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[ANN] THERE'S A PRETTY REASONABLY HIGH LIKELIHOOD THAT WE WILL
HAVE A SURGE OF ILLNESS FROM THIS H1N1 VIRUS BEFORE A VACCINE IS
AVAILABLE FOR USE.
SO WE REALLY NEED TO BE THINKING OF OTHER WAYS TO PROTECT OURSELVES
AND OF HOW TO MANAGE THAT ISSUE.
WE'VE ALWAYS THOUGHT THAT SEASONAL INFLUENZA VACCINE IS REALLY
IMPORTANT TO PROTECT PEOPLE, TO PROTECT COMMUNITIES, AND
WE HAVE RECOMMENDATIONS FOR MOST AMERICANS TO RECEIVE
A SEASONAL INFLUENZA VACCINE.
IT'S VERY LIKELY THAT OUR SEASONAL INFLUENZA VACCINE CAMPAIGN OR
SEASON WILL BE ONGOING IN A TIME THAT'S OVERLAPPING WITH THIS NEW
H1N1 VACCINATION EFFORT THAT WE'RE PLANNING FOR NOW.
WE MAY HAVE DIFFERENT TARGET POPULATIONS TO SOME EXTENT
FOR SEASONAL FLU VACCINE, WHERE WE FOCUS ON MANY GROUPS, BUT IN
PARTICULAR WE WANT TO MAKE SURE THE ELDERLY ARE VACCINATED,
AND THEY ARE THE ONES THAT GET MORE VACCINE THAN ANYBODY ELSE.
WE MIGHT BE LOOKING AT A SCENARIO WHERE THERE ARE SOMEWHAT DIFFERENT
RECOMMENDATIONS FOR DIFFERENT POPULATION GROUPS.
ANYONE HERE WHO DEALS WITH SEASONAL INFLUENZA VACCINE
KNOWS THAT IT'S A VERY CHALLENGING COMMUNICATION ENVIRONMENT, A VERY
CHALLENGING HEALTH SERVICES ENVIRONMENT, WHERE WE GIVE
OUT ABOUT 100 MILLION DOSES OF VACCINE EACH YEAR -- OR THAT
MANY GET INTO PEOPLE -- OVER A MANY MONTH PERIOD.
WE MAY BE TALKING ABOUT A LARGE VOLUME, VOLUNTARY VACCINATION
CAMPAIGN IN -- THAT POTENTIALLY MIGHT NEED TWO DOSES IN --
IDEALLY IN AN EVEN SHORTER TIME PERIOD THAN WHAT WE
SEE FOR THE SEASONAL FLU VACCINE.
AS I -- WE COULD ALSO BE SEEING, AS WE HEARD FROM NEW YORK CITY
AND -- AND SOME OF THE OTHER AREAS, A HEALTH SYSTEM THAT
WAS KIND OF CHALLENGED WITH THE SURGE OF ILLNESS FROM -- FROM
THIS NEW H1N1 VIRUS, A HEALTH SYSTEM THAT'S ALREADY CHALLENGED
JUST WITH THE ACCESS ISSUES AND CAPACITY ISSUES.
AND SO WE -- WE ALSO NEED TO REMEMBER THAT SEASONAL FLU
VACCINE IS MAINLY GIVEN OUT BY THE PRIVATE SECTOR.
IT'S PURCHASED BY THE PRIVATE SECTOR.
IT'S DELIVERED THROUGH MOSTLY PRIVATE SYSTEM SERVICES.
AND THAT SYSTEM MAY BE PRETTY BUSY DEALING WITH INFLUENZA
OR OTHER FALL AND WINTER CONCERNS.
SO WE REALLY HAVE TO PLAN FOR WAYS THAT PEOPLE WHO WANT TO
BE VACCINATED CAN BE VACCINATED.
WE ALSO NEED TO BE READY FOR RANDOM OR RELATED SAFETY SIGNALS.
IF WE INTEND TO VACCINATE LOTS OF PEOPLE IN A RELATIVELY SHORT
PERIOD OF TIME, ADVERSE EVENTS WILL BE DETECTED.
WE NEED TO BE ABLE TO INTERPRET THEM.
IF PEOPLE HAVE GOTTEN BOTH SEASONAL INFLUENZA VACCINE
AND A NEW H1N1 VACCINE AND HAVE ADVERSE EVENTS, WE NEED TO
INTERPRET ALL OF THAT.
SO I THINK THAT IT'S TEMPTING IN THE PREPAREDNESS WORLD TO --
TO REALLY FOCUS ON A WORST-CASE SCENARIO, BUT I HOPE THAT I HAVE
ALERTED YOU TO THE IDEA THAT THE MOST LIKELY OR BEST-CASE SCENARIO
HAS A LOT OF CHALLENGES.
A KEY THING I WANT TO LEAVE YOU WITH BEFORE WE RETURN -- RETURN
TO THE PANEL IS TO -- TO SAY THAT WE HAVE AN OPPORTUNITY
FOR A COORDINATED, COLLABORATIVE PLANNING EFFORT OVER THE NEXT
SEVERAL WEEKS AND A COORDINATED, COLLABORATIVE RESPONSE OVER THE
NEXT SEVERAL MONTHS, AND I THINK THE AMERICAN PUBLIC
IS EXPECTING THAT OF US.
AND THIS TASTE OF THIS SPRING, WHERE I THINK MANY PEOPLE FELT
THAT A NUMBER OF THINGS WENT WELL, A NUMBER OF THINGS DIDN'T,
WE WANT TO FIX THOSE.
I REALLY HOPE THAT YOU LEAVE HERE COMMITTED TO TAKE BACK THE ISSUES
THAT YOU KNOW ARE GOING TO BE PROBLEMS AND WORK ACROSS THE
SECTORS WITH -- WITH YOUR LOCAL AREAS, WITH YOUR TRIBAL PARTNERS,
WITH THE EMERGENCY, EDUCATION, AND HEALTH SECTORS AND REALLY
MAKE SURE THAT WE DO WHAT I THINK ALL OF -- ALL OF OUR NEIGHBORS
AND FRIENDS ARE EXPECTING OF US.
I WANT TO MENTION THAT THE CDC HAS BEEN WORKING IN PARTNERSHIP
WITH STATE AND LOCAL HEALTH EXPERTS AND WITH THE MEDICAL
COMMUNITY TO DEVELOP SOME PLANNING SCENARIOS.
SECRETARY SEBELIUS MENTIONED THIS A BIT THIS MORNING, THE IDEA OF
SCHOOLS AND HEALTHCARE WORKERS AND EMERGENCY SERVICES PEOPLE
AND NON-ELDERLY ADULTS WHO HAVE UNDERLYING RISK FACTORS; THESE
ARE GROUP -- PREGNANT WOMEN AND YOUNG CHILDREN -- THESE
ARE GROUPS THAT HAVE BEEN DISPROPORTIONATELY AFFECTED
SO FAR, AND THEY'RE GROUPS THAT AREN'T NECESSARILY,
REALLY GETTING A LOT OF VACCINE.
AND SO OUR PLANNING SCENARIOS ARE AN URGING OF STATE AND LOCALS TO
WORK -- WORK AT HOME, FIGURING OUT HOW CAN YOU MAKE SURE THAT
VACCINATION'S AVAILABLE FOR THOSE PEOPLE.
THOSE PLANNING SCENARIOS ARE ON CDC'S WEBSITE: WWW.CDC.GOV.
THERE'S AN H1N1 SPOTLIGHT, AND IF YOU GO THERE YOU'LL SEE A
VACCINATION WEBPAGE THAT WE'VE DEVELOPED WITH THOSE SCENARIOS.
I WANT TO TURN, NOW, TO SOME QUESTIONS FOR THE PANEL,
BRIEFLY, AND THEN A CHANCE FOR US TO REALLY HEAR FROM YOU ABOUT THE
ISSUES YOU WANT CLARITY ON.
SO I WANT TO BEGIN -- I THINK SECRETARY SEBELIUS TALKED ABOUT
THIS JUST A LITTLE, BUT I KNOW IT'S ON PEOPLE'S MINDS.
SO BRIEFLY, DR. GELLIN, I HOPE THAT YOU COULD GIVE US A SENSE
OF WHERE WE ARE IN THE PROCESS OF VACCINE DEVELOPMENT AND PRODUCTION
AND WHAT DO YOU EXPECT IN TERMS OF THE TIMING FOR AVAILABLE PRODUCT.
[BRUCE GELLIN] OKAY, THANKS.
SO WE'RE -- WE'RE WORKING WITH THE FIVE VACCINE COMPANIES THAT
PRODUCE SEASONAL INFLUENZA VACCINE.
AGAIN, THE POINT OF THAT IS SO THAT THERE'S FAMILIARITY WITH
THE PROCESSES, AND WE'RE WORKING BETWEEN OUR REGULATORY --
REGULATORS AND THESE COMPANIES.
SO THAT -- THERE ARE FIVE COMPANIES THAT WE'RE ENGAGED IN.
AS THE SECRETARY MENTIONED, WE BEGAN THAT PROCESS BACK IN MAY,
AND IT'S -- HAVE EXPENDED OVER $1 BILLION TO BEGIN THAT PROCESS.
SO PART OF THAT IS TO DEVELOP THE -- THE -- YOU KNOW,
THE KEY INGREDIENTS, THE ANTIGEN AND THE ADJUVANT THAT MAY BE
INCLUDED IN A VACCINE.
AND THAT -- THAT WORK IS ONGOING NOW.
IN PARALLEL OF THAT, THERE ARE A SERIES OF CLINICAL STUDIES --
AND DR. FOUCHY [PHONETIC SP] MENTIONED THIS THIS MORNING --
THAT THE NIH IN CONJUNCTION WITH THE -- WITH THESE FIVE COMPANIES
WILL BE DOING A NUMBER OF STUDIES TO DETERMINE WHAT A DOSE MIGHT BE,
THE NUMBER OF DOSES, AND -- AND THE TIME INTERVAL BETWEEN --
THE POTENTIAL TIME INTERVAL BETWEEN TWO DOSES IF --
IF TWO DOSES ARE NEEDED.
IN ADDITION, UNLIKE OUR SEASONAL VACCINE, THERE'S THE POSSIBILITY
OF USING WHAT'S CALLED AN ADJUVANT, THE -- WHICH IS
AN INGREDIENT THAT CAN -- CAN SIMULATE AN IMMUNE -- AN IMMUNE
RESPONSE, SHOULD THERE BE A NEED FOR THAT.
SO THOSE ARE AMONG THE PIECES OF THESE CLINICAL STUDIES.
THE -- THESE ARE ALL IN PROCESS NOW.
THE CLINICAL STUDIES WILL BEGIN AT THE END OF THIS MONTH OR EARLY
NEXT MONTH TO BEGIN TO GENERATE THIS INFORMATION, AND THIS KEY
INFORMATION IS NEEDED TO BE ABLE TO DEVELOP A VACCINE.
THAT'S THE REASON WHY THE TIMELINE LOOKS RELATIVELY
LONG GIVEN THIS -- THE -- THE URGENCY THAT WE ALL
FEEL AND WHEN VACCINE COULD FIRST BE AVAILABLE.
SO IF WE HAD A MID-OCTOBER DATE FOR WHEN ALL THE INFORMATION
BECAME AVAILABLE ABOUT THE POTENTIAL VACCINE CLINICAL
TRIALS -- OR AT LEAST THE PRELIMINARY INFORMATION
THE CLINICAL TRIALS -- THAT WOULD BE THE POTENTIAL START DATE.
KNOW THAT THE NUMBER OF COMPANIES THAT WE'RE DEALING WITH,
THERE COULD BE A LOT OF VACCINE POTENTIALLY
AVAILABLE AT THAT TIME.
AGAIN, THIS IS IF ALL GOES WELL, AND, AS THE SECRETARY TOLD US,
THAT WE SHOULD BE PREPARED TO BE SURPRISED, AND THAT -- THAT'S
TRUE FOR THIS AS WELL.
BUT I THINK WE CAN IMAGINE THAT AT MID-OCTOBER WE MIGHT EVEN HAVE AS
MUCH AS 100 MILLION DOSES OF VACCINE AT THAT TIME, GIVE
OR TAKE, DEPENDING ON HOW THINGS GO.
SO I ONLY SAY THAT IN A SENSE OF TRYING TO THINK ABOUT WHAT THE --
THE VOLUME OF VACCINE THAT COULD BE AVAILABLE AT THE INITIATION
OF A PROGRAM.
[ANN] THANKS VERY MUCH.
DR. BIRKHEAD, YOU CHAIR THE NATIONAL VACCINE
ADVISORY COMMITTEE.
DO YOU WANT TO TALK A LITTLE BIT ABOUT WHAT THAT ADVISORY COMMITTEE
WILL BE DOING AND MAYBE MORE GENERALLY ABOUT
ADVISORY COMMITTEES?
[GUTHRIE BIRKHEAD] YEAH, SURE.
NVAC IS ONE OF THREE OR FOUR FEDERAL ADVISORY COMMITTEES
TO DO WITH VACCINES.
IT'S A -- IT'S A GENERAL COMMITTEE THAT'S A POLICY-LEVEL COMMITTEE.
THE ACIP AT CDC -- PEOPLE ARE FAMILIAR WITH, I THINK, WILL
MAKE RECOMMENDATIONS ON THE PRIORITIZATION OF THE GROUPS.
NVAC IS GOING TO FOCUS FOR THIS EVENT ON THE IMPLEMENTATION
ISSUES THAT ARISE AND ALSO PARTICULARLY FOCUS
ON THE SAFETY ISSUES.
I THINK, AS WE SAW IN 1976, SAFETY CONCERNS CAN QUICKLY
BRING A VACCINATION CAMPAIGN DOWN, IF YOU WILL, AND I THINK WE --
WE WANT TO BE SURE THAT WE HAVE A ROBUST WAY TO LOOK AT SAFETY.
AS YOU MENTIONED IN YOUR EARLIER COMMENTS, WE EXPECT TO SEE A
CERTAIN RATE OF ADVERSE EVENTS OCCURRING IN ANY LARGE POPULATION:
HEART ATTACKS, SUDDEN DEATHS, SPONTANEOUS
ABORTIONS IN PREGNANT WOMEN.
THOSE OCCUR ALL THE TIME, AND YOU ADD ON TOP OF THAT VACCINATION;
IT BECOMES VERY DIFFICULT TO FIGURE OUT WHETHER THE VACCINE
IS ACTUALLY CAUSING SOMETHING TO OCCUR OR WHETHER WE'RE JUST
PICKING IT UP BY CHANCE.
SO WE NEED TO HAVE A -- AND MAYBE WE TALK A LITTLE MORE ABOUT THIS
LATER IN THE SESSION -- SORT OF A ROBUST APPROACH.
SO NVAC WILL FOCUS ON THOSE TWO AREAS.
ACIP, I THINK, WILL FOCUS ON WHO THE PRIORITY GROUPS ARE,
AND THERE -- THERE'S A MEETING LATER THIS MONTH TO TRY TO
SETTLE ON THAT.
[ANN] RIGHT, AND JUST LET ME EXPAND A LITTLE BIT.
THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES
PLANS TO HAVE A MEETING JULY 29 IN ATLANTA.
AND THE ADVISORY COMMITTEE WILL PROBABLY BE FOCUSING
ON RECOMMENDED POPULATIONS BUT ALSO ON A QUESTION OF WHETHER
TIERING IS APPROPRIATE OR NOT.
SOME OF YOU MAY REMEMBER THE 2004/05 INFLUENZA SEASON,
WHERE WE HAD A SUDDEN SHORTAGE OF HALF OF THE VACCINE SUPPLY
FOR THAT YEAR.
PUBLIC HEALTH AND MEDICAL EXPERTS REALLY CAME TOGETHER TO FOCUS ON
WHO SHOULD GET VACCINE FIRST, AND WE HAD NATIONAL PSAS ABOUT
"STAND ASIDE," YOU KNOW -- "STEP ASIDE," I THINK IT WAS.
WHAT WE FOUND WAS THAT IN TRYING TO, YOU KNOW, MAKE SURE THE RIGHT
PEOPLE GOT VACCINE, WE DIDN'T ACTUALLY GIVE OUT ALL THE
VACCINE, AND WE ENDED UP WITH SURPLUS.
SO THERE'S SOME QUESTIONS ABOUT WHETHER TIERING GETS VACCINE
OUT AS EFFECTIVELY AS -- AS A BROADER AVAILABILITY.
SO I THINK THOSE ARE THE ISSUES THAT ACIP WILL BE LOOKING AT.
DR. BUTLER, YOU'RE RUNNING SOME -- SOME KIND OF VACCINE TASK FORCE
AT THE CDC.
WHAT THE HECK IS THAT, AND HOW ARE YOU WORKING WITH PARTNERS
ACROSS THE COUNTRY?
[JAY BUTLER] THANK YOU, ANN.
YES, I JUST CAME IN OUT OF THE COLD ABOUT TWO WEEKS MYSELF.
THE CDC HAS PUT TOGETHER A H1N1 VACCINE TASK FORCE FOCUSING ON
IMPLEMENTATION OF VACCINE PROGRAMS STATE-WIDE -- OR NATIONWIDE.
THAT SHOWS, I GUESS, I'VE JUST COME FROM A STATE.
I'M USED TO SAYING THAT.
WE'RE USED TO SAYING THAT ALL PREPAREDNESS IS LOCAL,
THAT -- WHICH IS PARAPHRASING THE OLD EXPRESSION OF ALL
POLITICS IS LOCAL.
AND WHEN IT COMES DOWN TO PUTTING VACCINE INTO PEOPLE'S ARMS OR
UP THEIR NOSES, THAT'S GOING TO BE DONE LOCALLY ALSO.
AND AS LOCALS WORK WITH STATES AS WORK WITH FEDS, THERE'S
A ROLE AT ALL LEVELS.
THE PARTICULAR ROLE FOR THIS TASK FORCE WILL BE TO COORDINATE AT
THE FEDERAL LEVEL WITH THE VARIOUS ADVISORY GROUPS THAT DR. BIRKHEAD
MENTIONED, AS WELL AS WITH BARDA, WITH OTHER AGENCIES, NIH, FDA,
AND THEN TO FOCUS ON GETTING VACCINE OUT TO THE LOCAL
AGENCIES THROUGH THE STATES WITH A FOCUS, THEN, ON BEING ABLE TO
TRACK THE DISTRIBUTION, KNOW HOW MUCH HAS GONE OUT, KNOW HOW MUCH
HAS BEEN ADMINISTERED AS MUCH AS POSSIBLE, TO BE ABLE TO ASSESS
VACCINE EFFECTIVENESS AND VACCINE SAFETY, AND TO BE
ABLE TO COMMUNICATE WITH EVERYONE.
COMMUNICATIONS WAS EMPHASIZED IN SEVERAL OF PRESENTATIONS
THIS MORNING.
WE RECOGNIZE THAT THAT'S OF CRITICAL IMPORTANCE
TO SUCCESS OF A VACCINE PROGRAM THAT'S GOING TO PROTECT THE
POPULATION FROM NOVEL H1N1.
THE TASK FORCE ALSO HAS A STEERING COMMITTEE, AND I JUST WANTED TO
ACKNOWLEDGE THAT A NUMBER OF PEOPLE AT THE TABLE HERE AS
WELL AS IN THE AUDIENCE PARTICIPATE IN THAT.
THAT GROUP INCLUDES REPRESENTATIVES FROM
ASTHO, CSTE, THE NATIONAL VACCINE ADVISORY COMMITTEE, AND OTHER
ORGANIZATIONS AS WELL.
AND THAT'S GOING TO BE AN IMPORTANT WAY TO PARTNER
AT LEAST AT THE NATIONAL LEVEL.
AND MAYBE ON THAT CLOSING NOTE, I'D LIKE TO EMPHASIZE TO EVERYONE
HERE THE IMPORTANCE OF PARTNERSHIP.
NO ONE AT ANY LEVEL CAN DO THAT ALONE, AND WE NEED TO RECOGNIZE
WHO IT IS WE NEED TO BE WORKING WITH.
THAT'S GOING TO BE THE PUBLIC AND PRIVATE SECTOR.
IT'S GOING TO BE THE SECULAR AND FAITH-BASED ORGANIZATIONS,
WORKING WITH TRIBAL ORGANIZATIONS.
MR. ROAN HORSE GAVE AN EXCELLENT PRESENTATION OF -- FROM THE
PERSPECTIVE OF THE NAVAJO NATION THIS MORNING.
WORKING AGENCY TO AGENCY: CERTAINLY WITH THE LIKELY
EMPHASIS ON VACCINATING KIDS, WORK BETWEEN HEALTH AND EDUCATION IS
GOING TO BE IMPORTANT AGAIN JUST AS IT WAS THIS PAST SPRING WHEN
WE LOOKED AT COMMUNITY MITIGATION MEASURES.
AND ALSO INTERNATIONALLY: SHARING INFORMATION IS
GOING TO BE CRITICAL AS WE LOOK TO THE SOUTHERN HEMISPHERE,
WHICH OFTENTIMES IS THE BAROMETER -- OR MAYBE
THE CRYSTAL BALL OF WHAT WE MAY BE SEEING THIS COMING FALL.
[ANN] THANKS.
YOU KNOW, WE'RE GOING TO TALK SOME MORE ABOUT VACCINE IN THE QUESTION
AND ANSWER, BUT I WANT TO BRIEFLY TO TURN TO SOME OF THE ANTIVIRAL
USE AND DISTRIBUTION EXPERIENCE.
YOU KNOW, MANY STATES -- OF COURSE, EVERY STATE
AND PROGRAM AREA RECEIVED PARTS OF THE STRATEGIC NATIONAL STOCKPILE
OF ANTIVIRALS, AND I THINK WE HAD A VARIETY OF STATE
EXPERIENCES WITH THAT.
I WONDER, MR. ERICKSON [PHONETIC SP], IF YOU COULD COMMENT A LITTLE
BIT ABOUT LESSONS THAT YOU LEARNED IN WASHINGTON OR THAT YOU'VE HEARD
FROM PEERS ABOUT ANTIVIRAL DISTRIBUTION, YOU KNOW,
WHAT WORKED AND WHAT DIDN'T WORK AND SO FORTH.
[MR. ERICKSON] YEAH, I'D BE GLAD TO.
LIKE MANY OF YOU, WE -- WE'VE BEEN WRITING PLANS AND DOING EXERCISES
NOW FOR -- FOR FIVE OR SIX YEARS, INCLUDING THE SMALL POX EFFORT
THAT LAID THE -- EXCUSE ME -- LAID A LOT OF THE GROUNDWORK
TO THE DISTRIBUTION SYSTEMS THAT WE HAVE SET UP.
AND, YOU KNOW, I GOT TO SAY THAT IT WAS HEARTENING TO
SEE THAT ALL THE WORK THAT WE HAD DONE IN THE LAST FEW YEARS
REALLY PAID OFF.
I MEAN, WE -- WE MADE MISTAKES.
IN WASHINGTON STATE, WE CERTAINLY DIDN'T GET IT OUT TO ALL OUR LOCAL
PARTNERS WITHIN 16 HOURS LIKE ILLINOIS DID.
I DON'T KNOW HOW THEY DID THAT.
I'M GOING TO HAVE TO FIND OUT.
[MALE SPEAKER] SMALLER STATE.
[MR. ERICKSON] SMALLER STATE THAN WASHINGTON?
I DON'T THINK SO.
BUT ANYWAY -- ANYWAY, LESSONS LEARNED: THE LOCALS QUICKLY
RAMPED UP TO ACCEPT IT, STORE IT.
WE HAD SOME LESSONS LEARNED ABOUT PROPER STORAGE OF THE
PHARMACEUTICALS, SOME WORK WITH THE PHARMACY BOARD THAT WE HAD
THOUGHT WE'D CLEARED UP TWO YEARS AGO, AND IT
KIND OF SURFACED AGAIN.
SO WE HAD A LESSON LEARNED THERE THAT WE HAD A -- TO GO TO THE
BOARD FOR SOME CORRECTIVE -- CORRECTIONS ON THAT.
BUT I THINK IT PUT US IN EXCELLENT POSITION TO
TAKE THE NEXT STEP THIS FALL.
[ANN] GREAT.
GUS [PHONETIC SP], DO YOU HAVE ANY OTHER COMMENTS ABOUT THE ANTIVIRAL
DISTRIBUTION YOU'D LIKE TO MAKE FROM NEW YORK'S EXPERIENCE?
[GUS] I WOULD AGREE THAT I THINK OUR PLANNING PAID OFF, AND IT
WENT RELATIVELY SMOOTHLY.
THERE WERE SOME GLITCHES IDENTIFIED IN INTERPRETATION
OF EMERGENCY USE AUTHORIZATION DOCUMENTS AND ALSO IN THE ACTUAL
SHIPPING AND WHEN SHIPMENTS ARRIVED, AND I THINK THERE --
THERE'S A AFTER-ACTION PROCESS UNDERWAY TO TRY AND IDENTIFY
AND FIX THOSE.
BUT IN GENERAL I THINK WE HAVE A PRETTY GOOD SYSTEM TO DISTRIBUTE,
AND WE, IN NEW YORK, FURTHER DISTRIBUTE IT TO OUR COUNTY LEVEL.
I WOULD SAY THE KINDS OF ISSUES THAT REALLY AROSE FOR US WERE
FOLLOWING THE DISTRIBUTION IN TERMS OF THE USE.
OUR VIEW OF THESE ASSETS IS THAT THEY ARE FOR EMERGENCIES, AND WHAT
QUICKLY BECAME EVIDENT IS THAT UNINSURED PEOPLE IN THE POPULATION
WERE HAVING TROUBLE POTENTIALLY PAYING FOR ANTIVIRAL MEDICATIONS.
AND THE QUESTION IS DID -- ARE THESE ASSETS -- IS THAT THE
EMERGENCY THAT WAS ENVISIONED FOR THESE ASSETS OR SOMETHING ELSE,
AND I THINK WE'RE STILL WORKING THROUGH THESE ISSUES -- THOSE
ISSUES, REALLY TRYING -- THERE ARE MECHANISMS TO COVER UNINSURED --
FOR EXAMPLE, THROUGH FEDERALLY QUALIFIED HEALTH CENTERS OR
OTHER MECHANISMS -- SO TO BE SURE THAT WE'RE FULLY ACCESSING WHAT
IS AVAILABLE FOR THE UNINSURED BEFORE WE DRAW ON WHAT WE ARE
STILL CONSIDERING TO BE AN EMERGENCY STOCKPILE.
[ANN] YEAH, I'LL JUST SAY FROM THE CDC'S PERSPECTIVE WE HAVE
HEARD FROM A NUMBER OF STATE AND LOCAL PUBLIC HEALTH PARTNERS AS
WELL AS THE CLINICAL COMMUNITY THAT OUR ANTIVIRAL GUIDANCE
FOR WHEN -- WHO SHOULD BE TREATED AND WHETHER THERE'S PREVENTIVE
USE OF THAT -- OF ANTIVIRALS RECOMMENDED, YOU KNOW,
WAS PERHAPS NOT AS CLEAR OR TIMELY OR EVIDENCE-INFORMED
AS EVERYONE WOULD LIKE.
AND I THINK WE'RE -- WE'RE REALLY TAKING THE NEXT SEVERAL WEEKS
TO LOOK CAREFULLY AT GUIDANCE SUCH AS THAT AND TRY TO GET THE BEST
EXPERT EVIDENCE BASE TOGETHER TO UPDATE THOSE.
SO I THINK LOOK IN THE WEEKS AHEAD FOR UPDATES ON -- ON SEVERAL OF
THE KEY GUIDANCE DOCUMENTS.
YOU KNOW, I HAD A FEW MORE PREPARED QUESTIONS FOR THE
PANEL, BUT I JUST KEEP LOOKING OUT HERE AND SEEING SO MUCH EXPERTISE,
AND WHAT I'D LIKE TO DO IS TAKE THE MODERATOR'S PREROGATIVE AND
FORGET ABOUT THE OTHER QUESTIONS AND ACTUALLY -- AND WE CAN GO
HAVE LUNCH NOW.
[LAUGHTER]
BUT, ACTUALLY, WHAT I'D LIKE TO DO IS -- WE HAVE SOME MICROPHONES,
I THINK. DO WE HAVE -- ANYBODY -- ANY -- OR MAYBE PEOPLE HAVE TO
TALK LOUD, AND THEN I'LL REPEAT IT FOR THE OTHER SIDE OF THE ROOM.
IF YOU HAVE QUESTIONS, I THINK THIS WOULD BE
GREAT TO GET THOSE OUT.
OKAY, SO WE HAVE A QUESTION OVER HERE.
[MALE SPEAKER] I HAVE A LOUD VOICE, SO I HOPE YOU'LL HEAR ME.
[ANN] [LAUGHS]
[MALE SPEAKER] CAN YOU HEAR ME?
[ANN] NO, IT'S JUST -- MAKE IT SHORT, AND I'LL REPEAT IT. [LAUGHS]
[MALE SPEAKER] [INAUDIBLE]
[ANN] JAY, DO YOU WANT TO -- DO YOU WANT TO TAKE --
TAKE THAT, DR. BUTLER.
OKAY?
GREAT.
[LAUGHTER]
AND THEN I'LL FIX IT AFTER YOU ANSWER.
[LAUGHTER]
HE'S JUST IN FROM ALASKA, AND I'M HIS NEW BOSS.
HIS FORMER BOSS WAS THE GOVERNOR, SO --
[JAY BRUCE] LET THE RECORD SHOW THAT THE QUESTION I GOT WAS NOT FROM
THE PREPARED LIST ANYWAY.
[ANN] OH, RIGHT.
[LAUGHTER]
SO, ACTUALLY CAN YOU REPEAT -- ALSO, JAY, COULD YOU REPEAT IT
FOR THE OTHER SIDE OF THE ROOM?
[JAY BRUCE] OKAY.
[ANN] I FORGOT TO DO THAT.
[JAY BRUCE] THE QUESTION -- AND CORRECT ME IF I'VE -- AM PARAPHRASING IT
WRONG -- IS WHICH AGE GROUPS WILL BE TARGETED FOR VACCINATION.
THE FINAL DECISION ON RECOMMENDATIONS FOR
CLINICAL USE OF THE VACCINE WILL COME FROM THE ADVISORY COMMITTEE
ON IMMUNIZATION PRACTICES, WHICH WILL MEET END OF THIS MONTH.
THAT SAID, I THINK WE CAN LOOK AT THE DATA AND BEGIN TO SEE THE
DIRECTION THAT WE SHOULD BE TAKING.
AND WE'VE TRIED TO GIVE THE STATES A HEADS UP ON THAT -- ALTHOUGH I
THINK MANY OF YOU HAVE ALREADY DISCERNED THIS YOURSELVES JUST
BY LOOKING AT THE EPIDEMIOLOGY -- WITH A DOCUMENT THAT WE JUST PUT
OUT LAST NIGHT THAT'S INTENDED TO PROVIDE GUIDANCE FOR PLANNING FOR
STATE IMMUNIZATION PROGRAMS, WHICH THEN, OF COURSE, WILL GO DOWN TO
THE LOCAL LEVELS ALSO.
AND THAT DOCUMENT PROPOSES TARGET POPULATIONS TO HELP PLANNERS THINK
IN TERMS OF VENUES OF WHERE THE VACCINE CAN BE ADMINISTERED AND
HOW IT MIGHT BE ADMINISTERED.
AND THOSE TARGET GROUPS ARE PRIMARILY CHILDREN.
WE FOCUS ON SCHOOLS AND CHILDCARE CENTERS, SO CHILDREN -- CHILDCARE
AND STUDENTS IN PUBLIC SCHOOLS -- OR REALLY IN SCHOOLS AT LEAST UP
THROUGH HIGH SCHOOL; ADULTS WITH UNDERLYING ILLNESSES, WHICH SEEM
THEY'D BE AT HIGHER RISK OF DISEASE AND AT HIGHER RISK
OF HOSPITALIZATION; AND CERTAIN OCCUPATIONAL GROUPS, PARTICULARLY
HEALTHCARE WORKERS AND ALSO, IF I CAN RETURN TO THE SCHOOLS,
THE EMPLOYEES WITHIN THE SCHOOLS; AND PREGNANT WOMEN AND FAMILIES
WITH YOUNG CHILDREN, SO THAT IN SOME WAYS, I MEAN, IT'S NOT THAT
FAR OFF FROM THE GROUPS THAT ARE CURRENTLY RECOMMENDED FOR THE
SEASONAL INFLUENZA VACCINE WITH THE MAJOR EXCEPTION
OF THE ELDERLY, WHO DO NOT SEEM TO BE AT AS HIGH A RISK.
TOGETHER WITH THE HEALTHCARE WORKERS, IT WOULD ALSO INCLUDE
EMERGENCY SERVICE PERSONNEL THROUGH -- BECAUSE OF THEIR
RISK OF BEING EXPOSED TO THE VIRUS AS WELL.
AND AGAIN, THOSE ARE NOT SPECIFIC RECOMMENDATIONS AND GROUPS TO BE
TARGETED BUT JUST BROAD STROKES OF POPULATIONS TO CONSIDER AS
TARGETED FOR PLANNING PURPOSES OVER THE NEXT MONTH AS WE AWAIT
THE ACIP STATEMENT.
[ANN] GREAT.
DR. OSTROFF [PHONETIC SP], I KNOW YOU HAVE A LOUD VOICE.
[LAUGHTER]
[DR. OSTROFF] I HAVEN'T HEARD ANY MENTION OF FDA AND A ROLE IN ANY OF THIS,
AND WHAT IS THE -- WHAT ARE THE ISSUES AROUND ACTUALLY WHETHER
OR NOT THE VACCINE IS GOING TO BE LICENSED [INAUDIBLE] IT'S
AVAILABLE AND WHAT CONTINGENCIES WILL HAVE TO [INAUDIBLE].
[ANN] RIGHT, THANKS FOR THAT QUESTION.
THE QUESTION WAS ABOUT THE ROLE OF THE FDA AND THEIR APPROACH
TO EVALUATING AND LICENSING THE H1N1 VACCINE.
LET ME LET DR. GELLIN ADDRESS THAT.
I MEAN, I -- AND I'LL CORRECT HIM IF HE'S NOT GOT IT RIGHT.
[LAUGHTER]
[BRUCE GELLIN] SO YOU GET THAT?
I DON'T WORK FOR HER, BUT SHE'LL STILL CORRECT ME.
[LAUGHTER]
SO THE -- THE FDA OBVIOUSLY IS A CRITICAL -- IS A --
IS A CRITICAL PIECE OF THIS.
AND WHAT -- AS I MENTIONED BEFORE, THESE -- THERE ARE A SERIES OF
CLINICAL STUDIES THAT ARE BEING LOOKED AT.
EACH OF THE COMPANIES HAS THEIR OWN STUDIES, AND THEN NIH HAS
STUDIES AS WELL.
AND THEY'VE LOOKED AT THESE AS A SET TO MAKE SURE THEY CAN ANSWER
ALL THE IMPORTANT QUESTIONS.
THE APPROACH THE FDA IS TAKING PRIMARILY IS LOOKING AT THIS
OF HOW QUICKLY THEY CAN GET THE DATA AVAILABLE TO BE ABLE TO
MAKE THEIR DETERMINATIONS.
IDEALLY A VACCINE THAT'S LICENSED, SIMILAR TO WHAT WE USE EVERY YEAR,
WOULD BE THE ONE WE WOULD LIKE TO LEAD WITH.
THE FDA HAS A PROCESS WHICH IS REFERRED TO EVERY YEAR WITH
SEASONAL FLU AS A STRAIN CHANGE, AND THAT'S WHAT ALLOWS THEM TO
MAKE A NEW -- TO HAVE A NEW VACCINE CREATED EACH YEAR
WHERE THE ONLY DIFFERENCE IS THE VIRUS.
IN THIS ONE, THE PATH THEY'RE TAKING IS SIMILAR
TO THE DEVELOPMENT OF THE H1N1 VACCINE, WHERE --
[ANN] H5 -- OH, OKAY: THE H1.
YOU SAID H1.
[BRUCE GELLIN] RIGHT.
[ANN] OKAY.
[BRUCE GELLIN] SO -- OKAY, WE'LL KEEP SCORE HERE.
[LAUGHTER]
NO, WHEN THEY DID THE H1N1 VACCINE THEY USED THAT SAME --
THAT SAME APPROACH.
THE DIFFERENCE WAS THAT THERE WERE A SERIES OF CLINICAL STUDIES THAT
WERE DONE TO TRY TO DETERMINE WHAT THE RIGHT DOSE WOULD BE.
THAT'S WHAT'S GOING ON NOW AS PART OF THIS DETERMINATION.
SO THE HOPE WOULD BE THAT THAT DATA IS AVAILABLE AS SOON AS
A VACCINE'S AVAILABLE FOR CLINICAL TRIALS AT THE -- LATER THIS MONTH
OR THE BEGINNING OF AUGUST TO ALLOW FOR A LICENSED VACCINE.
I'D MENTIONED IN MY OTHER COMMENT THAT THERE IS THE POTENTIAL USE
OF ADJUVANTS, WHICH ARE NOT IN CURRENTLY LICENSED VACCINES.
THERE ARE A NUMBER OF POTENTIAL ADVANTAGES TO ADJUVANTS AS FAR
AS THE IMMUNE RESPONSE AND PARTICULARLY IF THERE'S
A NEED FOR A BROADER IMMUNE RESPONSE, WHICH IS WHAT WE
FOUND WITH THE H1N1 VACCINE.
WE WON'T KNOW IF THAT'S [INAUDIBLE] --
[ANN] THE H5N1.
[BRUCE GELLIN] H5, SORRY.
[ANN] OKAY.
[BRUCE GELLIN] NO, YOU'RE RIGHT.
[ANN] YEAH.
[BRUCE GELLIN] SO WITH THE PREVIOUS VACCINE --
[LAUGHTER]
SO NOW WE'LL HAVE TO FIGURE THAT ONE OUT AS WELL.
[ANN] IT WAS WRONG BEFORE, TOO.
[BRUCE GELLIN] THE BOTTOM LINE, THOUGH, IS --
[LAUGHTER]
-- IS THE -- ARE YOU CUTTING INTO MY TIME?
[ANN] NO, I AM, ACTUALLY --
[BRUCE GELLIN] IS THAT -- IS THAT --
[ANN] BUT MY FAN CLUB UP THERE WANTS ME TO, SO --
[BRUCE GELLIN] IF THERE'S A NEED FOR -- IF THERE'S A NEED FOR AN
ADJUVANTED [PHONETIC SP] VACCINE THAT WILL -- THAT WON'T BE --
THAT WON'T BE LICENSED FOR THE -- FOR THIS FALL.
SO I THINK THAT'S AMONG THE BALANCE -- THE BALANCE WE'LL
HAVE TO TAKE A LOOK AT IS WHAT THE POTENTIAL ADVANTAGES WOULD BE FOR
THE USE OF AN ADJUVANTED VACCINE VERSUS AN UNADJUVANTED VACCINE.
THANK YOU.
[ANN] SO, AS WE'VE BEEN SAYING, COMMUNICATION IS REALLY
IMPORTANT, AND SO JUST AS I FEEL VERY COMFORTABLE TELLING BRUCE
WHEN HE GETS IT A LITTLE WRONG, I HOPE EVERYBODY WILL CONTINUE TO
FEEL COMFORTABLE TELLING US WHEN WE GET IT WRONG AND CONTINUING
TO GIVE FANTASTIC FEEDBACK TO -- TO US AS WE WORK TOGETHER ON THIS.
I THINK WE HAVE AN ADDITIONAL COMMENT FROM MR. ERICKSON.
[MR. ERICKSON] I HAVE A QUESTION FOR BRUCE ALSO.
[ANN] OKAY.
[MR. ERICKSON] SO IS -- IS THERE ANY CHANCE THAT THIS VACCINE, COME THE MIDDLE OF
OCTOBER, WILL BE IND ALL -- AND ALL THE PAPERWORK
THAT'S ASSOCIATED?
[BRUCE GELLIN] THE GOAL FOR AN UNADJUVANTED -- FOR AN UNADJUVANTED VACCINE,
AGAIN, AND A VACCINE THAT WOULD BE SIMILAR TO THE KINDS OF VACCINES
USED EVERY YEAR, WOULD BE FOR IT TO BE LICENSED.
IF THERE IS A NEED TO USE ADJUVANTS, THEN THAT WOULD
COME UNDER WHAT'S CALLED EMERGENCY USE AUTHORIZATION, WHICH IS --
[MR. ERICKSON] YES, A BEAR.
[BRUCE GELLIN] -- A LESS CUMBERSOME PROCESS THAN AN IND, BUT WOULD SIGNAL THAT
THERE'S NOT -- THERE'S -- THERE IS -- THERE'S A LOT OF DATA BUT NOT
SUFFICIENT TO GET A LICENSE.
[MR. ERICKSON] OKAY.
[ANN] OKAY, I'M GOING TO GO TO THIS SIDE OF THE ROOM.
UP HERE THERE'S A QUESTION.
[MALE SPEAKER] [INAUDIBLE]
[ANN] LET'S SEE IF THERE'S AN EXPERT IN THE ROOM WHO WANTS TO UPDATE
BECAUSE I'M ACTUALLY BLANKING ON THE INFORMATION.
DR. --
[MALE SPEAKER] SO -- SO AS ROBIN ROBINSON --
[ANN] YES.
[MALE SPEAKER] -- THE DIRECTOR OF BARDA COMES TO THE MICROPHONE --
[ANN] AND HE'S GOING TO ANSWER THE --
[MALE SPEAKER] -- THE QUESTION IS --
[ANN] -- HE'S GOING TO REPEAT THE QUESTION AND THEN ANSWER IT.
[MALE SPEAKER] THE QUESTION IS ABOUT THE SUPPLY AND RAMP UP OF ANTIVIRALS AND
PARTICULARLY SOME OF THE THINGS THAT ARE IN THE PIPELINE LIKE
INTRAVENOUS PARAMETER.
[ROBIN ROBINSON] YOU KNOW, WHERE WE ARE RIGHT NOW -- SO I'LL TAKE THE LICENSED
PRODUCTS FIRST, TAMIFLU AND RELENZA, AND WHAT'S ACTUALLY
AVAILABLE IN THE UNITED STATES AND GLOBALLY.
FIRST OF ALL, FOR TAMIFLU AND RELENZA MOST OF WHAT
WAS AVAILABLE IN THE UNITED STATES HAS BEEN BOUGHT, AND MANY --
MANY OF THOSE TREATMENT COURSES WILL BE AVAILABLE ON THE WHOLESALE
DISTRIBUTION MARKET TO GO TO THE RETAIL MARKET.
THAT'S A GOOD THING, IN FACT.
BUT THEY'RE RUNNING THREE SHIFTS A DAY IN TWO DIFFERENT FACILITIES
IN THE UNITED STATES AND LOOKING TO ACTUALLY GO INTO ANOTHER
FACILITY TO RAMP UP THERE.
AND THE DEPARTMENT IS LOOKING AT BEING ABLE TO ACQUIRE ANOTHER
TRANCHE OF ANTIVIRALS THAT MAY BE AVAILABLE IN THE FORM OF PROBABLY
ZANAMIVIR AND MAYBE PEDIATRIC TAMIFLU.
NOW, LET'S TALK ABOUT THE DRUGS THAT WE HAVE UNDER DEVELOPMENT
THAT ARE FAR ENOUGH ALONG TO ACTUALLY BE CONSIDERED
SERIOUSLY FOR THIS YEAR'S FLU SEASON, WHETHER IT BE
FOR H1N1 OR SEASONAL INFLUENZA.
THERE IS A DRUG CALLED PERAMIVIR; IT'S A NEURAMINIDASE INHIBITOR.
IT WAS ORIGINALLY TRIED AS AN ORAL FORMULATION, AND IT WAS -- DID NOT
HAVE VERY GOOD BIOAVAILABILITY THAT WAY.
BUT IT WAS TRIED PARENTALLY, AND THE CLINICAL STUDIES THAT I'VE
DONE -- ALL THAT WE HAVE SUPPORTED ACTUALLY SHOW THAT THERE IS A VERY
GOOD TREND ON PHASE II STUDIES THAT IT MAY BE EFFICACIOUS.
AND SO THERE -- AT THE SAME TIME THAT THEY WILL BE AS POSSIBLE
USAGE IN CONSIDERATION AS WE GO THIS SUMMER THEY WILL --
PHASE III CLINICAL STUDIES WILL START LOOKING AT ACTUALLY
PIVOTAL EFFICACY TRIALS.
SO THAT'S ONE POSSIBILITY THAT -- THAT MAY BE, AND THIS WOULD BE
USED IN SEVERELY ILL INDIVIDUALS THAT MAY BE HOSPITALIZED AND,
AGAIN, GIVEN INTRAVENOUSLY.
THE OTHER ONE UNDER CONSIDERATION IS
ACTUALLY NOT AS FAR ENOUGH ALONG.
THIS IS THE IV ZANAMIVIR, WHICH -- WHICH IS NOT
A LICENSED INDICATION.
AND THERE WILL BE A NEED TO DO A NUMBER OF CLINICAL STUDIES BEFORE
IT CAN BE ACTUALLY CONSIDERED TO BE USED UNDER EUA.
SO THAT'S WHERE WE ARE RIGHT NOW WITH -- WITH THE REAL PRODUCTS
THAT MAY BE UNDER CONSIDERATION.
[ANN] YEAH, THANKS VERY MUCH, ROBIN.
OKAY, I THINK WE HAD A QUESTION UP -- OH, UP THERE FIRST?
UH-HUH.
YEAH, YOU.
[LAUGHS]
[FEMALE SPEAKER] [INAUDIBLE]
[ANN] YEAH, THANKS FOR THAT QUESTION.
THE QUESTION'S ABOUT FAST-TRACKING THE PNEUMOCOCCAL CONJUGATE
13-VALENT PRODUCT THAT IS UNDER REVIEW NOW AT THE FDA BECAUSE
OF BACTERIAL COMPLICATIONS OF INFLUENZA AND AN EXPERIENCE
WITH SOME SEVERE COMPLICATIONS.
I DO WANT TO MAKE A REMINDER THAT THE PNEUMOCOCCAL POLYSACCHARIDE
VACCINE IS RECOMMENDED FOR MOST -- MANY ADULTS WITH THE SAME KIND OF
RISK FACTORS AS WE'RE SEEING IN THIS H1N1 VIRUS.
AND SO FOR HEALTHCARE AND PUBLIC HEALTH, WHO KIND OF FORGET ABOUT
THAT VACCINE, IT'S A GOOD TIME TO REMEMBER.
WE DON'T HAVE EXCELLENT COVERAGE OF THAT VACCINE IN YOUNGER ADULTS
WHO HAVE RISK FACTORS.
AND WE ARE NOW SEEING IN SOME OF OUR EPIDEMIOLOGIC AND CLINICAL
DATA BACTERIAL COMPLICATIONS OF THIS H1N1 VIRUS.
SO I DON'T HAVE THE ANSWER TO THE FAST-TRACKING QUESTION.
AS WE HEARD, WE DIDN'T INVITE FDA TO BE ON THIS PANEL.
WE'RE SORRY, BUT I CAN SAY THAT THE ADVISORY COMMITTEE
FOR IMMUNIZATION PRACTICES HAS ALREADY REVIEWED A LOT OF DATA
AND WAS EXPECTING TO BE MAKING RECOMMENDATIONS ON THAT AFTER
FDA HAD CONVENED.
A QUESTION HERE, DR. JARRIS [PHONETIC SP].
[PAUL JARRIS] [INAUDIBLE]
[ANN] YEAH, THANK YOU.
I THINK VACCINE SAFETY MONITORING IS JUST GOING TO BE CRITICAL.
DR. BUTLER, DO YOU WANT TO START TALKING ABOUT THAT A BIT?
[JAY BUTLER] YES.
[LAUGHTER]
[ANN] NOW HE'S SCARED OF ME; LOOK AT HIM.
[JAY BUTLER] IT'S REALLY GOING TO REQUIRE, PAUL, A MULTI-MODAL APPROACH
IN A NUMBER OF DIFFERENT SYSTEMS.
AND LET ME START WITH -- IT'S PROBABLY NOT A GOOD TIME TO
START UP WITH SOME COMPLETELY NEW SYSTEM.
SO WE'RE FOCUSING ON THE EXISTING SYSTEMS.
HOW CAN WE ENHANCE THEM AND USE THEM AS BEST AS POSSIBLE?
AND THINK OF IT IN TERMS OF BOTH SIGNAL DETECTION AND THEN ABILITY
TO WORK UP ANY SIGNALS THAT ARE DETECTED AS WELL.
VAERS, THE VACCINE ADVERSE EVENT RECORDING SYSTEM, IS ONE THAT
CERTAINLY NEEDS SOME ENHANCEMENT, BUT IT'S ONE THAT'S THERE THAT
OFTENTIMES THE CLINICIANS HAVE SOME FAMILIARITY WITH.
THE MOVEMENT WITH VAERS IS TOWARDS WEB-BASED REPORTING
SUCH THAT NOT JUST CLINICIANS FILLING OUT PAPERWORK THAT
THEN GOES INTO THE MAIL AND TAKES FOREVER TO COME IN IS WHAT COMES
THROUGH THAT MASSIVE SYSTEM, BUT PEOPLE ACTUALLY WHO'VE RECEIVED
THE VACCINE COULD LOG ON AND REPORT ANY ADVERSE EVENTS
THAT THEY'VE -- THEY'VE EXPERIENCED AS WELL.
SO THAT WOULD BE ONE SIGNAL DETECTION SYSTEM.
ANOTHER WOULD BE THE VACCINE SAFETY DATA LINK, WHICH IS
A POPULATION-BASED SYSTEM WORKING OUT OF SOME MANAGED
CARE ORGANIZATIONS, PRIMARILY ON THE WEST COAST, WITH
POPULATION-BASED -- I BELIEVE OVER ABOUT NINE MILLION PEOPLE.
AND THAT WILL BE ANOTHER, LITTLE MORE FOCUSED -- I DON'T KNOW IF
PASSIVE IS REALLY A GOOD TERM FOR THAT ONE -- A WAY TO LOOK FOR
SIGNAL DETECTION THAT WE CAN LOOK FOR SEVERAL ANTICIPATED AS WELL
AS UNANTICIPATED POSSIBLE COMPLICATIONS.
CERTAINLY GIVEN THE EXPERIENCE OF 1976, GUILLAIN-BARRE WILL BE ONE
OF THOSE SIGNALS THAT WE'RE LOOKING FOR.
BUT ALSO ANOTHER OF OTHER TYPES OF AUTOIMMUNE DISEASES WOULD
BE MONITORED AS WELL.
[MALE SPEAKER] [INAUDIBLE]
[MALE SPEAKER] SO I DON'T KNOW IF -- IF ANYONE COULD HEAR -- OR IF MANY PEOPLE
COULD HEAR YOUR SUGGESTION.
I THINK THAT -- WHILE PAUL JARRIS FROM ASTHO HAS A SPECIFIC
SUGGESTION, I THINK THAT MAYBE THE TO ME THE MESSAGE
IS PEOPLE ARE HERE BECAUSE THEY'RE GOING TO GO BACK AND TAKE A LOOK
AT HOW THIS IS GOING TO WORK IN THEIR STATES AND SEE WHAT
SYSTEMS -- AS JAY SAID, SYSTEMS MAY ALREADY --
THAT -- BE AVAILABLE THAT MAY BE APPLICABLE TO THIS.
I THINK THE MOST IMPORTANT MESSAGE IS AS YOU'RE GOING TO GO BACK AND
THINK ABOUT THE IMMUNIZATION PART OF PLANNING FOR THE FALL IS TO
THINK HARD ABOUT AS THE DECISIONS ARE MADE ABOUT WHO TO VACCINATE
IS TO LOOK IN WHAT SYSTEMS THOSE PEOPLE EXIST AND HEALTHCARE
SYSTEMS BECAUSE THE CRITICAL THING IS TO BE ABLE TO CONNECT
THAT THEY RECEIVED A VACCINE AND SOME HEALTH OUTCOME LATER.
THERE ARE A LOT OF WAYS TO GO ABOUT THIS, AND I THINK THAT'S
WHERE SOME CREATIVE -- SOME CREATIVE IDEAS THAT MAY BE
LOCAL WOULD BE VERY IMPORTANT.
AND I'LL REINFORCE WHAT GUS MENTIONED BEFORE IS THAT
THE NATIONAL VACCINE ADVISORY COMMITTEE HAS A SAFETY WORKING
GROUP THAT'S TAKING THIS ONE ON.
SO I THINK THAT THAT'S A GOOD PLACE FOR THEM TO HEAR ABOUT
SOME OF THESE OTHER THINGS THAT -- THAT ARE -- THAT ARE IN ADDITION
TO THE SYSTEMS THAT JAY MENTIONED.
[ANN] OKAY, I'M GETTING THE FIVE MINUTE SIGN HERE, AND THERE'S
A LOT OF PEOPLE WHO WANT TO ASK QUESTIONS.
LET ME START RIGHT HERE.
UH-HUH.
[DAN FUKUE] HI, DAN FUKUE [PHONETIC SP], AMERICAN ACADEMY OF PEDIATRICS.
I GUESS SOME OF MY QUESTIONS ARE SOME OF THE DISCUSSIONS WITH SOME
OF MY COLLEAGUES ALSO.
ONE IS ABOUT COMMUNICATION AND PUBLIC REASSURANCE ALONG THE
SAFETY ISSUES, AND WE GET CONCERNED ABOUT [INAUDIBLE]
AND WHATEVER [INAUDIBLE].
THE SECOND PART IS WHO IS GOING TO LEAD, YOU KNOW, OR SPEARHEAD THE
GUIDANCE, AND ARE YOU GUYS MAKING IT MANDATORY, FOR EXAMPLE,
VACCINATIONS IN SCHOOLS.
THAT WOULD BE [INAUDIBLE] VACCINATE SOME CHILDREN
OR THE HIGH-RISK POPULATION THAT YOU'RE GOING TO ADDRESS.
[INAUDIBLE]
SO THOSE ARE SOME OF THE QUESTIONS I WANTED TO ASK.
[INAUDIBLE]
[ANN] YEAH, THANKS FOR THOSE QUESTIONS, AND WE'RE REALLY GLAD THAT THE
AMERICAN ACADEMY OF PEDIATRICS IS HERE.
THE PARTNERSHIP BETWEEN PEDIATRICS AND PUBLIC HEALTH IN IMMUNIZATION
IS JUST AWESOME TO ME, AND WE KNOW THAT WE HAVE A VERY
STRONG IMMUNIZATION SYSTEM DESPITE A LOT OF CHALLENGES BECAUSE OF
FRONTLINE PEDIATRICIANS AND FAMILY PHYSICIANS.
COMMUNICATING ABOUT VACCINE SAFETY, WHETHER IT'S ROUTINE
IMMUNIZATION OR AN H1N1 VACCINATION PROGRAM, IS VITAL.
WE TOTALLY NEED THE AMERICAN PUBLIC TO KNOW WHAT WE'RE
DOING TO TRACK SAFETY, WHAT WE KNOW ABOUT PRODUCTS WHEN WE'RE
USING THEM, AND WHAT WE'RE DOING TO FIND OUT MORE.
AND THIS IS JUST GOING TO BE VERY IMPORTANT, ONE OF THE REASONS
WE WELCOME THIS DISCUSSION AT THIS POINT, AND WE'RE REALLY TRYING TO
MAKE SURE WE HAVE SYSTEMS THAT CAN DETECT SIGNALS
AND CAN INTERPRET CHALLENGES.
BUT AS WE'VE BEEN HEARING, EVERYTHING IS LOCAL.
IF YOU LOOK BACK TO THE 1976 EXPERIENCE, CLUSTERS OF EVENTS
IN ONE PLACE PROMPTED A LOCAL RESPONSE, AND THAT COMMUNICATION
RESPONSE REALLY CATALYZED NATIONAL CHANGES IN ATTITUDES, AND SO I
THINK WE REALLY WANT EVERYBODY THINKING AHEAD ABOUT RISK
COMMUNICATION, ABOUT SHARING INFORMATION YOU HAVE WITH
THE PUBLIC WHEN YOU HAVE IT, AND HELPING THEM UNDERSTAND
AND INTERPRET INFORMATION.
IN ANYTHING LIKE THIS, THERE'S APT TO BE A LOT OF MISINFORMATION,
AND SO WE WANT TO MAKE SURE THAT THE ACCURATE INFORMATION, WHETHER
IT'S BAD NEWS OR NOT, GETS OUT FROM CREDIBLE SOURCES, AND I
HOPE WE WILL ALL WORK TOGETHER EFFECTIVELY ON THAT.
WE KNOW MOST PARENTS LOOK TO THEIR PROVIDERS FOR INFORMATION ABOUT
VACCINES AND THEIR KIDS, AND SO YOU GUYS ARE GOING
TO BE CRITICAL PARTNERS.
YOU ASKED ABOUT MANDATES, AND I THINK SECRETARY SEBELIUS
IN ANNOUNCING THIS DECISION THIS MORNING, I THINK SHE CHOSE HER
WORDS FAIRLY CAREFULLY, AND SHE TALKED ABOUT A VOLUNTARY
VACCINATION PROGRAM.
THAT'S CERTAINLY WHAT WE ARE INTENDING IN THE -- IN TERMS
OF THE PLANNING ASSUMPTIONS.
DO WE HAVE -- I THINK WE HAVE TIME FOR -- OH, WE HAVE THREE MINUTES,
SO WE HAVE TIME FOR TWO MORE QUESTIONS IF I STOP TALKING.
OKAY, THERE WE HAVE ONE OVER HERE.
[MALE SPEAKER] [INAUDIBLE]
[ANN] YEAH, THANKS.
THE QUESTION WAS ABOUT REIMBURSEMENT AND ABOUT
CMS AND MEDICAID AND ISSUES ABOUT HOW THIS IS REALLY
GOING TO BE FUNDED.
YOU KNOW, I THINK THE EXPECTATION, AS SECRETARY SEBELIUS TALKED
ABOUT THIS MORNING, THE FEDERAL PROCUREMENT AND FEDERAL SUPPORT
FOR THIS PROGRAM WAS THE INTENTION, BUT
FOR A VACCINE THAT'S DELIVERED IN THE PRIVATE SECTOR THE EXPECTATION
WAS THAT REIMBURSEMENT FOR THE ADMINISTRATION WAS A --
POTENTIALLY COULD HAPPEN FOR SOME CIRCUMSTANCES.
PART OF THE -- THE TASK FORCE EFFORT THAT DR. BUTLER'S LEADING
IS TO WORK WITH THE INSURANCE ENVIRONMENT, CMS AND OTHERS,
TO UNDERSTAND THESE ISSUES AS QUICKLY AS POSSIBLE AND
TO GET THEM -- MOVE FORWARD.
I WANT TO LET DR. BIRKHEAD SPEAK TO THIS BECAUSE IT'S A VERY
IMPORTANT PART OF NVAC'S WORK AS WELL.
[GUTHRIE BIRKHEAD] YEAH, ACTUALLY THE NATIONAL VACCINE ADVISORY COMMITTEE
IS WORKING ON THE FINANCE ISSUE AND HOPEFULLY WILL HAVE SOME
RECOMMENDATIONS AT ITS JULY 27 -- WE'RE HAVING A PUBLIC
TELECONFERENCE MEETING, AND FINANCE WILL BE ONE
OF THE THINGS.
BUT I AGREE WITH YOU; TO THE EXTENT THAT THIS IS GOING
TO BE DELIVERED IN THE PRIVATE SECTOR WE NEED MECHANISMS, AND
WE KNOW FROM A REPORT THAT NVAC ISSUED LAST YEAR THAT MEDICAID
REIMBURSEMENT, FOR EXAMPLE, VARIES ALL OVER THE MAP
AROUND THE COUNTRY, FROM AS LITTLE TWO DOLLARS ADMINISTRATION FEE,
WHICH DOESN'T BEGIN TO COVER COSTS.
SO THE OTHER FACTOR IS MEDIKIDS AND SCHIP AND MEDICAID ARE ON --
IN MANAGED CARE PLANS WHERE THE ADMINISTRATION FEE IS
SORT OF A BLACK BOX.
IT'S A NEGOTIATED ELEMENT.
SO I AGREE THAT THERE NEEDS TO BE SOME EFFORT THERE.
THERE'S ALSO FINANCING ISSUES ON THE PUBLIC SIDE AS WELL.
THE $350 MILLION THAT THE SECRETARY REFERENCED THIS
MORNING IS IMPORTANT FUNDING, BUT IF YOU EVEN TAKE AN AVERAGE
FIGURE OF TEN DOLLARS PER VACCINE DELIVERED, IF YOU -- TO THE --
THAT -- THAT DOESN'T -- IT'S AN ORDER OF MAGNITUDE OFF IN TERMS
OF WHAT WE WOULD NEED.
I BELIEVE THERE IS A SUPPLEMENTAL OR CONTINGENCY FUNDING IN THE SAME
APPROPRIATION OF $5 BILLION, WHICH COULD POTENTIALLY GO TO HELP THAT
PART OF THE ISSUE.
[ANN] YEAH, WELL, YOU KNOW, I'VE GOTTEN THE ZERO TIME SIGNAL.
WHAT I WANT TO DO IN THE TIME THAT I DON'T HAVE LEFT IS TO THANK YOU
FOR YOUR ACTIVE PARTICIPATION.
I WANT TO MAKE ONE, FINAL, CLOSING REMARK, THOUGH.
I'D LIKE TO HEARKEN BACK TO OUR PRESIDENT'S REMARKS THIS MORNING
AND OUR SECRETARY'S ADMONITION THAT THIS
IS A TIME FOR AGGRESSIVE PLANNING.
I HOPE YOU RECOGNIZE THAT WE DO HAVE A LOT TO PLAN FOR AND THAT
YOU'LL USE THE WEEKS AHEAD TO GET TOGETHER IN YOUR COMMUNITIES AND
REALLY TAKE THIS -- TAKE ON THIS WONDERFUL CHALLENGE SERIOUSLY.
WE REALLY LOOK FORWARD TO WORKING WITH YOU OVER THE WEEKS AHEAD.
SO THANK YOU ALL.