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>>> THANK YOU, AND WELCOME TO THE ACIP MEETING.
WE'RE FORTUNATE THIS MORNING TO HAVE DR. TOM FRIEDEN, TO LEAD
OFF THE MEETING, PROVIDE OPENING REMARKS, AND WELCOME ALL OF OUR
AUDIENCE PARTICIPANTS, INCLUDING OUR KEY MEMBERS OF THE ACIP.
>> THANK YOU VERY MUCH, LARRY, AND THANK YOU TO ALL OF YOU.
WELCOME TO ACIP AND OUR THREE-YEAR MEMBERS AND YOU'D
HEAR MORE ABOUT THAT IN A BIT. I ALSO WANT TO WELCOME OUR
INTERNATIONAL VISITORS FROM JAPAN, CHINA AND THOSE WHO ARE
LISTENING IN ON LINES AND OTHER MEANS OF TRACKING WHAT WE'RE
DOING, AND I THINK ONE OF THE FUNDAMENTAL CONCEPTS OF ACIP
THE PRINCIPLES BY WHICH CDC OPERATES, TO BASE ALL DECISIONS
ON THE HIGHEST QUALITY DATA OPENLY AND OBJECTIVELY DERIVED.
THAT DOESN'T MEAN THEY'LL ALWAYS BE UNANIMITY OF OPINION ON WHAT
SHOULD BE DONE. IT ALWAYS MEANS IT WILL BE
TRANSPARENT ABOUT THE DECISION-MAKING PROCESS, ABOUT
THE DATA GOES INTO THAT DECISION-MAKING PROCESS AND
ABOUT THE THINKING THAT GOES INTO THE DECISION AND THE
DELIBERATIONS THAT WE HAVE, AND I THINK THE ACIP IS REALLY A
MODEL THIS. IN ORDER FOR PROGRESS TO BE MADE
WE NEED TO HAVE COLLABORATION BETWEEN THE PUBLIC SECTOR AND
THE PRIVATE SECTOR, AND WE NEED TO HAVE SAFE SPACE FOR THAT TO
HAPPEN, AND THE ACIP IS A SAFE SPACE FOR THAT COLLABORATION.
AND IF YOU THINK ABOUT THE VACCINE SCHEDULE, WHICH IS ONE
OF THE THINGS WE'LL BE DISCUSSING AND IN FACT VOTING ON
TODAY. DISCUSSING FOR ADULTS.
THAT VACCINE SCHEDULE IS A WAY THAT WE ARE LITERALLY AS ONE
COUNTRY ON THE SAME PAGE ON VACCINATION.
NOW, IT DOESN'T MEAN THAT THERE WON'T BE DEVIATIONS FROM THAT
SCHEDULE BY SOME CLINICIANS, SOME PARENTS FOR SOME REASONS,
BUT IT DOES MEAN THAT THERE'S A STANDARD THAT'S OPENLY AND
OBJECTIVELY DERIVED, AND I DO WANT TO SAY THAT WE ARE SO
DELIGHTED NOT ONLY THAT YOU ARE HERE, BUT WE'RE AT LEAST AS
DELIGHTED THAT WE ARE HERE. [ LAUGHTER ]
THE SHUTDOWN WAS VERY FRUSTRATING AND VERY
CHALLENGING, AND VERY ANXIETY-PROVOKING, BECAUSE WE
WERE NOT ABLE TO KEEP ALL OF OUR COMMITMENTS TO OUR PARTNERS IN
THIS COUNTRY AND AROUND THE WORLD.
WE WERE NOT ABLE TO MAINTAIN MOMENTUM ON SOME OF THE PROGRAMS
WE WERE SCALING UP, LIKE VACCINATION, NOT ABLE TO TRACK
DISEASES AS INTENSELY AS IN THE PAST, SUCH AS FLU, AND WE'RE
VERY GRATEFUL TO THE COMMISSIONED OFFICERS WHO PINCH
HIT AND DID SOME OF THE PREF PREFERATORY WORK, FROM PETTING
IN THE LABORATORY TO FEEDING ANIMALS.
THEY'RE PART OF THE UNIFORMED AND PUBLIC HEALTH SERVICE.
NOW, WE KNOW THAT VACCINES ARE ONE OF THE GREAT SUCCESS STORIES
OF THE PAST 100 YEARS, AND WE KNOW THAT THERE ARE ENORMOUS
ACHIEVEMENTS, AND WE KNOW, ALSO, THAT THE RETURN ON INVESTMENT IS
PHENOMENAL WITH ABOUT $10 IN SOCIETAL RETURN WITH ABOUT $3 IN
HEALTH CARE RETURN FOR EVERY DOLLAR SPENT ON VACCINE, BUT WE
ALSO KNOW THAT THERE IS UNFINISHED BUSINESS IN
VACCINATION. AND WE KNOW THAT THERE'S MUCH
MORE THAT WE NEED TO DO, BUT WE ALSO SHOULD, I THINK, TAKE A
MOMENT TO RECOGNIZE THAT THIS IS A VERY SPECIAL ANNIVERSARY.
IT'S THE 20thOF THE VACCINES FOR CHILDREN PROGRAM,
T VFC.
THE VFC IS TRULY ONE OF THE GREAT SUCCESS STORIES OF PUBLIC
HEALTH IN THIS COUNTRY. IT'S EASY SOMETIMES TO TAKE IT
FOR GRANTED, BUT IT DIDN'T JUST HAPPEN.
IT HAPPENED BECAUSE OF A LOT OF HARD WORK, ADVOCACY AND DATA AND
INVOLVEMENT OF GROUPS OUTSIDE AND INSIDE OF THE GOVERNMENT.
THE VFC HAS VIRTUALLY ELIMINATED HEALTH DISPARITIES AMONG
VAXEN -- IN VACCINATION RATES AMONG OUR NATION'S KIDS, AND
THAT IS REMARKABLE IN AND OF ITSELF AND IT'S REMARKABLE AS AN
EXAMPLE FOR WHAT CAN BE DONE TO REDUCE HEALTH DISPARITIES.
IT ALSO GOT KIDS VACCINATED IN THEIR MEDICAL HOMES.
THIS WAS A BIG PROBLEM BEFORE VFC.
BUT IT REINFORCED THE MEDICAL HOME THROUGH ANOTHER TYPE OF
PUBLIC-PRIVATE PARTNERSHIP. IT WAS GOOD FOR KIDS, GOOD FOR
PARENTS GOOD FOR PROVIDERS AND GOOD FOR THE COMMUNITY.
NOW, THERE'S A LOT OF AREAS IN WHICH WE CAN MAKE MORE PROGRESS,
BUT ONE I WANT TO MENTION IN PARTICULAR IS HPV VACCINE.
NOW, I'VE CARED FOR WOMEN WHO HAVE DIED FROM CERVICAL CANCER
AND I THINK OF THEM WHEN I THINK OF WHERE WE ARE WITH HPV.
THERE'S BEEN SOME SUCCESS. RECENT DATA SHOWS THAT THE
INFECTION ADDRESSED BY HPV ARE DOWN BY MORE THAN HALF SINCE
2006, AND THAT'S PROGRESS. BUT WITH KNOW THAT WE'RE STILL
AT ONLY ABOUT ONE IN THREE GIRLS FULLY VACCINATED IN THIS
COUNTRY. NOW, RWANDA IS AT 85% OR HIGHER.
IF OUR VACCINATION RATES WAS THAT OF RWANDA, THERE WOULD BE
MORE THAN 50,000 FEWER CASES OF CERVICAL CANCER AMONG GIRLS
ALIVE TODAY AGES 0 TO 12 AND FOR EVERY YEAR WE DELAY, IT'S 4,400
MORE WOMEN WHO WILL GET CERVICAL CANCER, DESPITE PAP SMEAR
SCREENING. SO WE DO NEED TO DO MUCH BETTER.
WE'RE USED TO A SCALE UP WHEN NEW VACCINES ARE INTRODUCED,
MAYBE ABOUT 10% PER YEAR INCREASE.
THE MOST RECENT YEAR FOR WHICH WE HAVE DATA, 2012, THERE WAS NO
INCREASE IN HPV VACCINATION. SO THIS IS DISAPPOINTING AND WE
NEED TO STEP UP OUR EFFORTS TO PROTECT KIDS.
THIS IS AN ANTI-CANCER VACCINE, AND WE REALLY NEED TO MAKE THAT
POINT CLEARLY. I REALLY WANT TO THANK ALL OF
YOU FOR BEING HERE, FOR YOUR ATTENTION TO DETAIL ON THE
MATERIALS. WE REALLY APPRECIATE IT.
WE KNOW YOU'RE ALL BUSY. WE KNOW YOU ALL HAVE DEMANDS AND
WE APPRECIATE EVERY ONE WHO CONTRIBUTED TO THIS MEETING,
AND, OF COURSE, IT IS A TIME TO REMIND EVERYONE TO GET A FLU
SHOT AND HAVE YOU MAKE SURE ALL YOUR PATIENTS GET A FLU SHOT AND
ALL HEALTH WORKERS GET FLU SHOTS TO PROTECT OUR FAMILIES AND OUR
PATIENTS AS WELL.
SO THANK YOU VERY MUCH FOR WHAT YOU DO AND WE LOOK FORWARD TO
THE DELIBERATION OF YOUR WORK. THANK YOU.
[ APPLAUSE ] >>> OUR THANKS TO DR. FRIEDEN
FOR THE COMMENTS. I THINK WE WILL MOVE TO THE
OPENING COMMENTS FROM DR. PICKERING.
>> GOOD. THANK YOU, DR. TEMTE.
GOOD MORNING, AND WELCOME AGAIN, AND AGAIN WE REALLY APPRECIATE
DR. FRIEDEN BEING HERE AND OPENING OUR MEETING, HE'S REALLY
VERY, TO ME, AT LEAST, VERY, VERY INVIGORATING.
THE PROCEEDINGS OF THIS MEETING WILL BE ACCESSIBLE TO THOSE ON
THE WORLD WIDE WEB. WELCOME TO ALL THOSE WHO JOIN R
CAN'T JOIN US IN PERSON, HOPEFULLY NEXT MEETING YOU'LL BE
ABLE TO JOIN US. SEVERAL WILL BE WITH IS ARE US
FOR THE DURATION OF MEETING TO ASSIST WITH MEETING FUNCTIONS
AND WE OWE THE FOLLOWING INDIVIDUALS SPECIAL THANKS.
AS DR. FRIEDEN MENTIONED DURING THE SHUTDOWN IS WAS VERY
DIFFICULT FOR THEM BECAUSE THEY COULDN'T COMPLETE THEIR WORK BUT
CAME BACK AND DID COMPLETE IT IN A YEOMAN'S MANNER.
FELICIA BENTONCOURT, NATALIE GREEN, REID WALTON AND STEPHANIE
THOMAS AND CHRIS CAREAWAY ON THE COMPUTER, AND I WOULD LIKE TO
ESPECIALLY THANK DR. GENE SMITH A MEMBER OF THE COMMISSION CORE
HERE WORKING WITH THE DOCTOR AS YEO PEOPLE ON GETTING THE
MEETING TOGET@W WITHOUT THEM THIS MEETING WOULD
NOT HAVE BEEN POSSIBLE. SO TO GENE, THANK YOU, AND TO
ANN, THANK YOU. [ APPLAUSE ]
WE HAVE A FULL AGENDA TODAY AND TOMORROW.
UNTIL WE ADJOURN, AAPPROXIMATELY 5:45, IF THE DOCTOR KEEPS US ON
TIME TODAY AND ABOUT 1:00 TOMORROW.
COFFEE FREK FIST ITEMS AS WELL AS LUNCH BOX ITEMS WILL BE OUT
IN THE FOYER. I HAND OUT THE SLIDES TO BE
PRESENTED HAVE BEEN DISTRIBUTED TO THE ACIP MEMBERS.
HANDOUTS ARE ON THE BACK TABLE AND, OF COURSE, IT WILL BE
POSTED APPROXIMATELY TWO WEEKS AFTER THE CONCLUSION OF THIS
MEETING. THE LIVE WEBCAST VIDEO ES WILL
BE POSTED ABOUT FOUR WEEKS AND GENERALLY WE HAVE OUR MEETING
MINUTES POSTED ABOUT 90 DAYS AFTER THE MEETING COMPLETES.
THE MEETING, THE AJEOPARDY AGE LAST MEETING HAS NOT BEEN POST
BAWD OF THE THREE-WEEK DELAY BUT WILL YOU POSTED SOON FOR THOSE
WHO WANT TO REVIEW. MEMBERS.
PRESS CONTACT JAMELAY JONES OR JASON McDONALD FOR THE
INTERVIEWS. I SPOKE TO JAMELAY OR JAYS CAN'T
PROVIDE, ANY ASSISTANCE, PLEASE KAX THEM.
OVER ON OUR LEFT AGAINST THE WALL.
AT THIS TIME WE WELCOME THE THREE NEW ACIP VOTING MEMBERS
FOR WHOM THIS WILL BE THEIR FIRST MEETING AND DR. TEMTE WILL
MANY INTRODUCE OUR THREE NEW ACIP MEMBERS.
>> THANK YOU VERY MUCH, DR. PICKERING.
GOING TO START OFF WITH A COUPLE OF QUICK COMMENTS, AND FIRST OF
ALL, OUR NEXT SLIDE, PLEASE. AH.
CONGRATULATIONS TO LARRY. HE DIDN'T KNOW THIS WAS COMING.
WE JUMPED THIS ON, BUT AT THE I.D. WEEK IN SAN FRANCISCO TWO
WEEKS AGO, DR. PICKERING RECEIVED THE PEDIATRIC
INFECTIOUS DISEASE SOCIETY'S DISTINGUISHED SERVICE AWARD FOR
OUTSTANDING CONTRIBUTIONS IN THE FIELD OF PEDIATRIC INFECTIOUS
DISEASE AND I'VE GOT TO JUST READ FROM -- I HAVE MY COPY
HERE, AND DR. PICKERING IS FEATURED IN HERE, BUT THROUGH
ALL OF THESE ENDEAVORS DR. PICKERING'S PASSION AND ENERGY
HAVE IMPROVED THE LIVES OF CHILDREN THROUGHOUT THE UNITED
STATES AND THE WORLD. PERHAPS HIS GREATEST IMPACT ON
GLOBAL CHILD HEALTH HAS OCCURRED SINCE 2005 WHEN HE WAS NAMED AS
THE ACIP'S EXECUTIVE SECRETARY. THE ACIP DETERMINES ALL OF THE
RECOMMENDATIONS IN THE U.S. AND DR. PICKERING HAS EXCELLENTLY
GUIDED THIS ORGANIZATION TO POSITION OF GLOBAL -- THROUGH
WORLDWIDE COLLABORATIONS WITH COUNTERPARTS AND COUNTRIES ON
EVERY CONTINENT. I THINK THE NUMBER OF VISITORS
WE HAVE HERE FROM ACROSS THE WORLD IS A TESTAMENT TO THAT AS
WELL, SO, JUST CONGRATULATIONS TO DR. PICKERING.
[ APPLAUSE ] NEXT SLIDE, PLEASE.
WE HAVE INTRODUCTIONS HERE, AND -- NEXT SLIDE -- FIRST,
DR. ALLISON KEMPE.
IT'S KEMPE WITH A P NOT A T. THE DOCTOR HAS ACTUALLY, HAS
BEEN HERE SEVERAL TIMES IN THE PAST.
SHE HAS REALLY EXTENSIVE EXPERIENCE AS A PEDIATRIC HEALTH
SERVICE RESEARCHER AND CLINICIAN.
COMING FROM DENVER AND DENVER CHILDREN'S HOSPITAL, SHE HAS
RECEIVED RESEARCH GRANTS IN THE FIELD OF IMMUNIZATION, SERVICES
DELIVERY, AND INVOLVED IN -- INVOLVED IN DESIGNING AND
EVALUATING INTERVENTIONS TO IMPROVE IMMUNIZATION COVERAGE.
SHE'S PUBLISHED MORE THAN 30 ORIGINAL MANUSCRIPTS IN THIS
FIELD AND ESTABLISHED A VACCINE POLICY COLLABORATIVE INITIATIVE
AND PROVIDES RAPIDLY ACCESS TO VACCINE-RELATED ANONG PRIMARY
CARE PROVIDERS, NOT ONLY PEDIATRICIANS BUT FAMILY
PHYSICIANS AS WELL. SHE BRINGS IN THE PERSPECTIVE OF
A PRACTICING PRIMARY CARE PEDIATRICIAN TO ACIP, AND WE'RE
LOOKING FORWARD GREATLY TO HER CONTRIBUTIONS.
NEXT. CINDY PELLEGRINI IS THE SENIOR
VICE PRESIDENT IN PUBLIC POLICY AND GOVERNMENT AFFAIRS IN THE
FOUNDATION IN WASHINGTON. JUST AS A HISTORIC NOTE, MARSHA
DIMES ACTUALLY HAD A HISTORIC, 75 YEARS AND FOUNDED BY FRANKLIN
ROOSEVELT FOR NATIONAL PR PARALYSIS.
WE'RE HOPING DURING HER TENURE WE'LL SEE DRAMATIC LEAPS IN THE
FIELD OF POLIO. FROM 2004 THROUGH 2011, SHE
ADVANCED THE AMERICAN ACADEMY OF PEDIATRICS ADVOCACY AGENDA ON A
NUMBER OF ISSUES. RESPONSE TO IMMUNIZATION AND
ENVIRONMENTAL HEALTH. SINCE 2011, SHE HAS OVERSEEN THE
MARCH OF DIMES ADVOCACY AGENDA AT BOTH STATE AND FEDERAL
LEVELS. SHE HAS A LONG-STANDING
REPUTATION AMONG CHILD ADVOCACY COMMUNITIES, AND IS A
KNOWLEDGEABLE AND UNWAVERING ADVOCATE OF PEDIATRIC HEALTH.
SO WE'RE LOOKING FORWARD TO YOUR CONTRIBUTIONS AS WELL.
NEXT WE HAVE DR. ART RANGEL. PROFESSOR OF EPIDEMIOLOGY, AND
SHE AT THE SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF
CALIFORNIA, AT BERKELEY. MANY OF US HAVE KNOWN ART FROM
PRESENTATIONS HERE DEALING WITH THE STRATEGIC ADVISORY GROUP OF
EXPERTS AND APPLICATIONS OF GRADE THROUGH THE WORLD HEALTH
ORGANIZATION. THE DOCTOR WORKED OVER 30 YEARS
ON PREVENTION CONTROL AND INFECTIOUS DISEASES AT THE
NATIONAL AND GLOBAL LEVEL, ESPECIALLY IN DEVELOPING
COUNTRIES. HE HAS A GREAT DEAL OF
EXPERIENCE INVESTIGATING VACCINE-PREVENTABLE DISEASES.
HE IS A MEMBER OF THE WORLD HEALTH ORGANIZATION, STRATEGIC
ADVISORY GROUP OF EXPERTS ON IMMUNIZATION WHERE HE HAS
HELPED, AGAIN, DEVELOP THE GUIDANCE ON EVIDENCE-BASED
RECOMMENDATIONS THROUGHOUT THE WORLD.
HE SERVED AS LIAISON TO OUR EVIDENCE-BASED RECOMMENDATION
WORKING GROUP, AND HE BRINGS JUST A GREAT DEAL OF KNOWLEDGE
FROM HIS MANY ENDEAVORS IN THE PAST.
SO, AGAIN, WE WELCOME DR. REINGOLD.
SO WELCOME TO ALL THREE OF OUR NEW MEMBERS.
[ APPLAUSE ] JUST A HAPPY BIRTHDAY.
AND FOLLOWING DR. FRIEDEN'S COMMENTS ABOUT THE ROLE OF GOOD
EVIDENCE-BASED PRACTICE IN MEDICINE, AT THIS MEETING THREE
YEARS AGO WE UNANIMOUSLY ADOPTED -- NEXT SLIDE -- JUST IN
PASSING -- JUST -- MENTION THAT HOLLY WAS THE LAST PERSON TO
CONTRACT POLIO -- OR SMALL POX IN THE WORLD, AND FOLLOWING THAT
HE SPENT HIS TIME WORKING TO ERADICATE POLIO IN SOMALIA.
UNFORTUNATELY HE JUST DIED THIS PAST JULY AT AGE 59 FROM
MALARIA. BUT HE USED HIS EXAMPLE OF BEING
A VACCINE REFUSER FOR SMALL POX IN TALKING TO FAMILIES AND
VACCINATING PARENTS TRYING TO ENCOURAGE THE ADOPTION AND
ACCEPTANCE OF POLIO VACCINE IN SOMALIA, AND LAST SLIDE HERE.
JUST A SPECIAL THANKS TO ALL OF OUR DEDICATED COLLEAGUES WHO
WENT TO VERY EXTRAORDINARY EFFORTS TO MAKE SURE THIS
MEETING OCCURRED AS SCHEDULED. SO I THINK JUST A QUICK ROUND OF
APPLAUSE, AGAIN, FOR -- [ APPLAUSE ]
AND WITH THAT, I TRANSACT BACK TO DR. PICKERING.
>> THANK YOU, DR. TEMTE. ONE OF THE HIGHLIGHTS OF OUR
MEETING IS OUR ABILITY TO INTERACT WITH OUR INTERNATIONAL
VIS VISITORS.
TODAY WE HAVE FOUR. DR. LI LI, DIRECTOR OF THE CHINA
IMMUNIZATION PROGRAM. DR. LI ATTENDED THE LAST ACIP
MEETING AND SINCE THEN HAS ACQUIRED INFORMATION ABOUT THE
U.S. IMMUNIZATION PROGRAM, ESPECIALLY FOR US, HOW ACIP
WORKS. DR. LI HAS SERVED ACTIVITIES OF
SEVERAL ACIP WORK GROUPS AND WILL BE AT CDC AN ADDITIONAL 1.5
MONTHS AND ANY OF YOU WHO HAVE NOT MET DR. LI I SUGGEST YOU DO
SO. HE'S AN ABSOLUTELY WONDERFUL
GENTLEMAN AND WE THOROUGHLY ENJOYED YOU'RE BEING HERE.
SO, AGAIN, WELCOME. [ APPLAUSE ]
WE WELCOME TWO OTHER VISITORS FROM CHINA.
DR. YA LI *** FROM THE NATIONAL CENTER FOR ADD VERSUS DRUG
REACTIONS MONITORING AT THE CHINA CENTER FOR DRUG
RE-EVALUATION IN BEIJING, CHINA, AND DR. KILI LI JOINS US
FOLLOWING IMMUNIZATION SURVEILLANCE OF THE NATIONAL
IMMUNIZATION PROGRAM AT CHINA'S CONTROL AND PREVENTION ALSO IN
BEIJING. AGAIN, THOSE OF YOU, I SUGGEST
THAT YOU INTERACT WITH THESE INDIVIDUALS I JUST INTRODUCED.
IN MY BRIEF TIME WITH THEM I LEARNED A GREAT DEAL ABOUT THE
SYSTEMS IN CHINA AND WE THOROUGHLY WELCOME YOU HERE,
ALSO. [ APPLAUSE ]
ALSO VISITING US IS A LONGTIME FRIEND.
DR. NBUKIO OCABE AT THE JAPAN INSTITUTE FOR PUBLIC HEALTH.
A FORMER DIRECTOR OF THE INFECTIOUS DISEASE SURVEILLANCE
CENTER OF THE NATIONAL INSTITUTE OF INFECTIOUS DISEASE AND
DOCTOR, IT'S ALWAYS GOOD TO SEE YOU, AND WELCOME TO THE ACIP
MEETING. [ APPLAUSE ]
WE USUALLY HAVE MINISTRY OF HEALTH REPRESENTATIVES AT THIS
MEETING FROM THE PAN-AMERICAN HEALTH ORGANIZATION.
WE DO NOT HAVE REPRESENTATIVES THIS TIME, BUT AT THE NEXT
MEETING WE WILL HAVE REPRESENTATIVES FROM ONE OF
THEIR REPRESENTATIVE COUNTRIES. WE NEED TO PROVIDE INFORMATION
FOR FUTURE INTERNATIONAL VISITORS, AND, AGAIN, WE
ANNOUNCED THIS LAST TIME, BUT, AGAIN, IT'S VERY IMPORTANT SO WE
WILL MENTION IT AGAIN. DUE TO CHANGES IN THE DEPARTMENT
OF HOMELAND SECURITY POLICY, ADDITIONAL FORMS WILL BE
REQUIRED FOR EACH MEETING AT THE TIME AN INTERNATIONAL GUEST
REGISTERS. IT IS CRITICAL THAT
INTERNATIONAL VISITORS COMPLETE AND SUBMIT THESE FORMS AS SOON
AS POSSIBLE FOLLOWING REGISTRATION AND FELICIA
BETANCOURT AT THE TABLE IN THE BACK OF THE ROOM AND OUR
COMMITTEE MANAGEMENT SPECIALIST, WILL BE ABLE TO HELP WITH IN
QUESTIONS AND CONCERNS ABOUT THIS PROCESS AND, AGAIN, THE
EARLIER THIS HAS BEGUN TO REGISTER FOR THE NEXT MEETING
THE BETTER. THE NEXT ACIP MEET WG TAKE PLACE
AT THE CDC IN THIS ROOM ON WEDNESDAY AND THURSDAY FEBRUARY
26th AND 27th. REGISTRATION FOR ALL MEETING
ATTENDEES IS REQUIRED AND IS NOW OPEN ON THE ACIP WEBSITE.
I THINK IT'S OPEN TODAY. YOU CAN REGISTER FOR THE NEXT
MEETING TODAY. SO IT WILL BE FINISHED, AND WE
ENCOURAGE PEOPLE TO DO THAT AS SOON AS POSSIBLE.
REGISTRATION FOR U.S. CITIZENS WILL BE CUT OFF A WEEK
BEFOREHAND ON MONDAY, FEBRUARY 3 -- 3rd.
REGISTRATION FOR NON-U.S. PARTICIPANTS FEBRUARY 3rd.
FOR U.S. CITIZENS IS WILL BE FEBRUARY THE 10th.
WITH REGARD TO OUR LIAISON REPRESENTATIVE, CAROL HAYES WILL
REPRESENT THE AMERICAN NURSES ASSOCIATION LIKE KATIE BREWER IS
ON MATERNITY LEAVE AND FROM WHAT WE UNDERSTAND KATIE AND HER BABY
ARE DOING VERY WELL. WE REQUEST THAT ALL CELL PHONES
BE TURNED OFF FOR THE DURATION OF THE MEETING.
TOPICS PRESENTED INCLUDE OPEN DISCUSSION WITH TIME RESERVED
FOR PUBLIC COMMENT, WHICH ACIP MEMBERS CONSIDER TO BE EXTREMELY
IMPORTANT. TIME FOR PUBLIC COMMENT
PERTAINING TO TOPICS ON THE AGENDA HAS BEEN SCHEDULED
FOLLOWING THE AFTERNOON SESSIONS ON EACH DAY.
TIME FOR PUBLIC COMMENTS ALSO MAY BE PROVIDED PRIOR TO
SPECIFIC POSTS BY ACIP TO ENABLE THESE COMMENTS BY THE PUBLIC TO
BE CONSIDERED BEFORE A VOTE IS TAKEN.
PEOPLE WHO PLAN TO MAKE PUBLIC COMMENTS SHOULD VISIT THE
REGISTRATION TABLE AT THE REAR OF THE AUDITORIUM, FILL OUT A
BRIEF FORM AND FELICIA BETANCOURT CAN HELP YOU WITH
THAT. PEOPLE WHO MAKE PUBLIC COMMENTS
SHOULD PROVIDE THREE AREAS OF INFORMATION.
ONE IS THEIR NAME. SECONDLY, THEIR ORGANIZATION AND
THEN LASTLY, ANY CONFLICTS OF INTERESTS.
DISCLOSURE. SOW USUMMARIZE CONFLICTS OF
INTEREST AS NOTED IN THE ACIP POLICIES AND PROCEDURES MANUAL,
MEMBERS OF THE ACIP AGREE TO FORGO PARTICIPATION IN CERTAINLY
ACTIVITIES RELATED TO VACCINES DURING THEIR TENURE ON THE ACIP
COMMITTEE. FOR CERTAIN OTHER INTERESTS THE
POTENTIALLY ENHANCING THE MEMBER'S EXPERTISE WHILE SERVING
ON THE COMMITTEE, CDC ISSUEDLIM WAIVERS.
MEMBERS WHO CONDUCT VACCINE CLINICAL TRIALS OR WHO SERVE ON
DATA SAFETY MONITORING BOARDS MAY PRESENT TO THE COMMITTEE ON
MATTERS RELATED TO THESE VACCINES.
HOWEVER, THEY ARE PROHIBITED FROM PARTICIPATING IN
DELIBERATIONS FOR COMMITTEE VOEFT
VOTES ON ISSUES RELATED TO THOSE SPECIFIC VACCINES.
DETAILED INSTRUCTIONS FOR NAMES FOR POTENTIAL CANDIDATE.
THIS IS THE LAST, NEXT TO THE LAST SLIDE THAT WE WANT TO SHOW.
THE TIME IS ALMOST HERE FOR THE CUTOFF.
SO DETAILED INSTRUCTIONS CAN BE FOUND ON THE ACIP WEBSITE.
THE CUT OFF NOVEMBER 15th WHEN THE TERM WILL BEGIN ON JULY
2014. WHAT IS DONE, MEMBERS ARE
SUBMITTED. ALL CDs AND APPLICATIONS
REVIEWED BY STEERING COMMITTEES. NAMES ARE FORWARDED TO HHS AND A
FINAL DECISION THEN IS MADE ABOUT THE NEW MEMBERS.
ONE LAST COMMENT. AT EVERY MEETING WE PROVIDE AN
UPDATE ON THE STATUS OF THE ACIP RECOMMENDATIONS.
A LIST OF RECOMMENDATIONS IS SHOWN ON THIS SLIDE AND THESE
ARE THE RECOMMENDATIONS THAT HAVE BEEN PUBLISHED SINCE THE
LAST MEETING. LINKS TO THESE RECOMMENDATIONS
AND SCHEDULES CAN BE FOUND ON THE ACIP WEBSITE.
THE TWO THAT ARE NOT UP THERE THAT ARE STILL IN VARIOUS
DEGREES OF CLEARANCE AR THE INFLUENZA B RECOMMENDATION
REPORT AGAIN, R & R IS A LARGE DOCUMENT, SOMETIMES 40 AND 50
PAGES, VERY INCLUSIVE. THE SECOND ONE IS THE JAPANESE
ENCEPHALITIS RECOMMENDATIONS FOR CHILDREN 2 MONTHS THROUGH 16
YEARS OF AGE. THIS WILL BE WHAT'S CALLED A
POLICY NOTE, AND THESE ARE VERY BRIEF.
ABOUT 1,400 WORDS, HAVING THEM BRIEF ALLOWS US TO GET THEM
PUBLISHED IN A MUCH QUICKER MANNER.
WITH THAT, DR. TEMTE, TIME FOR ROLL CALL AND CONFLICT OF
INTERESTS REQUESTS. >> OKAY.
WE'RE START OUT WITH DR. KARRON AND GO AROUND CLOCKWISE.
>> NO CONFLICT. >> NO CONFLICTS.
>> NO CONFLICTS. >> ART REINGOLD.
NO CONFLICTS. >> HARRIMAN NO CONFLICTS.
>> JENKINS, NO CONFLICTS. >> RUBIN, NO CONFLICTS.
>> INSTITUTION RECEIVED FROM THE PHARMACEUTICAL CLINICAL TRIALS.
>> NO CONFLICTS. >> HARRISON, NO CONFLICTS.
>> NO CONFLICTS. >> PELL LA GREEGRINI, NO CONFLI
>> NO CONFLICTS. >> NO CONFLICTS.
>> WITH THAT I THINK WE MOVE STRAIGHT ON INTO THE AGENCY
UPDATES AND I WILL ASK FOR DOCTOR SHUCCA TO TAUMT FOR CDC.
>> THANKS SO MUCH. I JUST FIRST WANT TO WELCOME
EVERYBODY HERE AND SAY THAT THE MOST COMMON QUESTION I GOT
DURING THE SHUTDOWN WAS, ARE WE GOING TO HAVE THE ACIP MEETING?
I FEEL LIKE THIS IS THE ROLLING STONES CONCERT AND I'M GRATEFUL
WE DID NOT HAVE TO CANCEL IT. I HAVE UPDATES ON THREE AREAS OF
THE AGENDA. THE FIRST IS ABOUT IMMUNIZATION
COVERAGE. BETWEEN JULY AND SEPTEMBER, CDC
ISSUED SIX WORs ON UPDATES INCLUDING HPZ TEENS,
KINDERGARTNERS, ON INFLUENZA. SUSTAINED HIGH OR INCREASING
RATES WITH THE NOTABLE HPZ. CDC'S HIGHEST PRIORITY FOR
URGENT IMPROVEMENTS IN COVERAGE. YOU'LL HEAR MORE ABOUT SOME OF
THE ACTIVITIES GOING ON ON THAT TOMORROW DURING THE HPD
SESSIONS. ONE FALLOUT TO THE SHUTDOWN WE
WEREN'T ABLE TO HAVE THE PREGNANCY SESSION.
I WANTED TO PROVIDE A BRIEF UPDATE.
THE STATEMENT ON RECOMMENDING THIS IN EVERY PREGNANCY WAS
PUBLISHED IN FEBRUARY 2013, AND AT THE JUNE MEETING THERE WAS AN
UPDATE SKETCHING OUT THE FORWARD PLANS FOR THIS.
BUT TO SUMMARIZE WHAT IS GOING ON, CDC AND FDA CONTINUE TO
MONITOR THEIRS FOR REPORTS. THE STUDIES IN THE VACCINE
SAFETY DATA LINK ARE VFD HAVE BEGUN.
WE DON'T HAVE ANY UPDATE ON COVERAGE AVAILABLE.
SO DATA THROUGH 2011 WERE PRESENTED AT THE JUNE MEETING,
AND THOSE SHOWED, AS YOU MAY RECALL, IN 2011, ONLY 1.6% OF
PREGNANCIES OUTSIDE CALIFORNIA IN THE VFC SITES HAD TDAF.
WE BELIEVE THINGS ARE BETTER NOW, BUT NOT ALL THE WAY BETTER
AND WE LOOK FORWARD TO UPDATES ON THAT.
INITIAL SAFETY DATA FROM THE VFD SITE IS EXPECTED BY THE SUMMER
OF 2014. THERE ARE PRE-SPECIFIED OUTCOMES
THEY'RE LOOKING AT BUT WE DON'T ACTUALLY HAVE RESULTS FROM THAT
AT THIS POINT. THE PROGRAM IS ALSO DEVELOPING A
PROSPECTIVE CLINICAL STUDY OF TDAF SAFETY IN WOMEN FOR THE
COLLABORATION, SO THAT'S WHAT WE CAN SAY ABOUT THIS IN PREGNANCY
KNOWING THERE'S A LOT OF INTEREST AND IT WILL BE UPDATED
IN THE FUTURE. THIRD ITEM, FEDERAL SUPPORT FOR
IMMUNIZATION THROUGH THE DISCRETIONARY SECTION 317
PROGRAM. YOU HEARD ABOUT THE VFC 20th
ANNIVERSARY. THE PROGRAM IS THE BASIS OF OUR
DISCRETIONARY IMMUNIZATION RESOURCES.
LIKE MOST PROGRAMS, DURING THE ERA OF BUDGET PRESSURES, WE HAVE
TO PRIORITIZE AND I WANT TO WLEEPT OUR THREE TOP PRIORITIES
ARE OR THE 317 FUNDING. FIRST MAINTAIN IMMUNIZATION
INFRASTRUCTURE, THAT'S THE PEOPLE AND SYSTEMS THAT SUPPORT
VACCINE DELIVERY, SURVEILLANCE AND RESPONSE AND DEVELOPING AND
MAINTAINING THE EVIDENCE-BASED SUPPORTING IMMUNIZATION POLICY
THAT THIS COMMITTEE REVIEWS REGULARLY.
SECOND, MODERNIZING SYSTEMS AND SUPPORTING TECHNOLOGY,
INNOVATIVE, THROUGH THE MANY INITIATIVES GOING ON INCLUDING
INOPERABILITY BETWEEN ELECTRONICS HEALTH RECORDS AND
RECHS REGISTRIES ES SET RA. AND LASTLY, MAINTAINING FUNDING
TO FILL GAPS WHICH MAINLY WOULD BE UNINSURED ADULTS AND PUBLIC
RESPONSE TO EMERGENCIES OR OUTBREAKS.
RECENTLY WE IMPLEMENT ADD CHAEDE IN THE VACCINE POLICY TO NO
LONGER REQUIRE C.H.I.P. FROM THE 317 FUNDING BUT INSTEAD REQUIRED
STATES TO HAVE PURCHASED ORDERED BEFORE THEIR ORDERS CAN BE
PLACED THROUGH OUR V-TRACK SYSTSTEM FOR STATE OR C.H.I.P.
VACCINE. IMPLEMENTED THIS OCTOBER 1.
WE DID AN ENORMOUS AMOUNT OF WORK TO GET IT READY.
WE DIDN'T HAVE MUCH TIME. BUT IT WAS JUST IN TIME POLICY
BECAUSE WE WORKED ON THIS AND HAD A SOFTWARE UPDATE.
OUR NEW SYSTEM MEANT THAT THE GOVERNMENT SHUTDOWN AND LAPSE IN
FUNDING FOR THE 317 VACCINE DID NOT HAVE TO STOP THE ORDERING OF
STATE AND C.H.I.P. VACCINES. WE ACTUALLY PROCESSED STATE AND
C.H.I.P. ORDERS TO 800,000 DOSES OF VACCINE BETWEEN OCTOBER 1 AND
OCTOBER 17th, DESPITE NO DOLLARS IN THE 317 VACCINE FUND.
WE'RE WORKING NOW WITH HO ON A WORKING GROUP TO STRENGTHEN THE
COLLABORATION AROUND FUTURE PROGRAM CHANGES.
THIS WAS A DIFFICULT ONE FOR THE PROGRAMS, AND WE'LL BE WORKING
FORWARD ON HAVING MORE ADVANCED NOTICE BEFORE SUCH CHANGES.
THANK YOU. >> THANK YOU, DOCTOR.
MARY BETH HANCE COULD NOT TRAVEL, DUE TO SHUTDOWN.
SO SHE HAS SENT THIS IN TO BE, JUST ENTERED INTO THE RECORD.
IN TERMS OF MEDICARE FLU VACCINE DATA FROM, THIS IS FROM CENTERS
FOR MEDICAID AND MEDICARE SERVICES, CMS WORKED WITH THE
NATIONAL HEALTH RESOURCES AND SERVICES ADMINISTRATION, AND THE
NATIONAL VACCINE PROGRAM OFFICE TO POST MEDICARE FLU VACCINATION
INFORMATION FOR THOSE IN FEE FOR SERVICE ON THE MVP WEBSITE.
THIS IS UPDATED WEEKLY. IN TERMS OF COVERAGE OF
PREVENTIVE SERVICES FOR ADULTS CURRENTLY ENROLLED IN MEDICAID,
WHILE THE BENEFIT PACKAGE FOR ADULTS WHO RECEIVE HEALTH CARE
COVERAGE UNDER THE AFFORDABLE CARE ACT IS REQUIRED TO INFLUID
COVERAGE OF PREVENTIVE SERVICES INCLUDING COVERAGE OF ALL ACIP
RECOMMENDATIONS STATES CONTINUE TO HAVE THE OPTION TO COVER OUR
PREVENTIVE COVERAGES FOR ADULTS CURRENTLY ENROLLED IN MEDICAID.
THE AFFORDABLE CARE ACT ADDRESSES THIS INCLUDING A
PROVISION, SECTION 4106 THAT PROVIDES INCENTIVE TO STATES TO
PROVIDE COVERAGE FOR ALL ACIP RECOMMENDED VACCINES AND THEIR
ADMINISTRATION AS WELL AS THE GRADE A AND B U.S. PREVENTIVE
TASK FORCE RECOMMENDED SERVICES. TO DATE, SUBMITTED A REQUEST TO
CMS TO COVER THESE SERVICES AND RECEIVE THE INCENTIVE.
CLUDING CALIFORNIA, HAWAII, NEVADA, NEW HAMPSHIRE AND NEW
YORK. CMS CONTINUES TO WORK WITH ALL
STATES TO ENCOURAGE COVERAGE OF PREVENTIVE SERVICES.
DEPARTMENT OF DEFENSE. >> YES.
GOOD MORNING. DEPARTMENT OF DEFENSE HAS NO NEW
UPDATES FOR THIS MEETING. WE CONTINUE TO ALIGN OUR
SERVICE-SPECIFIC VACCINE POLICIES WITH THAT OF CDC AND
ACIP. THANK YOU.
>> THANK YOU. WE HAVE NEXT THE DEPARTMENT OF
VETERANS AFFAIRS, AND DR. LINDA KISSINGER IS NOT HERE.
AND HAS SENT THE FOLLOWING AS AN UPDATE.
THE VETERANS ADMINISTRATION AND DEPARTMENT OF DEFENSE CONTINUE
TO WORK TWORZ INFORMATION EXCHANGE OF CLINICAL DATA
BETWEEN OUR TWO ELECTRONIC HEALTH RECORDS SYSTEMS.
THE VA IS WORKING ON CERTIFICATION OF THEIR EHR FOR
MEANINGFUL USE AND UNDERTAKEN AN EFFORT TO MODIFY THE UNDERLYING
IMMUNIZATION FILE STRUCTURE TO ADDRESS THOSE NEEDS.
THE VA IS ALSO INVOLVED IN SEVERAL PILOT PROJECTS INVOLVING
EXCHANGE OF IMMUNIZATION INFORMATION WITH RETAIL
PHARMACIES. THEY HAVE DEVELOPED AN INFLUENZA
IMMUNIZATION MOBILE A.PP. THE STAFF WILL IMPLEMENT THIS
SEASON. THE APP IS DESIGNED TO PROVIDE
AN EASY WAY TO DOCUMENT ADMINISTRATION OF FLU VACCINE IN
MASS VACCINATION SCENARIOS SUCH AS A HEALTH FAIR.
A FEW CASES OF INFLUENZA HAVE BEEN CONFIRMED IN VA FACILITIES
AND A TOTAL OF DOSES HAVE BEEN RECORDED SINCE AUGUST 1st.
THAT ENDS THE UPDATE FROM THE DEPARTMENT OF VETERANS AFFAIRS.
NEXT, FDA AND DOCTOR? >> GOOD MORNING.
JUST A BRIEF UPDATE FROM THE FDA.
SINCE THE LAST ACIP MEETING, THERE'S BEEN NO WORTHY APPROVALS
OF WHICH ARE INFLUENZA VACCINE, QUAD DRA VEILANT APPROVED FOR
THOSE OVER 3 YEARS OLD. THE FLU ALSO APPROVED FOR AGES 3
TO 17, AND WE ALSO APPROVED THE USE OF MENVIO, A MENINGOCOCCAL
VACCINE FOR THOSE OVER 23 MONTHS.
THIS YEAR, THE STRAIN FOR INFLUENZA VACCINE INCLUDED FOUR
QUAD DRA VEILANT VACCINES AND FIVE TRIALEANTS.
THANK YOU. >> THANK YOU, DOCTOR.
DOCTOR FROM HRSA? >> A BRIEF UPDATE.
THE HRSA PROPOSED YOU'LLMAKING BY THE SECRETARY TO ADD SEASONAL
INFLUENZA VACCINE SHOULD BE PUBLISHED SHORTLY AND COVERED
UNDER THE PROGRAM. THANK YOU.
>> THANK YOU. FROM HEALTH SERVICE?
>> GOOD MORNING. JUST A BRIEF UPDATE ON INFLUENZA
ACTIVITIES WITH THE INDIAN HEALTH SERVICE.
WE'RE STARTING TO POST REPORTS ON OUR WEBSITE AND TO DATE I
DON'T HAVE THE SPECIFIC NUMBER AT THE VA BUT ADMINISTERED ABOUT
15% OF OUR POPULATION AND A QUICK WORD ON HPD, CLEARLY A
HIGH PRIORITY AREA, UNDERTAKING AN EFFORT TO WORK WITH SITES AND
DOING EVALUATION WITH DATA AND TARGETING SOME OF THE SITES FOR
SPECIFIC INTERVENTIONS TO SEE IF WE CAN CONTINUE TO INCREASE OUR
RATES. >> THANK YOU.
NATIONAL PROGRAM OFFICE, AND DOCTOR?
>> WE HAVE A JOINT -- START WITH THAT.
WE HAD OUR MEETING. THE NATIONAL VACCINE ADVISORY
COMMITTEE APPROVED A REVISION TO THE STANDARDS FOR ADULT
IMMUNIZATION PRACTICES. THE CHANGE IN THE TEN YEARS
SINCE THE STATEMENT, AND THIS ONE IS ADDRESSED INSTEAD OF ONE
SET OF RECOMMENDATIONS, THERE ARE RECOMMENDATIONS TO EVERYONE
AND THEN AN AUDIENCE-BASED FOR PROVIDERS, FOR VIRUSES AND
SEEING PATIENTS BUT GENERALLY DON'T VACCINATE.
HEALTH DEPARTMENTS, HEALTH ORGANIZATIONS AND OTHERS.
IN FACT, A REPORT APPROVED FROM THE GLOBAL IMMUNIZATION WORKING
GROUP THAT FOCUSES IN SIX SETS OF AREAS, INCLUDING ENHANCING
POLIO ERADICATION IN BEISEL CELL ELIMINATION, STRENGTHENING
GLOBAL IMMUNIZATION SYSTEMS ENHANCING VACCINE SAFETY
MONITORING, IMPROVING RND CAPACITY.
IMPROVING CAPACITY TO MAKE DECISIONS.
THE GLOBAL IMMUNIZATION COMMITTEES OR COUNTRY
IMMUNIZATION COMMITTEES AND COORDINATION OF HHS GLOBAL
IMMUNIZATION EFFORTS. THERE ARE THREE OTHER WORKING
GROUPS THAT NVAC IS SUPPORTING. ONE DEALS WITH MATERNAL
IMMUNIZATION WITH THE GOAL INITIALLY OF IMPROVING CURRENT
IMPLEMENTATION OF RECOMMENDATIONS FOR PREGNANT
WOMEN. THAT PROBABLY WOULD BE CLOSE TO
FINALIZATION AT THE FEBRUARY MEETING, AND AFTER THAT THEY
WILL LOOK AT BARRIERS TO RND WITH REGARD TO DEVELOPMENT OF
NEW VACCINES FOR PREGNANT WOMEN. WE ALSO HAVE A WORKING GROUP ON
VACCINE ACCEPTANCE/HESITANCY AS WELL AS IMPROVING HPD COVERAGE
AND THEY ARE ACTIVITY WORKING TO TRY AND ADDRESS CONCERNS TO
PROVE VACCINATION UPTAKE. >> SO PART TWO OF THE ONE-TWO
PUNCH. SO JUST TO REINFORCE ABOUT THE
ADULT STANDARDS, IT'S GOING TO BE PUBLISHED IN PUBLIC HEALTH
REPORTS EARLY IN THE SPRING. THERE'S A SUMMARY TABLE THAT'S
ACTUALLY, BEING PRODUCED NOW THAT I ENCOURAGE YOU TO LOOK AT.
AN OVERVIEW OF THE DETAILS THAT WERE MENTIONED.
OTHER THINGS YOU'VE ALREADY MENTIONED, JOHN, ABOUT THE CMS
MAPPING TOOL FOR ADULT INFLUENZA IMMUNIZATION FOR THE CMS
BENEFICIARIES IS NOT JUST ON THE HOME PAGE BUT FEATURED ON THE
HHS HOME PAGE WHICH IS GETTING A LOT OF TRAFFIC THESE DAYS, BUT I
ENCOURAGE YOU TO LOOK AT IT, BECAUSE WHAT IT LET'S YOU DO IS
ACTUALLY ZOOM IN ON A MAP AND FIND YOUR ZIP CODE, AND SEE
WHAT'S GOING ON, PARTICULARLY LOOKING AT RACIAL AND ETHNIC
DISPARITIES. JUST AT THE END OF SEPTEMBER,
NBO. A CONTRACT DEVELOPING AN ADULT
IMMUNIZATION STRATEGY. AND TO DEVELOP ADULT
IMMUNIZATION STRATEGIC PLAN. RAND HELPED US WITH THE NATIONAL
VACCINE PLAN. THIS LAYERED ON TOP OF THAT.
MANY OF YOU WILL HEAR FROM THEM TO GET YOUR THOUGHTS ABOUT THE
DIRECTIONS WE SHOULD BE TAKING. AND THEN FINALLY, IF YOU'VE
HAD -- THERE'S BEEN A, AN EFFORT THAT YOU'VE HEARD ABOUT BEFORE
FROM THE INSTITUTE OF MEDICINE ON A TOOL THAT THEY'VE BEEN
DEVELOPING TO -- IT'S A DECISION SUPPORT TOOL ON VACCINE RND
PRIORITIES. A PRESENTATION HERE WHICH IS
PART OF THEIR BETA ROLLOUT, SCREEN SHOTS OF SOFTWARE.
NOW YOU CAN ACTUALLY LOOK AT THEY'RE SOFTWARE.
I ENCOURAGE YOU TO TAKE A LOOK. GO TO THE WEBSITE CALLED RANKING
VACCINES AND HAVE A LOOK THAT. WE IN PARTICULAR, THE COMMITTEE,
WOULD BE INTERESTED IN YOUR FEEDBACK ABOUT THAT.
THAT'S IT FOR ME. >> THANK YOU, DOCTORS.
AND NIH? >> THANK YOU, DR. TEMTE WITH A
T. ON SEPTEMBER 23rd IN 2013, IN
BAKERSFIELD, CALIFORNIA, THE CENTERS FOR DISEASE CONTROL AND
PREVENTION AND THE NATIONAL INSTITUTES OF HEALTH ANNOUNCED
THEY WOULD LAUNCH A RANDOMIZED CLINICAL CONTROLLED TRIAL TO GET
A BETTER UNDERSTANDING HOW TO CONTROL VALLEY FEVER.
THE TRIAL WILL INVOLVE ABOUT 1,000 PEOPLE DIAGNOSED WITH
COMMUNITY ACQUIRED PNEUMONIA. THE MOST COMMON PRESENTATION OF
VALLEY FEVER. ONE-HALF WILL BE RANDOMLY CHOSEN
TO RECEIVE A TRADITIONAL ANTIBIOTIC AND PLACEBO, THE
OTHER HALF, AN ANTIFUNGAL MEDICINE INITIALLY USED TO TREAT
VALLEY FEVER. THE PATIENTS TESTED IMMEDIATELY
AND EVERY TWO WEEKS TO SEE IF THEY HAVE VALLEY FEVER AND WHICH
TREATMENTS PROVES MOST EFFECTIVE.
BOTH DOCTORS PRESENT SAID THE TRIAL WILL SPREAD AWARENESS
ABOUT THE DISEASE AND EDUCATE PHYSICIANS, RESEARCH, AND
PATIENTS ABOUT DIAGNOSE AND TREATMENT.
INSIDE OF AN IED, NAMED HEAD OF THE VACCINATION RESEARCH CENTER.
ACTING DIRECTOR AND BEFORE THAT DIRECTOR OF THE CORE BIOLOGY
LAB. HIS WORK DEMONSTRATED PROTECTIVE
ROLE OF ANTIBODY RESPONSE IN *** INFECTIONS AND THAT WORK HELPED
DIRECT THE DISCUSSION OF THE DEVELOPMENT OF *** VACCINES.
ON SEPTEMBER 16th, 2013, THE NATIONAL INSTITUTE OF HEALTH OF
ALLERGY AND INFECTION DISEASE HELD A MINI SUMMIT FOR ***
VACCINES. THE PARTICIPANTS WERE GREETED
AND GIVEN CHARGE BY THE DOCTOR. THAN ANALYSIS OF PREVIOUS
STUDIES USING THE VIRUS PLATFORMS AND *** VACCINES WAS
DISCUSSED. QUESTIONS OF BIOLOGICAL
PLAUSIBILITY INCREASING RISK AND WHETHER OR NOT THIS RISK APPLIES
TO OTHER FACTORS WERE DISCUSSED. A SPIRITED DISCUSSION OF THESE
QUESTIONS AS WELL AS FUTURE RESEARCH PATHWAYS THAT COULD BE
TAKEN TO ANSWER THE QUESTIONS RAISES.
A WRITTEN REPORT OF THAT MEETING WILL BE FORTHCOMING.
ON AUGUST 8, 2013, AND ARTICLE PUBLISHED ON "SCIENCE ONLINE"
DEVELOPED BY A CORPORATION AND TESTED IN THE NIAID CLINICAL
CENTER. THE VACCINE FOUND SAFE AND
EFFECTIVE AND SEEMED TO INDICATE THERE IS A DOSE DEPENDENT
IMMUNOLOGICAL THRESHOLD FOR THE DEVELOPMENT OF MALARIA IN THE --
GETTING DOWN TO THE DMID AREA ON SEPTEMBER 18,
2013, THE VTU SITE INITIATED MIX AND MATCH STUDIES OF THE H 7 N 9
VACCINES. THESE TRIALS WILL USE INFLUENZA
ANTIGEN FROM ONE MANUFACTURE AND ADMINISTER THIS ANTIGEN EITHER
UNAGE'S VENTED. AGE VENTED WITH ASO 3.
THERE ARE TWO TRIALS. ONE TRIAL WILL TEST NS 59 ALONE,
THE OTHER TRIAL TESTS MAINLY ASO 3 BUT WILL HAVE MF 59 ARMS.
THE TARGET ENROLLMENT FOR THE TWO TRIALS IS 1,700 SUBJECTS.
WE ARE APPROXIMATELY TWO-THIRDS THROUGH THE RECRUITMENT AT THIS
TIME. ON SEPTEMBER 26th A NEW ROUND OF
VTU AWARDS WERE ANNOUNCED AND THE LIST OF THE SITES WILL BE IN
MY, DELIVERED MINUTES. IN TERMS OF VACCINES IN
PREGNANCY, FOR THE LAST SEVERAL YEARS, DIFFERENT AREAS,
SPONSORED CLINICAL TRIALS THAT ENROLL PREGNANT WOMEN.
DESIGNING, IMPLEMENTING AND DOING DATA ANALYSIS OF THE
STUDIES, THEY'VE IDENTIFIED MULTIPLE CHALLENGES SPECIFIC TO
CONDUCTING RESEARCH IN THESE POPULATIONS.
TO ADDRESS THESE CHALLENGES, DMID CONTINUES TO SEEK
CONSULTATIVE INPUT FROM EXPERTS IN THE FIELD OF IMMUNING TO,
MEDICINE AND PK CLINICAL TRIALS AND REVEALER TO ISSUES.
DURING 2011 AND 2012, DMID ORGANIZED THREE CONFERENCES IN
ORDER TO DEVELOP A TEMPLATE FOR PROTOCOL DESIGN OF VACCINES
ADMINISTERED DURING PREGNANCY AND HARMONIZE ASSESSMENTS OF
ADVERSE EVENTS EMERGING DURING THESE STUDIES.
THE OUTPUT OF THESE MEETINGS HAS BEEN PUBLISHED IN TWO RELATED
ARTICLES AND AN EDITORIAL IN THE JOURNAL OF VACCINES.
GIVEN THE CDC'S EMPHASIS ON HPV, DMID WAS ALSO CONDUCTING A
TRIAL, ACTUALLY AN EPIDEMIOLOGICAL STUDY LOOKING
FOR THE TWEENERS. PEOPLE WHO START THEIR PROCESS
BUT DON'T COMPLETE IT ON TIME FOR HPB VACCINE TO SEE WHETHER
OR NOT THEIR VACCINES, THEIR, WE'LL CALL THEM ULTIMATE VACCINE
SCHEDULES ARE EQUALLY EFFECTED TO ONE THAT IS PRESENTLY
RECOMMENDED BY THE FDA. THANK YOU.
>> THANK YOU, DOCTOR.