>>> I'D LIKE TO HAVE
DR. SHIMABUKURO
INTRODUCE VACCINE SAFETY.
GOOD AFTERNOON.
I'M GOING TO REINTRODUCE FEBRILE
SEIZURE IN TRY VALENT ACTIVATED
INFLUENZA VACCINE AS A LEAD-IN
TO OUR TWO MAIN PRESENTATIONS.
FIRST SOME INFORMATION ON
FEBRILE SEIZURES. SO A FEBRILE SEIZURE IS ACCOMPANIED BY FEVER
WITHOUT CENTRAL NERVOUS SYSTEM
INFECTION THAT OCCURS IN INFANTS
AND CHILDREN SIX MONTHS TO 60 A.
FEBRILE SEIZURES ARE FAIRLY
COMMON DURING CHILDHOOD.
ABOUT 2 TO 5% OF YOUNG CHILDREN
WILL HAVE AT LEAST ONE FEBRILE
SEIZURE.
FEBRILE SEIZURES CAN HAPPEN WITH
ANY CONDITION THAT CAUSES A
SEIZURE INCLUDING TYPICAL
CHILDHOOD ILLNESSES, MANY OF
WHICH CAN BE PREVENTED BY
VACCINATION.
NEARLY ALL CHILDREN WHO
FEBRILE SEIZURE RECOVER QUICKLY
AND ARE HEALTHY AFTERWARDS WITH
NO LASTING EFFECTS.
HOWEVER, FEBRILE SEIZURES OFTEN
RESULT IN A VISIT TO AN
EMERGENCY ROOM
FRIGHTENING TO PARENTS AND
CAREGIVERS.
SO THIS TABLE INCLUDES THE POST
MONITORING INFRASTRUCTURES THAT
ARE GOING TO BE PRESENTED
FROM THESE INSTRA
STRUCTURES.
YOU HEARD THIS MORNING FROM DR.
CANO.
IT USES A LARGE LENGTH DATABASE
FOR ACTIVE SURVEILLANCE AND
RESEARCH.
THE PROJECT IS A COLLABORATION
CLINICAL C AND ACADEMIC CDC AS
RESEARCH.
THE SAFETY MONITORING SYSTEM IS
AN FDA SYSTEM.
IT'S ALSO A LARGE LINKED
DATABASE SYSTEM USED FOR ACTIVE
SURVEILLANCE AND RESEARCH.
SO THE DEFINITION OF A SIGNAL IN
FARMCO VINLG RANS, REPORTED
INFORMATION ON CAUSAL
RELATIONSHIP BETWEEN ADVERSE
EVENT -- BETWEEN ADVERSE EVENT
AND A DRUG.
THE RELATIONSHIP BEING
UNKNOWN -- PREVIOUSLY UNKNOWN OR
INCOMPLETELY DOCUMENTED.
USUALLY MORE THAN A SINGLE
REPORT FOR A SIGNAL DEPENDING ON
SERIOUSNESS OF EVENTS AND
QUALITY OF THE INFORMATION AND
THAT'S FROM W.H.O.
RECAP BACKGROUND AND KEY EVENTS.
IN 2010, 2011, THERE WAS AVARS
DATA MINING FOR FLU ZONE,
CLINICALLY RELEVANT AGE
CHILDREN SIX TO 23-MONTH-OLD.
IT'S IMPORTANT TO KNOW ZONE
IS THE ONLY TIV APPROVED
IN CHILDREN 6 TO 23-MONTH-OLD.
AT THE SAME TIME CONDUCTING
RAPID PSYCHOANALYZE -- REMIND
YOU RAPID PSYCHOANALYSIS WEEKLY
NEAR REALTIME SURVEILLANCE THAT
WE DO DURING THE INFLUENZA
SEASON AND FOR OTHER VACCINES.
IN THE VACCINE SAFETY DATA LINK.
CHILDREN 659-MONTH-OLD.
AT THE SAME TIME WE WERE
SURVEILLANCE FOR PS 18 WE WERE
ABLE TO DO AN EPIDEMIOLOIC
STUDY LOOKING AT FEBRILE SEIZE
OOURS.
RISK PEAKED AT 16 MONTHS WITH
ADDITIONAL FEBRILE SEIZE OOURS
FOR 100,000 CHILDREN VACCINATED.
FOLLOWING SEASON 2011 AWE 2012 .
SAME TIV FORMULATION IN '11,
'12, 2010, 2011.
RAPID CYCLE SIGNAL PERSISTED.
DURING THAT SEASON WE
CONDUCTED A SEESAW TIBPC 13
FEVER STUDY.
THE KEY FINDING FROM THAT
WAS THAT CHILDREN 6 TO
23-MONTH-OLD WHO RECEIVED TID
AND 13 TOGETHER AT THE SAME
VISIT WERE ABOUT THREE TIMES AS
LIKELY TO HAVE FEVER DAYS ZERO
TO 1, DAY OF VACCINATION TO
AFTER COMPARED TO TIV OR PC 13
WITHOUT THE OTHERUCT.
THEN IN 2012 CHANGE IN
FORMULATION AND 2013, 2014
DIFFERENT THAN 2010, 2011, NO
VFD RAPID CYCLE ANALYSIS SIGNAL
FOR TIV.
THIS ILLUSTRATES.
LEFT TO RIGHT, 2010-'11 SEASON
TO CURRENT.
FEBRILE SEASON TRIVALENT
ACTIVATED INFLUENZA VACCINE IN
YOUNG CHILDREN.THE SOERN MEMORI
INFLUENZA SEASON PRECEDES
INFLUENZA SEASON.
BECAUSE OF THIS FINDING IN
AUSTRALIA, CDC AND FDA CONDUCTED
ENHANCED MONITORING IN 2010
SEIZURES.
WE RETEENLY DO THIS.
IN AUSTRALIA, REVIEWING EVERY
SEIZURE REPORT, LOOKING AT OTHER
RISK INTERVALS IN RAPID CYCLE
ANALYSIS, ONE-DAY RISK IN
ADDITION TO 0 TO SEVEN-DAY RISK
INTERVAL.
SO THIS IS A GRAPH WHICH IS
ADAPTED FROM THE ORIGINAL VFD
STUDY USING 2010-2011 DATA.
YOU CAN SEE FROM HERE ON THE
BOTTOM YOU HAVE IN THE GREEN T
IV THEN DOTTED LINE PCP 13
WITHOUT TIV.
YOU CAN SEE A SMALL INCREASED
RISK FOR FEBRILE SEIZURES
PEAKING AROUND 16 MONTHS OF AGE.
HOWEVER WHEN TIB AND PC 13 WERE
GIVEN TOGETHER, SEE THAT
NOTICEABLY LARGE PEAK AT 16
MONTHS OF AGE IN FEBRILE
SEIZURES.
THAT WAS 45 ADDITIONAL PER
100,000 CHILDREN VACCINATED WITH
TIB AND 3 TOGETHER.
REVIEWED THE DATA DURING
2010-2011 SEASON AND AFTER
EVALUATING ALL THE INFORMATION,
DETERMINED NO CHANGES IN THE
CHILDHOOD IMMUNIZATION SCHEDULE
WERE NECESSARY AND WE POSTED
THIS INFORMATION ON THE CDC
WEBSITE.
WE ALSO UPDATED VACCINE
INFORMATION STATEMENT FOR TIB
FOR FOLLOWING SEASON TO INCLUDE
THIS LANGUAGE.
YOUNG CHILDREN WHO GET ACTIVATED
INFLUENCE FLAX AVACCINE AND
PNEUMOCOCCAL MAY BE AT RISK FOR
DISEASE CAUSED BY FEVER.
SOME ADDITIONAL QUESTIONS AFTER
2010 AND 2011 SEASON.
NAMELY DID THE VACCINES PLAY A
ROLE.
WAS THERE SMSHL UNUSUAL ABOUT
THE VACCINE THAT RESULTED IN
NICK IN ARE FEBRILE SEIZURES FOR
YOUNG CHILDREN.
AND WHAT DID THE DATA FOR THE
SEASON SHOW?
SO NOW WE'RE GOING TO HEAR TWO
PRESENTATIONS, SEIZURES
FOLLOWING MULTIPLE VACCINES OF
DATALING STUDY FROM DR. JONATHAN
DUFFY AND AFTER TRIVALENT
VACCINES 2010-2011 INFLUENZA
SEIZURES POST LICENSURE RAPID
IMMUNIZATION MONITORING SYSTEM
BY DR. ALLISON FROM HARVARD.
>> AS TOM SAID DEFINITION OF
FEBRILE SEIZURES SPECIFIC TO
CHILDREN IN 6 TO 60 MONTHS WHO
DID NOT HAVE INTERCRANIAL
INFECTION OR HISTORY OF FEBRILE
SEIZURES.
SO PRIOR TO THE 2010-'11
INFLUENZA SEASON OTHER VACCINES
HAD BEEN ASSOCIATED WITH
INCREASED RISK OF FEBRILE
SEIZURE AND LISTED ON THE SLIDE.
THE VACCINE AND MMR V AS YOU CAN
SEE RISK INTERVAL FOR EACH
VACCINE IS DIFFERENT.
TALKING ABOUT A TRANSIENT RISK
OVER A SEVERAL DAY PERIOD IN
POST VACCINATION.
MMR AND MMRV LIVE VACCINES RISK,
INCUBATION PERIOD OF THE VIRUS
AND THEN IN 2010-'11 THIS NEW
FINDING FOR PCB 13 WITH SIGNALS.
SO THE STUDY I'M TALKING ABOUT
NOW IS IN RESPONSE TO FINDINGS
IN 2010-'11.
SO IN ADDITION TO WHAT TOM SAID,
THE INTEREST IN PCB 13 IN 2010
WAS BECAUSE THE VACCINE WAS NEW
IN THAT YEAR AND THAT'S WHY
THERE WAS A PARTICULAR INTEREST
OR FOCUS ON THE VACCINE AT THAT
TIME.
SUBSEQUENT IT WAS CONCLUDED
WHICH DID NOT FIND ANY INCREASED
RISK FEBRILE SEIZURE COMPARING
PCB 13.
OBVIOUSIVE OF MY CURRENT ASSESS
WHETHER VACCINES GIVEN WITH
TOGETHER AFFECT RISK OF FEBRILE
SEIZURE.
VACCINE SAFETY DATA LINK.
COLLABORATION BETWEEN CDC AND
SEVERAL INTEGRATED HEALTH CARE
SOWINGS, COMBINED ANNUAL
POPULATION OF 9 MILLION PEOPLE,
APPROXIMATELY 3% OF THE U.S.
POPULATION.
SO FOR THIS STUDY 10 DIFFERENT
SITES CONTRIBUTED DATA TO THE
STUDY.
GEOGRAPHICALLY DISPERSED
THE UNITED STATES AND TEND TO
REPRESENT MORE CLOSE MODEL
HEALTH PLANS THAT HAVE GOOD DATA
CAPTURE AND WELL-DEFINED
POPULATIONS.
SO THE METHODS WE USED TO FIND
FEBRILE SEIZURE CASES ANY
MEDICAL VISIT WITH DIAGNOSES
CODE OF 7083, SEIZURE IN PATIENT
SETTINGS, FIRST IN 40 DAYS TO
FIND INCIDENTS AND EVENTS AND
EXCLUDE FOLLOW-UP FOR PREVIOUS
EVENTS.
WE THEN CONFIRMED CASES,
REVIEWED MEDICAL RECORDS TO
CONFIRM DIAGNOSES AND CONFIRM ON
SET.
FOCUSED ON THE STUDY PERIOD OF
2006 THROUGH 2011.
WE FOCUSED ON AGES 6 THROUGH 23
MONTHS BECAUSE THEY ARE THE
HIGHEST RISK FOR FEBRILE STAGES
BASED ON STAGES IN THE
RECOMMENDED SCHEDULE.
SO OUR FEBRILE SEIZURE
DEFINITION CLINICIAN DIAGNOSIS
OF SEIZURE EXCLUDING METABOLIC
OR HISTORY OF FEBRILE SEIZURES.
THE TYPE OF ANALYSIS WE USE IS
CALLED SELF-CONTROLLED RISK
INTERVAL.
A MODEL INCIDENT RATIO.
WE'RE COMPARING THE INCIDENCE OF
FEBRILE SEIZURE AND 0 TO 1 DAYS
POST VACCINATION WE REFER AS
RISK INTERVAL AND COMPARING THAT
TO INCIDENCE RATE DURING THE DAY
WHICH WE REFER TO AS A
COMPARISON INTERVAL.
AGAIN WITH THE THOUGHT BEING 0
TO 1 APPLICABLE BIOLOGICAL RISK
PERIOD FOR FEBRILE SEIZURES
FOLLOWING INACTIVATED VACCINES.
20 DAY PERIOD RISK VACCINATION
PLAYS NO ROLE IN THE INCIDENCE
OF FEBRILE SEIZURE.
WE ALSO MEASURED ATTRIBUTED
RISK, TAKING RELATIVE RISK,
MULTIPLYING BY BACKGROUND
INCIDENCE RATE AND PER PERSON
RAPOLATION.TO FACT LOOKING ATTW.
SO NOW TO THE RESULTS.
I WANT TO SHOW YOU BACKGROUND ON
THE POPULATION.
LOOKING AT THE POPULATION, THE
BACKGROUND RATE OF SEIZURES
REGARDLESS OF VACCINATION AS WE
CAN SEE AS EXPECTED VARIES BY
TIME.
SHOWN HERE ON THE GRAPH BETWEEN
AGES SIX AND 60 MONTHS PEAK
INCIDENCE AT 16-MONTH-OLD.
AND AS THE PEAK INCIDENCE, IT'S
ALMOST FIVE SEIZURES PER 100,000
PERSONS PER DAY.
WE'RE ALSO INTERESTED IN VACCINE
COMBINATIONS IN THE STUDY.
WHEN YOU LOOK AGAIN AT THE
ENTIRE POPULATION, LOOKING AT
THESE AGE GROUPS, THE NUMBER OF
UNIQUE VACCINE COMBINATIONS
RECEIVED BY CHILDREN IN PRACTICE
IS VERY LARGE.
OVER 2,000 DIFFERENT
COMBINATIONS WHEN YOU CONSIDER
UNIQUE PRODUCTS AND UNIQUE
FORMULATIONS.
WITH THE VACCINATION.
AS WE LOOK AT HOW VACCINATIONS
ARE GIVEN TO CHILDREN.
FIRST ALL THE VACCINES LISTED.
SECOND COLUMN TOTAL DOSES GIVEN
DURING THIS TIME PERIOD.
THIRD COLUMN NUMBER OF DOSES
GIVEN ALONE, GIVEN ON A DAY
WHICH NO OTHER VACCINE WAS
RECEIVED AT THE SAME TIME.
SO WHEN WE LOOK IN THE FOURTH
COLUMN YOU SEE THE PERCENT AS
OTHER.D FOR MOST VACS LOW INES
SO ONEPTION TO THIS IS
VACCINE, 50% OF THE TIME IN THE
POPULATION GIVEN BY ITSELF ON A
DAY WHEN NO OTHER VACCINE IS
RECEIVED.
LOOKING AT THIS MORE CLOSELY ON
THE NEXT SLIDE, WHEN WE LOOK AT
THIS BY FLU SEASON DURING THE
STUDY, FAIRLY CONSISTENT OVER
THE YEARS WE EXAMINE, ABOUT 50%
IN THIS AGE GROUP.
SO NOW THIS IS JUST A
PRELIMINARY ANALYSIS,
SELF-CONTROLLED RISK ANALYSIS OF
TIV FLU SEASON TO GET AN INITIAL
SENSE OF WHETHER THERE WERE
DIFFERENCES IN FLU VACCINE CROSS
SEASONS WE CAN SEE THAT IN YEARS
PRIOR TO 2010, 11 STRATIFY JUST
FLU VACCINES ALONE NOT GIVEN
WITH RISK OF FEBRILE SEIZURE.
2011 LOOKS LIKE THERE COULD BE
SOMETHING DIFFERENT THAT YEAR.
FAR RIGHT PROBLEM PEOPLE WHO
RECEIVED WE SEE HIGHER
RELATIVE RISK.
THIS IS WHAT WE WANT TO EXAMINE
FURTHER.
MOVING ONTO OUR CHART ANALYSIS.
OUR CASE FINDING STARTED WITH
1.9 MILLION VACCINATION VISITS
FOR PEOPLE IN OUR FOCUSED AGE
GROUP.
AMONG THESE PEOPLE WE IDENTIFIED
586 FOR A CONVULSION
PRESPECIFIED POST VACCINATION
INTERVALS.
WE TOOK A RANDOM SAMPLE OF
THESE.
AMONG THE CHARTS AVAILABLE, 428
WERE AVAILABLE FOR REVIEW.
SO THEN WHEN REVIEWING THESE
CHARTS, WE SEE SOME OF THESE
CODED CASES DID NOT REPRESENT A
NEW SEIZURE EVENT, SOME THE
CLINICIAN WAS NOT SURE IF IT WAS
A SEIZURE OR NOT.
THEY SAID POSSIBLY A SEIZURE.
SOME OF THESE EVENTS REPRESENTED
PEOPLE WHO DID HAVE A SEIZURE
BUT A NONFEBRILE SEIZURE.
IN 27 OF THESE CASES WE DON'T
KNOW IF IT WAS A FEBRILE SEIZURE
OR NOT.
WE EXCLUDE SEVERAL CASES FOR
REASONS RELATED TO WHEN IT
OCCURRED IN RELATION TO
VACCINATION.
FOR EXAMPLE TWO PEOPLE
VACCINATED AFTER THEY HAD A
SEIZURE.
WE HAD SOME PEOPLE AT THE TIME
OF ON SET DIFFERENT THAN WHAT
WOULD HAVE BEEN RECORDED IN THE
ADMINISTRATIVE DATA.
SO IN THE END WE HAVE 333
CONFIRMED FEBRILE SEIZURES.
NOW WHEN WE LOOK AT THESE
PATIENTS AND DIVIDE THEM INTO
OUR TWO GROUPS, RISK INTERVAL
AND COMPARISON INTERVAL
COMPARING PEOPLE WITH A FEBRILE
SEIZURE IN THE 0 TO 1 DAYS
FOLLOWING VACCINATION TO THOSE
WHO HAD IT IN THE 14 TO 20 DAYS
FOLLOWING VACCINATION, WE CAN
SEE MORE OF THESE SEIZURES
OCCURRED IN THE 12 TO 23 MONTHS
AGE GROUP AS WOULD BE EXPECTED
FROM THE BASELINE.
NO SIGNIFICANT DIFFERENCES BY
SEX, RACE, OR ETHNICITY,
ALTHOUGH THIS IS A DIVERSE
POPULATION.
FURTHER LOOKING AT PATIENTS AND
MEDICAL HISTORY WE'D SEE THAT
FOR ABOUT HALF THESE PATIENTS
EVENT REPRESENTED FIRST EVER
SEIZURE IN THEIR LIFETIME, WHICH
MEANS FOR HALF IT DID NOT.
PREVIOUS HIS OF SEIZURE.
NO DIFFERENCE BETWEEN THESE
GROUPS, FAMILY OF FEBRILE
SEIZURE, PREMATURE BIRTH, LAY
OUT POTENTIAL RISK FACTORS FOR
FEBRILE SEIZURE.
THOSE PEOPLE HAD SEIZURE RECEIVE
ANTIBIOTICS BEFORE THEIR
SEIZURE, NOT LIKELY TO RECEIVE
ANT BOBCATS.
LOOKED AT WHETHER PEOPLE HAD
NONVACCINE CAUSES OF FEVER
DOCUMENTED AT THE TIME OF THEIR
EVALUATION, WE FOUND MOST COMMON
OTITIS MEDIA.
COMPARED TO 77% OF CHILDREN IN
THE COMPARISON INTERVAL, WHICH
SORT OF EXPECTED, SUGGEST SOME
SEIZURES INFLUENCED BY THEIR
RECENT VACCINATION.
LOOKING IN THE LAST ROW, WHETHER
OR NOT PEOPLE ADMITTED FOR THE
SEIZURES, ONE IN TEN WERE AND NO
DIFFERENCE BY VACCINE
ASSOCIATION.
SO NOW I'M LOOKING AT THE
VACCINE EXPOSURE TO THESE.
FIRST COLUMN ALL THE DIFFERENT
VACS EXPOSED TO IN DESCENDING
ORDER OF FREQUENCY.
PCV 7, MOST COMMON VACCINES.
FURTHER RIGHT CRUDE RELATIVE
RISK WHICH DOES NOT TAKE INTO
ACCOUNT CONFOUNDING OR
INTERACTION BETWEEN VACCINES.
JUST ILLUSTRATES LOOKING AT
VACCINE WITHOUT TAKING INTO
ACCOUNT VACCINES, YOU DON'T HAVE
A GOOD, TRUE ESTIMATE OF THE
REST.
THAT'S WHAT WE WANT TO DELVE
INTO FURTHER.
LOOKING AT THE ISSUE OF
COMBINATIONS OF DIFFERENT
VACCINES RECEIVED ON THE SAME
DAY.
AMONG 3 AND 33 PEOPLE, 129
UNIQUE VACCINE COMBINATIONS
RECEIVED, AGAIN, CONSIDERING
EACH OF THOSE VACCINES AT A
PREVIOUS TABLE VACCINE TYPE.
AMONG THE COMBINATIONS ONLY 21
RECEIVED BY FOUR OR MORE
PATIENTS, WHICH IS TO SAY MOST
COMBINATIONS -- UNIQUE
COMBINATIONS NOT INVOLVED IN A
LOT OF CASES.
CAN'T LOOK AND ESTIMATE
RISK-FREE SEPARATELY.
OUR APPROACH TO THIS TO DELVE
INTO ALL THESE DIFFERENT
VACCINES, ON A PREVIOUS SLIDE,
REGRESSION MODEL, FIRST EXAMINED
TWO TIME PERIODS SEPARATELY.
THE EARLIER TIME PERIOD AND
2010-'11 FLU SEASON SEPARATELY
TO SEE IF THERE WERE
DIFFERENCES.
BASED ON THOSE RESULTS,
FINDINGS, WE THOUGHT IT WAS
VALID TO PULL ALL THE STUDY TIME
TOGETHER.
OUR APPROACH WAS MODELING TO
IDENTIFY VACCINES ASSOCIATED
WITH INCREASED RISK OF FEBRILE
SEIZURE COMPOUNDING AFFECT
MODIFICATION BETWEEN MULTIPLE
VACS RECEIVED.
STARTED OUT BY VACCINES SHOWN IN
THE PREVIOUS SLIDE AND MANUAL
ELIMINATION PROCESS TO CONSIDER
ALL OF THEM AND LOOK FOR THOSE
THAT HAD SOME EFFECT ON FEBRILE
SEIZURE.
NOT SHOWING INTERIM PROCESS,
MODELS, FINAL RESULT VACCINES IN
THE MODEL WERE T IV PCV 7 AND 13
ARE CONSIDERED A GROUP.
ONCE WE IDENTIFIED VACCINES IN
THE PROCESS, WE THEN WENT ON TO
ALSO LOOK AT THOSE AND STRATIFY
MODELS TO FIND MUTUALLY
EXCLUSIVE COMBINATIONS.
NEXT SLIDE TO ILLUSTRATE OUR
FINDINGS.
AGAIN, LOOKING AT THE EARLIER
TIME PERIOD, 2006-'7THROUGH
2009-'10.
RISK ANALYSIS LOOKING AT
STRATIFIED RESULTS FOR DIFFERENT
MUTUALLY EXCLUSIVE COMBINATIONS
OF VACCINES.
IN THE FIRST LOOKING AT PIV WHEN
GIVEN WITHOUT OTHER TWO
VACCINES.
WE SAID THERE WAS NO SUGGESTION
OF INCREASED RISK OF FEBRILE
SEIZURE.
THEN LOOKING AT PCV 7 WHEN GIVEN
ON A DAY WITHOUT OTHER VACS, THE
RISK OF TWO, WHICH IS BORDERLINE
SIGNIFICANT, WHICH IS CONSISTENT
WITH PREVIOUS FINDINGS.
LOOKING AT VACCINES GIVEN
WITHOUT THESE OTHER TWO
VACCINES.
WE DO NOT SEE SUGGESTION OF
INCREASE.
THEN WHEN LOOKING AT PCV GIVEN
AT THE SAME TIME AT DTAP,
SIMILAR TO WHEN PCV IS GIVEN
ALONG.
LOOKING WHEN TIV IS GIVEN WITH
TTAP INCREASED RISK OF 3.5,
WHICH IS STATISTICALLY
SIGNIFICANT.
LOOKING AT WHEN TIV GIVEN THE
SAME DAY AS PCV 7 WE SEE THE
SAME RESULTS.
THE DAYS PEOPLE RECEIVE ALL
THREE VACCINES TOGETHER WE SEE
THE HIGHEST RELATIVE RISK.
REPLICATING THIS ANALYSIS FOR
2010-'1'1, USE STAPLE APPROACH
FOR DATA, FINAL FLU SEASON A
SMALLER SAMPLE SIZE AND NONE OF
OUR RELATIVE RISKS STATISTICALLY
SIGNIFICANT WITH A SINGLE FLU
SYSTEM BUT WE SEE SIMILAR
PATTERN.
SO ON THE NEXT SLIDE, RESULTS
FOR TWO TIME PERIODS AGAIN BASED
ON STATISTICAL AND
SIMILAR TRENDS WE THOUGHT IT WAS
APPROPRIATE TO PULL OUR DATA FOR
ALL THE TIME PERIODS TOGETHER
SEEING NO SIGNIFICANT
DIFFERENCES BETWEEN THE SEASONS.
THEN WE SEE POOLED RESULTS, BEST
ESTIMATE OF RISK.
NEXT EXTRAPOLATE RISKS INTO
CONTRIBUTOR RISKS SHOWN HERE. S.
SHOWN, THE RI AT SIX
5 MONTHS.
SO
DIFFERENT AGENTS
DIFFERENCE IN
FEBRILE IN
ION. RELATIVE
FAR RIGHT COLUMN IT'S THE BOTTOM
ROW.
OUR HIGHEST ESTIMATE IS
THREE-WAY COMBINATION OF THREE
WHICH GIVES US OF 38
FEBRILE SEIZURECCINATED WITH THT
OF VACCINES COMPARED TO THE
BACKGROUND RATE OR NO VACCINE.
SO IN CONCLUSION, THE COMMON
ADMINISTRATION OF T IV PCV OR
PLUS DTAP HAD HIGHER RISK OF
FEBRILE SEIZURE WHEN VACCINES
ARE GIVEN I OBJECTEDLY.
THE CONCOMITANT VACCINES HAD THE
HIGHEST RELATIVE RISKS.
THESE RISKS VACCINATIONS
OBSERVED IN ALL INFLUENZAS
STUDIED NOT JUST DURING 2010
SEASON.
THAT CONCLUDES -- I'D LIKE TO
ACKNOWLEDGE MY COLLEAGUES AND
THEN ALSO OUR COLLEAGUES IN THE
BACK, MORE THAN 50 PEOPLE, I
DON'T SPACE HERE BUT THEY ARE
PART OF THIS PROJECT.
AT THIS POINT I'LL TURN THE
PODIUM OVER TO OUR NEXT SPEAKER.
GOOD AFTERNOON, THE DOCTOR
GAVE AN EXCELLENT OVER VIEW OF
RISK OF FEBRILE SEIZURES.
MORE DETAIL 2010-'11 FLU SEASON
INVESTIGATORS FOUND 2.4 FOLD
RISK OF SEIZURES FOLLOWING TIB
WHEN ADJUSTING FOR PCV 13, THEY
FOUND 2.5 FOLD SEIZURES
FOLLOWING PCV 13 WHEN ADJUSTING
FOR TIV.
GREATER RISK OF SEIZURES SAME
DAY VACCINATION COMPARED TO
SEPARATE DAY VACCINATIONS.
HOWEVER, FORMAL TEST OF
SIGNIFICANCE WAS NOT AVAILABLE
AT THAT TIME.
ALSO REGULAR VANITY TO THE
REPORTS I'M REPORTING ON ARE THE
VERS FINDINGS MENTIONED EARLIER,
PROPORTIONAL REPORTING OF
FEBRILE SEIZURE FOLLOWING 2011
FLU.
AS A RESULT OF THE FINDINGS,
POST ADD NOTICE ON THE WEBSITE
TELLING THE PUBLIC ABOUT
FINDINGS, ALSO STATED THAT
FURTHER INVESTIGATION WAS UNDER
WAY AND AS PART OF THAT
INVESTIGATION WE WERE FUNDED BY
THE FDA CENTERS FOR BY LOGIC
EVALUATION RESEARCH TO CONDUCT
THE CURRENT STUDY.
WE ASK TWO STUDY QUESTIONS IN
THIS EVALUATION BOTH AMONG
CHILDREN SIX TO 59 MONTHS OF AGE
2010-'11 INFLUENZA SEASON.
FIRST WE ASK WAS EXPOSURE TO TIB
OR PCV 13 ASSOCIATED WITH
GREATER RISK FOR FEBRILE
SEIZURES COMPARED TO THE NO RISK
PERIOD.
ASKED DID ADMINISTERING THEM ON
SEPARATE DAYS -- EXCUSE ME
ADMINISTERING ON THE SAME DAY
DIFFER FROM SEPARATE DAYS.
WE EXAMINED THESE QUESTIONS IN
THE POST LICENSURE RAPID SAFETY
MONITORING SYSTEM OR PRISM FOR
SHORT.
PRISM IS VACCINE SAFETY
COMPONENT OF FDA SPONSORED PILOT
PROGRAM DEVELOPED FOR MEDICAL
PRODUCT SAFETY.
PRISM DATA PARTNERS CURRENTLY
CONSIST OF FIVE HEALTH INSURERS.
IN THIS STUDY WE INCLUDE DATA
FROM THREE PRISM PARTNERS
PARTICIPATING IN THE STUDY,ETTE
ANY HEALTH CORPS AND HUMAN ARK,
FOR THOSE VACCINATED JULY 1,
2010, JULY 30th, 2011 FOR TIB
AND PCV 13, COLLECTED
INFORMATION ON DTAP JUST FOR
THEIR CONFOUNDING INFLUENCE.
WE USED A SELF-CONTROLLED
INTERVAL DESIGN LIKE THE DOCTOR
DESCRIBED FOR THE STUDY AND ALSO
A ONE-DAY RISK INTERVAL.
FOR THE CONTROL INTERVAL WE USED
14 TO 20 DAYS.
EXPOSURES TO VACCINATIONS WERE
IDENTIFIED IN CLAIMS
IMMUNIZATION REGISTRY DATA.
WE ALSO VALIDATED IN MEDICAL
RECORDS IF AVAILABLE.
FOLLOWING REVIEW CASES LATER
EXPOSED TO LAV OR PCV 7
ACCORDING TO MEDICAL RECORDS.
IDENTIFIED INITIALLY USING A
SIMILAR DEFINITION DR. DUFFY
DESCRIBED EARLIER.
IP 9 CODES FOR SEIZURES,
FEBRILE, COMPLEX VIRAL SEIZURES
OR OTHER AND CODES FOR INPATIENT
AND CDC SETTINGS ONLY.
VALIDATED FEBRUARY RIGHT STATUS
REVIEW.
EACH CASE INDEPENDENTLY REVIEWED
BY ADJUDICATOR FINDING
VACCINATION STATUS.
FEBRILE SEIZURES CONFIRMED IF
SEIZURE AND FEVER WITHIN 24
HOURS OR DIAGNOSIS OF FEBRILE
SEIZURE.
WE EXCLUDED THOSE AMERICAN
ACADEMY OF FEBRILE SEIZURES,
ALSO SHREWDED UNLESS WITH
COMPLEX FEBRILE SEIZURES.
WE IDENTIFIED APPROXIMATELY 1.9
MILLION CHILDREN WHO ARE
POTENTIALLY ELIGIBLE FOR THIS
STUDY.
OF THOSE APPROXIMATELY 840,000
CHILDREN RECEIVED ONE OF THREE
VACCINES OF INTEREST IN THIS
STUDY.
OF THOSE 252 WERE IDENTIFIED TO
HAVE A FEBRILE SEIZURE EVENT
ACCORDING TO ELECTRONIC DATA.
AS I MENTIONED EARLIER, WE
CONDUCTED MEDICAL RECORD REVIEW
OF POTENTIAL FEBRILE SEIZURE
CASES IDENTIFIED IN ELECTRONIC
DATA.
OF THE 252, APPROXIMATELY 85%
HAD CHARTS AVAILABLE TO CONFIRM
STATUS.
152 ARE CONFIRMED FOR POSITIVE
VALUE OF 70%.
OF THE 64 NOT CONFIRMED, 19 WERE
EXCLUDED BECAUSE SEIZURES WERE
ROLLED OUT.
SEVEN DEEMED POSSIBLE SEIZURES
WITHOUT SUFFICIENT
DOCUMENTATION.
EIGHT WERE SEIZURES WITHOUT
SUFFICIENT DOCUMENTATION OF
FEVER.
22 WERE AFEBRILE SEIZURES, EIGHT
SKLOUDED DUE TO OTHER REASONS.
WE ALSO CONDUCTED MEDICAL RECORD
REVIEW OF VACCINES IDENTIFIED IN
CLAIMS AND IMMUNIZATION REGISTRY
DATA.
FOR THE VAST MAJORITY IDENTIFIED
IN ELECTRONIC DATA, MEDICAL
RECORDS ARE AVAILABLE.
79% OF CHARTS WERE AVAILABLE FOR
TIB EXPOSURE WHILE 91 CHARTS
AVAILABLE FOR DTAP OR PCV 13
EXPOSURE.
WHEN MEDICAL CHARTS WERE
AVAILABLE TO CONFIRM
VACCINATION, CONFIRMATION RATES
WERE HIGH.
TIB VACCINE CONFIRMED IN 98% OF
CASES, PCV 137 CONFIRMED IN 94%
OF CASES.
FINALLY DTAP CONFIRMED IN ALL
CASES.
BECAUSE THE RATE OF VACCINATION
WAS SO HIGH ANALYSIS INCLUDE
VACCINE IN ELECTRONIC DATA OR
MEDICAL RECORDS.
FOLLOWING MEDICAL RECORD REVIEW
FIVE CASES EXCLUDED BECAUSE
MEDICAL RECORDS INDICATED
SEIZURES OCCURRED OUTSIDE THE
RISK OR INTERVALS FOLLOWING
VACCINATION.
ANOTHER FIVE EXCLUDE BECAUSE LAV
OR PCV 7 WAS IDENTIFIED IN THE
MEDICAL RECORDS.
HERE I'D LIKE TO TAKE A MOMENT
TO PRESENT THE DESCRIBIVE
CHARACTERISTICS.
VAST MAJORITY BEFORE TWO YEARS
OF AGE AS EXPECTED.
MOST IN THE SETTING WITHOUT
REQUIRING HOSPITALIZATION.
ABOUT A THIRD EXPERIENCED MORE
THAN ONE -- MORE THAN ONE
VACCINE OF INTEREST ON THE INDEX
DATE OF VACCINATION
DEMONSTRATING HIGH RATE OF
CONCOMITANT VACCINE ALTHOUGH
I'LL NOTE IT'S MUCH LOWER THAN
WHAT WAS SEEN IN VSD.
NEXT WE ASKED RESEARCH QUESTION.
2010-'11 RESEARCH SEASON, WAS
THE EXPOSURE ASSOCIATED WITH
GREATER RISK OF FEBRILE SEIZURES
WHEN COMPARED TO UNEXPOSED
PERIODS.
WE DID THIS BY CALCULATING
RELATIVE RISK STEMS COMPARING
EXPOSED TO UNEXPOSED PERIODS.
WE ESTIMATE A RELATIVE RISK
USING A SERIES OF CONDITION
MODELS.
THE FIRST FOR UNADJUSTED MODEL,
THEN WE ADJUSTED FOR AGE AND
CALENDAR TIME.
PRIMARY ANALYSIS AGE, CALENDAR
TIME AND THREE VACCINES OF
INTEREST.
FOR SOME INFORMATION OUR AGE AND
CALENDAR TIME ADJUSTMENTS WE
DETERMINED AGE AND RISK CURVES
PRIOR TO INCLUDING THEM IN THE
AGE AND TIME ADJUSTED MODEL.
TO DO THIS WE INCLUDED PERSON
TIME FROM UNDERLYING PRISON
COHORT REGARDLESS OF
VACCINATION, SPECIFICALLY
QUADRATIC USED FOR AGE AND
CALENDAR TIME.
AS YOU CAN SEE, EACH RATIO ABOVE
ONE.
PCV 13 SIGNIFICANTLY ASSOCIATED
WITH RISK OF FEBRILE SEIZURES.
WHEN WE FURTHER ADJUSTED FOR AGE
AND CALENDAR TIME RESULTS
SIMILAR PCV 13 ASSOCIATED WITH
RISK OF FEBRILE SEIZURES.
WHEN WE FURS ADJUSTED FOR
CONCOMITANT VACCINES, TIB AND
PCV 13, IT WAS NO LONGER
ASSOCIATED WITH RISK OF
SEIZURES, DTAP GREATLY TO 1.0 OR
ONE.
I DESCRIBED RELATIVE RISK
ESTIMATES.
THOUGHT IT IMPORTANT TO QUANTIFY
ON ABSOLUTE SCALE ANY POTENTIAL
INCREASE IN RISK FOLLOWING
VACCINATION.
WE DID IT BY CALCULATING A RISK
BY AGE AND WEEK SINCE THE RATE
TO FEBRILE SEIZURES PRETTY
DRAMATIC BY AGE.
THE RISK CALCULATED AS FUNCTION
OF INTEREST RATE RATIOS FROM THE
PRIMARY MODEL AS WELL AS THE
BASELINE RATE FOR SEIZURES
IDENTIFIED IN CLAIMS DATA AND
PRISM POPULATION AND ADJUSTED
RATE DOWNWARD USING POSITIVE
VALUE OF CLAIMS CODE FROM THE
EVALUATION, MULTIPLIED BY TWO
RISK INTERVAL OF DAY TO GET THE
RISK PER DOSE RATHER THAN PER
PERSON DAY.
SO ASSUMPTIONS WE MADE WHEN
CALCULATING THE RISK, INTEREST
RATE RATIO SEEMED TO BE CONSTANT
ACROSS ALL AGES, INTEREST RATE
FOR QUADRATIC FOR AGE DESCRIBED.
POSITIVE VALUE BASED ON CHART
REVIEW CONTROLLED INTERVAL
CASES.
AND HERE ARE RISK ESTIMATES.
AS YOU CAN SEE EACH OF THE RISKS
REGARDLESS OF VACCINATION OR AGE
BELOW 400,000 DOSES.
HIGHEST RISK FOR PCV 13 FOLLOWED
BY TIB DTAP PRETTY NEGLIGIBLE.
HIGHEST RISK AT 15 MONTHS OF AGE
AND LOWEST AT 59 MONTHS OF AGE.
ALSO CALCULATED RISK BASED ON
WORST CASE SCENE ARISCENARIO.
WE DID THIS BY CORRESPONDING TO
INTERVALS FOR RELATIVE RISK.
UNDER THESE ASSUMPTIONS, THE
RISK FOR TIV RANGED .93, 7.1 PER
100,000 DOSES.
PCV 13, 1.2, 9.2 PER 100,000
DOSES.
WE CONSIDER THESE ATTRIBUTABLE
RISKS UNDER THE WORST CASE
SCENARIO ARE QUITE MODEST IN
SIZE CONSIDERING BASED ON RISK
OF FEBRILE SEIZURES APPROXIMATE
2,700 ACROSS A CHILD'S LIFETIME.
WE ADDRESSED WHY ASSOCIATED WITH
AS COMPARED TO FEBRILE
UNEXPOSED PERIOD.
NEXT WE ASKED A DIFFERENT
QUESTION.
SPECIFICALLY ASSUMING THEY
RECEIVED TIB AND PCV 13 IN THE
2010 INFLUENZA SEASON DID
ADMINISTERING ON THE SAME DAY
LEAD TO GREATER RISK OF FEBRILE
SEIZURES.
BEDS THIS BY CALCULATING
DIFFERENCE IN ATTRIBUTABLE RISK
VACCINATION VERSUS THAT OF
CELEBRATE DAY VACCINATION.
RISKS WERE TRANSLATED FROM
INTEREST RATE RATIO FROM
SELF-CONTROLLED RISK DESIGN DATA
I JUST DESCRIBED EARLIER.
THIS CARTOON HERE DESCRIBES OR
SHOWS THE CONCEPT OF SAME DAY
VERSUS SEPARATE DAY TIB, PCV 13.
ON THE TOP TIB AND PCV 13 ON
THE SAME DAY.
THE BOTTOM SHOWS HYPOTHETICAL
EXAMPLE OF RECEIVING THEM ON
SEPARATE DAYS.
AS YOU CAN SEE, THE PURPLE SILD
THE ATTRIBUTABLE RISK FOR SAME
DAY VACCINATION.
CALCULATED THE RISK FOR SAME DAY
VACCINATION BASED ON INTEREST
RATE FROM THE TRADITIONAL MODEL
I DESCRIBED EARLIER.
IN THIS HYPOTHETICAL EXAMPLE
RISK FOR SEPARATE DAY
VACCINATION IS REPRESENTED BY
STACKING THE RED CYLINDER ON TOP
OF THE BLUE CYLINDER.
CALCULATED RISK FOR TIB WITHOUT
CONCOMITANT PCV 13 PLUS
ATTRIBUTABLE RISK FOR PCV 13
WITHOUT TIB VACCINATION.
ASSESSED WHETHER IT WAS FOR SAME
DAY VERSUS SEPARATE DAY.
TO TEST WHETHER THERE'S
MEANINGFUL DIFFERENCE FOR SAME
DAY OR SEPARATE VACCINE, THEN
SUBTRACTED TWO ATTRIBUTABLE
RISK, 95% INTERVALS USING MONTE
CARLO SIMULATIONS.
WHEN WE DID THE ANALYSIS WE DID
NOT FIND ANY EVIDENCE TO SUGGEST
THAT SAME DAY TIB AND PCV 13
ASSOCIATED WITH FEBRILE SEIZURES
WHEN COMPARED TO SEPARATE DAY.
SAME DAY ED 1.1 FEWER PER
ALTHOUGH RESULT NOT
SIGNIFICANT AND INTERVAL QUITE
WIDE.
NOW FOR THE DISCUSSION.
BEFORE I MAKE MY CONCLUSIONS, I
THOUGHT IT WOULD BE IMPORTANT TO
LAY THE PRISM RESULTS IN THE
CONTEXT OF THE PRIOR RESULTS
FROM THE 2010-'11 SEASON.
INTEREST RATE RATIOS
SPECIFICALLY SIGNIFICANT IN THE
STUDY BUT THEY ARE NOT IN THE
PRISM STUDY.
HOWEVER, WE CONSIDER THESE
RESULTS BETWEEN THE TWO STUDIES
TO BE CONSISTENT FOR TWO REASONS
OF FIRST INTEREST RATE RATIOS
ESTIMATE ABOVE ONE FOR BOTH
STUDIES.
SECOND CONFIDENCE INTERVALS
OVERLAP WIDELY.
INTERVALS IN THE PRISM STUDY
MUCH NARROW AND LOWER, WE
THEREFORE THINK THE MAGNITUDE
INCREASED RISK IS PROBABLY LOWER
THAN PREVIOUSLY THOUGHT.
COMPARE SAME DAY VERSUS SEPARATE
DAY VACCINATION OF TISM B VERSUS
PCV 13 IN THE PRIOR STUDY AND
THE PRISM STUDY RESULT I JUST
PRESENTED, WE FOUND THAT SAME
DAY VACCINATION WAS ASSOCIATED
WITH APPROXIMATELY 1.1 PER
100,000 CHILDREN, FEWER FEBRILE
SEIZURES WITH SAME DAY
VACCINATION WHEREAS VSD FOUND
7.3 CASES PER 100,000 VACCINATED
WITH BOTH VACCINATIONS.
NO TEST WAS DONE.
I'D ALSO LIKE TO POINT OUT THE
STRENGTH AND LIMITATIONS OF THIS
PRISM STUDY.
SELF-CONTROLLED RICK INTERVAL
ADJUST FOR TIME FACTORS RELATIVE
TIME FACTORS WE IMPLEMENTED
RIGOROUS ADJUDICATION OF FEBRILE
SEIZURE CASES TWO PEDIATRICIANS
VACCINATION STATUS.
WE IMPLEMENTED AGE CALENDAR TIME
DTAP ADJUSTMENTS IN OUR ANALYTIC
MODELS.
FINALLY PERHAPS THE GREATEST,
80% POWER FOR RATIOS THE SIZE OF
TWO OR ABOVE.
HOWEVER, LIKE ANY OTHER
OBSERVATIONAL STUDY, THIS STUDY
WAS SUBJECT TO LIMITATIONS.
FIRST WE WERE UNABLE TO VALIDATE
ALL VACCINE EXPOSURES.
HOWEVER WHEN WE DID HAVE MEDICAL
CHARTS AVAILABLE WE CONFIRMED
THEM IN OVER 90% OF CASES.
FINALLY INTEREST RATE RATIOS
BELOW 2014 HOWEVER, THIS THE
LARGEST STUDY TO DATE.
IN 2010 IN THE U.S. POPULATION.
AS A RESULT IN THE NAR WEST
INTERVALS TO DATE.
FINALLY FOR MY CONCLUSION WE
CONCLUDE IN THE 2010-'11 SEASON,
ESTIMATES WERE ABOVE ONE.
TIB, DTAP AND PCV 13 NOT
SIGNIFICANTLY ASSOCIATED WITH
FEBRILE SEIZURES IN THE PRIMARY
ANALYTIC MODEL.
CAN'T RULE OUT PRESENCE OF RISK.
HOWEVER IF THEY EXISTED WE
CONCLUDE THE INTEREST RATE
RATIOS IS LOWER THAN ORIGINALLY
THOUGHT.
AS WELL WE CONCLUDE THAT ANY
POTENTIAL INCREASE ON THE
ABSOLUTE SCALE WOULD BE QUITE
MODEST IN SIZE.
WE SAY THIS BECAUSE ATTRIBUTABLE
RISK ON THE 95 CONFIDENCE
INTERVALS SUGGEST THIS.
FINALLY CONCLUDE ASSUMING
CHILDREN RECEIVE TISM B AND PCV
13 IN 2010-'11 SEASON
ADMINISTERING BOTH VACCINES ON
THE SAME DAY WAS NOT ASSOCIATED
WITH RISK OF FEBRILE SEIZURES
WHEN COMPARED TO SEPARATE
VACCINATIONS.
FINALLY I WANT TO TAKE A MOMENT
TO ACKNOWLEDGE COLLABORATOR AT
FDA, PRISM TEAM AT HARVARD AS
WELL AS CLINICAL ADJUDICATORS.
THANK YOU.
>> WANT TO THANK FOR TWO
EXCELLENT PRESENTATIONS.
THANK CDC AND FDA STAFF, STAFF
OF PARTNER ORGANIZATIONS WHO
HAVE INVESTIGATED THIS ISSUE
OVER THE PAST FOUR YEARS.
SO WHAT I'M GOING TO DO NOW IS
SUMMARIZE THIS INFORMATION FOR
I'M GOING TO DO THAT THROUGH A
SERIES OF Q&A SLIDES.
SO WAS THE OVERWHELM RISK OF
FEBRILE SEIZURE INCREASED WITH
2010-2011 FORMULATION OF TIV?
EVIDENCE FROM PUBLIC LICHD
STUDIES INCLUDE SIGNAL
2010-2011, RAPID ANALYSIS
2010-2011 AND VSD LOOKING
AT CONCOMITANT TIB A PCV 13
WHICH FOUND THAT ELEVATED RISK
FOR FEBRUARY RIGHT SEIZURES
PEAKING IN 60 MONTHS 45
ADDITIONAL FOR 100,000
VACCINATED.
THE RAPID NATIONAL FOR TIV11 AN
STUDY THAT FOUND THREE-FOLD
HIGHER RATE OF FEVER 0 TO 1 WHEN
THEY WERE GIVEN TOGETHOPPOSED T.
THE ABOVE STUDIES COULD NOT
ADEQUATELY DISTINGUISH
INDEPENDENT RISK OF FEBRILE
SEIZURE ASSOCIATED WITH TIV
ALONE VERSUS RISK WITH
CONCOMITANT VACCINATION.
SO WHAT WAS THE INDEPENDENT
AFFECT OF TIV ON RISK OF FEBRILE
SEIZURES.
PRISM FOUND NO STATISTICALLY
SIGNIFICANT RISK OF FEBRILE
SEIZURE ASSOCIATED WITH TIV
DURING 2010-2011 SEASON.
YOU SAW THE RELATIVE RISK OF 1.4
WITH THE NONSIGNIFICANT COMPSTH.
THIS WAS AN ADJUSTED ANALYSIS
TIV ADJUSTED FOR 13 AND DTAP.
NO SIGNIFICANT INCREASED RISK
FOR FEBRILE SEIZURE ASSOCIATED
TIV 2010, 2011 SEASON, RELATIVE
RISK OF 1.2.
IN THE STRATIFIED ANALYSIS TIV
GIVEN WITHOUT PCV 13 OR DTAP.
IN THE UPDATED ANALYSIS FOUND NO
INDEPENDENT RISK OF FEBRILE
SEIZURE FOR TIV GIVEN WITHOUT
PCV OR DTAP DURING 2006 AND 2009
INFLUENZA SEASON.
SO WAS THE RISK OF FEBRILE
SEIZURE GREATER WHEN GIVEN WITH
TIV OR DTAP.
THE UPDATED ANALYSIS FOR THE
2010-2011 INCREASED THREE
FOLLOWED WHEN GIVEN W TOGETHER.
SIMILAR RESULTS FOR 2006 AND
2009 INFLUENZA SEASON.
THE PRISM ANALYSIS DID NOT FIND
ANY GREATER RISK FOR FEBRILE
SEIZURES FOR SAME DAY OR
SEPARATE WITH TIV AND PCV 13
DURING ON2010 AND 2011 INFLUENZA
SEASON.
SO THE WEIGHT OF THE EVIDENCE
AND CONSISTENCY OF FINDINGS FROM
THE ANALYSIS OVER SEVERAL
SEASONS SUGGEST WHEN TIV GIVEN
ALONE RISK OF SEIZURE WAS NOT
INCREASED.
WHEN TIV WAS GIVEN WITH PCV OR
DTAP THE RISK OF SEIZURE IS
INCREASED.
HIGHEST RISK WHEN T IV PCV AND
DTAP GIVEN TOGETHER AT 15 MONTHS
OF AGE.
38 PER 100,000 CHILDREN
VACCINATED WITH THAT
COMBINATION.
SIMILAR TO THE FEBRILE SEIZURE
RISK SEEN WITH MMRCINE.
SO TO CONCLUDE, SIMULTANEOUS
ADMINISTRATION OF TIV WITH PCV
OR DTAP VACCINE APPEARS TO BE
ASSOCIATED WITH AN INCREASED
RISK FOR FEBRILE SEIZURES IN
YOUNG CHILDREN.
THIS INCREASED RISK IS TRANSIENT
DAY OF TO DAY AFTER VACCINATION.
ALTHOUGH FRIGHT THINK FOR
PARENTS AND CAREGIVERS, FEBRUARY
RIGHT SEIZURES DO NOT HAVE
LASTING EFFECTS.
GETTING RECOMMENDED VACCINES HAS
IMPORTANT BENEFITS.
ON TIME VACCINATIONS KEEP
CHILDREN PROTECTED AGAINST
INFECTIOUS DISEASES AND MULTIPLE
VACCINATIONS IN HEALTH CARE
VISITS MINIMIZES THE NUMBER OF
VISITS PARENTS AND CHILDREN MUST
MAKE.
I'D LIKE TO ACKNOWLEDGE THE
FOLLOWING INDIVIDUALS.
FOR HELPING WITH THIS
PRESENTATION.
AT THIS TIME I'M GOING TO INVITE
DR. DUFFY AND QUY UP TO THE
STAGE AND WE'LL TAKE QUESTIONS
ON THE PRESENTATION.
I WANT TO THANK YOU FOR THE
PRESENTATION.
I HAVE A TECHNICAL QUESTION AND
COMMENT ABOUT THE OVERALL
INTERPRETATION.
TECHNICAL, CONTROL INTERVAL YOU
CHOSE IS AFTER RISK INTERVAL
RATHER THAN BEFORE.
I WONDER IF YOU'VE DONE THE SAME
ANALYSIS USING COMPARISON AND OR
THE RISK INTERVAL IF IT MAKES
ANY DIFFERENCE.
SO YES.
THAT RISK INTERVAL IS CHOSEN
SPECIFICALLY TO EXCLUDE RISK
PERIOD FOR MMR AND MMRV
VACCINES.
SO OTHER METHODS HAVE BEFORE AND
AFTER IN TIME.
I THINK OUR GOAL IN THIS
ANALYSIS, WE DID NOT
SPECIFICALLY USE PREVACCINATION
IN TIME BUT REPLICATE ORIGINAL
FINDINGS SO THEY WILL BE CLOSELY
COMPARABLE TO THE SURVEILLANCE.
>> I'M SORRY.
I'M NOT SURE THAT'S THE ANSWER
TO MY QUESTION.
MY QUESTION IS IF YOU CHOOSE THE
CONTROLLED INTERVAL BEFORE
RATHER THAN AFTER, DOES IT MAKE
ANY DIFFERENCE?
WE DON'T THINK IT SHOULD BUT
WE HAVEN'T LOOKED AT IT.
I'M JUST CURIOUS, BECAUSE IT
SEEMS TO ME IF FOR EXAMPLE
SOMETHING TOUCHES OFF A SEIZURE,
MAYBE FOR SEVERAL WEEKS AFTER
THAT YOU HAVE A LOWER RISK.
I'M NOT CURIOUS WHY, CURIOUSYOUT
WAY.
MY COMMENT THE ISSUE OF PRISM
ANALYSIS, SHOWING THERE'S
BASICALLY WHAT I EXPECTED WHEN
YOU BASICALLY LOOKED AT THE
COMBINED RISK GIVING THE
VACCINES SEPARATELY, THERE'S
BASICALLY NO GREATER RISK OF
GIVING THEM TOGETHER ON THE SAME
DAY WHEN YOU LOOK
ATTRIBUTABLE RISK WHICH IS WHAT
I WOULD HAVE EXPECTED.
SEEMS TO BE SOMEWHAT AT ODDS
WITH CONCLUSION OF RELATIVE RISK
OF GIVING THEM TOGETHER ON THE
SAME DAY IS INCREASED.
HOW CAN YOU EXCLUDE
POSSIBILITY THAT EACH OF THE
INDIVIDUAL VACCINES GIVEN
SEPARATELY HAS PERHAPS A 50%
INCREASE IN RELATIVE RISK
RELATIVE RISK OF 1.5 WHICH DON'T
HAVE THE POWER TO EXCLUDE.
IN POINT OF FACT, THE OVERALL
RISK IS NO DIFFERENT GIVING THEM
COMBINED ON THE SAME DAY AS
OPPOSED TO GIVING THEM
SEPARATELY ON INDIVIDUAL DAYS.
I'M NOT ENTIRELY SURE
INDEPENDENT THE QUESTION.
IN OUR STUDY DID EXAMINE SAME
DAY WAS ASSOCIATED WITH THE RISK
OF FEBRILE SEIZURES AND WE DID
NOT FIND ANY DIFFERENCE.
FOR RELATIVE RISK ESTIMATES
WANTED TO ISOLATE EFFECT OF
THREE VACCINES WHICH IS WHY WE
DON'T PRESENT JOINT EFFECTS OF
TIV AND PCV 13 IN RELATIVE RISK
FORMAT.
GOING BACK TO THE CONCLUSION
SLIDE FROM BEFORE THIS ONE, OR .
ABOUT THE SIMULTANEOUS
ADMINISTRATION WITH THE RISK OF
SEIZURE. ABOUT ATTRIBUTABLE
RISK AND QU
ATTRIBUTABLE RISK
BETWEEN THE DIFFERENT S?
I GUESS I DOABOR THE POINT.
MY POINT IS IF GIVING ONE
VACCINE ON ONE DAY HAS A
RELATIVE RISK OF 1.5 WHICH YOU
CAN'T EXCLUDE WITH YOUR
CONFIDENCE INTERVALS, THEN
PERHAPS THE RISK OF GIVING THE
VACCINES INDIVIDUALLY ON
SEPARATE DAY OVERALL IS NO
GREATER RELATIVE RISK THAN
GIVING THEM ALL TOGETHER ON ONE
DAY.
OKAY.
SO WE DID TEST THAT IN THE
MODEL.
SO AGAIN USING THE MODEL
INCLUDED ALL THREE VACCINES IN
THE SAME MODEL, WE DID TEST FOR
MODIFICATIONS, SEE THE RESULTS
FOR DIFFERENCE BY CONCOMITANT
VACCINE.
TIB, PCV13 INTERACTION ALMOST
.05 OR LESS.
THE INTERACTION MORE
SPECIFICALLY SEEN, REACTION 4.7,
NOTCHING UP.
I WOULD ARGUE THIS SUGGESTS
THERE IS A DIFFERENCE IN
RELATIVE RISK FOR THE TWO-WAY
COMBINATION SO WE SUGGEST
INTERACTION FOR THREE-WAWAY
COMBINATION DIFFERENT THAN
GIVING THEM ON SEPARATE DAYS
WITH INDEPENDENT OVER THE
VACCINE.
>> OTHER QUESTIONS OR COMMENTS?
THIS IS A QUESTION THAT HAS
TO DO WITH THE MODEL.
I EXPECT I'M GOING TO SEE THE
MODEL AGAIN SO I'D LIKE TO SEE I
AGAIN.
ARE YOU TALKING ABOUT THE
DISTRIBUTION AROUND LAMBDA AS
THE MODEL.
A TRADITIONAL MOECOND QUESTI
YOU TALK ABOUT QUADRATIC
SMOOTHING OR QUADRATIC -- MY
UNDERSTANDING, THAT'S A
LOGARITHMIC FUNCTION, NOT
QUADRATIC OR IS THAT A POLICY
ISSUE THAT'S CHANGED IN THE 30
YEARS SINCE I LOOKED AT THIS
LAST.
>> WE USED PASCHON AND
QUADRATIC.
COULD YOU REPEAT THE QUESTION,
PLEASE?
I'M NOT ENTIRELY SURE I FOLLOWED
IT.
>> IN THE DARK AGES WHEN WE
TALKED ABOUT PASSAN MODEL, AND
YOU TALKED ABOUT QUADRATICS.
I WAS WONDERING IF THERE WAS A
DIFFERENCE IN TERMINOLOGY OR A
DIFFERENCE IN HOW YOU DO THE
MATH.
THANK YOU.
OKAY.
I DON'T KNOW.
MAYBE I CAN JUMP IN.
QUADRATIC SPINE FOR THE AGE
EFFECT, NOT FOR RELATIVE RISK.
THEY WERE JUST TRYING TO
MODEL --
THANK YOU.
YES, THAT'S CORRECT.
USE CRAD-OF- QUADRATIC SPINE FOR
THE AGE AND CALENDAR WEEK --
CALENDAR WEEK EFFECT, NOT THE
EFFECTS OF VACCINATION.
THANK YOU.
>> THIS IS PROBABLN
FOR THE AAP REPRESENTATIVES, BUT
WHAT IS THE RECOMMENDATION
CONCERNING USE OF ANTI-PIRETICS
FOR TIB OR ARE THERE SITUATION
RECOMMENDATIONS.
>> RECENT THEY ARE NOT
SUPPORTIVE OF PROPHYLACTIC
ANTI-PIRETICS BUT COMFORTABLE
FOR USING IT FOR PEOPLE WHO
DEVELOP FEVER.
SO IS THERE ANY POSSIBILITY
OF REEXAMINING THAT IN LIGHT OF
THE DATA SUGGESTING TIV TOGETHER
WITH OTHER VACCINES INCREASES
THE RISK?
>> I THINK THAT BECAUSE OF THE
CONCERNS OF THE SAFETY OF THE
ANTI-
ANTI-PIRETICS IN THE AGE GROUP
YOU WOULD HAVE TO BALANCE THE
RISK WITH THE RISK OF FEBRILE
SEIZURES.
MY GUESS IS IT WOULD COME OUT
PRETTY MUCH A WASH.
GIVEN THIS DATA THAT SUGGESTS OT
INCREASE, YOU'D BE GIVING ANAWF
ANTI-PIRETICS TO PREVENT A FEW.
NOT A LOAD OF GOOD DATA THAT
SHOWS USING THEM
PROPHYLACTICALLY WOULD REDUCE
FEBRILE SEIZURES.
WE WOULD STAND ON THE
RECOMMENDATION THAT FOR PR
PROPHYLACT
PROPHYLACTIC.
>> I KNOW YOU HAVE SOME
BACKGROUND HERE.
>> I JUST WANTED TO LET THE
COMMITTEE KNOW WE HAVE PILOT
GOING ON WITH THE PROJECT
THROUGH DUKE UNIVERSITY AND CDC
AND WE'RE JUST EXPLORING THE
EFFECT OF USING PROPHYLACTIC
ANTI-PIRETIC VERSUS PLACEBO
VERSUS RESPONSE A THE WORK IS
JUST BEGINNING BUT I THINK DATA
OVER THE NEXT YEAR OR TWO MIGHT
BE INFORMATIVE, AT LEAST TO
SPEAK TO THE ISSUE WHETHER YOU
BLUNT RESPONSES WITH
ANTI-PIRETICS.
THAT'S THE CONCERN THAT YOU
WOULD BLUNT IMMUNE RESPONSES
AFTER THESE VACCINES AND MAY NOT
SEE THE PROTECTIVE EFFICACY.
THANK YOU.
JUST WANTED TO ADD ADDITIONAL
COMMENTS IN RESPONSES TO THE
QUESTIONS THAT WERE RAISED.
IT'S A GREAT QUESTION.
I THINK DOCTOR RAISED WHY NOT
PRECONTROL VERSUS POST POST.
WE'VE ALWAYS DONE THAT BECAUSE
OF THE HEALTHY VACCINE EFFECT.
YOU CAN ARGUE IN THIS INSTANCE
PROBABLY WOULD HAVE BEEN OKAY
BECAUSE OF THE SHORT TIME
INTERVAL AND PROBABLY MADE NO
DIFFERENCE EITHER WAY.
WE DIDN'T DO THAT IN THIS
PARTICULAR INSTANCE.
IN TERMS OF THE SECOND QUESTION,
THE ANSWER IS BOTH
INTERPRETATIONS ARE CORRECT BUT
QUESTIONS.
ONE BEING TWO VACCINES IN AN
EXPOSED PERIOD COMPARED TO
UNEXPOSED PERIOD.
YES, IF YOU GIVE TWO VACCINES,
THERE'S MORE RISK OF FEVER AND
POTENTIALLY THAT PUTS YOU AT
RISK FOR HIGHER RISK FOR FEBRILE
SEIZURES.
WHEN YOU'RE TALKING ABOUT THE
ASSUMPTION CHILDREN WILL RECEIVE
VACCINES AND WHETHER OR NOT
THERE'S A GREATER RISK FOR SAME
DAY VERSUS SEPARATE DAY AT LEAST
IN THE PRISM STUDY WE BELIEVE
THERE'S NO GREATER RISK GIVING
THEM ON THE SAME DAY, ASSUMING
YOU'RE GOING TO VACCINATE YOUR
KIDS ANYWAY.
WE DIDN'T HAVE THE METHOD
AVAILABLE IN THE PRIOR STUDY TO
BE ABLE TO PROVIDE CONFIDENCE
INTERVALS.
IT LOOKED ELEVATED, MAY HAVE
BEEN CONFIDENCE INTERVALS WERE
WIDE IN THE FIRST PLACE AND WE
COULDN'T SAY EITHER WAY.
ONE OTHER QUESTION RAISED,
QUADRATIC LINE, SPECIFICALLY
BECAUSE THERE'S SO MUCH TIME
CONFOUNDING BY AGE, BY WEEK OF
AGE, WE FELT THE NEED TO ADJUST
FOR THAT BUT IT WAS A
TRADITION
TRADITIONAL.
>> ANOTHER QUESTION?
I JUST WANTED TO KNOW --
[ INAUDIBLE ]
ONE ADDRESSING CUMULATIVE
RISK OVER TIME VERSUS TRANSIENT
RISK.
THIS STUDY OR DATA WOULDN'T
ADDRESS CUMULATIVE EFFECT OVER A
CHILD'S LIFETIME HOW MANY
SEIZURES THEY WOULD HAVE AFTER
BEING VACCINATEED WITH A
PARTICULAR VACCINE.
BUT AGAIN LOOKING AT THIS
SPECIFICALLY 0 TO 1 DAY RISK
POST VACCINATION WHICH, YOU
KNOW, LOOKING AT THE OTHER
VACCINES WE DIDN'T LOOK AT
VACCINES THESE CHILDREN
RECEIVED.
NO OTHER BESIDES THREE WE'VE
TALKED ABOUT HAD INDEPENDENT
EFFECT ONCE YOU CONTROLLED.
THERE'S NO SUGGESTION OF AN
INDEPENDENT RISK OF FEBRILE
SEIZURE IN THAT 0 TO ONE-DAY
PERIOD.
[ INAUDIBLE ]
>> ALSO WE'RE ON TIME, WE'LL
INTRODUCE.
IT GIVES ME GREAT PLEASURE TO
INTRODUCE THE ADULT IMMUNIZATION
SESSION.
ONCE WE GET THE FLAG UP,
ACKNOWLEDGEMENT OF OUR WORK
GROUP.
I'M ETERNALLY GRATEFUL FOR THIS
GROUP THAT WORKED REALLY, REALLY
HARD.
OUR WORK GROUP HAS SUBWORK
GROUPS AS WELL.
I'D LIKE TO ACKNOWLEDGE ACIP,
EX-OFFICIO, CDC LEAD DR. CAROLYN
BRIDGES WHO WORKED TIRELESSLY TO
MAKE SURE THE WORK CAN GET DONE,
SO THE GROUP, ALSO LIAISON,
GROUP REPRESENTATIVE AND
CONSULTANT.
I'D LIKE TO ACKNOWLEDGE DR.
DAVID KIM, WHO WILL ACTUALLY BE
TRANSITIONING INTO CDC LEAD ROLE
FOR THE PARTICULAR WORK GROUP
AND COLLECTIVELY WOULD LIKE TO
ACKNOWLEDGE DR. KIM, DR. BRIDGES
AND OUR CONSULTANT L.J. TAN AS
WELL AS DIANE PETERSON FOR ALL
THE WORK THEY DID NOT ONLY ON
THE WORK GROUP BUT DEVELOPMENT
OF OUR ANNUAL NATIONAL ADULT
IMMUNIZATION.
SO IF I CAN GO TO OUR THIRD
SLIDE, I'D LIKE TO SUMMARIZE
SOME OF THE KEYIES THAT
WE'VE HAD.
THOSE INCLUDE ACTUALLY
PUBLISHING RECOMMENDATIONS IN
THE AN ALES IN FEBRUARY.
THIS WAS APPROVED BY AMERICAN
COLL WELL AS
AMERICAN ACADEMY OF FAMILY
PHYSICIANS, AMERICAN COLLEGE OF
OBSTETRICS AND GYNECOLOGIST AS
WELL AS AMERICAN COLLEGE OF
NURSE ES.
IT WAS ALSO PUBLIC LICHD IN
MMWR.
E TWO
PUBLICATIONS, MMWR HIGHLIGHTED
CHANGES FROM THE PREVIOUS YEARS
AND IT DID NOT INCLUDE FIGURES
IN THE CONTRAINDICATION TABLES.
SINCE THAT TIME, MANY
COMMUNICATION DOCUMENTS DONE BY
MANY INDIVIDUALS AT THE CDC AND
THE CDC ALSO UPDATED ADULTS IN
ADOLESCENT IMMUNIZATION QUIZ IN
FEBRUARY.
I'D LIKE TO THANK THOSE
INDIVIDUALS WHO WILL BE
PROVIDING PRESENTATIONS TODAY ON
THE NEXT SLIDE WE'LL SEE
WELCOMING AGAIN DR. WALTER
WILLIAMS, WHO HAS GRACIOUSLY
AGREED TO COME AGAIN AND PROVIDE
A SUMMARY OF RECENTLY PUBLISHED
NO ONE VACCINE INFLUENZA AND
DOCTOR WILL PROVIDE UPDATE
DESCRIBING IMMUNIZATION
CAMPAIGN.
THEN I WILL COME BACK AND CLOSE
OUT WITH SOME OF THE ACTIVITIES
WE'VE DONE TO ADDRESS LAGGING
COVERAGE IN ADULTS.
DR. WILLIAMS.
.
>> AGAIN, THIS PRESENTATION
SUMMARIZES RESULTS FROM THE 2012
NATIONAL HEALTH INTERVIEW SURVEY
THAT WAS PUBLISHED IN MMWR IN
FEBRUARY OF THIS YEAR.
I WILL DESCRIBE THE DATA PROVIDE
TOP LEVEL SUMMARY OF ADULT
COVERAGE BY AGE, RACE, ETHNICITY
AND VACCINATION TARGET CRITERIA
BRIEF LIMITATIONS, CONCLUSIONS
AND PROVIDE SOURCES FOR
ADDITIONAL INFORMATION.
NHIS IS ANNUAL IN-HOME SURVEY OF
HEALTH AND HEALTH STATUS OF
NONINSTITUTIONALIZED CIVILIANS
IN THE UNITED STATES CONDUCTED
IN THE HOMES OF THOSE
INDIVIDUALS.
IT'S DONE ANNUALLY.
QUESTIONS ABOUT RECEIPT OF ADULT
VACCINATIONS IS ACTS OF RANDOMLY
SELECTED ADULT IN EACH FAMILY OF
EACH HOUSEHOLD.
WEIGHTED DATA WERE USED TO
PROVIDE NATIONAL COVERAGE
ESTIMATES.
THE FINAL RESPONSE RATE WAS 61%
FOR 2012 NHIS.
SAMPLE SIZE WAS JUST OVER
34,000.
THIS REPORT DOES NOT INCLUDE
INSULIN BUT DID YOU DOES INCLUDE
NUMB
PNEUMOCOCCAL.
HEPATITIS A, B, ZOSTER AND HPV.
PROPORTION OF PNEUMOCOCCAL BY
TYPES OF VACCINE WAS NOT
MEASURED IN 2012 NHIS.
DTAP RESULTS COLLECTED FOR THE
FIRST TIME IN 2012 NHIS, ADULT
65 AND OLDER AND ANALYSIS DONE
ON THAT GROUP.
COMPREHENSIVE INFORMATION ON
HIGH-RISK STATUS WAS NOT
COLLECTED IN NHIS, 2012 NHIS, SO
THERE'S LIMITED INFORMATION ON
HEP A AND B, TRAVEL STATUS,
LIVER, DIABETES.
HIGH-RISK CONDITIONS FOR
PNEUMOCOCCAL VACCINATIONS SHOWN
ON THE NEXT SLIDE.
WE DID COLLECT INFORMATION ON
HEALTH CARE PERSONNEL INCLUDING
THOSE WHO PROVIDED CARE.
DEFINITION FOR PNEUMOCOCCAL WERE
THOSE ADULTS TOLD BY A DOCTOR OR
OTHER HEALTH CARE PROFESSIONAL
THEY HAD ANY OF THE CONDITIONS,
SELECTED CONDITIONS LISTED HERE
OR WERE CURRENT SMOKERS.
LOOKING AT COVERAGE ESTIMATES,
PNEUMOCOCCAL, OVERALL ESTIMATES
FOR BOTH VACCINES, HIGH-RISK
INDIVIDUALS 19 TO 64 YEARS
COVERAGE 20% FOR THOSE 65 AND
OLDER 60%.
AMONG ADULTS 60 YEARS AND OLDER,
20% REPORTED RECEIVING HERPES
ZOSTER, 4.4 PERCENTAGE INCREASED
COMPARED TO ESTIMATES IN 2011.
THAT WAS PRIMARILY DUE TO
INCREASES THAT OCCURRED AMONG
NONSPANK WHITES.
LOOKING AT TETANUS DURING THE
PREVIOUS TEN YEARS, THE
PROPORTION OF ADULTS THAT
RECEIVED TETANUS IN THAT PERIOD,
ADULTS 64 YEARS AS WELL AS THOSE
50 TO 64 YEARS.
TD VACCINATION FOR ADULTS 65 AND
OLDER, 65%.
LOOKING AT ADULTS 19 THROUGH 64
WHO RECEIVED TDAP, ESTIMATE WAS
16% REPRESENTING 3.2 PERCENTAGE
INCREASE COMPARED TO 2011.
AGAIN, THAT NICK DUE TO NONSPANK
WHITES.
PERSONS LIVING IN HOUSEHOLD LESS
THAN ONE YEAR OF AGE, TDAP 26%
SIMILAR TO 2011.
AMONG HEALTH CARE PERSONNEL, AGE
19 TO 64, TDAP WAS 33%.
THIS WAS A 5.8 PERCENTAGE POINT
INCREASE COMPARED TO 2011.
34% OF RESPONDENTS EXCLUDED FROM
TDAP CREATING A POTENTIAL FOR
BIAS.
EXCLUDING THOSE WITHOUT YES OR
NO RESPONSE TO TETANUS
VACCINATIONS IN THE PAST TEN
USERS.
THOSE WITHOUT RESPONSE DURING
THE PERIOD 2005 TO 2012, THOSE
WHO REPORTED TETANUS
VACCINATIONS OR EITHER WERE NOT
TOLD OR DID NOT KNOW THE VACCINE
TYPE.
WE CONDUCTED A SENSITIVITY
ANALYSIS TO ASSESS MAGNITUDE OF
POTENTIAL BIAS THAT MIGHT RESULT
FROM THESE EXCLUSIONS.
DEPENDING ON WHAT PROPORTION OF
EXCLUDED RESPONDENTS ACTUALLY
RECEIVED TDAP, ACTUAL TDAP
COVERAGE COULD FALL IN THE RANGE
OF 11 TO 31% -- 11 TO 39% FOR
ADULTS 19 TO 64 YEARS AND 6 TO
34 FOR ADULTS 65 AND OLDER.
IN THIS SENSITIVITY ANALYSIS
ASSUMES NO ERRORS IN REPORTING
WHEN RESPONSES ARE ALL YES OR NO
COMBINATIONS.
LOOKING AT THE PROPORTION OF
ADULTS WHO RECEIVED TDAP AMONG
THOSE WHO RECEIVED ANY TETANUS
VACCINATION AMONG ADULTS 19 AND
OLDER, TETANUS VACCINATION
PERIOD 2005 TO 2012, 53% EITHER
WERE NOT TOLD, ANOTHER 11% COULD
NOT RECALL THE VACCINATIONS THAT
THEY RECEIVED.
OF THE REMAINING PERSONS WHO
RECEIVED TETANUS VACCINATION IN
THAT GROUP, 65% REPORTED TDAP.
AMONG HEALTH CARE PERSONNEL, 33%
WERE NOT TOLD.
ANOTHER 9% COULD NOT RECALL.
AMONG THE REMAINING HEALTH CARE
PERSONNEL, 76% REPORTED
RECEIVING TDAP.
VACCINATION OF HEALTH CARE
PERSONNEL FOR TDAP WAS
STATISTICALLY HIGHER THAN THAT
AMONG NONHEALTH CARE PERSONNEL.
HEPATITIS A, B,
HEPATITIS A COVERAGE REMAINED
LOW AT12% FOR PERSONS 19 TO 49
YEARS OLD.
THIS ESTIMATE
THAT OF 2011.
HEP A CO AMONG
TH TRAVELEDOUS
UNITED STATES TO AN ENDEMIC AREA
AT 19% COMPARED TO THOSE WITH NO
ENDEMIC AREA AT 9%.
HEPATITIS B
PERSONN OLDER WAS 65%.
THIS ESTIMATE WAS SIMILAR TO
THAT2011.
HEP B COVERAGE AMONG PERSONS 19
TO 49% WAS 35%, 19 TO 49
RAT%.
THIS SI
201SONS WITH DIABETES,
HEPATITIS B VACCINATION WAS ES
HIGHLIGHTING NEED TOASE A OF A
HIGHER RISK FOR ACUTE HEPATITIS
B AND THE NEED FOR VACCINATION.
LOOKING AT HPV VACCINATION AMONG
WOMEN AGE 19 TO 26 YEARS, 35%
REPORTED RECEIVING AT LEAST ONE
DOSE OF HPV VACCINE.
THIS REPRESENTED A 5 PERCENTAGE
POINT INCREASE COMPARED TO 2011.
AGAIN, THIS INCREASE WAS
PRIMARILY DUE TO INCREASES IN
NON-HISPANIC WHITES.
COVERAGE AMONG WOMEN 19 TO 21
WAS 34% AMONG WOMEN 22 TO 26, 22
TO 28, THIS WAS A 6.7%
PERCENTAGE POINTS INCREASE
COMPARED TO 2011.
THE INCREASE AMONG WOMEN 22 TO
26 YEARS INDICATED SOME CATCHUP
VACCINATION IS OCCURRING IN THIS
AGE GROUP PRIMARILY AMONG WHITE
WOMEN.
WE DID NOT COLLECT DATA OR AGE
OF VACCINATION IN 2012, SO COULD
NOT DETERMINE WHETHER
VACCINATION OF YOUNGER WOMEN,
SUCH AS AGE 19 TO 21 OCCURRED AS
PART OF AN ADOLESCENT PROGRAM OR
WHEN THEY WERE 19 OR OLDER.
WE ARE COLLECTING DATA ON AGE
VACCINATION 2013.
COVERAGE AMONG MALES LOW SINCE
AFFIRM CIP RECOMMENDATIONS TO
VACCINATE MALES IN OCTOBER 2011.
THIS JUST SUMMARIZES INCREASES I
DESCRIBED TO YOU FOR THREE
VACCINES THAT HAVE BEEN MORE
RECENTLY RECOMMENDED FOR ADULTS.
THE RANGE OF INCREASES IS FROM
3% TO 5 PERCENTAGE POINTS.
THE INCREASE IN HPV TDAP AND
ZOSTER, NON-HISPANIC WHITE
WOMEN, NON-HISPANIC WHITES
OVERALL INDICATING A WIDE GAP
BETWEEN NON-HISPANIC WHITES,
BLACKS AND NON-ASIANS.
DIFFERENCE OR DISPARITY IN HPV
VACCINATION OF WOMEN IS NOT SEEN
WHEN WE LOOK AT DATA FROM THE
NATIONAL IMMUNIZATION SURVEY
AMONG TEENS.
WE ARE LOOKING AT THAT IN
GREATER DETAIL AND COMPARING
COHORTS VACCINATED IN NHIS
VERSUS NIS.
WHEN COMPARING THE RESULTS
OVERALL, WE HAVE SIMILAR OVERALL
RESULTS WHEN WE COMPARE HPV
COVERAGE PERSONS 17 YEARS OLD
AND 18-YEAR-OLD AND NHIS DATA,
EXCEPT THERE WERE SUBSTANTIAL
DIFFERENCES FOR HISPANICS THAT
MAY ACTUALLY INDICATE A LARGE
BIAS IN THEE NHIS SELF-REPORTED
DATA FOR HPV VACCINATION AMONG
WOMEN.
THIS GRAPHIC SUMMARIZES ALL THE
DISPARITIES SEEN IN THIS
ANALYSIS.
IT SHOWS VACCINATION GROUP WE
BY RACE,
ETHNICITY, VACCINATION COVERAGE
AMONG NON-HISPANIC WHITES AND
THE DIFFERENCE IN COVERAGE FOR
NON-HISPANIC BLACKS,
NON-HISPANIC ASIANS COMPARED TO
WHITES.
ALL OF THE SIGNIFICANT FINDINGS
IN BOLDED RED OR BLUE.
SHOWN IN RED WE SEE THERE WERE
STATISTICALLY SIGNIFICANT
DISPARITIES FOR 31 OF THE 42
COMPARISONS BY VACCINE AND AGE
TARGET GROUPS.
THESE DISPARITIES RANGE FROM
MINUS 2 PERCENTAGE POINTS FOR
HISPANICSIN HEP
A, 19 TO 49-YEAR-OLD ADULTS TO A
MINUS 27% FOR ASIANS VERSUS
WHITES FOR HPVO
26-YEAR-OLD WOMEN.
THERE WAS ONLY ONE INSTANCE WITH
HIGHER COVERAGE THAN WHITES AND
THAT WAS ASIANS HAVING HEP A
COVERAGE 7 PERCENTAGE POINTS
HIGHER THAN WHITES FOR AGE GROUP
19 TO 49 YEARS.
SO TO SUMMARIZE RACIAL AND
ETHNIC DISPARITIES SHOWN IN THIS
REPORT COMPARED WITH 2011,
DIFFERENCES PERSISTED FOR ALL
SIX VACCINES AND WIDENED FOR
TDAP, HERPES ZOSTER, HP V
NON-HISPANIC BLACKS WHITES
HAD LOWER COVERAGE FOR ALL
VACCINES ROUTINELY RECOMMENDED
FOR ADULTS WITH THE EXCEPTIONS
LISTED HERE.
AMONG HEALTH CARE PERSONNEL,
NON-HISPANIC BLACK AND HISPANIC
HEALTH CARE PERSONNEL HAD LOWER
COVERAGE FOR TDAP BUT SIMILAR
COVERAGE TO WHITES FOR HEP B.
THE REPORT HAD SEVERAL
LIMITATIONS, NHIS EXCLUDES
PEOPLE IN THE MILITARY AND
PEOPLE RESIDING IN INSTITUTIONS,
SO THE RESULTS APPLY ONLY TO THE
CIVILIAN NONINSTITUTIONALIZED
POPULATION.
THE RESPONSE RAFT 61% IS LOW AND
CAN RESULT IN SAMPLING BIAS IF
NONRESPONSIVE UNEQUAL AMONG
PARTICIPANTS REGARDING
VACCINATION.
SELF-REPORT OF VACCINATION AND
HEALTH STATUS IN NHIS WAS NOT
VALIDATED BY A REVIEW OF MEDICAL
RECORDS SO THERE IS A POTENTIAL
FOR RECALL BIAS.
SELF-REPORTED VACCINATION HAS
BEEN SHOWN, HOWEVER, TO BE SHOWN
TO BE SENSITIVE FOR ALL THE
VACCINES IN THE REPORTS AND
SPECIFIC FOR ALL THE
VACCINATIONS EXCEPT TETANUS
VACCINATION.
IT'S IMPORTANT TO NOTE ACCURACY
OF RECALL BY YOUNG ADULTS OF
VACCINATIONS ROUTINELY
RECOMMENDED BY ADOLESCENTS HAS
NOT BEEN STUDIED.
TDAP ESTIMATES, AGAIN, THERE WAS
A POTENTIAL FOR BIAS DUE TO THE
EXCLUSION.
AGAIN, AGE OF VACCINATION NOT
KNOWN FOR VACCINES REPORTED AND
EVER RECEIVED, SO IT'S UNCLEAR
IF VACCINATION OCCURRED AS A
YOUNG ADULT OR PART OF A CHILD
WITH ADOLESCENT VACCINATION
PROGRAM.
SO IN CONCLUSION, OVERALL FOR
THE THREE VACCINES IN HEALTHY
PEOPLE 2010, PNEUMOCOCCAL
VACCINE, ZOSTER AND HPV FOR
HEALTH CARE, WELL BELOW PEOPLE
TARGET FOR 2013.
DESPITE SOME IMPROVEMENTS FROM
2011, VACCINATION OVERALL FOR
ADULTS STILL REMAINS LOW, RACIAL
AND ETHNIC DISPARITIES REMAIN,
WHICH LEADS US WITH QUITE A BIT
OF WORK TO DO TO INCREASE
UTILIZATION.
I WANT TO ACKNOWLEDGE
COLLABORATORS ON THIS REPORT,
DR. LORI MARKOWITZ WAS LEFT OFF
THE COLLABORATIVE GRAPHIC.
RECOMMENDATIONS FOR ACIP
SPECIFIC VACCINES, URL SHOWN
THERE AND NONINFLUENZA COVERAGE
REPORT IS AT THAT URL.
THANK YOU.
HI, GOOD EVENING.
IT'S MY PLEASURE TO HAVE THE
OPPORTUNITY TO UPDATE YOU ON
CDCs COMMUNICATION ACTIVITY
RELATED TO ADULT IMMUNIZATION.
I'LL PROVIDE A BRIEF OVERVIEW OF
OUR PROGRAM AS WELL AS HIGHLIGHT
FOR YOU SOME OF OUR
COMMUNICATION ACTIVITIES AND NEW
RESOURCES WE'VE MADE AVAILABLE.
IN THE FALL OF 2012, WE LAUNCHED
A TWO-YEAR ADULT COMMUNICATION
PROGRAM.
OUR BROAD GOAL IS TO DEVELOP A
BRAND AS W AND HAT COULD HELP
AWARENESS AND PROMOTE
IMMUNIZATION ACCORDING TO THE
RECOMMENDED SCHEDULE BY
TARGETING BOTH ADULTS AND THE
PHYSICIANS AND OTHER HEALTH CARE
PROFESSIONALS OBSERVE THEM.
KNOWING THAT MAKING CHANGES IN
SOCIAL NORMS AND BEHAVIORS
RELATED TO ADULT IMMUNIZATION
REQUIRES A LONG-TERM EFFORT WELL
BEYOND OUR TWO-YEAR PROJECT TIME
LINE, WE SET OUT TO LAY A STRONG
FOUNDATION FOR THIS IN FUTURE
WORK THROUGH FORMATIVE
COMMUNICATION RESEARCH.
OUR RESEARCH INCLUDED A NATIONAL
SURVEY, WHICH I SHARED WITH YOU
LAST YEAR, FOCUS GROUPS WITH
ADULTS, AS WELL AS A REVIEW OF
AVAILABLE PUBLISHED LITERATURE
RELATED TO ADULTS.
IN ADDITION WE WERE ABLE TO
CONDUCT 28 INTERVIEWS WITH
PHYSICIANS, NURSE PRACTITIONERS
AND REGISTERED NURSES.
THE TOPICS WE DISCUSSED WITH
THEM ARE LISTED HERE AND INCLUDE
THE VACCINE CONVERSATIONS THEY
HAVE WITH THEIR PATIENTS AS WELL
AS THE RECOMMENDATION PROCESS.
WE DO HAVE SUMMARIES OF RESEARCH
AVAILABLE FOR THOSE WHO ARE
INTERESTED IN MORE DETAILS.
BASED ON OUR RESEARCH, BEST
PRACTICES IN A NUMBER OF HELPFUL
BEHAVIOR CHANGE MODELS AND
THEORIES WE DEVELOPED A
FRAMEWORK HOW COMMUNICATION
EFFORTS CAN ENCOURAGE ADULTS TO
GET VACCINATED.
I WON'T GO INTO DETAILS.
BOTTOM LINE, BEHAVIOR CHANGE IS
COMPLICATED.
ON THE RIGHT SIDE, AS WE ALL
KNOW, ARE THE DIFFERENT STAGES
THAT PEOPLE MAY GO THROUGH IN
TERMS OF VACCINE DECISION
MAKING.
ON THE OTHER SIDE, DIFFERENT
STRATEGIES CAN BE HELPFUL IN
MOVING PEOPLE THROUGH THOSE
CHANGES.
IN THE MIDDLE ARE SOME OF THE
KEY FACTORS THAT MEDIATE THOSE.
AND WE KNOW THAT ALL OF THIS IS
VERY IMPORTANT TO BE DELIVERED
BY THE MOST TRUSTED SOURCE AND
THOSE ARE DOCTORS AND OTHER
HEALTH CAR
THUS, THE GREEN ARROW GOING
THROUGH ALL THE STAGES.
THERE'S SOME KEY DRIVERS IN OUR
FRAMEWORK AND APPROACH TO
COMMUNICATING WIUT
IMMUNIZATION.
THEY INCLUDE STRESSING THE
RELEVANCE AND IMPORTANCE OF
TIMELY VA
HIGHLIGHTING SUSCEPTIBILITY AND
EXPLAINING THE SEVERITY ANDTIAL
DISEASES.
HOWEVER, THIS INFORMATION HAS TO
BE BALANCED WITH EMPOWERING
MESSAGES THAT PRESENT
VACCINATION AS A DOABLE STEP
THAT CAN B PROTECT
THEMSELVES AND THEIR LOVED ONES.
WE ALSO NEED PLAIN LANGUAGE
INFORMATION THAT CAN HELP ADULTS
MAKE INFORMED DECISIONS AND
PROVIDE SUPPORT IN GETTING
VACCINAT INFORMATION SHOULD BE
TAILORED AS MUCH AS POSSIBLE.
WE ENCOURAGE THEM TO TALK TO
DOCTOR, HEALTH CARE PROVIDER FO.
KEY PRINCIPLES WITH HEALTH CARE
PROVIDERS INCLUDE REMINDING THEM
WHY VACCINATION IS AN IMPORTANT
PREVENTIVE MEASURE AND THEIR
ROLE IN MAKING SURE THEIR
PATIENTS ARE PROTECTED.
THE RECENTLY UPDATED STANDARDS
PROVIDE GUIDELINES THAT CALL IN
ALL HEALTH CARE PROVIDERS TO
TAKE CERTAIN STEPS INCLUDING
SHARING A STRONG RECOMMENDATION.
SO IT WILL BE IMPORTANT TO SHARE
WHAT WE'VE LEARNEDOM CONSUMER
RESEARCH REGARDIN
RECOMMENDATIONS COMPELLING AND
HOW TO BEST ADDRESS PATIENT
QUESTIONS AND CONCERNS.
IN OUR MOST RECENT RESEARCH WITH
HEALTH CARE PROFESSIONALS, NOT
ALL PHYSICIANS RESPONDED
POSITIVELY TO OUR INFORMATION
ABOUT THE STANDARDS.
IN SOME CASES FEELING IT'S NOT
REALISTIC FOR US TO ASK THEM TO
ASSESS VACCINATION STORM TRACKER
US AND DISCUSS VACCINES AT EVERY
VISIT.
FOR INSTANCE, WHEN THEY ARE
DEALING WITH A PATIENT WITH AN
ACUTE ISSUE.
A CRITICAL PIECE OF WHAT WE
FOCUSED ON IS THE CONVERSATION
BETWEEN PROVIDERS AND THEIR SOS
CLEAR, STRONG RECOMMENDATION A
VACCINE IS NEEDED MAY BE
SUFFICIENT.
OTHERS MAY WANT ADDITIONAL
INFORMATION.
WE'VE SUMMARIZED FIVE BEST MAIN
PRACTICES WE IDENTIFY FOR
STRENGTHENING VACCINATION
RECOMMENDATIONS AND APPROACH WE
CALL SHARE.
WHILE THERE'S NO MAGIC MESSAGE
OR SCRIPT THAT CAN WORK ACROSS
ALL ADULT VACCINES AND FOR ALL
PATIENTS, WE BELIEVE THESE ARE
IMPORTANT COMMUNICATION
STRATEGIES THAT PROVIDERS SHOULD
KEEP IN MIND WHEN HELPING
PATIENTS MAKE THE DECISION TO
GET RECOMMENDED VACCINES.
WE'VE DEVELOPED A VARIETY OF
RESOURCES THAT CAN BE USED WITH
A BROAD GENERAL AUDIENCE OF
ADULTS AS WELL AS THOSE WITH
CHRONIC CONDITIONS.
THESE INCLUDE OUTREACH PRODUCTS
LIKE POSTERS, FLYERS, AS WELL AS
MATERIALS THAT CAN BE USED FOR
PATIENT EDUCATION INCLUDING FACT
SHEETS AND TOOLS TO ASSIST
ADULTS LIKE ONLINE QUIZ AND
REVAMPED WEBSITE.
HERE IS JUST A FEW SAMPLES OF
SOM
PRODUCTS.
WE HAVE ALSO DEVELOPED
COMMUNICATION PRODUCTS,
RESOURCES AND TOOLS ENC SUPPORT.
AS WENOW, THEY ARE SOULTS VACCI.
ONE THING THAT ISN'T ON THE
SLIDE BUT WORTH MENTIONING, WE
LAUNCHED OR VACCINE SCHEDULE.
IN THE FIRST 20 DAYS OF BEING
AVAILABLE IT'S BEEN DOWNLOADED
2600 TIMES.'T INCLUDE ADULT
IMMUNIZATION SCHEDULE.
SO OUR MATERIALS FOR HEALTH CARE
PROVIDERS DOES INCLUDE A SERIOUS
ON IMPROVING
ADULT IMMUNIZATION PRACTICE
INCLUDING VACCINE ASSESSMENT,
RECOMMENDATION,ON
REFERRAL AND DOCUMENTATION.
EACH SHEET COVERS ONE OF THE
STEPS AND PROVIDES IPS,
RESOURCES AND TOOLS IN
IMPLEMENTATION.
THE SECOND SHEET IN THE SERIES
INCLUDES THE SHARE APPROACH AS
WELL AS SOME TIPS ON HOW TO
ADDRESS COMMON QUESTIONS.
WE CONTINUE TO LOOK FOR
OPPORTUNITIES TO GET THE WORD
OUT BROADLY ABOUT ADULT
IMMUNIZATION.
WE HAVE THE OPPORTUNITY TO DO
THAT IN FEBRUARY WITH THE
RELEASE OF THE DATA THAT WALTER
JUST PRESENTED.
SOME OF OUR ACTIVITIES ARE
LISTED HERE.
AND OUR NEXT BIG PUSH OR
OUTREACH EFFORT WILL BE DURING
NATIONAL IMMUNIZATION AWARENESS
MONTH.
WE LOOK FORWARD TO WORKING WITH
PARTNERS TO TRY TO GET THE WORD
OUT ABOUT ADULT IMMUNIZATION
DURING THAT MONTH.
SO NEXT STEP FOR US INCLUDES
CONTINUING TO SHARE KEY RESEARCH
FINDINGS WITH PARTNERS AND
HEALTH COMMUNICATION
PROFESSIONALS, TO CONTINUE TO
TEST AND DEVELOP EDUCATIONAL
MATERIALS AND OTHER HEALTH CARE
PROFESSIONAL RESOURCES INCLUDING
IN SPANISH AS WELL AS
DISSEMINATE MESSAGE PRODUCTS AND
RESOURCES THROUGH THE ENGAGEMENT
IN PARTNERS AND MEDIA.
OF COURSE AS FLU SEASON IS
APPROACHING, WE'LL LOOK FOR
OPPORTUNITIES FOR ADULT AS WELL
AS GETTING FLU VACCINATIONS."
AS ALWAYS WE ASK PARTNERS TO USE
OUR PRODUCTS IN A NUMBER OF
DIFFERENT WAYS AND FEEL FEE TO
GIVE US INPUT AND FEEDBACK.
SHE'S NOT LISTED ON THE SLIDE.
I WANT TO SAY A SPECIAL THANKS
TO HER, THIS IS HER SLIDE.
IF SHE WERE HERE, SHE WOULD BE
PRESENTING THIS FOR US.
SHE'S DONE SO MUCH OF THE HEAVY
LIFTING ON THE PROGRAM, WE HAVE
TO CALL HER OUT ESPECIALLY BUT
ALSO THANKS TO OTHERS WHO HAVE
BEEN INVOLVED.
OF COURSE AT ANY TIME IF YOU
HAVE QUESTIO
INPUT, YOU CAN SEND THAT TO ME
OR HERE.
THANK YOU TO OUR
APPREHENDERS.
I'M JUST GOING TO PRESENT A
LITTLE ABOUT KEY ACTIVITIES
GOING ON WITH WORK GROUP TO
ADDRESS LAGGING COVERAGE IN
ADULTS.
I WANT TO HIGHLIGHT ONE OF OUR
PRIMARY ACTIVITIES, WHICH IS
NATIONAL ADULT INFLUENZA SUMMIT.
IN THIS SUMMIT IS A PARTNERSHIP
OF 300 ORGANIZATIONS WHOSE GOALS
ARE ADULT IMMUNIZATION KEY
STAKEHOLDERS.
BUT NOT JUST TO CONVENE AS A
GROUP BUT TO ACTUALLY LEAVE THAT
SUMMIT WITH ACTIONS TAKEN BY THE
MEMBERS TO IMPROVE THE UPTAKE OF
OUR ACIP ADULT RECOMMENDED
VACCINES AND IMPROVE UPTAKE OF
INFLUENZA VACCINE AMONG ALL
AGES.
AS I MENTIONED, THIS IS AN
ANNUAL CONFERENCE THAT TAKES
PLACE.
OUR LAST CONFERENCE WAS ACTUALLY
IN MAY.
IT WAS HELD IN ATLANTA.
OUR WORK GROUPS, IN FACT, MEET
YEAR-ROUND.
THESE ARE SUBGROUPS I REFERRED
TO.
THEY ARE FIVE WORK GROUPS
DEDICATED TO ISSUES RELATED TO
PROVIDERS, PATIENT EDUCATION,
COLLABORATION, ACCESS, QUALITY
AND DECISIONMAKERS.
I'D LIKE TO JUST PRESENT A FEW
OF THE HIGHLIGHTS FROM THE
MEETING.
SOME OF OUR HIGHLIGHTS INCLUDED
PRESENTATIONS AND A CREATIVE AND
INNOVATIVE PRESENTATION WHICH
HELPED US TO THINK CREATIVELY
AND INNOVATIVELY ABOUT WAYS WE
COULD VACCINATE ADULTS IN
CREATIVE LOCATIONS.
SOME PRELIMINARY DATA FROM THE
INVESTIGATOR AT THE UNIVERSITY
OF COLORADO LIMITED
KNOWLEDGE AMONG PROVIDERS
REGARDING ISSUES OF BILLING AND
PAYMENT FOR ADULT IMMUNIZATIONS.
LIKEWISE THERE'SIMITED
USE OF IMMUNIZATION SYSTEMS BY
MANY OF OUR ADULT MEDICAL
PROVIDE LEARNED, WE SEE
WITH ADOLESCENT AND CHILDHOOD AS
WEL EVIDENCE TO
SUGGEST THAT PATIENTS ARE
ACTUALLY WILLING TO GET
VACCINATED IF THEY RECEIVE A
STRONG RECOMMENDATION FRS THEIR
ADULT PROVIDER.
SOME OTHER MEETI CUSSIONS, PRESI
CHALLENGES OFNG QUALITY
MEASURES FOR ADULT
RESENTED EXAMPLES
RAISING
PRACTICE STANDARDS
IMMUNIZATIONS WERE APPLIED.
I REALLY WOULD LIKE TO REFER YOU
TO THE WEBSITE THAT YOU SEE HERE
BECAUSE MANY OF THESE SUCCESS
STORIES CAN ACTUALLY BE FOUND P
WEBSITES. ALSO HEARD FROM MANUS
THAT
WERE TO BE AVAILABLE
FOR INFLUENZA, WE DO NOT BELIEVE
WE'LL HAVE ANY SUPPLY-RELATED
ISSUES.
AS I MENTIONED, ONE OF THE KEY
THINGS IS NOT JUST CONVENING KEY
STAKEHOLDERS BUT
LEAVING THE MEETING WITH ACTION
ORIENTED PLANS THAT WE INTEND TO
DO THE YEAR AFTER THIS PROGRAM.
I JUST WANT TO SHARE A COUPLE OF
THOSE WITH YOU.
THE MEMBERSTO
EXPLORING A CODE FOR VACCINE,
PROMOTE IMPLEMENTATION OF
STANDARDS OF PRACTICE FOR ADULT
IMMUNIZATIONS, ACTUALLY
INCREASING AWARENESS OF ADULT
IMMUNIZATION THROUGH MULTIPLE
VENUES BUT IN PARTICULAR THROUGH
NATIONAL AWARENESS MONTH YOU
JUST HEARD ABOUT.
WE ALSO WANT TO IDENTIFY AND
DISSEMINAT BUSINESS
TOLLS TO REDUCE PRACTICE COST AS
BARRIERS FOR PROVIDERS.
WE WAN THIS TO BE A WINNING
PROPOSITION NOT JUST FOR OUR
PATIENTS BUT ALSO FOR PROVIDERS
AND THEIR OFFICES.
WE ALSO WANT TO CONTINUE THE
EVALUATION OF ADULT
QUALITY MEASURES.
AND FINALLY, ADDRESS ANY
BARRIERS THAT ARE RELATED TO
IN-NETWORK STATUS REQUIREMENTS
THAT OCCUR
OUR PROVIDERS.
I WOULD FOR YOU LIKE TO CALL DR.
WILLIAMS UP TO THE PODIUM SO WE
CAN ADDRESS ANY QUESTIONS THAT
MIGHT EXIST.
>> THANK YOU VERY MUCH FOR THE
PRESENTATION.
>> THANK YOU FOR THAT DISCUSSION
OF REALLY IMPORTANT WORK.
ONE QUESTION I IN OUR
PRACTICE WITH PUBLIC HEALTH, WE
DEAL WITH HEALTH CARE PROVIDERS,
IMMUNIZATION ISSUES AND FIND
THAT ONE OF THE BARRIERS, THE
TIME INVESTED NEEDED BY THE
PROVIDER TO DO THE KINDS OF
THINGS WE'RE ASKING THEM TO DO,
EXPLAINING THE RISK AND THE
BENEFITS, THE BURDEN OF DISEASE,
OCCUPATIONAL RISK, I GUESS I HAD
TWO QUESTIONS.
ONE IS, ARE YOU LOOKING AT HOW
MUCH TIME IT TAKES A PROVIDER TO
IMPLEMENT THE TYPES OF
RECOMMENDATIONS YOU'VE DEVELOPED
HERE IN THE PRACTICE SETTING SO
WE CAN TELL THEM.
I THINK IT'S PRETTY IMPORTANT
FOR THEM HAVE A REALISTIC
EXPECTATION OF HOW MUCH TIME
THIS WILL TAKE.
AND THE SECOND QUESTION IS MORE
AND MORE PATIENTS ARE BEING
MANAGED BY MEDICAL TEAMS AS
OPPOSED TO INDIVIDUAL PROVIDER.
THOSE TEAMS HAVE SPECIALISTS
THAT DEAL WITH SPECIFIC ASPECTS
OF THE PATIENT'S HEALTH, CHRONIC
DISEASE AND WHATEVER.
I'M WONDERING IF YOU'VE EXPLORED
POTENTIAL TO HAVE IMMUNIZATION
BE A PART OF THE TEAM MEDICINE
APPROACH IN THOSE THAT USE THE
SO THANK YOU FOR THAT HAT MIGHT
QUESTION.
I HAPPEN TO BE A MEMBER OF THE
PROVIDER WORK GROUP.
A LOT OF THOSE ISSUES ARE
DISCUSSED BY THE PROVIDER WORK
GROUP.
AND TO TALK ABOUT SPECIFICALLY
THE VERY FIRST QUESTION YOU ASK
IS HOW MUCH TIME IT TAKES AND
REALLY HOW INVOLVED THAT IS.
THAT REALLY IS ONE OF THE MAIN
REASONS WHY WE'RE LOOKING INTO
THE DEVELOPMENT OF A CODE.
NOT ONLY CAN WE EVALUATE HOW
MUCH TIME IT TAKES BUT
PHYSICIANS CAN ALSO BE
REIMBURSED FOR THAT TIME.
AS IT RELATES TO THE SECOND PART
OF THAT QUESTION, THAT'S
SOMETHING WE'RE DISCUSSING.
MY PARTICULAR WORK WITH VACCINE
MEETS MONTHLY AND MORE
FREQUENTLY WHEN WE NEED TO.
WE WILL CERTAINLY TAKE THAT
UNDER ADVISEMENT AND ARE REALLY
CONSIDERING THAT AS WELL.
CAROLYN, DID YOU WANT TO ADD
ANYTHING ADDITIONAL TO THAT?
I SHOULD ACKNOWLEDGE SUSAN
FARRELL WHO IS THE LEADER OF OUR
WORK GROUP AND DOES A FANTASTIC
JOB, NOT ONLY FOR SUBWORK GROUP
BUT ENGAGED IN THE SUMMIT AS
WELL.
[ INAUDIBLE ]
[ LAUGHTER ]
WE'VE BEEN DISCUSSION
IMMUNIZATION FOR SO MANY YEARS
AND I'VE STRUGGLED FOR SO LONG
DISCOURAGING.
I THINK A COUPLE OF THINGS JUST
TO BUILD ON WHAT THE DOCTOR WAS
SAYING.
ONE, THERE HAS BEEN A LOT OF
WORK DONE LOOKING GRANULARLY
WHAT ITS TO IMMUNIZE
ADULTS.
[ INAUDIBLE ]
SECOND THING WE DID COME TO THE
CONCLUSION I THINK YEARS AGO
THAT REALLY THE ONLY WAY TO PUSH
THIS -- OH, CAN YOU HEAR ME NOW?
OKAY.
NOW?
CAN YOU HEAR ME NOW?
PRETTY CLOSE.
I COULD SWALLOW IT.
OKAY.
I'M SORRY.
SO ON THE SECOND POINT ABOUT
USING TEAMS -- NOW I'M BLOWING
OUT OUR EARS, I THINK THAT IS A
REALLY CRITICAL POINT.
I THINK MANY YEARS AGO WE
ESTABLISHED IN OUR OWN COMMUNITY
THAT USING EXTENDERS OF
PROFESSIONALS WAS REALLY THE
BEST APPROACH.
MOST COST EFFECTIVE AND MOST
EFFICIENT.
AND I THINK, YOU KNOW, ALL OF ,S
CAN BE AUTOMATED TO A LARGE
EXTENT.
WE REALLY WAN TO LOOK FOR
SOLUTIONS THAT MAKE THIS PART OF
THE WAY PROVIDERS DO BUSINESS
AND THEIR OFFICES DO BUSINESS,
THROUGH AUTOMATION, USE OF
EXTENDED TEAM.
STANDING ORDERS, LETS NOT FORGET
STANDING ORDERS.
HELPFUL IN THIS
SETTING.
DR. KIM?
>> THANK YOU.
JUST TO RESPOND A LITTLE BIT TO
WHAT WAS SAID AS WELL.
IN OUR NATIONAL SURVEYS OF
INTERNISTS AND FAMILY MEDICINE
PROVIDERS, ONE OF THE BIGGEST
THINGS IS FIGURE WHAT PEOPLE
NEED AND NOT HAVE THE
INFORMATION TO DO THAT.
I JUST WANT IN A GENERAL WAY
HAVING SPENT MY CLEAR DOING
IMPLEMENTATION OF DELIVERY IN
PEDIATRIC PRACTICE, I THINK WE
CAN L LOT FROM EACH OTHER,
PEDIATRICS LARGELY, DELIVER
IMMUNIZATIONS.
I HOPE WE CAN LEARN LESSONS FROM
ONE ANOTHER.
ONE OF THE BIGGEST PLUGS I WANT
TO PUT IN FOR IS FOR SYSTEMS.
BEHAVIOR CHANGE IS VERY
DIFFICULT, BUT THE LOW HANGING
FRUIT REALLY IS MUCH EASIER AND
THE MAJORITY OF ADULTS AS
PARENTS, CHILDREN, ARE NOT
VACCINE HESITANT OR RESISTANT.
THEY SIMPLY DON'T KNOW THEY NEED
IT AND AREN'T THERE AT THE RIGHT
TIME.
IMMUNIZATION REGISTRIES, WHICH
NOW EXIST IN EVERY STATE CAN S
RECORDS.
IN FACT, MANY STATES DO.
CAN PROVIDE A FORECASTING
FUNCTION AT THE POINT OF CARE,
CAN FORECAST THAT PATIENTS NEED.
CAN AUTOMATICALLY GENERATE
REMINDER RECALLS FOR ENTIRE
POPULATIONS.
AND THE EFFICIENCY THERE IS JUST
HUGE.
I THINK GETTING FROM 20 TO 60
COULD BE PRETTY QUICK, HONESTLY,
IF SYSTEMS LIKE THAT WERE
IMPLEMENTED.
THEN YOU HAVE TO GET INTO THE
COMMUNICATION THAT TAKES A LONG
TIME WITH PATIENTS THAT ARE
HESITANT OR WORRIED.
THE LOW HANGING FRUIT TO ME IS
THE SYSTEMS ISSUE.
I'D LIKE TO JUST PICK UP ON
THAT POINT VERY QUICKLY.
AND FOR AFP AND FOR ACP, I DO
HAVE DR. RILEY AND EVAN IN QUEUE
HERE.
I JUST WENT THROUGH MY
RECERTIFICATION PROCESS THIS
YEAR FOR AFP.
THE MAINTENANCE AND
CERTIFICATION IS KIND OF A DIRTY
WORD I THINK FOR INTERNISTS,
FROM WHAT I UNDERSTAND OF A
PETITION TO GO AROUND, YET IT'S
SOMETHING WE'RE REQUIRED TO DO
EVERY SEVEN TO TEN YEARS.
PART OF THAT IS A QUALITY
IMPROVEMENT PROJECT.
I THINK IF CDC WERE TO PARTNER
WITH THE PROFESSIONAL SOCIETIES
IN TERMS OF CREATING A LOW
HANGING FRUIT EASY TO DO, WHEN I
HAD TO DO MY QUALITY PROJECT, I
PICKED IMMUNIZATION.
WHAT IT DOES IS GETS SOMEBODY IN
THE HABIT OF DOING AN
ASSESSMENT, A REMINDER RECALL.
THOSE ARE THINGS FOR AFP WE HAVE
SOMEWHERE AROUND 9,000 FAMILY
DOCS A YEAR HAVING TO RECERTIFY.
THAT'S ONE OF THOSE
METHODOLOGIES OUT THERE I THINK
WE COULD SLOWLY TURN THE TIDE.
ONCE YOU START LOOKING AT YOUR
OWN DATA AND START REALIZING HOW
YOUR REALITY COMPARES TO YOUR
INTERNAL ESTIMATION, IT CARB
SHOCKING AT TIMES.
LET ME -- MISS HAYES?
THE AMERICAN COLLEGE FUNDED
TO WORK ON COMMUNICATIONS
PROJECT AND WE HAD A LOT OF FUN.
I HAVE TO SAY IT WAS A BLAST.
ONE OF THE THINGS WE DEVELOPED
WAS SUPER WOMEN THATTHE
MOST AMAZING GRAPHICS, THEY
HAVE SHIELDS WITH BACTERIA AND
VIRUSES COMING OUT THEM.THIS WA
WEBSITE, THROUGH CDC.
WE'D LIKE TO THANK YOU SO MUCH.
THE POSTERS ARE GIANT AND
GORGEOUS AND AVAILABLE FOR
SHIPPING COST ONLY.
IF YOU GO TO MID WIFE MRG.ORG
RECOMMENDATIONS, IT'S A LOT OF
BEAUTIFUL STUFF.
>> DOCTOR.
FOR A LONGTIME, KNOWN
GETTING OBSTETRICIAN,
GYNECOLOGISTS ON BOARD WITH
IMMUNIZATIONS, OUR CAMPAIGN HAS
BEEN DIFFICULT AND WE'VE KNOWN
FOR A LONG TIME IT'S THE
BUSINESS ASPECT OF STARTING
IMMUNIZATION PROGRAM WITHIN THE
OFFICE.
SO ACOG DID TEAM UP AS THE
DOCTOR SUGGESTED, WE DID TEAM UP
WITH AP AND THERE'S A WEBINAR
COMING CLOSE TO YOU ON WEDNESDAY
JULY 30th FROM NOON TO 1:00.
IT'S ENTITLED IMMUNIZATION
BUSINESS AND CLINICAL STRATEGIES
FORYN PRACTICES.
SO BASICALLY IT'S OBJECT
DESCRIPTION GYNECOLOGIST LEARN
WHAT PEDIATRICIANS HAVE BEEN
DOING FOR YEARS AND DOING VERY
WELL.
YOU CAN GET MORE INFORMATION
ABOUT IT ON THE ACOG WEBSITE.
ANYBODY IS WELCOME.
>> THE INTENDED AUDIENCE IS
REALLY OB-GYNs BUT IT COULD BE
ANY PRACTITIONER BECAUSE IT'S
STARTING THE IMMUNIZATION
PRACTICE WITHIN YOUR OFFICE.
PASS THE MICROPHONE YOUR
RIGHT.
AMERICAN COLLEGE HEALTH
ASSOCIATION.
WE HAVE ADOPTED THAT IDEA THAT
AN INSTITUTION IS A REALLY GOOD
WAY TO GET COLLEGE STUDENTS UP
TO DATE ON THEIR IMMUNIZATIONS.
THE AMERICAN COLLEGE HEALTH
ASSOCIATION HAS A DOCUMENT THAT
JUST SAYS HERE ARE THE
RECOMMENDED IMMUNIZATIONS FOR
COLLEGE STUDENTS.
WE KEEP IT UP TO DATE BASED ON
THE CHANGES WITH ACIP.
AS A PRACTITION DIRECTOR
OF A HEALTH CENTER, MY CHALLENGE
HAS BEEN NOT THE INTEREST IN OUR
PROVIDERS BUT THE COMPLEXITY --
I THINK THAT'S WHERE A REGISTRY
WOULD BE FABULOUS.
WE HAVE ONE -- IF WE GIVE
IMMUNIZATION OUR ELECTRONIC
RECORD WILL DUMP IT INTO THE
STATE REGISTRY BUT STUDENTS COME
FROM ALL OVER THE COUNTRY AND
FAX US AND SEND US THEIR A
MILLION DIFFERENT APPEARANCE
DOCUMENTATION RECORDS AND WE
HAVE ONLY A FEW THAT WERE
ACTUALLY REQUIRED.
SO WE PAY ATTENTION TO THOSE.
THEN WHEN A STUDENT COMES TO US
FOR A VISIT AND WE'RE TRYING TO
INCREASE THE FAMILIARITY OF THE
NURSES AND PROVIDERS TO SAY THIS
IS A CHANCE, HAVE YOU HAD HAD
YOUR TDEPP, KNOW THE
ONES WITH THEIR -- LOW HANGING
FRUIT.
I THINK, AGAIN, IT'S PROBABLY
THE DOCUMENTATION COMPONENT AND
REGISTRY WOULD BE HELPFUL AN
JUST THE STUDENTS THEMSELVES DO
OF PAPERHOPEFULLY SENT US.UNT
WE DO HAVE A WAY TO GO.
OUR PROVIDERS ARE INTERESTED IN
MOVING IT FORWARD.
DR.
>> ONE QUESTION TO DR.
WILLIAMS WAS WHETHER THERE WAS
ANY ANALYSIS BY INCOME LEVEL.
IT SEEMS TO ME IF THERE ARESPAR
MAY BE LINKED TO DISPARITIES BY
INCOME.
I THINK THE ISSUE OF PRACTICES
THAT SERVE LOW IN COME
POPULATIONS IS ANOTHER CHALLENGE
FOR WHAT TAMARA IS WORKING ON IN
TERMS OF THE BUSINESS MODEL.
PEDIATRICIANS WILL TELL YOU
SETTING UP TO DO IMMUNIZATIONS
IS INCREDIBLY EXPENSIVE IN TERMS
OF THE EQUIPMENT, THE TYPE OF
HAVE IN
ORDER TO MANAGE IMMUNIZATIONS.
SO 2.1, DO WE KNOW ANYTHING
ABOUT THE IN COME DIFFERENTIAL,
TWO, FOR TAMARA, WHETHER THE
PROVIDER GROUP IS LOOKING AT
PRACTICES THAT MAY NEED SOME
INCENTIVES IN ORDER TO BE ABLE
TO SET UP FOR IMMUNIZATION.
>> THANK YOU VERY MUCH FOR YOUR
QUESTION.
FOR THIS PARTICULAR REPORT, WE
BASICALLY LOOKED AT THOSE
COVARIANCO-VA
CO-VARIA
CO-VARIANTS, AGE, HIGH-RISK
STATUS CRITERIA.
WE HAVE DONE SPECIFIC ANALYSIS
ON INDIVIDUAL VACCINES WHERE WE
LOOKED AT OTHER DEMOGRAPHIC AND
ACCESSED CARE CHARACTERISTIC
LIKE EDUCATION, WHETHER OR NOT A
PERSON HAD A REGULAR DOCTOR,
WHETHER OR NOT THEY HAD HEALTH
INSURANCE, TYPES OF INSURANCE.
WHERE THOSE TYPES OF ANALYSIS
HAVE BEEN DONE, CONSISTENTLY WE
SEE A RISK FOR LOWER VACCINATION
AMONG THOSE WHO HAVE LOWER
VACCINATION, WHO DON'T HAVE A
REGULAR DOCTOR, WHO DON'T HAVEI
MONEY, SO YOUR IS WELL
TAKEN.
>> I THINK THAT THE QUESTION
THAT YOU ASKED IN REGARDS TO THE
PROVIDERS AND WHAT WE'RE LOOKING
AT, PROVIDER WORK GROUP, I THINK
THE QUESTION IS REALLY
INTERESTING FOR A NUMBER OF
REASONS.
WE'VE TALKED ABOUT IMMUNIZATION
REGISTRIES.
IN FACT, WE KNOW FROM THE SLIDE
I PRESENTED TO YOU EARLIER THAT
ADULTS COMPLETELY UNDERUTILIZE
UTILIZATION REGISTRY.
YOUR QUESTION TO THE LARGER
ISSUE, WE ASSUME EVERYONE HAS AN
ELECTRONIC HEALTH RECORD.
SO WHEN YOU LOOK AT THE
DIVERSITY OF PROVIDERS AND WHO
THEY SERVE AND EVEN JUST THE
RESOURCES PEOPLE HAVE WITHIN
THEIR OFFICES, THERE'S A WIDE
RAN
RANGE.
SO TO MEET THAT NEED, ONE THING
IMPORTANT IS WE HAVE A DIVERSITY
OF PROVIDERS AS MEMBERS OF THOSE
WORK GROUPS TO HELP US FIGURE
OUT WHAT ARE THE NEEDS THAT YOU
PARTICULARLY HAVE.
I ALSO APPRECIATE THE
CONVERSATION ABOUT TEAMS BECAUSE
REALLY THAT'S HOW VACCINE NATION
PROGRAMS CAN BE DONE MOST
EFFICIENTLY AND SUCCESSFULLY IN
OFFICE.
WE DON'T MEAN TO IMPLY AT ALL
THE WORK IS EASY BUT GETTING A
DIVERSITY OF OPINIONS, DIVERSITY
OF PRACTICES WHO HAVE A WIDE
VARIETY OF RESOURCES, VERY
IMPORTANT TO COMBAT THIS ISSUE.
IMMUNIZATION REGISTRIES ARE
REALLY, REALLY IMPORTANT AND SO
ARE THING LIKE ELECTRONIC HEALTH
RECORDS AND ACCESSING THEM,
THEIR PRACTICES WITHOUT INTERNET
ACCESS.
THE GENTLEMAN AT THE
MICROPHONE.
I'M FROM MERCK VACCINES.
THANK YOU VERY MUCH FOR A
THOUGHT PROVOKING PRESENTATION.
ONE KIND OF DATA I DIDN'T SEE IN
YOUR PRESENTATION, HOWEVER, WERE
DATA ABOUT THE RATES OF
IMMUNIZATION AMONG HEALTH CARE
PROVIDERS.
I WONDER IF IT'S REALLY
REALISTIC TO EXPECT THAT
PROVIDERS ARE GOING TO CARRY THE
MESSAGES WE WANT THEM TO CARRY
IF THEY ARE NOT GETTING
VACCINATED THEMSELVES.
WE KNOW EVEN IN THE SETTING OF
H1N1 PANDEMIC IT WAS REALLY A
CHALLENGE.
SO I WONDERED IF ANY OF YOU HAD
ANY THOUGHTS ABOUT THAT AND WHAT
KIND OF ACTIVITIES WE MIGHT
ENGAGE IN IN THAT AREA TO
IMPROVE ADULT IMMUNIZATION
RATES.
>> THERE WERE AT LEAST TWO DATA
POINTS PROVIDED FOR HEALTH CARE
PERSONNEL IN THE PRESENTATION ON
COVERAGE.
ONE FOR TDEPP, ONE FOR HEPATITIS
IN THAT SUMMARY.
YOU'RE CORRECT OUR EXPERIENCE
HAS BEEN WHEN HEALTH CARE
PROFESSIONALS SERVE AS MODELS AS
WELL AS OFFERING STRONG
RECOMMENDATIONS IN THEIR
PRACTICES FOR CLIENTS,
VACCINATION LEVELS IN THOSE
TYPES OF PRACTICES ARE MUCH
HIGHER THAN WHEN THAT
CIRCUMSTANCE IS NOT THE CASE.
>> AMERICAN COLLEGE OF
PHYSICIANS.
I CAN'T LET THE FAMILY MEDICINES
ONE UP US.
THE INTERNISTS DO HAVE A QI
PROJECT YOU CANNOT GET MOC
CREDIT FOR.
AMERICAN COLLEGE OF PHYSICIANS
HAS AFFIRM CP CONNECT.
WHAT WE'RE TRYING TO DO IS FIND
JOY AND QUALITY IMPROVEMENT SO
WE CAN SHARE IN THE JOY OF
KNOWING OUR PATIENTS ARE
VACCINATED.
>> THANK YOU FOR THAT UPDATE.
COMING BACK TO THE MICROPHONE.
>> BOB HOPKINS FROM EMERGENT
BIOSOLUTIONS.
I'M NOT SURE IF THIS IS A
COMMENT OR QUESTION.
I'VE ALWAYS WONDER IF IT'S
POSSIBLE TO IMPLEMENT SOMETHING
LIKE A PERSONAL VACCINE RECORD
RATHER THAN AN ELECTRONIC
MEDICAL RECORD BUT PERSONAL
MEDICAL RECORD, SOMETHING THAT
WOULD JUST BE VERY SPECIFIC TOO
VACCINES SO YOU SORT OF EMPOWER
THE PATIENT.
MAYBE GIVE IT TO THE
OBSTETRICIAN TO START FROM BIRTH
AND GO ALL THE WAY THROUGH.
MOST PEOPLE CAN PUT IN YOUR
CONTACT LIST.
SO THE QUESTION IS CAN PEOPLE
ENTER THEMSELVES VACCINES AND
WOULD THEY GET REMINDED, SENT
REMINDER, SO SORT OF SKIRT THE
HEALTH CARE PROFESSIONAL ALL
TOGETHER AND GO RIGHT TO THE MOM
AND THEN DHAER FORWARD TO
TEENAGER, COLLEGE, AND FURTHER.
>> IT'S A VERY PROVOCATIVE
COMMENT OR QUESTION.
IN FACT, I SEE THIS MORE IN
PEDIATRICS THAN IN ADULTS.
BUT YOU KNOW, THIS HAPPENS QUITE
FREQUENTLY IN NONINDUSTRIALIZED
COUNTRIES.
I HAPPEN TO DO A LOT OF MISSION
WORK.
ONE OF THE THINGS THAT'S REALLY
INTERESTING TO ME, OFTENTIMES
THERE ISN'T AN ELECTRONIC HEALTH
RECORD, THERE ISN'T AN
IMMUNIZATION REGISTRY.
BUT SOMEHOW BUILT INTO SOME OF
THE CULTURES AND COUNTRIES WHERE
I WORK THAT ARE
NONINDUSTRIALIZED THEY CARRY
AROUND A HEALTH RECORD WITH THEM
IN THE WAY WE CARRY AROUND A
PURSE, OR THE WAY WE MIGHT CARRY
OUR WALLET.
AND IT'S ENTERED INTO THAT
PARTICULAR HEALTH RECORD
WHENEVER THEY SEE A HEALTH CARE
PROVIDER.
SO I COULD BE IN SOME OF THE LOW
WEALTH COMMUNITIES THAT ACTUALLY
HAVE HIGH IMMUNIZATION
POPULATION BASE DATA FOR THEIR
POPULATIONS BUT YET DON'T HAVE
THE ADVANTAGES WE HAVE.
I DO BELIEVE THERE'S THE
OPPORTUNITY TO EMPOWER FAMILY,
EMPOWER PATIENTS, EMPOWER ADULTS
TO KEEP THEIR OWN RECORDS.
WE DID THIS A LOT IN PEDIATRICS
CERTAINLY MANY YEARS AGO WHERE
EVERYONE HAD YOUR AAP GUIDE
WHERE YOU STAMPED IN WHAT THEIR
RECORDS ARE.
I THINK THAT'S A GREAT
ALTERNATIVE IN ADDITION TO
TRYING TO DO SOME OF THE
AUTOMATION WE'RE TALKING ABOUT.
WE DO HAVE A PUBLIC COMMENT
HERE BY A DR. WILLIAM SCHAFFNER.
I BELIEVE THAT MIGHT BE YOU UP
AT THE MICROPHONE.
I WAS JUST GOING TO MAKE A
COMMENT ON THE APP BUT I HATE TO
CUT OFF THE DOCTOR.
I THINK THE COMMENT ABOUT AN APP
IS ALSO REALLY WORTH THINKING
ABOUT.
LIKE TEXTS FOR BABIES, HARD
PRESSED TO GET ADULTS TO
DOWNLOAD AN APP ONLY ABOUT
IMMUNIZATION, BUT SORT OF
WRAPPED UP IN THE DIFFERENT
THINGS THEY NEED AT THE
DIFFERENT STAGES OF THEIR LIFE
AND IMMUNIZATION WAS A PART OF
THAT, I THINK THAT WOULD BE MUCH
MORE LIKELY TO BE SOMETHING
FOLKS WOULD PUT ON THEIR iPADs
OR iPHONES.
I APPRECIATE THE COMMENT.
>> THIS IS BILL SCHAFFNER, I'M
STANDING ON BEHALF OF MY FRIENDS
AT THE GERONTOLOGY SOCIETY OF
AMERICA.
PLEASED TO PRESENT THIS ON
BEHALF OF NATIONAL ADULT VACCINE
PROGRAM, MULTI-STAKEHOLDER
INDUSTRY COLLABORATION
TO IMPROVE ADULT VACCINATIONS
ALIGNED WITH RECOMMENDATIONS OF
CDC ADVISORY COMMITTEE ON
IMMUNIZATION PRACTICES.
MEMBERS INCLUDE RESEARCHERS,
PRACTITIONERS, EDUCATORS,
ECONOMISTS, HEALTH POLICY
EXPERTS AND OTHERS INTERESTED IN
EXPANDING SCIENTIFIC KNOWLEDGE
ACROSS THE LIFE SPAN, MAKING IT
A NATURAL HOME FOR NAVP,
NATIONAL ADULT VACCINATION
PROGRAM PROMOTES IMMUNIZATIONS
CONTINUE TO BE ONE OF THE
GREATEST PUBLIC HEALTH SUCCESS
STORIES.
ADDITIONALLY NAVP, ALONG WITH
THIS COMMITTEE, CLEARLY
RECOGNIZES VACCINE PREVENT I
BELIEVE DISEASES
DISPROPORTIONATELY AFFECT OLDER
ADULTS.
WITH THIS IN MIND ON BEHALF OF
GA'S NAVP, WE LOOK FORWARD TO
JOINING WITH ACIP AS YOU
CONTINUE TO CONSIDER THE NEED
FOR STRONG VACCINE
RECOMMENDATIONS THAT INCLUDE
UNIQUE CHALLENGES OF OLDER
ADULTS AND THE NEED TO PROTECT
THEM FROM PREVENTIBLE DISEASES
THROUGH VACCINES.
THANKS.
THANK YOU FOR THE COMMENT.
TURN IT OVER TO DR. GELLER.
GOING TO STEAL A MINUTE OUT
OF THE UPDATE FOR TOMORROW
BECAUSE OF THIS TOPIC.
AS MENTIONED, HE MADE ADULT
IMMUNIZATIONS A PRIORITY FOR
HIM.
HE ASKED FOR DEVELOPMENT OF
ADULT STRATEGIC PLAN, WHICH IS
IN DEVELOPMENT.
YOU'LL SEE THAT WHEN IT COMES.
I WANTED YOU TO KNOW THAT WAS
COMING.
ORKING WITH NATIONAL
QUALITY FORUM TO DEVELOP
PERFORMANCE MEASURES.
THOSE ARE OUT IN DRAFTS.
TAKE A LOOK AT THOSE AND COMMENT
BECAUSE THIS IS THE TIME TO DO
THAT.
THERE'S A WEBINAR SCHEDULED FOR
NEXT WEEK AS WELL, ALL RELATED
TO IMPROVING SYSTEMS FOR ADULT
IMMUNIZATIONS.
THANKS.
THANK YOU VERY MUCH.
IS THERE FURTHER COMMENT,
QUESTION?
OKAY.
THANKS TO THE ADULT IMMUNIZATION
GROUP FOR THE PRESENTATION, AND
I THINK WE STAND CLOSED FOR THE
DAY.
THANK YOU SO MUCH.