>>> I FIRST WOULD LIKE TO
ACKNOWLEDGE THE WORKING GROUP
MEMBERS AND LISA WHO WORKED AS A
PHS MEMBER WORKING VERY HARD ALL
DURING THE SHUTDOWN.
TO TRY TO GET ALL OF THIS
MATERIAL READY FOR US TODAY.
THERE HAVE BEEN A NUMBER OF
DEVELOPMENTS SINCE THE JUNE ACIP
MEETING.
THE FIRST, OF COURSE, IS THE
PUBLICATION OF THE 2013-14 ACIP
INFLUENZA STATEMENT.
AND THIS YEAR, THAT WAS NO SMALL
TASK.
BECAUSE IN ADDITION TO THE USUAL
SUMMARY OF THE VIRUS STRAINS FOR
THE 2013-2014 VACCINE, THERE'S A
SUMMARY THAT YOU'LL FIND THERE
OF SIX RECENTLY APPROVED
VACCINES, FOUR XWAQUADRIVALENT
VACCINES AND TWO NEW VACCINES
FLU CELL BACKS AND FLU BLOCKS.
THERE WAS A REVISION OF THE EGG
ALLERGY STATEMENT TO INCLUDE FLU
BLOCKS IN EGG ALLERGIC
INDIVIDUALS 18 TO 49 YEARS.
WE ALSO HEARD ABOUT THE
LICENSURE OF FLU QUADRIVALENT
FOR CHILDREN AND ADULTS AGES 3
AND ABOVE.
AND A NEW AGE INDICATION FOR FLU
EVOLVED TRI VALENT SO THAT IT
WAS AHD SS KA LATED SO NOW
CHILDREN AGES 3 AND ABOVE CAN IT
IT IN ADDITION TO ADULTS.
WE HEARD A PRELIMINARY
DISCUSSION OF THE FLU ZONE HIGH
DOSE VACCINE.
AND YOU'LL HEAR MORE ABOUT THAT
TODAY.
SO TODAY YOU'LL HEAR THREE
TALKS.
AND I SHOULD SAY THAT ONLY ONE
OF THESE HAS THE INFLUENCE WORK
GROUP HEARD BECAUSE OF THE
SHUTDOWN.
WE HAVE HEARD THE THIRD TALK
THAT YOU'LL HEAR ABOUT, THE
PRESENTATION BY SANOFI OF THE
TRIAL EFFICACY RESULTS.
IN ADDITION, WE'LL HEAR FROM A
FLU SURVEILLANCE UPDATE FROM
LISA GROHSKOPF.
AND COVERAGE FROM JIM SINGLETON.
AT THIS POINT, I'LL TURN IT OVER
TO LISA.
THIS WILL BE A BRIEF UPDATE OF
THE SURVEILLANCE OF SYSTEMS SO
FAR.
THIS INFORMATION COMES FROM FLU
VIEW AND IT IS FOR THE MOST
CURRENT REPORT, WHICH IS WEEK
NUMBER 41 IN OUR CALENDAR.
THAT'S THE WEEK OF OCTOBER 6th
THROUGH 12, 2013.
FIRST, THIS IS THE MAP THAT
SUMMARIZE AES GEOGRAPHIC SPREAD
OF INFLUENZA ACTIVITY THAT IS
SUMMARIZED THROUGH WEEKLY
REPORTS BY STARE TERRITORIAL
EPIDEMIOLOGY GISTS.
THIS, AGAIN, GEOGRAPHIC SPREAD
AND IS NOT INTENDED TO BE
INTERRUPTED AS SEVERITY.
WE HAVE ONE REGION, PUERTO RICO,
THAT REPORTED REGIONAL ACTIVITY.
THREE STATES FOR THIS PARTICULAR
WEEK REPORTED.
LOCAL ACTIVITY, THOSE BEING
TEXAS, MISSISSIPPI AND SOUTH
CAROLINA, AND MOST OF THE REST
OF THE COUNTRY REPORTING EITHER
NONE OR SPORADIC ACTIVITY WITH
THE EXCEPTION OF NEVADA, WHICH
DID NOT SUBMIT A REPORT.
FOR THE SAME WEEK, WEEK SIX,
THIS IS A SUMMARY OF INFLUENZA
POSITIVE TESTS THAT WERE
REPORTED TO CDC BY THE W.H.O.
AND NATIONAL RESPIRATORY AND
SURVEILLANCE LABORATORIES
THROUGHOUT THE UNITED STATES.
THESE LABS SUPPORT THE NUMBER OF
SPECIMEN SUBMITTED AND PRESENTED
AND THE ONES THAT ARE POSITIVE
FOR INFLUENZA.
FOR WEEK 41, WE HAVE 3,534
SPECIMEN TESTED, OF WHICH 166,
OR 4.7% WERE POSITIVE 37 THE
BREAKDOWN BY THYME TYPE IS
SUMMARIZED IN COLOR ON THE BARS.
WITH 91% BEING FLU A, 9% BEING
FLU B.
AMONG THE As, 25% H1N1 SPB 2009.
AND 68% NOT SUBTYPED AS As.
THIS IS DATA FROM IOLINET.
THAT IS THE NETWORK OF OVER
2,900 PROVIDERS THAT REPORT ON
OUT-PATIENT BUSINESS.
AND BASICALLY FIND THE REPORT OF
A SORE THROAT OR COUGH THAT
CAN'T BE ATTRIBUTED TO ANOTHER
KNOWN CAUGHT.
THE CURRENT SEASON WE'RE SEEING
ABOUT NOW IS WAY OFF THE TO THE
LEFT.
THAT'S ALL WE HAVE FOR THIS
SEASON SO FAR.
IT IS FAIRLY EARLY.
THIS LAST SLIGHT SLIDE IS THE
PEDIATRIC DEATH SUMMARY SLIDE,
PEDIATRIC DEATHS DUE TO THOSE
THAT HAVE BEEN REPORTINGBLE
SINCE 2004.
FOR 2013, '14, NO PEDIATRIC
DEATH REPORTS HAVE BEEN RECEIVED
YET.
THE TOTAL FOR 2012-13 WAS 165
CASES.
THAT'S ALL I HAVE FOR THIS.
I'M HAPPY TO TAKE ANY QUESTIONS.
>> LOOKS LIKE THAT WAS A VERY
COMPLETE REPORT THERE.
ANY QUESTIONS AT ALL?
IF NOT, WE CAN MOVE ON TO THE
DISCUSSION OF THE VACCINATION
DISTRIBUTION AND COVERAGE.
>> THANKS VERY MUCH.
>>> HELLO.
I'D LIKE TO TALK ABOUT THE
VACCINE COVERAGE RESULTS FOR THE
2012-13 SEASON.
THESE RESULTS WERE RELEASED IN
SEPTEMBER 27.
JUST AN OVERVIEW FOR THE 2013
SEASON, THE THIRD SEASON IN
WHICH WE'VE HAD THE UNIVERSAL
FLU RECOMMENDATION AND THIS
THIRD SEASON AFTER THE 2009
PANDEMIC.
AND THE 2012-13 SEASON AGAIN WAS
MODERATELY SEVERE AND DURATIONS
LONGER THAN AVERAGE.
THERE WERE SHORTAGES OF THE FLU
VACCINE REPORTED IN JANUARY.
AN UPDATE OF THE HEALTHY PEOPLE
DATA, TEN OBJECTIVES FOR
DIFFERENT GROUPS WERE
CONSOLIDATED INTO FOUR GROOEPS
GROUPS, ONE FOR CHILDREN, ONE
FOR ADULTS, ONE FOR HEALTH KERR
PERSONNEL AND ONE FOR PREGNANT
WOMEN.
THE TARGET WAS 7 0% COVERAGE FOR
CHILDREN AND ADULTS AND 90% FOR
HEALTH CARE PERSONNEL.
FOR PREGNANT WOMEN, THERE'S NO
SERGEANT TET BECAUSE THAT WOULD
MOVE TO A DEVELOPMENTAL
OBJECTIVE WHICH MEANS THAT WE'RE
VAULTING DIFFERENT DATA SOURCES
TO DETERMINE THE BEST ONES AND
MONITOR COVERAGE FOR HEALTHY
PEOPLE.
WE WILL CONTINUE TO MORE TON THE
OTHER, ALL THE POPULATIONS THAT
WERE LOOKED AT BEFORE.
SO THIS SLIDE SHOWS THE
CUMULATIVEION OF FLU
VACCINATIONS FOR DIFFERENT
SEASONS.
IN THE RED IS THE 2012-13
SEASON.
134.9 MILLION DOSES.
DISTRIBUTED SIMILAR TO THE PRIOR
SEASON AND THEN THE CURRENT
SEASON, I CAN SEE THAT ABOUT 70
MILLION -- 73 MILLION WERE
DISTRIBUTED BY SEPTEMBER 20th.
JUST THE DATA METHODS, WE'RE
UPDATING, WE PRODUCED INTERIM
ESTIMATES IN NOVEMBER OF 2012
BASED ON EARLY SEASON DATA.
WE HEAR ARE REPORTING SURVEY
DATA FOR THE GENERAL POPULATION.
IT'S A LE LARGE SAMPLES OF
CHILDREN FROM THE NATIONAL
COMMUNEZATION SURVEY.
AND FROM THE BEHAVIORAL
SURVEILLANCE SYSTEMS.
WE CONDUCTED PANELS OF SURVEYS
FROM HEALTH CARE PERSONNEL AND
PREGNANT WOMEN.
1900 AND 1700 SAMPLES ARE
PUBLISHED.
SO THIS SHOWS RECENT TRENDS
BASED ON THE NIS AND THE BFIIS.
FOR CHILDREN, WE SHOW THE
INCREASING TREND REACHING 57% IN
THE 2012-13 SEASON FOR ADULTS,
42% IN THE 2012-13 SEASON
OVERALL, ABOUT 45% IN THE
POPULATION.
JUST SHOWING -- THIS SHOWS
ACCUMULATIVE UPTAKE OF VACCINE
BY MONTH FOR CHILDREN ON THE
LEFT, ADULTS ON THE RIGHT.
AND YOU CAN SEE THAT FOR
CHILDREN, THEY HAD ABOUT 5%
INCREASE AT THE END OF THE
SEASON COMPARED TO THE PRIOR
SEASON.
AND THAT INCREASE OCCURRED
PRIMARILY IN DECEMBER AND IS
JANUARY.
FOR ADULTS, THERE WAS A 2.7
PERCENTAGE POINT INCREASE BY THE
END OF THE SEASON.
THAT HAPPENED MORE IN JANUARY
AND FEBRUARY.
THREE MONTHS OLD AND 43% IN THE
13 TO 17-YEAR-OLDS.
THE INCREASES FROM THE PRIOR
SEASON WERE MONTH PRONOUNCED,
STATISTICALLY SIGNIFICANT FOR
THE 5 TO 12-YEAR-OLDS THAN THE
13 TO 17-YEAR-OLDS AT 4 TO 9
PERCENTAGE POINTS INCREASE.
THIS IS DATA WE'RE LOOKING AT
FULL VACCINE COVERAGE NOW FROM
ISS SITES.
2012-13, THERE WERE SIX SITES
REPRESENTED HERE.
THE PRIOR SEASON THERE WERE
EIGHT SITES THAT WE MEASURED.
BUT YOU HAVE IN THE DARK BLUE
BARS RECEIVING ONE OR MORE DOSES
AND FULLY VACCINATED IN TWO
DIFFERENT WAYS.
THE SIMPLE WAY IN BLUE, WHICH IS
JUST BASED ON VACCINES BRIEFLY
FROM 2010-11 FORWARD AND THEN
THE MONTH COMPLICATED APPROACH
THAT CAN ELIMINATE SOME OF THE
CHILDREN WHO NEED TWO DOSES IN
THE PURPLE BARS.
BUT WE SEE THAT THE RATIO OF
FULL COVERAGE TO FULLY
VACCINATED BASED ON THE
COMPLICATED APPROACH IS ABOUT
69%, 73%, 74% RESPECTIVELY FOR
THE THREE AGE GROUPS.
SO FOR MORE THAN TWO-THIRDS OF
THOSE THAT GOT ONE DOSE, WERE
ACTUALLY FULLY VACCINATED.
FOR THE SIMPLE ALGORITHM FOR THE
5 TO 8-YEAR-OLDS, YOU HAVE A
DIFFERENCE OF 20 PERCENTAGE
POINTS FROM 20 TO 29%.
IT WAS PRIOR TO 2010-11 AND THAT
ONLY OCCURS IN THE OLDERAGE
GROUP.
SWITCH TO GO ADULTS, WE SEE 45%
OF ADULTS 18 AND OVER REPORTED
TWO VACCINATIONS FOR THE 2012-13
SEASON.
AN INCREASE IN THE PRIOR SEASON.
IT'S FOR 29% FROM 18 TO
49-YEAR-OLDS.
31% FOR THE 2012-13 SEASON AND
THEN 66%.
PERSONS 65 AND OLDER AND THE
INCREASES WERE STATISTICALLY
SIGNIFICANT IN EACH AGE GROUP
RANGING FROM 1 TO 3 PERCENTAGE
POINTS.
AND WHEN WE LOOK AT PERSONS 18
TO 49, THEIR COVERAGE WAS HIGHER
THAN ALL OF THE PERSONS 18 AND
OVER -- 18 TO 49.
40% TO 41%.
SO WE CONTINUE TO SEE VARIATIONS
IN COVERAGE FOR CHILDREN AND
ADULTS BY STATE.
SO ON THE LEFT, THE RANGE OF 44%
TO 82% AMONG STATES FOR
CHILDREN.
31 TO 53% FOR ADULTS.
AND SO GENERALLY SPEAKING,
CHILDREN HIGHER THAN ADULTS BY
STATE AS WELL AS NATIONALLY.
ON THE LEFT, NONHIS PANIC WHITES
AND NATIVE AFRICAN-AMERICANS
FROM 54% TO 59%.
ALL OTHER AGES GROUPS WAS HIGHER
AND STATISTICALLY SIGNIFICANT,
RAISING UP TO 66% IN ASIANS.
FOR ADULTS, COVERAGE FOR
HISPANICS, OTHER MULTIPLE RACES
AND BLACKS WAS LOWER THAN
COVERAGE IN WHITES.
AGAIN, WE'VE SEEN LONG STANDING
DISPARITIES IN BLACKS AND
HISPANICS COMPARED TO WHITES FOR
ADULTS AND FLU VACCINATION.
NOW, SWITCHING TO HEALTH CARE
WORKERS, THIS SHOWS THE TREND
OVER TIME USING THE NATIONAL
INTERVIEW SURVEY, WHICH IS IN
BLUE, AND THEN THE INTERNET
PANEL SURVEY AND THE MORE RECENT
YEARS.
AND THEY'RE BOTH TRENDING
UPWARDS.
YOU CAN SEE THAT THE INTERNET
PANEL SERVICE TENDS TO GET
SLIGHTLY HIGHER ESTIMATES, BUT
THEY ARE TRENDING SIMILARLY.
NOW THE INTERNET PANEL SERVICE
ALSO ALLOW A TIMELY WAY TO LOOK
AT COVERAGE BY DIFFERENT
OCCUPATIONS AND ON HEALTH CARE
WORKERS.
SO HERE YOU SEE A GRAPHIC ON THE
IMAGE OF THE ARTICLE AND
COVERAGE AT THE HIGHEST YOU HAVE
POSITIONED GENERALLY INCREASING
IN ALL OCCUPATION GROUPS.
THEN THE HIGHEST COVERAGE
POSITION AT 92% IN 2012-13, 89%
NURSE PRACTITIONERS PHYSICIANS
ASSISTANTS AND 85 FERS IN
NURSES.
AND THE LOWEST WAS IN
NONCLINICAL WORKERS AT 65%.
NOW, LOOKING AT IT BY WORK
SETTING, HIGHEST COVERAGE WAS IN
HOSPITALS AT 83%.
73% IN PHYSICIAN OFFICES AND THE
LOWEST, 59% IN LONG-TERM CARE
FACILITIES.
GENERALLY, THE TREND HAS BEEN
INCREASING, BUT FOR LONG-TERM
CARE FACILITIES, IT'S BEEN
BOUNCED AROUND.
AND THERE'S MORE INFORMATION IN
THE ARTICLE.
THERE'S THE PREVALENCE OF
DIFFERENT WORKERS INSTEAD IT'S
BEING UNDER REQUIREMENT FOR
VACCINATION, HIGHLY ASSOCIATED
WITH TIGHT COVERAGE, ALSO WITH
AVAILABILITY OF VACCINE AT THE
WORK SITE.
SO THOSE ARE STRONGLY ASSOCIATED
WITH VACCINATION.
SWITCHING TO PREGNANT WOMEN, WE
HAVE MULTIPLE SOURCES FOR
PREGNANT WOMEN.
WE'VE GOT DATA HERE INCLUDES
INTERNET PANEL SURVEYS IN THE
PURPLE AND WE HAVE CRAMPS DATA
FOR SELECTED YEARS.
IS FOR THE DATA WHERE WE HAVE
TIME THEORIES, IT'S PREPARED AND
PANEL SERVICE WE'VE SEEN IS
GOING TO BE INCREASING TREND
HIGHER COVERAGE THAN WE HAD IN
PRIOR YEARS BEFORE 2009-10.
AND IT'S NOT EVIDENT HERE, BUT
IN THE 2010-11 SEASON, WE LOOKED
AT THE DATA FROM STATES, WE GOT
THE SAME ESTIMATE WE GOT FROM
THE INTERNET PARTIAL SURVEY
RESTRICTED FROM THE STATES.
SO FROM THE INTERNET PANEL
SURVEYS, ABOUT HALF OF WOMEN WHO
WERE PREGNANT ANYTIME DURING
OCTOBER 2012 THROUGH JANUARY
2013 HAD RECEIVED A FLU VACCINE
BEFORE OR DURING THEIR
PREGNANCY.
THIS IS RESULTS FROM THE
INTERNET PANEL SURVEY.
AGAIN, 50.5% OVERALL VACCINATED.
WHEN WE ASKED IF THEY HAD
RECEIVED A RECOMMENDATION AND
RECEIVED A PROVIDER OFFERS FOR
VACCINATION, SAYS THEY GOT BOTH.
71% WERE VACCINATED.
IF THEY JUST GOT A
RECOMMENDATION BUT NOT AN OFFER
AT 46%, AND IF THEY DIDN'T GET
EITHER, THEN IT WAS 16%.
THAT WERE VACCINATED.
ACROSS SOCIAL DEMOGRAPHIC GROUPS
AND EVEN AMONG THOSE SEEN FOR
VACCINATION.
THE VACCINATION INFORMATION
REPORTED.
FOR CHILDREN ABOUT 6% OF ACTS IN
SCHOOLS COMPARED TO ADULTS.
WE SEE 18% VACCINATED.
17% IN THE WORKPLACE.
SO IN SUMMARY, VACCINE COVERAGE
FOR THE 2012-13 SEASON INCREASED
BY PERCENTAGE POINTS FROM THE
PRIOR SEASON AMONG CHILDREN,
COVERAGE FOR ADULTS INCREASED 3
PERCENTAGE POINTS.
INCREASED IN THE AGE GROUP AND
AMONG CHILDREN, COVERAGE WAS
HIGHER, THE NON-HISPANIC WHITE
FOR ASIANS, BLACKS AND CHILDREN
OF OTHER MULTIPLE RACES.
RATIONALE ETHNIC DISPARITIES
EXISTED.
A WIDE VARIATION OF COVERAGE IN
STATES.
MAINTAIN LAST SEASON INCREASES
FOR PREGNANT WOMEN, INCREASED
COVERAGE FOR PERSONNEL.
AND WE ALSO ARE SHOWING THAT
THERE'S WIDE VARIATION AMONG
HEALTH CARE WORKERS BY
OCCUPATION SETTINGS AND THE
POLICIES TOWARDS VACCINATIONS.
THE IMAGE OF YOUR SURVEILLANCE
SUMMARY SUMMARIZE THE DATA FOR
2010-11 SEASON, BUT ALSO GOES
INTO DETAIL TO DESCRIBE THE
DIFFERENT DATA SOURCES AND THE
CHARACTERISTICS.
THAT IS SCHEDULED TO BE
PUBLISHED TOMORROW.
THERE'S THE CHANGE IN THE
DEFINITION STATUS FOR PREGNANT
WOMEN INTT INTERNET PANEL
SURVEYS.
WE INCLUDED VACCINATIONS IN
JULY.
AND WE DID THAT, TOO, FOR THE
GENERAL POPULATIONS, COUNTY JULY
VACCINATIONS.
AND THIS YEAR, WE EXCLUDED
VACCINATIONS RECEIVED AFTER
PREGNANCY.
IT DOESN'T REALLY CHANGE THE
EXCLUSION THAT COVERAGE IS ABOUT
HALF, 50% IN PREGNANT WOMEN.
OF COURSE, IT'S ALL STUFF
RECORDED VACCINATIONS NOT
REPORTED BY MEDICAL RECORDS.
MORE PEOPLE VACCINATED AND
DISTRIBUTED.
SO WE GENERAL KNOW THAT THESE
ESTIMATES ARE TRACKING TRENDS.
WE'RE CONTINUE TO GO EVALUATE
THE INTERNET PANEL SURVEYS FOR
REPRESENTS AND OR
CHARACTERISTICS.
THE RECOMMENDATIONS ARE TO
INCREASE FLU VACCINE COVERAGE
AMONG ALL GROUPS, PRODUCE
DESPAISPARITIES IN COVERAGE AMO
ADULTS.
INCREASE COVERAGE THAT ARE
LISTED HERE.
THE INFORMATION SYSTEMS WAS MORE
RECENT RECOMMENDATIONS.
THIS INFORMATION IS MORE
DETAIL
DETAILED.
IT'S A NATIONAL INFLUENZA 78EL
THROUGH THE 14th AND WE ARE PLAN
ZA 78EL
PLANNING VACCINATIONS FOR HEALTH
CARE WORKERS IN PREGNANT WOMEN
SOMETIME DURING THAT WEEK.
I WANT TO ACKNOWLEDGE A LOT
PEOPLE WHO COLLECTED THE DATA
AND DID ALL THE WORK THAT I
SUMMARIZED TODAY.
WE HAVE TIME FOR QUESTIONS?
>> I THINK THERE'S TIME FOR
QUESTIONS.
DR. BENNET.
>> THANK YOU FOR THAT EXCELLENT
SUMMARY.
AND I THINK MANY OF US REMEMBER
WHEN THE IMMUNIZATION RATE AMONG
HEALTH CARE WORKERS WAS
ABYSMALLY LOW.
SO THESE DATA ARE REALLY, REALLY
EXCITING.
MY QUESTION IS, DO WE HAVE ANY
DATA ABOUT DECREASED ABSENTEEISM
OR ANY KIND OF OUTCOME DATA
AMONG HEALTH CARE WORKERS THAT
WOULD BE USEFUL TO CONVINCE
OTHER EMPLOYERS TO ENGAGE IN
MORE AGGRESSIVE VACCINATION
CAMPAIGNS?
>> I DON'T THINK CDC
SYSTEMICALLY COLLECTS THAT DATA,
BUT THERE MAY BE OTHERS WHO KNOW
OF STUDIES.
>> YEAH.
OUR STUDIES, THE STUDIES THAT WE
DO ANNUALLY FOR VACCINE
EFFECTIVENESS DON'T MEASURE
ABSENTEEISM OF HEALTH CARE
WORKERS, OBVIOUSLY.
THERE HAVE BEEN STUDIES IN THE
LITERATURE THAT DESCRIBED
ABSENTEEISM AMONG WORKERS AS A
RESULT OF VACCINATION POLICIES,
BUT NONE FROM CDC STUDIES, AS
WELL.
>> I'D LIKE TO JUMP IN HERE AND
MENTION THAT DR. FARUK AMAD HAS
PUBLISHED A SYSTEMIC REVIEW ON
THE EFFECT OF HEALTH CARE WORKER
VACCINATION IN REDUCING
TRANSMISSION.
AND SO THAT CAME OUT, I BELIEVE,
THIS SUMMER.
I DON'T HAVE THE CITATION, BUT
IT WAS A VERY NICELY DONE REPORT
USING GRADE.
DR. FOSTER.
>> THANK YOU FOR THE VAST AMOUNT
OF INFORMATION THAT YOU HAVE
PRESENTED HERE.
I WOULD BE REMISS IF I DIDN'T
POINT OUT, WHILE NOT SHOWING ON
THE GRAPH, PARDON ME CYSTS ARE
THE NUMBER TWO GROUP THAT THE
THE VACCINATION RATES HIGHEST.
>> YES.
THOSE ARE SPLIT OUT IN THE MWR
ARTICLE FOR THOSE WHO WANT TO
LOOK AT THAT.
>> I HAVE DR. CHURN.
>> SO THANK YOU.
I HAVE TWO QUESTIONS.
ONE GOES BACK TO THE SLIDE SEVEN
WHERE IT'S ACTUALLY CUMULATIVE
VACCINATION FOR ADULTS AND
CHILDREN.
AND THE QUESTION THAT I HAVE
ABOUT THAT IS THERE'S THIS --
PARTICULARLY, THERE'S THIS TALE
FOR CHILDREN FROM NOVEMBER ON.
AND DOES THAT REFLECT MAYBE SOME
OF THE YOUNGEST CHILDREN GETTING
A SECOND DOSE OR IS THAT A FIRST
DOSE?
AND IF IT'S A FIRST DOSE, I KNOW
A HEARD -- THE COMMUNITY ABOUT
THE POSSIBILITY AND SHORTNESSES
AND WE KNOW.
>> THIS IS THE FIRST DOSE
REPORTED FOR CHILDREN.
WE ASK IF THEY -- EACH ONE, BUT
WE'RE REPORTING HERE.
>> OKAY.
AND SO THEN DO WE KNOW HOW THIS
RELATES TO VACCINES?
>> DR. SCHUPTE.
>> I THINK THERE'S A COUPLE
FACTORS TO ROLL IN.
WE DO THE NATIONAL VACCINATION
EVENT.
AND I BELIEVE THERE WAS A PRESS
CONFERENCE.
HIGHLIGHTS THAT WE'RE HAVING AN
EARLY BAD -- AND WE THINK THAT
WAS FAIRLY EFFECTIVE IN RAISING
DEMAND.
TLZ AING IN OPEN YAUBZ WUB STHE
NUMBER OF AREAS WE'RE SEEING
THAT SUPPLY AVAILABILITY.
I THINK THERE WAS TA OTHER GRAPH
WHERE SUPPLY AVAILABILITY WAS
PRETTY EARLY LAST YEAR.
OF COURSE, SOME FORMULATIONS
WERE ALWAYS -- YOU KNOW, YOU GET
THEM LATER.
THE PARTICULAR FORMULATION, THE
PARTICULAR PRACTICES DO NOT GET
ALL THAT THEY WANT.
IT'S HOW THE DISTRIBUTION,
RATHER, WHERE YOU CAN SORT OF
SEE THAT MOST OF THE DOSES HAD
GONE OUT BY NOVEMBER.
THERE'S PARTICULAR DOSES THAT
YOU WANT.
>> YES.
>> JUST ONE FOLLOW-UP.
AND THAT HAS TO DO WITH THE
HEALTH CARE WORKERS.
SO WHAT I REALLY WANT TO KNOW IS
WHAT DO WE REALLY -- WE WENT
FROM 70% TO 85% IN TWO YEARS.
WOULD IT PROBABLY STICK?
I AGREE SO.
BUT IT'S INTERESTING THAT THE
NONMEDICAL PERSONNEL WAS CLEARLY
LAGGING BEHIND AND ARE THERE
POLICIES OR PROCEDURES WE SHOULD
BE PUTTING INTO PLACE TO HAVE
THOSE INCREASES, AS WELL.
>> TO ADDRESS THE INCREASE IN
NURSES, I'M GOING TO HAVE TO
GIVE THE CDC CREDIT, BECAUSE
THEY GAVE A GRANT TO THE
AMERICAN NURSES ASSOCIATION TO
INCREASE VACCINATION AMONG
NURSES.
AND SO IT WAS A BIG PROJECT THAT
WE WORKED ON FOR A COUPLE OF
YEARS.
THERE ARE A LOT OF HOSPITALS
THAT ARE NOW REQUIRING THAT
EMPLOYEES BE VACCINATED.
AND WHEN YOU LOOK AT THE
NONCLINICAL PERSONNEL, I'M
WONDERING HOW MANY OF THOSE ARE
WORKING IN PERSONAL CARE HOMES
OR NURSING HOMES WHERE THEY
DON'T HAVE THE SAME KIND OF PUSH
THAT HOSPITALS HAVE.
SO THAT MAY BE PART OF THE
ANSWER.
>> I ALSO HAD A QUESTION ABOUT
THE INTERNET SURVEY FOR PREGNANT
WOMEN.
INHERENTLY, I THINK THE
SELF-SELECTION AMONG PREGNANT
WOMEN.
THE PREGNANT WOMEN THAT I CARE
FOR, A LOT OF THEM DON'T HAVE
ACCESS TO THE INTERNET.
I ALWAYS FEEL LIKE THAT SHOULD
BE A CAVEAT IN THAT REPORT.
I'M CURIOUS IF YOU EVER COLLECT
DATE ON WHAT THE INSURANCE IS
AND WHETHER THEY HAVE MEDICAID
OR PRIVATE INSURANCE.
>> WE DO ASK THE HEALTH
INSURANCE STATUS ON THE SURVEY.
I THINK THERE ARE SOME ESTIMATES
BY HEALTH INSURANCE STATUS ON
THE MWR ARTICLE.
WE DO SELECT THAT AND WE CAN
LOOK AT THAT.
>> I KNOW THAT 60% OF THE BIRTH
NECESSARY GEORGIA ARE MEDICAID
BIRTHS.
THAT'S 60% OF WOMEN
ARE LOWINCOME.
SO A LOT OF THEM MAY NOT HAVEAC.
I WONDER IF IT'S A WISH TO
CAPTURE THE POPULATION TO KNOW
WHAT THE VACCINATION RARTS ARE.
>> YEAH.
WE HAVE THE VRFS, WE ONLY ASK IF
YOU'RE CURRENTLY PREGNANT.
SO WE TOOK DECEMBER THROUGH
FEBRUARY INTERVIEWS AND THE
WOMEN CURRENTLY PREGNANT DURING
THAT TIME WOULD BE IN THE TARGET
POPULATION.
AND WE COULD LOOK MORE AT THAT
DATA SOURCE.
THE DATA IS STATE SPECIFIC AND
NOT IN ALL STATES.
BUT HAS A LOT DATA THAT
COULD BE LOOKED AT.
AND I THINK THERE ARE SOME --
THERE WAS AN ARTICLE THAT JUST
CAME OUT FROM MASSACHUSETTS THAT
LOOKED IN DETAIL AFTER THE
ASSOCIATED VACCINATION BY
PREGNANT WOMEN.
THE PANELS INCLUDE SOMEONE WHO
DOES NOT HAVE INTERNET ACCESS.
COMPARED TO OTHER SURVEYS, THE
PRAM BEING ONE, AND VRFS BEING
ANOTHER ONE, THEY'RE GENERALLY
TRACKING THE SAME AND WE ADDED
SOME QUESTIONS TO THE HEALTH
INTERVIEW SURVEY THAT WE HAD
THAT DATA TO LOOK AT.
>> ONE OF THE INCENTIVES THAT'S
OPERATING RECENTLY IN ACUTE
COMPARE HOSPITALS IS CMS
INCENTIVES PAY FOR REPORTING
HEALTH CARE WORKER VACCINATIONS.
SO, YOU KNOW, THOSE
IMPROVEMENTS, DISPOSITIONS AND
NURSES AND NURSE PRACTITIONERS
MIGHT BE LOOKING AT THE
PHARMACISTS ARE DOING A GREAT
JOB WITHOUT THAT KIND OF INCE E
INCENTI
INCENTIVE.
>> IT'S POSSIBLE THAT INCREASING
NUMBER OF FACILITIES ARE HAVING
VIRMTS.
THEY DON'T WANT TO -- THAT'S --
WE HAVEN'T ANALYZED IT HERE TO
SHOW YOU, BUT THAT'S ANOTHER
HIGH POT SIGNIFICANT THAT WE'VE
LOOKED AT.
WHAT WE DO FOR THE LOCK TERM
CARE FACILITIES, A LOT OF THOSE
EMPLOYERS ARE IN FACILITIES THAT
HAVE VACCINE REQUIREMENTS TO BE
COMPARED TO HOSPITAL EMPLOYEES.
>> OF THE DOSES OF VACCINES
DISTRIBUTED SO FAR THIS YEAR, WE
HAVE THE IDEA OF THE RELATIVE
NUMBER OF VACCINATIONS.
QUADRIVALENTS AVAILABLE FOR THE
PROGRAM.
IT WOULD HAVE ANY MORE HERE.
>> IT'S A REMINDER THAT ALL OF
THE LAIP ARE QUADRIVALENT AND
THE PROGRAM PURCHASE D VACCINE
AND I BELIEVE, YOU KNOW, I DON'T
ACTUALLY KNOW THE TOTAL FROM ALL
THOSE DIFFERENT COMPONENTS, BUT
WE PRETTY MUCH HAD CONTRACTS
THROUGH EVERYTHING.
>> I THINK MISS SHIELDS AND MISS
GROOM.
>> WE HAD POTENTIAL FROM THAT IS
BACK TO THE NURSING QUESTION,
WHAT'S GOING ON THERE.
I THINK SEVERAL THINGS.
ONE, I DO THINK THAT HOSPITAL
RES -- KNOW ABOUT CMS AND SO
MORE ORGANIZATIONS ARE MORE
WILLING TO BE STRICT AND FIRM
AND EVEN MANDATING THIS.
SECONDLY, I THINK THERE IS MUCH
BETTER RECORDING, SO WE ACTUALLY
KNOW BY ROLE WHO ACTUALLY IS
GETTING VACCINATED IN HOSPITALS.
THIRD, I THINK IT'S MANY
HOSPITALS HAVE EITHER GET
VACCINATED OR WEAR A MASK AND,
YOU KNOW, MASK WEARING IS NOT
FUN.
SO MORE PEOPLE DO VACCINATION.
BUT I ALSO THINK JUST IN TERMS
OF THE LUMPING,
SPLITTING OUT GROUPS IN YOUR
DATA IS MUCH BETTER.
I'D ASK YOU ON SPLIT ONE MORE
AND THAT'S NURSE PRACTITIONERS
AND PHYSICIAN ASSISTANTS.
SO I THINK OUR DATA OVERALL IS
BETTER, TOO.
>> I BELIEVE THOSE ARE SPLIT OUT
IN THE -- MAYBE IN THE MWR.
THEY'RE NOT?
OKAY.
THAT'S PROBABLY BECAUSE OF
SAMPLE SIZE ISSUES.
A QUICK QUESTION ON THE HEALTHY
PEOPLE 2021 AND THE NOO OF THE
DATA SOURCE.
IN THE PAST, NHS HAS USED 19 AND
OLDER.
I NOTICED THE AGE GROUP SG LOOKS
AT VACCINES 19 AND OLDER.
>> THAT WAS NHIS AND IT'S
CONSIDERED TO BE THE MOST
REPRESENTATIVE WITH THE RESPONSE
RATES FROM THE TELEPHONE SURVEY.
AND SO IT'S CONSIDERED -- THE H
SPLIT IS PRIMARILY A MATTER OF
CONVENIENCE AND ESTIMATATION
BECAUSE THE SURVEYS HAVE
DIFFERENT GROUPS.
17 IS THE CUTOFF FOR A CHILD FOR
LEGAL PURPOSES FOR SURVEYS.
IF YOU'RE 18 IN MOST STATES YOU
GET SURVEYED YOURSELF.
OBVIOUSLY IT INCLUDES THE
19-YEAR-OLDS.
AND THE 18-YEAR-OLDS.
>> DOES NHIS HAVE DATA ON 18 AND
OLDER?
>> 18 AND OVER HAVE INCLUDED.
18-YEAR-OLDS ARE INCLUDED WITH
THE ADULTS.
>> THANK YOU VERY MUCH.
I THINK KEEPING AN EYE ON THE
CLOCK, WE'LL MOVE ON TO THE
PRESENTATION BY DR. GREENLBURG
ON THE FLUZONE HIGH-DOSE
INFLUENZA VACCINE.
GOOD AFTERNOON.
THANK YOU FOR GIVING ME THE
OPPORTUNITY TO PRESENT THE
RESULTS FROM OUR FLUZONE
HIGH-DOSE EFFICACY TRIAL.
I'LL PLEASED TO BE HERE.
FIRST OF ALL, START WITH
BACKGROUND INFORMATION ON THE
RATIONALE FOR DEVELOPING THIS
VACCINE, PRESENT KEY DATA FROM
OUR PRELICENSURE PHASE THREE
SAFETY AND IMMUNOGENICITY STUDY.
REVIEW RESULTS FROM OUR RECENTLY
COMPLETED EFFICACY TRIAL AND
TELL BUT OUR PLANS TO SUBMIT
THESE DATA TO THE FDA.
IN MOST SEASONS, PEOPLE 65 YEARS
OF AGE AND OLDER ACCOUNT FOR
NEARLY TWO-THIRDS OF THE
INFLUENZA HOSPITALIZATIONS AND
ABOUT 90% OF INFLUENZA RELATED
DEATHS.
EACH YEAR, ABOUT 65% TO 70% OF
THIS POPULATION RECEIVES THE
VACCINE, BUT STUDIES COMPLETED
BY THE CDC AND OTHERS HAVE
DEMONSTRATED THAT INFLUENZA
VACCINES PROTECT OLDER ADULTS
LESS WELL THAN YOUNGER ADULTS.
THIS IS EVIDENCE AGAIN, LAST
SEASON, WHEN INFLUENZA VACCINES
OFFERED LIMITED PROTECTION
AGAINST THE H3N2 STRAIN AMONG
THIS OLDER POPULATION.
RELATIVELY LOWER PROTECTION IN
ON OLDER ADULTS MAY BE DUE TO
ESSENCE.
FLUZONE VACCINE GENERATED LOWER
GEOMETRIC ANTIBODY TITERS IN THE
GREEN BARS.
BUT THE QUESTION IS WHETHER
THESE LOWER ANTIBODY STUDIES
REALLY MATTER.
AVAILABLE DATA CLEARLY POINT TO
A CLEAR CORRELATION BETWEEN
RESISTANCE TO INFLUENZA
INFECTION LEVELS ANTIBODY TO
HUMAN DMRUTEN.
THIS IS REPRESENTATIVE OF MANY
THAT HAVE BEEN PUBLISHED
GENERATING CORRELATION BETWEEN
POST VACCINATION OR POST
INFECTION HIATITERS AND
PROTECTION AGAINST INFECTION
UPON EXPOSURE TO INFLUENZA
VIRUS.
SO WITH THE PRECEDING VACCINE IN
MIND, THEY SET OUT TO
MANUFACTURE AND LICENSE A
VACCINE THAT WOULD INDUCE HIGHER
ANTIBODY TITERS AND PROVIDE
BETTER PRODUCTION FOR THIS
VULNERABLE POPULATION.
FLUZONE HIGH DOSE PRESENTS 60
GRAM OF HEMOGLOBIN STRAIN IN THE
FLU VACCINE.
BEFORE PRENING THE DATA FROM OUR
EFFICACY TRIAL, I'LL GO OVER THE
PRELICENSURE STUDY AND
IMMUNOGENICI
IMMUNOGENICITY.
FLU ZONE HIGH DOSE VACCINE WITH
ADULTS 65 YEARS OF AGE AND
OLDER.
NEARLY 4,000 PARTICIPANTS WERE
RANDOMIZED IN THIS DOUBLE-BLIND
STUDIY TO RECEIVE EITHER FLU
ZONE HIGH DOSE OR A VACCINE IN A
TWO TO ONE RATIO.
INJECTION SITE REACTIONS WERE
REPORTED MORE OFTEN AMONG THE
HIGH DOSE RECIPIENTS COMPARED TO
FLUZONE RECIPIENTS BY ABOUT 5
PERCENTAGE POINTS FOR PAIN AND 3
TO 4 PERCENTAGE POINTS FOR
SWELLING.
SYSTEMIC REACTIONS WERE REPORTED
BY THE HIGH DOSE RECIPIENTS MORE
OFTEN THAN IN THE FLUZONE
RECIPIENT.
FURTHER, A SIX-MONTH IS LISTED
AS ADVERSE EVENTS IN A FLU
VACCINE GROUPS.
COMPARED WITH FLU VACCINE IN THE
ORANGE VIRUS AGAINST ALL THREE
STRAINS BASED ON FDA AGREED
CRITERIA, FLUZONE HIGH-DOSE
INTRODUCED SUPERIOR ANTIBODY
RESPONSES FOR THE H1N1 AND H 2N
3 STRAINS.
IN SUMMARY, THE PRELICENSURE
STUDY FLUZONE HIGH DOSE VACCINE
RESULTED IN HIGHER RATES IN
SYSTEMIC REACTIONS, BUT SERIOUS
ADVERSE EVENTS OCCURRED AT
COMPARABLE RATES TO THOSE AFTER
FLUZONE VACCINE.
IMPORTANTLY, FLUS ON HIGH DOSE
STATISTICALLY HIGHER ANTIBODY
RESPONSES AGAINST ALL THREE
STRAINS AS ASSESSED BY
CONVERSION RATES AND PROTECTION
RATES COMPARED TO FLU ZONES.
AND I MET THE PRESPECIFIED
PERIOD FOR DEMONSTRATING IMMUNE
LOGICAL SUPERIORITY TO THE TWO A
STRAINS.
THE FDA LICENSED FLUS IN LATE
2009 UNDER THE PROCESS WITH THE
HOPE OF PROVIDING IMPROVED
PROTECTION AGAINST INFLUENZA
AMONG SENIORS BASED ON THE
VACCINE SUPERIOR IMMUNO
GENICITY.
13 MILLION DOSES HAVE BEEN
DISTRIBUTED IN THE FIRST THREE.
DESPITE THIS PERIOD OF
IMMUNOGENICITY, ABOUT 19% OF THE
WORK RECEIVE THIS VACCINE
LARGELY BECAUSE HEALTH CARE
PROVIDERS AND ADVISORY GROUPS
HAVE BEEN WAITING FOR THE
RESULTS OF OUR POST LICENSURE
EFFICACY TRIAL.
SO NOW I'LL TELL YOU ABOUT THAT
STUDY.
IT WAS A BLINDED EFFICACY TRIAL
OF APPROXIMATELY 32,000
INDIVIDUALS, AT LEAST 65 YEARS
OF AGE WHO WERE RANDOMIZED OF
THE FLU ZONE HIGH DOSE ON A ONE
TO ONE RATIO.
MANY DID HAVE HIGH CHRONIC --
THE STUDY WAS CONDUCTED OVER TWO
SEASONS CONCLUDED AT THE END OF
THE 2012-13 SEASON.
PARTICIPANTS WERE ENROLLED IN
GEOGRAPHIC SITES SHOWN HERE.
THE PRIMARY OBJECTIVE WAS TO
COMPARE THE CLINICAL EFFICACY OF
FLU ZONE HIGH DOSE TO THAT OF
FLU ZONE AGAINST THAT OF
LABORATORY CONFIRMED CULTURE
POSITIVE OR APR CAUSED BY ANY
VIRAL TYPE OF SUBTYPE ASSOCIATED
WITH THE OCCURRENCE OF A
PROTOCOL DEFINED INFLUENZA LIKE
ILLNESS, WHICH WAS DEFINED AS
THE OCCURRENCE OF AT LEAST ONE
PRESESS FIED RESPIRATORY SYSTEM
AND ONE PRESESS FIED SYSTEMIC
SYMPTOMS.
THE SECONDARY OBJECTIVES
INCLUDES ASSESSMENT OF CLINICAL
EFFICACY BASED ON VARIOUS
CLINICAL DEFINITIONS, METHODS OF
INFLUENZA CONFIRMATION AND
SIMILARITY OF THE CASE STRAINS
AND THE VACCINE STRAINS.
AND BECAUSE PREVIOUS STUDIES
HAVE DEMONSTRATED CLINICAL
BENEFIT OF INFLUENZA VACCINE
AGAINST CERTAIN RELATED
COMPLICATIONS, INCLUDING THE
RECENT PUBLICATION IN JAMA BY
UDELL COLLEAGUES AND TORONTO,
PNEUMONIA, CARDIO RESPIRATORY
CONDITIONS, HEALTH CARE VISITS
AND MEDICATION USE IN THE TWO
VACCINE GROUPS.
THIS SUMMARIZE TESS TRIAL DESIGN
THAT I'VE JUST DESCRIBED,
ENROLLED AND RANDOMIZED AT THE
BEGINNING OF EACH SEASON.
AND INDIVIDUALS WHO PARTICIPATED
IN BOTH SEASONS ON WERE
WE RANDOMIZED AT THE BEGINNING OF THE SECOND SEASON.
AT THE SURVEILLANCE WAS
CONDUCTED THROUGHOUT THE STUDY
START TWOG WEEKS AFTER
VACCINATION.
ST STUDY CENTERS IF THEY
EXPERIENCE ANY RESPIRATORY
SYSTEMS.
ACTIVE SURVEILLANCE STARTING 14
DAYS AFTER VACCINATION, THE
FREQUENCY OF CONTACT WAS WEEKLY
THROUGH THE END OF DECEMBER,
TWICE A WEEK DURING JANUARY AND
FEBRUARY, AND WEEKLY AGAIN
DURING MARCH AND APRIL.
AND THEN IT WAS A FINAL CONTACT
MADE IN MISS MAY OF EACH SEASON.
A SWAB WAS OBTAINED AS SOON AS
POSSIBLE AFTER THE SDWRON SET OF
A RESPIRATORY ILLNESS AND NO
LATER THAN FIVE DAYS.
PCR POSITIVE SAMPLES UNDERWENT
GENOMA ZEEBSING.
AND VIRUSES GROWN IN CULTURE
WITH VAR YA ANTI-SERA WITH
SIMILARITY TO THE VACCINE
STRAINS.
IF BOTH WERE AVAILABLE, THE FERA
AND ANTI-FERA TOOK PRIORITY.
PARTICIPANTS WERE SIMILARLY
DISTRIBUTED BETWEEN THE TWO
VACCINE GROUPS WITH REGARD TO
GENDER, AGE, RACIAL ORIGIN AND
ETHNICITY.
NOW WE COME TO THE MOST
IMPORTANT PART OF THE RESULTS.
FLU ZONE HIGH DOSE MET THE
PRESESS PHI CRITERIA.
THE PRIMARY ANALYSIS.
DEMONSTRATED WITH SUPERIOR
CLINICAL EFFICACY COMPARED TO
FLU ZONE VACCINE AGAINST
LABORATORY CONFIRMED INFLUENZA
ASSOCIATED WITH PROTOCOL
DEFINING ILI BY ANY VIRAL TYPE
OR SUBTYPE REGARDLESS OF
SIMILARITY TO THE VACCINE
STRAINS.
FLU ZONE HIGH DOSE REDUCED THE
INCIDENCE OF CLINICAL INFLUENZA
COMPARED TO FLU ZONE VACCINE.
LOWER BOUND OF THE 95%
CONFERENCE INDIANAER VAL WAS
ABOVE TO DEMONSTRATE SUPERIOR
CLINICAL BENEFIT.
IN THE FOLLOWING SERIES OF
SLIDES, 22.4% IS SHOWN IN THE
UPPERMOST TABLE IN THE RELATIVE
EFFICACIES OF SUBGROUP ANALYSES
IS SHOWN BELOW IT.
KEEP IN MIND TA BECAUSE THE
NUMBER OF CASES ARE SMALL IN
SOME OF THESE SUBGROUP ANALYSES,
THE 95% CONFERENCE INTERVALS ARE
WIDE COMPARED TO THE PRIMARY
ANALYSIS.
BUT AS I'LL SHOW YOU, THE POINT
ESTIMATES ARE ALL POSITIVE AND
IN THE SAME RANGE.
FOR EXAMPLE IN THE SUP GROUP
ANALYSIS, THE CLINICAL BENEFIT
OF THE FLU ZONE HIGH DOSE WAS
DEMONSTRATED ACROSS STUDY YEARS
WITH A RELATIVE EFFICACY POINT
ESTIMATE OF APPROXIMATELY 45% IN
YEAR ONE.
THE CLINICAL BENEFIT ON
HIGH-DOSE IS DEMONSTRATED ACROSS
TYPES WITH APPROXIMATELY 24%
AGAINST TYPE A AND 27% AGAINST
TYPE B.
THE CLINICAL BENEFIT OF FLUZONE
HIGH DOSE WAS SOMEWHAT BETTER
AGAINST INFLUENZA STRAIN
APPEARED TO BE SIMILAR TO THE
ESTIMATE OF APPROXIMATELY 35%.
THE CLINICAL BENEFIT WAS
DEMONSTRATED ACROSS AGE GROUPS
WITH RELATIVE EFFICACY POINT
ESTIMATES OF APPROXIMATELY 20%
AMONG PARTICIPANTS OF 65 TO 42
YEARS OF AGE AND 2% OF THOSE 75
XWREERS OF AGE AYEARS OF AGE AN
OLDER.
THE EFFICACY WAS SMA HIGHER DUE
TO THE EFFICACY IN THIS OLDER
COHORT.
THE CLINICAL BENEFIT WAS
DEMONSTRATED ACROSS ILLNESS
DEFINITIONS WITH RELATIVE
EFFICACY POINT ESTIMATES OF 21%
AGAINST LABORATORY CONFIRMED
INFLUENZA ASSOCIATED WITH A
MODIFIED CDC ILI WHICH REQUIRED
FEVER PLUS COUGHS OR SORE THROAT
AND 18% AGAINST LABORATORY
CONFIRMED ASSOCIATED INFLUENZA
CAUSED BY -- ASSOCIATED WITH ANY
SYMPTOMS OF A RESPIRATORY
ILLNESS.
AND FINALLY, THE CLINICAL
BENEFIT WAS DEMONSTRATED NOT
ONLY AGAINST INFLUENZA THAT WAS
LABORATORY CONFIRMED BY EITHER
PCR OR CULTURE, WHICH WAS THE
PRIMARY ANALYSIS, BUT ALSO
AGAINST INFLUENZA THAT WAS
RESTRICTED TO CULTURAL
CONFIRMATION WITH A RELATIVE
POINT EFFICACY OF APPROXIMATELY
23%.
SWITCHING GEARS, THIS AND THE
NEXT TWO SLIDES SHOW RELATIVE
RISKS OF DEVELOPING A PRESESS
FIED OUTCOME WITHIN 30 DAYS OF
ILSEN ASSOCIATED WITH MODIFIED
CDC ILI OR RESPIRATORY ILLNESS.
IN THE UPPER TABLE OF EACH SIDE,
ALL THE CASES CONNIRM LABORATORY
CONFIRMED INFLUENZA.
THE NUMBER OF CASES ARE SMALL,
BUT ALL OF THE RELATIVE RISK
RATIOS ARE LESS THAN ONE,
SUGGESTING THAT FLU ZONE HIGH
DOSE OFFERED BETTER PROTECTION
AGAINST ASSOCIATED NUMBERS
COMPARED WITH FLU ZONE VACCINE.
IN THE LOWER TABLE OF EACH
SLIDE, THE ILLNESSES ARE WITHOUT
REGARD TO LABORATORY
CONFIRMATION.
AGAIN, ALL THOSE RELATIVE RISK
RATIOS SOME SIGNIFICANT
INDICATING THAT FLU ZONE
HIGH-DOSE OFFERS BETTER
PROTECTION AGAINST PNEUMONIA
AFTER ANY STUDY ILLNESS.
A NUMBER OF THESE CASES MUST
HAVE BEEN -- BUT THE INFECTION
WAS NOT LABORATORY CONFIRMED.
THE PATTERN OBSERVED FOR CARDIO
RESPIRATORY CONDITIONS
SUGGESTING BETTER PRODUCTION FOR
FLU ZONE HIGH DOSE VACCINE
AGAINST CARDIAC AND RESPIRATORY
RELATED COMPLICATIONS.
LASTLY, HOSPITALIZATIONS
OCCURRED LESS FREQUENTLY IN THE
FLU ZONE HIGH DOSE GROUP
COMPARED TO THE FLUZONE GROUP
WITHIN 30 DAYS OF EITHER
LABORATORY CONFLIRM INFLUENZA OR
WITHIN 30 DAYS OF STUDY ILLNESS
WITHOUT CONFIRMATION.
>> I'LL FINISH THE DATA
PRESENTATION WITH THIS SLIDE ON
SAFETY INFORMATION COLLECTED
THROUGHOUT THE STATES.
SAEs INCLUDING ALL
HOSPITALIZATIONS OF ANY CAUSE.
WERE REPORTED LESS FREQUENTLY IN
THE FLU ZONE HIGH DOSE GROUP,
PRIMARILY BECAUSE OF THE LOWER
FREQUENCY OF VARIOUS ILL PS
ASSOCIATED COMPLICATIONS AS I
JUST DESCRIBED IN THE
PREKREEDZING SLIDE.
>> THE POLICY STARTED ONE DAY
POST VACCINATION, IT'S
HIGHLIGHTED IN 117 DAYS FROM THE
VACCINATION.
THE GROUPS INCLUDED AND STEVIE
JOHNSON DROP SDWROM DEVELOPED
160 DAYS POST VACCINATION.
IN CONCLUSION, THE STUDY
DEMONSTRATED THE FLU ZONE HIGH
DOSE PROVIDES SUPERIOR
PROTECTION AGAINST THE FLU
VACCINE OF ANY VIRAL TYPE OR
SUBTYPE AMONG THOSE 65 YEARS OF
AGE AND OLDER.
FLUZONE HIGH-DOSE VACCINE
REDUCED THE INCIDENCE OF
SYSTEMIC INFLUENZA BY 24%
COMPARED TO FLU ZONE AND THE
LOWER BOUND OF THE 95% INTERVAL
MET THE PRESPECIFIED PERIOD.
THIS CLINICAL BENEFIT WAS
DEMONSTRATED ACROSS THE YEARS
AGAINST TYPE A AND TYPE B
STRAINS AMONG PARTICIPANTS ABOVE
AND BELOW 75 YEARS OF AGE.
AGAINST ALL STRAINS, INCLUDING
THOSE SIMILAR TO VACCINE
STRAINS.
ACROSS VARIOUS CLINICAL ILLNESS
DEFINITIONS AND REGARDLESS OF
THE METHOD OF LABORATORY
CONFIRMATION.
IN ADDITION, THE DATA OF THIS
LICENSURE EFFICACY TRIAL
SUGGESTS BETTER PRODUCTION
AGAINST COMPLICATIONS SUCH AS
PNEUMONIA, CARDIO RESPIRATORY
DISEASE AND HOSPITALIZATIONS.
THE RESULTS OF THIS AND OTHER,
SAFETY FLU ZONE AGAINST ALL
VIRAL STRAINS CONFIRMING THE
RESULTS OF THE PRELICENSURE
STUDSES.
AS YOU MIGHT IMAGINE IN THE 2012
DATABASE IS VERY LARGE AND THE
PROJECT TEAM IS CONTINUING TO
ANALYZE THE DATA.
THE TEAM'S FOCUS FOR NOW IS A
CLINICAL STUDY REPORT WITH THE
FDA AS SOON AS POSSIBLE.
AT THE SAME TIME WE'LL SUBMIT A
REVISED PI CONTAINING KEY DATA
FROM THIS TRIAL WITH SUPPORT
WITH CLINICAL BENEFITS.
FINALLY, THE TEAM WILL DEVELOP A
SERIES OF MANUSCRIPTES FROM THIS
RICH DATABASE.
I'D LIKE TO ACKNOWLEDGE THE
32,000 STEADY PARTICIPANTS, THE
126 CLINICAL SITES AND THEIR
INVESTIGATORS INCLUDING CHIP
TALBETT AT VANDERBILT AND THE
1012 TEAM INCLUDING THE DATA AND
THE CLINICAL LEAD AND VICKI
LANDOLF.
THIS AND THE NEXT SLIDE, JUST TO
LET THE CURRENT INDICATIONS AND
FLU ZONE
AND FLU ZONE HIGH-DOSE VACCINE.
I'LL CONCLUDE BY EMPHASIZING
THAT THIS IS AN EXTREMELY
IMPORTANT LANDMARK STUDY BECAUSE
IT PROVES ONCE AND FOR ALL THE
FLUZONE HIGH-DOSE VACCINE
PROVIDES CLINICAL BENEFIT, IT IS
SUPERIOR COMPARED TO FLUZONE
VACCINE COMPARED TO CLINICALLY
RELEVANT INFORMATION.
>> THANKS VERY MUCH FOR A VERY
NICE AND CONCISE PRESENTATION.
I HAVE A FOR DR.
BRUSI HERE.
PLEASE REMIND ME AND PERHAPS
EVERYBODY ELSE HERE WHAT WE TEND
TO THINK OF AN ATTACK RATE FOR
ADULTS AGE 65 AND OLDER WHO ARE
NOT VACCINATED.
DO WE HAVE ANY GOOD GUESSES?
>> LET ME LOOK IT UP IN 30 SKDZ.
>> OKAY.
OTHER QUESTIONS?
DR. KEMP.
>> I HAVE A COUPLE OF ANALYTIC
QUESTIONS, WHICH IS ODD FOR ME.
BUT I MISSED A COUPLE THINGS.
FIRST OF ALL, HOW DID YOU DEAL
WITH THE FACT THAT MANY PEOPLE
WERE INVOLVED IN BOTH SEASONS
AND THAT THEY MAY HAVE BEEN
RANDOMIZED.
SECONDLY, I THOUGHT I HEARD YOU
SAY THAT A LOT OF THE CLINICAL
OUTCOMES WERE SIGNIFICANTLY
DIFFERENT WHEN A LOT OF THOSE
APPEARED TO CROSS ONE.
SO I'M CONFUSED ABOUT THAT
CONCLUSION.
>> REGARDING THE INDIVIDUALS WHO
PARTICIPATED IN BOTH YEARS, THAT
WAS CONSIDERED BEFORE THE TRIAL
TOOK PLACE AND IT WAS AN
EXTENSIVE ANALYSIS TO ASSESS
WHETHER OR NOT THAT WOULD
SOMEHOW SKEW THE RESULTS AND, IN
FACT, WE WERE SHOWING THAT IT
WAS NOT EXPECTED TO OCCUR.
SO NOW THAT THE STUDY IS OVER
AND THE GROUP HAS RUN BLINDED
AND THE NAS ANALYSIS HAS TAKEN
PLACE, THE ANALYSIS FOR ALL OF
THESE DIFFERENT PARAMETERS ARE
BEING LOOKED AT OVER TIME WITH
REGARD TO THOSE WHO DID AND DID
NOT PARTICIPATE BOTH YEARS.
NOW, IT TURNS OUT THAT, IN FACT,
MANY INDIVIDUALS DID PARTICIPATE
BOTH YEARS, BUT THE VERY THINGS
THAT HAVE BEEN LOOKED AT SO FAR,
SUCH AS THE POINT ESTIMATES OF
RELATIVE EFFICACY APPEAR TO BE
THE SAME OVER THE YEARS AS WELL
AS THOSE THAT HAVE NOT.
SO THERE APPEARS NOT TO BE ANY
SUBSTANTIAL INFLUENZA UPDATE ON
THAT.
YES, INDEED.
AS I MENTIONED AT THE BEGINNING,
THE STUDY WAS POWERED UP AT THE
PRIMARY ANALYSIS.
AND SO THERE'S NO QUESTION AS
YOU GET DOWN INTO THESE SMALLER
SUBGROUP NATURANALYSANALYSES, T
ENOUGH CASES IN EACH GROUP TO
NECESSARILY HAVE CONFIDENCE
INTERVALS THAT DO NOT CROSS ONE.
I THINK WHAT'S IMPORTANT IS JUST
BY THAT FACT, THE POINT
ESTIMATES ARE ALL IN THAT
GENERAL RANGE OF 20%, 30% FOR
MOST OF THE ANALYSIS.
SO YEAH, COULD WE HAVE DONE A
STUDY OF 1100,000 PEOPLE?
I SUPPOSE OVER FIVE INFLUENZA
SEASONS, PERHAPS.
BUT OBVIOUSLY, EVERYONE WANTED
TO GET RESULTS FROM THE STUDY,
AND THE PRIMARY ENDPOINT OF THE
NUMBER OF CASES WAS ACHIEVED AND
STEADY BLIND AND BROKEN AND
ANALYZED.
>> WE HAVE A COUPLE OF
QUESTIONS.
I'VE HEARD YOUR PRESENTATION
BEFORE.
AND I UNDERSTAND THE RATIONALE
FOR NOT USING CDC DEFINED ILI
BECAUSE IT DOESN'T ALWAYS OCCUR
IN THE ELDERLY.
BUT IF I UNDERSTAND THIS
ENDPOINT CORRECTLY, ANYBODY WITH
A RUNNY OR STUFFY NOSE WHO WAS
FOUND ON SURVEILLANCE BECAUSE
THERE WERE WEEKLY PHONE CALLS
WOULD HAVE COUNTED IN THE
NUMBERS.
AND I GUESS I WOULD SUGGEST THAT
WHAT WE'RE PROBABLY TRYING TO
PREVENT IS, YOU KNOW, MEDICALLY
RELEVANT ILLNESS, ILLNESS THAT
GETS TO THE LEVEL ON GOING TO A
PROVIDER OR SOMETHING LIKE THAT.
AND I WAS WONDERING IF YOU HAVE
ANY DATA ON THAT AND THEN I HAVE
A SECOND QUESTION.
>> WELL, THE CLINICAL ENDPOINT
DEFINITION FOR WHAT WE CALL IN
THESE SLIDES IS RESPIRATORY
ILLNESS WAS THAT SITUATION YOU
DESCRIBED WHERE SOMEBODY COULD
HAVE ANY SINGLE RESPIRATORY
SYMPTOM, SNEEZING, COUGH, SORE
THROAT AND THAT'S ALL THAT THEY
WOULD NEED.
THE PROTOCOL TO FIND OUT ILI
INCLUDED AT LEAST ONE SYSTEMIC
SYMPTOM, AS WELL, AND THE
MODIFIED CDC ILI MANDATED FEVER
GREATER THAN 99.
AND COUGH OR SORE THROAT.
SO, YOU KNOW, THE FULL SPECTRUM
OF THE ILLNESS DEFINITIONS WERE
USED AND SO THE EFFICACY -- THE
RELATIVE EFFICACIES THAT WERE
DESCRIBED ARE QUITE CONSISTENT
ACROSS ALL THREE.
THAT ESSENTIALLY IS FOUND BY
PCR, CULTURE TO BE POSITIVE.
THEY HAD ANALYSIS AND IT WAS 18%
FOR THAT ANALYSIS WHERE IT WAS
24% FOR THE PROTOCOL TO FIND
ILI.
IT WAS SIMILAR FOR THE MODIFIED
ILI.
SO WE TOOK THAT INTO ACCOUNT AND
I THINK BY INSISTING ON HAVING
AT LEAST ONE RESPIRATORY SYMPTOM
AND AT LEAST ONE SYSTEMIC
SYMPTOM AND THEN THE CDC
MANDATING THAT THE ONE SYSTEMIC
RECEIVER IS -- YOU KNOW, IT
COVERS THE FULL RANGE OF
POSSIBILITIES.
>> AND THE OTHER QUESTION I KNOW
YOU'VE HEARD FROM ME BEFORE, BUT
I THOUGHT I WOULD ASK AGAIN,
WHICH IS OBVIOUSLY IN THE
ELDERLY, ONE OF THE THINGS WE
REALLY WORRY ABOUT IS DURATION
OF PROTECTION AND WE WORRY ABOUT
EARLY VACCINATION.
AND DO YOU HAVE ANY DATA
STRATIFIED BY TIME OF
VACCINATION VERSUS TIME OF
ILLNESS TO HAVE ANY OR DATA
INDICATING DURABILITY OF
RESPONSE?
>> YES.
SO THAT THE -- AS I MENTIONED,
THIS IS A DATABASE AND THE TEAM
IS CONTINUING TO ANALYZE THE
DATA.
SO SOME OF THE RESULTS JUST CAME
AVAILABLE IN THE LAST COUPLE OF
DAYS.
JUST GETTING INTO THE SLIDE,
WE'LL BE HAPPY TO SHARE MORE
INFORMATION WITH THE WORK GROUP
IN THE COMING WEEKS AND MONTHS.
BUT YES, IT WAS LOOKED AT AT
LEAST INITIALLY.
AND THE CLINICAL EFFICACY, THE
RELATIVE EFFICACY POINT ESTIMATE
WAS SIMILAR FOR DISEASE THAT
OCCURRED PRIOR TO 90 DAYS AFTER
VACCINATION AND THE PROFILE.
SO AT LEAST WITH THAT ONE EARLY
ANALYSIS, NO DIFFERENCE
THROUGHOUT THE SEASON.
LESS THAN OR GREATER THAN 90
DAYS POST VACCINATION.
>> MEANING THAT THE RELATIVE
EFFICACY WAS NO BETTER 90 DAYS
LATER THAN --
>> YEAH.
AND NO WORSE.
SO IT'S NOT AS IF THE -- RIGHT.
YEAH.
YOU CAN THINK OF IT BOTH WAYS,
BE YES, IT WAS NO DIFFERENCE.
>> DR. DUCHIN.
>> THANK YOU FOR DOING THAT
STUDY.
YOUR MENTION EARLY ON IN YOUR
SECTION OF DOING THE TESTING
WITHIN FIVE DAYS OF SYMPTOM
ONSET MADE ME WONDER WHETHER
THERE WAS ANY DIFFERENCE IN THE
TWO GROUPS AND WITH RESPECT TO
THE TIMING OF THEIR DIAGNOSTIC
TESTING.
AND THAT WASN'T SHOWN.
THEN THE OTHER QUESTION IS, ARE
YOU AWARE OF ANY OTHER STUDIES
OF THE EFFECTIVENESS OF THIS
VACCINE THAT ARE IN PROGRESS OR
PLANNED PARTICULARLY LOOKING AT
SOME OF THE MORE SIGNIFICANT
HEALTH OUTCOMES.
>> THANKS.
>> SURE.
>> WITH REGARD TO THE FIVE DAY
REQUIREMENT, ALL OF THE CULTURE
PCR CONFIRMED CASES, THE SAMPLES
WERE OBTAINED WITHIN THAT
FIVE-DAY PERIOD.
THEY HAVE TO GO BACK AND SEE IF
THERE MIGHT HAVE BEEN A FEW
STRAGGLERS BEYOND FIVE DAYS.
BUT THAT WAS A STEADY TEAM.
WE'LL TRY TO STICK TO THAT
RETIREMENT.
>> AS FAR AS OTHER HEALTH
OUTCOMES, THERE ARE MORE DATA IN
THIS STUDY.
ON WHICH HAVE NOT BEEN ANALYZED
SOME VARIOUS OTHER OUTCOMES AND
COMPLICATIONS BEING OPENED, AND
HOW THAT MIGHT RELATE BACK TO,
YOU KNOW, ESSENTIALLY THE COST.
IT'S NOT ABSOLUTE NUMBERS.
IT'S NOT AS IF WE WENT INTO
DATABASES TO FIND OUT WHAT THE
COST OF EACH OF THE
HOSPITALIZATIONS WERE, OR EACH
OF THE PNEUMONIAS.
BUT CERTAINLY WE HAVE A VERY
GOOD SENSE OF THESE POOR HEALTH
OUTCOMES, AND WE'LL TRY TO
TRANSLATE THAT IN FUTURE
ANALYSES.
>> JUST AS A FOLLOW-UP, ONE OF
THE THINGS I'VE BEEN IMPRESSED
WITH AS I LEARN MORE ABOUT
INFLUENZA, IS HOW DIFFERENT EACH
SEASON IS DIFFERENT, THE
RELATIVE PROTECTION OFFERED BY
THE VACCINES.YOU'VE GIVEN US ON
CROSS-SECTIONAL SNAP SHOT OF HOW
THE VACCINE WORKS.
I GUESS MY QUESTION IS, WHAT ARE
YOUR THOUGHTS ABOUT, YOU KNOW,
HOW THE TWO VACCINES MAY COMPARE
WITH RESPECT TO THE INFLUENZA B
AND A COMPONENTS OVER A NUMBER
PARTICULARLY WITH BETTER MEMORY
RESPONSE TO THE "B" COMPONENT
AND HAVING MORE APPRECIATION OF
THE IMPACT OF TYPE-B DISEASE ON
ADULTS, YOU KNOW, HOW THE TWO
VACCINES MIGHT COMPARE?
MIGHT THERE BE SOMETHING
DIFFERENT THAN WHAT WE'RE SEEING
IN THIS PRESENTATION?
>> WELL, CERTAINLY, AS YOU SAY,
EVERY SEASON IS DIFFERENT.
THE NICE THING ABOUT THIS STUDY
AND THE TWO SEASONS THAT THE
STUDY COVERED WAS THEY WERE VERY
DIFFERENT.
IT'S AMAZING HOW DIFFERENT THE
TWO SEASONS WERE.
SO THE FIRST SEASON WAS, AS I
RECALL BEING DESCRIBED HERE BY
THE CDC IS THE LIGHTEST
INFLUENZA SEASON ESSENTIALLY ON
RECORD, AND YET, YOU MAY KNOW
FROM OTHER INFLUENZA STUDIES
CONDUCTED OVER THE DECADES, THAT
SOMETIMES ONE FINDS NO
DIFFERENCE OR NO CLINICAL
BENEFIT OF INFLUENZA VACCINE
WHEN IT'S A VERY LIGHT SEASON.
AND YET, IN THIS STUDY, GREAT
CLINICAL BENEFIT WAS DESCRIBED.
SO THAT, I THINK, WAS A NICE
OFFSHOOT OF THE STUDY.
AND THE SECOND YEAR, OF COURSE,
A HEAVY YEAR, BUT WAS -- BUT THE
STRAIN, SUCH AS THE H3N2 WAS NOT
GREATLY MATCHED TO THE VACCINE
STRAIN, WE STILL SHOWED ADDITIVE
CLINICAL BENEFIT OF THE
HIGH-DOSE VACCINE COMPARED TO
FLUZONE.
THE A AND B STRAINS, AS I
DEMONSTRATED, THE DATA SEEM TO
INDICATE THAT PROTECTION WAS
AFFORDED TO BOTH A AND B
STRAINS.
WHEN WE LOOK AT SIMILARITY TO
THE VACCINE STRAINS, A GREATER
CLINICAL BENEFIT OF THE FLU
HIGH-DOSES, WITH THE CIRCULATING
VIRUS MATCHED THE VIRUS STRAINS.
WERE THESE TWO SEASONS
REPRESENTATIVE OF ALL SEASONS?
PERHAPS NOT.
BUT I THINK WE HAD A GREAT
COMPARISON HERE TWO SEASONS THAT
WERE QUITE DIFFERENT, AND THAT
RELATIVE EFFICACY HELD UP IN
BOTH YEARS.
>> DR. RENGOLD.
>> A VERY NICE STUDY.
I SUSPECT YOU'LL BE TELLING ME
THAT THESE RESULTS ARE
FORTHCOMING, BUT TWO RELATED
QUESTIONS.
ONE IS, OBVIOUSLY, PEOPLE OVER
65, A FAIRLY DIVERSE GROUP --
SOME ARE QUITE HEALTHY, MANY WHO
MAY HAVE UNDERLYING ILLNESSES.
CAN YOU TELL US SOMETHING ABOUT
THE CLINICAL PROTECTION AND
VARIATION OF HOW SICK THE PEOPLE
WERE AT BASELINE, AND WHETHER
YOU HAVE GOOD -- I ASSUME YOU'LL
BE LOOKING AT CORRELATION
PROTECTION, AND WHAT YOU CAN
TELL US ABOUT THE IMMUNE
RESPONSE IN THOSE SICKER OR
ELDER, IN TERMS OF WHAT THE
CORRELATING PROTECTION IS IN THE
STUDY?
>> CERTAINLY.
THE FIRST QUESTION ABOUT THE --
HOW ILL THE PARTICIPANTS WERE,
AS I MENTIONED, WE DID INCLUDE,
OR WE DID COLLECT INFORMATION ON
COMO
CO-MORBIDITIES, AND ANALYSES
HAVE BEEN DONE, BUT WE DIDN'T
HAVE TIME TO GET THEM IN THE
SLIDES, THAT THE RELATIVE
EFFICACY OF THE HIGH-DOSE
VACCINE, COMPARED TO FLUZONE,
WAS THE SAME.
VERY SIMILAR AMONG PARTICIPANTS
WHO DID NOT HAVE CO-MORBIDITIES,
AND THOSE WHO DID.
MANY DID.
TWO-THIRDS HAD ONE
INFLUENZA-RELATED
CO-MORBIDITIES, AND ONE-THIRD
HAS TWO OR MORE CO-MORBIDITIES.
IMMUNEGENICIT, AND EFFICACY, IT
WAS THE SAME AMONG THOSE WHO ARE
CO-MORBIDITIES, SO AT LEAST
WITHIN THIS CONTEXT, IT LOOKS
LIKE THE PROTECTIONSELF PROVI D
PROVIDED -- PROTECTION IS
PROVIDED IN BOTH.
YES, THERE WILL BE ANALYSES
LOOKING FOR THE PROTECTION.
THAT'S ONE OF THE AIMS OF THE
STUDY.
THOSE ANALYSES HAVE NOT YET BEEN
DONE.
BY THE WAY, IN TERMS OF HOW THE
VACCINE PERFORMS AMONG EVEN
SICKER INDIVIDUALS, LIKE THOSE
WHO ARE IN LONG-TERM CARE
FACILITIES, WRIT ZIMMERMAN, WHO
I THINK MOST OF THE PANEL KNOW,
THE STUDY DONE AT THE UNIVERSITY
OF PITTSBURGH, IN NURSING HOMES,
LONG-TERM CARE FACILITIES IN
THEIR AREA SHOWING, AGAIN,
SUPERIOR IMMUNEGENICITY.
IT'S NOT AN EFFICACY STUDY, BUT
FOLLOW SAFETY, WHICH IS FINE,
AND THEN SUPERIOR ANTIBODY
RESPONSES.
>> DR. LAIR.
>> TWO QUICK QUESTIONS.
ONE VERY SIMPLE ONE.
ARE YOU WORKING ON A
QUADRIVIRULENT HIGH DOSE?
>> YES.
SO WE RECOGNIZE IT AS SOMETHING
THAT PEOPLE ARE GOING TO BE
EXPECTING, AND THERE ARE
CLINICAL STUDIES THAT NEED TO BE
CONDUCTED, BUT WE HAVE IT IN THE
CLINICAL DEVELOPMENT PROGRAM,
AND, YES, WE'RE PLANNING TO DO
THAT.
>> AND MY SECOND QUESTION IS
JUST CHECKING MY MATH, IF I'M
DOING THE MATH QUICKLY ON SLIDE
19, IT LOOKS LIKE FOR EVERY
1,000 PEOPLE VACCINATED WITH
HIGH-DOSE FLU VERSUS REGULAR
FLUZONE, YOU'LL HAVE 4.6 FEWER
CASES OF FLU.
IS THAT MATH CORRECT?
>> YEAH, SO YOU'RE COMPARING
THESE -- ON THE X LINE?
>> YES.
>> YOU'RE COMPARING THE TWO
GROUPS -- SO, YES, THE INCIDENCE
OF THE LABORATORY CONFIRMED
INFLUENZA FOR THE TWO GROUPS IS,
AS YOU POINTED OUT, ABOUT 1.4
AND 1.9 CASES OF A PERCENT.
A PERCENTAGE SHOWN ON THE SLIDE.
SO, YES, THERE'S A DIMINUTION OF
THE NUMBER AND INCIDENTS RATE OF
INFLUENZA IN THE HIGH-DOSE GROUP
COMPARED TO FLUZONE.
WHAT'S NOT HERE IS A PLACEBO
GROUP, NO PLACEBO GROUP IN THE
STUDY.
>> COMPARING HIGH DOSE VERSUS
FLUZONE, FOR EVERY 1,000 DOSE,
YOU'LL HAVE 4 TO 5 FEWER CASES
OF FLU?
>> I HAVE TO CHECK THE MATH.
IT LOOKS RIGHT.
BUT, YEAH, SOMETHING IN THAT
ORDER.
>> ANY OTHER QUESTIONS OUT
THERE, COMMENTS?
QUICK QUESTION.
DID WE HAVE ANY ESTIMATE -- I'M
CERTAIN --
>> THE DEER IN THE HEADLIGHT
STEER IS BECAUSE OF MY FANCY
(UNINTELLIGIBLE).
IF YOU WANT TO COMPARE IT TO
THAT, WE DON'T HAVE ACTIVE, GOOD
ESTIMATES ONION GOING ESTIMATES
OF RATES OF DISEASE OR
CLINIC-BASED DISEASE,
LAB-CONFIRMED DISEASE FROM THE
SURVEILLANCE SYSTEMS.
WE DO SURVEY FOR
HOSPITALIZATIONS CLEARLY, AND
THINK ABOUT OVER THE LAST TEN
YEARS, A RATE OF
HOSPITALIZATIONS ABOUT 1%.
LAST YEAR, IT WAS 150 PER
100,000.
WHAT WE KNOW FROM THE EARLY
STUDIES THAT ARE COMMUNITY
STUDIES, IN THE EARLY '70s, WAS
THE ANNUAL RATE OF OVERALL
INFLUENZA IS 5%, 15%, TO 20% OF
THE POPULATION, AND IN THE
ELDERLY PEOPLE, THE RATES OF
DISEASE, ON THE LOW END OF THAT.
IF YOU COMPARE IT TO THIS, I
DON'T KNOW THE REAL ANSWER, AND
WE'LL DREDGE IT UP AND SEND IT
AROUND TO THE ACIP.
BUT THINK ABOUT THE 5% RANGE OR
SO, ANNUAL ATTACK RATE.
I'M MAKING THIS UP A BIT.
AND AS LONG AS IT'S NOT BEING
RECORDED I'LL --
[ LAUGHTER ]
>> YEAH, THE RECORDING PEOPLE
WENT HOME AT 1:00.
SO YOU'RE OFF THE HOOK.
MY QUICK REMINDER TO THE
FEBRUARY REGISTRATION IS LIVE
AND FUNCTIONING.
SO FOR THE UPCOMING MEETING.
AND THERE'S NO FURTHER COMMENT
OR DISCUSSION, I WISH EVERYBODY
HAPPY TRAVELS ON YOUR WAY HOME.
AND THANKS FOR YOUR ATTENTION
AND ATTENDANCE.
UR WAY HOME.