BOTH SEXES FROM THE 4-VALENT TO THE 9-VALENT AND THE MODEL
SUGGESTS THAT THE COST PER QUALITY IS LESS THAN ZERO OR
COST SAVING. WE THINK THIS BOTTOM ROW IS THE
MOST APPLICABLE TO THE DECISION WE’RE FACING NOW BECAUSE
SEX-SPECIFIC VACCINE STRATEGIES ARE LIKELY NOT A VIABLE POLICY
ALTERNATIVE IN THE U.S. THIS IS THE BOTTOM LINE RESULT
FROM THE U.S. HPV ADVISE MODEL. I’LL SHOW YOU THE BOTTOM LINE
RESULTS FROM ALL THREE OF THE MODELS.
THE 9-VALENT VACCINATION COMPARED TO 4-VALENT VACCINATION
FOR BOTH SEXES. THE FIRST COLUMN OF RESULTS
SHOWS THE SCENARIO IN WHICH THERE’S NO CROSS PROTECTION
ASSUMED FOR THE 4-VALENT VACCINE, AND ALL THREE MODELS
INDICATE THE THIS STRATEGY IS LIKELY COST SAVING.
WHEN WE ASSUME CROSS PROTECTION FOR THE 4-VALENT VACCINE,
RESULTS ARE STILL SIMILAR ACROSS MODELS IN THAT THE COST PER
QUALITY GAINED BY THE 9-VALENT VACCINATION IS LOW.
IT REMAINS COST SAVING IN THE ADVISE MODEL AND IS ONLY $8,000
IN THE SIMPLIFIED MODEL. THE RESULTS WERE CONSISTENT IN A
RANGE WHEN WE COMPARED 9-VALENT TO BOTH SEXES TO 4-VALENT FOR
BOTH SEXES. THE MEAN PER GAIN WAS LESS THAN
$4 IN MOST EVERY SCENARIO WE EXAMINED.
THERE WERE A COUPLE EXCEPTIONS WHEN WE ASSUMED PROTECTION FOR
THE 4-VALENT VACCINE AS WE SHOWED HERE.
THE UNCERTAINTY LEVELS GENERATED IN THE ANALYSES, THE COST PER
QUALITY GAINED BY THE 9-VALENT VACCINE REMAINED LESS THAN
$10,000 WHEN ASSUME NOTHING CROSS PROTECTION FOR THE
4-VALENT AND REMAINED LESS THAN $25,000 WHEN ASSUMING CROSS
PROTECTION FOR THE 4-VALENT VACCINE.
SO IN CONCLUSION, THE CURRENT 4-VALENT VACCINE PROGRAM IS
EXPECTED TO REDUCE HPV-RELATED DISEASES SUBSTANTIALLY IN THE
UNITED STATES AND SWITCHING TO A 9-VALENT PROGRAM IS EXPECTED TO
FURTHER REDUCE PRECANCEROUS LESIONS AND CERVICAL CANCER.
THE HPV REVISE MODEL SUGGESTED REDUCTIONS OF 19% AND 14% IN
CERVICAL CANCER WITH PERHAPS MORE MODEST REDUCTIONS IN THE
OTHER HPV-ASSOCIATED CANCERS. PROVIDING 9-VALENT VACCINE FOR
GIRLS PROVIDE A GREAT MAJORITY OF BENEFITS OF PROVIDING
9-VALENT VACCINATION TO BOTH SEXES.
AND TO CONCLUDE FOR THE COST EFFECTIVENESS, PRIMARY 9-VALENT
VACCINE FOR BOTH SEXES IS LIKELY COST SAVING COMPARED TO 4-VALENT
VACCINE FOR BOTH SEXES. AGAIN, THESE RESULTS ARE
CONSISTENT NOT ONLY ACROSS THE THREE MODELS BUT WITHIN EACH
MODEL AS WE VARY THE ASSUMPTIONS.
THE COST PER QUALITY DID NOT EXCEED $25,000 IN THE
SENSITIVITY ANALYSES, LESS THAN ZERO NO-IN MOST OF THE SCENARIOS
WE EXAMINED. FINALLY, ANALYSES OF ADDITIONAL
9-VALENT VACCINATION FOR PRIOR THREE-DOSE 4-VALENT VACCINE
KNEES, PRELIMINARY RESULTS ARE HIGHLY VARIABLE BECAUSE OF THE
INCREMENTAL HEALTH BENEFIT IN TERMS OF GAIN PER PERSON VACCINE
IS QUITE SMALL. THANK YOU.
>>THANK YOU, DR. CHESSEN. AND DR. MARKOWITZ.
>>OKAY. SO WHAT I’M GOING TO DO IS
REVIEW THE PROPOSED HPV VACCINATION RECOMMENDATION JUST
DISCUSSED BY THE WORK GROUP. I WANT TO MENTION JUST FROM THE
START HERE OF MY PRESENTATION THAT WE WILL NOT BE ADDRESSING
THE LAST POINT THAT DR. CHESSEN MENTIONED, WHICH IS THE
PROVIDING 9-VALENT VACCINE TO INDIVIDUALS WHO ALREADY RECEIVED
QUADRIVALENT VACCINE. THIS IS AN ONGOING
CONSIDERATION. WE’RE DOING ADDITIONAL MODELING.
AND IN LIGHT OF THE TIME RESTRICTIONS OF THE ACIP AT THIS
TIME, WE DIDN’T FEEL WE HAD TIME TO ADDRESS IT ADEQUATELY IN
THIS SESSION. SO AFTER WE GET APPROVAL FOR
THESE, WE ARE PLANNING ON PUBLISHING A POLICY NOTE.
WHAT I LIKE TO DO TODAY IS GO OVER SPECIFIC SECTIONS OF THE
RECOMMENDATIONS WHICH INCLUDE ROUTINE RECOMMENDATIONS, SOME
CHANGES IN THE SECTION ON ADMINISTRATION AND INTERVALS,
INTERCHANGEABILITY. I JUST WANT TO GAVE BRIEF UPDATE
ON THE PREGNANCY REGISTRY ISSUES AND DISCUSS A SECTION CALLED
FUTURE POLICY ISSUES. SO FOR ROUTINE RECOMMENDATIONS
AND AGE GROUPS, THE WORK GROUP PROPOSES THE SAME AGE GROUPS AS
IN OUR CURRENT RECOMMENDATIONS. FOR THESE RECOMMENDATIONS,
9-VALENT VACCINE USE IN MALES OLDER THAN AGE 15 WOULD BE OFF
LABEL AT PRESENT AND AS DISCUSSED PREVIOUSLY IN THIS
SESSION, MALES 16 TO 26 WERE PRESENTED TO ACIP IN OCTOBER
INCLUDING GRADE SUBMITTED TO FDA.
COMPARED WITH QUADRIVALENT VACCINE, 9-VALENT VACCINE WOULD
PROVIDE A LITTLE ADDITIONAL BENEFIT FOR MALES.
HOWEVER, PROGRAMMATIC ISSUES WERE CONSIDERED FOR THESE
RECOMMENDATIONS, INCLUDING THE LOW LIKELIHOOD THAT PROVIDERS
WOULD STOCK TWO DIFFERENT VACCINES THEN THE FACT THERE
WILL EVENTUALLY BE A TRANSITION FROM QUADRIVALENT TO 9-VALENT
VACCINE. AND THIS IS THE PROPOSED
RECOMMENDATION ON THIS IN SUBSEQUENT SLIDES.
THE UNDERLINE INDICATES THE NEW WORDING.
I WON’T READ THE BEGINNING BECAUSE IT’S THE SAME AS THE
RECOMMENDATION THAT WAS GONE OVER IN THE RECOMMENDATION IN
TERMS OF AGE GROUPS FOR MALES AND FEMALES.
THE NEW SECTION WILL BE VACCINATION OF FEMALES
RECOMMENDED WITH 5-VALENT, QUADRIVALENT, AS LONG AS THIS
FORMULATION IS AVAILABLE OR 9-VALENT VACCINE, AND
VACCINATION OF MALES IS RECOMMENDED WITH QUADRIVALENT AS
LONG AS THIS FORMULATION IS AVAILABLE OR 9-VALENT VACCINE.
AND THERE WILL BE A LINK TO THE GRAY TABLES THAT THE POINT IN
THE RECOMMENDATION. THIS SLIDE SHOWS SOME ADDITIONAL
WORDING FOR THE ROUTINE RECOMMENDATIONS, AND I WANT TO
POINT OUT THAT THE PROPOSED WORDING DOES NOT SPECIFICALLY
STATE A PREFERENCE FOR ANY VACCINE BUT OUTLINES THE
DIFFERENCES BETWEEN THE VACCINES AND WHAT THEY CAN PROTECT
AGAINST. NOW, THE NEXT SESSION FOR
DISCUSSION IS ON ADMINISTRATION AND INTERVALS.
IN OUR CURRENT RECOMMENDATIONS, THE WORDING IN THIS SECTION IS
THE SECOND DOSE SHOULD BE ADMINISTER UP WITH TO TWO MONTHS
AFTER THE FIRST AND THE THIRD DOSE SIX MONTHS AFTER THE
FIRST. OF NOTE, STUDIES OF QUADRIVALENT
VACCINE SHOW LONGER INTERVALS BETWEEN DOSES DO NOT RESULT IN
LOWER ANTIBODY TITERS AND SOME STUDIES HAVE FOUND HIGHER
TITERS AFTER INTERVALS. WORK GROUP DISCUSSED PROS AND
CONS OF FLEXIBILITY IN INTERVALS.
SOME MEMBERS FELT THIS WAS IMPORTANT AND OTHERS HAD
CONCERNS ABOUT POSSIBLE CONFUSION FOR PROVIDERS.
OF NOTE, THE SCHEDULE ON THE — I MEAN THE INTERVALS ON THE
SCHEDULE WILL REMAIN THE SAME, ZERO, ONE TO TWO AND SIX.
THIS IS THE WORDING THAT HAS BEEN PROPOSED.
BIVALENT, QUADRIVALENT, 9-VALENT ARE ADMINISTERED IN A THREE-DOSE
SCHEDULE, THE SECOND DOSE ADMINISTERED ONE TO TWO MONTHS
AFTER THE FIST DOSE AND THE THIRD DOSE AT LEAST SIX MONTHS
AFTER THE FIRST DOSE. SOME STUDIES HIGHER ANT BODY
TITERS AFTER LONGER INTERVALS BETWEEN DOSES.
IF THE VACCINE SCHEDULE IS INTERRUPTED, THE VACCINE THEORY
DID NOT READ KNEAD TO BE RESTARTED.
THE NEXT SECTION I’D LIKE TO DISCUSS IS ON
INTERCHANGEABILITY. THERE’S BEEN NO STUDY OF
INTERCHANGEABILITY OF HPV VACCINES.
HOWEVER, THERE ARE SOME DATA ON 9-VALENT VACCINE AFTER THREE
DOSES OF QUADRIVALENT VACCINE FROM A STUDY THAT WAS CONDUCTED
AS PART OF THE 9-VALENT CLINICAL PROGRAM.
THE WORK GROUP DISCUSSED PROGRAMMATIC ISSUES RELATED TO
TRANSITION TO THE 9-VALENT VACCINE FOR CONSIDERATION OF
WORDING CHANGES IN THIS SECTION. THIS SLIDE SHOWS THE PROPOSED
WORDING. AGAIN, THE CROSSOUTS AND THE
UNDERLINES RECOMMEND THINGS TO REMOVE AND ADD.
WE HAVE DELETED THE FIRST SENTENCE IN OUR CURRENT
RECOMMENDATIONS WHICH STATES THAT “ACIP RECOMMENDS THAT THE
VACCINATION SERIES FOR FEMALES BE COMPLETED WITH THE SAME
VACCINE PROJECT WHENEVER POSSIBLE.” INSTEAD, WE PROPOSED STARTING WITH THE SECOND CURRENT SENTENCE,
WHICH SAYS, “IF VACCINATION PROVIDERS DO NOT KNOW OR HAVE
AVAILABLE THE VACCINE PRODUCT PREVIOUSLY ADMINISTERED OR ARE
IN SETTINGS TRANSITIONING TO 9-VALENT VACCINE FOR PROTECTION
AGAINST 16 AND 18, ANY HPV PRODUCT MAY BE USED TO CONTINUE
OR COMPLETE THE SERIES FOR FEMALES.
AND QUADRIVALENT OR 9-VALENT VACCINE MAY BE USED TO CONTINUE
OR COMPLETE THE SERIES FOR MALES.”
THERE’S NO CHANGE IN OUR RECOMMENDATIONS FOR VACCINATION
DURING PREGNANCY. AND I’M ONLY SHOWING THIS AS AN
UPDATE. INFORMATION ON VACCINE AND
PREGNANCY REGISTRIES HASN’T CHANGED A BIT. THERE WILL BE A PREGNANCY REGISTRY FOR 9-VALENT VACCINE, AND
OF NOTE, EARLIER THIS MONTH, THE BIVALENT VACCINE REGISTRY WAS
CLOSED WITH CONCURRENCE FROM FDA.
SO WE WILL ADD WORDING ABOUT THE 9-VALENT VACCINE AND MAKE A NOTE
THAT BOTH THE QUADRIVALENT AND THE BIVALENT VACCINE REGISTRIES
HAVE BEEN CLOSED AND THERE WILL BE LINKS TO PHONE NUMBERS.
THE QUADRIVALENT VACCINE WAS CLOSED PREVIOUSLY.
AND FINALLY, THE SHORT SECTION ON FUTURE POLICY ISSUES IS
PROPOSED AT THE END OF THE POLICY NOTE.
THE WORK GROUP DISCUSSION HERE CENTERED ON WHAT SHOULD BE
INCLUDED IN THE POLICY NOTE RELATED TO AN ONGOING TRIAL OF
TWO-DOSE SCHEDULES FOR 9-VALENT HPV VACCINE.
SOME WORK GROUP MEMBERS WERE CONCERNED ABOUT, AGAIN,
CONFUSION FOR PROVIDERS LEADING TO POSSIBLE DELAY IN
VACCINATION. HOWEVER, WE CAME UP WITH A
COMPROMISE, AND THIS IS THE PROPOSED WORDING FOR THIS VERY
SHORT SECTION. A CLINICAL TRIAL IS ONGOING TO
ASSESS ALTERNATE DOSING SCHEDULES OF 9-VALENT VACCINE.
ACIP WILL FORMALLY REVIEW THE RESULTS THE DAY THEY BECOME
AVAILABLE. HPV VACCINATION SHOULD NOT BE
DELAYED PENDING AVAILABILITY OF 9-VALENT VACCINE OR A FUTURE
CLINICAL TRIAL DATA. AGAIN, I MENTION THAT WE’RE NOT
GOING TO BE CONSIDERING THIS, BUT I WANT TO LET YOU KNOW THE
WORK GROUP IS DISCUSSING 9-VALENT HPV VACCINE FOR PERSONS
WHO COMPLETED HPV VACCINATION SERIES.
IMPORTANTLY, THE MANUFACTURER DID NOT SEEK AN INDICATION FOR
NONVALENT HPV VACCINATION, PERSONS WHO HAVE PREVIOUSLY
RECEIVED HPV VACCINE. HOWEVER, ONE STUDY WAS CONDUCTED
AND THE DATA ARE INCLUDED IN THE LABEL.
I’M NOT GOING TO READ THIS TODAY, BUT DUE TO TIME
LIMITATIONS, THIS WILL BE PRESENTED TO ACIP AT THE NEXT
MEETING. I WANT TO THANK ALL THE WORK
GROUP AGAIN. I KNOW THIS WAS MENTIONED
EARLIER. WE’VE HAD A LOT OF CONFERENCE
CALLS OVER THE LAST FEW MONTHS AND THE LAST FEW WEEKS,
PARTICULARLY. AND, AGAIN, FOR DISCUSSION AND
VOTE, JUST FOR APPROVAL OF THE ROUTINE RECOMMENDATIONS AND AGE
GROUPS THAT I REVIEWED, THE WORDING ON ADMINISTRATION AND
INTERVALS, INTERCHANGEABILITY AND FUTURE POLICY ISSUES.
>>THANK YOU, DR. MARKOWITZ. AND I’M JUST APPRECIATIVE OF THE
ENTIRE HPV WORKING GROUP FOR A VERY NICE, COMPLETE, AND VERY
SUCCINCT PRESENTATION. THAT WAS VERY UNDERSTANDABLE.
WE’RE OPEN FOR ANY QUESTIONS OR COMMENTS.
DOCTOR? CAN YOU PUT THE SLIDE BACK UP
WITH THE SUGGESTED LANGUAGE AGAIN?
>>FOR THE MAIN ONE? YES.
>>OKAY. THERE’S TWO SLIDE.
ONE IS — THIS IS OUR BASIC RECOMMENDATION FOR THE AGE
GROUPS. AND ALL WE’RE DOING AT THE END,
WHICH WE HAD BEFORE, MENTIONING WHICH VACCINES CAN BE USED FOR
FEMALES AND WHICH VACCINES CAN BE USED FOR MALES.
BUT ACTUALLY THE BASIC RECOMMENDATION WHICH IS ROUTINE
AT 11 OR 12 STARTING AT AGE 9, 13 TO 26 FOR FEMALES AND 138 TO
21 FOR MALES HAS NOT BEEN CHANGED.
WE WILL HAVE A FOOTNOTE, BY THE WAY, THAT LINKS TO THE
RECOMMENDATION FOR MEN WHO HAVE SEX WITH MEN AND
IMMUNOCOMPROMISED PERSONS, AND THAT’S IN A SEPARATE SECTION IN
THE POLICY NOTE. GREAT.
THANK YOU. MR
>>MS. PELLEGRINI. THANK YOU.
FIRST, I WANT TO THANK THE WORK GROUP VERY MUCH FOR THE REVISED
LANGUAGE ON ADMINISTRATION. I THINK THAT’S ACTUALLY GOING TO
BE VERY HELPFUL IN OUR PARENT EDUCATION, SAYING THAT YOU DON’T
HAVE TO COMPLETE THE SERIES WITHIN THAT VERY RESTRICTIVE
TIME FRAME FOR YOUR TEENAGER. BUT IT CAN BE SPREAD OUT IF
NECESSARY OR IF THAT’S THE WAY LIFE GOES.
COULD WE LOOK AT THE DRAFT WORD ON THE INTERCHANGEABILITY
SLIDE? I THINK IT’S NINE.
IF I’M READING THIS CORRECTLY, IT SEEMS LIKE THERE’S AN
IMPLICIT RECOMMENDATION NOT TO USE BIVALENT SAYING YOU SHOULD
USE QUADRIVALENT OR 9-VALENT TO COMPLETE A SERIES.
SO YOU CAN SORT OF GO — YOU CAN GIVE MORE STRAINS BUT YOU SHOULD
NOT COMPLETE A SERIES WITH BIVALENT IF YOU DON’T KNOW WHAT
IT WAS STARTED WITH, CORRECT? THAT’S FOR MALES.
FOR FEMALES, WE BASICALLY ARE SAYING THAT ANY VACCINE CAN BE
USED TO CONTINUE OR COMPLETE THE SERIES.
AND THIS IS — LAST TIME, SINCE WE ONLY HAD ONE VACCINE THAT WAS
APPROVED AND RECOMMENDED FOR MALE, WE DIDN’T HAVE TO HAVE A
SEPARATE STATEMENT FOR MALES. SO THAT’S WHY THERE’S TWO
SEPARATE STATEMENTS NOW HERE. OKAY.
MAYBE JUST FOR FUTURE DISCUSSION, I’M NOT — I’M NOT
SURE WHY WE’RE — WELL, I’LL COMMUNICATE WITH THE WORK GROUP
OFFLINE. THANK YOU.
>>DR. HARRIMAN. ON THAT SAME LANGUAGE, WHEN I
READ THAT, IT SORT OF INDICATES TO ME THAT IF YOU’VE GOT
QUADRIVALENT VACCINE AND THAT’S WHAT SOMEBODY STARTED WITH, THAT
THAT’S PREFERRED. I MEAN, THAT’S SORT OF HOW I
WOULD READ THAT. PERHAPS IF I WERE A PROVIDER.
BUT I THINK YOU’RE SAYING THAT IT DOESN’T MATTER, BUT YET THE
LANGUAGE SORT OF READS LIKE IF YOU CAN’T GIVE QUADRIVALENT THEN
YOU CAN GIVE THE 9-VALENT. SO I JUST KIND OF WONDER ABOUT
THAT LANGUAGE A LITTLE BIT, UNLESS YOU REALLY DO SAY THAT
SOMEBODY SHOULD CONTINUE WITH THE SAME VACCINE, THE
QUADRIVALENT. BUT —
>>WE’VE TRIED TO SOFTEN THE LANGUAGE BY REMOVING THAT FIRST
SENTENCE BECAUSE I THINK THAT IS WHAT THAT FIRST SENTENCE DID SAY
THAT, THAT ACIP RECOMMENDS THAT THE VACCINATION SERIES FOR
FEMALES SHOULD BE COMPLETED WITH THE SAME PRODUCT WHENEVER
POSSIBLE. AND WE WANTED TO LIBERALIZE
THIS, ACKNOWLEDGING WHAT WAS GOING TO BE HAPPENING DURING THE
TRANSITION WITHOUT — I THINK THIS IS AS FAR AS WE FELT
COMFORTABLE GOING. DOCTOR, DO YOU AGREE WITH THAT?
YEAH. SO IS THERE A PREFERENCE TO
USE QUADRIVALENT IF THAT’S WHAT WAS ALREADY STARTED?
IF THERE’S NOT, THEN IT ALMOST SEEMS LIKE YOU COULD USE THE
LANGUAGE THAT’S USED FOR MALES. I FEEL LIKE WE DID — WE
TRIED TO MAKE THE LANGUAGE FOR MALES AND FEMALES THE SAME.
THEY ARE THE SAME. THE ONLY DIFFERENCE IS THE
VACCINES THAT ARE RECOMMENDED FOR FEMALES AND MALES.
SO MAYBE WE NEED TO HAVE THE SAME — IS THE PART OF THE
LANGUAGE THAT YOU THINK EXPRESSES THAT, IF VACCINE
PROVIDERS DO NOT KNOW OR HAVE AVAILABLE OR TRANSITIONING?
>>RIGHT. IT JUST SEEM LIKE IT COULD JUST
READ, YOU KNOW, IF THE VACCINE SERIES HAS ALREADY BEEN STARTED
COMPLETE THE SERIES RATHER THAN “IF YOU DON’T HAVE IT OR IF” —
I DON’T KNOW. MAYBE I’M THE ONLY ONE THAT
WOULD READ THAT IT WAY. LET ME JUST SAY, WE MEANT
THAT SENTENCE TO APPLY TO BOTH THE MALES AND THE FEMALES.
WE DIDN’T MEAN IT TO READ THAT THAT WAS JUST FOR THE FEMALES.
>>DR. BENNETT. I DON’T KNOW IF THIS IS THE
CONFUSION, BUT FOR FEMALES YOU COULD STILL BE GIVING THE
BIVALENT VACCINE. SOY THINK THAT’S WHAT YOU WERE
LEAVING ROOM FOR? WHEREAS FOR MALES THAT WOULD NOT
BE INDICATED. SO.
>>DR. MARKOWITZ, JUST FOR A REMINDER, CAN YOU GIVES US A AN
INDICATION WHAT PERCENTAGE OF HPV VACCINE IN THE UNITED STATES
IS A QUADRIVALENT CURRENTLY? YES.
YEAH. PROBABLY OVER 98% OF VACCINE
BEING USED IS QUADRIVALENT. SO OUR RECOMMENDATIONS ARE
REALLY GEARED TOWARDS PEOPLE WHO ARE MARKETING QUADRIVALENT
VACCINES. SO IN ESSENCE YOU’RE BEING
VERY, VERY INCLUSIVE HERE, BUT ALSO ACKNOWLEDGING WHAT REALITY
IS. SO I THINK THAT IS CONVEYED
NICELY HERE. YES.
>>IN YOUR LANGUAGE ABOUT EXTENDING THE INTERVAL THAT IS
THE STATEMENT THAT SOME STUDIES HAVE DEMONSTRATED HIGHER TITERS
WITH LONGER INTERVALS WILL INVITE PROVIDERS TO ASK, WELL,
HOW MUCH LONGER AND HOW ARE YOU GOING TO ADVISE THEM IN YOUR
POLICY STATEMENT ABOUT SPECIFIC DATA OR ARE YOU JUST GOING TO
LEAVE IT OPEN AT LONGER INTERVALS CAN BE AS LONG AS YOU WANT? WE CAN ADD SOME
CLARIFICATION. WE HAVE NOT — BECAUSE — WE
HAVE FOR A POLICY NOTE WE DO NOT HAVE A LOT OF ROOM IN THE
DOCUMENT. WE HAVE NOT GONE INTO THAT IN
DETAIL. SO MAYBE WE SHOULD ADD
SOMETHING. IS THAT YOUR SUGGESTION OR
SHOULD WE TAKE THAT OUT? I THINK YOU NEED SOMETHING
OTHERWISE THOSE WITH QUESTIONS FROM PROVIDERS ABOUT INTERVALS
ARE GOING TO GET PHONE CALLS, SHOULD I WAIT 12 MONTHS, 15
MONTHS? WE NEED SOMETHING TO GIVE A
BOUNDARY AROUND THAT OR AT LEAST WHAT THE DATA SHOW, THEN THE
PROVIDER CAN DECIDE. OKAY.
THAT’S A GOOD SUGGESTION. DOCTOR?
>>THANK YOU. LAURIE, YOU INDICATED THAT YOU
DIDN’T HAVE TIME TODAY TO TALK ABOUT THE DATA AROUND
REVACCINATION, BUT WILL THAT — SOME GUIDANCE ABOUT THAT STILL
APPEAR IN THE POLICY NOTE EVEN IF YOU’RE NOT PRESENTING IT TO
THE ACIP TODAY? IN VACCINATION OF —
>>OF PEOPLE WHO HAVE ALREADY COMPLETED A SERIES WITH SAY
QUADRIVALENT VACCINE. I THINK THAT’S SOMETHING
MAYBE WE CAN ASK THE ACIP MEMBERS HOW THEY FEEL ABOUT.
WE HAVE NOT BEEN ABLE TO DISCUSS THAT SO, WE COULD BE SILENT ON
THAT AND JUST LEAVE SOMETHING OUT ENTIRELY.
OR WE COULD INDICATE — ONCE WE COULD INDICATE SOMEPLACE EVEN IN
THE FUTURE POLICY ISSUES THAT WE WERE TALKING ABOUT THAT OR WE
COULD HAVE SOME TYPE OF STATEMENT IN THE POLICY NOTE IF
THE ACIP MEMBERS FEEL THAT’S IMPORTANT.
THIS IS AN EVOLVING ISSUE BASED ON THE LIMITED ACIP MEETING THAT
WE’RE HAVING. RIGHT.
>>DOCTOR? YES.
IF THIS ISSUE NEEDS THE ACIP TO DELIBERATE, THE ACIP HAS NOT
BEEN ABLE TO DELIBERATE, THERE ARE OTHER WAYS THAT CDC CAN MAKE
SOME FACTUAL INFORMATION AVAILABLE TO CLINICIANS PENDING
ACIP DELIBERATING ON THIS. SO IN TERMS OF THE EVIDENCE BASE
THAT’S OUT THERE AND NOT CONTRAINDICATED AND THAT KIND OF
STUFF. I THINK WE CAN MANAGE SOME THING
FOR THE CONFUSION THAT MAY BE OUT THERE PENDING LETTING ACIP
THOUGHTFULLY DELIBERATE ON WHAT THEY WANT TO SAY.
>>AND THIS WILL DEFINITELY COME UP AT THE JUNE MEETING SO I’M
NOT UNCOMFORTABLE WITH HAVING A FOUR-MONTH WINDOW HERE,
ESPECIALLY TALKING ABOUT AN OFF-LABEL USE FOR A NEW PRODUCT
THAT PEOPLE ARE JUST GETTING FAMILIAR WITH.
I THINK WE’RE PROBABLY WITHIN OUR CAPACITY RIGHT NOW.
DR. HARRISON. I’M A LITTLE UNCLEAR.
ARE WE ANTICIPATING A VOTE IN JUNE OR JUST AN INFORMATIONAL
SESSION IN JUNE ABOUT THE USE IN PREVIOUSLY VACCINATED WITH THE
QUADRIVALENT? I WOULD ASSUME WE WOULD BE
ANTICIPATING A VOTE ON THE WORDING BECAUSE IF PEOPLE WOULD
WANT THAT INCLUDE IN A POLICY STATEMENT.
>>I’M JUST WONDERING WHETHER WE SHOULDN’T CONSIDER AN
INFORMATIONAL SESSION BEFORE THE NEXT MEETING FOR BOTH THIS ISSUE
AN MENINGOCOCCAL B ISSUE.
I MEAN, IN THE PAST WE’VE HAD SOME DIFFICULTY BEING PRESENTED
WITH SOMEWHAT NOT STRAIGHTFORWARD INFORMATION OR
DECISIONS ON THE SPOT AND THEN TAKING A VOTE DURING THE SAME
MEETING. DR. SHUCHAT?
>>THAT’S NOT GOING TO BE POSSIBLE.
>>WE CAN CERTAINLY PROVIDE SOME INFORMATION TO PEOPLE AS
BACKGROUND MATERIALS BEFORE THE MEETING.
I THINK THAT WOULD PROBABLY BE THE BEST WAY TO GET THE ACIP
MEMBERS — TO PROVIDE ENOUGH BACKGROUND INFORMATION TO BE
ABLE TO ADDRESS THIS. SO WE CAN CERTAINLY DO THAT AS
PART OF THE REGULAR PROCESS. OTHER — OH, YES,
DR. MIDDLEMAN. DR. MIDDLEMAN FROM HEALTH AND
MEDICINE. I’M JUST LOOKING AT THE WORDING
THAT IS UP THERE AND WONDERING IF, GIVEN THE OPEN-ENDEDNESS
DR. SAWYER HAD MENTIONED ABOUT THE LONGER INTERVALS, WOULD BIT
HELPFUL — DO PEOPLE THINK IT WOULD BE HELP TO FEEL ADD A
STATEMENT ABOUT EFFICACY ONLY BEING KNOWN IF THE SERIES IS
COMPLETED OR SOMETHING ALONG THOSE LINES TO MAKE SURE THERE’S
COMPLETION AT THE END GAME? ONE OTHER WAY THAT MIGHT
AVOID CONFUSION WOULD BE TO ELIMINATE THIS SENTENCE ENTIRELY
THAT SOME STUDIES HAVE FOUND. WE CAN JUST SAY THE SECOND DOSE
SHOULD BE ADMINISTERED AT LEAST ONE TO TWO MONTHS AND THE THIRD
DOSE AT LEAST SIX MONTHS, AND WE CAN ELIMINATE THIS SENTENCE
WHICH SEEMS TO BE CAUSING SOME CONFUSION.
I THINK THAT THAT WOULD SERVE THE SAME PURPOSE.
>>I AGREE WITH THAT. THANK YOU.
>>I THINK THAT’S A GOOD IDEA AS WELL.
JUST TO TAKE THE AMBIGUITY UNTIL IT’S FURTHER DISCUSSED.
DO WE HAVE OTHER DISCUSSION OR QUESTIONS?
>>AND I JUST WANT TO MENTION ABOUT THAT, IT’S NOT THAT
DIFFERENT FROM OUR CURRENT RECOMMENDATION, WHICH WE SAY THE
VACCINATION SCHEDULE IS INTERRUPTED, DOESN’T NEED TO BE
RESTARTED. SO WE HAVE ALREADY MADE THIS
STATEMENT. WE’RE JUST CLARIFYING IT BY
HIGHLIGHTING THE INDIVIDUAL INTERVALS.
>>VERY GOOD. SO WE HAVE SOME DRAFT WORDING UP
HERE THAT WE’VE GONE THROUGH. IS THERE ANY TENDER OF A MOTION?
DR. RUBEN. I MAKE A MOTION TO ACCEPT IT
WITH THE DELETION OF THAT SENTENCE ON THE SLIDE REGARDING
THE ANTIBODY LEVELS BEING HIGHER.
>>AND IS THERE A SECOND? I THINK I SAW DR. VASQUEZ.
OKAY. FURTHER DISCUSSION?
SEEING NONE, WE WILL START WITH DR. KEMP AND GO TO YOUR LEFT.
>>CAN I CLARIFY, WE’RE VOTING ON ALL OF THIS, OR JUST VOTE ON
THIS ONE? WE’RE GOING TO VOTE ON THE
ENTIRE PASSAGE BECAUSE I THINK WE HAVE GONE THROUGH IT AND MADE
CHANGES WHERE WE FELT APPROPRIATE.
>>OKAY. IF YOU DON’T MIND —
>>YES. THAT’S GOOD.
>>QUESTION? YES.
>>THAT WHOLE PACKAGE THAT’S BEING VOTED ON INCLUDES USE OF
HPV 9 AND PRIOR RECIPIENTS OF HPV 4?
THAT WORDING WAS PRESENTED. THE WORDING IS SUCH THAT A
PATIENT WHERE WE DON’T KNOW WHAT THE PREVIOUS VACCINE WAS, ONE
COULD USE FOR MALES HPV 4 OR HPV 9, FOR FEMALES THAT WE DON’T
KNOW WHAT THEY HAD RECEIVED BEFORE, THEY COULD RECEIVE THE
BIVALENT, THE QUADRIVALENT, OR THE 9-VALENT FOR THE PROTECTION
OF 16 AND 19 — 16 AND 18. 18.
>>THANK YOU. DRAFT WORDAGE OF PREVIOUSLY
VACCINATED WITH HPV 4, THAT IS NOT BEING VOTED ON.
>>YES, BECAUSE THAT HAD BEEN DISTRIBUTED BEFORE THE COMPRESS
SESSION WHEN WE KNEW WE WERE NOT GOING TO HAVE ENOUGH TIME SO WE
HAD TAKEN THAT OFF THE AGENDA. ANY FURTHER CLARIFICATION?
AND SEEING NONE, I’M GOING TO GO BACK TO DR. KEMP.
>>KEMP, YES. KAREN, YES.
>>POLLANGE, YES. HARRISON, YES.
>>HARRIMAN, YES. ROMEO, YES.
>>RUBEN, YES. BENNETT, YES.
>>TEMPTE, YES. PELLEGRINI, YES.
>>BRIAN GOLD, ABSTAINED. CAMP, YES.
>>VASQUEZ, YES. OKINI, YES.
>>REILLY, YES. AND THE MOTION PASSES WITH 14
VOTES FOR AND 1 ABSTENTION. THANK YOU VERY MUCH TO THE HPV
WORK GROUP. MY APOLOGY FOR NOT TAKING ANY
FORMAL BREAKS HERE. I’LL JUST REMIND PEOPLE, FEEL
FREE TO GET UP AS THEY NEED. DR. FRYHOFER AS A COMMENT.
>>LIAISON FOR ACIP. JUST — I UNDERSTAND THE TIME
CONSTRAINTS OF THIS CURRENT MEETING, BUT JUST TO PUT IT OUT
THERE, I THINK THE QUESTION ABOUT REVACCINATION WITH HPV 9
FOR PATIENTS THAT HAVE RECEIVED HPV 4 IS CERTAINLY SOMETHING A
THAT A LOT OF PRACTITIONER ASK AND REALLY LOOK FORWARD TO
GUIDANCE FROM ACIP AND GETTING THE WORD OUT THERE AS TO WHAT WE
SHOULD DO. THANK YOU.
>>THANK YOU. SO I THINK AT THIS POINT,
DR. SANTOLLI IS COMING UP — OH, ANN —
>>>I WILL MAKE THIS VERY FAST. IDSA.
I THINK ONE OF THE MOST COMMON QUESTIONS WE’LL GET AFTER THESE
NEW RECOMMENDATIONS ARE SEEN WILL RELATE TO THE TIME LINE OF
THE AVAILABILITY OF THE 9 VALENT AND THE PLY.
SO IT WOULD BE HELPFUL IF SOMEBODY BEFORE THE END OF THE
SESSION COULD COMMENT ON THOSE TWO ISSUES.
>>IS THAT SOMETHING YOU’RE ABLE TO —
>>I CAN SAY A LILLE BIT. I THINK I’LL ALSO DEFER TO
COLLEAGUES FROM MERCK TO — IF MERCK COULD COME ON UP.
>>WE HAVE CURRENT AVAILABILITY OF THE 9 VALENT AND CONTINUED
SUPPLY OF GUARD SILL. WE ARE ALSO WAITING FOR GREATER
COMMERCIAL COVERAGE FROM AN INSURANCE PERSPECTIVE WHETHER
WHERE IT WILL BE MORE BROADLY AVAILABLE IN THE U.S.
>>THANK YOU, DR. SANTOLLI FOR THE RESOLUTION.
>>THE PURPOSE IS TO UPDATE THE RESOLUTION TO INCLUDE USE OF
9-VALENT HPV VACCINE AND TO CLARIFY THE SCHEDULE AND TIMING
OF VACCINE INTERVALS. THE ELIGIBLE GROUP SECTION IS ON
THE TABLE. THE ADDITIONAL COLUMN ON THE
RIGHT IN YELLOW HAS BEEN ADDED TO REFLECT THE NEW 9-VALENT
VACCINE. THE REMAINDER OF THE TABLE IN
WHITE IS THE TABLE AS IT CURRENTLY EXISTS IN THE
RESOLUTION. WE DID USE THIS OPPORTUNITY TO
CLARIFY THE LANGUAGE AND THE SCHEDULE AND INTERVAL SECTION.
IT SHOULD BE VERY FAMILIAR TO YOU AS MUCH OF ITT’S
IN THE POLICY NOTE SO, THE RECOMMENDATION FOR ROUTINE
VACCINATION AGE 11 OR 12 YEARS AND THEN ELIGIBLE FEMALES AND
MALES AS YOUNG AS 9 YEARS OLD MAY BE VACCINATED.
VACCINATION IS RECOMMENDED FOR TALES AND MALES 13 THROUGH 18
YEARS OF AGE WHO HAVE NOT BEEN PREVIOUSLY VACCINATED OR NOT
COMPLETED THE FULL SERIES. HPV 2, 4, AND 9 ARE ADMINISTERED
IN A THREE-DOSE SCHEDULE, THE SECOND DOSE ADMINISTERED ONE TO
TWO MONTHS AFTER THE FIST DOSE AND THE THIRD DOSE AT LEAST SIX
MONTHS AFTER THE FIST DOSE. IF PROVIDERS DO NOT HAVE THE
VACCINE PREVIOUSLY ADMINISTERED FOR PROTECTION AGAINST HPV 16 OR
18, ANY AVAILABLE HPV PRODUCT MAY BE USED TO CONTINUE OR
COMPLETE THE SERIES FOR FEMALES. HPV 9 OR HPV 4 MAY BE USED TO
CONTINUE OR COMPLETE THE SERIES FOR MALES.
AGAIN, THIS IS — MIRRORS THE LANGUAGE YOU WERE JUST
DISCUSSING. THEN IN TERMS OF INTERRUPTED
VACCINATION SCHEDULE AND MINIMUM INTERVALS, IF THE SCHEDULE IS
INTERRUPTED IT DOES NOT NEED TO BE RESTARTED.
THE FIST AND SECOND DOSES SHOULD BE SEPARATED BY AN INTERVAL OF
AT LEAST FOUR WEEKS. THE SECOND AND THIRD SEPARATED
BY AN INTERVAL OF AT LEAST 12 WEEKS WITH A MINIMUM INTERVAL OF
24 WEEKS BETWEEN THE FIRST AND THIRD DOSE.
THE DOSAGE INFORMATION IS ARE REFERRED TO THE PACKAGE INSERTS
AS ARE THE CONTRAINDICATIONS AND PRECAUTIONS.
AND THEN THE STATEMENT ABOUT REFERRING TO PUBLISHED LINKS
ONCE ADDITIONAL PUBLICATIONS ARE MADE.
AND THAT CONCLUDES THE UPDATE TO THE RESOLUTION.
>>ARE THERE ANY QUESTIONS? YES, DR. HARRIMAN.
>>JUST ONE QUICK COMMENT ON INTERVALS.
WOULDN’T IT BE VALUABLE TO PERHAPS USE THE EXACT SAME
LANGUAGE THAT’S USED IN THE POLICY NOTE IN THE VFC RATHER
THAN WEEKS AND — WE CAN CERTAINLY DO THAT.
>>SOME OF THE MINIMAL INTERVALS HISTORICALLY HAVE BEEN IN WEEKS
AND THAT RELATE TO SOMETHING TO DO WITH THE REGISTRIES AND
HOW THEY’RE — SOME OF THIS IS USED.
SO WE WILL — THEY DO MIRROR EACH OTHER.
LET ME SAY THAT. THE MINIMAL INTERVAL.
I DIDN’T SHOW THAT IN WHAT WE DISCUSSED.
THE MINIMAL INTERVALS HAVEN’T CHANGED.
>>I THINK AS A CLARIFICATION, THE FORECASTING FOR THE SYSTEM
NEEDS SPECIFIC NUMBERS OF DAYS, WHICH YOU DON’T GET WITH A MONTH
BECAUSE MONTHS CAN BE VARIABLE. AND SO AS LONG AS THIS IS
CONSISTENT WITH OTHER VFC RESOLUTIONS OUT THERE, I THINK
WE CAN LET THAT STAND. DR. HARRIMAN?
>>THAT’S FINE. IT’S JUST NICE IF LANGUAGE IS
HARMONIZED THROUGHOUT. MAYBE IT NEEDS TO GO IN THE
OTHER DIRECTION, THE POLICY NOTE SHOULD MIRROR THE VFC OR
SOMETHING. DR. SHUCHAT.
>>THE READERS OF THE VFC NOTE ARE NOT THE SAME, SO, I MEAN,
OBVIOUSLY THERE’S PLENTY OF STRENGTHENING THE QUALITY OF HOW
WE WRITE THESE THINGS THAT WE’LL TAKE BACK.
>>OTHER QUESTIONS OR COMMENTS ON THIS RESOLUTION?
SEEING NONE, LET ME SEE IF THERE IS A MOTION FOR.
DR. KEMP? ANY SECOND?
DR. ROMERA. ANY FURTHER DISCUSSION?
IF NOT, MS. PELLEGRINI AND GO TO YOUR RIGHT, WHICH IS ME.
>>PELLEGRINI, YES. TEMPTE, YES.
>>BENNETT, YES. RUBEN, YES.
>>ROMERO, YES. HARRIMAN, YES.
>>HARRISON, YES. BOLLANGE, YES.
>>KAREN, YES. KEMP, YES.
>>REILLY, YES. VASQUEZ, YES.
>>YES. RYAN GOLD, ABSTAINED.
>>FOR THE RESOLUTION WE HAVE 14-1, ONE ABSTENTION.
MOTION CARRIES. AS FOR CUEING UP THE SLIDES
FOR JAPANESE ENCEPHALITIS, I UNDERSTAND THERE IS ONE MORE OF
THE PUBLIC COMMENTS WHO NEEDS TO LEAVE.
AND I BELIEVE THAT IS CARL BREWER?
IF YOU CAN COME UP TO THE MICROPHONE AND WE CAN TAKE YOUR
COMMENT AS WE’RE GETTING READY FOR THE SESSION ON JAPANESE
ENCEPHALITIS. THANK YOU SO MUCH FOR YOUR
FLEXIBILITY. YELLOW FEVER, NOT JAPANESE
ENCEPHALITIS. THANK YOU, GUYS.
I’M TOM, AND HOPEFULLY THIS MICROPHONE WORKS OKAY.
I’M SO GRATEFUL TO HAVE THE CHANCE TO SPEAK HERE TODAY
REPRESENTING THE NATIONAL MENINGITIS ASSOCIATION.
I SURVIVED BACTERIAL MENINGITIS WHEN I WAS 14, AND JUST LAST
YEAR LEARNED IT WAS SERA GROUP B.
I SPENT FIVE MONTHS IN THE HOSPITAL, LOST THREE OF MY
FINGERS AND BOTH LEGS BELOW THE KNEE ON HALLOWEEN.
I HAD 11 SURGERIES, TOOK ME ALMOST FOUR YEARS TO LEARN HOW
TO WALK AGAIN ON MY PROSTHETICS. TO DATE MY MEDICAL BILLS HAVE
FAR EXCEEDED $2 MILLION, BUT I STILL CONSIDER MYSELF LUCKY.
11 YEARS LATER I HAVE A COLLEGE DEGREE, A GREAT JOB AND A
BEAUTIFUL WIFE. MOST SURVIVORS I KNOW FEEL THE
SAME WAY. WE HAVE PRETTY GOOD ATTITUDES
AND HAVE BEEN ABLE TO FIND THE POSITIVES IN THIS DISEASE.
FOR EXAMPLE, MY WIFE AND I LIKE TO TALK ABOUT MY PERKS LIST,
WHICH INCLUDES THINGS THAT MY FEET NO LONGER FALL EIGHT SLEEP
AND THE ABILITY TO KNOW EXACTLY WHAT SHOE SIZE I NEED.
HOWEVER, THERE ARE ALSO SOME CONS.
I CAN NO LONGER ENJOY FUZZY SLIPPERS AND ZIPLOC BAGS HAVE
BECOME MY WORST ENEMY. BUT NO MATTER HOW LUCKY WE ARE,
MOST OF WILL DEAL WITH THE EFFECTS OF THIS DISEASE FOR THE
REST OF OUR LIVES. MY FELLOW SURVIVOR, SAMANTHA,
HAS HAD MORE THAN 37 30 SURGERIES IN 30 YEARS AND STILL
HAS PAIN ON A DAILY BASIS. AND KYLA, WHO LOST BOTH LEGS AND
MOST OF HER FINGERS AND HAVE GONE THROUGH A DOZEN SURGERIES
IN RECENT YEARS TO LENGTHEN HER THUMB, BECAUSE SHE SAYS
OPPOSITION IS EVERYTHING. BLAKE LEARNED SO MUCH AS AN
OUTPATIENT BEFORE A TRANSPLANT THAT HE BECAME A DIALYSIS NURSE.
SOME OF US LIKE FRANCESCA HAVE INVISIBLE SCARS LIKE LOSS OF
COGNITIVE FUNCTION OR HEARING OR VISION.
MANY OF US ENDURED AND SOME CONTINUE TO ENDURE ANXIETY,
FEAR, AND DEPRESSION BECAUSE OF THIS TERRIBLE DISEASE.
WHEN WE GET TOGETHER, WE TALK ABOUT THE CHALLENGES WE DEAL
WITH THAT MOST PEOPLE DON’T EVEN THINK ABOUT, LIKE HOW TO TAKE A
SHOWER WHEN YOU’RE TRAVELING WITH NO LEGS OR HOW HARD IT IS
TO COUNT TO TEN ON YOUR FINGERS WHEN YOU’RE MISSING A FEW.
FOR MOST OF US, IT AFFECT YOUR FINANCES FOR THE REST OF OUR
LIVES. OUR COST OF LIVE WILLING ALWAYS
BE HIGHER AND WE MAY NEED ADDITIONAL SUPPORT.
MORE OBVIOUS THINGS SUCH AS NEEDING MORE TIME OFF WORK TO
DEAL WITH ADDITIONAL SURGERY OR COMPLICATIONS.
EVEN WITH GREAT INSURANCE PLANS WE PAY ENORMOUS CO-PAYS AND
OUT-OF-POCKET EXPENSES. OTHER THINGS NO INSURANCE WILL
COVER SUCH AS RETROFITTING CARS TO FIT OUR NEEDS OR RENOVATING
HOMES. WE ARE ALL VERY DIFFERENT, BUT
ONE THING WE AGREE ON — WE DON’T WANT ANYONE TO HAVE TO GO
THROUGH WHAT WE WENT THROUGH AND STILL DEAL WITH ON A DAILY
BASIS. WHEN YOU LOOK AT THE COST OF
PREVENTION, I HOPE YOU’LL CALCULATE HOW HIGH THE COST OF
SURVIVAL IS AS WELL THANK YOU FOR YOUR TIME.
THANK YOU VERY MUCH FOR YOUR COMMENTS.

2 Replies to “February 2015 ACIP- Human Papillomavirus (HPV) Vaccine”

  1. In a recent review titled "Could the human papillomavirus vaccines drive virulence evolution?" DOI: 10.1098/rspb.2014.1069Published 26 November 2014 . There is a concern since virus shedding is common with HPV vaccination, that virus evolution can be accelerated. 

    How do you address the likely hood of viral pathogen replacement, and or evolutionary mutations that if this study is correct, MAY bring is into unknown territory in the future. 

    Thanks,

    Ralph Turchiano

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