Tip:
Highlight text to annotate it
X
>>> GOOD MORNING.
WELCOME TO THE SECOND DAY OF OUR OCTOBER 2013 ACIP MEETING.
AS MENTIONED YESTERDAY IN TERMS OF UNFINISHED BUSINESS,
I'LL HAVE DR. DEB WEKSLER COME TO THE MICROPHONE.
>> OKAY. THANK YOU.
HI, I'M DR. DEBORAH WEKSLER, EXECUTIVE DIRECTOR OF THE
IMMUNIZATION ACTION COALITION. WE RECEIVED FUNDING FROM ALL THE
VACCINE COMPANIES PRETTY MUCH, AND WE'RE PROUD OF IT AND HAPPY
ABOUT IT. AND ALSO FROM THE CENTERS OF
DISEASE CONTROL AND PREVENTION AND SEVERAL PRIVATE DONORS.
I'M HERE TODAY, I WANTED TO LET ACIP AND ALL OF YOU KNOW ABOUT
IAC'S NEW CAMPAIGN. IT'S CALLED GIVE BIRTH TO THE
END OF HEP-B. THE CAMPAIGN IS BASED ON THE
ACIP RECOMMENDATIONS OF THE YEAR 2005 TO MAKE SURE THAT
INFANTS ARE GIVEN THE BIRTH DOSE OF HEPATITIS B PRIOR TO HOSPITAL
DISCHARGE. THE REASON WE'RE ON THIS
CAMPAIGN IS BECAUSE RIGHT NOW ABOUT ONE OUT OF THREE INFANTS
ARE NOT RECEIVING THAT BIRTH DOSE BEFORE THEY LEAVE THE
HOSPITAL, AND THIS IS RESULTS IN APPROXIMATELY 800 BABIES GETTING
INFECTED -- BECOMING CHRONICALLY INFECTED WITH HEPATITIS B DURING
THAT FIRST YEAR OF LIFE. SO THIS CAMPAIGN IS TO HELP STOP
THAT. WHAT WE'VE DONE IS CREATED A
BOOK ABOUT 85 PAGES LONG OF A RESOURCE GUIDE ABOUT WHAT YOU
CAN DO, WHAT HOSPITALS CAN DO TO PROTECT NEWBORNS AND IT'S BEEN
ENDORSED BY THE CDC, THE AMERICAN ACADEMY OF PEAT YACHT
TRICKS, THE AMERICAN ACADEMY OF OBSTETRICIANS AND GYNECOLOGISTS.
IT'S FREE ON OUR WEBSITE AT
IMMUNIZE.ORG/PROTECT-NEWBORNS.
I HOPE YOU'LL LOOK AT IT. IN ADDITION TO CREATING THE BOOK
AND MATERIALS TO HELP HOSPITALS AND EDUCATE THEM ABOUT THE
RECOMMENDATIONS, BECAUSE WHAT WE'VE FOUND IS THAT A LOT OF
HOSPITALS AREN'T AWARE OF THE USE OF THIS GUIDANCE TO GIVE THE
BIRTH DOSE PRIOR TO DISCHARGE AND THAT IT'S A RECOMMENDATION
OF ALL THESE PROFESSIONAL SOCIETIES AND CDC.
WE'VE ALSO CREATED SOMETHING CALLED THE HEPATITIS B BIRTH
DOSE HONOR ROLL, AND WHAT THAT IS IS A LISTING ON IAC'S WEBSITE
OF HOSPITALS THAT HAVE IMPLEMENTED POLICIES TO GIVE THE
BIRTH DOSE TO EVERY NEWBORN PRIOR TO HOSPITAL DISCHARGE.
AND IT'S TO HONOR THOSE HOSPITALS THAT HAVE ACHIEVED 90%
OR GREATER RATE OF VACCINATING ALL NEWBORNS BEFORE HOSPITAL
DISCHARGE. AND I'M HAPPY TO SAY THAT THIS
WAS JUST LAUNCHED IN JULY AND WE JUST STARTED ADDING MORE
HOSPITALS IN SEPTEMBER AND WE HAVE 20 HOSPITALS RIGHT NOW THAT
WE'VE HONORED ON OUR WEBSITE WHO ARE ACHIEVING THE RATE OF 90% OR
MORE OVER A ONE-YEAR PERIOD AND WHO HAVE WRITTEN POLICIES IN
PLACE TO GIVE THE BIRTH DOSE. SO IF ANY OF YOUR HOSPITALS
ARE -- QUALIFY FOR THE BIRTH DOSE OR WOULD LIKE TO FIND OUT
MORE ABOUT THE BIRTH DOSE HONOR ROLL, I URGE YOU TO LOOK AT THE
WEBSITE, WHICH IS IMMUNIZE.ORG/PROTECT-NEWBORNS.
I HOPE WE'LL SEE MANY, MANY MORE HOSPITALS ON THE HONOR ROLL.
THANK YOU. >> THANK YOU, DEBORAH.
I JUST WANT TO GIVE A GENERIC THANKS TO ALL THE PARTICIPANTS
HERE FOR JUST WONDERFUL DISCUSSION ON BOTH THE
PNEUMOCOCCAL AND THE HER PIECE ZOSTER ISSUES.
I THINK THE INFORMATION WAS VERY USEFUL FOR OUR WORK GROUPS TO
TAKE BACK FOR FURTHER CONSIDERATION.
OUR NEXT TOPIC, I HAVE THE PLEASURE OF INTRODUCING JOHN
ABRAMSON WHO WILL BE TALKING ON GLOBAL IMMUNIZATION ISSUES.
DR. ABRAMSON IS ON THE FACULTY AT WAKE FOREST UNIVERSITY SCHOOL
OF MEDICINE. HE'S BEEN THERE SINCE 1981 AND
SERVES AS THE CHAIR OF THE DEPARTMENT OF PEDIATRICS AND
PHYSICIAN IN CHIEF AT BRENNER CHILDREN'S HOSPITAL SINCE 1996.
DR. ABRAMSON SERVED AS THE CHAIR OF THE AMERICAN ACADEMY OF
PEDIATRICS COMMITTEE ON INFECTIOUS DISEASE AND FROM 2003
THROUGH 2007 HE WAS A MEMBER OF ACIP SERVING FROM 2003 TO 2007
RIGHT AT THIS LOCATION. HE'S SERVED AS A MEMBER OF THE
WORLD HEALTH ORGANIZATION'S STRATEGIC ADVISORY GROUP OF
EXPERTS ON IMMUNIZATION AND AS OF SEPTEMBER 2013 HAS SERVED AS
CHAIR OF SAGE. AND THIS HAS TAKEN HIM DOWN THE
ROUTE OF SERVING AS CHAIR IN A LOT OF DIFFERENT CONTEXTS FOR
SAGE, INCLUDING THE COLORADO VACCINE MENINGOCOCCAL VACCINE
WORKING GROUPS AND PARTICIPATION WITH RUBELLA AND GLOBAL VACCINE
ACTION PLAN. SO CURRENTLY HE CHAIRS THE
VARICELLA VACCINE WORKING GROUP, A MEMBER OF THE INFLUENZA
SEASONAL AND PANDEMIC WORKING GROUP AND SERVING AS OUR ONLY
TECHNICAL -- SCIENTIFIC AND TECHNICAL ADVISORY GROUP FOR THE
GLOBAL ALLIANCE FOR VACCINES AND IMMUNIZATIONS.
WELCOME, JON. WE APPRECIATE YOUR WILLINGNESS
TO COME. >> GOOD MORNING.
IT'S GREAT TO SEE SO MANY OLD FRIENDS HERE, AND I DON'T MEAN
OLD BUT -- I GUESS WE ALL ARE GETTING THERE.
SO I THINK THAT WHAT I'M GOING TO TRY TO DO IS GIVE YOU A
LITTLE BIT WHERE THINGS STAND RIGHT NOW GLOBALLY, MAINLY OVER
ONE END OF THE ULTIMATE GOAL, WHICH IS DECREASING DEATHS IN
CHILDREN LESS THAN 5 BY 2/3. REMEMBER, THOSE WERE CREATED IN
2004 FOR A GOAL IN 2015 SO WE'RE MOVING THERE PRETTY QUICKLY.
THE DATA THAT USED THAT COMPARISON IN 1990 DATA AS THE
BASELINE DATA. SO, AFTER THAT I'LL GIVE YOU A
FEELING FOR HOW SAGE FUNCTIONS AND WHAT ITS ROLE IS AT THE
WORLD HEALTH ORGANIZATION AND ALSO IN MAKING GLOBAL
RECOMMENDATIONS WHICH GO TO THE DIRECTOR GENERAL.
AND I'LL TRY TO TAKE YOU THROUGH THE LAST THREE YEARS OF WHAT
WE'VE ACCOMPLISHED. I'M GOING TO SHOW YOU WHAT WE'RE
WORKING ON NOW. I'LL GIVE MORE OF THAT TALK
TOMORROW TO THE GLOBAL DIVISIONS.
I'M HAPPY AT THE END, I TRY TO LEAVE SOME TIME TO ANSWER ANY
QUESTIONS THAT YOU HAVE. SO --
SO I HAVE NO -- CONFLICTS.
SO THE EIGHT MILLENNIUM DEVELOPMENT GOALS
THAT THE WORLD IS FUNCTIONING UNDER RIGHT NOW HAD A BOLD
VISION FOR THE ENTIRE INTERNATIONAL COMMUNITY TO WORK
TOWARDS A COMMON END SO THAT HUMAN DEVELOPMENT REACHES
EVERYONE. MANY OF THESE GOALS ARE ONLY
PARTIALLY HEALTH SPECIFIC. SOME DEAL WITH EDUCATION, SOME
DEAL WITH POVERTY, BUT I REALLY DON'T INTEND TO GO THROUGH ALL
THE GOALS, BUT THEY WERE ADOPTED BY OVER 190 COUNTRIES IN 2000.
AS I SAID, THEY USED 1990 DATA AS THE SET POINT.
THEY HAVE 21 QUANTIFIABLE TARGETS MEASURED BY 60
INDICATORS, AND OF ALL OF THE MILLENNIUM DEVELOPMENT GOALS ARE
ACHIEVED, WORLD POVERTY WOULD BE CUT IN HALF.
THAT'S ALREADY OCCURRED. THAT GOAL HAS BEEN MET.
D.D TENS OF MILLIONSIVES MILLIONS HAVE BEEN SAVED BUT
WE'RE NOT AT THE TEN MILLION YET.
OLD HABITS DIE SLOWLY. SO, AGAIN, AS I SAID, THE GOAL
IS TO REDUCE DEATHS IN CHILDREN LESS THAN 5 AND IN 1990 THE
MORTALITY RATE IN CHILDREN LESS THAN 5 YEARS OF AGE WAS 160 PER
1,000 LOW INCOME COUNTRIES AS COMPARED TO 8 PER 1,000 IN
DEVELOPED COUNTRIES. BY 2012 THE MORTALITY RATE IN
LOW INCOME COUNTRIES WAS REDUCED TO 88 PER 1,000 IN CHILDREN LESS
THAN 5 YEARS OF AGE, 45% REDUCTION.
SO NOT AT THAT 2/3. GLOBAL DEATH DECREASED FROM 12
MILLION TO 6.6 MILLION. EACH -- BECAUSE OF THIS OR AS A
PART OF THIS, 17,000 FEWER CHILDREN DIE EACH YEAR IN 2012
THAN DID IN -- DIE EVERY DAY, SORRY, IN 2012 THAN DID IN 1990,
BUT STILL 18,000 CHILDREN LESS THAN 5 YEARS OF AGE STILL DIE
EVERY DAY IN 2012. MANY OF THESE DEATHS THAT ARE
STILL GOING ON ARE STILL VACCINE PREVENTIBLE, AND THAT'S WHERE
SAGE SPENDS ALMOST ALL OF ITS TIME.
THIS GIVES YOU AN IDEA OF THE RECENT DATA ON WHAT THE DEATH
RATE WAS PER 1,000 IN LIVE BIRTHS IN 2012.
AS YOU CAN SEE, MOST OF THE -- MOST OF THE ISSUES ARE IN
AFRICA, NO SURPRISE, AND ASIA. SO, TO DATE WE'VE SAVED 90
MILLION LIVES. 260 MILLION CHILDREN HAVE DIED
BEFORE AGE 5. IF WE ACHIEVE OUR MILLENNIUM
GOAL ON TARGET ON DATE, WE WOULD SAVE AN ADDITIONAL 3.5 MILLION
CHILDREN'S LIVES IN THE NEXT FEW YEARS.
IF CURRENT TRENDS CONTINUE IN ALL COUNTRIES OF THE WORLD, WE
WILL MILLENNIUM GOALS UNTIL 2028.
WHAT IS SAGE AND HOW DOES IT FUNCTION?
SAGE STANDS FOR STRATEGIC ADVISORY GROUP OF EXPERTS ON
IMMUNIZATI IMMUNIZATION.
THE WHO HAS A MANDATE TO PROVIDE LEADERSHIP ON GLOBAL POLICY,
STANDARDS AND NORMS AND TO SUPPORT COUNTRIES IN APPLYING
THESE NATIONAL NORMS. SAGE WAS ESTABLISHED BY THE
WORLD HEALTH ORGANIZATION DIRECTOR GENERAL IN 1999 TO BE
THE PRINCIPLE IMMUNIZATION ADVISORY GROUP AND SAGE PROVIDES
RECOMMENDATIONS ON GLOBAL POLICIES AND STRATEGIES FOR ALL
VACCINE PREVENTIBLE DISEASES. IT'S COMPOSED OF 15 MEMBERS.
THERE ARE SIX WORLD HEALTH ORGANIZATIONS WHICH DIVIDES THE
GLOBE INTO SIX REGIONS. THERE'S A BROAD RANGE OF
DISCIPLINES THAT ARE INVOLVED SO THE 15 MEMBERS DON'T ALL HAVE
THE SAME EXPERTISE. THERE'S A SPECTRUM OF
AFFILIATIONS GEOGRAPHICALLY AND DIVERSITY WIDE.
THAT'S CONSIDERED VERY IMPORTANT.
THE INITIAL TERM IS THE THREE YEARS YOU CAN HAVE ONE REPEAT
TERM. YOU CAN BE ASKED TO REPEAT IT,
AND THE ACTUAL CHAIR ACTUALLY SERVES FOR THREE YEARS.
SO WITHOUT TRYING TO GET INTO ALL OF THE ISSUES, THERE ARE
LOTS OF OTHER COMMITTEES THAT DEAL WITH GLOBAL IMMUNIZATION.
THERE'S THE SAFETY COMMITTEE. LINDA WHARTON HERE THE CDC IS
THE CURRENT CHAIR OF THAT. THERE'S AN EXPERT COMMITTEE ON
BIOLOGIC STANDARDS. THERE'S A COMMITTEE THAT LOOKS
AT WHAT VACCINE RESEARCH WOULD HELP MOVE MILLENNIUM DEVELOPMENT
GOALS FORWARD FASTER, WHAT WOULD HELP US GET TO OUR GOAL FASTER.
AND THERE ARE IMMUNIZATION PRACTICE ADVISORY COMMITTEES.
THERE ARE ALSO REGIONAL AND NATIONAL TECHNICAL ADVISORY
GROUPS. THE REGIONS ELECT THEIR OWN
PERSON AND THAT PERSON COMES -- ACTUALLY, PEOPLE FROM EACH
REGION COME TO SAGE AND THEY GET 15 MEMBERS,
BUT THEY CERTAINLY HAVE INPUT SAGE ISABOUT
AND WHAT SAGE'S RECOMMENDATIONS ARE.
SAGE MEETS -- ITS MAIN MEETINGS ARE TWO TIMES A YEAR.
USUALLY IN THE SPRING AND FALL. IT HAS LOTS OF WORKING GROUPS,
AND I'LL SHOW YOU SOME OF IT DOES HAVE, YOU KNOW,
ADDITIONAL MEETINGS WHERE SAGE MEETS TOGETHER OVER VARIOUS
ISSUES, SUCH AS WHEN WE HAD THE 2009 PANDEMIC AND ALSO OVER A
DECADE OF VACCINE PLANNING AND IT'S AN OPEN FORUM.
THEY HAVE LOTS OF OBSERVERS. GARVEY, WHICH IS THE GLOBAL
ALLIANCE FOR VACCINES AND IMMUNIZATIONS WHICH PROVIDE LOTS
OF MONEY. IT DOES THE FUNDRAISING TO GET
IN TO ALLOW US TO ACTUALLY GET OUR RECOMMENDATIONS
DOWN INTO THE ARMS OF CHILDREN. THERE'S UNICEF.
LOTS OF REGIONAL PEOPLE AND THERE'S LOTS OF OTHER PEOPLE IN
THERE. IT USUALLY HAS 300 PEOPLE AT THE
MEETING. IT ADDRESSES QUESTIONS AND --
THAT THE WORLD HEALTH ASSEMBLY MAY ASK US TO ADDRESS, IF WE
KNOW OF NEW VACCINES OR IF WE NEED NEW POLICIES ON OLD
VACCINES. THEY ARE EVIDENCE-BASED
RECOMMENDATIONS, AND THEY INFORM A COUNTRY.
THEY DO NOT SAY A COUNTRY HAS TO DO SOMETHING.
IN FACT, IF A COUNTRY WANTS TO USE, FOR INSTANCE, HUMAN
PAPILLOMA VIRUS VACCINE, A LOW INCOME COUNTRY, $1500 MEDIUM PER
CAPITA INCOME OR LESS, THAT COUNTRY WOULD HAVE TO WRITE WHAT
IT PLANS TO DO TO GAVI AND GAVI WILL SAY AYE OR NAY.
IF IT SAYS NAY IT WILL SAY WHAT THEY WANT ADDITIONALLY.
I TOLD YOU, OLD HABITS DIE HARD. IN ADDITION TO GRADING, WHICH
HAS BEEN GOING ON FOR THREE OR FOUR YEARS NOW, MAYBE EVEN FIVE
YEARS, THEY'RE STARTING TO COME UP WITH SOMETHING THAT I DECIDED
NOT TO PUT IN FRONT OF YOU BECAUSE IT'S REALLY NOT YET
READY FOR PRIMETIME, BUT IT'S BASICALLY LOOKING AT THE SIDE.
YOU CAN GRADE A LOT OF THINGS AND A LOT OF PEOPLE WHO GRADE
WHO PARTICIPATE IN THIS SOMETIMES GET FRUSTRATED THAT IT
DOESN'T TELL THE WHOLE STORY AND SO THE DECIDE MECHANISM IS
ANOTHER WAY OF LOOKING, WHAT'S THE REAL IMPACT AND OUR
VARICELLA WORKING GROUP IS THE FIRST GUINEA PIG TO TRY TO USE
THE DECIDE PART ON TOP OF THE GRADE TO REALLY SAY WHAT WE
THINK AN IMPACT WOULD BE OR NOT OF VARIOUS RECOMMENDATIONS.
ALL RIGHT. SO SAGE MAKES -- I'LL GO INTO
THIS A LITTLE BIT MORE. SAGE MAKES ITS RECOMMENDATIONS.
IT HAS INPUT FROM LOTS OF PEOPLE.
THE RECOMMENDATIONS GO UP TO THE DIRECTOR GENERAL.
I PERSONALLY DO NOT KNOW THE TIME WHEN TH
SAYS NO. ART WHO'S SITTING NOW AT ACIP IS
THERE THREE YEARS BEFORE I WAS AND SO HE MAY TELL ME THERE WAS
A TIME WHEN DIRECTOR GENERAL SAID NO, BUT THESE
RECOMMENDATIONS GO OUT AND THEN THEY GO IN FRONT OF THE WORLD
COUNTRIES AND LOTS OF TECHNICAL CAPABILITIES ARE PROVIDED TO
COUNTRIES WHO WANT THOSE -- OUR RECOMMENDATIONS.
SO SAGE INDEPENDENTLY REVIEWED IN 2008 AND BY REQUEST
OF THE DIRECTOR GENERAL AND THE CONCLUSION WITH SAGE
RECOMMENDATIONS HAVE BECOME A NECESSARY STEP TO THE
INTRODUCTION AND USE OF VACCINES, ESPECIALLY IN
DEVELOPING COUNTRIES, AND AS A CONSEQUENCE HAVE CLEAR AND
SIGNIFICANT IMPACT. THE INDEPENDENT RECOMMENDATION
RECOMMENDS THAT THE WHO TAKE IMMEDIATE STEPS TO CONSOLIDATE
AND BUILD ON THE SUCCESS OF SAGE AND RAPIDLY DISSEMINATE
RECOMMENDATIONS AT THE COUNTRY CARRIED OUT.
I'LL GET TO THIS BECAUSE THIS DEALS WITH THE VACCINES.
DECADE OF VACCINES. TO A LARGE EXTENT IT WAS STARTED
OUT BECAUSE GATES FOUNDATION WAS WILLING TO GIVE $10 BILLION OVER
THIS DECADE THAT WE'RE IN TO MOVING THIS ALONG, AND THE
VISION IS WE ENVISION A WORLD IN WHICH ALL INDIVIDUALS AND
COMMUNITIES ENJOY LIVES FREE FROM VACCINE PREVENTIBLE
DISEASE. THE MISSION IS TO EXTEND BY 2020
AND BEYOND THE FULL BENEFITS OF IMMUNIZATIONS TO ALL PEOPLE
REGARDLESS OF WHERE THEY'RE BORN, WHO THEY ARE OR WHERE THEY
LIVE. IT IS A UNIQUE MOMENT BECAUSE
THERE'S LOTS OF MONEY -- IT'S NOT ONLY BILL AND MELINDA GATES.
THERE YOU ARE. LOTS OF COUNTRIES GET TO GAVI.
LOTS OF OTHER INDIVIDUALS GET TO GAVI.
SO GAVI IS NOT ONLY GETTING MONEY FROM GATES.
SETH BERKOWITZ WHO'S THE SECRETARIAT OF GAVI IS AN
INCREDIBLY EFFECTIVE FUND-RAISER.
SO THERE'S A VERY SYMBIOTIC RELATIONSHIP BETWEEN GAVI, BILL
GATES, WHO. THEY'RE INDEPENDENT BUT IT WORKS
WELL. SO THE GOALS OF THE DECADE OF
VACCINE ARE ACHIEVABLE, WE'VE MISSED TWO DEADLINES.
WE HAVE ANOTHER ONE IN FRONT OF US AND IT'S IMPORTANT WE MEET
THAT. MEET VACCINATION COVERAGE
TARGETS IN EVERY REGION, COUNTRY AND COMMUNITY.
YOU CAN'T JUST LOOK AT A WHOLE COUNTRY AND SAY YOU HAVE 85%
IMMUNIZATION WHEN THE PRIMARY VACCINE AND THINK YOU'RE DOING A
GOOD JOB. THAT'S NOT GOING TO GET IT DONE.
EXCEED THE MILLENNIUM DEVELOPMENT TARGET FOR REDUCING
CHILD MORTALITY, MEET GLOBAL AND REGIONAL ELIMINATION TARGETS.
I'LL TELL YOU A QUICK STORY WHICH IS GIVEN WHERE WE ARE WITH
POLIO, AT THAT POINT AND THE POINT WE REALLY ARE RIGHT NOW,
WE WERE ASKED TO CONSIDER MEASLE ERADICATION.
AND THE ANSWER FROM SAGE, THERE WERE PEOPLE VERY UNHAPPY WITH
US, WAS THAT WE'RE NOT READY TO DO IT.
NOT READY TO DO IT FOR TWO THINGS.
WE HAVE TO GET POLIO DONE. AND, TWO, IS UNLESS WE FIGURE
OUT VACCINE IN EUROPE, WHICH IS VERY DIFFERENT THAN THE ISSUES
OF GETTING VACCINES TO AFRICA, UNLESS WE FIGURE OUT THAT, WE
CANNOT GET IT DONE. SO THE ANSWER WAS, NO, WE'RE NOT
READY. IT'S NOT SAYING WE'LL NEVER SET
AN ERADICATION DATE, BUT ELIMINATION TARGETS WERE SET FOR
FIVE REGIONS. AND DEVELOP AND INTRODUCE NEW
AND IMPROVED VACCINES AND TECHNOLOGY.
BEYOND ALL THE MONEY THAT GATES IS GIVING TO US AND TO -- NOT TO
SAGE ITSELF BUT TO THE VACCINE, HE'S ALSO WORKING ON
TECHNOLOGIES TO LOGISTICALLY HELP GET TECHNOLOGIES IN.
HE'S WORKING ON TECHNOLOGIES TO DEVELOP *** VACCINES, PV
VACCINES, MALARIA VACCINES. HE'S NOT WORKING ON THEM
HIMSELF, HE'S GIVING FUNDING. I THINK A VERY CLEVER FUNDING
MECHANISM, INCLUDING THE $100,000 WRITE TWO PAGES.
EVEN I WOULD TAKE THE TIME TO WRITE TWO PAGES IF I THOUGHT I
COULD GET $100,000. THE GLOBAL VACCINE PLAN IS
WHAT'S GOING TO ACHIEVE THE FIVE DECADE VACCINE GOALS.
I'M NOT GOING TO GO INTO ALL OF THE OBJECTIVES AND ACTUALLY
QUANTIFIABLE MEASURES, BUT IT'S A COLLABORATIVE EFFORT FOR ALL
OF THE BENEFITS OF THE VACCINE BY THE END OF 2012.
CHILDREN AND ADULTS. IT'S ENDORSED BY THE MEMBER
COUNTRIES BY THE WORLD HEALTH ASSEMBLIES.
I SHOULD SAY, SAGE HAS BEEN ASKED TO BE A WORKING GROUP AND
OVERSEE THE PROGRESS OF THE CIN. SO WHY NEW VACCINE PLAN
BEEN DEVELOPED FOR THE DECADE OF VACCINES?
OF THE THINGS WE HAVEN'T BEE
GET DONE. ELIMINATION OF MEASLES,
ERADICATION OF POLIO, MORE RAPID INTRODUCTION OF EXCELLENT
VACCINES INTORE RAPIDTRODUCTION OF
VA CONCEIVABLE NOW IN THIS DECADE WE'LL HAVE A
MALARIA VACCINE THE PREVIOUS GLOBAL IMMUNIZATION
STRATEGY IN THE LAST DECADE IS REPLACED BY THE
VACCINE ACTION PL THE GLOBAL VACCINE STRATEGY HAS
CREATED SOME OF THE MBCs BUT IT'S NO LONGER ADEQUATE TO MEET
WHAT WE'RE TRYING TO DO NOW. WE'LL STOP FOR A SECOND AND JUST
LET YOU LOOK AT THE DIFFERENCE OF FOCUS BETWEEN THE PREVIOUS
PLAN AND THE GLOBAL VACCINE ACTION.
ONE OF THE THINGS, ACCOUNTABILITY IS A HUGE ISSUE
AND I'VE WATCHED THIS OVER THE LAST FOUR OR FIVE YEARS.
THE COUNTRIES ARE BEING HELD MUCH, MUCH MORE ACCOUNTABLE FOR
THE MONEY THAT'S BEEN GIVEN. AND I THINK THAT'S A HUGE STEP
FORWARD. BUT YOU CAN SEE THE DIFFERENCE
BETWEEN THE VARIOUS PLAYERS. THEY FOCUS ON SIMILAR THINGS BUT
IT HAS MORE BREADTH AND DEPTH TO IT.
SO THERE'S COUNTRY OWNERSHIP, THEY HAVE TO OWN THE PLAN.
IF THEY WANT MONEY, FOR INSTANCE LOW INCOME COUNTRIES THAT ARE
FINANCED BY GAVI, IF THEY WANT MONEY, THEY HAVE TO WRITE THE
PLAN, THEY HAVE TO FOLLOW THE PLAN.
GAVI ACTUALLY HAS PEOPLE ON THE GROUND ENSURING THAT THAT'S
HAPPENING. SHARED RESPONSIBILITY AND
PARTNERSHIP. IT'S NOT JUST AN INDIVIDUAL,
IT'S NOT JUST THE COMMUNITY, IT'S NOT JUST THE COUNTRY.
ALL THE SHARING. EQUITABLE ACCESS.
THIS WAS A HUGE ISSUE WHEN WE WERE IN THE PANDEMIC AND WHAT
DEVELOPING COUNTRIES WERE GOING TO GET FROM THE SUPPLY OF
VACCINE THAT WAS COMING ALONG. INTEGRATION.
IT IS INCREDIBLY IMPORTANT THAT WE NOT JUST LOOK AT VACCINES,
VERTICAL PROGRAMS THAT DON'T HAVE ANY ABILITY TO HELP
MAXIMIZE HORIZONTAL HEALTH PROGRAMS THAT ARE GOING.
SO, FOR INSTANCE, IF WE'RE INTRODUCING HPV VACCINE INTO A
COUNTRY TO ADOLESCENTS, THERE ARE ALL SORTS OF HEALTH
EDUCATION GRANTS, STDs, OTHER THINGS WE CAN DO TO COINCIDE
WITH THAT PROGRAM. AND INNOVATION.
SO THE PROGRESS TO DATE. YOU CAN SEE THAT FOR SOME OF THE
VACCINES WE'RE AT A FAIRLY STABLE LEVEL.
YOU CAN ALSO SEE THAT THE MOST RECENT VACCINES THAT WE'VE
INTRODUCED, HIB, PCV, THEIR UPTAKE IS SLOWER.
PART OF WHAT THE DECADE OF THE VACCINE IS ABOUT IS TO MAKE THAT
CURVE WITH THE OTHER VACCINES MUCH SHARPER, MUCH QUICKER UP.
SO, WHAT HAVE WE DONE SINCE 2010?
THROUGH AN INCREDIBLY COMPLEX SET OF NEGOTIATIONS, DEAL,
THINKINGE WERE ABLE WE, THE GLOBAL WE, WERE ABLE TO GET
AND TO CONJUGATE A VACCINE, MENINGOCOCCAL A VACCINE.
THINK ABOUT THAT. IN AND COUNTR WROTE ALONG THE AFRICAN BELT,
I'LL SHOW YOU MORE OF THAT IN A SECOND SO I'LL WAIT
MINUTE, WE'VE DONE -- CONJUGATED PNEUMOCOCCAL VACCINE WHICH THE
UPTAKE HOPEFULLY WILL GO UP A LOT FASTER NOW.
WE ACTUALLY DRIVE THE PRICE DOWN FURTHER AND FURTHER.
DANGI, IT WAS NOT RECOMMENDED DUE TO A OF
THE CONCERN OF THE SECOND INFECTION MAY BE OFTEN WORSE
THAN THE FIRST INFECTION. HEPATITIS A, WE'VE DECREASED THE
COST BY RECOMMENDING ONE DOSE INSTEAD OF TWO.
NOW A LOT OF -- AND I'LL GO THROUGH THIS BIG TIME WHEN WE
LOOK AT ROTO VIRUS. THE RECOMMENDATION WE MADE TO
NOT USE ROTO VIRUS VACCINE WHEN WE NOTICED IT BACK IN THE 1990s
WAS -- I WILL STILL SAY WAS THE RIGHT DECISION FOR THE UNITED
STATES AND WE MADE IT AS CLEAR AS WE COULD IN OUR LAST
PARAGRAPH THAT WE DID NOT THINK THIS WAS THE RIGHT DECISION FOR
DEVELOPING COUNTRIES BUT FOR A GOOD PERIOD OF TIME WE DELAYED
THE IMPLEMENTATION OF IT. SO WHEN I SAY WE ARE, WE ARE
VERY -- WE LIKE THIS HEPATITIS A WINDOW.
DOESN'T MEAN IT'S RIGHT FOR THE UNITED STATES OR FOR ANOTHER
DEVELOPING COUNTRY. THOSE COUNTRIES -- OR FOR
ANOTHER DEVELOPED COUNTRY. THOSE COUNTRIES WILL MAKE THEIR
OWN DECISION. INFLUENZA, PREGNANT WOMEN GIVEN
HIGHEST PRIORITY. THAT'S A MARKED SHIFT FROM THE
2000 -- I'LL GO INTO THAT, THE 2005 PREVIOUS RECOMMENDATION,
THAT THOSE 55 AND OLDER WILL BE PRIORITIZED.
ROTOVIRUS, REMOVAL I'LL SHOW YOU SOME DATA ON THAT.
THAT WAS -- HAD LOT OF ETHICAL CONSIDERATIONS THAT WENT INTO
THAT DECISION. ENCEPHALIT
ENCEPHALITIS, THAT WAS A WHO RECOMMENDATION FOR THEGION.
YELLOW FEVER VACCINE, RECOMMENDED ON
NEEDED AND WE DON'T HAVE TO GET BOOSTERS.
THAT WAS TWO MONTHS AFTER I WENT TO AFRICA AND GOT A BOOSTER
DOSE. NOT HAPPY.
AND USE IN PREGNANT AND LACTATING WOMEN SHOULD BE
CONSIDERED BASED ON RISK/BENEFIT, NOT JUST
CONTRAINDICATED. IF WE'RE IN THE MIDDLE OF AN
OUTBREAK, MORTALITY IS 10 TO 30%, YOU MAY WANT TO THINK ABOUT
GIVING IT. SO WE'LL TALK A LITTLE BIT MORE
ABOUT THIS. SO EVERYBODY KNOWS WHERE IT IS.
THE AFRICAN BELT, 20 TO 30 MILLION PEOPLE LIVE THERE.
THE POPULATION IS VERY CONCERNED ABOUT THE OUTBREAKS
OF MAINLY MENINGA. IT'S NOT ONLY A.
SO THE EPIDEMICS OF TYPE A OCCUR EVERY 7 TO 10 YEARS.
IN 200988,000 CASES OCCURRED WITH 10,000 DEATHS.
IN A CONJUNCTION WITH THE GATES FOUNDATION A MASSIVE
IMMUNIZATION PROGRAM HAS BEGUN USING A CON GU GATED A VACCINE
AND HAS BEEN INITIATED FROM EVERYONE FROM 1 TO 29 YEARS OF
AGE. WE MADE THIS RECOMMENDATION.
INCLUDE PREGNANT WOMEN, INCLUDE LACTATING WOMEN.
ABOUT A MONTH LATER WE GOT CALLED TO A MEETING, NOT FROM
THE WHO STANDPOINT, SOME OUTSIDE GROUPS WERE NOT HAPPY WE WERE
RECOMMENDING FOR PREGNANT WOMEN. SO ONE OF THE ISSUES WE'LL BE
DEALING WITH IN NOVEMBER IS HOW TO CREATE A FRAMEWORK FOR THE
VACCINE. IN THE SIX COUNTRIES WHERE THE
VACCINE HAS BEEN USED TO DATE, THE DISEASE INCIDENCE HAS
DECREASED BY 95% OR GREATER. THIS IS THE FLU.
THIS TABLE BASICALLY SAYS HOW WE CAME TO THIS CONCLUSION, AND
THAT IS WE WEIGHED THE RISK GROUPS, WE TOOK THE RISK GROUPS
AND WEIGHED THE FEASIBILITY OF DELIVERY, THE VACCINE
EFFECTIVENESS AND INDIRECT BENEFIT.
OF COURSE, WE'VE LEARNED A LOT SINCE 2005 ABOUT HIGH MORTALITY,
HIGH MORBIDITY IN PREGNANT WOMEN.
SO THE DISEASE SEVERITY WAS SUBSTANTIAL.
VACCINE EFFECTIVENESS LOOKS GOOD.
THERE'S AN INDIRECT BENEFIT THAT'S SUBSTANTIAL IT APPEARS
THROUGH INFANTS BORN TO THOSE MOMS WITH PROTECTION.
SO FOR MANY REASONS WE SWITCHED IT.
THE FEASIBILITY WAS A BIG ISSUE FOR US BECAUSE GIVEN TETANUS
PLATFORM, WE COULD JUST BUILD ON TOP OF THAT.
IT'S NOT THAT WE DON'T RECOMMEND THESE OTHER GROUPS, BUT IF ALL
YOU'RE GOING TO DO IS BRING THEM, YOU KNOW, A FEW MILLION
DOSES OF VACCINE TO THE WE RECOMMEND YOU PRIORITIZE
THOSE. SO THIS IS THE RECOMMENDATION AS
IT COMES OUT. ALL THE OTHER GROUPS I SHOWED
YOU ARELET COUNTRIES PICK FROM BECAUSE THEY DON'T HAVE ENOUGH
VACCINE. ROTO VIRUS.
SO, IN 2009 WHO RECOMMENDED ROTO VIRUS VACCINE FOR INFANTS
INCLUDING ALL NATIONAL PROGRAMS. DUE TO THE CONCERNS ABOUT IN ITS
INCEPTION THE FIRST DOSE WAS RECOMMENDED TO BE GIVEN BEFORE
15 WEEKS AND THE LAST DOSE BY 32 WEEKS.
DATA STARTS POURING IN. HOW MANY CHILDREN BECAUSE OF
THAT RESTRICTION, HOW MANY CHILDREN ARE WE NOT IMMUNIZING?
SO WE REMOVED IT BASED ON THE FOLLOWING DATA.
AND THESE WERE VERY CONSERVATIVE ESTIMATES.
WE MINIMIZE CONSERVATIVELY THE NUMBER OF DEATHS AVERTED.
WE INCREASED PROBABLY BY ALMOST SOMEWHERE AROUND 5 TO 10 FOLD
THE INCEPTION RATE THAT WE THOUGHT WAS OCCURRING, NOW WE'RE
TALKING ABOUT THE TWO NEW ROTO VIRUS VACCINES.
SO IT LOOKS LIKE THIS. YOU ESTIMATE, OBVIOUSLY THERE'S
RANGES, 43,000 LIVES SAVED FOR 317 AGAINST.
VERY CONSERVATIVE NUMBER. IT'S PROBABLY A HIGHER NUMBER OF
LIVES SAVED. A VERY CONSERVATIVE NUMBER FOR
INCEPTIONS, PROBABLY NOT THAT HIGH.
AND WE HAD A LOT OF DISCUSSION, AND SAGE WORKS BY CONSENSUS.
IT DOES NOT WORK BY VOTES. IT'S DIFFERENT.
I TOLD LARRY ONE TIME, HOW DID THAT HAPPEN?
AND IT ACTUALLY WORKS WELL BY CONSENSUS.
AFTER LISTENING TO ALL THE INPUT FROM SAGE MEMBERS, OTHER PEOPLE
INCLUDED IN THE REGION, IT MOVES FORWARD AND IT MAKES PRETTY BOLD
RECOMMENDATIONS. SO THIS WE ARE RECOMMENDING FOR
DEVELOPING COUNTRIES TO TAKE A RESTRICTION OUT.
YELLOW FEVER. THIS PAST APRIL AT THE LAST
MEETING WE RECOMMENDED THAT ONLY ONE RATHER THAN TWO DOSES IS
NEEDED TO PROVIDE LIFELONG PROTECTION AND THAT THE VACCINE
SHOULD BE CONSIDERED TO BE USED IN PREGNANT AND LACTATING WOMEN
BASED ON A RISK VERSUS BENEFIT CONSIDERATION.
THAT'S A HUGE STEP FORWARD IN THE SENSE OF WE'VE DONE THIS NOW
FOR AN ACTIVATED VACCINE OR FOR COMMON TYPE VACCINES.
WE HAVE NEVER DONE THIS FOR A LIVE VACCINE.
THE REASON IS IS YOU'RE IN AN OUTBREAK, THE MORTALITY IS
SOMEWHERE BETWEEN 10 AND 30%. YOU GET THE DISEASE.
THAT'S A VERY HIGH MORTALITY. AND WHAT WE KNOW IS THAT
SOMEWHERE CLOSE TO 600 MILLION DOSES.
LET ME PUT THIS ALL IN AND THEN I'LL TELL THE STORY.
WHAT WE KNOW IS AFTER 600 MILLION DOSES HAVE BEEN GIVEN
OUT WE DO NOT KNOW OF A SINGLE CASE OCCURRING IN A PREGNANT
WOMAN. WE DO KNOW OF THREE CASES
OCCURRING IN MOMS WHO ARE BREAST FEEDING AND THEIR BABIES.
STILL, IT'S NOT SAYING YOU HAVE TO USE IT.
IT'S NOT SAYING THAT EVERY INFANT IT SHOULD BE USED.
PROBABLY THE YELLOW FEVER CAMPAIGN PREVENTION, YOU MIGHT
HAVE A DIFFERENT EQUATION, BUT IT GIVES THE ROUTE THE FIRST
TIME, A LIVE VIRUS VACCINE IN A PREGNANT WOMAN.
ALL RIGHT. SO BASICALLY I JUST TOLD THAT
STORY. ALL RIGHT.
HIGHLIGHTS ONION GOING TOPICS. SO WE HAVE A WORKING GROUP ON
GLOBAL VACCINE ACTION PLAN. THE FIRST REPORT OUT FROM THIS
WORKING GROUP WILL BE IN TWO WEEKS AT THE NOVEMBER SAGE
MEETING. WE HAVE HEPATITIS WORKING GROUPS
THAT ARE FORMED TRYING TO HAVE THE HEPATITIS VACCINE.
IT IS ACTUALLY TRYING FOR THE FIRST TIME TO THINK ABOUT
MARKETING GLOBALLY RATHER THAN NATIONALLY.
WE HAVE A MALARIA VACCINE GROUP THAT WORKS IN CONJUNCTION WITH
THE -- I KNOW THE MALARIA ADVISORY GROUP AND WILL COME
BACK PROBABLY IN 2015 AND MAKE ITS RECOMMENDATIONS.
SOME OF YOU HAVE SEEN THE DATA THAT JUST RECENTLY REPORTED OUT.
YOU HAVE A 50% EFFICACY IN A VACCINE, THAT'S NOT GREAT,
THAT'S TRUE, BUT YOU ALSO HAVE A LOT OF DEATHS SO IT'S GOING TO
BE AN INTERESTING CONVERSATION. THE PERFECT TUS SES VACCINE, FOR
THE MOMENT WE RECOMMEND TO COUNTRIES TO HALT THE SWITCH TO
PERTUSSIS VACCINE WHILE WE'RE SEEING WHAT THE REAL ISSUES ARE
IN PROTECTIONS AND EFFECTIVENESS.
TALKED ABOUT -- WELL, I TALKED ABOUT THAT.
I THINK I'LL SHOW YOU THIS IN POLIO.
WE'RE WORKING ON THE VACCINE RECOMMENDATIONS IN 2014, VARY
CELL LA AND ZOSTER. VERY TOUGH ISSUES AND WE HAVE
LITTLE DATA FROM AFRICA AND WORRIED ABOUT AN IMPACT IF WE
ONLY GET A CERTAIN PERCENTAGE OF THE POPULATION IMMUNIZED.
WE ALSO ARE WORKING ON THE ZOSTER VACCINE AND ALL OF THIS
IN THE MIDST OF WHERE WILL COUNTRIES PRIORITIZE THIS.
VACCINE WORKING GROUPS HAS BEEN WORKING FOR A YEAR.
DON'T KNOW WHAT THE PLAN IS. I WILL SAY THE POLIO GROUP IS
COMING UP WITH SOME VERY GOOD METHODOLOGIES FOR OVERCOMING
SOME OF THE TYPES OF TENDENCIES THAT ONE MIGHT SEE IN AFRICA OR
ASIA. I DON'T KNOW WHERE THE PROGRESS
IS ON THE TYPES THAT WE'RE SEEING IN PLACES LIKE EUROPE.
VERY DIFFERENT SPECIES. VACCINE NOT SPECIFIC EFFECTS.
THE QUESTION OF THERE'S BEEN SOME REPORTS OUT THERE THAT IF
YOU GIVE CERTAIN VACCINES, YOU ACTUALLY DECREASE DISEASE AND
DEATHS DUE TO OTHER DISEASES NOT IN THAT VACCINE AND IN SOME
CASES INCREASE DISEASES AND DEATHS.
ALL RIGHT. SO POLIO, OBVIOUSLY I'M MISSING
SOMALIA, I THINK I HAD TO DRAW THE THING, SO THERE'S OBVIOUSLY
A MAJOR OUTBREAK IN SOMALIA RIGHT NOW.
INDIA HAS BEEN NOW WELL PAST A YEAR, MAYBE COMING IN ON TWO
YEARS IT'S BEEN POLIO FREE. THAT'S A HUGE STEP.
HAD A LOT TO DO WITH TWO THINGS, BIVALENT OPV AND ACCOUNTABILITY.
THEY WENT IN AND FIRED PEOPLE WHO WEREN'T ACTUALLY DOING THEIR
JOB. THERE ARE INACCESSIBLE AREAS
RIGHT NOW THAT ARE VERY DIFFICULT.
I MEAN, POLIO WORKERS HAVE BEEN KILLED.
WE KNOW THAT THERE ARE -- IN NIGERIA IN THE LAST YEAR OR SO,
WE KNOW THAT ALL OF A SUDDEN WE'RE GOING TO AN INACCESSIBLE
AREA AND WE FIND 211 CASES THAT ARE COMPATIBLE BUT ARE NOT
CONFIRMED AND CAN'T BE CONFIRMED.
VERY CONCERNED ABOUT THIS AS WE TRY TO ERADICATE POLIO FROM THE
WORLD. CONGO OUTBREAK.
THE THREE ENDEMIC COUNTRIES. AFGHANISTAN.
THAT'S GOOD. IT'S BEING CAUSED BY LINKAGE
ACROSS THE PAKISTANI BORDER. THERE ARE STILL
AREAS SO IT'S A MAJOR PROBLEM.
>> BASICALLY THE PROBLEM FOR LACTATING WOMEN, THE RECENT
VACCINES ARE NOT ALWAYS GIVEN TO PREGNANT WOMEN OR WOMEN THAT ARE
LACTATING THAT COULD BENEFIT THEM AND THEIR INFANTS.
AN EXAMPLE IS INFLUENZA, YELLOW FEVER AND PERTUSSIS.
THE SITUATION CONTINUES TO EXIST.
WHEN I WAS CHAIR OF THE ACIP I ACTUALLY ASKED THEM TO LOOK AT
THE ISSUE OF PREGNANCY, AND I THOUGHT I KNEW WHAT PEOPLE WERE
COMFORTABLE DOING. SO THE COMPANY -- WHAT HAPPENS
AND WILL CONTINUE TO HAPPEN UNTIL WE DO SOMETHING ABOUT IT
IS THE COMPANY WILL EXCLUDE PREGNANT WOMEN FROM TRIALS DUE
TO LITIGATION. THE REGULATORY AGENCY GIVES
ESSENTIALLY NO DATA FOR PREGNANT WOMEN.
THE PREGNANCY REGISTER YOU'RE REQUIRED TO HAVE DECADES GO BY.
THAT'S A BIG PROBLEM. REMEMBER, WE BEAT THIS IN DRUGS
FOR CHILDREN. IN THE UNITED STATES WE OVERCAME
THIS ISSUE BY DIRECTLY GOING TO CONGRESS AND SAYING, HERE'S THE
PROBLEM. 80% OF THE DRUGS YOU'RE USING IN
CHILDREN ARE NOT LABELED. THE DRUG IS NOT BEING STUDIED IN
CHILDREN. THIS HAS GOT TO END.
SO THERE WERE VARIOUS APPROACHES TO THINK ABOUT THIS.
AT THE NOVEMBER SAGE MEETING WHEN YOU THINK ABOUT WHAT
FRAMEWORK WE COULD USE TO MOVE THIS FORWARD.
WE DO HAVE SOME REGULATORY AGENCIES TELLING US THEY'RE VERY
INTERESTED IN MOVING THIS FORWARD.
ALL RIGHT. UT WHAT HAPPENED
IN CHILDREN. AND WE TALKED ABOUT WHY WE'RE
CONCERNED. WE TALKED ABOUT THAT.
OKAY. SO I HAVE TO ACKNOWLEDGE LARRY
PICKERING EQUIVALENT AT SAGE, PHIL DECLOSE.
I BELIEVE AS MUCH TIME I SPENT WITH LARRY AND AS GOOD AS I
THINK HE IS, PHIL I THINK IS HIS EQUAL.
THAT'S SAYING SOMETHING. HELEN REESE WHO'S IMMEDIATE PAST
CHAIR. I'VE SEEN A LOT OF LOT OF CHAIRS
IN MY DAY OF ORGANIZATIONS. I'VE NEVERANYONEGIFTS THAT SHE .
SO LET ME OPEN IT UP TO QUESTIONS.
>> WE'RE OPEN FOR ANY COMMENT OR QUESTION.
>> THANK YOU FOR THAT COMPREHENSIVE UPDATE.
REALLY FASCINATING. CONGRATULATIONS ON THE PROGRESS
THAT YOU'RE MAKING AND SOME OF THE GREAT THINGS THAT YOU'RE
PLANNING. DR. JEFF DUCHIN.
THE QUESTION I HAVE IS ABOUT SURVEILLANCE.
I KNOW JUST TO MY KNOWLEDGE OF THE MEASLES RUBELLA INITIATIVE
THAT SURVEILLANCE IS A FORMAL PIECE OF THE APPROACH, AND YOU
DIDN'T -- YOU KNOW, PROBABLY THE TIME TO TALK ABOUT THAT PIECE.
I'M WONDERING IF YOU CAN COMMENT ON, YOU KNOW, HOW THAT'S WORKING
OUT AND WHETHER THAT'S INTEGRATED AT ALL WITH WHAT'S
BEING REQUIRED THROUGH THE REVISED INTERNATIONAL HEALTH
REGULATIONS. >> NO MATTER IT'S BETTER, WE'RE
NEVER HAPPY WITH IT. KATE O'BRIEN IS PRESENTING AT
SAGE IN NOVEMBER A SESSION ON HOW TO MAKE IT BETTER.
THERE'S A WORKING GROUP WORKING ON THAT.
PART OF IT IS WHERE DO YOU SPEND YOUR MONEY, RIGHT?
WITH ROTO VIRUS AT ONE POINT WE WERE -- SOME GROUPS WERE SAYING
YOU HAVE TO DO SURVEILLANCE IN EVERY COUNTRY BEFORE YOU
RECOMMEND. WE DON'T BUY THAT EQUATION, BUT
DO WE THINK IT'S GOOD ENOUGH RIGHT NOW?
NO. AND, AGAIN, WE THINK THAT THERE
ARE WAYS OF IMPROVING IT AND THERE ARE TECHNIQUES AND TOOLS
NOW THAT ARE MORE AVAILABLE BY THE ROADSIDE, IF I CAN USE THAT
TERM THAT MAY HELP SUBSTANTIALLY.
>> DR. HARRISON? >> YES.
I WAS CURIOUS ABOUT THE THOUGHTS AMONG SAGE MEMBERS ABOUT, YOU
KNOW, GIVEN THE SUCCESS OF THE A CONJUGATE VACCINE, THE FOCAL
OUTBREAKS OF X DISEASE. WHAT'S THE THINKING AMONG SAGE
MEMBERS THERE? >> THERE ARE REALLY TWO PARTS TO
THAT QUESTION. WE WERE WORRIED THAT IF WE WIPED
OUT A WOULD WE SEE MORE OF SOMETHING ELSE, RIGHT?
THERE'S ACTUALLY V. THERE'S A BUNCH OF OTHER SUR
TYPES THERE OR SUR GROUPS THERE AND I'M NOT SURE WE KNOW YET THE
ANSWER TO THAT QUESTION. AS FAR AS I KNOW, THEY'RE STILL
TRYING TO GET INTO -- WE'VE DONE SIX AND WE HAVE 15, SOMETHING
LIKE THAT. THEY'RE TRYING TO GET THROUGH
THIS PROCESS OF GETTING THE A. AND THEN IF WE SEE ANYWHERE NEAR
THE NUMBERS WE SAW WITH A, THEN I THINK WE'LL GO BACK.
AND THERE ARE MORE AND MORE COMPANIES GLOBALLY BEING --
VACCINE COMPANIES. CHINA I THINK IS ABOUT TO TAKE
OFF AS A GLOBAL MAKER OF VACCINES.
AND SO I HAVEN'T GOTTEN INTO -- IF YOU'RE INTERESTED AND YOU'RE
HERE IN TOWN ON FRIDAY, I'M TALKING TO GLOBAL DIVISION.
THERE'S A LOT OF WORK BEING DONE ABOUT MARKET SHAPING, HOW YOU
SHAPE THE MARKET, HOW YOU STILL WORK WITH COMPANIES AND GET THE
PRICE DOWN TO SATISFY THEM BY VOLUME AND SOME OTHER THINGS,
AND WE'RE GOING TO HAVE A LOT OF DISCUSSION AROUND THAT BECAUSE
ALL OF THIS -- THE A WAS CONTINGENT ON GETTING THIS
VACCINE FOR 50 CENTS. THAT'S WHAT IT WAS CONTINGENT
ON, AND I HOPE WE DON'T HAVE TO GO THROUGH ALL OF THE THINGS WE
WENT THROUGH TO GET THAT DONE, BUT THAT'S A BIG ISSUE.
>> DR. BAKER AND THERE DR. PODKIN.
>> JON, THANKS FOR THE NICE REVIEW.
I HAVE A QUESTION AND ONE COMMENT.
MY QUESTION IS IN A SIMPLE WAY HOW DO YOU MANAGE TO GET PEOPLE
IN THE DEVELOPING WORLD TO IMMUNIZE PREGNANT WOMEN?
IN OTHER WORDS, WE MAKE RECOMMENDATIONS HERE IN THE
UNITED STATES AND IT JUST DOESN'T HAPPEN, BUT HOW DOES IT
ACTUALLY HAPPEN FOR TETANUS, WHATEVER YOU WANT TO SAY,
INFLUENZA? >> SO ARGENTINA AND BRAZIL WERE
POINTED OUT THAT THEY ACHIEVED -- IN THE FIRST YEAR OF
OUR RECOMMENDATION THEY ACHIEVED ONLY 50%, SIMILAR TO WHAT THE
UNITED STATES ACHIEVED. IN THEIR SECOND YEAR IN
ARGENTINA AND BRAZIL THEY ACHIEVED 90% SO IT'S MASS
CAMPAIGN, IT'S COMMUNICATION THAT FITS NOT ONLY THE COUNTRY
BUT ALSO FITS THE COMMUNITY. IT'S ALL ABOUT COMMUNICATION AND
IT'S NOT ONLY COMMUNICATION TO THE DOCTORS, WHICH HELPS, DON'T
MISUNDERSTAND ME. I THINK IN THE UNITED STATES I
THINK MOST OBs NOW BUY IT. I DON'T FIND A LOT OF OBs
TELLING ME WHY ARE WE GIVING FLU VACCINES.
WE MAKE IT MANDATORY IN OUR INSTITUTION FOR EMPLOYEES.
>> WELL, BUT YOUR EMPLOYEES ARE NOT PREGNANT WOMEN SO --
>> WELL -- >> I SEE THE BARRIER IN THE
UNITED STATES BASED ON SURVEY DATA, NOT THE WOMEN ONCE THEY'RE
EDUCATED, BUT THE PROVIDERS. >> YES.
SO AS I SAY, I THINK POTUS LED THE WAY ON THIS.
IT'S MATCHING EDUCATI COMMUNITY.
AND YOUR COMMENT? >> WELL, MY COMMENT IN GENERAL
ABOUT MATERNAL IMMUNIZATION. I UNDERSTAND PRESENTING THE IDEA
TO COMPANIES FOR MORE THAN 30 YEARS.
FOR THE FIRST FIVE I HEARD LITIGATION, WHICH WAS COMPLETELY
FAIR, AND THEN SOME WISE PEOPLE SAID, WELL, YOU NEED TO GET
CONGRESS TO DO IT. AND I SAID TO MYSELF, THEY
DIDN'T TEACH ME HOW TO GO TO -- IN MEDICAL SCHOOL HOW TO GO TO
CONGRESS AND GET LEGISLATION DONE SO, YOU KNOW, I DON'T KNOW
HOW TO GET THE JOB DONE THERE. THERE ARE SOME DISEASES THAT CAN
BE DONE AND I DON'T SEE A PATHWAY TO LICENSURE OF NEW
VACCINES THAT MIGHT PREVENT MATERNAL AND BABY DISEASE BASED
ON EFFICACY TRIALS BECAUSE SOME OF THESE DISEASES HAVE A LOW
INCIDENCE IN THE UNITED STATES BECAUSE THERE'S OTHER MEASURES,
HYGIENE, NUTRITION, ANTIBIOTICS, PROPHYLAXIS, ETC.
IN THE DEVELOPING WORLD THE PROBLEM IS ATTAINMENT.
PREGNANT WOMEN, THEIR LIFE IS AEs SO, YOU KNOW, ASSURING
SAFETY WITH ALL THAT NOISE, ACTUALLY GETTING BLOOD DRAWS
FROM MOTHERS AND BABIES OR EVEN DOING BLOOD CULTURES OR VIRAL
CULTURES IN BABIES. ASCERTAINMENT OF REAL DISEASE IS
A BIG PROBLEM, SO I DON'T SEE -- IT'S NICE THAT THE REGULATORY
AGENCIES ARE SMILING, BEING POLITE, NOT SLAMMING THE DOOR,
ALL THESE NICE WORDS, BUT, YOU KNOW, IT'S A BIG CHALLENGE.
>> LET ME JUST FOLLOW UP A LITTLE BIT ON THAT.
TO SAY THAT THE FRAMEWORK -- ONE OF THE FRAMEWORKS WE MIGHT COME
AWAY WITH, I DON'T KNOW WHAT WE'RE GOING TO DO IN NOVEMBER.
THIS WILL BE THE FIRST DISCUSSION OF IT, IS TO LOOK AT
INACTIVE VATING VACCINES OR SEPARATE FROM LIVE VACCINES,
RIGHT? LOOK AT ADJUVENTED VACCINES AND
TAKE THAT FRAMEWORK AND SEE IF WE CAN COME UP WITH AGREEMENT,
FOR INSTANCE. WHEN THEY CAME TO ME AND SAID
HOW COULD YOU USE A MENINGOCOCCAL VACCINE ON A
LACTATING WOMAN? I'M GOING, WHAT BIOLOGICAL
REASON ARE YOU TELLING ME I CAN'T DO THAT?
THAT'S THE FRAMEWORK I'M TALKING ABOUT.
IN THE MEANTIME, WHEN YOU START DOWN THIS ROAD, YOU PUSH PEOPLE
ALONG THE WAY, I DON'T MEAN THAT IN A BAD WAY, I MEAN IT IN A
GOOD WAY, HOPEFULLY WE'LL MOVE IT ALONG.
WE DIDN'T HAVE TO LOBBY CONGRESS.
WE WENT TO THE NAP AND GOT SOME HELP.
>> DR. PLEXTON. >> WELL, JON.
[ INAUDIBLE ] [ INAUDIBLE ]E SECOND QUESTION
SAGE EVER LOOKED AT HAVING A MILLION DOLLARS A YEAR IN
TOTALLY ERADICATING? REALLY SERIOUS.
WE ALL WANT THE END TO POLIO, BUT WHAT CAN YOU DO WITH
MILLION DOLLARS SPENT ON [ INAUDIBLE ]
[ INAUDIBLE ] THAT IS SPONSORING A SERIES OF
MEETINGS. THE FIRST ONE WILL BE HELD IN
FEBRUARY AT THE SCRIPPS INSTITUTE AND THE IDEA WILL BE
TO ATTACK THE PROBLEMS THAT WE HAVE WITH CURRENT VACCINES AND
FUTURE VACCINES TO PRODUCE PROLONGED AND POTENT IMMUNE SPO.
THE SECOND IS AN INITIATIVE BY NIH ALSO WHICH WILL START NEXT
YEAR WITH MEETINGS LOOKING AT THE IMMUNOLOGICAL ISSUES WITH
RESPECT TO VACCINATION, WHY SOME OF OUR VACCINES ARE IMPERFECT.
ALSO, I WOULD SUGGEST THAT SAGE LOOK AT THE VACCINE INDUSTRY AS
A WHOLE. THAT IS, THE ISSUE OF SUPPLY,
THE WORLD SUPPLY OF VACCINES, WHERE IS THAT GOING TO COME FROM
TO IMMUNIZE THE WHOLE WORLD'S POPULATION, AND, SECONDLY, THE
ISSUE OF WHERE IS INNOVATION GOING TO COME FROM.
AS YOU KNOW, THERE ARE MANY NEW VACCINE MANUFACTURERS IN
DEVELOPING COUNTRIES, BUT BY AND LARGE THEY ARE NOT DOING
INNOVATIVE RESEARCH. MEANWHILE, THE MANUFACTURERS IN
A DEVELOPED COUNTRY IS CUTTING DOWN THEIR R AND D.
SO WE HAVE A REAL ISSUE AS TO WHERE NEW VACCINES ARE GOING TO
COME FROM. AND I THINK THAT THE WORLD,
WHICH IS ESSENTIALLY YOUR COMMITTEE, NEEDS TO LOOK AT THIS
ISSUE AND HOW TO PROMOTE INNOVATION.
IT'S AN ISSUE THAT I THINK IS GOING TO LOOM VERY LARGE IN THE
NEAR FUTURE. >> YOU MAKE A LOT OF GOOD
POINTS. LET ME GO BACK TO THE MEASLES
AND RUBELLA. I'M GIVING A TALK TO THE GLOBAL
DIVISION ON FRIDAY AND I REALIZED WHEN I SENT THIS IN I
LEFT OUT MEASLES. WE HAVE BEEN WORKING ON MEASLES
AND RUBELLA. WE'VE SAID STOP USING MEASLES,
ONLY USE MEASLES AND RUBELLA. IN MANY WAYS, THAT MAKES A TON
OF SENSE. AND THOSE -- THE WORKING GROUP
IS STILL ACTIVE. IT'S STILL WORKING ON IT.
IT HAS ISSUES THAT IT'S TRYING TO DEAL WITH.
SOME OF THEM ARE NOT THE SIMPLE QUESTION -- NOT THE -- SIMPLE.
NOT THE QUESTION OF ELIMINATION VERSUS ERADICATION, BUT CAN WE
GET ENOUGH MONEY TO GO IN AND IMMUNIZE WITH AN MR VACCINE ON
AN SIA, A SUPPLEMENTAL IMMUNIZATION, TO DO IT NOT JUST
TO 5, TO 15. SO WE'RE WORRIED ABOUT SHIFTING
AGES AS WE ARE IN VARICELLA. AS FAR AS YOUR POLIO QUESTION, I
CAN'T TELL YOU HOW MANY TIMES HOW MANY SAGE MEMBERS HAVE ASKED
THAT QUESTION ABOUT WE'RE SPENDING A BILLION DOLLARS RIGHT
NOW TO ELIMINATE A COUPLE HUNDRED CASES A YEAR BUT THERE
IS SUCH MAJOR -- I DON'T WANT TO USE THE WORD JUST POLITICAL.
POLITICAL, SOCIAL IMPLICATIONS OF FAILING AT THIS THAT IS THE
REASON WHY SAGE RECOMMENDED CALLING IT A PUBLIC HEALTH
EMERGENCY. IF WE FAIL THIS TIME, WE WILL
NOT BE ANYWHERE CLOSE. WE WILL HAVE A TERRIBLY HARD
TIME GETTING ANYBODY TO THINK ABOUT MEASLES ERADICATION.
IF YOU ASK ME BACK TWO DECADES AGO LOOKING BACK SHOULD WE HAVE
DONE MEASLES BEFORE POLIO, IT'S AN INTERESTING QUESTION.
IN A LOT OF WAYS IT WOULD HAVE BEEN TECHNICAL LY EASIER.
I SYMPATHIZE WITH THE QUESTION OF A BILLION DOLLARS.
I UNDERSTAND THE QUESTION. I THINK WE HAVE TO ERADICATE THE
DISEASE OR PROVE WE CAN. WE ARE USING A TREMENDOUS AMOUNT
OF EFFORT AND ENERGY TO DO THIS. THAT'S ALL I CAN SAY.
>> DR. QUICK COMMENTS IN RESPONSE TO THE POINTS OF DR.
PLODKIN. THE POLIO EE RAD CASE INITIATIVE
IN ADDITION TO THE INTENSE FOCUS ON ENDING TRANSMISSION HAS A
COMPONENT OF PLANNING AND EFFORT RIGHT NOW FOCUSED ON THE LEGACY
OF POLIO AND REALLY PLANNING HOW TO CAPITALIZE ON THE ENORMOUS
INVESTMENTS AND CAPACITIES THAT POLIO EE RAD CASE IS -- HAS BEEN
CREATING AND MAKES SURE THAT THERE'S A LASTING IMPACT OF THAT
FOR OTHER BENEFITS. THE SECOND COMMENT IS THAT THE
GAVI ALLIANCE HAS OPENED WINDOWS FOR THE POORER COUNTRIES OF THE
WORLD TO APPLY FOR MR VACCINES IN CAMPAIGNS THAT GO UP TO AGE
15 SO THERE'S QUITE A BIT OF BUDGET GOING INTO THAT AND
EXPECTATIONS FOR HUNDREDS OF MILLIONS OF YOUNG PEOPLE TO GET
MEASLES RUBELLA VACCINES IN THE POOREST COUNTRIES OF THE WORLD
OVER THE NEXT FIVE YEARS. >> I'M GOING TO TRY TO BRING
THIS TO CONCLUSION, BUT I HAD DR. VAZQUEZ, DR. REILLY AND DR.
HINMAN. >> I HAD A VERY QUICK AND SIMPLE
QUESTION. WHEN YOU TALK ABOUT THE
EXTENSION OF THE ROTO VIRUS VACCINE AGE LIMITS, CAN YOU BE
MORE SPECIFIC? >> WELL, AGAIN, SOMEBODY COMES
IN AT 16 WEEKS GETTING THAT FIRST DOSE, THEY GET IT.
>> SO UP TO 16 WEEKS? >> RIGHT.
SOMEBODY COMES IN AT 40 WEEKS TO GET THEIR THIRD -- OR SECOND
DOSE, ESSENTIALLY MOST OF THE DEVELOPING COUNTRIES IT'S TWO
DOSES THAT'S USED. THEY COME TO GET THE SECOND
DOSE, THEY GET IT. >> DO YOU HAVE A SENSE OF HOW
MANY CHILDREN ARE GETTING IT AT THE EXPANDED AGE RANGE?
>> NO. WELL, AGAIN, WE JUST RECENTLY
MADE THAT RECOMMENDATION, BUT THE SURVEILLANCE IS GOING ON TO
TRY TO DETERMINE THE IMPACT OF OUR RECOMMENDATION.
>> DR. ELLIOTT. >> I'LL MAKE THIS QUICK.
I JUST WANT TO SAY THANK YOU FOR PUTTING PREGNANCY AT THE TOP OF
THE LIST. THIS IS SOMETHING OBVIOUSLY THAT
I MENTIONED YESTERDAY, AND I IT'S A HUGE
ISSUE, OBVIOUSLY. THE ONLY OTHER THING I WANT TO
MENTION, WHICH YOU PROBABLY, JON, ALREADY KNOW.
AS DR. HELEN REESE WHO WAS THE PRIOR CHAIR HAD MADE A REQUEST
DIRECTLY TO ME THROUGH ACOG THAT WE HELP WORK WITH
OBSTETRICIANS/GYNECOLOGISTS ACROSS THE WORLD SO THERE IS
GOING TO BE AN IMMUNIZATION DISCUSSION AT THE NEXT IF HE D
FEDERATION OF OBSTETRICS AND GYNECOLOGY I THINK IT IS NEXT
YEAR. THERE WILL BE SOME TEACHING
GOING ON AT THAT MEETING FOR ALL OBSTETRICIAYNECOLOGISTS WHO
ATTEND. WE'RE ALL CONCERNED ABOUT
TESTING, NOT ABOUT PREK NANT WOMEN BEING EXCLUDED FROM, YOU
KNOW, DRUG TRIALS AS WELL AS VACCINE TRIALS, AND SO THERE IS
SOME WORK BEING DONE THROUGH ACOG AS WELL AS THROUGH THE
SOCIETY OF MATERNAL FETAL MEDICINE WHICH IS HIGH RISK
OBSTETRICIANS WHERE WE ARE DOING THE LEGISLATIVE WORK TO NOW TRY
AND BUILD AT LEAST SOME CAPACITY TO DO SOME OF THESE THINGS IN
PREGNANT WOMEN BASICALLY BASED ON WHAT AAP HAS DONE.
SO THAT IS OUT THERE AND WE ARE TRYING.
>> THAT ALL SOUNDS GREAT. >> DR. HINMAN?
>> YES. JUST TWO VERY QUICK
AMPLIFICATIONS ON SOMETHING. ONE IS THAT THE SOUTHEAST ASIAN
REEJ GOVERN RECENTLY PASSED A RESOLUTION CALLED FOR REGIONAL
ELIMINATION OF MEASLES. ALL SIX WHO REGIONS HAVE
ELIMINATION TARGETS FOR MEASLES. THEN IT WAS POINTED OUT THAT
GAVI HAS PROVIDED SUPPORT FOR RUBELLA VACCINE.
JUST IN TERMS OF GLOBAL EXPENDITURES, I JUST WANTED TO
MENTION THAT THE GAVI A LIEPS THIS YEAR WILL PROVIDE $1.6
BILLION WORTH OF SUPPORT TO THE 73 POOREST COUNTRIES IN THE
WORLD TO INTRODUCE VACCINES AND TO HASTEN, TO NARROW THE GAP
BETWEEN WHEN VACCINES ARE INTRODUCED IN DEVELOPED
COUNTRIES AND WHEN THEY'RE INTRODUCED IN DEVELOPING
COUNTRIES. THANK YOU.
>> DR. RYANGOLD. >> THANK YOU.
I WANTED TO FOLLOW UP ON WHAT ANN SAID IN TO DR.
PLODKIN'S COMMENT. THERE IS A DISCUSSION GOING ON
ABOUT HOW AS POLIO LINES UP, IF YOU WILL, HOW THAT
INFRASTRUCTURE AND RESOURCES CAN BE USED TO MORE EFFECTIVELY
DISCUSS MEASLES AND RUBELLA AND THE CHALLENGE IS TO NOT CREATE
ANOTHER VERY STRONG VERTICAL DISEASE SPECIFIC PROGRAM AND TO
DO IT IN A FASHION WITH ROUTINE IMMUNIZATION.
THAT IS A DISCUSSION THAT IS GOING ON AT THE MOMENT.
>> THANK YOU VERY MUCH. IT WAS WONDERFUL TO JUST GET A
SENSE OF WHAT WE DO -- HOW WHAT WE DO HERE DOVETAILS IN WHAT'S
BEING DONE GLOBALLY. THANK YOU VERY MUCH, JON.
WE APPRECIATE YOUR TIME.