June 2013 ACIP Meeting — Opening Remarks

June 2013 ACIP Meeting — Opening Remarks


>>WE MAY AS WELL GET STARTED.
I’D LIKE TO CALL THIS MEETING OF THE U.S. ADVISORY COMMITTEE OF
THE IMMUNIZATION PRACTICES INTO SESSION.
DR. PICKERING.>>YES.
THANK YOU, JON. WELCOME TO THE JUNE 2013 ACIP
MEETING. THE PROCEEDINGS OF THIS MEETING
WILL BE ACCESSIBLE TO PEOPLE NOT IN ATTENDANCE BY THE WORLDWIDE
WEB. WELCOME TO ALL OF THOSE WHO CAN
ATTEND. AS YOU CAN SEE BY THE LOVELY
HYDRANGEAS HERE, ATLANTA IS BEAUTIFUL THIS TIME OF YEAR SO
PEOPLE WHO ARE NOT HERE, UNFORTUNATELY, WILL NOT BE ABLE
TO SEE THE BEAUTY. BUT WE’LL SHARE A LITTLE BIT
WITH YOU DURING THE COURSE OF THE MEETING.
SEVERAL PEOPLE WILL BE WITH US FOR THE DURATION OF THE MEETING
TO HELP IN ANY WAY THAT WE CAN. FELICIA BETTENCOURT WILL BE AT
THE REAR OF THE ROOM AT THE BACK TABLE, AS WILL REID WALTON AND
NATALIE GREEN. IF ANYONE NEEDS HELP WITH
ANYTHING, PLEASE LET THEM KNOW OR JEAN, JON OR I KNOW.
WE WILL ADJOURN APPROXIMATELY 5:30 TODAY, APPROXIMATELY 3:15
TOMORROW. COFFEE AND BREAKFAST ITEMS WILL
BE OUT IN THE HALL, AS WILL LUNCH FOR BOTH DAYS.
HANDOUTS OF ALL THE SLIDES HAVE BEEN GIVEN TO ALL OF THE ACIP
MEMBERS AND ARE ON THE TABLE OUTSIDE OF THE ROOM IF ANYONE
WOULD LIKE TO GET THEM. WE HAVE THREE THINGS THAT ARE
PLACED ON THE ACIP WEBSITE AFTER EACH MEETING.
THE SLIDES THAT ARE SHOWN WILL ALL BE PLACED THERE.
WE TRY TO GET THEM UP WITHIN TWO WEEKS.
LIVE WEBCAST WILL BE POSTED ABOUT FOUR WEEKS.
OF COURSE THE MINUTES GO UP ABOUT 90 DAYS AFTER THE MEETING.
THOSE GO THROUGH A LOT OF READING AND EDITING BEFORE
THEY’RE POSTED. MEMBERS OF THE PRESS WHO ARE
INTERESTED IN CONDUCTING INTERVIEWS WITH ACIP MEMBERS
SHOULD SEE JEMELIA HOWARD-JONES IN ASSISTANCE WITH RANKING
INTERVIEWS. SHE’S RIGHT OVER HERE.
SHE’S TAKING TOM SKINNER’S PLACE, AND WELCOME.
>>>AT THIS TIME WE WANT TO THANK THREE ACIP VOTING MEMBERS
FOR WHOM THIS WILL BE THEIR LAST MEETING.
WENDY KYLE, MARK SAWYER AND SARA ROSENBAUM WILL BE ROTATING OFF
THE COMMITTEE. SARA IS NOT HERE TODAY.
HER LAST MEETING WAS IN FEBRUARY.
WE WILL REMEMBER HER ANYHOW. WE WANT TO TAKE A MOMENT TO
RECOGNIZE PARTICULARLY DR. KYLE AND DR. SAWYER FOR THEIR
INCREDIBLE CONTRIBUTIONS TO THE ACIP OVER FOUR YEARS.
YOU WERE HERE DURING A REAL TRANSFORMATIONAL TIME AT ACIP.
IT IS A TIME WE WENT THROUGH ESTABLISHING A GRADE PROCESS,
WHICH WAS VERY INTERESTING, AS YOU KNOW.
I PERSONALLY WANT TO THANK EACH OF YOU FOR YOUR TIME AND
COMMITMENT AND THE WAY THAT YOU HAVE THE ABILITY TO MAKE YOUR
THOUGHTS KNOWN IN A WAY THAT RESPECTFUL OF EVERYONE IN THE
ROOM.>>NO CONFLICT.
>>NO CONFLICT.>>NO CONFLICT.
>>NO CONFLICT.>>WE RECEIVED CLINICAL TRIAL
FUNDING –>>NO CONFLICT.
>>SAWYER, NO CONFLICT.>>NO CONFLICT.
>>NO CONFLICT.>>TEMTE, NO CONFLICT.
>>COULD I HAVE THE NEXT SLIDE, PLEASE?
STARTING OUT WITH DR. WENDY KYTEL, WENDY COUPLES WISDOM,
KNOWLEDGE AND PASSION AND HAS JUST BEEN A JUST RESOURCE FOR
ACIP. ON THE SLIDES, THE NUMBER OF
ACIP RELATED PUBLICATIONS ARE LISTED HERE.
PROFESSOR AT BAYLOR COLLEGE OF MEDICINE, HER INTERESTS INCLUDE
DEVELOPMENT AND EVALUATION WITH EMPHASIS ON PREVENTION FOR
INFECTION. SHE HAS BEEN INVOLVED IN
CLINICAL AND CLINICAL DEVELOPMENT.
IN RECENT ACTIVITIES THAT FOCUS ON IMPROVED INACTIVATED
INFLUENZA VACCINE OR VIRUS VACCINES, INCLUDING H1N1 AND
CANDIDATE VACCINES FOR H7, H9. SHE’S ALSO EXPLORING
IMMUNIZATION IN PREGNANT WOMEN TO PROTECT BOTH THE MOTHER AND
INFANT FROM INFLUENZA. THINGS THAT YOU SHOULD KNOW
ABOUT WENDY, SHE IS AN AVID HERDER.
SHE’S A GENEROUS DONOR TO THE HOUSTON AREA AUTOBAHN SOCIETY.
BUT GETTING BACK TO THE POINT ON HER EXPLORING IMMUNIZATION
PREGNANT WOMEN, IF YOU LOOK AT HER CV AND PUBLICATIONS, YOU
COME ACROSS INTERESTING THINGS LIKE THIS.
PRENATAL TRANSFER OF MATERNAL IMMUNITY IN ASIAN ELEPHANTS.
IT ALSO — AN INTERESTING ARTICLE, PROSPECTUS ON HUMAN BIO
ETHICS. WENDY BRINGS A WEALTH OF
BACKGROUND OF KNOWLEDGE AND INTEGRATES VERY BEAUTIFULLY INTO
OUR VACCINE POLICY HERE. SO THANK YOU VERY MUCH, DOCTOR.
YOU HAVE THE OPTION FOR REBUTTAL HERE.
>>THANK YOU, BOTH, FOR YOUR VERY KIND REMARKS.
THERE WAS A LITTLE HOOK IN THERE ON ELEPHANTS.
THE WAY WE GOT INVOLVED WAS THAT I WAS CALLED BY THE HOUSTON ZOO
AN THEY SAID WE WERE TOLD YOU CAN MAKE A VACCINE FOR ELEPHANT
HERPES VIRUS. SO WHAT I REALIZED WAS THEY KNEW
ABSOLUTELY NOTHING ABOUT WHAT WAS GOING ON WITH THE ELEPHANTS
AND CERTAINLY VACCINE LONG WAY THE ROAD BEFORE THEY FOUND A LOT
OF THINGS OUT. ONE OF THE FIRST THINGS I
SUGGESTED WAS THAT THEY GAIN SOME UNDERSTANDING OF THE LOSS
OF ACTIVE IMMUNITY BECAUSE OF THE AGE AT WHICH THE ELEPHANTS
START DYING OF THIS LETHAL INFECTION THAT ACTUALLY
THREATENS THE WORLDWIDE POPULATION OF ELEPHANTS.
SO IT’S BEEN VERY INTERESTING, AS HAS ALL OF MY OTHER WORK,
PARTICULARLY HERE AT THE ACIP. AND I THINK YOU ALL VERY MUCH
FOR HAVING HAD THE OPPORTUNITY.>>NEXT SLIDE, PLEASE.
>>DR. ROSENBAUM IS NOT HERE TODAY.
HER LAST MEETING IN FEBRUARY WAS HER LAST MEETING.
BUT I’M SURE SHE’S HERE IN SPIRIT.
SHE IS THE PROFESSOR OF HEALTH LAW AND POLICY AND THE FOUNDING
CHAIR OF THE DEPARTMENT OF HEALTH POLICY AT GEORGE
WASHINGTON UNIVERSITY SCHOOL FOR PUBLIC HEALTH AND HEALTH
SCIENCES. SHE’S REALLY DEVOTED HER ENTIRE
PROFESSIONAL CAREER TO ISSUES OF HEALTH JUSTICE FOR POPULATIONS
WHO ARE MEDICALLY UNDER SERVED AS A RESULT OF RACE, POVERTY,
DISABILITY OR CULTURAL EXCLUSION.
SHE HAS PROVIDED HER SERVICE TO SIX PRESIDENTIAL
ADMINISTRATIONS, 15 CONGRESSES SINCE 1977.
BEST KNOWN FOR HER WORK ON MEDICAID, THE EXPANSION OF
COMMUNITY HEALTH CENTERS, PATIENTS’ RIGHTS AND MANAGED
CARE, CIVIL RIGHTS AND HEALTH CARE AND NATIONAL HEALTH REFORM.
WHAT YOU MAY NOT KNOW IS BETWEEN 1993 AND ’94, SARA WORKED FOR
PRESIDENT CLINTON DIRECTING THE DRAFTING OF THE HEALTH SECURITY
ACT AND DESIGNED THE VACCINE FOR CHILDREN’S PROGRAM, WHICH AS WE
ALL KNOW NOW, OFFERS NEAR UNIVERSAL COVERAGE OF VACCINES
FOR LOW-INCOME AND MEDICALLY UNDER SERVED CHILDREN.
UP ON THE SLIDE, SHE’S BEEN A MEMBER IN THE SMALLPOX VACCINE
WORKING GROUP, THE HERPES WORKING GROUP AND IN THE
EVIDENCE-BASED RECOMMENDATION WORKING GROUP.
AS YOU KNOW, SARA HAS BEEN A TIRELESS MEMBER WHO HAS HAD
ENORMOUS VOLUMES OF WISDOM AND KNOWLEDGE REGARDING THE
POLICY AND ESPECIALLY WITH THE AFFORDABLE CARE ACT.
SOME OF THE INTERESTING THINGS IN TERMS OF HER VERY, VERY LONG
LIST OF PUBLICATIONS, HEALTH POLICY IN THE AFTERMATH OF
HURRICANE KATRINA, VACCINATING HEALTH CARE WORK FORCE, STATE
LAW VERSUS INSTITUTIONAL REQUIREMENTS AND MATERNAL CARE
AND LIABILITY. SARA’S GOING TO BE GREATLY
MISSED HERE, AS THE CONSUMER REPRESENTATIVES ON ACIP.
>>NEXT SLIDE. DR. MARC, YOU SHOULD ALWAYS BE
CAREFUL WHAT YOU PUT ON THE INTERSET.
CHAIR OF THE HEPATITIS WORK GROUP, CHAIR OF THE VIRUS
RECOMMENDATIONS AND MMRV. SEVERAL PUBLICATIONS EMERGE FROM
HIS WORK ON ACIP. MARC IS PROFESSOR OF CLINICAL
PEDIATRICS AND PEDIATRIC INFECTIOUS DISEASE AT THE
UNIVERSITY OF CALIFORNIA SAN DIEGO SCHOOL OF MEDICINE AND AT
CHILDREN’S HOSPITAL. HE’S ALSO MEDICAL DIRECTOR OF
THE SAN DIEGO IMMUNIZATION PARTNERSHIP, A PARTNERSHIP
BETWEEN UNIVERSITY OF CALIFORNIA, SAN DIEGO AND SAN
DIEGO COUNTY FOR HEALTH AND HUMAN SERVICES.
THEY EXIST FOR THE PURPOSE OF IMPROVING IMMUNIZATION DELIVERY
IN SAN DIEGO. HE IS AN ACTIVELY STRONG VOICE
FOR PRO IMMUNIZATION POLICIES AND ALWAYS ON THE LOOKOUT FOR
CROSS EFFECTIVE WAYS TO PROTECT PUBLIC HEALTH.
MARC HAS SOME INTERESTING QUOTES HERE.
WHEN ASKED WHY HE WENT INTO PEDIATRICS, “THE REASON I WENT
INTO PEDIATRICS IS THAT SICK ADULTS ARE OBNOXIOUS.”
AND THINGS THAT YOU MAY NOT KNOW ABOUT MARC IS HE IS AN AVID CHEL
LIST. HERE IS A QUOTE, “I PLAY CELLO
IN A COMMUNITY ORCHESTRA. I WAS NEVER A PROFESSIONAL BUT I
PLAY IN A BUNCH OF CHAMBER GROUPS.
AND JUST TO SHOW HOW LONG YOU CAN STAND MU SIS WITH BEING IN
ONE OF MY QUARTETS I’M THE YOUNGEST BY 25 YEARS.
WE GET TOGETHER IN THE AFTERNOON BECAUSE THE THREE OTHERS CAN’T
STAY UP TOO LATE AT NIGHT. ONE OF THE INTERESTING
PUBLICATIONS I CAME ACROSS, MISSED OPPORTUNITIES TO
IMMUNIZE. DESPITE THE COMIC HE MADE ABOUT
SICK ADULTS, THIS KIND OF MAKES HIM SOUND LIKE A FAMILY DOC.
I’M GOING TO CHECK AND SEE IF WE CAN MAKE HIM A MEMBER.
WE HAVE APPRECIATED YOUR APPROACH HERE.
MARC ALWAYS KNOWS WHEN YOU’RE WRONG BUT HE NEVER TELLS YOU.
HE JUST VERY CAREFULLY AND CAUTIOUSLY AND WITH KINDNESS
COAXES YOU INTO THE RIGHT DIRECTION.
SO WE APPRECIATE HIS EFFORTS HERE.
MARC HAS HAD ACTUALLY A FIVE-YEAR RUN HERE ON ACIP AND
WE APPRECIATE YOUR SERVICE.>>WELL, THANK ONE JON, FOR
THOSE KIND AND INTERESTING REMARKS THAT YOU FOUND ON THE
INTERNET. I WOULD JUST LIKE TO REITERATE
WENDY’S COMMENTS AND THOSE OF MANY MIGHT HAVE PREDECESSORS AS
THEY’VE LEFT THIS COMMITTEE AND HIGHLIGHT WHAT A PRIVILEGE IT’S
BEEN TO BE PART OF THIS ROBUST SYSTEM THAT WE HAVE IN PLACE TO
MAKE SURE THAT ONLY THE BEST RECOMMENDATIONS ON IMMUNIZATION
COME FORWARD FROM CDC. IT’S BEEN GREAT TO MEET SO MANY
WONDERFUL PEOPLE ON THE COMMITTEE, AMONG THE LIAISONS,
ON THE WORK GROUPS. BUT MOST IMPORTANTLY I WOULD
LIKE TO ACKNOWLEDGE AND PERSONALLY THANK THE CDC STAFF
WHO HAVE SUPPORTED THE WORK GROUPS I’VE BEEN ON AND THIS
COMMITTEE. WITHOUT THEM WE REALLY COULDN’T
DO THE WORK THAT WE DO SO I’D LIKE TO THANK THEM.
THANK YOU.>>NEXT SLIDE, PLEASE.
>>I’LL MAKE A FEW MORE COMMENTS.
WE HAVE ONE OTHER DISTINGUISHED GUEST THAT WE’D LIKE TO
INTRODUCE. DR. LILI, DIRECTOR OF THE CHINA
CDC NATIONAL IMMUNIZATION PROGRAM WITH THE HELP OF FORMER
DIRECTOR OF CDC’S IMMUNIZATION SERVICES, DR. LILI IS HERE TO
LEARN MORE ABOUT THE U.S. IMMUNIZATION PROGRAM, ESPECIALLY
HOW ACIP WORKS TO MAKE EVIDENCE BASED RECOMMENDATIONS.
DR. LI WILL BE IN ATLANTA FOR APPROXIMATELY SIX MONTHS, DURING
WHICH TIME HE WILL ROTATE THROUGH THE DIFFERENT DIVISIONS
OF WORK ON IMMUNIZATION, OBSERVING SOME OF THE ACIP WORK
GROUPS AND WORKING WITH THE ACIP SECRETARY TO SECURE A BETTER
UNDERSTANDING ON THE ACIP STRUCTURE AND FUNCTION.
SO WELCOME TO YOU. WE’RE EXCITED THAT YOU’RE HERE
FOR SIX MONTHS WHICH ARE GOING TO GO VERY QUICKLY.
IF ANYONE WOULD LIKE TO MEET WITH THE DOCTOR, HE’LL BE AROUND
THE REST OF THE MEETING. SO GOOD TO HAVE YOU HERE.
WE USUALLY HAVE, AS PEOPLE WHO COME REGULARLY TO THIS MEETING,
DELEGATES FOR THE PAN AMERICAN HEALTH ORGANIZATION ATTENDING
EACH MEETING, BUT A GROUP WILL NOT BE JOINING US THIS MEETING.
WE WILL HOST THE NEXT DELEGATION IN THE OCTOBER ACIP MEETING.
WE’VE HAD — WE DO, HOWEVER, HAVE SIMULTANEOUS TRANSLATION
SERVICES AVAILABLE FOR SPANISH SPEAKING GUESTS.
PLEASE INQUIRE WITH OUR ACIP STAFF AT THE BACK OF THE ROOM IF
ANYONE IS INTERESTED IN ACQUIRING THE SPANISH
TRANSLATION OR IF YOU WANT TO PRACTICE YOUR SPANISH A BIT,
THIS IS A GOOD WAY TO DO IT. WE WANT TO TAKE A MOMENT TO
PROVIDE SOME INFORMATION FOR OUR INTERNATIONAL VISITORS TO THE
ACIP MEETING. THIS IS VERY IMPORTANT.
DUE TO THE CHANGES IN THE DEPARTMENT OF HOMELAND SECURITY
POLICY, ADDITIONAL FORMS HAVE BEEN AND WILL BE REQUIRED FOR
EACH MEETING AT THE TIME AN INTERNATIONAL GUEST REGISTERS TO
COME TO THE ACIP. SO WHEN OUR INTERNATIONAL GUESTS
REGISTER, THESE FORMS WILL BE PROVIDED.
IT IS CRITICAL THAT THEY BE COMPLETED AND SUBMITTED AS SOON
AS POSSIBLE FOLLOWING REGISTRATION.
UNLIKE IN THE PAST, WE WILL BE UNABLE TO MAKE ANY EXCEPTIONS
FOR LATE, MISSING OR UNPROSECESD DATA.
WE ARE NOT GOING TO BE ABLE TO DO THAT, UNFORTUNATELY, ANYMORE.
SO THESE REGISTRATIONS ARE TIMELY.
FLEE IS A BETANCOURT WILL BE ABLE TO HELP WITH ANY QUESTIONS
AND CONCERNS THAT ANYONE MAY HAVE ABOUT THE PROCESS.
THE NEXT ACIP MEETING WILL TAKE PLACE AT THE CDC IN OCTOBER,
23rd AND 24th. REGISTRATION OF ALL MEETING
ATTENDEES WILL BE REQUIRED. THE MEETING REGISTRATION FOR THE
OCTOBER MEETING WILL BE OPEN AFTER THIS ACIP MEETING WHICH IS
A GOOD TIME TO REGISTER FOR IT AND GET IT OVER WITH.
WE’RE GOING TO CLOSE THE INTERNATIONAL REGISTRATION A
WEEK EARLY. SO SEPTEMBER 30th IT WILL CLOSE.
SO PLEASE, OUR INTERNATIONAL ATTENDEES, GET REGISTERED AS
SOON AS POSSIBLE. AND FRIDAY WOULD BE A PERFECT
DAY TO DO IT. WITH US TODAY IS DIRECTOR —
ANOTHER SPECIAL DISTINGUISHED GUEST, DIRECTOR GENERAL OF
MEXICO’S NATIONAL CENTER FOR CHILD AND ADOLESCENT HEALTH.
DR. RUIZ. SERVING TO THE MINISTER OF
HEALTH IN MEXICO AND WE LOOK FORWARD TO WORKING WITH YOU AND
WELCOME. AND HAS BEEN REQUESTED BY OTHER
OTHER INTERNATIONAL VISITORS, SPANISH SPEAKING VISITORS, WE
WILL TRY TO SPEAK SLOWLY, WHICH IS VERY DIFFICULT FOR MANY OF
US. WE WANT TO THANK DR. RICHARDSON
WHO SERVED IN THIS POSITION FOR A LONG PERIOD OF TIME.
HE LEFT THE NATIONAL MINISTRY OF HEALTH TO LEAD THE MINISTRY OF
HEALTH FOR MEXICO AND WE WISH HER THE BEST OF LUCK IN HIS
POSITION. DR. BREWER IS TAKING TIME OFF TO
WELCOME A NEW BABY. KATY HAS ASSURED US THE BABY
WILL BE FULLY IMMUNIZED. AND I’M SURE BREASTFED.
SANDY FRYHOFFER SERVES AS LIAISON TO THE AMERICAN COLLEGE
OF PHYSICIAN IN PLACE OF DR. GREG FULLER.
SANDY, ONLY YOU CAN DO DOUBLE DUTY FOR GREG.
DR. MARTIN FOR THE ASSOCIATION OF STATE AND TERRITORIAL HEALTH
OFFICIALS IS HERE TO REPRESENT THE ORGANIZATION IN PLACE OF
JOSE MONTERA. WE WILL NOT HAVE REPRESENTATIVES
FROM THE ASSOCIATION OF PREVENTION, TEACHING AN RESEARCH
OR FROM THE NATIONAL MEDICAL ASSOCIATI
ASSOCIATION. WE REQUESTED ALL CELL PHONES BE
TURNED OFF. TOPICS PRESENTED AT ACIP
MEETINGS INCLUDE OPEN DISCUSSIONS WITH TIME RESERVED
FOR PUBLIC COMMENTS. TIME FOR PUBLIC COMMENTS
PERTAINING TO TOPICS ON THE AGENDA HAS BEEN SCHEDULED AT THE
END OF EACH DAY. SO PLEASE SIGN UP AT THE DESK AT
THE BACK. IF THERE ARE ANY QUESTIONS,
FELICIA WILL BE HAPPY TO TRY TO ANSWER THEM.
WE ASK THAT PEOPLE WHO MAKE PUBLIC COMMENTS GIVE THREE
PIECES OF INFORMATION. ONE IS THEIR NAME, ORGANIZATION,
IF APPROPRIATE, AND ANY CONFLICTS OF INTEREST.
WE’RE ALMOST DONE. SUMMARIZED CONFLICTS OF
INTERESTS PROVISIONS APPLICABLE TO ACIP IS NOTED IN THE ACIP
POLICIES 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, CDC HAS ISSUED
LIMITED CONFLICT OF INTEREST WAIVERS.
MEMBERS WHO EXACT VACCINE CLINICAL TRIALS OR SERVE ON DATA
SAFETY MONITORING BOARDS MAY PRESENT TO THE COMMITTEE ON
MATTERS RELATED TO THOSE VACCINES.
HOWEVER, THEY ARE PROHIBITED FROM PARTICIPATING IN
DELIBERATIONS OR COMMITTEE VOTES ON ISSUES RELATED TO THESE
VACCINES. REGARDING OTHER VACCINES OF THE
AFFECTED COMPANIES, A MEMBER MAY PARTICIPATE IN DISCUSSIONS WITH
THE PROVISO THAT HE OR SHE ABSTAIN ON ALL VOTES RELATED TO
VACCINES OF THAT COMPANY. INSTRUCTIONS FOR SUBMISSION OF
NAMES FOR POTENTIAL CANDIDATES ARE ON THE SL ON THE
SCREEN. PEOPLE THAT WANT TO SERVE AS
ACIP MEMBERS, MEMBERSHIP DEADLINE IS NOVEMBER.
NO LATER THAN NOVEMBER 15th OF THIS YEAR FOR THE FULL-YEAR TERM
BEGINNING IN JULY. SO IF YOU WOULD LIKE TO BECOME
AN ACIP MEMBER OR KNOW PEOPLE WHO YOU THINK WOULD BE
INTERESTED, PLEASE LET THEM KNOW SO THE PROCESS CAN BE BEGUN.
ONE LAST COMMENT. AT EVERY MEETING WE PROVIDE AN
UPDATE ON THE STATUS OF ACIP RECOMMENDATIONS FOR THIS VERY
BUSY COMMITTEE, AS WE SAW FROM THE PUBLICATIONS THAT WERE
APPROVED THROUGH MARC AND WENDY AND SARA’S TENURE. A LISTING OF THESE ARE ON THE
SCREEN. LINKS CAN BE FOUND ON THE ACIP
WEBSITE. SINCE THE LAST MEETING THERE
HAVE BEEN PUBLICATIONS ON PREGNANT WOMEN PREVENTION AND
CONTROL OF INFLUENZA WITH VACCINES AND PREVEX OF MEASLES,
RUBELLA AND MUMPS. WITH THAT, DR. TEMTE, YOU’VE
ALREADY DONE ROLL CALL AND CONFLICTS OF INTEREST AND YOU
UNDERSTAND YOU HAVE A SPECIAL PRESENTATION.
>>JUST A FEW QUICK COMMENTS HERE.
NEXT SLIDE. TALKING ON IMPLEMENTATION OF
GRADE OF VACCINATIONS. I BELIEVE YOU CAN SEE DR. LILI
IN THE FRONT ROW TAKING COPIOUS NOTES BUT THE PRESENTATION WAS
ENTHUSIASTICALLY RECEIVED AND CHINA IS WELL AND AWAY INTO
INCORPORATING GRADE INTO VACCINE RECOMMENDATIONS STARTING OUT
WITH A NEW RECOMMENDATION ANOTHER VACCINE.
AGAIN, IF YOU RECOGNIZE THE DOCTOR IN THE FRONT ROW THERE,
DR. LILI IN THE MIDDLE OF THE BACK ROW AND OTHER MEMBERS OF
THE IMMUNIZATION PROGRAM OF CHINA.
BUT JUST A WONDERFUL EXCHANGE THAT WE HAD AND ENTHUSIASTIC
RECEPTION IN THAT COUNTRY. NEXT SLIDE.
THERE ARE SOME NOTABLE ANNIVERSARIES FOR ALL OF US TO
BE AWARE OF. AS I MENTIONED WITH SARA
ROSENBAUM, WE ARE NOW IN THE 20 YEARS OF THE VACCINE FOR
CHILDREN PROGRAM. IT WAS CREATED BY THE OMNIBUS
BUDGET RECONCILIATION OF 1993 AND HAS BEEN OPERATING EVER
SINCE. NATIONAL VACCINE ADVISORY
COMMITTEE CAME IN TO PLAY 25 YEARS AGO.
DR. ORNSTEIN CANNOT BE HERE TODAY BUT HE IS NOW CHAIR AND
WAS PRESENT AT THE VERY FIRST MEETING 25 YEARS AGO ON JUNE
8th, 1988. 50 YEARS AGO THE 317 PROGRAM
CAME INTO PLAY UNDER THE IMMUNIZATION ASSISTANCE ACT,
PASSED IN 1962 AND IMPLEMENTED IN ’63.
THIS WAS A MEANS FOR THE FEDERAL GOVERNMENT TO BEGIN TO PROVIDE
SOME SUPPORT TO STATE AND COMMUNITY LEVEL IMMUNIZATION
PROGRAMS. NEXT SLIDE.
AS LARRY HAD MENTIONED, WE HAVE JUST PUBLISH JUNE 14th THE
UPDATED PREVENTION OF MEASLED, R,
CONGENITAL RUBELLA AND MUMPS. BUT OF NOTE IS A COUPLE
ANNIVERSARIES. NEXT SLIDE, PLEASE.
THIS IS THE 50th ANNIVERSARY OF THE MUMPS VACCINE ç CULTURE.
DR. HILLMAN FIRST COLLECTED MUMPS VIRUS FROM HIS DAUGHTER IN
A CLEAR VIOLATION OF HIPAA REGULATIONS, HE NAMED THE STRAIN
AFTER HIS DAUGHTER AND THIS IS THE STRAIN THAT CONTINUES TO BE
IN USE TODAY. YOU CAN SEE BY THE GRAPHIC ON
THE LOWER LEFT HAND CORNER, THE MARKED REDUCTION IN MUMPS IN
THIS COUNTRY. THEN FINALLY, NEXT SLIDE — THIS
IS THE 50th ANNIVERSARY OF THE MEASLES VACCINE.
LICENSED IN 1963, AND HAS PREVENTED AN INCREDIBLE NUMBER
OF ILLNESSES AND DEATHS WORLDWIDE.
WHEN I GOT STARTED WITH VACCINE ISSUES BACK IN 2000, WE WERE
STILL AT ABOUT A MILLION DEATHS A YEAR OF CHILDREN ACROSS THE
WORLD. THIS HAS DROPPED DOWN TO I
BELIEVE 158,000 LAST YEAR AND CONTINUES TO DECLINE.
SO JUST SO EVERYONE IS AWARE THAT THIS HAS BEEN AN IMPRESSIVE
IMPLEMENTATION OF WONDERFUL TECHNOLOGY THAT HAS BEEN JUST
LIFE SAVING ACROSS THE GLOBE. MANY THANKS TO EVERYBODY WHO HAS
BEEN INVOLVED WITH MEASLES VACCINE, DEVELOPMENT, MARKETING,
TESTING, AND DISTRIBUTION. WITH THAT, DR. PICKERING.
>>I JUST WOULD LIKE TO SAY ONE THING.
WE RING THIS BELL AS EVERY MEETING.
I WOULD JUST LIKE TO RECOGNIZE THE SAYING ON THIS BELL SAYS,
“MAY THE ACIP RECOMMENDATIONS ALWAYS RING CLEAR.”
THIS WAS DONATED BY DR. SAM KATZ IN OCTOBER OF 1993.
DR. KATZ WAS THE CO-DISCOVERER, OF COURSE, OF THE VACCINE WITH
DR. HILLMAN. SAM, IF YOU’RE LISTENING TO US,
YOU’RE STILL WITH US IN SPIRIT. THANK YOU FOR ALL THE WORK THAT
YOU’VE DONE. AND THE LAST THING BEFORE WE
START, IS I RECEIVED YESTERDAY SOMETHING THAT’S ABSOLUTELY
WONDERFUL. IT IS THE IMMUNIZATION RESOURCES
FOR OBSTETRICIANS AND GYNECOLOGISTS, A COMPREHENSIVE
TOOLKIT. LAURA RILEY, IF YOU WOULDN’T
MIND, JUST SAYING A FEW COMMENTS ABOUT THIS.
WE WILL PUT THE WEBSITE UP WHERE THIS CAN BE OBTAINED FOR PEOPLE
AND SO MANY OF US — AND I KNOW CAROL WILL BE EXTREMELY HAPPY
ABOUT THIS — HAS CONTINUED IMPORTANT IMMUNIZATION OF
PREGNANT WOMEN IS BEING STRESSED BY OB-GYN.
>>THANK YOU. THANKS FOR THE OPPORTUNITY.
THIS IS THE WEBSITE, IMMUNIZATIONFORWOMEN.ORG.
IT IS AVAILABLE TO ANYBODY AND EVERYBODY WHO NEEDS IT.
THE TOOLKIT THAT DR. PICKERING HAS SHOWN JUST CAME OUT THIS
MONTH. IT IS INCREDIBLY COMPREHENSIVE.
IT IS OUR EFFORT TO CONTINUE TO EDUCATE OBSTETRICIANS AND
GYNECOLOGISTS ABOUT WHAT NEEDS TO BE DONE BOTH IN PREGNANCY AS
WELL AS NON-PREGNANT ADULT WOMEN.
TRYING TO GET IMMUNIZATION IN TO STANDARD OB-GYN PRACTICE, AS
MANY OF YOU IN THIS ROOM KNOW, THAT’S AN UPHILL BATTLE, BUT I
THINK WE’RE SLOWLY BUT SURELY WINNING THE BATTLE.
AT LEAST WITH EDUCATION. AND SO THIS IS OUR HUGE EFFORT.
IF YOU GO ON TO THE FIRST PAGE OF THE WEBSITE, YOU’LL SEE THIS
TOOLKIT. ALL OF THE INFORMATION IN IT IS
AVAILABLE ONLINE. ONE OF THE MAJOR PIECES OF THE,
INFORMATION, IS IN ADDITION TO OUR COMMITTEE OPINIONS WHICH HAS
BEEN OUT THERE FOR A LONG TIME, THERE’S A NICE BOOK ON CODING
WHICH IS PARTICULARLY IMPORTANT FOR OB-GYNs AS THEY PUT IT INTO
THEIR PRACTICES. THERE’S LAMB NAYINATED CARDS, TS
TEAR-OFF SHEETS THAT CAN BE USED IN THE OFFICE.
SO IF YOU KNOW OF ANY OB-GYN PRACTICES OUT THERE STILL NOT
DOING WHAT NEEDS TO BE DONE, AT LEAST YOU COULD MENTION TO THEM
TO LOOK ON THEIR OWN WEBSITE AND LOOK UNDER IMMUNIZATI
IMMUNIZATIONFORWOMEN.ORG. JUST ONE LAST THING.
A LOT OF THE INFORMATION THAT’S ON THERE, WE HAVE INFORMATION ON
ALL VACCINES, BUT ONE OTHER ISSUE IS OBVIOUSLY THE
RECOMMENDATIONS THAT HAVE NOW COME OUT.
THEY’RE ON THE WEBSITE. IN ADDITION WE HAVE FREQUENTLY
ASKED QUESTIONS, TEAR-OFF PADS, WHICH WILL BE AVAILABLE AT THE
END OF JULY. SO THOSE WERE FAST-TRACKED SO
THE PHYSICIANS CAN PUT THEM IN THEIR OFFICES, PUT THEM OUT, LET
PATIENTS TEAR THEM OFF AND THEN ASK QUESTIONS ABOUT IT AND GET
THEIR VACCINES. THANK YOU TO EVERYBODY ON THE
ACOG IMMUNIZATION COMMITTEE THAT WORK VERY HARD TO PUT ALL OF
THIS INFORMATION TOGETHER. SO WE’RE STILL WORKING AT IT.
THANK YOU.>>THANK YOU, DOCTOR.
I’D LIKE TO MOVE ON WITH THE AGENCY UPDATES A.
>>THANKS. THE PUBLIC HEALTH COMMUNITY HERE
IN THE UNITED STATES AND AROUND THE WORLD ARE DEALING WITH
SEVERAL VACCINE PREVENTABLE DISEASED OUTBREAKS.
JUST WANT TO MENTION THREE. THERE’S THE LARGEST OUTBREAK OF
MEASLES IN THE UNITED STATES SINCE WE ELIMINATED INDIGENOUS
SPREAD IS OCCURRING NOW IN PART OF NEW YORK CITY.
THE HEALTH DEPARTMENT IS MANAGING THIS BUT IT IS
OCCURRING IN A RELIGIOUS COMMUNITY THAT DOESN’T VACCINATE
REGULARLY. THERE IS ALSO AN OUTBREAK OF
HEPATITIS A AFFECTING PEOPLE WHO LIVE IN WESTERN STATES.
IT’S BEEN LINKED TO A PRODUCT OF — A BLEND OF BERRIES AND
POMEGRANATE MIX THAT WAS DISTRIBUTED BY COSTCO AND THE
PUBLIC HEALTH FOLKS IN THE EIGHT STATES THAT HAVE RECEIVED THE
PRODUCT ARE MANAGING VACCINATION OF EXPOSED PEOPLE.
THE THIRD OUTBREAK IS PARTICULARLY UNFORTUNATE AND IS
AFFECTING THE HORN OF AFRICA WITH A RESURGENCE OF POLIO IN
SOMALIA AND REFUGEE CAMPS IN KENYA.
SO LARGE-SCALE VACCINATION IS HAPPENING THERE.
WE STILL ARE CLOSER THAN EVER TO POLIO ERADICATION.
THIS IS A SETBACK, BUT IT IS BEING AGGRESSIVELY RESPONDED TO.
ON A MORE POSITIVE NOTE, I WANT TO ANNOUNCE THAT THE I.T. SYSTEM
FOR ORDERING VACCINES THROUGH THE VACCINES FOR CHILDREN
PROGRAM OR 317 PROGRAM, WHICH WE CALL VTRX, HAS BEEN SUCCESSFULLY
ROLLED OUT TO ALL OF THE STATE AND VERY GRANTEES AS OF MAY
2013, 73% OF PROVIDERS IN THE COUNTRY ARE ON THE SYSTEM NOW,
EITHER DIRECTLY OR THROUGH THEIR REGISTRIES INTERACTING WITH THE
VTRACK SYSTEM AT THE STATE DEPARTMENT.
OUR TARGET IS TO GET 85% OF HIS YEAR AND WE SEEM SYSTEM BY
TO BE WELL ON THE WAY TO DOING THAT.
THIS HAS BEEN A MULTI-YEAR EFFORT WITH HUGE COLLABORATION
BETWEEN STATE AND LOCAL PUBLIC HEALTH AND I.T. EXPERTS HERE IN
ATLANTA. I WANT TO THANK EVERYBODY WHO’S
GOTTEN THIS SO FAR.>>THANK YOU.
MOVING ON TO CMS.>>HI.
THANK YOU FOR THE OPPORTUNITY TO MAKE UPDATES.
WE ARE ACTIVE LY WORKING ON IMPLEMENTATION OF THE PROVISIONS
OF THE AFFORDABLE CARE ACT RELATED TO IMMUNIZATIONS.
THREE PRIMARY PROVISIONS ARE THE PRIMARY CARE PAYMENT INCREASE
WHICH IS ALSO KNOWN AS SECTION 1202.
EVERY STATE WITH THE EXCEPTION OF ALASKA, WHICH ALREADY PAYS AT
THE MEDICARE RATE, SUBMITTED AN APPLICATION BEFORE THE MARCH
31st DEADLINE AND WE’RE IN THE PRACTICE OF REVIEWING THOSE.
WE’RE CLOSE TO APPROVING 40 OF THEM AND THE LAST GROUP WE’RE
WORKING HARD TO GET APPROVED AS QUICKLY AS POSSIBLE.
THAT MEANS THAT PROVIDERS WILL SOON BE ABLE TO RECEIVE THAT
INCREASE IN PAYMENT FOR ALL PRIMARY CARE SERVICES, AS WELL
AS FOR THE VACCINE ADMINISTRATION IF STATES CHOOSE
TO COVER ALL ADS SERVICES, AS WELL AS ALL ACIP RECOMMENDED
VACCINES IN THEIR ADMINISTRATION FOR ADULTS, CURRENTLY THOSE
SERVICES ARE OPTIONAL SERVICES. IF STATES CHOOSE TO COVER ALL
THOSE SERVICES AND HAVE NO COST SHARING THEY CAN RECEIVE AN
ADDITIONAL 1% OF FEDERAL FUND FOR THOSE SERVICES.
WE HAVE FOUR STATES THAT HAVE SUBMITTED APPLICATIONS AND WE
HAVE APPROVED ONE OF THOSE. AN WE’RE HOPING THAT AS TIME
GOES BY WE’LL RECEIVE APPLICATIONS FROM ANY OTHER
STATES. WE’RE ALSO HOPEFULLY VERY CLOSE
TO PUBLISHING THE FINAL RULE THAT WILL DEFINE THE BENEFIT
PACKAGE FOR THE MEDICAID EXPANSION POPULATION THAT WILL
GO INTO EFFECT ON JANUARY 1st. THAT WILL INCLUDE EMPHASIS ON
PREVENTION. THERE WILL BE MUCH MORE
INFORMATION ON THAT COMING OUT VERY SOON.
>>THANK YOU. DEPARTMENT OF DEFENSE?
>>THANK YOU. DOD HAS NO NEW UPDATES TODAY BUT
ON BEOF HALF OF DOD I WOULD LIKE TO THANK CDC AND ACIP FOR THEIR
ONGOING GREAT COLLABORATIVE COMMUNICATION WITH DOD AS FAR AS
IMMUNE DAYS PROGRAMS AS WE CONTINUALLY REASSESS OUR
PROGRAMS TO ENSURE THEY ARE CLOSELY ALIGNED WITH THAT OF CDC
AND ACIP. AN EXAMPLE WOULD BE DOD’S RECENT
GUIDANCE UPDATE IN PUBLICATION BY THE OFFICE OF ASSISTED
SECRETARY ON THE ENCEPHALITIS VACCINE THIS MONTH.
THANK YOU.>>GOOD MORNING.
I’D LIKE TO JUST MENTION SEVERAL THINGS THAT WE’RE DOING IN
COLLABORATION WITH OUR FEDERAL PARTNERS AROUND ELECTRONIC
HEALTH RECORDS AND IMMUNIZATIONS.
WE’RE CONTINUING TO WORK WITH PARTNERS IN THE DOD TO DEVELOP A
JOINT IMMUNE DAYS MODULE FOR OUR ELECTRONIC HEALTH RECORDS THAT
WORK AS ONGOING. IT WILL PROBABLY BE ONGOING FOR
A WHILE YET BUT IT WILL BE A WONDERFUL TOOL WHEN IT IS DONE.
AS A RESULT OF THE ADULT IMMUNIZATION MEETINGS LAST
MONTH, WE’VE DEVELOPED SOME — ARE STARTING TO DEVELOP SOME
RELATIONSHIPS TO WORK WITH THE CDC ON SEEING IF WE CAN FIND
WAYS FOR VA PROVIDERS TO HAVE ACCESS TO NON-VA IMMUNIZATION
REGISTRIES IN THE STATE. WE ARE TRYING TO SEE IF WE CAN
WORK THAT OUT. WE’RE ALSO WORKING CLOSELY WITH
THE INDIAN HEALTH SERVICE ON SHARING IDEAS ABOUT DECISION
SUPPORT TOOLS FOR OUR ELECTRONIC RECORDS.
LOTS OF GOOD WORK GOING ON AROUND ELECTRONIC HEALTH
RECORDS.>>THANK YOU.
DR. SUN FOR FDA.>>GOOD MORNING, EVERYBODY.
JUST A COUPLE OF NOTEWORTHY THINGS SINCE THE LAST MEETING.
AS FAR AS APPROVALS, SOMETHING YOU’LL HEAR MORE ABOUT LATER ON,
THE APPROVAL OF THE JAPANESE ENCEPHALITIS VACCINE, FOR THE
PEDIATRIC INDICATION FROM 2 MONTHS TO 17 YEARS OLD.
PRIOR TO THAT, THERE HAS BEEN NO — DUE TO THE EXPIRATION OF
JE-VC, THAT NO PEDIATRIC VACCINE LICENSE FOR THE PEDIATRIC
POPULATION. THIS FULFILLS THAT NEED.
THE OTHER NOTABLE APPROVAL SINCE LAST MEETING IS THE APPROVAL OF
QIV, A VACCINE THAT IS THE THIRD LICENSED QIV VACCINE IN THE
UNITED STATES. THIS ONE HAS AGE INDICATION FROM
6 MONTHS AND ABOVE. THEN LASTLY, AGAIN, SOMETHING
THAT WILL BE DISCUSSED TOMORROW, FDA CONDUCTED A POST MARKETING
STUDY OF A VACCINE IN THE PRISON STUDY.
THIS IS NOTABLE IN THAT THIS IS THE FIRST INSTANCE IN WHICH THE
AUTHORITY GIVEN TO FDA BY FDA AMENDMENT ACT OF 2007 WHICH AN
AGENCY CAN REQUIRE NEW SAFETY INFORMATION TO BE PLACED IN A
PACKAGE INSERT. THANK YOU.
>>THANK YOU. THE ADVISORY COMMISSION FOR
CHILDHOOD VACCINES MET TWO WEEKS AGO AND PRODUCED RECOMMENDATIONS
FOR THE SECRETARY, RECOMMENDATIONS OF INTEREST
WOULD BE EXTENDING THE STATUTE OF LIMITATIONS UP TO EIGHT YEARS
WITH NO OPT-OUT PERIOD DURING THAT EXTENDED PERIOD OF TIME.
THE ACCV ALSO RECOMMENDED THAT THE SECRETARY WORK TO EXPAND
COVERAGE UNDER TO INCLUDE VACCINES THAT ARE ROUTINELY
RECOMMENDED FOR CATEGORIES OTHER THAN CHILDREN SUCH AS PREGNANT
WOMEN AND ARE NOT SPECIFICALLY RECOMMENDED FOR ROUTINE
ADMINISTRATION TO CHILDREN. THE ACCV ALSO RECOMMENDED TO THE
SECRETARY THAT SHE SHOULD SUPPORT ELIGIBILITY TO PURSUE
COMPENSATION FOR INJURIES SUSTAINED BY A LIVE-BORN INFANT
WHOSE MOTHER RECEIVED A VACCINE WHILE THE INFANT IS IN UTERO.
IN ADDITION, WE’RE VERY CLOSE TO PUBLISHING OUR ROTA VIRUS TABLE.
WE RECEIVED A RECOMMENDATION FROM OMB SO IT DOESN’T NEED TO
GO THROUGH OMB CLEARANCE AND THAT SHOULD BE PUB LILISHED IN
NEXT FEW WEEKS.>>NIH LIKE MANY OTHER
ORGANIZATIONS IN THE GOVERNMENT IS PREPARING FOR H7N9 IF AND
WHEN THIS BECOMES AN EPIDEMIC. IN TERMS OF RESPONDING TO FUTURE
FLU EPIDEMICS, WE ARE ALSO WORKING HARD AT THIS PARTICULAR
MANUFACTURERS TECHNIQUES TO REDUCE OUR RELIANCE ON EGG-BASED
TECHNOLOGY. IN A PUBLIC-PRIVATE PARTNERSHIP,
R ROTAVIRUS.NOUNCED POSITIVE THAT’S A PARTNERSHIP OF NIH,
DBT, BIOTECHNICAL SOCIETY, STANFORD UNIVERSITY SCHOOL OF
MEDICINE, BILL AND MELINDA GATES FOUNDATION AND THE RESEARCH
COUNCIL OF NORWAY. THIS WILL INCREASE OUR VACCINE
SUPPLY FOR THAT PARTICULARLY IMPORTANT VACCINE IN THAT
COUNTRY. SMALL NOTE, THE NIAID
HAS ALSO ANNOUNCED THE A LEADERSHIP GROUP IN
ANTIMICROBIAL RESISTANCE. THAT WILL BE ME THE
FIRST TIME TODAY WHILE I’M HERE. THEY’LL BE MEETING AT NIH TO
START THAT PARTICULAR EFFORT. THANK YOU.
>>AND THANK YOU VERY MUCH.>>>I GUESS — DR. PICKERING,
ONE ITEM HERE. FOR THE RECORD, WE HAVE A QUORUM
FOR THIS MEETING OF 13 VOTING MEMBERS AND SEVEN EX-OFFICIO
NON-VOTING MEMBERS.>>THANK YOU JON.

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