>>> GOOD MORNING. I'D
LIKE TO WELCOME EVERYBODY
TO THE FEBRUARY 2013
MEETING OF THE U.S.
ADVISORY COMMITTEE ON THE
IMMUNIZATION PRACTICES.
I'M JON TEMTE AND
SERVE AS CHAIR.
I'LL TURN THINGS OVER TO
LARRY PICKERING IN A SECOND.
I JUST WANTED TO APOLOGIZE
TO EVERYBODY WE CUT
IN FRONT OF BECAUSE
WE WERE TOLD WE
NEEDED TO BE HERE.
SO WHEN THEY CUT IN LINE,
THEY'RE DOING SO UNDER
THE AUTHORITY OF
DR. PICKERING HERE, OKAY?
>> THANK YOU VERY MUCH.
YOUR AUTHORITY
WILL BE REVOKED FOR
THE NEXT MEETING.
OKAY, WELCOME TO
THE FIRST MEETING,
FIRST ACIP MEETING OF 2013.
THE PROCEEDINGS OF THIS
MEETING, AS HAS BEEN
DONE IN THE
PAST COUPLE YEARS,
WILL BE BROADCAST OVER
THE WORLD WIDE WEB.
SEVERAL PEOPLE
WILL BE WITH US TO
ASSIST FOR THE DURATION
OF THE MEETING.
STEPHANIE THOMAS, WHO
WILL BE AT THE BACK
OF THE ROOM ON MY LEFT,
FELICIA BETTENCOURT,
NATALIE GREEN, REID
WALDON AND CHRIS CARAWAY
ON THE DRUMS UP
HERE, ON THE COMPUTER.
WE'VE GOT A FULL AGENDA TODAY
AND TOMORROW UNTIL WE ADJOURN.
WE'RE GOING TO ADJOURN TODAY
AROUND 6:00 OR 6:15,
DEPENDING ON HOW EFFICIENT
DR. TEMTE IS,
AND ABOUT 1:30 P.M. TOMORROW.
COFFEE AND BREAKFAST ITEMS WILL
BE SERVED OUTSIDE
AND LUNCH WILL BE AVAILABLE
ONLY TODAY.
IT WILL NOT BE AVAILABLE
TOMORROW,
BUT THERE WILL BE OTHER
THINGS TO EAT.
HANDOUTS TO BE
PRESENTED HAVE BEEN
DISTRIBUTED TO ALL THE
ACIP MEMBERS AND ARE
AVAILABLE FOR MEMBERS
OF THE PUBLIC ON
THE TABLE OUTSIDE
THE AUDITORIUM.
AND THEN, AGAIN, THREE THINGS.
IN TWO WEEKS,
AFTER THIS MEETING,
THE SLIDES WILL BE
PUT ON THE ACIP WEBSITE.
FOUR WEEKS AFTER
THIS MEETING, THE
LIVE WEBCAST WILL BE
PUT ON THE ACIP SITE.
AND 90 DAYS AFTER
THE MEETING, THE MINUTES
OF THIS MEETING,
WHICH ARE WHAT,
162 SINGLE-SPACED
PAGES FOR THE LAST MEETING
WILL BE PUT ON THE WEBSITE.
IT'S REALLY GREAT READING.
MEMBERS OF THE PRESS WHO ARE
INTERESTED IN CONDUCTING
INTERVIEWS SHOULD CONTACT
TOM SKINNER, WHO WILL BE HERE
FOR THE DURATION OF THE MEETING.
WE'RE VERY HONORED TODAY
TO HAVE A DELEGATION
OF VISITORS FROM
THE PAN AMERICAN
HEALTH ORGANIZATION
OF THE WORLD HEALTH
ORGANIZATION IN
ATTENDANCE, INCLUDING THE
EXECUTIVE SECRETARY
OF THE EL SALVADORAN
ADVISORY COMMITTEE ON
IMMUNIZATION PRACTICES
ACCOMPANIED BY
TECHNICAL STAFF FROM THE PAHO
OFFICE IN WASHINGTON,
AND THEY'RE STANDING.
YESTERDAY, THE PAHO GROUP
AND CDC STAFF FROM THE
GLOBAL IMMUNIZATION
DIVISION HAD A
MEETING TO EXCHANGE
EXPERIENCES ON THE
USE OF EVIDENCE FOR
IMMUNIZATION DECISION-MAKING.
DELEGATES FROM THE EL SALVADORAN
ADVISORY COMMITTEE ON
IMMUNIZATION PRACTICES LEARNED
ABOUT HOW THIS COMMITTEE DRAWS
UPON EVIDENCE TO FORMULATE
IMMUNIZATION POLICY, AND IN
PARTICULAR, HOW ACIP HAS
INCORPORATED GRADE TO EVALUATE
THE QUALITY OF EVIDENCE.
AND GENE SMITH AND DOUGLAS AND
FARUK AHMAD DIRECTED THAT AND I
WENT TO A LITTLE BIT OF IT AND
IT WAS ABSOLUTELY FANTASTIC.
SO, WE APPRECIATE THE
EL SALVADORAN GROUP BEING HERE,
AND ANYTHING ANY OF US CAN DO TO
ASSIST, LET US KNOW.
THIS MEETING IS BEING SIMULCAST
IN SPANISH, SO OUR MEMBERS WILL
BE ABLE TO UNDERSTAND, IF ANYONE
CAN, WHAT WE'RE SAYING DURING
THE COURSE OF THE DAY.
SO, WE'D LIKE TO EXPRESS OUR
APPRECIATION AND TO THE PAN
AMERICAN HEALTH ORGANIZATION AND
THE INSTITUTE WHICH PROVIDES
FINANCIAL AND LOGISTICS SUPPORT
FOR PARTICIPATION OF THE
NATIONAL IMMUNIZATION COMMITTEE
MEMBERS FROM LATIN AMERICA.
IF YOU REMEMBER, WE HAD A GROUP
HERE LAST WEEK FROM COSTA RICA,
THA
AND THAT ALSO WAS VERY
SUCCESSFUL.
NEXT, WE HAVE A VERY SPECIAL
GROUP HERE FROM THE WALKER
SCHOOL, FIVE JUNIOR AND SENIOR
HIGH SCHOOL EPIDEMIOLOGY
STUDENTS.
THEY'RE HERE FROM THE WALKER
SCHOOL OF PUBLIC HEALTH PROGRAM,
WHICH IS A --
[ APPLAUSE ]
THEY CAN STAND.
WHICH IS A PARTNERSHIP BETWEEN
THE WALKER SCHOOL AND THE DAVID
J. SENSOR MUSEUM AT CDC.
THEIR FOCUS THIS SEMESTER IS
VACCINE SAFETY, AND FOUR OF
THESE FIVE EXCEPTIONAL YOUNG
WOMEN WILL BE INTERNING AT THE
CDC THIS SUMMER.
AND I UNDERSTAND THAT ONE OF THE
BOOKS YOU'RE STUDYING IS A BOOK
BY THE DOCTOR WHO IS HERE THIS
MORNING TALKING THIS MORNING,
AND HE'S INTERESTED IN MEETING
WITH EACH OF YOU DURING THE
COURSE OF THIS MEETING.
SO, THANK YOU FOR BEING HERE.
ACIP WELCOMES THE INFECTIOUS
DISEASE SOCIETY AT THE NEW
LIAISON AND DR. JACK ANGLON IS
HERE TODAY REPRESENTING THEM.
THEY ARE ACTIVELY INVOLVED IN
THE TRAINING AND EDUCATION OF
PEDIATRICIANS AND OTHER HEALTH
CARE PROVIDERS AND HEALTH CARE
PREVENTION THROUGH THE USE OF
IMMUNIZATION RESEARCH AND PUBLIC
HEALTH MAJORS.
WELCOME BACK.
THE NATIONAL VACCINE ADVISORY
COMMITTEE LIAISON REPORT
TOMORROW WILL BE GIVEN BY DR.
GALENFORT, DR. GOLDSTEIN, DR.
MARY CURRIER, A HEALTH OFFICER,
MISSISSIPPI STATE DEPARTMENT OF
HEALTH IS REPRESENTING ASO FOR
DR. MONTERO, AND WE JUST LEARNED
THAT DR. SANDY FRYHOFER HAS BEEN
APPOINTED AS THE LIAISON FOR THE
AMERICAN MEDICAL ASSOCIATION.
SO SANDY, WE'RE VERY HAPPY WE'LL
BE SEEING YOU AGAIN REGULARLY.
SO, THANK YOU.
JUST A FEW REQUESTS.
WE REQUEST THAT ALL CELL PHONES
BE TURNED OFF, AND TOPICS THAT
ARE PRESENTED AT ACIP MEETINGS
INCLUDE OPEN DISCUSSION WITH
TIME RESERVED FOR PUBLIC
COMMENT.
TIME FOR PUBLIC COMMENT
PERTAINING TO TOPICS ON THE
AGENDA HAS BEEN SCHEDULED AT THE
END OF EACH AFTERNOON SESSION.
AND THE TIME FOR PUBLIC COMMENT
ALSO MAY BE PROVIDED PRIOR TO
SPECIFIC VOTES BY ACIP TO ENABLE
THESE COMMENTS TO BE CONSIDERED
BY THE MEMBERS BEFORE THE VOTE
IS TAKEN.
SO, PEOPLE, AGAIN, WHO PLAN TO
MAKE PUBLIC COMMENTS, IF YOU'VE
NOT ALREADY SIGNED UP, PLEASE DO
SO AT THE BACK OF THE ROOM.
STEPHANIE THOMAS WILL RECORD
YOUR NAME AND PROVIDE ANY
INFORMATION THAT IS NEEDED ABOUT
PUBLIC COMMENT.
LASTLY ABOUT DISCLOSURES.
TO SUMMARIZE CONFLICT OF
INTEREST PROVISIONS APPLICABLE
TO ACIP IS NOTED IN THE ACIP
POLICY AND PROCEDURES MANUAL.
MEMBERS OF THE ACIP AGREE TO
FOREGO PARTICIPATION IN CERTAIN
ACTIVITIES RELATED TO VACCINES
DURING THEIR TENURE ON THE
COMMITTEE.
FOR CERTAIN OTHER INTERESTS THAT
POTENTIALLY ENHANCE THE MEMBER'S
EXPERTISE WHILE SERVING ON THE
COMMITTEE, ACIP HAS ISSUED
LIMITED CONFLICT OF INTEREST
WAIVERS.
MEMBERS WHO CONDUCT VACCINE
CLINICAL TRIALS OR SERVE ON DATA
SAFETY MONITORING BOARDS MAY
PRESENT TO THE COMMITTEE ON
MATTERS RELATED TO THE VACCINES.
HOWEVER, THEY ARE PROHIBITED
FROM PARTICIPATING IN COMMITTEE
VOTES ON ISSUES RELATED TO THESE
VACCINES.
IN ADDITION, OTHER VACCINES THE
AFFECTED COMPANY MEMBER MAY
PARTICIPATE IN DISCUSSIONS
PROVISO THEY STAY IN RELATION TO
THAT VACCINE COMPANY.
ON THE NEXT SLIDE ARE THE
DETAILED APPLICATIONS FOR
SUBMISSION OF NAMES FOR
POTENTIAL CANDIDATES TO SERVE AS
ACIP MEMBERS, AND THIS MAY BE
FOUND ON THE ACIP WEBSITE.
MEMBERSHIPS, APPLICATIONS FOR
MEMBERSHIP ARE DUE NO LATER THAN
NOVEMBER 15th FOR THE TERM
BEGINNING IN JULY OF 2014.
AND IT'S NEVER TOO EARLY TO
START THINKING ABOUT PEOPLE OR
OTHER MEMBERS HERE, OTHER PEOPLE
HERE WHO WOULD WANT TO
POTENTIALLY SERVE AS AN ACIP
MEMBER.
AT EVERY MEETING, WE PROVIDE AN
UPDATE ON THE STATUS OF ACIP
RECOMMENDATIONS THAT ON THE NEXT
SLIDE, A LISTING OF
RECOMMENDATIONS THAT HAVE BEEN
PUBLISHED SINCE OCTOBER OF 2012,
MEANING LAST YEAR, IS SHOWN ON
THE SCREEN.
A LINK TO ALL THESE
RECOMMENDATIONS ARE FOUND ON THE
WEBSITE.
AND THERE'S, OF COURSE, THE
PNEUMOCOCCAL CONGREGATE VACCINE
FOR ADULTS WITH
IMMUNOCOMPROMISING CONDITIONS,
INFANT MENINGOCOCCAL VACCINE FOR
THE ACIP RECOMMENDATIONS.
THE SCHEDULE, COMBINED
ADULT/CHILDHOOD SCHEDULE, WHICH
WE'LL HEAR ABOUT, AND THEN THE
UPDATED RECOMMENDATIONS FOR USE
IN TDAP IN PREGNANT WOMEN I
THINK WILL BE OUT THURSDAY.
AND THERE ARE SIX OTHERS THAT
ARE ON THE AGENDA TO BE
PUBLISHED, SO THIS COMMITTEE
CONTINUES TO DO VERY HIGH
QUALITY AND A LOT OF WORK.
SO, WITH THAT, DR. TEMTE, I
THINK WE'RE READY FOR ROLL CALL
AND CONFLICTS OF INTEREST.
>> THANK YOU.
THANK YOU VERY MUCH.
LET ME START HERE WITH DR.
BENNETT, AND WE WILL -- I HAVE
TO GET THIS DOWN CORRECT LY -- E
WILL MOVE COUNTERCLOCKWISE.
>> BENNETT, NO CONFLICTS.
>> RUBIN, NO CONFLICTS.
>> SAWYER, NO CONFLICTS.
>> ROSENBAUM, NO CONFLICTS.
>> VASQUEZ, NO CONFLICTS.
>> INSTITUTION FOR EASE FUNDING
FOR CRIMINAL TRIALS FOR MARKED
PHARMACEUTICALS.
>> DUCHIN, NO CONFLICT.
>> HARRISON, NO CONFLICT.
>> NO CONFLICT.
>> BOCCHINI, NO CONFLICT.
>> HEROIN CAIRNS, NO CONFLICT.
>> NO CONFLICT.
>> TEMTE, NO CONFLICT.
>> I'D ALSO LIKE TO JUST EXTEND
A PERSONAL WELCOME TO DR. HERB
YOUNG AND LEONARD SCHUF FROM THE
DIVISION OF SCIENTIFIC
ACTIVITIES AT THE AMERICAN
ACADEMY OF FAMILY PHYSICIANS.
IT'S NICE TO HAVE YOU HERE, SO,
OVER HERE.
WITH THAT, I THINK WE CAN MOVE
ALONG AND MOVE INTO THE AGENCY
UPDATES.
SO, I'LL START OUT CALLING ON
THE DOCTOR.
>> THANK YOU.
I'D JUST LIKE TO MAKE A BRIEF
UPDATE ABOUT WHAT CDC'S DONE
SINCE THE HHS INSPECTOR GENERAL
RELEASED A REPORT IN JUNE ON
STORAGE AND HANDLING OF VACCINES
AND THE VACCINES IN CHILDREN
PROGRAMS.
THIS REPORT LOOKS AT VACCINE
STORAGE AND HANDLING AND
PROVIDER OFFICES IN FIVE STATES
AND ONE CITY AND IDENTIFIED A
NUMBER OF ISSUES WITH STORAGE
AND HANDLING OF VACCINES.
SINCE THEN, PARTICULARLY THE
STAFF IMMUNIZATION SERVICES
DIVISION HAS FOCUSED AN ENORMOUS
AMOUNT OF ENERGY AND EFFORT ON
WORKING WITH OUR IMMUNIZATION
PROGRAMS IN STATES AND CITIES TO
IMPROVE STORAGE AND HANDLING
PRACTICE.
AMONG THE THINGS THAT HAVE BEEN
DONE IS THE REVISION OF THE
OPERATIONS GUIDE TO STRENGTHEN
PROGRAMMATIC AND OTHER TYPE
GUIDANCE, AND THIS WAS UPDATED
AND MADE AVAILABLE ON THE WEB IN
NOVEMBER.
THERE ALSO HAVE BEEN UPDATES TO
VACCINE STORAGE AND HANDLING
GUIDELINES WITH INTERIM
GUIDELINES FOR VACCINE STORAGE
AND HANDLING AGAIN RELEASED IN
NOVEMBER.
THERE IS ONGOING WORK WITH THE
NATIONAL INSTITUTE OF STANDARDS
AND TECHNOLOGIES TO EXTEND THE
SCIENCE BASE FOR STORAGE AND
HANDLING PRACTICE AND REGIONAL
TRAININGS FOR THE OVERSIGHT
STAFF ARE PLANNED IN THE FIRST
HALF OF THIS YEAR THAT SHOULD
REALLY HELP GET EVERYBODY UP TO
SPEED ON THE NEW GUIDELINES.
THIS HAS BEEN AN ONGOING AND
IMPORTANT EFFORT AND, AGAIN, HAS
BEEN VERY INTENSE WORKING ON IT,
AND I'D JUST LIKE TO THANK ALL
OF THE CDC STAFF AND PROGRAM
STAFF WHO'S BEEN WORKING SO
DILIGENTLY TO IMPROVE VACCINE
STORAGE AND HANDLING.
ONE OF THE THINGS THAT IS CLEAR
TO US IS THAT ALTHOUGH THE FOCUS
OF THE REPORT WAS ON THE
PROGRAM, CLEARLY, TO THE EXTENT
WE CAN IMPROVE VACCINE STORAGE
HANDLING, WE'LL DO THAT FOR ALL
VACCINES IN PROVIDER OFFICES.
SO, WE THINK IT'S AN AREA FOR
IMPROVEMENT AND FEEL A GREAT
DEAL OF PROGRESS HAS BEEN MADE.
THANK YOU.
>> THANK YOU.
DR. HANS FROM CMS.
>> HI.
I HAVE TWO UPDATES RELATED TO
TWO AFFORDABLE CARE ACT
DIVISIONS THAT WENT INTO EFFECT
ON JANUARY 1st, MEDICAID AND
IMMUNIZATIONS.
THE FIRST IS THE PRIMARY CARE
PAYMENT FOUND IN SECTION 1202 OF
THE AFFORDABLE CARE ACT, WHICH
INCLUDES A PAYMENT INCREASE FOR
VACCINE ADMINISTRATION FOR BOTH
CHILDREN AND ADULTS IN MEDICAID
WHEN THEY ARE GIVEN VACCINES BY
PROVIDERS THAT QUALIFY WITH THE
PRIMARY CARE PAYMENT.
ALSO INCLUDED WAS THE FIRST
UPDATE WE'VE DONE SINCE IT WAS
IMPLEMENTED.
THE SECOND PROVISION IS 4106 OF
THE AFFORDABLE CARE ACT, AND
THIS GIVE STATES WHO CHOOSE, OR
ADULTS, WHO CHOOSE TO COVER ALL
PREVENTIVE SERVICES WHO ARE
GIVEN AN "A" OR "B"
RECOMMENDATION FROM THE U.S.
PREVENTIVE SERVICES TASK FORCE
OR ALL THE RECOMMENDATIONS AND
IMMUNIZATIONS AND VACCINE
ADMINISTRATION.
IF THEY COVER ALL OF THOSE
SERVICES WITHOUT COST-SHARING,
THEN STATES ARE ELIGIBLE FOR A
1% INCREASE IN THE FEDERAL
MEDICAL ASSISTANCE FOR THOSE
SERVICES.
>> THANK YOU.
DR. GEIB FROM THE DEPARTMENT OF
DEFENSE.
>> YES, GOOD MORNING.
I JUST WANTED TO COMMENT ON A
FEW DIFFERENT IMMUNIZATIONS IN
TERMS OF INFLUENZA IMMUNIZATION
SERVICE RATES AS OF THE 19th OF
FEBRUARY, AND THIS INCLUDES ALL
ACTIVE DUTY AND ALL RESERVISTS
IN ALL THE SERVICES.
WE'RE JUST OVER 95% WITH THE
RESERVISTS TYPICALLY BRINGING
THE NUMBERS DOWN A BIT.
AGAIN, YES, IT'S EASY TO GET
THAT HIGH WHEN YOU CAN FORCE THE
IMMUNIZATIONS, BUT WE LIKE TO
GLOAT A LITTLE ABOUT THAT, SO.
I'D LIKE TO ALSO COMMENT ON
ADNOVIRUS VACCINES.
SINCE THE DEPARTMENT OF DEFENSE
STARTED PROVIDING THESE, TYPE 4
AND TYPE 7, ON THE 23rd OF
OCTOBER 2011 AND AS OF THE 16th
OF FEBRUARY THIS YEAR, OVER
57,000 ACTIVE-DUTY SERVICE
MEMBERS HAVE BEEN VACCINATED.
AND THUS FAR, BASED ON PREVIOUS
YEARS AND RATES, IT IS ESTIMATED
THAT OVER 50,000 LOST TRAINING
DAYS, 15,000 CASES OF FEBRIAL
RESPIRATORY ILLNESS AND OVER
50,000 HOSPITALIZATIONS HAVE
BEEN PREVENTED THUS FAR USING
THIS VACCINE.
SO I THINK IT'S BEEN WORKING OUT
VERY WELL IN THAT AREA.
I'D ALSO LIKE TO COMMENT ON
JAPANESE ENCEPHALITIS VACCINE.
THE SERVICES HAVEN'T HAD ANY
KNOWN CASES OF JAPANESE
ENCEPHALITIS IN ACTIVE DUTY FOR
MORE THAN TWO DECADES, BUT THEY
ARE CONTINUING TO REINFORCE ACIP
RECOMMENDATIONS, USE OF VACCINE
IN HIGH-RISK SETTINGS, NEED FOR
CAREFUL SCREENING AND ASSESSMENT
OF LOCAL RISK CONDITIONS.
AND THE LAST COMMENT I HAVE IS
ON HPV VACCINE.
DoD ACKNOWLEDGES THAT THERE HAVE
BEEN CHALLENGES IN GETTING
PERSONS WHO STARTED THE
THREE-SESSION SERIES AND THEY'RE
IN A SESSION OR BASIC TRAINING.
TO COMPLETE THAT AT THEIR FIRST
PERMANENT DUTY STATION, BUT DoD
IS EMPHASIZING AND CONTINUES TO
MAKE THE VACCINE AVAILABLE TO
BOTH MALE AND FEMALE SERVICE
MEMBERS AT THEIR FIRST PERMANENT
DUTY STATION AND MEDICAL
DEPARTMENTS WILL OFFER THE
VACCINE TO BENEFICIARIES AND
ACTIVE-DUTY MEMBERS PER THE
CURRENT ACIP RECOMMENDATIONS.
THANK YOU AND THAT'S ALL I HAVE.
>> THANK YOU.
DR. KINSINGER FROM THE
DEPARTMENT OF VETERANS AFFAIRS.
>> GOOD MORNING.
JUST A FEW THINGS TO MENTION.
I'D FIRST LIKE TO THANK DR.
ANDREW KROGER FOR GIVING A VERY
WELL-DONE PRESENTATION ON THE
NATIONAL CALL LAST WEEK,
UPDATING OUR FIELD ON THE ADULT
IMMUNIZATION SCHEDULE.
THAT WAS A VERY WELL-RECEIVED
CALL.
SOME OF MY COLLEAGUES IN THE
OFFICE OF PUBLIC HEALTH ALSO
RECENTLY GOT A NATIONAL CALL ON
THE USE OF TDAP IN PREGNANT
WOMEN.
SO, WE'RE DOING A LOT OF
EDUCATION OF OUR STAFF AROUND
IMMUNIZATION ISSUES.
IN TERMS OF INFLUENZA, WE SAW,
AS DID THE REST OF THE COUNTRY,
AN EARLY SPIKE IN CASES.
THAT'S NOW DECLINING BECAUSE,
AGAIN, INTRINZENT IN THE REST OF
THE COUNTRY, AND AS OF LAST WEEK
HAD GIVEN OVER 1.8 MILLION DOSES
OF INFLUENZA VACCINE TO OUR
PATIENTS.
>> THANK YOU.
DR. SUN, FDA?
>> GOOD MORNING.
SO, JUST A COUPLE OF UPDATES ON
THE FDA.
SINCE THE LAST MEETING HERE,
WE'VE HAD TWO APPROVALS OF
ORIGINAL BIOLOGICAL LICENSE
APPLICATIONS, BOTH FOR FLU, A
VACCINE, AND FLU BLOG BY PROTEIN
SCIENCES.
BOTH ARE CELL-BASED INFLUENZA
VACCINES.
AND THEN WE'VE ALSO HAD
APPROVALS FOR TWO SUPPLEMENTS TO
EXISTING VACCINES, SO WE HAVE
QUADRAVALIN, WHICH IS THE SECOND
TYPE OF THAT VACCINE APPROVED.
WE'VE ALSO EXTENDED THE
INDICATION FOR PREVNO-13 TO AGE
6 TO 17 YEARS OLD.
THE OTHER MAJOR THING AT THE FDA
IS THE IMPLEMENTATION OF THE
FOOD AND DRUG SAFETY AND
INNOVATION ACT.
THAT WAS AN ACT BY CONGRESS ON
JULY 9th, 2012.
THIS IS A WIDE-RANGING LAW WITH
11 NEW TITLES.
I THINK THE ONES THAT ARE MOST
RELEVANT TO VACCINES ARE TITLES
5, WHICH DEALS WITH PEDIATRIC
DRUGS AND DEVELOPMENT AND TITLE
9, WHICH DEALS WITH DRUG
APPROVAL AND PATIENT ACCESS.
ONE OF THE NEW -- ONE OF THE --
LET'S SEE -- NEW THINGS ABOUT
THIS IS THE IMPLEMENTATION OF
WHAT'S CALLED BREAK-THROUGH
THERAPY, AND WE'RE IN THE
PROCESS OF DEVELOPING GUIDANCES
FOR THAT.
THANK YOU.
>> THANK YOU.
IS THERE ANYONE FROM HRSA?
OKAY.
I'M GOING TO MOVE ON TO IMMUNO
HEALTH SERVICES, BUT BEFORE SHE
SPEAKS, I'M GOING TO PICK ON HER
A LITTLE BIT.
IF YOU'RE NOT AWARE OF A
PUBLICATION IN "PEDIATRICS,"
DETAILING THE INCREDIBLE EFFECTS
OF COVERAGE IN THE AMERICAN A
NATIVE ALASKAN POPULATION WITH A
PARITY WITH CAUCASIAN CHILDREN
IN THE UNITED STATES, BUT A
VERY, VERY NICE TESTAMENT WITH
WHAT'S BEEN DONE TO IHS, SO.
>> THANK YOU, DR. TEMTE.
JUST A FEW UPDATES FROM THE
INDIAN HEALTH SERVICE.
WE'RE IN THE FIFTH YEAR OF
MONITORING OUR HEALTH FOR
PERSONNEL INFLUENZA VACCINATION
AND IT'S WHERE WE'VE BEEN FOR
THE LAST FOUR YEARS, SO WE'RE
NOT PLEASED WITH OYER UNABILITY
TO MAKE ANYTHING BUT INCREMENTAL
PROGRESS, AND THAT'S SOMETHING
WE'RE GOING TO BE THINKING ABOUT
HOW TO DO BETTER FOR NEXT YEAR.
WE CONTINUE TO MONITOR ADULT
VACCINE COVERAGE ON A QUARTERLY
BASIS.
IT'S SOMETHING WE INSTITUTED
BACK IN NOVEMBER AND WE HAVE OUR
SECOND QUARTERLY REPORT.
WE'VE BEEN DOING A LOT OF ADULT
EDUCATION, BOTH WITH OUR
PROVIDERS.
WE HAD A WEBINAR FOR IHS
PROVIDERS AND WE'RE ALSO
REACHING OUT TO OUR COMMUNITY
HEALTH REPRESENTATIVES, WHICH
ARE LAY HEALTH CARE WORKERS THAT
REALLY INTERACT WITH THE
COMMUNITY AND TRYING TO BRING
THAT UP TO SPEED ON INFLUENZA,
BUT OTHER ADULT VACCINES,
BECAUSE WE THINK IT'S IMPORTANT
TO INTERFACE WITH THE COMMUNITY
TO GET THE COMMUNITY BINDS.
WITHIN OUR HEALTH RECORD, WHEV
THE CLINICAL SUPPORT FOR MOST
ADULT IMMUNIZATIONS, BUT THEY'RE
ONLY AGE-BASED AND WE'RE LOOKING
TO EXPAND INTO RISK-BASED
FORECASTING, SO WE'RE GOING TO
BE LOOKING AT HEPATITIS-A AND B
FOR CHRONIC LIVER DISEASE
PATIENTS AND THOSE WITH HELP C,
LOOKING FOR HEPC FOR A HEALTH
DIAGNOSE NICE AND DIABETICS.
>> DR. GAIL, NATIONAL VACCINE
PROGRAM OFFICE.
>> THANKS.
I'M GOING TO GIVE A BLENDED --
RUTH ORNSTEIN'S NOT HERE, SO I'M
GOING TO BLEND THE NVAC REPORT.
WE HAD A MEETING EARLIER THIS
MONTH WITH THE IMPLEMENTATION OF
THE AFFORDABLE CARE ACT AND
SARAH ROSENBAUM AND MARY BETH
WERE SOME OF THE SPEAKERS THERE
FOCUSING ON THE CHALLENGES AND
IMPLEMENTATIO
IMPLEMENTATIONS.
SO AS THOSE ISSUES COME UP,
WE'RE GLAD TO TAKE THOSE FOR
FURTHER DELIBERATIONS.
THERE WAS A LARGE FOCUS ON HPV
VACCINE IN TERMS OF HELPING THE
2020 GOALS.
THIS IS AN AREA WHERE NVAC HAS
BEEN ASKED BY THE ASSISTANT
SECRETARY OF HEALTH TO LOOK AT
THE 2020 GOALS AND PARTICULARLY
THOSE THAT ARE NOT ON TRACK.
THERE IS NOW AN NVAC WORKING
GROUP THAT'S GOING TO FOCUS ON
THIS TO TRY TO BETTER UNDERSTAND
THE ROOT CAUSES AND EVALUATE
CURRENT EFFORTS AND MAKE
RECOMMENDATIONS ON FURTHER
ACTIONS.
THE OTHER WORKING GROUPS IS A
GLOBAL IMMUNIZATIONS WORKING
GROUP THAT'S FOCUSED ON GOAL
FOUR OF THE NATIONAL VACCINE
PLAN WITH A RANGE OF
RECOMMENDATIONS THAT THEY'LL BE
PRESENTING LATER THIS YEAR.
AND THERE'S ALSO THE
ESTABLISHMENT OF A WORKING GROUP
ON VACCINE HESITANCY AND
RECOGNIZING THAT VACCINE
HESITANCY CAN OCCUR THROUGHOUT
THE LIFESPAN.
THE FOCUS INITIALLY WILL BE ON
UPTAKE OF CHILDHOOD VACCINES.
BOTH NVAC AND MVPO HAVE A LARGE
FOCUS ON ADULT IMMUNIZATIONS.
YOU'LL HEAR MORE ABOUT THIS
TOMORROW AND AN UPDATE ON WHERE
WE ARE WITH THE UP TAKE OF ADULT
IMMUNIZATIONS, BUT THEY ALSO
FEEDS INTO THE SUMMIT LATER THIS
SPRING AND MAY IN ATLANTA.
ALSO KNOW THAT WHAT WAS FORMERLY
THE FLU VACCINE FINDER HAS NOW
MORPHED INTO THE ADULT VACCINE
FINDER.
SO, YOU CAN FIND IT AT HEALTH
MAP, AND IT'S AN OPPORTUNITY NOT
ONLY TO LEARN WHAT THE VACCINES
ARE THAT ADULTS SHOULD GET BUT
WHERE YOU CAN GET THEM WITHIN
SOME RADIUS OF YOUR ZIP CODE.
AND THEN ANOTHER MIPIECE OF WOR
IS THE RECENT ISSUE OF PUBLIC
HEALTH REPORTS THAT FEATURE NVAC
RECOMMENDATIONS IN AN EDITORIAL
FROM DR. KOEWE, SO WE CONTINUE
TO LOOK AT THAT, BOTH IN THE
SYSTEM AND THROUGHOUT THE HEALTH
CARE SYSTEM, AND THERE WERE
PRESENTATIONS ON THIS FROM CDC,
CMS AND THE JOINT COMMISSION ON
SOME OF THE ACTIVITIES GOING
FORWARD.
AND THEN TWO OTHER PIECES THAT
ARE RELATED TO THE WORK WITH THE
INSTITUTE OF MEDICINE.
IN THE PAST, YOU'VE HEARD A
PRESENTATION FROM THEM ON THEIR
SMART VACCINES PROJECT.
IOM HAD A STAKEHOLDERS MEETING
IN NOVEMBER.
THEY'RE NOW WORKING ON THE
SECOND PHASE AND THERE WILL BE
SOFTWARE THAT'S AVAILABLE IN THE
FALL, BUT IT'S A WATCH THIS
PHASE TO LOOK AT THE FOCUS OF
THAT, DECISION-MAKING AND A
DECISION FRAMEWORK FOR VACCINE
RESEARCH AND DEVELOPMENT.
AND THEN FINALLY, AS A PROJECT
THAT NVPO AND CDC'S REPORTED
THAT YOU'LL HEAR TOMORROW FROM
THE INSTITUTE OF MEDICINE, WHICH
IS LOOKING AT THE SAFETY OF THE
VACCINE SCHEDULE, AND I WON'T
STEAL THEIR PUNCH LINE.
THANKS.
>> THANK YOU VERY MUCH.
AND DR. GORMAN FOR NIH.
>> THANK YOU.
IN TERMS OF NIH, THERE'S BEEN
ONE LEADERSHIP CHANGE.
DR. GARY NAVAL WILL BE MOVING TO
BE THE CHIEF SCIENTIFIC OFFICER
AT SANOFI.
UPCOMING WATCH THIS SPACE, I
LIKE THAT FROM DR. GALEN, SO I
WILL NOW USE THIS FOREVER.
THE ROTAVIRUS MIX-AND-MATCH
STUDY IS SIX WEEKS FROM
COMPLETING ENROLLMENT.
THAT'S 1,300 BABIES, LOOKING AT
ALL THE DIFFERENT VARIATIONS OF
POSSIBLE ROTAVIRUS MIX-AND-MATCH
VACCINATIONS AND SCHEDULE.
THERE IS A STUDY ONGOING AND
COMPLETED ENROLLMENT ON THE H3N2
VARIANT INFLUENZA VIRUS THAT WAS
AN ISSUE AT STATE FAIRS OVER THE
SPRING AND SUMMER.
A STUDY HAS BEEN COMPLETED AND
WILL SOON BE PRESENTED AT A
NATIONAL PUBLIC MEETING ON
MATERNAL PERTUSSIS VACCINATION
THAT WILL HELP STRENGTHEN THE
PERTUSSIS AND HPV IN PREGNANCY.
AND WE JUST COMPLETED PHASE ONE
OF A PHASE ONE-TWO STUDY AND 70
ELIGIBLE SUBJECTS WILL BE
PRESENTED TO THE FDA AND THE
DSMB TO SEE WHETHER THAT STUDY
CAN GO ON TO PHASE TWO.
>> THANK YOU VERY MUCH.
I THINK THAT CONCLUDES THE
AGENCY UPDATES.
AND WITH THAT, WE WILL MOVE ON
TO THE PNEUMOCOCCAL VACCINE
SESSION AND WE'LL ASK DR.
BENNETT TO TAKE THE STAGE.
THIS SECTION WILL CONTAIN THE
FIRST OF THREE VOTES DURING THIS
MEETING.
>> GOOD MORNING.
WE THOUGHT WE'D START RIGHT AWAY
WITH A VOTE JUST TO MAKE OUR DAY
LIVELIER.
SO, THIS MORNING, I'D LIKE TO
JUST BRING YOU TO THE
PNEUMOCOCCAL SESSION THAT WE'RE
GOING TO HAVE.
FIRST, I WOULD LIKE TO, AS --
OKAY, NOT WORKING.
FIRST, I'D LIKE TO ACKNOWLEDGE
AND THANK OUR COMMITTEE.
IT'S A VERY HARD-WORKING
COMMITTEE AND WE'RE VERY
APPRECIATIVE OF EVERYONE'S
EFFORTS, AND IN PARTICULAR, ALSO
THE SUPPORT OF OUR CDC STAFF AS
WE MOVE THROUGH THESE FAIRLY
COMPLICATED ISSUES.
THE PNEUMOCOCCAL WORK GROUP
REVIEWS THE DATA ON
IMMUNOGENICITY, EFFICACY AND
COST-EFFECTIVENESS OF THE
PNEUMOCOCCAL VACCINES.
WE'RE CHARGED WITH DETERMINING
WHETHER DATA AVAILABLE TO DATE
ON PCV13 IMMUNOGENICITY
EFFECTIVENESS AND EFFICACY ARE
EFFICIENT TO DETERMINE THE VALUE
OF IMMUNIZING WITH PCV13, AND
FINALLY, TO DEVELOP A REVISED
STATEMENT ON PNEUMOCOCCAL
IMMUNIZATION AS NECESSARY.
IF YOU REMEMBER, WE'VE BEEN
WALKING OUR WAY THROUGH THIS
PROGRAM FOR THE LAST SEVERAL
MONTHS.
WE REVIEWED AND PRESENTED
EVIDENCE ABOUT THE USE OF PCV13
AMONG ADULTS OVER THE AGE OF 50.
AT THAT TIME, WE ELECTED TO
DEFER THE RECOMMENDATION FOR TWO
REASONS.
ONE WAS TO BE ABLE TO REVIEW THE
RESULTS OF THE CAPITAL TRIAL
BEFORE MAKING A DECISION ABOUT
THE USE OF THIS VACCINE IN
ADULTS.
AND SECONDLY, TO BE ABLE TO
REVIEW THE INDIRECT EFFECTS OF
PCV13 USE IN CHILDREN.
AND WE WILL BE GIVING YOU SOME
FOLLOW-UP DATA ON THE SECOND
THIS MORNING.
WE DID VOTE, HOWEVER, TO
RECOMMEND PCV13 FOR ADULTS 19
YEARS AND OLDER WITH
IMMUNOCOMPROMISING CONDITIONS.
SINCE THAT TIME, THE FDA, AS YOU
ALREADY HEARD THIS MORNING, HAS
APPROVED PREDNAR 13 FOR USE IN
INDIVIDUALS 6 THROUGH 17 YEARS
OF AGE.
THIS WAS BASED ON IMMUNOGENICITY
STUDIES THAT WE ARE NOT GOING TO
BE REVIEWING THIS MORNING.
THOSE WERE IN HEALTHY CHILDREN.
WE'RE GOING TO BE TALKING ABOUT
THE USE OF THIS VACCINE IN
UNHEALTHY CHILDREN, OR THOSE WHO
HAVE IMMUNOCOMPROMISING
CONDITIONS.
FOR THIS AGE GROUP, PCV13 IS
INDICATED FOR THE PREVENTION OF
THE 13 STRAINS THAT ARE
INCLUDED.
SO, TODAY DURING OUR WORK GROUP,
THE AGENDA IS TO FIRST REVIEW
THE IMPACT OF PCV13 IN CHILDREN,
AND MATT MOORE WILL GO THROUGH
THAT WITH US.
WE WILL THEN GO THROUGH THE DATA
AND THE GRADE PROCESS FOR THE
USE OF PCV13 IN CHILDREN 6
THROUGH 18 YEARS OF AGE WHO HAVE
IMMUNOCOMPROMISING CONDITIONS.
AND TAMARA PILISHVILI WILL DO
THAT WITH US.
AND LASTLY, WE WILL MAKE A
RECOMMENDATION FOR A VOTE FOR
THE USE OF THIS VACCINE IN
IMMUNOCOMPROMISED CHILDREN.
WE HOPE TODAY THAT WE CAN CHANGE
THE PERMISSIVE RECOMMENDATION
FOR PCV13 TO A ROUTINE
RECOMMENDATION, AND WE WILL ASK
THE COMMITTEE TO CONSIDER THIS.
THE EVIDENCE AND THE RATIONALE
FOR THIS POLICY WILL BE
DISCUSSED, AND WE WILL CONSIDER
A VOTE ON THE PROPOSED
RECOMMENDATION.
THANK YOU.
>> THANK YOU, DR. BENNETT.
GOOD MORNING, EVERYONE.
I'D LIKE TO GIVE YOU A BRIEF
UPDATE ON WHERE WE ARE WITH THE
EXCEPTION OF PCV13 IN CHILDREN
AND ITS IMPACT BOTH ON THE
INCIDENTS OF INVASIVE
PNEUMOCOCCAL DISEASE IN CHILDREN
AND IN ADULTS.
IT'S IMPORTANT FOR US TO TALK
ABOUT THIS THIS MORNING, BECAUSE
AS WE KNOW, WE OBSERVED VERY
SUBSTANTIAL REDUCTIONS IN THE
INCIDENCE OF PCV7 TYPE
PNEUMOCOCCAL DISEASE IN ADULTS
WITHIN THE FIRST SEVEN YEARS OF
PCV7 INTRODUCTION TO CHILDREN IN
CALENDAR YEAR 2000.
AS DR. BENNETT JUST MENTIONED,
AGE-BASED RECOMMENDATIONS FOR
PCV13 USE AMONG ADULTS WERE
DEFERRED PENDING THE RESULTS OF
THE RANDOMIZED CONTROLLED TRIAL
AND THE EVALUATION AND THE
DIRECT EFFECT OF PCV13 USE IN
CHILDREN.
CDC MONITORS THE INCIDENTS OF
INVASIVE PNEUMOCOCCAL DISEASE IN
TEN AREAS AROUND THE COUNTRY
USING ACTIVE POPULATION-BASED
SURVEILLANCE SYSTEM CALLED
ACTIVE ACTUAL CORVALLIS OR ABC.
THIS IS A GRAPH SHOWING YOU
ACCUMULATIVE CASES OF PCV5 TYPE
DISEASE.
THESE ARE CASES OF INVASIVE
PNEUMOCOCCAL DISEASE THAT ARE
INCLUDED IN PCV13 BUT NOT
INCLUDED IN PCV7.
AND EACH ONE OF THESE LINES
REPRESENTS THE ACCUMULATIVE
NUMBER OF CASES OF INVASIVE
PNEUMOCOCCAL DISEASE IN THIS AGE
GROUP.
CHILDREN UNDER THE AGE OF 2
DURING EACH YEAR FROM 2006
THROUGH 2012.
IF YOU FOCUS YOUR EYES FIRST ON
THIS GROUP OF LINES HERE, THE
BLUE FOR 2006, THE RED FOR 2007
AND THE DARK GREEN FOR 2008.
YOU SEE THAT THE NUMBER OF CASES
OF PNEUMOCOCCAL DISEASE GO UP
SOMEWHAT RAPIDLY DURING THE LATE
WINTER AND EARLY SPRING MONTHS.
THEN DURING LATE SPRING AND
SUMMER, THEY TEND TO LEVEL OUT.
THEN THEY GO BACK UP AGAIN AS WE
GET INTO THE FALL AND WINTER OF
THE SUBSEQUENT YEAR.
BUT IN 2010, WHEN THE VACCINE
WAS INTRODUCED RIGHT AROUND THIS
TIME PERIOD, YOU CAN SEE THAT
THOSE CASES OF INVASIVE
PNEUMOCOCCAL DISEASE IN KIDS
UNDER 2 CONTINUE TO GO UP, THEY
LEVEL OFF, AND THEN RIGHT ABOUT
HERE, THEY FAIL TO CONTINUE TO
GO UP AT THE SAME RATE THAT THEY
HAD IN PREVIOUS YEARS AND THEY
LEVELED OFF SUBSTANTIALLY.
IN THE NEXT YEAR, 2011, IT WAS
MUCH, MUCH CLEARER THAT THERE
WAS A MARKED REDUCTION IN THE
INCIDENCE OF DISEASE, AND UP AND
THROUGH THE END OF JUNE 2012,
THIS IS WHERE WE WERE CONTINUING
TO SEE REDUCTION OF THE DISEASE
IN THIS POPULATION.
SO, NOW THAT WE UNDERSTAND
WHAT'S HAPPENING IN YOUNG
CHILDREN WHO ARE ACTUALLY
RECEIVING THE VACCINE, LET ME GO
ON AND TALK A LITTLE BIT ABOUT
SOME OF THE ADULT POPULATION.
ACTUALLY, LET ME POINT OUT HERE,
I PUT A RED BOX HERE TO
REPRESENT THE "Y" AXIS TO THE
SCALE THAT REPRESENTS 180 PER
100,000.
BUT IN ADULTS 50 AND OLDER WHERE
THE BURDEN OF DISEASE IS MUCH
HIGHER, IT GOES UP TO 500.
SO I WANT YOU TO BE AWARE OF
THAT.
HERE YOU SEE A SIMILAR PATTERN
IN THE SEASONALITY OF DISEASE,
THAT IS THAT THE PATTERNS OF
DISEASE GO UP IN WINTER, LEVEL
OFF DURING THE SUMMER, THEN
START TO GO UP AGAIN.
SO, NOW, RATHER THAN SEEING A
CHANGE IN THE INCIDENCE OF
DISEASE IN 2010, AS WE SAW WITH
CHILDREN, IT WASN'T UNTIL LATE
2011 THAT WE STARTED TO SEE
LIGHT CHANGE IN THE ACCUMULATION
OF CASES AT THE END OF THAT
YEAR.
IT BECAME EVEN MORE OBVIOUS IN
2012, SO THIS IS WHERE WE ARE IN
THIS POPULATION OF INDIVIDUALS
50 TO 64 YEARS OF AGE.
AND THEN FINALLY, IN ADULTS OVER
THE AGE OF 64, A VERY SIMILAR
PATTERN.
RATES OF PACE STARTED TO LEVEL
OFF A LITTLE BIT, OR STARTED TO
DECLINE, RATHER, IN LATE 2011,
AND THEY HAVE DRAMATICALLY
TAILED OFF AND TAILED OFF IN
2012.
WE HAVE DONE SOME MODELING
AROUND THESE CHANGES SO THAT WE
CAN GET AN IDEA OF THE
PERCENTAGE REDUCTIONS IN THE
INCIDENCE OF DISEASE.
AND YOU CAN SEE ON THIS SLIDE
THAT THE INCIDENCE OF DISEASE IN
CHILDREN UNDER THE AGE OF 2 AND
CHILDREN 2 TO 4 YEARS OF AGE
CAUSED BY THESE ADDITIONAL
CHANGES IN THE VACCINE HAVE
DECLINED DRAMATICALLY, BUT EVEN
IN THE ADULT AGE GROUPS WE'RE
SEEING SUBSTANTIAL REDUCTIONS OF
AT LEAST 50%.
IMPORTANTLY, ABOUT 75% OF THE
AVERTED CASES UP TO THIS POINT
HAVE ACTUALLY BEEN PREVENTED IN
ADULTS.
SO, WE'RE SEEING VERY, VERY
POSITIVE RESULTS FROM THE
INTRODUCTION OF THE VACCINE FOR
CHILDR
CHILDREN, BOTH IN CHILDREN AND
IN ADULTS.
WE HAVE CLEAR EVIDENCE OF
REDUCTIONS IN IPD CAUSED BY
THESE CONDITIONAL CIROTYPES,
FIRST EVIDENT IN KIDS UNDER 2 IN
THE FIRST QUARTER OF 2010 AND
ADULTS IN THE FOURTH QUARTER OF
2011.
IN THESE TEN AREAS AROUND THE
UNITED STATES, THIS IS NOT A
NATIONAL PROJECTION, BUT JUST IN
THE TEN AREAS AROUND THE UNITED
STAT
STATES, WE'VE ESTIMATED THAT
OVER 200 CASES OF INVASIVE
DISEASE HAVE ALREADY BEEN
AVERTED, NOLL ADULTS.
WE CONTINUE TO MONITOR THESE
DATA THROUGH OUR SURVEILLANCE
PROGRAM AND WE'LL REPORT BACK IN
FUTURE MEETINGS.
>> DR. MOORE?
IF YOU WANT TO STAY AFTER FOR A
FEW QUESTIONS NOW OR TAKE THEM
AT THE END?
>> I THINK MAYBE IF THERE ARE
CLARIFYING QUESTIONS RIGHT NOW,
I COULD TAKE THEM OR WE COULD
RETURN TO THEM LATER ON.
>> I JUST HAVE ONE QUICK
QUESTION REGARDING JUST THE
WONDERFUL DIAGRAMS YOU SHOWED
WITH THE DROPPING, AND JUST
CURIOUS ABOUT THE RELATIONSHIP
BETWEEN INFLUENZA CASES IN
ADULTS AND ESPECIALLY OLDER
ADULTS AND SECONDARY
PNEUMOCOCCAL INFECTIONS AND
WHETHER OR NOT WE'RE GOING TO
SEE ANYTHING OFF THAT NICE GRAPH
FOLLOWING JANUARY OF THIS YEAR?
>> GREAT QUESTION.
WE'LL LOOK INTO IT AND GET BACK
TO YOU ABOUT THAT.
>> DR. CAHILL?
>> THANK YOU VERY MUCH.
WERE YOU ABLE TO STRATIFY
ACCORDING TO OTHER UNDERLYING
RISK CONDITIONS AND RATE
REDUCTIONS?
>> NO, WE HAVEN'T BEEN ABLE TO
DO THAT YET.
>> YES, DOCTOR.
I KEEP ON DOING THIS.
MY APOLOGIES.
>> KATHY NUSEL, IBSA.
JUST A QUICK QUESTION ABOUT THAT
2000 CASE ESTIMATE.
IS THAT JUST FROM ABCs, OR DID
YOU EXTRAPOLATE THAT TO A
BROADER POPULATION?
>> ONLY FROM ABCs.
WE'RE WORKING ON EXTRAPOLATING
THAT TO THE LARGER POPULATION,
BUT IT HAS TO DO WITH RACIAL
DIFFERENCES AND INCIDENTS, SO
THERE ARE IMPORTANT ISSUES TO
TAKE INTO CONSIDERATION THERE.
>> OKAY.
THANK YOU.
>> SURE.
>> OKAY, LET'S MOVE ON TO DR.
PILISHVILI.
>> GOOD MORNING.
SO, THIS PRESENTATION AND THE
REMAINDER OF THIS SESSION WILL
FOCUS ON RECOMMENDATIONS ON
EVIDENCE AND RECOMMENDATIONS FOR
13-VALID PNEUMOCOCCAL CONGREGATE
USE IN CHILDREN 6 TO 18 YEARS OF
AGE WITH IMMUNOCOMPROMISING
CONDITIONS.
OKAY.
SO, THE POLICY QUESTION
CONSIDERED BY THE WORKING GROUP
IS SHOULD ACIP MAKE A ROUTINE
RECOMMENDATION FOR PCV13 USE
AMONG IMMUNOCOMPROMISED
PCV13-NAIVE CHILDREN 6 THROUGH
18 YEARS OF AGE?
SO, IN THIS PRESENTATION, FIRST
I WILL REVIEW THE EXISTING
RECOMMENDATIONS FOR PCV13 USE
FOR CHILDREN AND ADULTS.
THEN I WILL GIVE YOU SOME
INFORMATION ON THE BURDEN OF
DISEASE AMONG DIFFERENT RISK
GROUPS WITHIN THIS AGE GROUP,
AND ALSO THE PROPORTION OF
DISEASE, INVASIVE PNEUMOCOCCAL
DISEASE PREVENTIBLE BY DIFFERENT
VACCINE FORMULATIONS.
AND LASTLY, WE'LL GO THROUGH THE
EVIDENCE THAT HAS BEEN REVIEWED
BY THE WORKING GROUP IN ORDER TO
COME UP WITH THE
RECOMMENDATIONS, AND WE'LL APPLY
THE GREAT FRAMEWORK TO THE
REVIEW OF THIS EVIDENCE.
SO, THE ACIP ROUTINELY
RECOMMENDS PCV13 FOR HIGH-RISK
CHILDREN 6 THROUGH 71 MONTHS OF
AGE.
IN ADDITION, ONE PART OF PCV13
IN 2010, THE RECOMMENDATIONS
WERE THAT THE ONE DOSE MAY BE
GIVEN TO CHILDREN AGE 6 THROUGH
18 YEARS OF AGE WITH AN ATOMIC
OR FUNCTIONAL, INCLUDING SICKLE
CELL DISEASE WITH COCHLEAR
IMPLANTS, LEAKS, HIV
INFECTION, CHRONIC RENAL FAILURE
AND CHRONIC SYNDROME AND
DISEASES ASSOCIATED WITH
TREATMENT WITH IMMUNOSUPPRESSIVE
DRUGS.
IN ADDITION, CHILDREN WITH
UN CONDITIONS
SHOULD RECEIVE THE POLYSACCHARID
VACCINE AFTER PCV13.
AND ONE DOSE OF PCV23 IS
RECOMMENDED FOR CHILDREN AGE 2
YEARS OR OLDER WITH AT LEAST
EIGHT WEEKS AFTER THE RECENT
DOSE OF PCV13.
AND JUST TO REMIND THIS
COMMITTEE THAT THE PERMITTED
RECOMMENDATIONS FOR CHILDREN 6
THROUGH 18 YEARS OF AGE FOR
PCV13, IF WE WERE TO APPLY THE
GRADE LANGUAGE, ALTHOUGH THE
GRADE VARIATION WAS NOT
CONDUCTED AT THAT POINT, IT
WOULD BE THE "B"
RECOMMENDATION.
AND ALSO, THE RECOMMENDATIONS AT
THAT POINT WERE OFF-LABEL.
THE LIKELY FOR
THIS AGE GROUP.
IN JUNE 2012, ACIP MADE
CATEGORY "A" RECOMMENDATION FOR
PCV13 USE IN HIGH-RISK ADULTS.
ONE DOSE OF PCV13 IS RECOMMENDED
FOR ADULTS 19 YEARS OF AGE OR
OLDER WITH THENDITIONS
AS I LISTED PREVIOUSLY FOR
CHILDREN 6 TO 18 YEARS OF AGE.
AND THE EXISTING RECOMMENDATIONS
HAVE NOT BEEN CHANGED IN 2012.
WE MADE THE RECOMMENDATIONS FOR
BOTH PPSV23-NAIVE ADULTS, THOSE
WHO HADN'T PREVIOUSLY RECEIVED
THE 23 VALID VACCINE.
FOR THOSE, ONE DOSE OF THE PCV13
WAS RECOMMENDED FOLLOWED BY THE
EXISTING REGIMEN OF THE PPSV23
STARTING EIGHT WEEKS OR LATER,
AND ALSO FOR ADULTS WHO RECEIVED
PPSC23 PREVIOUSLY.
ONE DOSE OF PCV13 WAS
RECOMMENDED AT LEAST ONE YEAR
AFTER PPSV23 AND NO CHANGES WERE
MADE TO THE EXISTING
RECOMMENDATIONS FOR THE
REMAINING DOSES OF THE PPSV23.
AND TO REMIND THE COMMITTEE,
AGAIN, THIS WAS A CATEGORY "A"
RECOMMENDATION.
SO, THE RATIONALE FOR THE
WORKING GROUP TO HAVE A
STRONG FOR
CHILDREN AND ADOLESCENTS WAS B
EARLIER, ON JANUARY THIS
YEAR, FDA LICENSED PCV13 FOR ALL
CHILDREN 6 THROUGH 17 YEARS OF
AGE.
IN ADDITION, CHILDREN WITH
IMMUNOCOMPROMISING CONDITIONS,
THEY REPRESENT A SMALL
POPULATION, A SMALL PROPORTION N
THAT ARE AT A VERY HIGH RISK OF
DISEASE.
SO, THERE IS AN OPPORTUNITY TO
PROVIDE ADDITIONAL PROTECTION IN
ADDITION TO CURRENTLY
RECOMMENDED PPSV23 IN THESE AGE
GROUPS.A STRONG RECOMMENDATION
IMPROVE VACCINE
HIGH-RISK GROUP AND ALSO, THIS
WILL GIVE US AN OPPORTUNITY TO
HARMONIZE THE LANGUAGE WITH THE
ADULT RECOMMENDATIONS THAT JUST
RECENTLY HAVE BEEN MADE.
DEPICTED ON THIS GRAPH ARE
INCIDENCE OF RATES PCV13 OF
CHILDREN 6 TO 18 YEARS OF AGE
WITH SICKLE CELL DISEASE, CANCER
OR HIV/AIDS.
THESE ARE COMPARED TO THE
DISEASE RATES AMONG CHILDREN
WITHOUT EACH OF THESE
CONDITIONS, AND THIS IS THE
REASON WHY THE GRAY BARS ARE
DIFFERENT, A DIFFERENT HEIGHT.
AND JUST TO POINT YOUR ATTENTION
TO THE "Y" AXIS OF THIS GRAPH.
THE SCALE IS FOR CASES PER
100,000 INCIDENTS, BUT IT'S ON A
LOG SCALE, YOU'LL NOTICE, TO
ACCOMMODATE THE LARGE
DISPARITIES THAT ARE SEEN IN
DISEASE RATES BETWEEN CHILDREN
WITH AND WITHOUT THESE
CONDITIONS.
AND THE GRADE RATIOS PRESENTED
HERE, IT RANGED FROM 43 FOR
CHILDREN WITH SICKLE CELL
DISEASE TO OVER 1,000 FOR
CHILDREN WITH HEMATOLOGICAL
MALIGNANCIES.
SO, THE DATA REPRESENTS HIGH
RATES OF DISEASE IN THESE
GROUPS, AND IF YOU LOOK AT THE
YEARS, 2007 THROUGH 2009, THIS
IS IN SPITE OF THE MANY YEARS OF
THE PCV7 USE IN THIS COUNTRY.
THE FOLLOWING GRAPH ALSO
REITERATES THE PREVIOUS MESSAGE
THAT I SAID HAVE COME FROM THE
RESULTS OF THIS STUDY EVALUATING
THE RISK OF PNEUMOCOCCAL DISEASE
IN PERSONS 5 YEARS OF AGE OR
OLDER WITH DIFFERENT UNDERLYING
CONDITIONS STRATIFIED BY RISK
GROUPS, AND THIS IS A
RETROSPECTIVE COMPILED STUDY
USING U.S. HEALTH CARE INSURANCE
CLAIMS DATA.
PRESENTED IN RED BARS ARE IPD
RATES AMONG AGE GROUP AMONG
PERSONS WITH UNDERLYING
CONDITIONS, SUCH AS
IMMUNODEFICIENCY, AUTO ATOMIC
DYSFUNCTIONAL, COCHLEAR
IMPLANTS, CHRONIC RENAL FAILURE
AND MALIGNANCY AND TREATMENT
WITH IMMUNOSUPPRESSIVE DRUGS.
WITH THE BLUE BARS, THESE ARE
CHILDREN ALSO WITH CHRONIC
CONDITIONS BUT IMMUNOCOMPETENT.
AND WITH THE BLACK BARS,
CHILDREN WITHOUT ANY OF THESE
CONDITIONS.
AS YOU CAN SEE, THE GRAPH JUST
REITERATES THE MESSAGE THAT IS
SHOWN ON THE PREVIOUS SLIDE, BUT
THERE ARE LARGE DISPARITIES SEEN
IN THE DISEASE RATES AMONG
CHILDREN WITH HIGH-RISK
CONDITIONS VERSUS THOSE WITHOUT.
AND THE RATE RATIOS HERE FOR AGE
GROUPS THAT WE ARE INTERESTED
IN, 5 THROUGH 17 IN THIS CASE,
RANGED FROM 30 TO 45.
AND OVERALL, IF YOU NOTICE,
COMPARED TO THE PREVIOUS SLIDE,
THEY ARE LOWER.
AND THE REASON WHY, IT'S A
DIFFERENT DATA SOURCE.
THE PREVIOUS SLIDE PROVIDED DATA
THAT COMES FROM THE ROUTINE
SURVEILLANCE, WHEREAS HERE, THE
DATA COMES FROM INSURANCE
CLAIMS, SO IT'S MORE HIGHER
SOCIOECONOMIC STATUS POPULATION.
THE PIE CHART IN THIS SLIDE
DEMONSTRATES OF PORTION OF COST
BY SEROTYPES WITH THE VACCINE.
IN CHILDREN WITH
IMMUNOCOMPROMISING CHILDREN, THE
SEROTYPES IN PPSV23 BUT NOT
PCV13 ACCOUNT FOR AN ADDITIONAL
33%.
SO, IF YOU CAN SEE, THE BROADER
SEROTYPE COVERAGE IS PROVIDED BY
THE USE OF VACCINES IN THIS AGE
GROUP.
SO, NEXT, THE WORKING GROUP
FOLLOWED THE GRADE STEPS THAT
ARE OUTLINED ON SLIDE, AND
THESE STEPS ARE FORMULATING THE
SPECIFIC POLICY QUESTION ALL THE
WAY THROUGH DETERMINING THE
RECOMMENDATION CATEGORY.
AND AS I PRESENT THE DATA, WE
WILL GO THROUGH EACH OF THESE
STEPS.
SO, THE FIRST, THE QUESTION WE
GRADED, SHOULD PCV13 BE
ADMINISTERED ROUTINELY TO
CHILDREN 6 THROUGH 18 YEARS OLD
WITH IMMUNOCOMPROMISING
CONDITIONS?
THE POPULATION OF INTEREST IS
PCV13-NAIVE CHILDREN 6 THROUGH
18 YEARS OLD WITH
IMMUNOCOMPROMISING CONDITIONS,
FUNCTIONAL OR SICKLE CELL
DISEASE, CSF LEAKS OR COCHLEAR
IMPLANTS, AND THE INTERVENTION
IS A SINGLE DOSE OF THE
PNEUMOCOCCAL CONGREGATE VACCINE.
OUR CONTROL WAS A PLACEBO, AND
H ALL THE CLINICAL HE COMMITTEE
OUTCOMES THAT ARE CONSIDERED
IMPORTANT TO PRESENT, AND THESE
OUTCOMES WERE RANKED BY THE
SO, THE WORKING GROUP DECIDED
THAT INVASIVE DISEASE,
PNEUMONIA, HOSPITALIZATION,
DEATH, IMMUNOGENICITY ARE
SERIOUS AND SYSTEMIC ADVERSE
EVENTS WERE CONSIDERED CRITICAL.
AND FOR ALL THE CRITICAL
OUTCOMES, EXCEPT THE
HOSPITALIZATION DATA WERE
AVAILABLE OR WAS INCLUW.
SO, THE NEXT STEP FOR EACH OF
THE CRITICAL OUTCOMES, WE
SUMMARIZED ALL OF THE EVIDENCE
AND WE ASSESS AD THE QUALITY OF
THE EVIDENCE FOR EACH CRITICAL
OUTCOME.
SO, GO THROUGH THESE TWO
STEPS FOR EACH OF THE CRITICAL
OUTCOMES.
FOR THE CRITICAL OUTCOME OF
INVASIVE PNEUMOCOCCAL DISEASE,
WE INCLUDED TWO RANDOMIZED
CONTROLLED TRIALS.
ONE OF THE TRIALS IS SUMMARIZED
HERE.
IT WAS AN EFFICACY TRIAL AMONG
HIV-INFECTED ADULTS, 15 YEARS OF
AGE OR OLDER, CONDUCTED IN
MALAWI.
IT WAS A DOUBLE-BLIND, RANDOM, .
AN IPD WAS DEFINED AS AN
ISOLATION OF PNEUMOCOCCAL WITH .
WITH THIS TRIAL, ALL OF THE
PARTICIPANTS HAD RECOVERED FROM
THE INVASIVE NUKE COOKAL DISEASE
AND THE VACCINE REGIMENT WAS
THOSE WITH THE VACCINE GIVEN
FOUR WEEKS APART.
FOR THE OUTCOME OF INVASIVE
PNEUMOCOCCAL DISEASE, THE
VACCINE EFFICACY AGAINST VACCINE
TYPE IPD WAS MEASURED AT 74%,
AND THIS FINDING WAS
SIGNIFICANT.
THE NEXT CLINICAL TRIAL THAT WE
INCLUDED FOR THE IPD OUTCOME WAS
A DOUBLE-BLIND RANDOMIZED,
PLACEBO-CONTROLLED TRIAL THAT
WAS CONDUCTED IN SOUTH AFRICA.
IT'S AN EFFICACY TRIAL AMONG
HIV-INFECTED AND HIV-UNINFECTED
CHILDREN.
THE SAME DEFINITION OF THE IPD
WAS APPLIED.
AND IN THIS TRIAL, THERE WAS A
NINE-BALANCE PNEUMOCOCCAL
CONGREGATE VACCINE USED, AND THE
VACCINE WAS GIVEN ON A
THREE-DOSE SCHEDULE AT 6, 10 AND
14 WEEKS OF AGE.
FOR THE OUTCOME OF IPD VACCINE
TYPE IPD, VACCINE EFFICACY WAS
MEASURED AT 65%, AND THIS
FINDING WAS SIGNIFICANT.
AND TO POINT, THERE WAS A
SEPARATE ANALYSIS DONE FOR
HIV-INFECTED AND HIV-UNINFECTED
CHILDREN, AND THE DATA PRESENTED
HERE ARE FOR HIV-INFECTED
CHILDREN ONLY.
THE OVERALL EFFICACY FOR THE TWO
CLINICAL TRIALS THAT I JUST
PRESENTED FOR THE IPD OUTCOME
WAS ESTIMATED AT 69%, AND THIS
IS A SUMMARY ESTIMATE FOR THE
TWO TRIALS, AND THE RESULTS OF
THE TEST WERE PRESENTED, WHICH
SUGGESTS THAT THE DATA IS
HOMOGENOUS AND THERE WAS
CONSISTENCY IN TERMS OF THE
TRIALS IN TERMS OF THE POINT
ESTIMATE OF THE EFFICACY.
IN ORDER TO CALCULATE NUMBER
NEEDED TO VACCINATE, WE APPLIED
THE COMBINED EFFICACY OF 69%
ESTIMATED FROM THE SUMMARY
ESTIMATE FROM THE TWO CLINICAL
TRIALS, AND WE APPLIED THIS
EFFICACY TO THE PCV13-TYPE IPD
INCIDENCE IN THE U.S. AMONG
CHILDREN UNDER 19 YEARS OF AGE.
AND THIS WAS ESTIMATED AT OVER
1,200 CASES PER 100,000.
SO, USING THIS ESTIMATE, WE
CALCULATED THAT THE RATE AMONG
VACCINATED WOULD BE 392 PER
100,000.
AND THIS RESULTED IN A NUMBER
NEEDED TO VACCINATE ON ALL FOR
115, THEREFORE, THEY ESTIMATED
NUMBER NEEDED TO VACCINATE TO
PREVENT A SINGLE CASE OF IPD IN
THIS AGE GROUP AMONG
HIV-INFECTED CHILDREN WOULD BE
115.
AND AS A POINT OF REFERENCE, I'D
LIKE TO REMIND THE COMMITTEE
THAT WHEN WE HAD THE SAME
ESTIMATES FOR THE ADULTS WITH
HIGH-RISK CONDITIONS, THE NUMBER
NEEDED TO VACCINATE WAS 2,000.
SO, JUST, AGAIN, TO REITERATE
THAT THIS IS A VERY SMALL GROUP
OF VERY HIGH-RISK INDIVIDUALS.
WE INCLUDED ONE OF THE ORIGINAL
STUDIES FOR THE CLINICAL OUTCOME
OF INVASIVE PNEUMOCOCCAL
DISEASE.
THIS WAS A POPULATION-BASED
STUDY OF PCV7 ON RATES WITH
CHILDREN WITH SICKLE CELL
DISEASE.
THE RATES WERE LINKED TO IPD
DATA FOR OVER 1,200 CHILDREN
UNDER 10 YEARS OF AGE WITH
SICDISEASE.
THE ANALYSIS IN THE STUDY WAS
CONDUCTED, STUDIED BY
SURVIVALIST ANALYSIS TO ESTIMATE
THE PCV7 EFFECT ON IPD RATES,
LONG ADJUSTING FOR EFFECTS.
VACCINE EFFECTIVENESS FOR MORE
THAN ONE DOSE OF PCV7 WAS
ESTIMATED TO BE 81%, CONTROLLING
FOR THE PRESENCE OF HARD
IMMUNITY IN THE TWO YEARS AFTER
SO, IN ASSESSING THE QUALITY OF
EVIDENCE FOR IPD OUTCOME, WE
INCLUDED TWO RCTs AND ONE
OBSERVATIONAL STUDY.
THE WORKING GROUP HAD SERIOUS
CONCERNS ABOUT THE INDIRECTNESS
OF DATA COMING FROM THE
RANDOMIZED, CONTROLLED TRIALS
THAT WE INCLUDED IN THE EVIDENCE
DIFFERENT POPULATIONS, THE
POPULATION IN MALAWI AND SOUTH
AFRICA, ADULT POPULATION, A VERY
LOW PERCENTAGE ON
ANTIRETROVIRALS, AND ALSO
DIFFERENT VACCINE FORMULATIONS
AND A DIFFERENT REGIMEN FROM THE
ONES WE ARE INTERESTED IN FOR
THE QUALITY QUESTION.
SO, BECAUSE OF THAT, THE QUALITY
OF EVIDENCE FOR RANDOMIZED,
CONTROLLED TRIALS WAS DOWNGRADED
TO TYPE THREE.
AND FOR OBSERVATIONAL STUDY, A
SINGLE OBSERVATIONAL STUDY WE
INCLUDED, THERE WERE NO SERIOUS
CONCERNS ABOUT THE BIAS OR
INDIRECTNESS OR IMPRECISION.
BUT BY DEFINITION, THIS IS
EVIDENCE TYPE THREE.
FOR THE CRITICAL OUTCOME OF
PNEUMONIA, WE INCLUDED A SINGLE
STUDY.
IT'S THE SAME RCT IN SOUTH
AFRICA AMONG HIV-INFECTED AND
NONINFECTED INDIVIDUALS.
AND ALSO FOR THE CRITICAL
OUTCOME OF DEATHS, WE INCLUDED
THE SAME TRIAL.
SO, FOR RAID LOGICALLY CONFIRMED
PNEUMONIA, WHICH WAS DEFINED AS
CONSOLIDATION AND W.H.O.
DEFINITIONS WERE APPLIED HERE TO
DEFINE THE RADIOLOGICALLY
CONFIRMEDMONIA.
VACCINE EFFICACY WAS RATED AT
15%, AND THIS STATISTIC WAS NOT
SIGNIFICANT.
ALSO, THE ESTIMATE THAT I'M
PRESENTING HERE IS FOR
HIV-INFECTED CHILDREN ONLY.
FOR HIV-UNINFECTED CHILDREN, A
20% EFFICACY AND A SIGNIFICANT
CONFIDENCE INTERVAL WAS
OBSERVED.
SO, 13% IS ONLY FOR HIV-INFECTED
CHILDREN.
FOR ALL CAUSE MORTALITY AMONG
CHILDREN AND 16% REDUCTION WAS
OBSERVED.
AND FOR MORTALITY ATTRIBUTABLE
TO PNEUMONIA, A 4% REDUCTION AND
BOTH FINDINGS WERE NOT
STATISTICALLY SIGNIFICANT.
TO ASSESS THE QUALITY OF THE
EVIDENCE FOR PNEUMONIA AND
DEATH, WE, OF COURSE, INCLUDED
ONLY SINGLE TRIAL FOR BOTH OF
THESE CRITICAL OUTCOMES.
AND AGAIN, THE WORKING GROUP HAD
SERIOUS CONCERNS ABOUT
INDIRECTNESS OF THE DATA.
SO, THE QUALITY OF EVIDENCE FOR
BOTH OF THESE OUTCOMES WAS
ASSESSED TO BE A TYPE THREE.
IN EVALUATING THE EVIDENCE FOR
THE CRITICAL OUTCOME OF
IMMUNOGENICITY, WE INCLUDED A
PHASE THREE OPEN-LABEL,
SINGLE-ARM STUDY
THROUGH 17 YEARS OF AGE
DIAGNOSED WITHELL
DISEASE PREVIOUSLY IMMUNIZED
WITH THE23-VALID VACCINE, AND
23-VALID VACCINE WAS EVEN SIX
MONTHS OR MORE PRIOR TO THE
ENROLLMENT.
PARTICIPANTS IN THIS STUDY
RECEIVED TWO OF THE
13-VALENT VACCINE, GIVEN
APPROXIMATELY SIX MONTHS APART,
AND THE SAMPLES WERE COLLECTED
PRIOR TO AND ONE MONTH PRIOR
EACH OF THE DOSES OF PCV13.
PSEUDOTYPE SPECIFICS WERE
MEASURED FOR ALL 13 SEROTYPES.
AND BECAUSE OF THE POLICY
QUESTION THAT WE ARE CONSIDERING
TODAY, EVEN THOUGH IN THIS STUDY
THE PRIMARY OBJECTIVE WAS TO
COMPARE THE SECOND DOSE TO THE
FIRST DOSE IT WAS A TWO-DOSE
REGIMEN GIVEN, WE WILL ONLY
PRESENT THE RESULTS FOLLOWING A
SINGLE DOSE OF PCV13.
PSEUDOTYPE SPECIFIC OR OMETR
GEOMETRIC, FULL RISES ARE
PRESENTED HERE POST DOSE ONE.
THE OPAGMTs ONE MONTH AFTER DOSE
ONE WERE HIGHER THAN THE OPAGMTs
BEFORE DOSE ONE FOR ALL
SEROTYPES.
GEOMETRIC FOLD RISES FROM BEFORE
TO AFTER DOSE ONE RANGED FROM
3.5 FOR SEROTYPE 14 TO 40.3 FOR
SEROTYPE 23F.
PSEUDOTYPE SPECIFIC
IOD-GEOMETRIC MEAN
CONCENTRATIONS BEFORE AND AFTER
DOSE ONE AND GEOMETRIC MEAN FOLD
RISES ARE PRESENTED IN THIS
TABLE.
THE IDGGFCs WERE HIGHER FOR DOSE
TWO THAN DOSE ONE.
THEY SHOWED RISES FROM ONE MONTH
BEFORE DOSE ONE TO AFTER DOSE
ONE RANGED 1.74 FOR SEROTYPE 5
TO 6.05 FOR SER OTYPE 4.
SO, THE ANTIBODIES MEASURED
THROUGH OPA INCREASED AFTER A
SINGLE DOSE OF THE 13-VALENT
VACCINE.
WE ALSO INCLUDED IN OUR REVIEW
TWO RCTs IN HIV-INFECTED
INFANTS.
ONE OF THEM INCLUDED A FOUR-DOSE
SCHEDULE OF PCV7, AND THE SECOND
ONE IS AN RCT IN SOUTH AFRICA.
THAT IS WHICH I HAVE ALREADY
SUMMARIZED, AND THREE DOSES OF
THE 9-VALENT CONJUGAL VA VACCINE
WERE GIVEN.
WE INCLUDED THE VACCINES FOR
HIV-AFFECTED ADULTS.
IN THESE STUDIES, THE COUNT WAS
GREATER THAN OR EQUAL TO 100.
AND SOME OF THE COMPARISONS THAT
WERE EVALUATED IN THE ADULT
STUDIES WERE -- SOME OF THEM
WERE WITH PLACEBO AND OTHERS
COMPARED THE RESPONSES TO
PPSV23.
SO, TO SUMMARIZE THE FINDINGS OF
THE PUBLISHED IMMUNOGENICITY
STUDIES, THE WORKING GROUP
CONCLUDED THAT PCV DOES ILLICIT
A RESPONSE FROM IMMUNO CHILDREN
AND ADULTS, HIGHER
IN THE PCV ARM VERSUS THE
PLACEBO GROUP WERE OBSERVED IN
STUDIES.
AND IN ADULT STUDIES, THE
RESPONSE FOLLOWING A SINGLE DOSE
OF PCV IS AS GOOD OR BETTER THAN
THE POLYSACCHARID VACCINE, BOTH
IN VACCINE-NAIVE AND PREVIOUSLY
VACCINATED ADULTS.
THAT'S THE QUALITY OF EVIDENCE
FOR IMPORTANT OUTCOME OF
IMMUNOGENICITY WITH TYPE THREE.
SO, FOR THE FOUR RCTs IN
HIV-INFECTED ADULTS AND TWO RCTs
IN CHILDREN, THERE WERE VERY
SERIOUS CONCERNS ABOUT
INDIRECTNESS, SO THE EVIDENCE
QUALITY WAS DOWNGRADED TO TYPE
THREE.
AND FOR THE TWO SINGLE-ARM
STUDIES, THE EVIDENCE QUALITY
STARTED AT TYPE THREE, BECAUSE
NO SERIOUS CONCERNS WERE RAISED
ABOUT BIAS OR INDIRECTNESS, THE
EVIDENCE REMAINED A TYPE THREE.
IN EVALUATING THE SAFETY
OUTCOME, WE INCLUDED TWO RCTs OF
PCV7 AND PCV9 AMONG HIV-INFECTED
INFANTS AND THREE RCTs AMONG
HIV-INFECTED ADULTS.
IN STUDIES CONSIDERED HERE, NO
SERIOUS ADVERSE EVENTS WERE
REPORTED.
AND FOR THE SERIOUS SYSTEMIC
EVENTS REPORTED, NO
STATISTICALLY SIGNIFICANT
DIFFERENCES WERE NOTED BETWEEN
THE STUDY AND THE CONTROL ARM.
MILD SELF-LIMITED SECONDARY
EFFECTS, SUCH AS LOCAL PAIN,
FEVER, NAUSEA WERE REPORTED IN
ADULT STUDIES WITH NO
STATISTICAL SIGNIFICANT
DIFFERENCE OBSERVED BETWEEN THE
ARMS.
WE ALSO INCLUDED TO ENSURE THE
EVALUATION OF THE SAFETY OUTCOME
A PHASE THREE SINGLE-ARM STUDY
IN CHILDREN 6 TO 17 YEARS OF AGE
WITH SICKLE CELL DISEASE.
MOST COMMONLY REPORTED SYSTEMIC
EVENT FOLLOWING A SINGLE DOSE
WERE HEADACHE, FATIGUE AND
MUSCLE PAIN.
SEVERE SYSTEMIC EVENTS REPORTED
BY MORE THAN 10% OF SUBJECTS
AFTER A SINGLE DOSE OF PCV13
INCLUDED HEADACHE, FATIGUE AND
MUSCLE PAIN.
THE MOST FREQUENTLY REPORTED
ADVERSE EVENT WERE SICKLE CELL
ANEMIA WITH CRISIS FOLLOWED BY
PYRIXIA, HEADACHE AND VERNACULAR
OCOLLUSION.
AFTER DOSE ONE, 8% OF SUBJECTS
REPORTED SEVERE ADVERSE EVENTS.
THE MOST FREQUENTLY REPORTED
SEVERE ADVERSE EVENT WERE SICKLE
CELL ANEMIA WITH CRISIS, ACUTE
CHEST SYNDROME AND PYREXIA.
NO LIFE-THREATENING ADVERSE
EVENTS WERE REPORTED DURING THE
STUDY PERIOD.
TO EVALUATE THE QUALITY OF
EVIDENCE FOR THE CRITICAL
OUTCOME OF SERIOUS AND SYSTEMIC
ADVERSE EVENTS, WE INCLUDED FIVE
RANDOMIZED CLINICAL TRIALS AMONG
ADULTS AND CHILDREN AND ONE
SINGLE-ARM STUDY PREVIOUS TO THE
IMMUNOGENICITY STUDY.
THE ONLY SERIOUS CONCERNS
INVOLVED INDIRECTNESS, BECAUSE
THE RCTs IN CHILDREN INCLUDED A
DIFFERENT VACCINE FORMULATION,
AND RCTs AMONG ADULTS INCLUDED A
DIFFERENT COMPARISON, PPSV23.
SO, THE QUALITY OF EVIDENCE WAS
TYPE THREE.
SO, NEXT, WE SUMMARIZED THE
QUALITY OF EVIDENCE ACROSS ALL
CRITICAL OUTCOMES.
SO, FOR EACH INDIVIDUAL CRITICAL
OUTCOME, THE EVIDENCE FOR
QUALITY WAS CONSIDERED TYPE
THREE, SO OVERALL QUALITY OF
EVIDENCE WAS ALSO CONSIDERED TO
BE TYPE THREE.
SO, THE NEXT STEP IN THE GRADE
PROCESS INVOLVES THE REVIEW OF
HEALTH ECONOMIC DATA.
FOR ADULTS FOR THE SIMILAR
QUESTION THAT WE CONSIDERED IN
JUNE OF 2012 BEFORE THIS
COMMITTEE, THE
COST-EFFECTIVENESS ANALYSIS
AMONG ADULTS WITH
IMMUNOCOMPROMISED CONDITIONS,
THE RESULTS OF THAT ANALYSIS
WERE SHARED WITH THE COMMITTEE,
AND THAT ANALYSIS INDICATED THAT
PCV13 IMMUNIZATION IS
COST-SAVING FOR FOUR SELECTED
SUBPOPULATIONS THAT WE WERE ABLE
TO INCLUDE IN THE MODEL.
HOWEVER, GIVEN THE POLICY
QUESTION THAT WE ARE CONSIDERING
TODAY INVOLVES A VERY SMALL
GROUP POPULATION OF VERY
HIGH-RISK INDIVIDUALS, AND ALSO
THAT THE RECOMMENDATIONS HAVE A
TIME-LIMITED UTILITY.
IT INCLUDES ONLY PCV13-NAIVE
CHILDREN 6 TO 18 YEARS OLD WITH
THESE CONDITIONS.
WE DID NOT EVALUATE THE
COST-EFFECTIVENESS FOR THE
GRADE.
IN ORDER TO DETERMINE THE
RECOMMENDATION CATEGORY, THE
WORKING GROUP CONSIDERED FOUR
QUESTIONS.
THE FIRST IS WHETHER THE
EVIDENCE QUALITY OR LEVEL WAS
LOWER, AND THE WORKING GROUP
CONCLUDED THAT, YES, THE
EVIDENCE QUALITY IS LOW DUE TO
INDIRECTNESS OF EVIDENCE COMING
FROM RCTs AND ALSO MOST OF THE
EVIDENCE COMING FROM
OBSERVATIONAL STUDIES.
THE NEXT QUESTION, WHETHER THERE
IS A CERTAINTY ABOUT THE BALANCE
VERSUS HARM AND BURDEN.
THE COMMITTEE CONCLUDED THAT
THERE IS A VERY HIGH BURDEN OF
DISEASE IN THIS GROUP OF PERSONS
THAT WE ARE CONSIDERING FOR THE
POLICY CHANGE.
IS THERE A VARIABILITY OR A
CERTAINTY ON WHAT IS IMPORTANT?
AND THE ANSWER WAS NO.
THE WORKING GROUP REACHED A
CONSENSUS OF WHICH OUTCOME FOR
CRITICAL AND IMPORTANT TO
PREVENT.
AND IS THERE UNCERTAINTY ABOUT
WHETHER THE NET BENEFITS ARE
WORTH THE COST?
AND AS I MENTIONED EARLIER,
THERE IS AN UNCERTAINTY THAT
REMAINS, AS WE WERE NOT ABLE TO
CONDUCT THE COST-EFFECTIVENESS
ANALYSIS, AND THERE IS AN
UNCERTAINTY REGARDING THE KEY
INPUTS THAT ARE NEEDED FOR THE
COST-EFFECTIVENESS ANALYSIS.
SO, IN CONCLUSION, THE WORKING
GROUP DECIDED THAT THERE IS AN
EXTREMELY HIGH BURDEN OF DISEASE
AMONG IMMUNOCOMPROMISED CHILDREN
6 THROUGH 18 YEARS OLD.
GRADE PROCESS LED TO THE
CONCLUSION THAT PCV13 IS LIKELY
EFFECTIVE IN THIS GROUP AND THAT
BENEFITS LIKELY OUTWEIGH HARM.
WE DON'T EXPECT ANY ADDITIONAL
DATA TO BECOME AVAILABLE IN THE
NEAR FUTURE IN INFLUENZA GRADE
CONCLUSIONS FOR THIS PARTICULAR
GROUP.
AND AS WE SAW IN ADULT
POPULATIONS WITH THESE HIGH-RISK
CONDITIONS, IN DIRECT EFFECT OF
PCV13 USE IN CHILDREN, ARE
UNLIKELY TO ELIMINATE PCV13 SER
SEROTYPES FROM IMMUNOCOMPROMISED
PERSONS, AND EVEN THOUGH FOR
THIS PARTICULAR AGE GROUP, WE
DIDN'T HAVE POWER TO EVALUATE
THIS QUESTION, THE DATA IN
ADULTS DOES SUPPORT THIS
STATEMENT.
AND IN CONCLUSION, BENEFITS
LIKELY OUTWEIGH HARMS AND PCV13
SHOULD BE ROUTINELY RECOMMENDED
FOR PCV13-NAIVE CHILDREN 6
THROUGH 18 YEARS OLD WITH
IMMUNOCOMPROMISING CONDITIONS,
FUNCTIONAL OR ANATOMIC, CSF
LEAKS OR COCHLEAR IMPLANTS.
AND THE WORKING GROUP REACHED
THE DECISION THAT THIS SHOULD BE
A CATEGORY "A" RECOMMENDATION
BASED ON EVIDENCE TYPE THREE.
AND I WOULD LIKE TO PAUSE HERE
FOR QUESTIONS BEFORE THE NEXT
PRESENTATION, IF I MAY.
THANK YOU.
>> QUESTIONS FROM THE ACIP
MEMBERS.
MS. ROSENBAUM.
>> CAN YOU TALK A LITTLE BIT
ABOUT WHAT THE EFFECT IS ON
ACCESS TO THE VACCINE ITSELF IF
THE CLASSIFICATION IS LESS
PREVENTIVE AND IT'S TO MAKE AN
OFF-LABEL USE?
>> IT'S NOT GOING TO BE LABELED
BECAUSE THE VACCINE IS ALREADY
>> RIGHT.
IF WE WORK TO ADOPT THIS, IF
THIS WERE LEFT AN OFF-LABEL
PERMISSIVE USE, WHAT ARE THE
IMPLICATIONS FOR ACCESS TO
COVERAGE?
>> I THINK THEY WOULD BE BETTER
TO ANSWER THIS QUESTION, BUT I
BELIEVE THE VACCINE IS COVERED,
EVEN WITH THE PERMISSIVE
RECOMMENDATIONS AND THE LANGUAGE
WAS INCLUDED.
SO, UNDER THAT, THE VACCINE WAS
COVERED FOR THE HIGH-RISK
INDIVIDUALS.
>> HOW ABOUT PRIVATE INSURANCE
PLANS?
>> I CANNOT COMMENT ON THAT,
WHETHER INSURANCE -- WOULD HAVE
COVERED.
IF THERE'S ANYONE IN THE ROOM
WHO CAN COMMENT?
>> YEAH, THAT QUESTION, PROBABLY
THE BEST ANSWER IS IT WILL BE
VARIABLE, BECAUSE SOME ALLOW THE
PERMISSIVE USE IF THE CONDITIONS
EXIST FOR WHICH IT SHOULD BE
APPLIED.
IT'S FAIRLY STRICT AROUND
UTILIZATION ONLY FOR THOSE WHO
HAVE A ROUTINE RECOMMENDATION.
>> THAT'S WHAT I THOUGHT.
THANK YOU.
>> OTHER QUESTIONS?
I'D JUST LIKE TO COMMEND THE
WORKING GROUP FOR A VERY NICE
AND CLEAR PRESENTATION USING
GRADE.
I'M ALMOST WILLING TO SAY THAT
THIS IS STARTING TO FEEL
SOMEWHAT ROUTINE, AND WE'RE KIND
OF INCHING OVER THE CORNER OF
THE LEARNING CURVE WITH THIS,
BUT THIS IS ALL VERY NICE AND
CLEAR, SO THANK YOU VERY MUCH.
ANY OTHER QUESTIONS FROM
LIAISONS OR --
>> I'VE GOT ONE MAYBE ON
MANAGING THE AGE GROUPS.
THE ORIGINAL APPROVAL FOR THIS
IN ADULTS WAS 19 AND OLDER, IS
THAT CORRECT?
AND -- YES, FOR THE ADULTS, THE
ORIGINAL APPROVAL --
>> NO, IT'S NOT CURRENTLY
APPROVED FOR ADULTS UNDER 5.
18 TO 50 CURRENTLY IS NOT
APPROVED.
>> OKAY, SO 18.
YEAH.
SO, THIS RECOMMENDATION THEN IS
THROUGH 18 YEARS OF AGE, WHICH
FITS INTO THE IMMUNIZATION
SCHEDULE, BUT IT'S LICENSED 1
THROUGH 17, SO THIS WILL BE A
ONE-YEAR, SO-CALLED OFF-LABEL.
IT'S TOO BAD THE STUDY WASN'T
DONE THROUGH 18 YEARS OF AGE,
BUT IT WASN'T.
SO, JUST TO CLARIFY THAT.
>> RIGHT.
IF I CAN REITERATE, OUR PREVIOUS
RECOMMENDATIONS COVERED ADULTS
19 YEARS OF AGE OR OLDER.
SO, FROM 19 TO 49-YEAR-OLDS, THE
RECOMMENDATIONS ARE OFF-LABEL,
OUR 2012 RECOMMENDATIONS.
WITH THIS APPROVAL, FDA
APPROVAL, IT APPROVES THROUGH
17, AS YOU MENTIONED, THROUGH 17
YEARS OF AGE, BUT OUR
RECOMMENDATIONS ARE CONSISTENT
WITH THE PEDIATRIC TABLES'
RECOMMENDATIONS.
SO, 18-YEAR-OLDS ARE STILL
OFF-LABEL.
>> DR. KEITEL?
>> I WONDER IF THE MANUFACTURER
CAN PROVIDE INFORMATION ABOUT
WHETHER THEY WERE ABLE TO TEASE
THAT SINCE THE TIME THEY RECEIVE
THE POLYSACCHARID VACCINE AND
ITS EFFECT ON IMMUNOGENICITY.
>> IF YOU'RE REFERRING TO THE
SICKLE CELL STUDY, THAT'S A
QUESTION THAT WE ACTUALLY RAISED
TO OUR COLLEAGUES, AND THEY WERE
ABLE TO PROVIDE US DATA, BUT
LOOKING AT THEIR RESPONSE, I
TRIED TO CORRELATE THE RESPONSE
BY TYING IT TO THE POLYSACCHARID
VACCINE, AND IT DOESN'T SEEM TO
MAKE A DIFFERENCE ON THE
RESPONSE.
IT'S A VERY LOW CORRELATION.
AND IF THERE IS ANYTHING ELSE.
>> OKAY.
I GUESS WE CAN MOVE ALONG.
>> SO, NEXT I WOULD LIKE TO MOVE
TO THE ACTUAL RECOMMENDATION
LANGUAGE, AND FIRST TO REMIND
THE COMMITTEE THAT WE ARE
PROPOSING THE FOLLOWING
INDICATIONS FOR THE ROUTINE USE
OF PCV13 IN CHILDREN 6 THROUGH
18 YEARS OF AGE.
ANATOMIC ASPLEENA, HIV
INFECTION, AND THE LEAST OF
IMMUNOCOMPROMISING CONDITIONS.
AND IN ADDITION TO THAT,
CHILDREN WITH COCHLEAR IMPLANTS
OR CSF LEAKS WHO HAVE ALREADY
BEEN INCLUDED IN OUR PERMISSIVE
RECOMMENDATIONS.
SO, A SINGLE DOSE OF PCV13 WOULD
BE RECOMMENDED FOR CHILDREN AGE
6 THROUGH 18 YEARS OLD WHO HAVE
NOT RECEIVED PCV13 PREVIOUSLY
AND WHO ARE AT INCREASED RISK
FOR INVASIVE PNEUMOCOCCAL
DISEASE BECAUSE OF THE
AFOREMENTIONED CONDITIONS.
AND REGARDLESS OF WHETHER THEY
HAVE PREVIOUSLY RECEIVED PCV7 OR
PPSV23.
OUR RECOMMENDATIONS FOR PPSV23
USE FOR CHILDREN IN THIS AGE
GROUP REMAIN UNCHANGED.
AND JUST TO REITERATE THE
CURRENT RECOMMENDATIONS, WHICH
ARE ALSO NOT CHANGING FOR THE
COMBINED USE OF PCV13 AND PPSV23
AND THE RECOMMENDED INTERVAL.
SO, FOR PPSV23-NAIVE CHILDREN,
PCV13 DOSE IS RECOMMENDED TO BE
GIVEN BEFORE PPSV23, WHENEVER
POSSIBLE.
PPSV23 SHOULD BE GIVEN AT LEAST
EIGHT WEEKS AFTER A DOSE OF
PCV13, AND THIS IS IN ACCORDANCE
WITH THE 2010 RECOMMENDATIONS.
AND RECOMMENDATIONS FOR THE
SECOND DOSE OF PPSV REMAIN
UNCHANGED, ALSO ACCORDING TO THE
ALREADY EXISTING
RECOMMENDATIONS.
FOR PPSV23 AS CHILDREN, A DOSE
OF PCV13 SHOULD BE GIVEN AT
LEAST EIGHT WEEKS AFTER PPSV23
DOSE, AND A TOTAL NUMBER AND
INTERVAL BETWEEN THE PPSV DOSES
REMAIN UNCHANGED FROM THE
EXISTING RECOMMENDATIONS.
AND ALSO, TO REITERATE THE
CURRENT PPSV RECOMMENDATIONS,
AND THESE APPLY TO ALL CHILDREN
2 THROUGH 18 YEARS OF AGE.
SO, CHILDREN 2 YEARS OF AGE OR
OLDER WITH UNDERLYING MEDICAL
CONDITIONS SHOULD RECEIVE PPSV23
AFTER COMPLETING ALL RECOMMENDED
DOSES OF PCV13.
THESE CHILDREN SHOULD BE
ADMINISTERED ONE DOSE OF PPSV23
AT AGE 2 YEARS OR OLDER, AND AT
LEAST EIGHT WEEKS AFTER THE MOST
RECENT DOSE OF PCV13.
CHILDREN WHO HAVE RECEIVED
PPSV23 PREVIOUSLY ALSO SHOULD
RECEIVE RECOMMENDED PCV13 DOSES.
AND THEN CURRENT RECOMMENDATIONS
FOR REVACCINATION WITH A PPSV23
AMONG CHILDREN AT HIGHEST RISK
UNCHANGED.
A SECOND DOSE OF PPSV23 IS
RECOMMENDED FIVE YEARS AFTER THE
FIRST DOSE OF PPSV23 FOR
CHILDREN WHO HAVE UNATOMIC
ASPLENIA, INCLUDING SICKLE CELL
DISEASE, INFECTIONS OR OTHER
IMMUNOCOMPROMISED CONDITIONS AND
NO FURTHER PPSV23 DOSES ARE
RECOMMENDED.
SO, IF THERE IS ANY MORE
QUESTIONS, I WOULD LIKE TO
PRESENT TO THE COMMITTEE THE
LANGUAGE OF THE VOTE.
>> MS. ROSENBAUM.
>> I BELIEVE UNDER THE WORDING
OF THE AFFORDABLE CARE ACT, IT'S
IMPORTANT THAT WE USE
SPECIFICALLY THE WORD ROUTINE
SOMEWHERE.
AND I DIDN'T SEE IT ON THE
SLIDE, SO MY ONE TECHNICAL
RECOMMENDATION WOULD BE, IS IT
THERE?
I'M LOOKING.
WE WERE SWITCHING FROM
PERMISSIVE TO ROUTINE.
>> SO, TO ADD THE WORDING THAT
WE RECOMMEND ROUTINELY.
>> WE NEED TO CLARIFY THAT THIS
WOULD BE A ROUTINE IMMUNIZATION
FOR IMMUNOCOMPROMISED CHILDREN.
>> WE CAN ALTER THE LANGUAGE.
>> COULD YOU JUST REMIND ME OR
CLARIFY FOR ME THE
RECOMMENDATION IN PEOPLE WHO
HAVE BEEN PREVIOUSLY IMMUNIZED
WITH POLYSACCHARID WITH REGARD
TO INTEGRAL TO THE SUBSEQUENT
CONJUGATE VACCINE?
I THINK FOR ADULTS, YOU'RE
SUPPOSED TO WAIT ONE YEAR.
AND DID I JUST READ FOR
CHILDREN, WE'RE WAITING EIGHT
WEEKS?
AND IF THAT'S CORRECT, COULD YOU
JUST EXPLAIN THE DIFFERENCE AND
WHETHER THAT INTERVAL IS PART OF
WHAT WE'RE VOTING ON?
>> SO, THE INTERVAL REMAINS
UNCHANGED FOR PEDIATRIC
RECOMMENDATIONS.
THIS IS WHAT WE CURRENTLY HAVE
IN 2010 RECOMMENDATIONS.
FOR ADULT RECOMMENDATIONS, THE
COMMITTEE DID VOTE, AND THE
WORKING GROUP DID DECIDE ON AN
INTERVAL WAITING ONE YEAR, SO
THERE IS A DISCREPANCY IN JUST
THE WAITING PERIOD FOLLOWING THE
PPSV23 BETWEEN THE ADULT
RECOMMENDATIONS AND PEDIATRIC
RECOMMENDATIONS.
WITH ADULT RECOMMENDATIONS, WE
WERE LIMITED WITH THE DATA THAT
WAS AVAILABLE TO US.
NONE OF THE STUDIES THAT WE USED
IN OUR EVIDENCE WERE DESIGNED TO
EVALUATE THE OPTIMAL INTERVAL,
AND BASED ON THE EXPERT OPINION,
IT WAS DECIDED THAT ONE YEAR
WAITING PERIOD WILL BE
SUFFICIENT TO POTENTIALLY
OVERCOME ANY RISK OF
HYPERRESPONSIVENESS IF THE
VACCINES WERE GIVEN TOO CLOSE TO
EACH OTHER.
WITH CHILDREN, THAT WAS THE
RECOMMENDATION, AND I WAS NOT
INVOLVED IN THE RECOMMENDATION.
AND AGAIN, THE EVIDENCE IS VERY
CLEAN AND THERE IS NO EVIDENCE
AVAILABLE AS TO WHAT IS THE
OPTIMAL INTERVAL.
BUT ACCORDING TO THE 2010
RECOMMENDATIONS, THAT WAS
CONSIDERED TO BE THE OPTIMAL
WAITING PERIOD.
>> I'M GOING TO FOLLOW UP ON
THAT COMMENT VERY QUICKLYLY AND
JUST ASK DTHE DOCTOR, AS SOMEON
WHO IMMUNIZED BOTH CHILDREN AND
ADULTS, IS THAT GOING TO BE A
PROBLEM?
OR IS IT THAT CHILDREN LIKE THIS
ARE RARE ENOUGH THAT YOU'RE NOT
GOING TO SEE IT IN YOUR USUAL
PRACTICE?
>> THIS IS THE LATTER CASE.
THIS IS SO UNUSUAL THAT YOU'RE
GOING TO LOOK IT UP PRACTICALLY
EVERY SINGLE TIME.
>> DR. HARRISON.
>> LET ME TRY AND UNDERSTAND THE
INCREMENTAL BENEFIT OF PCV13 IN
THE FACE OF RECEIPT OF THE
POLYSACCHARID VACCINE.
SO, YOUR NUMBER TO VACCINATE, IS
THAT INCREMENTAL TO THE RECEIPT
OF THE POLYSACCHARID VACCINE?
>> SO, PPSV'S PREVACCINATION WAS
NOT CONSIDERED IN OUR EFFICACY
ESTIMATION OR IN OUR ESTIMATION
OF NUMBER NEEDED TO VACCINATE
AND WE WOULD HAVE NO
SUFFICIENT -- WE WOULDN'T HAVE
SUFFICIENT DATA TO EVALUATE
THEM.
WE WOULD HAVE TO MAKE
ASSUMPTIONS ABOUT THE PPSV
EFFICACY FOR THIS GROUP IN ORDER
TO ESTIMATE THE INCREMENTAL
EFFECTS.
SO, IT WAS CONSIDERED FOR NUMBER
NEEDED TO VACCINE ESTIMATION WAS
BASED ON NAIVE CHILDREN.
>> DR. CAMPOS-OUTCALT.
>> I'M LOOKING FOR WAYS TO
SIMPLIFY THIS RECOMMENDATION.
WHY IS IT -- WOULD THIS NOW BE
COMBINED WITH THE RECOMMENDATION
FOR AGES 2 AND ABOVE?
I MEAN, WE HAVE NOW A
RECOMMENDATION FOR ONE AGE GROUP
AND ANOTHER RECOMMENDATION FOR
ANOTHER AGE GROUP, WHICH IS
ESSENTIALLY THE SAME
RECOMMENDATION.
SO, WOULDN'T WE COMBINE THEM
INTO ONE RECOMMENDATION,
STARTING AT, YOU KNOW, AGE SAY 2
OR WHATEVER IT IS, ALL THE WAY
THROUGH 18, RATHER THAN HAVE TWO
SEPARATE RECOMMENDATIONS?
>> I THINK THE ULTIMATE GOAL OF
THE WORKING GROUP IS TO REVISE
AND COMBINE ALL THE
RECOMMENDATIONS.
SO, CURRENTLY, WE ARE FOCUSING
ON 6 TO 18-YEAR-OLDS.
THE PREVIOUS RECOMMENDATIONS
FOCUSED ON SPECIFIC NAIVE ADULTS
19 AND OLDER, AND AS YOU
MENTIONED, THERE IS ALSO A GROUP
OF 2 TO 5-YEAR-OLDS.
HOWEVER, THE REASON WE FOCUSED
ON THE 6 TO 18-YEAR-OLDS IS THIS
IS THE AGE GROUP FOR WHICH IN
2010 THERE WERE PERMISSIVE
RECOMMENDATIONS THAT WERE MADE
THROUGH AGE OF 5.
WE HAVE STRONG RECOMMENDATIONS
FOR THE SAME GROUP OF KIDS.
SO, ESSENTIALLY, IF WE WERE TO
REVISE THE RECOMMENDATIONS, IT
DROPS ONE DOCUMENT.
IT WILL COVER CHILDREN 2 THROUGH
18 YEARS OF AGE.
>> DO WE HAVE ANY OTHER
QUESTIONS?
COMMENTS?
DR. DUCHIN.
>> I'D LIKE TO MAKE A MOTION TO
ACCEPT THE RECOMMENDATION
LANGUAGE AS WRITTEN WITH THE
ADDITION OF THE WORD ROUTINE,
ALTHOUGH I DO HAVE SOME
QUESTIONS ABOUT ALL THE
RECOMMENDATIONS THAT DON'T
INCLUDE THE WORD ROUTINE.
WHAT'S GOING TO HAPPEN TO THEM
UNDER ACA?
>> AND THE QUESTION IS WHETHER
OR NOT WE CAN DO SOME
WORDSMITHING WHEN THESE ARE
PULLED TOGETHER AND HARMONIZED,
BECAUSE THEY'RE ESSENTIALLY THE
SAME THING.
SO, ARE YOU SUGGESTING THAT
AFTER PCV13 IN THE FOURTH LINE,
WE SHOULD SAY "SHOULD ROUTINELY
RECEIVE"?
>> I'M NOT GOING TO MAKE A
RECOMMENDATION ABOUT THE WORD
ROUTINE.
I'M NOT SURE I UNDERSTAND THE
NEED FOR IT.
>> AGAIN, THIS IS BACK INTO THE
COURT OF MS. ROSENBAUM.
>> SO, IN IMPLEMENTING HHS
REGULATIONS FOR THE PREVENTIVE
SERVICES BENEFIT UNDER THE
AFFORDABLE CARE ACT, THE
REGULATIONS CLEARLY TIE COVERAGE
OF IMMUNIZATIONS TO ROUTINE
RECOMMENDATIONS OF THE ACIP.
AND IF WE DO NOT USE THE WORD
ROUTINE, GIVEN THE FACT THAT
THIS IMMUNIZATION HAS BEEN
TREATED, AS I UNDERSTAND IT, AS
A PERMISSIVE IMMUNIZATION, WE
RISK THE POSSIBILITY, AS WE
HEARD BEFORE, OF SIGNIFICANT
VARIATION IN COVERAGE POLICIES
BECAUSE YOU END UP WITH
PERMISSIVE LANGUAGE WHICH HAS
BEEN UNDERSTOOD AS PERMISSIVE
NOT ONLY TO THE CLINICIAN, BUT
PERMISSIVE TO THE INSURER.
THEREFORE, I AM STRONGLY
RECOMMENDED THAT IF WE ARE
MOVING FROM USE YOUR CLINICAL
JUDGMENTS ABOUT WHETHER TO GIVE
THE IMMUNIZATION TO A STANDARD
THAT SAYS WE ARE RECOMMENDING
THAT FOR CERTAIN
IMMUNOCOMPROMISED CHILDREN THEY
ROUTINELY GET AT LEAST THIS
IMMUNIZATION, WE WANT TO USE THE
LANGUAGE OF THE IMPLEMENTING
FEDERAL REGULATIONS OF THIS
AGENCY.
>> THANK YOU.
DR. KEITEL.
>> MY UNDERSTANDING IS THAT USE
OF THE WORD "MAY" IMPLIES
JUDGMENT, AND USE OF THE WORD
"SHOULD" IMPLIES ROUTINE.
SO, WE MAY WANT TO LOOK ACROSS
VARIOUS RECOMMENDATIONS AND SEE
WHEN WE USE THE WORD ROUTINE
VERSUS USING THE WORD SHOULD OR
DEFINE SHOULD AS BEING THAT
APPLIES TO GEVERYBODY IN THAT
GROUP.
>> I -- CERTAINLY, WHATEVER THE
CUSTOM IS HERE, WHAT YOU DON'T
WANT TO LEAVE ANY DOUBT ABOUT IS
THAT AS OUR RECOMMENDATION'S
GOING TO THE CDC DIRECTOR WHO
MAKES THE FINAL DECISION ABOUT
WHETHER TO ISSUE THIS AS A
ROUTINE VACCINE, THEREFORE
TRIGGERING THE COVERAGE
REQUIREMENTS, WE JUST WANT TO BE
CLEAR THAT WHAT WE NEED TO END
UP WITH IS A RECOMMENDATION AT A
LEVEL THAT LEAVES NO QUESTION
ABOUT THE FACT THAT IT GOES ON
TO A SCHEDULE FOR COVERAGE
PURPOSES.
>> AND I THINK THAT'S ALSO THE
PURPOSE OF HAVING OUR CATEGORY
"A" AND CATEGORY "B."
SO, THE CATEGORY "A" IS SIM
POLICEIT AND THE QUESTION OF
WHETHER OR NOT THERE ALSO NEEDS
TO BE A LANGUAGE OR A WORD
INSERTED FOR THE IMPLEMENTATION
OF ACA.
DID I SEE DR. JENKINS' HAND?
OH, DR. CAMPOS-OUTCALT.
>> I WAS GOING TO MAKE THE
RECOMMENDATION YOU DID, WHICH IS
THIS IS GOING TO BE A CATEGORY
"A" RECOMMENDATION.
WE DEFINED WHAT A CATEGORY "A"
RECOMMENDATION IS, SO I THINK
WE'RE COVERED ON THAT.
>> DR. DUCHIN?
>> IN THAT CASE, I WILL REPHRASE
MY MOTION TO ACCEPT THE PROPOSED
LANGUAGE AS WRITTEN.
>> DO WE HAVE A SECOND?
FURTHER DISCUSSION?
MS. ROSENBAUM.
>> I'M SORRY.
I'M LIKE A DOG WITH A BONE ON
THIS.
I'M PERFECTLY HAPPY TO GO ALONG
WITH THE LANGUAGE AS WRITTEN IF
IT IS UNDERSTOOD IN PART OF THE
RECORD THAT WE INTEND THE
LANGUAGE AS WRITTEN TO BE
UNDERSTOOD AS ROUTINE FOR
PURPOSES OF THE COVERAGE
STANDARDS UNDER THE AFFORDABLE
CARE ACT.
>> AND ALONG THAT LINE, I THINK
WE COULD SAY LET THE RECORD SHOW
THAT THE INTENT OF ACIP IS THAT
THIS IS A ROUTINE RECOMMENDATION
FOR CHILDREN 6 THROUGH 18 WITH
THESE UNDERLYING CONDITIONS.
OTHER DISCUSSION?
YOU ARE UNBELIEVABLY QUIET
TODAY.
BUT WITH THAT, IF THERE'S NO
FURTHER DISCUSSION, WE WILL
START WITH DR. KARRON AND GO
CLOCKWISE.
>> ACCEPT.
>> APPROVED.
>> I'M SORRY.
I DON'T KNOW WHICH WAY THE
CLOCK GOES. [ LAUGHTER ]
BOCCHINI, YES.
>> HARRIMAN, YES.
>> HARRISON, YES.
>> DUCHIN, YES.
>> BEASLEY, YES.
>> YES.
>> ROSENBAUM, YES.
>> SAWYER, YES.
>> RUBIN, YES.
>> YES.
>> TEMTE, YES.
>> KEITEL, YES.
>> CAMPOS-OUTCALT, YES.
>> JENKINS, YES.
>> AND THE MOTION IS APPROVED.
AND THEN, I BELIEVE WE NEED TO
HAVE DR. SANTOLI?
COME UP TO PRESENT INFORMATION
REGARDING THE VACCINE FOR
CHILDREN VOTE.
>> SO, THIS IS THE PNEUMOCOCCAL
VFC RESOLUTION UPDATE.
SORRY.
SO, JUST TO NOTE, WE COVERED
THIS A MINUTE AGO, BUT THE VFC
RECOMMENDATION FOR PNEUMOCOCCAL
DISEASE CONTAINS THE PCV AND THE
PP23 COMPONENTS.
THIS UPDATE APPLIES ONLY TO THE
UPDATE TO THE RESOLUTION.
THERE ARE NO PROPOSED CHANGED TO
THE PPV23 COMPONENT.
THE PURPOSE OF THIS UPDATE IS TO
UPDATE RECOMMENDATIONS REGARDING
THE USE OF THIS VACCINE IN
PCV13-NAIVE CHILDREN AGE 6 TO 18
YEARS.
THE WORDING FOR THE ELIGIBLE
GROUPS REMAINS UNCHANGED AND
REFERS TO THE TABLE BELOW, WHICH
IS THIS TABLE.
THIS IS ALSO UNCHANGED.
IN TERMS OF THE RECOMMENDED
SCHEDULE AND DOSAGE INTERVALS,
THIS PART OF THE TABLE IS
UNCHANGED.
AND HERE I'VE HIGHLIGHTED IN RED
THE CHANGES.
SO, FIRST, JUST A CHANGE IN THE
WORDING THAT DESCRIBES THE 24 TO
71-MONTH-OLDS.
IT ACTUALLY REFERS BACK TO THE
TABLE SHOWN EARLIER, WHICH I'LL
SHOW YOU HERE.
IT'S CALLED TABLE TWO IN THIS
PRESENTATION, BUT IT'S ACTUALLY
TABLE ONE IN THE VFC RESOLUTION.
WE HAD PREVIOUSLY DESCRIBED
THOSE CHILDREN.
HERE WE REFER TO THE TABLE.
SO, IT CAN BE COMPLETE.
AND THEN THE ADDITION OF THE 6
TO 18-YEAR-OLD GROUP OF CHILDREN
WHO ARE AT INCREASED RISK FOR
INVASIVE PNEUMOCOCCAL DISEASE AS
DEFINED IN FOOTNOTE FOUR, WHO
ARE NOT PREVIOUSLY VACCINATED
WITH PCV13 AND ARE RECOMMENDED
TO RECEIVE ONE DOSE.
THESE ARE THE TABLE FOOTNOTES.
FOOTNOTES ONE THROUGH THREE ARE
UNCHANGED, AND FOOTNOTE FOUR HAS
BEEN ADDED.
INCLUDES CHILDREN WITH ANATOMIC
OR FUNCTIONAL ASPLENIA,
INCLUDING SICKLE CELL DISEASE,
HIV INFECTION OR OTHER INI
MUNOCOMPROMISING CONDITION,
COCHLEAR IMPLANTS OR CEREBRAL
SPINAL FLUID LEAK. LANGUAGE ABO
SUPPLEMENTAL DOSE IS UNCHANGED.
THAT'S STILL IN EFFECT AS
CHILDREN AGE OUT OF THE NEED FOR
THAT SUPPLEMENTAL DOSE.
THERE IS NO CHANGE TO THE
RECOMMENDED DOSAGE WORDING,
THOUGH THE CONTRAINDICATIONS AND
PRECAUTIONS HAS BEEN UPDATED
WITH A LINK TO THE PUBLISHED
RECOMMENDATIONS.
AND THEN, FINALLY, THE STATEMENT
REGARDING AN UPDATE BASED ON
PUBLIC DOCUMENTS IF
RECOMMENDATIONS ARE PUBLISHED
FOLLOWING THIS, ALL BUT THE
ELIGIBLE GROUP SECTION CAN BE
REPLACED WITH THE LANGUAGE
THAT'S DIRECTLY IN THE
RECOMMENDATIONS.
>> THANK YOU.
IS THERE DISCUSSION?
OR QUESTIONS?
>> MOVE TO APPROVE ACCEPTING THE
RESOLUTION AS PRESENTED.
>> SECOND.
>> SECOND BY DR. COYNE-BEASLEY.
SO, WE HAVE A MOTION SECOND FOR
THE DISCUSSION.
SEEING NONE, WHY DON'T WE START
WITH MS. ROSENBAUM AND GO
COUNTERCLOCKWISE?
>> ROSENBAUM, YES.
>> VAZQUEZ, YES.
>> COYNE-BEASLEY, YES.
>> DUCHIN, YES.
>> HARRISON, YES.
>> HARRIMAN, YES.
>> OKIM, YES.
>> KARRON, YES.
>> JENKINS, YES.
>> CAMPOS-OUTCALT, YES.
>> KEITEL, YES.
>> TEMTE, YES.
>> BENNETT, YES.
>> RUBIN, YES.
>> SAWYER, YES.
>> AND THE MOTION FOR THE VFC
RESOLUTION IS PASSED
UNANIMOUSLY.
AND I BELIEVE THIS CONCLUDES THE
SESSION.
AGAIN, I WOULD LIKE TO JUST
AGAIN COMPLIMENT THE WORK GROUP
ON A VERY CLEAR, VERY
UNDERSTANDABLE, VERY NICELY
PRESENTED DISCUSSION HERE.
THIS MAKES OUR WORK I THINK MUCH
EASIER, AND IT ALSO PROVIDES
THAT TRANSPARENCY THAT WE ASPIRE
TO, SO THANK YOU VERY MUCH FOR
THAT.