>> WHEN THE WORKING GROUP BEGAN
THE DISCUSSIONS, THEY DECIDED TO
FOCUS ON PREGNANT WOMEN BEFORE
THE GENERAL POPULATION.
BEFORE I PRESENT THE DATA,LY
BEGIN WITH THIS.
RECENTLY, THE WORKING GROUP
HEARD ABOUT A CASE OF FATAL
PERTUSSIS IN AN INFANT WORN TO A
MOTHER VACCINATED WITH TDAP.
HE DEVELOPED ILLNESS AT 8 DAYS
OLD AND HOSPITALIZED AT 32 DAYS.
HE WAS POSITIVE FOR PERTUSSIS.
HE WAS PLACED ON MECHANICAL --
>> THE INFANTS MOTHER HAD A CUFF
ILLNESS STARTING RUN WEEK PRIOR
TO DELIVERY.
NO MEDICAL ATTENTION WAS SOUGHT.
SHE RECEIVED TDAP MOST PARTUM
TWO YEARS PRIOR.
SHE HAD THREE OTHER CHILDREN.
OF THE TWO THAT WERE ILL, ONE
WAS ON SENT TWO WEEKING BEFORE
THE INFANTS BIRTH.
ALL WERE TREATED AFTER THE
INFANT DIED.AS O THEY
RIGHT, BUT THE
MOTHETDAP YEARSS NOT
AS W GIVE OF THE SESSION, COVER
ADOLESCENTS HAVE
RE DATA
ON T PERSISTENCE OF MATERNAL AN.
THEY WANT TO PREVENT INFANT
MORTALITY IN LIGHT OF THE
INCREASE IN CASES.
A REMINDER THAT TDAP IS APPROVED
FOR SINGLE USE ONLY, AND IT IS
RECOMMENDED AS A SINGLE
LIFE-TIME DOSE.
AS BECAUSE OF THIS, THE CURRENT
ACIP RECOMMENDATION IS ONLY FOR
WOMEN NOT PREVIOUSLY IMMUNIZED
WITH TDAP.
WHEN CONSIDERING IT FOR EVERY
PREGNANCY, THE WORKING GREW
REVIEWED VACCINATING PREGNANT
WOMEN.
SAFETY ON MULTIPLE DOSES ON
TDAP, AND THE ASSISTANCE ON
BIRTH.
THERE ARE NUMEROUS BENTS TO
VACCINATING PREGNANT ONE.
ONE IS TO VACCINATE IF THE
PATIENT'S HISTORY IS
UNDOCUMENTED OR UNKNOWN.
BECAUSE THIS RECOMMENDATION IS
ONLY A YEAR OL, MANY PROGRAMS
ARE STILL FOE DOES-- FOCUSED ON
POSTPARTUM TDAP.
THERE ARE SEVERAL INITIATIVES
AIMED AT IMPROVING VACCINATION
OF PREGNANT WOMEN THAT WILL BE
MENTIONED LATER.
AS THE FLU VACCINE HAS TAUGHT S
US -- AGAIN, TO DRAW UPON THE
EXPERIENCE FROM FLU, IT HAS
TAKEN TIME FOR COVERAGE OF FLU
VACCINE IN PREGNANT WOMEN TO
INCREASE.
WE'RE HOPING THAT BY CONTINUING
TO REMOVE BARRIERS, COVERAGE OF
TDAP WILL IMPROVE AS IT HAS WITH
FLU VACCINE.
>> FROM THE PREFS PRESENTATION.
THIS ARE THE CURVES IN HEALTH
ADULTS.
ANTIBODY LEVELS PEAKED AFTER THE
FIRST DOSE.
THE WORKING GROUP ASKED WOULD A
CURRENTLY PREGNANT WOMAN PROVIDE
HIGH ENOUGH CONCENTRATIONS OF
MATERNAL PERTUSSIS ANTIBODIES TO
HER FETUS IS PREVIOUSLY
VACCINATED.
WE LOOKED AT THE LEVEL OF
ANTIBODIES AFTERTDAP.
>> IN THE MEANTIME, THE TDAP
VACCINATIONS WAS 13.7 MONTHS.
19 WOMEN WERE IMMUNIZED DURING
PREGNANCY.
THEY WERE AT SIX WEEKS GESTATION
BEFORE THEY KNEW THEY WERE
PREGNANT.
THEY WERE ISSUED AND COURT AND
MATERNAL RATIOS WERE CALCULATED.
IT WAS STILTED USING THE
ACCEPTED HALF-LIFE OF 36 DAYS.
BASED ON THE PTIGG-GMC STUMTED
DECAY OF AGE, WITHIN TWO MONTHS,
IT DECLINED.
RESULTS FROM THE STUDY VERIFY
THE TRANSPORT OF ANTIBODIES, BUT
THERE WAS A DIFFERENT BETWEEN
THOSE VACCINATED PREPREGNANCY,
AND BOTH WERE LOW.
AT THE TIME, THE ESTIMATES
CONCENTRATION FELL TO LEVELS
LIKELY TOO LOW TO ENSURE
PROTECTION FOR INFANTS.
THE WORKING GROUP CONCLUDED THAT
A SINGLE DOSE OF TDAP AT ONE IS
IF PREGNANT WOMEN WERE
RECOMMENDED A OF TDAP --
RECOMMENDATION WAS
THAT TDAP SAFE IN
PREGNANCY, AND SOIONAL
DATA WAS REVIEWED ON MULTIPLE
DOSES.
THE WORKING GROUP LOOKS AT THE
RISK OF ADVERSE EFFECTS.
THIS STUDY ON HEALTHY,
NONPREGNANTADOLESCENTS, SHOWS
THE DIFFERENCE IN TWO YEARS.
THESE ARE THE REPORTED EFFECTS.
THE X AXIS IS THE YEARS.
AS THE INTERVAL BECAME SHORTER,
ADVERSE EFFECTS DID NOT
INCREASE.
THERE WAS NO DIFFERENCE FROM
TO TEN YEAR INTERVALS.
SEVERE EVENTS WERE NOT OBSERVED
IN THE STUDY.
FOR HEALTHY NONPREGNANT ADULTS
THAT RECEIVED IT TWO YEARS AFTER
TD, THE MOST COMMONLY REPORTED
EVENTS WERE PAIN, REDNESS, AND
SWELLING.
SERIES ADVERSE EFFECTS WERE NOT
ED OR REPORTED.
IT ALSO REVIEWED PUBLILISHED DA
FIVE OR TEN YEARS AFTER A
PREVIOUS TDAP
TDAP WAS WELL
TOLERATED WIN JEX SITE PAIN
THE MOSTREPORTED AS
VERSE EVENT.
FOR THE SECOND
SIMILAR TO THE FIRST DOSE IN THE
STUDY GROUP.
OF THE FEW SERIES ADVERSE EVENTS
REPORTED, NONE HER ATTRIBUTED TO
RECEIPT OF VACCINE.
THE PRIMARY CONCERN WAS THE
POTENTIAL FOR SEVERE ADVERSE
EFFECTS.
FOR PREGNANT WOMEN WHO HAVE
MULTIPLE PREGNANCYS IN A SHORD
PERIOD OF TIME.
BOTH REACTIONS HAVE BEEN RELATED
TO THE VACCINES.
A REVIEW OF HISTORICAL DATA ON
MULTIPLE DOSES OF TETANUS AND
VACCINES TELLS US THAT IT'S A
HIGH ER LEVEL OF ANTIBODIES.
ONE STUDY SHOWED THAT POSTSECOND
TDAP GNC'S DID NOT CHANGE.
>> IT IS UNLIKELY EVEN IN A
SMALL NUMBER OF WOMEN WHO MIGHT
WE RECEIVE SMALLER DOSES.
FOR PREGNANT WOMEN, WHS TWO OR
MORE DOSES TO COMPLETE THE
PRIMARY SERIES.
DATA ON THE NUMBER OF DOSES
ADMINISTERED AND ADVERSE EFFECTS
ARE NOT COLLECTING.
MAW THEY HAVE BEEN REPORTED
SEVERE EVENTS, AND SYSTEMIC
EVENTS LIKE FEVER, BODY ACHE, OR
LETHARGY.
THERE HAS BEEN CHANGING TO
TOXOID AMOUNTS.
NO DATA DAUGHTER AND SONNED WHAT
WE REALLY WANT, TDAP IN MULTIPLE
PREGNANCIES.
MUCH OF THE DATA IS HISTORICAL
SUGGESTING WE WE KUS THE RISK
WITH CURRENT FORMULATIONS.
THE WORKING GROUP THOUGHT THAT
THE CURRENT DATA SUGGEST NO
EXCESS RISK OF ADVERSE EVENTS,
BUT THE WORKING GROUP HAS A KNEE
FOR SAFE TIFF STUDIES.
THE WORKING GROUP WUSHED FOR
MORE DATA ON THE CONCERNS FOR
SEVERE ADVERSE EFFECTS.
THIS WAS NOT TRON DETER THE
WORKING GROUP TO MAKINGRECOMMENY
PREGNANCY OR TO LIMIT THE NUMBER
OF DOSES.
>> IN THE UNITED STATES, MORE
THAN 4 MILLION BUIRTHS OCCUR INA
YEAR.
ON AVERAGE, TWO CHILDREN ARE
BORN PER WOMAN.
THIS AND THAT MOST WOMEN
WOULD BE PREGNANT TWO TIMES AND
RECEIVE TWO DOSES OF TDAP.
THIS SHOWS THE NUMBER OF BIRTHS
FROM FIRST TO SECOND --
PREGNANCY IS RESULTS IN MULTIPLE
BIRCHTS.
AMONG WOMEN WITH TWO BIRTHS,
ONLY 2 357B9% FROM TWO MONTHS OR
LESS BETWEEN BIRTHS.
THE MAJORITY OF WOMEN HAVE AN
INTERVAL OF 13 MONTHS OR MORE
BETWEEN BIRTH.
FOR WOMEN OF LOWER SOESH YOU
KMUK STATUS, THE TIME BETWEEN
PREGNANCIES ISGENERALLY 18
MONTHS OR LONGER.SO HOW MA HAVEN
THE AVERAGE NUMBER OF
THESE DATA SUGGUND
5% OF WOMEN HAVE FOUR OR MORE
BABIES.
A SMALL PROPORTION OF WOMEN
WOULD RECEIVE MORE THAN TWO OR
THREE DOSES OF TDAP.
THE WORKING GROUP CONCLUDED THAT
THE INTERVAL BETWEEN SUBSEQUENT
PREGNANCIES IS LIKELY GREATER
THAN THE MATERNAL AINGS PRESEN
LANGUAGE, THE WORKING GROUP
CONCLUDED THE FOLLOWING --
ALTHOUGH SAFETY DATA ARE LIMITED
ON MULTIPLE DOSES OF TDAP,
AVAILABLE DATA FOR THE VACCINE
SUGGEST NO ACCESS OF RISK OF
ADVERSE EFFECTS, AND THE WORKING
GROUP REASSURED THAT A SMALL
PROPORTION OF WOMEN WOULD BE
RECOMMEND LD FOUR OR MORE DOSES
OF TDAP.
THEY REPORTED ON GOING SAFETY,
AND THEY ADDRESSED CONCERNS
ABOUT THE POTENTIAL INCREASE IN
SEVERE ADVERSE EFFECTS DURING
SUBSEQUENT PREGNANCIES.
THE FOLLOWING ARE PLANS FOR SAFE
TIFF MO
SAFETY MONITORING.
THE REPORTING SYSTEM WILL
IMPLEMENT ENHANCED MONITORING
FOR PREGNANT WOMEN.
AND THE DATA LINKS WILL BE
IMPLEMENTING STUDIES ASSESSING
ACUTE ADVERSE EFFECTS AFFECTING
THE MOTHER, AND BIRTH OUTCOMING
FOLLOWING RECEIPT OF TDAP AND
OTHER VACCINES DURING PREGNANCY.
THE STUDY DEPENDS ON UPTALK AND
MAY TAKE A FEW YEARS.
THE WORKING GROUP ALSO CONCLUDED
THAT A SINGLE DOSE OF TDAP AT
ONE PREGNANCY WAS INSUFFICIENT
FOR SUBSEQUENT PREGNANCIES, AND
THAT THE BENEFITS OF VACCINATION
OUTWEIGH THE RISKS OF MULTIPLE
DOSES OF TDAP.
WITH THE UP TAKE IN PREGNANT
WOMEN, THEIR WORKING TO CONTINUE
THE VACCINE UP TAKE AND PREVENT
INFANT PERTUSSIS MORBIDITY AND
MORTALITY.
A MORE UNIVERSAL RECOMMENDATION
FOR PREGNANT WOMEN WOULD REMOVE
REAL OR PRESERVED BARRIERS TO
VACCINATIO
VACCINATIONS.
THE NATIONAL FOUNDATION
COMMITTEE ARE WORKING TO REMOVE
BARRIERS TO MATERNAL
IMMUNIZATION.
THEY'RE COLLABORATING WITH OTHER
PROFESSION
PROFESSIONALS TO CONTINUE THIS
RECOMMENDATION AND EFFORT TO
MONITOR THE COVERAGE IN PREGNANT
WOMEN, AND THROUGH THE CBC
INTERNET PANEL SURVEY OF
PREGNANT WOMEN.
CHANGES TO THE 2011
RECOMMENDATION REFLECT THE DATA
AND EXPERT OPINION.
THEY INCLUDE A DOSE OF TDAP
IRRESPECTIVE OF PREVIOUS TDAP
HISTORY.
TDAP FOR EVERY PREGNANCY, AND
SIMPLE RECOMMENDATION BY MOVING
A RECOMMENDATION ON DOSE TO THE
GUIDANCE SECTION.
WE'LL DISCUSS IT IN THE GUIDANCE
SECTION OF THE UPDATED PERTUSSIS
VACCINE STATEMENT.
THE PROPOSED STATEMENT ON USE OF
TDAP READ THAT PROVIDERS PROVIDE
AN IMMUNIZATION PROGRAM FOR ALL
WOMEN.
HEALTH CARE PERSONNEL SHOULD
ADMINISTER A DOSE OF TDAP EVERY
PREGNANCY REGARDLESS OF THEIR
PRIOR RECEIVING OF TDAP.
IF NOT ADMINISTERS DURING THE
PREGNANCY, IT SHOULD BE GIVEN
IMMEDIATELY POST PARTUM.
AS MENTIONED IN THE STATEMENT,
WE WILL HAVE AN EXPANDED SECTION
OF GUIDANCE FOR USE, AND
LANGUAONGSTANDINANGUAGE FOR ULTD
ADMINISTRATION.
FOR ACIP'S RECOMMENDATION, THE
RECOMMENDATION FOR TODAY'S VOTE
IS THAT PROVIDERS OF PREIN AAL
CARE IMPLEMENT A TDAP
IMMUNIZATION PROGRAM FOR ALL
PREGNANT WOMEN.
HEALTH CARE PERSONNEL SHOULD
ADMINISTER TDAP IN EACH
PREGNANCY IRRESPECTIVE OF A
PRIOR HISTONOT, IT SHOULD BE
ADMINISTERED IMMEDIATELY POST
PARTUM.
>>> THANK YOU VERY MUCH FOR AN
INFORMATIVE DISCUSSION.
WE OPEN IT UP TO DR. QUINN
BEASLY.
CERTAINLY DATA LOOKS COMPELLING.
MY REQUEST IS REGARDING MY OWN
UNDERSTANDING OF WHAT WAS PUT IN
THE FDA APPROVAL FOR ONE DOSE.
DO WE FEEL THERE MAY BE BASED ON
THE DATA CHANGE IN THE FDA
APPROVAL.
SOME PRACTITIONERS LIKE TO
FOLLOW WHAT THE FDA APPROVES.
DO WE FIND THERE BE ANY
R
RECOMMENDATION AND THE FDA
APPROVAL?
>>.
>> JUST BY WAY OF BACKGROUND,
THE WAY THAT LABELS ARE
CHALLENGED THROUGH ADMISSION OF
DATA FROM THE MANUFACTURERS.
SO IT WOULD BE ABOUT TO PROVIDE
SAFETY AND EFFECTIVENESS IN THE
STATE BEFORE PREGNANCY.
THAT WOULD BE THE ONLY DAY THAT
WE COULD MAKE THAT LABEL CHANGE.
I KNOW THIS ISSUE COMES UP QUITE
OFTEN, BUT I THINK BOTTOM LINE,
WE WOULD HAVE TO REVIEW THAT
DATA IN ORDER FOR IT TO BE IN
THE LABEL.
>> THANK YOU.
>> DR. ROSENBAUM.
>> JUST A FOLLOW UP QUESTION
BECAUSE THAT WAS VERY MUCH ON MY
MIND.
DOES THIS MEAN THAT WE'RE MAKING
AN OFF-LABEL USE RECOMMENDATION?
AND IF TO, WHAT WE NEED TO
UNDERSTAND IS HOW THE COVERAGE
OF IMMUNIZATIONS UNDER MEDICARE,
MEDICARE, AND INDIVIDUAL PLANS
ARE A RESULT OF THE AFFORDABLE
CARE ABOUT WILL BE EFFECTED.
SO I'M WONDERING IF ANY OF THE
PUBLIC OR PRIVATE INSURERS IN
THE ROOM CAN COMMENT ON WHAT
HAPPENS WHEN WE MAKE A
RECOMMENDATION FOR WHAT IS
BASICALLY AN OFF-LABEL USE, AND
HOW QUICKLY THE PROBLEM CAN BE
RECTIFIED.
>> AND MR. -- IS IT?
>> NO, I'M COVERING FOR HIM.
>> OKAY, THANK YOU.
>> MOST SPURNS PLANS --
INSURANCE PLANS FOLLOW ACIP
RECOMMENDATIONS EVEN WHEN THOSE
RECOMMENDATIONS ARE FOR AN OFF
LABEL USE.
AND WE DO HAVE PRECEDENT FOR
THAT IN THE PAST.
>> SO WE CAN ASSUME -- I THINK
IT'S SOMETHING THAT WE WOULD
WANT TO HAVE DOUBLE-CHECKED.
WE CAN ASSUME, AGAIN UNDER
EXISTING MEDICARE AND MEDICAID
THAT CMS IS CONFIDENT WITH
INSTRUCTIONS TO MEDICAID
PROGRAMS, THAT THE PLANS COVERED
BY THE ACIP RECOMMENDATION
PROVISIONS OF THE ACT ARE ALL
COVERED.
I JUST THINK WE WANT TO KNOW
THAT AND BE AWARE AND CONSULT
WITH THEM BACK ON IT.
>> I'M NOT SURE HOUR MEDICARE
AND MEDICAID --
>> RIGHT, BUT EACH FORM OF
COVERAGE SHOULD BE CHECKED.
>> YES, FOR MEDICAID, YOU FOLLOW
THE RECOMMENDATIONS.
MEDICARE DOES NOT FOLLOW THE
RECOMMENDATIONS.
SO IT'S SLIGHTLY DIFFERENT.
SO UNDER THE AFFORDABLE CARE
ABOUT.
IT FOLLOWS ACIP RECOMMENDATION.
>> THANK YOU, I THINK DR. KITEL
NEXT AND THEN DR. REUBEN.
>> I WOULD LIKE TO MAKE A
COMMENT, AND THEN ASK A COUPLE
OF QUESTIONS.
THE COMMENT IS THAT DURING THE
DEVELOPMENT OF THE A-CELLAR
VACCINES, SOME DISCUSSION WAS
UNDER TAKEN TO DETERMINE WHETHER
A A-CELLAR VACCINE MAY BE OF
SOME VALUE, AND IF IT -- IT
WOULD ALLEGATION THE HOPES THAT
THE DURATION OF PROTECTION WITH
THE A-CELLAR VACCINE WOULD BE
LONGER THAN WE ARE OBSERVING
NOW.
.
THE DISCUSSION IS TO CONSIDER
DEVELOPING STAND ALONE A-CELLAR
PRODUCT TOGS BE USED FOR THIS
CIRCUMSTANCE, AS WELL AS FOR
CONTROL WHERE THE POPULATIONS
ARE LARGELY VACCINATED.
SO THE QUESTIONS ARE HOW MANY --
DO YOU A ESTIMATE OF THE NUMBER
OF HOSPITALIZATIONS THAT WE'RE
LOOKING AT.
IT'S NOT AS LARGE, BUT THE
BURDEN OF ILL NANESS THAT WE'RE
WITNESSES.
AND DO YOU KNOW HOW MANY
PREGNANCIES ARE MONITORED OVER
THE COURSE OF EACH YEAR?
AND THEN BASICALLY, I HAD THE
SAME QUESTION FOR DR. SALSBURY.
TRYING TO GET THE POINT OF HOW
LONG IS IT GOING TO TAKE TO GET
SAFETY SAFELY DATABASE.
AND THEN FINALLY, THE APPROACH
IS TO RECOMMEND IT IN A RATHER
MORE NARROW TIME DURING THE
PREGNANCY WHERE AS WE ARE
RECOMMENDING ANY TIME IN
PREGNANCY -- NO? CLARIFIED THE
RECOMMENDATION ITSELF, BUT THE
GIENTS OF USE WOULD BE A THIRD
OR LATE SECOND TERM.
WE MODIFY IT TO 27 TO 36 WEEKS
BEING OPTIMAL, AND WHY.
>> THERE WERE A NUMBER OF
QUESTIONS THERE I THINK BOTH FOR
DR. LIANG AND DR. SALSBURY.
>> WITH REGARDS TO THE
PREVENTION AND HOSPITALIZATION,
I DON'T KNOW A SPECIFIC NUMBER,
BUT I REFER US BACK TO THE
DECISION ANALYSIS IN TERMS OF
COMPARING THE HOSPITALIZATIONS,
OR THE REDUCTION COMPARED TO THE
BASE CASE.
IN THAT DECISION ANALYSIS, THE
REDUCTION WOULD BE ABOUT 38%,
AND THAT IS IN THAT FIRST
COHORT, BUT I DON'T HAVE AN
EXACT NUMBER OF WHAT THAT WOULD
BE.
>> CAN YOU DO BACK OF THE
OF DISEASE IS X PER WORDS, WITH
1,000, AND INFANTS OF THAT AGE,
AND HOW MANY OF THOSE WOULD BE
HOSPITALIZED, AND YOU WOULD HAVE
A 38% REDUCTION -- WE COULD
PROBABLY GET A ROUGH GUEST OR
ESTIMATE.
>> HUNDREDS OF HOSPITALIZATIONS,
AND THE MAJORITY OF CASES ARE
ABOUT 50 TO 60%, AND THERE'S A
THAT EACH
YOUNGEST AGE GROUP.
>> WITH REGARD TO YOUR QUESTION,
I GUESS I WOULD LIKE TO SEE IF
THERE IS ANYONE FROM THERE THE
IMMUNIZATION SAFETY OFFICE TO BE
ABLE TO RESPOND TO THAT
QUESTION.
>> HI, I'M CLAUDIA, WITH REGARDS
TO THAT, WE HAVE AN AGENCY READY
TO MONITOR THE SAFETY OF ONE
DOSE DURING PREGNANCY.
COVERAGE IS LOW.
IT WILL TAKE SOME TIME.
HOWEVER, DO I THINK THAT THEY
HAVE A BIT BETTER UPTAKE THAN
THE 2. -- WHATEVER PERCENT THAT
YOU'RE EXPECTING.
WE EXPECT THAT GO UP WITH THE
NEW RECOMMENDATION.
SO IT WILL TALK A FEW YEARS, BUT
WE HAVE ALL RIGHT BEGUN THE
PROCESS.
>> YES, IF I CAN JUST REMEMBER
TO ANSWER THE OTHER QUESTIONS
FIRST, THE FIRST CO-HORT IS
650,000 PER YEAR.
THE FIGURE IN HI HEAD FOR THE
AVERAGE NUMBER OF PERSON PER
PEOPLE IS 2.4.
I DON'T HAVE THE DETAILS OF THE
PR
SPREAD BY NUMBERS OF THE FAMILY
OVER ONE, TWO, AND MORE
CHILDREN.
IN TERMS OF SAFETY MONITORING,
OUR EQUIVALENT HAS ALREADY
STARTED A PROCESS WHERE THEY
WILL LOOK AT THE ADVERSE EVENTS
REPORTED IN PREGNANCY, FOR WOMEN
THAT ARE VACCINATED, AND THEY
HAVE BANK ACCOUNT DATA ON THE
NUMBER OF INCIDENTS THEY EXPECT
IN REALTIME AS THE INFORMATION
COMES THROUGH.
CLEARLY WHAT COMES THROUGH WILL
DEFEND VERY MUCH ON THE
COVERAGE.
>> DO YOU HAVE ESTIMATES OF WHAT
THE PROJECTED UPTAKE WILL BE IN
THE U.K.?
>> NO, GIVE THAN THIS STARTED
THREE WEEKS AGO, THAT WOULD BE A
BIT PREMATURE.
WE WILL, OF COURSE, COMPARE IT
VERY CLOSELY WITH THE UPTAKE IN
THE SEASONAL INFLUENZA VACCINE,
SO WE HAVE THAT DATA BY WAY OF
COMPARISON, AND OUR
RECOMMENDATION IS NOT
SIGNIFICANTLY DIFFERENT TO
YOURS.
I BELIEVE YOURS IS 27 WEEKS TO
TERM, OURS IS 28 TO 38, AND WE
SAID THE IDEAL TIME WAS 28 TO 32
BECAUSE THAT FITS WITH THE
APPOINTMENTS, BUT I DON'T THINK
THERE IS A DIFFERENCE IN THE
TIME OF OUR RECOMMENDATION.
>> THANK YOU, I HAVE TWO
QUESTIONS.
DO WE HAVE ANY DATA ON THE
LIKELY ACCEPTABLE OF THIS NEW
DATA?
AND NUMBER TWO, IS THERE ANY
DATA ON EFFECTIVENESS ON THE
INDIVIDUAL VACCINES, AND WILL
THE WASHINGTON CASE ADDRESS THE
EFFECTIVENESS OF THE INDIVIDUAL
VACCINES? I THINK THEY TEND TO
WHAT AMERICAN COLLEGE OF
OBSTETRICS SAY IN THEIR
GUIDELINES.
SO, I WOULD HOPE
BE THE WAY TO DO IT, AND I THI
THE LINES OF COMMUNICATION RIGHT
NOW ARE PRETTY GOOD.
I THINK THERE IS AN OPPORTUNITY
TO PRESENT IT BY THE 2009
PANDEMIC.
IT'S STILL LESS THAN IDEAL, WITH
MATERNAL VACCINATION IS NOT A
FOREIGN IDEA ANY MORE.
>> I SEE MRS. BREWER'S HAND UP,
AND I WILL SEE IF THERE IS ALSO
A COMMENT ON FAMILY PHYSICIANS,
I THINK TWO-THIRDS OF DELIVERIES
ARE THROUGH ON CIS OBVIOUSTY --
>> WEIR ON BOARD, AND WE THINK
THIS IS A GOOD THING, BUT WE
NEED TO WORK HARDER ON GETTING
PROVIDERS TO DO THE RIGHT THING.
>> FAMILY PHYSICIANS ARE ALSO ON
BOARD IF THEY WERE PROVIDING THE
PREIN AAL CAR OR NOT BUT HAPPEN
TO SEE THE WOMEN DURING
PREGNANCY FOR OTHER REASONS.
>> THANK YOU.
>> DOCTOR, TO ADDRESS THE
SECOND -- --
>> THE TDAP STUDY IN WASHINGTON
STATE WE'LL TRY TO LOOK AT, BUT
THROUGH IS NO DATA FOR
PREFERENCE OVER ONE BRAND OTHER
THE OTHER.
AND I'M NOT EXPECTING TO SEE A
BIG DIFFERENCE.
SOME OF THE QUESTIONS ABOUT
BLUNTING, THIS HAS BEEN A
PROBLEM HISTORICALLY.
THE WORK GROUP REALLY CONCLUDED
THERE IS LIKELY AN
INTEREXPERIENCE, BUT THE DATA
WERE REASSURING THAT CONSISTENT
WITH THE HALF-LIFE THAT WAYNES
AND PROBABLY GOES AWAY BY THE
THIRD DOSE.
AND THEN WE HAVE A LURGE STUDY
ENROLLING WITH SEVERAL OF OUR
STATE HEALTH DEPARTMENT PARER
INS -- PARTNERS.
HOPEFULLY WE'LL HAVE SOME
EFFECTIVENESS DATA THAT GETS TO
A REAL WORLD PERFORM OF THE
VACCINE, SO WE CAN ALSO L
THE PRODUCT FOR THIS QUESTION
SPECIFICALLY.
>> AND JUST TO ADD ONE
ADDITIONAL COMMENT.
I THINK FOR THIS RECOMMENDATION
TOO THAT WE'RE FOCUSSING ON A
SHORT TIME FROM WHEN THE MOTHER
IS VACCINATED TO HER BUILDING
HER IMMUNE RESPONSE.
SO WE'RE LOOKING AT A MUCH
SHORTER DURATION AND
EFFECTIVENESS AND NOT
NECESSARILY ONE OR TWO YEARS OUT
AFTER RECEIVING A VACCINE FOR
THIS, BECAUSE RECOMMENDATION.
>> YES, AND THE CASE CONTROL IS
POWERED TO LOOK AT ANY CHANGE IN
RISK IN SLIGHTLY OLDER KIDS, SO
WE DON'T KNOW THE CLINICAL
RELEVANCE, WE BUILT IT INTO THE
DECISION ANALYSIS, AND FOUND AN
ADVERSE EFFECT.
MOST OF THE HOSPITALS AND WE
HOPE TO GET SOME CLINICAL
EVIDENCE FOR BLUNTING OR NOT,
YOU KNOW, IN OUR STUDY.
>> THANK YOU.
I HAVE A COUPLE MORE PEOPLE
UP -- I'M TRYING.
>> I HAVE A QUESTION, IS IT OKAY
IF I ASK THEM ONE AT A TIME?
THE FIRST ONE B I JUST WANTED SO
CLARIFICATION ON THE PREDICTED
BENEFITS OF THE STRATEGY.
IT LOOKS AND IF FOUND 49%
DEDUCTION.
CAN YOU REMIND ME ON THOSE
REDUCTIONS AND THE
HOSPITALIZATIONS AND HOW THEY
ARE DERIEFED?
HOW DO WE KNOW HOW THEY WILL --
>> SO THESE WERE COMPARED TO NO
TDAP INTERVENTION AT ALL.
THIS IS BASED ON JUST THE
INSTANT CASES THAT ARE MODELLED
AFTER WHAT WE REPORTED IN THE
NATIONAL DATA.
IT'S COMPARING THE POSTPARTUM
AND THE PREGNANCY TO WHAT IS
ALREADY THE INFANTS OUT THERE.
WE FEEL COMFORTABLE SUPPORTING
THIS MODEL BECAUSE WE KNOW IN
GENERAL IT'S IN THE LOW
POPULATION, SO WE KNOW THEY'RE
LOOKING AT THIS WINDOW AND
VACCINATION OF WOMEN.
>> ARE YOU SAYING THERE ARE
STUDIES THAT SHOW THE RESULTS
OF --
>> THERE HAVE NO -- ASIDE FROM
THIS ALL, THERE HAVEN'T BEEN ANY
STUDY THAT'S LOOK AT THAT
SPECIFICLY, AND THERE ARE
HISTORICAL DATA THAT HAVE LOOKED
AT WOMEN VACCINATED WITH WHOLE
CELL VACCINES.
WOMEN VACCINATED WITH WHOLE CELL
VACCINES, THERE WAS NO
PERTUSSIS --
>> SO THESE ARE ASSUMPTIONS FROM
THE MODEL THEN?
>> YES.
SO GIVEN THAT 42% OF COVERAGE
SEEMS OFF, IT'S GOING TO BE
QUITE AWHILE BEFORE WE SEE ANY
IMPACT FROM THE STUDY.
I'M SURE THAT'S AN ISSUE AS FAR
AS TRYING TO DETERMINE IF IT'S
EFFECTIVE OR NOT.
IS THERE A PLAN TO SET THE
BENEFICIAL IMPACT OF THIS AND
THE ABSENCE OF 72% COVERAGE, AND
HOW DO WE KNOW IF IT'S WORKING?
>> THERE ARE MPLANS IN CASE, AN
WE HAVE STUDIES THAT STARTED OUT
LOOKING AT CASE TROLL STUDIES.
BUT AS YOU SAID, BECAUSE
COVERAGE IS LOW, IT WILL BE
SEVERAL YEARS BEFORE WE DO HAVE
ANY DATA TO SHARE.
BUT YOU KNOW -- ARE THERE ANY
OTHER ADDITIONAL COMMENTS?
>> NO, I MEAN WE DID TAKE AN
AVERAGE FROM 2010 TO 2009 DATA,
AND THE DECISION ANALYSIS
APPROACH.
SO IT MISSES PEAK YEARS IN 2010
AND 2012.
WE HAVE -- WE DO KNOW THAT
BECAUSE OF THE CASE DEFINITION
REQUIRES TWO WEEKS OF COMP IN
THE ABSENCE OF CULTURE
CONFRONTATION, MANY INFANT
DEATHS DON'T MEET THAT
DEFINITION, SO DEATHS ARE UNDER
REPORTED.
AND IN THE DECISION ANALYSIS, WE
PRETTY MUCH USED THE OBSERVED
INCIDENT.
SO ANY UNDER REPORTING FAVORS
THE IMPACT OF THE PROGRAM
SUBSTANTIALLY.
>> AMONG THOSE WHO ARE
HOSPITALIZED AND DIE, ARE THERE
SOME FEATURES THAT CAN HELP US
IDENTIFY WHO SHOULD BE
EMPHASIZED TO RECEIVE THE
VACCINE?
ARE THERE SOCIAL, KMIBLG,
RACIAL, OR OTHER FACTORS, FAMILY
SUZ, OR OTHER THINGS WE KE USE?
THAT CAN TAKE A LONG TIME TO GET
WHERE WE NEED TO BE AS FAR AS
UNIVERSAL COVERAGE?
>> NO, NOT REALLY, HISPANICS ARE
SOMEWHAT OVERREPRESENTED AS WE
OBSERVED BEFORE, AND IT'S NOT
CLEAR IF IT'S BECAUSE THEY'RE
OVERREPRESENTED IN CAUSES.
THERE IS A LOT OF VARY ABILITY
IN THE RANGE THAT WE SEE STATE
TO STATE FROM 0 TO 1.
SO EVEN THE DIFFERENCES ARE KIND
OF CONSISTENT WITH THE OVERALL
CASE FATALITY.
THERE ARE A COUPLE CLINICAL
STUDIES GOING ON, BUT BY AND
LARGE, THE KIDS THAT GUY HAVE
PULMONARY HUPER TENSION, AND
REALLY BAD FIZZ OWE LONGIC
PROVILE.
NOT RELATED TO THE SOCIO
ECONOMIC STATUS --
>> I THINK THE DATA IS PARABLELY
REFERRED TO THE FACT THAT WE
HAVE A VACCINE, AND I'M
WONDERING WHAT'S GOING ON TO
GIVE US HOPEFULLY SOPT MISM
ABOUT THE EVENTUALLY -- OPTIMISM
ABOUT THE EVENTUALLY --
>> YES, I HAPPEN TO BE SANDING
HER, I WAS GOING TO RESPOND TO
DR. KITAL'S QUESTION, BUT FIRST
TO THIS QUESTION, IT'S IMPORTANT
TO KEEP IN MIND THAT TWLIEL HAVE
BEEN OUTBREAKS, IT'S STILL
IMPORTANT AND MORE STUDIES AND
INFORMATION ARE NEEDED TO FULLY
UNDERSTAND THE SITUATION AND TO
IDENTIFY SOLUTIONS.
AND WE CAN TRY TO GET BETTER
CONTROL OF PERTUSSIS IN THE
UNITED STATES.
INVESTIGATIONAL VACCINE WAS
DEVELOPED BY THE FDA IN THE
ADOLESCENTS AND ADULTS.
THIS STUDY WAS PUBLISHED IN
2005.
THAT STUDY REPORTED ON THE PAY
SIS OF THE PRIMARY PERTUSSIS
CASE VACCINATION.
IF THE CDC IS EXPRESSING
INTEREST IN A CELLAR PERTUSSIS
VACCI
VACCINE, AND THEN THEY WOULD OF
COURSE BE INTERESTED IN FURTHER
DISCUSSION.
AND THEN DISCUSSING WITH THE FDA
ABOUT A POTENTIAL
STRATEGY FOR ANY STAND ALONE
VACCINE, THANK YOU.
>>> THANK YOU FOR THAT RESPONSE,
JUST TO FOLLOW UP ON THAT, I'M
INTERESTED IN YOUR THOUGHTS
ABOUT ADDITIONAL INFORMATION --
YOU SAID WE NEED TO BETTER
UNDERSTAND THE SITUATION.
FROM YOUR PERSPECTIVE AS A
MANUFACTURER, WE SEEM TO BE
LOOKING AT THAT DATA SHOWS THE
DURATION IS VERY SHORT.
WHAT OTHER INFORMATION DO YOU
THINK WOULD BE USEFUL TO MAKE
THE CASE TO CONVINCE YOU THAT WE
NEED A VACCINE WITH A LONGER
DURATION OF ACTION?
>> THANK YOU, CLEARLY THE CASE
CONTROL STUDIES CONDUCTED NOW IN
WASHINGTON STATE ARE GOING TO BE
VERY IMPORTANT.
ACCURATE UNDERSTANDING OF
VACCINATION HISTORY.
COMPLETE UNDERSTANDING OF PRIOR
VACCINATION HIS.
ALL OF THIS INFORMATION IS
CRITICALLY IMPORTANT TO
UNDERSTAND THE FULL SITUATION,
AND THAT INFORMATION IS
PRELIMINARY.
IT NAMES TO BE DETERMINES AND
UNDERSTOOD --
>> DR. DECKER?
>> HELLO, I SUPPORT WHAT MY
COLLEAGUE JUST SAID AND I CAN
ADD FURTHER.
WE'RE SEAING DATA FROM ALL OVER
THE COUNTRY SAYING THE SAME
THING SPOP THE PROBLEM IS THAT
THEY'RE BASICALLY MEASURING THE
SAME THING, SO IT'S NOT
SURPRISING THEIR FINDING THE
SAME THING.
THESE STUDIES ARE SUSCEPTIBLE.
YOU A CORRELATION HERE BETWEEN
AGE, BETWEEN CHANGES IN
RECOMMENDATIONS, THE VACCINE
RECEIVED, AND OTHER FACTORS.
FOR EXAMPLE, THE SLIDE WAS UP
EARLIER THAT SHOWED AMONG THE
PEOPLE, AGE 16 TO 19 THAT
RECEIVED A MIXED SCHEDULE, AND
IT CORRELATES WITH THE TYPICAL
HOUSEHOLD DIFFERENCES FOR THE
EXPOSING OF YOUNGER KIDS.
SO I'M PERFECTLY WILLING TO
AGREE, BUT I WOULD ALSO LIKE
MORE EVIDENCE OF WHAT'S GOING
ON.
I DON'T KNOW IF YOU HAVE A
PROBLEM WITH THE INITIAL
FINNING, OR WITH DURABILITY, BUT
I DO HAVE A COUPLE QUESTIONS AND
COMMENTS.
FIRST IS WHAT WOULD DO WITH
RECOMMENDATIONS?
WOULD YOU ABANDON YOUR
PREFERENCE IN AND THE SECOND IS
IN A WORLD WITH DIFFERING
RECOMMENDATIONS FOR VACCINES,
AND ANY IS IT TRUEY, T--
>> HOW WOULDCINE GET
LICENSED.
AND HOW DOES ANYBODY FIGURE OUT
WHAT CHANGES TO MAKE IN THE
VACCINES, GIVEN THAT THERE ARE
NO ADEQUATE MODELS THAT YOU CAN
TEST HYPOTHETICAL CHANGES.
AND THERE IS OVER 3,000
ADDITIVES.
I WOULD LIKE A LIST OF THE ONES
INCLUDED IN THE VACCINE.
>> THOSE ARE VERY GOOD
QUESTIONS, AND I THINK WE WILL
REFER THOSE TO THE WORKING
GROUP.
THIS IS CALLED PROFESSIONALLY
WASHING ONES HANDS.
>> I JUST WANTED TO COMMENT ON
THE STAND ALONE A-CELLAR
PERTUSSIS.
THIS IS NOT -- B THIS IS AN
OLDER DISCUSSION, BUT WHAT
DRIVES A MANUFACTURER IS NEED
AND DEMAND, AND THAT'S REALLY
UNCLEAR AT THIS POINT IN TIME.
SO WE TALK ABOUT IT IN TERMS OF
OUTBREAKS, THERE COULD BE A
NEED, HOW SUSTAIN ABLE IS THAT
AND IS IT SOMEBODY THAT WE CAN
PRIORITIZE.
IT'S RELATIVELY STRAIGHT FORWARD
TO DO SO, BUT WE NEED TO
UNDERSTAND --
>> THANK YOU.
I'M GOING TO MOVE ON TO MR.
ROSENBAUM.
>> JUST A QUICK OBSERVATION.
I WAS VERY PLEASED TO SEE THAT
THE WORK HAS PRESENTED US
HERE NOT ONLY WITH EVIDENCE FOR
ADDING THE VACCINE,
SPOKEN TO THE ISSUE OF ACCESS TO
THE VACCINE.
WHILE WE HEARD FROM A NUMBER OF
EXPERTS REPRESENTING HEALTH CARE
PROFESSIONALS, I THINK IT'S
IMPORTANT TO NOTE THAT BASICALLY
HALF OF ALL LOW BIRTHS IN
THIS POINT, AND ONE IN EIGHT ARE
HAPPENING IN A COMMUNITY BIRTH
CENTER.
A FAIR PROPORTION OF THE
REMAINING ARE IN PUBLIC HOSPITAL
SETTINGS.
I'M VERY INTERESTED TO KNOW WHAT
THEY WILL DO TO THE HEALTH
CENTER'S PROGRAM, SO TRY TO
DIFFUSE THIS STANDARD, AND
NUMBER TWO, I WAS SO STRUCK
LISTENING TO THE REPRESENTATIVE
FROM THE UNITED KINGDOM THAT
THEY TOOK A VOTE IN THE MORNING
AND BY THE AFTERNOON THEY WERE
SHIPPING VACCINES TO CLINICAL
PRACTICES.
IN THE UNITED STATES, IT'S MUCH
MORE COMPLICATED BECAUSE WE'RE A
MULTIPAYER SYSTEM, BUT I WOULD
STRONGLY RECOMMEND WHETHER WE DO
IT IN THE CONTEXT OF THE VOTE,
WHETHER WE'RE DEALING WITH
INSURANCE COVERAGE, OR BECAUSE
THE WORK GROUP RAISED THE ISSUE
HERE, THAT WE THINK ABOUT AN
ADDITIONAL RECOMMEND FROM ACIP
THAT WITH RESPECT TO COVERAGE,
THAT WE URGE FUN
PRIVATE PAYERS TAKE T
AVAILABLE TO
ALTER THEIR COVERAGE AND PAYMENT
RULES TO BE ABLE TO INDICATION
TO PROVIDERS THAT THIS WILL BE A
COVERED AND PAYABLE SERVICE AS
QUICKLY AS POSSIBLE.
>> I THINK IT'S UNFORTUNATE THAT
IT'S NOT PART OF OUR PER VIEW,
BUT DID THEY TAKE THAT INTO
CONSIDERATION.
>> OKAY, I'M SITTING HERE TRYING
TO THINK WHAT WE DO AND DON'T
KNOW ABOUT THIS RECOMMENDATION.
AND FIRST, WE DON'T REALLY HAVE
ANY DIRECT DATA FOR THIS
STRATEGY FOR PREVENTING DEATHS
IN NEWBORNS, IS THAT CORRECT?
OKAY, IN TERMS OF THE HARM IN
PREGNANCY, THE DECLINE IN
ANTIBODIES, DO WE HAVE ANY
EVIDENCE OF THOSE ITEMS IN
SUBSEQUENT DOSES?
>> ARE YOU TALKING ABOUT
SUBSEQUENT DOSES FOR TDAPs?
>> WE DON'T BECAUSE THERE MAY BE
INSTANCES IN WOMEN WHO RECEIVE
MORE THAN ONE DOSE, BUT WE DON'T
HAVE ANY DATA ON THAT.
>> OKAY, SO, THAT'S WHAT I'M
TRYING TO CLARIFY.
WE DON'T HAVE DATA ON THAT.
>> CORRECT.
>> OKAY.
>> DR. SAWYER.
>> THE ONE PIECE OF DATA WE HAVE
IS ON SECOND DOSES, IN
NONPREGNANT INDIVIDUALS, AND THE
LEVELS ARE NOT HIGHER THAN THE
FIRST DOSE.
SO IT'S DOES NOT APPEAR BASED ON
THAT AMOUNT OF DATA THAT IT
MIGHT PREDICT.>> I WAS GOING TO
QUESTION ABOUT THE GUIDANCE FOR
TIMING.
DR. SALSBURY'S COMMENT ABOUT THE
HIGHER END OF THE RANGE SEEMS TO
MAKE MORE SENSE.
WE WOULD THEN HAVE AN
OPPORTUNITY TO PICK UP SOME OF
THE LATE PRE-TERM INFANTS.
AND BY WAITING TO 36 WEEKS FOR
HOSPITAL MALL TIMING WE WOULD
MISS THOSE.
I ASK WHETHER WE COULD CHANGE
THAT TO SOMETHING VERY SIMILAR
THAT DR. SALSBURY SAID.
>> I WONDER IF THERE IS ANY
INFORMATION OUT THERE ON LATE
ACQUISITION OF PREIN AAL CARE IN
THIS COUNTRY.
THERE ARE A NUMBER OF WE
SEE FOR THE FIRST TIME BETWEEN
34 AND 36 WEEKS.
>> I THINK THAT GOES BACK TO THE
BROKEN WINDOWS.
THE PEOPLE MOST VULNERABLE FOR
SHORT PREGNANCY INTERVAL, THAT'S
ALL -- THAT CAN BE ALL
CONCENTRATED HOSPITALS AND COMM
HEALTH CENTERS AND OTHER THINGS.
SO THAT'S CERTAINLY A LESS THAN
IDEAL SITUATION, AND I'M SURE
THERE'S DATA OUT THERE.
I DON'T KNOW IT OFF THE TOP OF
MY HEAD.
BUT, YOU KNOW, THAT WOULD STILL
BE AN OPPORTUNITY TO VACCINATE
AND GET AN ANTIBODY IF THEY WERE
GOING TO HAVE A TERM DELIVERY.
>> THANK YOU.
DR. HARRISON, THEN DR. POLAND.
>> YES, HOW WOULD WE GET SOME
REASSURANCE THERE WILL BE A
COLLECTIVE EFFORT TO GET
INFORMATION ON WOMEN WITH
MULTIPLE DOSES.
WE NEED A CONCERTED EFFORT TO
LOOK AT THAT SUBSET OF WOMEN WHO
ARE GETTING MULTIPLE DOSES.
I DON'T KNOW IF THAT WOULD BE A
CDC THING OR MANUFACTURER THING.
WE WOULD NEED THAT DATA IN THE
FUTURE.
>> ONE OF THE THINGS THAT THE
ACIP HAS REQUIRED IS THAT ANY
VACCINE THAT IS APPROVED, THE
SAFETY DATA BE PROVIDED AT EACH
MEETING AFTERWARD.
THAT'S ONE OF THE THINGS THAT
HAS CONTINUED.
IT WOULD BE EXPECTED THAT THE
SAFETY MONITORING SYSTEMS THAT
SHE'S MENTIONED WOULD BE SET UP
AND EACH MEETING FOLLOWING,
SAFETY DATA THAT ARE AVAILABLE
WOULD BE PRESENTED.
THAT'S ONE OF THE THINGS THIS
COMMUNITY IS VERY, VERY SERIOUS
ABOUT.
>> DR. POLAND.
>> WELL, IT'S A DIFFICULT
SITUATION.
OBVIOUSLY SOMETHING HAS TO BE
DONE.
LIKE JEFF AND DOUG AND OTHERS, I
WOULD URGE SOME CAUTION HERE.
THE PRESENTATION OPENED WITH AN
ANECDOTE.
IT PROCEEDED TO A SMALL STUDY
THAT WAS EXTRAPOLATATED AS IF I
WAS A CORRELATED PROTECTION.
WENT ON TO SOME MODELING THAT
LOOKED AT INTERVALS BETWEEN
CHILDBIRTH, NOT PREGNANCY, AND
WITH THE BOTTOM BULLET THERE,
PARTICULARLY IF I WERE WORKING
IN AN AREA WHERE ACCESS WAS A
PROBLEM AN I WASN'T SURE I WAS
GOING TO SEE A PREGNANT WOMAN
BACK ON A REGULAR BAY SSISBASIS
GIVE THE VACCINE AS SOON AS I
REALIZED SHE WAS PREGNANT.
SO THE ACTUAL NUMBER OF DOSES
AND INTERVAL MAY BE VERY
DIFFERENT IN THOSE AREAS THAN
WHAT YOU MODELED.
PERHAPS ONCE WAY TO SAY ALL OF
THIS IS I BELIEVE WE WERE GOING
TO GET IN THE HABIT OF USING
GRAID GRAID A-- G.R.A.D.E. AND
EVIDENCE BASE ON
RECOMMENDATIONS.
I'M CURIOUS, HOW WOULD YOU GRADE
THIS RECOMMENDATION?
WHAT LEVEL OF EVIDENCE DO YOU
BELIEVE THIS REPRESENTS?
>> UNFORTUNATELY, I DO NOT KNOW
G.R.A.D.E. WELL ENOUGH TO BE
ABLE TO ANSWER THAT QUESTION.
I DON'T KNOW IF TOM --
>> WELL, I MEAN, SPECIFICALLY,
BECAUSE THIS WAS KIND OF
CLEANING UP THE PREVIOUS
RECOMMENDATION.
WE RECOMMEND TDAP DURING
PREGNANCY.
CERTAINLY THE RECOMMENDATION IS
PREDICATED ON THE ASSUMPTION
THAT THE ANTIBODY PROTECTS.
I THINK WE HAVE SOME DATA THAT
CHILDREN BORN TO MOMS WHO HAVE
HAD PERTUSSIS OR WERE VACCINATED
WERE LESS LIKELY TO GET
PERTUSSIS.
WE KNOW ONE DOSE OF TDAP IN
INFANTS PROTECTS AGAINST
HOSPITALIZATIONS AND DEATHS IN
OBSERVATIONAL STUDIES.
WE DON'T HAVE ABSOLUTE NUMBERS.
WE HAVE A SITUATION IN WHICH
KIDS ARE DYING OF PERTUSSIS IN
THE U.S.
WE'RE MISSING SOME OF THOSE.
WE HAVE A SAFE, EFFECTIVE
VACCINE THAT'S LIKELY TO MAKE A
BENEFIT BASED ON ALL THE
CONSIDERATIONS.
>> WHILE I BELIEVE THAT, THAT'S
AN ASSUMPTION THAT'S YET
UNTESTED.
AND THE KEY THING IN A
RECOMMENDATION IS, AND WHAT I
THINK WHAT EVERYBODY IS
STRUGGLING WITH, IS THE BALANCE
BETWEEN COST, RISK, AND BENEFIT.
THEREIN ARE SOME CRITICALLY
MISSING DATA.
YOU KNOW, I CAN'T GRADE OFF THE
TOP OF MY HEAD, BUT THIS WOULD
MEET A VERY LOW THRESHOLD.
>> IF I CAN JUST COMMENT A
LITTLE BIT ON THE G.R.A.D.E.
PROCESS, JUST FROM AN OVERVIEW,
THIS WOULD PROBLEM GO INTO THAT
VERY LOW CATEGORY OF EVIDENCE,
WHICH BASICALLY MEANS THAT WITH
ADDITIONAL STUDIES, WE'RE LIKELY
TO CHANGE THE RESULTS OR BE
BETTER INFORMED.
IT SAYS WE'RE NOT REALLY
CONFIDENT AT THIS POINT IN TIME.
THAT BEING SAID, IN THE
G.R.A.D.E. PROCESS, THAT DOESN'T
PRECLUDE MAKING A
RECOMMENDATION.
IT'S JUST PREDICATED ON THE FACT
THAT THE EVIDENCE IS VERY OPEN
TO CHANGES AS MORE EVIDENCE AND
BETTER STUDIES ARE DONE.
I SAW DR. BAKER'S HAND UP.
>> YEAH, I'M GOING TO SPEAK
WEARING TWO HATS.
I TAKE CARE OF BABIES WHO DIE OF
PERTUSS
PERTUSSIS.
I DON'T THINK ANYBODY HAS SEEN
THAT.
THE NUMBER OF DEATHS IS SMALL.
THAT'S BECAUSE THOSE ARE THE
NUMBER OF CONFIRMED PERTUSSIS
DEATHS.
IF YOU'RE 2 MONTHS OLD AND HAVE
PERTUSSIS, YOUR FIRST SERIOUS
SYMPTOM IS APNEA.
SO A LARGE NUMBER OF RECORDED
SIDS IS PROBABLY PERTUSSIS.
NUMBER TWO, I WILL REMIND
EVERYBODY ON THE COMMITTEE,
THERE ARE NO FDA LICENSED
VACCINES FOR PREGNANCY.
DR. POLAND, MAYBE WE SHOULD TAKE
FLU VACCINE AWAY FROM PREGNANT
WOMEN.
NUMBER TWO, ALTHOUGH WE DO KNOW
THE DECAY OF ANTIBODIES TO
PERTUSSIS.
THEY WANE VERY DIFFERENTLY.
THE YOUNG INFANT AS OPPOSED TO
INFANTS, ADOLESCENTS, AND ADULTS
REMAIN WITH THE ANTIBODY,
WHEREAS OLDER PEOPLE, EVEN 4
YEAR OLDS, HAVE CELL IMMUNITIMM.
ANOTHER POINT IS EVERYBODY SEEMS
TO BE REALLY, REALLY WORRIED
ABOUT SAFETY.
I AGREE WITH ALL THE PLANS FOR
INTENSE SAFETY MONITORING.
IF YOUR WIFE WAS PREGNANT AND
YOU SAID, THIS IS THE SECOND
DOSE CONVERSATION, YOU MAY GET A
REALLY PAINFUL ARM.
YOU MAY GET YOUR WHOLE ARM
SWOLLEN FOR FOUR TO SEVEN DAYS.
YOU WANT THAT, OR DO YOU WANT A
DEAD OR HOSPITALIZED BABY?
I THINK THAT THE GENTLEMAN IN
THIS ROOM, SOME, NOT ALL, ARE SO
CONCERNED FOR THE SAFETY OF THE
PREGNANT WOMAN GIVEN A VACCINE
DURING HOPEFULLY THE EARLY THIRD
TRIMESTER FOR OPTIMAL ANTIBODY
LEVELS, THAT THEY'RE JUST NOT
UNDERSTANDING THAT PREGNANT
WOMEN, EVEN IF THEY HAVEN'T GONE
TO HIGH SCHOOL -- IF YOU HAVE
THIS CONVERSATION WITH THEM,
THEY'LL CHOOSE TO BE VACCINATED.
I THINK A LOT OF THE FLOW UPTAKE
IS PROVIDER HESITANCY, NOT
PREGNANT WOMEN HESITANCY.
SO TWO HATS.
I BELIEVE I DO REPRESENT THE
IDEA.
I CERTAINLY REPRESENT PREGNANT
WOMEN.
THANK YOU.
>> I'M GOING TO ASK THE DOCTOR,
BECAUSE I THINK YOU WERE UP
EARLIER AND SAT BACK DOWN.
WE'RE GOING TO LEAPFROG HERE.
>> I'LL TRY TO BE BRIEF.
THANK YOU.
I WOULD HOPE THAT CDC AND THE
STUDIES WITH TRYING TO LOOK
SPECIFICALLY AT PROTECTION.
AS TOM SAID, WE HAVE PRETTY GOOD
EVIDENCE THAT THE ANTIBODIES ARE
USEFUL.
WE JUST DON'T HAVE AN ABSOLUTE
LEVEL OF PROTECTION.
IT WOULD BE VERY IMPORTANT TO
OBTAIN THOSE DATA.
WHY?
BECAUSE IN RELATION TO THE
QUESTION, HOW DO WE MAKE A NEW
VACCINE, THERE'S A POSSIBILITY
OF NEW COMPONENTS.
BUT IN ORDER FOR FDA TO LICENSE
A NEW VACCINE SHORT OF THE
EFFICACY TRIAL, WHICH IS
IMPRACTICAL, A PROTECTION WOULD
BE VERY IMPORTANT SO THAT FDA
COULD JUDGE AND GO BACK TO THE
SWEDISH, ITALIAN, ET CETERA,
DATA TO ESTABLISH WHAT WOULD BE
A NEW LICENSABLE VACCINE.
SO I WOULD JUST HIGHLY RECOMMEND
THAT BE PART OF THE
INVESTIGATION THAT CDC IS NOW
DOING.
>> THANK YOU.
DR. DECKER.
>> YEAH, THE COMMENTS SO FAR
THIS MORNING MIGHT SUGGEST TO
SOME THAT THERE HAVE NOT BEEN
FORMAL STUDIES ON TDAP, SO I
WANTED TO CORRECT THAT.
MULTIPLE STUDIES HAVE BEEN
CONDUCTED ON TDAP, ALL OF WHICH
HAVE BEEN SUBMITTED OVER THE
COURSE OF THE YEARS TO THE FDA.
THERE HAVE BEEN STUDIES AT THE
ADMINISTRATION FIVE YEARS
FOLLOWING THE INITIAL
ADMINISTRATION, TEN YEARS
FOLLOWING THE INITIAL
ADMINISTRATION AND A
MULTINATIONAL STUDY TEN YEARS
FOLLOWING.
TO SUMMARIZE ALL THOSE, THEY ALL
SHOW YOU GET A GREAT ANTIBODY
RESPONSE SIMILAR TO THE INITIAL
ADMINISTRATION.
THAT'S NOT DIRECTLY ON POINT TO
THE ISSUE YOU'RE TALKING ABOUT,
BUT IT DOES GIVE YOU SOMETHING.
>> THANK YOU.
DR. FRIEDLAND.
>> THANK YOU.
YES, GSK HAS SIMILAR STUDIES.
WE LOOK FORWARD TO HAVING THE
OPPORTUNITY TO COME TO THE
COMMITTEE IN FEBRUARY 2013 AND
PRESENT OUR VACCINATION DATA.
>> AND I HAVE ANOTHER COMMENT UP
HERE.
>> YES.
AS HAS BEEN BROUGHT UP IN TERMS
OF G.R.A.D.E., I'D LIKE TO TAKE
THIS BACK AND ASK A QUESTION ON
COST EFFECTIVENESS.
WE HAVE AN APPROVED STRATEGY OF
ONE DOSE DURING PREGNANCY WITH
ONE PREGNANCY.
HAS THE GROUP TAKEN -- THE
DOCTOR TALKED ABOUT THE COST
ESTIMATION PER COST
EFFECTIVENESS OF THE NEW
STRATEGY.
>> ESSENTIALLY, THE DECISION
ANALYSIS APPLIES TO ALL BECAUSE
WE DIDN'T ASSUME ANYTHING ABOUT
THE HISTORY OF THE TDAP RECEIPT
AND THE COHORT OF WOMEN.
COVERAGE IS 72% IN THE MILLION
BIRTH COHORT, WHICH IS THE
NUMBER OF BABIES.
IT WAS HARD TO SORT OUT ONE DOSE
VERSUS SECOND DOSES, BUT THE
RESULTS OF THE COST EFFECTI
EFFECTIVENESS ARE THE SAME WITH
MULTIPLE DOSES.
>> ONE ADDITIONAL QUESTION.
THIS RELATES TO THE VACCINE
ENTRY COMPENSATION PROGRAM.
JUST REASSURANCE THAT BECAUSE
TDAP IS RECOMMENDED FOR
ADOLESCENTS, I ASSUME THAT ANY
VACCINE INJURY, IF IT'S ON THE
TABLE, IS AUTOMATICALLY COVERED
FOR A PREGNANT WOMAN.
>> YES, THE VACCINE WOULD COVER
THE PERSON WHO RECEIVES THE
VACCINE, WHICH WOULD BE THE
PREGNANT WOMAN.
CURRENTLY THE WAY THE LANGUAGE
IN THE CHILDHOOD ACT IS WRITTEN,
THE FETUS WOULD NOT BE COVERED.
SO SHOULD THERE BE ISSUES WITH
THE BABY BECAUSE OF RECEIPT OF
THE VACCINE, THAT WOULD NOT
CURRENTLY BE COVERED WITH OUR
CURRENT LANGUAGE.
THAT WOULD REQUIRE A LEGISLATIVE
CHANGE IN ORDER TO FIX THAT.
>> THANK YOU.
I SEE DR. WHITLEY WILLIAMS.
>> YES, NATIONAL MEDICAL
ASSOCIATION.
HAVING RECENTLY TAKEN CARE OF AN
INFANT WITH PERTUSSIS, AND IT
WAS A CASE WHERE THE MOTHER WAS
OFFERED TDAP IN THE POST-PARTUM
PERIOD.
SHE REFUSED BECAUSE SHE DIDN'T
BELIEVE IN VACCINES.
THIS WAS REALLY A TELLING CASE.
MY POINT IS THAT THERE ARE NOT
ONLY PROVIDER BARRIERS, BUT
THERE ARE ALSO, I BELIEVE,
PUBLIC BARRIERS.
IF THIS RECOMMENDATION FLIES,
THERE REALLY NEEDS TO BE
INFORMATION DISSEMINATED TO THE
PUBLIC ABOUT PERTUSSIS, THE
BURDEN OF DISEASE, NOT ONLY THE
MORTALITY, BUT EVEN MORE
STRIKING, I THINK THE MORBIDITY,
THE LENGTH OF STAY THAT THESE
INFANTS GO THROUGH.
AGAIN, I THINK IT'S NOT AS WELL
OR RECOGNIZED A DISEASE.
OBVIOUSLY, IN CERTAIN STATES
IF YOU WOULD SPEAK TO WOMEN IN
THEIR CHILDBEARING AGE YEARS,
ESPECIALLY MANY OF THOSE 20 TO
30 YEARS OLD, THEY HAVE NEVER
SEEN PERTUSSIS AND MAY NOT KNOW
THAT MUCH ABOUT IT.
SO I REALLY URGE NOT ONLY DO WE
FOCUS ON PROVIDER EDUCATION BUT
ALSO THE PUBLIC EDUCATION.
>> THANK YOU VERY MUCH.
I THINK WE WOULD -- DOCTOR.
>> JUST A QUICK QUESTION.
DOES ANYONE HAVE ANY NUMBERS IN
THE STUDIES FOR TDAP BEING
REPEATED WITH NO SIDE EFFECTS
FOR THE 5,000 PEOPLE IN THOSE
STUDIES OR THE 2,000 PEOPLE THAT
WOULD GIVE ME A SENSE OF HOW
MANY PEOPLE HAVE BEEN STUDIED?
>> WHEN ALL IS SAID AND DO
WILL BE MULTIPLEHOUSANDS OF
PEOPLE.
I MEAN, IT'S FAIRLY OBVIOUSLY
THAT THE TEN-YEAR ANNIVERSARY OF
THE INITIAL RECOMMENDATION OF
TDAP IS COMING UP.
[ INAUDIBLE ]
>> OKAY.
I'M SURE ALL OF US WOULD BE --
WOULD LOVE TO BE GOING INTO THIS
WITH A WELL-DESIGNED RANDOMIZED
CONTROLLED TRIAL POWERED WITH
ENOUGH PREGNANT WOMEN TO
REASSURE US ENTIRELY ABOUT
SAFETY AND CLINICAL EFFICACY.
I THINK SUCH THINGS ARE NEARLY
IMPOSSIBLE, SO WE ARE LIMITED.
IN THE QUIP THAT I MENTIONED IN
MY INTRODUCTORY, IT TALKS ABOUT
IN SCIENCE ALWAYS STANDING ON
THE KNOWN AND LOOKING FOR WHAT
IS HOPED FOR IN THE SCIENTIFIC
PROCESS.
I THINK THAT'S VERY APPROPRIATE
HERE.
THOUGH, HE STATES THAT MUCH MORE
ELOQUENTLY THAN I CAN.
ARE THERE OTHER COMMENTS, OR DO
WE HAVE A MOTION TO -- KATHY.
SORRY, TERRY.
>> I JUST WANTED TO THANK YOU,
ACTUALLY, FOR STARTING YOUR TALK
WITH THE ANECDOTE.
WHILE WE DON'T MAKE SCIENTIFIC
RECOMMENDATIONS BASED ON
ANECDOTES, I DO THINK IT'S
IMPORTANT TO SHARE THOSE HERE SO
THAT WE DON'T GET LOST IN
INTERVALS AND STATISTICS AND
LOSE SIGHT OF REALLY WHAT WE'RE
HERE FOR.
THAT IS KEEPING OUR EYE ON THOSE
FAMILIES AND THE HAZARDS THAT
CAN BEFALL THEM.
THANKS FOR SHARING THAT STORY.
>> DOCTOR.
>> THANK YOU.
WOULD IT BE POSSIBLE OR MAYBE A
DISCUSSION OF THE POTENTIAL TO
INCLUDE IN THE RECOMMENDATION
SOME STATEMENT THAT WOULD COMMIT
US TO EVALUATE THE EFFECTIVENESS
OF THIS INTERVENTION AND THEN
REASSESS THE APPROPRIATENESS OF
THE RECOMMENDATION BASED ON
THOSE DATA?
I MEAN, I HATE TO -- I'M VERY
UNCOMFORTABLE COMMITTING TO A
LONG-TERM RECOMMENDATION FOR A
COUPLE OF REASONS.
ONE IS THAT WE DON'T HAVE GOOD
DATA CURRENTLY ABOUT THE
EFFECTIVENESS.
YOU SAY THERE ARE CASE
CONTROLLED STUDY MISS IN
PROGRESS THAT SHOULD GIVE US
THAT INFORMATION.
SECONDLY, PERTUSSIS WAXES AND
WANES.
WHAT'S THE THRESHOLD AT WHICH
THIS MAKES SENSE?
HOW MANY CASES DO WE NEED TO
HAVE IN THE POPULATION?
WITH THESE LARGE, NATURALLY
OCCURRING OUTBREAKS, I IMAGINE
WE'LL HAVE MANY YEARS AND MANY
COMMUNITIES WITH VERY LOW RATES
BEFORE SUSCEPTIBILITY INCREASES
AGAIN AND WE SEE INCREASED
NUMBERS.
SO WE'LL BE VACCINATING MANY
PEOPLE WHO ARE LOW RISK AS WELL
AS SOME WHO ARE IN COMMUNITIES
THAT ARE HAVING OUTBREAKS LIKE
WE HAD IN THE LAST TWO YEARS.
SO SOME REASSURANCE WE'RE GOING
TO HAVE DATA THAT WILL ALLOWS TO
OBJECTIVELY EVALUATE THE
EFFECTIVENESS OF THE STRATEGY
WOULD BE HELPFUL TO ME, AT
LEAST.
>> I MEAN, I THINK WE WOULD
INCLUDE THAT KIND OF LANGUAGE IN
THE STATEMENTOU KNOW,
AS YOU STATED, THIS IS BASED
UPON LIMITED DATA.
SO TO HAVE THAT REASSURANCE AND
GOING BACK TO REVIEWING WHEN
DATA ARE AVAILABLE, THAT'S THE
EFFECTIVENESS OF THE STRATEGY.
I THINK IT'S PART OF THE LARGER
PICTURE OF WHAT WE'RE SEEING
WITH WITH PERTUSSIS IN GENERAL.
>> THERE'S BEEN A GREAT
RELUCTANCE TO EVER CHANGE OR GO
BACK ON A RECOMMENDATION ONCE
IT'S MADE, SO I'M TRYING TO MAKE
THIS EXPLICIT THAT THIS WOULD BE
A RECOMMENDATION THAT WOULD BE
REASSESSED WHEN DATA BECOME
AVAILABLE.
>> AND I THINK THAT --
>> INCLUDING THE SAFETY DATA.
>> I THINK THAT'S WITHIN THE PER
VIEW OF WHAT WE CAN DO.
DR. KIMBERLAND.
>> I'M STRUCK BY THE LACK OF
SPECIFIC SAFETY DATA, INCLUDING
ACTUAL NUMBERS AND ACTUAL
RESULTS OF THE SECOND DOSE OF
TDAP.
I HEAR FROM MIKE, I THINK IN THE
BACK, THAT GSK HAVE THOSE DATA.
IF I UNDERSTAND CORRECTLY,
THEY'LL BE PRESENTED AT THE
FEBRUARY 2013 ACIP MEETINNG.
IS THAT ACCURATE?
IS THAT GOING TO BE -- IN OTHER
WORDS, IF WE WAIT ONE MEETING,
WILL WE HAVE TO SAFETY DATA, OR
IS IN THE ON THE AGENDA?
>> WITH REGARDS TO THE PERTUSSIS
VACCINES, WE HAVE THESE ON
REVIEWING DATA ON THE
REVACCINATION OF TDAP.
IT'S AN ADDITIONAL DOSE OF TDAP.
THOSE STUDIES YOU MENTIONED ARE
WITHIN HEALTHY, NON-PREGNANT
PERSONS THAT THE SAFETY DATA ARE
AVAILABLE.
SO PART OF OUR PLAN IS TO BEGIN
THE CONVERSATION AND THE
DISCUSSION WITH ACIP ON
REVACCINATION.
THOSE WOULD BE PART OF THOSE
PRESENTATIONS.
>> TOM.
>> WHAT GROUP HAD REVIEWED THE
SAFETY DATA FOR THE PREGNANCY
RECOMMENDATION AND REVIEWED WHAT
WE KNOW ABOUT TDAP AFTER TETANUS
CONTAINING VACCINES?
THE SPECIFIC CONCERN WAS THE
SEVERE HYPERSENSITIVITY
REACTIONS.
THERE ARE ESSENTIALLY NONE IN
THESE LARGE DATABASES.
MUCH OF WHAT WE KNOW ARE FROM
HISTORICAL DATA WHICH ARE THE
RESULT OF OLDER VACCINATIONS AND
FORMULAS.
>> THAT'S EXACTLY RIGHT.
I CANNOT RECALL THAT WE'VE SEEN
ANY REACTIONS.
THAT'S GOING BACK TO THE
QUESTION.
ALL OF THE DATA WE HAVE AT
ADMINISTRATION HAVE BEEN
PROVIDED.
OF COURSE, THE DATA WE DON'T
HAVE YET HASN'T BEEN PROVIDED.
[ INAUDIBLE ]
>> ANY COMMENT FROM DR.
FRIEDLAND?
>> YES.
AS THE WORKING GROUP HAS
REQUESTED INFORMATION, WE'VE
BEEN FORCED TO PROACTIVELY SHARE
THE INFORMATION WITH THE WORKING
GROUP.
OUR STUDIES ARE ALSO ONGOING.
OUR TDAP VACCINE WAS FIRST
LICENSED IN THE UNITED STATES IN
2005.
[ INAUDIBLE ]
THE PATIENTS NOW ARE ABOUT TEN
YEARS OLDER.
AS OUR DATA CONTINUES TO BE
COLLECTED, WE'LL CONTINUE TO
SHARE THAT WITH THE WORKING
GROUP AND LOOK FORWARD TO BEING
INVITED TO FUTURE MEETINGS TO
SHARE THIS DATA WITH YOU.
>> THANK YOU.
>> I'M ALSO LOOKING AT THE
FINANCES IN THE SECOND TALK ON
SLIDE 23.
IT TALKS ABOUT THE DECISION
ANALYSIS.
THE DECISION ANALYSIS IS
FOCUSING MOSTLY ON ONE
PREGNANCY.
IT'S NOT TALKING ABOUT A
DECISION ANALYSIS FOR MULTIPLE
PREGNANCIES.
I'M NOT REALLY EVEN SEEING A
COST FOR MULTIPLE PREGNANCIES.
ALSO, THE BENEFITS SEEM TO BE
COMPARED TO THE BASE RATE, BUT
WE ALREADY HAVE THE TDAP
POST-PARTUM RATE, SO WE ALREADY
HAVE SOME OF THE BENEFITS POOIM
CONCERNED THIS MIGHT BE A FAIRLY
EXPENSIVE PROCEDURE WITH
MULTIPLE TDAPs FOR A FAIRLY
MINIMAL BENEFIT.
WENDY WAS ASKING ABOUT A BACK OF
THE ENVELOPE CALCULATION FROM
THAT SAME SLIDE.
IT APPEARS THESE HA
MAYBE 300 CASES AND 150
HOSPITALIZATIONS AND MAYBE SEVEN
TO TEN DEATHS.
>> YOU'RE RIGHT.
IN TERMS OF HOW THE DECISION
ANALYSIS WAS MADE.
ALSO KEEP IN MIND WITH REGARDS
TO THE EFFECTIVENESS OF THE
MODEL.
POST-PARTUM DOSE IS PART OF THE
COCOONING STRATEGY.
IN TERMS OF A COCOONING
STRATEGY, YOU'RE ADDING
ADDITIONAL DOSES FOR THE FATHER
AND ANY ADDITIONAL CLOSE CONTACT
OF THAT FAMILY AND COMPARING
THAT COST AS WELL TO JUST THE
ONE DOSE FOR THE PREGNANT WOMAN.
>> DOCTOR.
>> THE PROBLEM I'M HAVING IS A
LOT SIMILAR TO
THERE'S NO LIMIT ON THIS.
THERE'S NO LIMITS IN TERMS OF
NUMBER OF DOSES, THE INTERVAL
BETWEEN DOSES.
THERE'S NO LIMITS REGARDING THE
PREVALENCE OF DISEASE.
THAT ONE I HADN'T THOUGHT OF
BEFORE.
DOES THIS RECOMMENDATION REALLY
NEED IT?
IF WE RESORT TO OR GET BACK TO A
LOW-INCIDENT STATE.
SO I'M SITTING HERE THINKING TO
MYSELF, OKAY, I'M COMFORTABLE
WITH THIS FIRST PREGNANCY.
I'M PROBABLY COMFORTABLE SECOND
PREGNANCY.
WHAT IF THOSE PREGNANCIES ARE A
YEAR APART?
AM I NOW COMFORTABLE?
WHAT IF IT'S THE THIRD PREGNANCY
AND THREE HAVE OCCURRED WITHIN
THREE PREGNANCIES?
AM I COMFORTABLE NOW?
WE HAVE A PRESIDENTIAL CANDIDATE
WHO HAS FIVE KIDS.
THERE ARE FAMILIES OUT THERE WHO
HAVE MULTIPLE PREGNANCIES, AND
THEY OCCUR RATHER QUICKLY.
I'M JUST KIND OF WONDERING, DID
THE WORK GROUP AT ALL CONSIDER
LIMITS?
>> THAT WAS PART OF THE
DISCUSSION.
THE CONCERNS WERE ABOUT
SCENARIOS SUCH AS YOU DESCRIBED
WHERE WE HAVE POTENTIALLY A
WOMAN WITH THREE PREGNANCIES
WITHIN THREE YEARS.
REASSURINGLY, THE STATISTICS
AVAILABLE ON BIRTH IN THE UNITED
STATES, THE PREGNANCY INTERVALS
ARE GREATER THAN ONE YEAR.
ON AVERAGE, A WOMAN HAS ONLY TWO
KIDS.
I MEAN, IN ADDITION TO THAT,
WITH REGARDS TO PLACING LIMITS
ON THE NUMBER OF DOSES AND
REVIEWING THE SAFETY DATA, THE
WORKING GROUP FELT THAT, YES,
THERE ARE CONCERNS ABOUT THAT,
BUT THIS SHOULD NOT BE THE
REASON TO NOT DEFER OR NOT TO
MAKE THIS RECOMMENDATION.
DR. SAWYER?
IT'S A BAD PROBLEM.UMMARIZE IT,
WE NEED TO DO SOMETHING NOW.
NO DOUBT WE NEED ADDITIONAL
DATA.
NO DOUBT WE NEED TO REVISE --
POTENTIALLY REVISE THE
RECOMMENDATION OVER TIME.
I DON'T SEE WE HAVE AN
ALTERNATIVE NOW.
>> DR. BAKER.
>> DOUG, YOU NEED TO CHECK THE
ROMNEY CHILDREN INTERVAL.
YES, THERE ARE FIVE, BUT THEY'RE
NOT ONE YEAR APART.
IF HE'S GOING TO SAY SOMETHING
POLITICAL, SO AM I.
WHAT I WANT TO SAY IS, YOU KNOW,
IN MY YEARS ON THE ACIP, THE ONE
THING THAT I THOUGHT THE MEMBERS
REALLY TOOK BESIDES EVIDENCE --
AND THERE'S NO QUESTION WE NEED
MORE EVIDENCE HERE AND HARD
DATA.
ABSOLUTELY NO QUESTION.
IT'S RISK.
AND THIS IS TOP OF THE ICEBERG
RISK FOR INFANTS UNDER 2 MONTHS
OF AGE, VERSUS BENEFIT.
RISK TO THE MOTHER, BENEFIT.
THAT'S HOW I HOPE YOU WILL VOTE.
>> I THINK YOU HAVE A COMMENT.
>> I HAVE A FOLLOW-UP TO TOM'S
QUESTION.
CAN YOU REMIND US THE DURATION
AFTER NATURAL PERTUSSIS DISEASE
COMPARED TO IMMUNIZATION?
>> GOSH.
GENERALLY CONSIDERED LONGER, BUT
I DON'T THINK IT'S REASONABLE TO
TALK IN TERMS OF SOME INTERVAL
LIKE 4 TO 12 YEARS.
I THINK PROTECTION JUST WANES
SORT OF IMMEDIATELY OVER TIME.
WE'RE SEEING A SMALL INCREASE IN
THE RATE AT WHICH WANING OCCURS.
SO, YEAH.
>> WHAT IS THE TIME INTERVAL FOR
WHICH WE MIGHT BE ABLE TO
ANTICIPATE HAVING DATA TO
REASSESS IF WE APPROVE THIS
RECOMMENDATION?
WHEN COULD WE SAY WE'LL REVISIT
IT?
>> I MEAN, THE RESULTS WILL
HINGE ON COVERAGE AMONG THE
CONTROL GROUP, BASICALLY.
WE POWERED IT FOR 20% COVERAGE.
SO WE ASSUME IT WOULD BE LOW.
IT'S HUNDREDS OF CASES NEEDED.
WE THINK BASICALLY A YEAR,
TOWARDS NEXT SUMMER, WHEN WE
HOPE TO HAVE RESULTS.
>> THANK YOU FOR ALL THE
DISCUSSION.
I JUST HAVE A QUESTION.
I AGREE WITH ALL THE DISCUSSION
THAT'S GONE AROUND REGARDING A
MOTHER'S CHOICE REALLY IS NO
CHOICE WHETHER IT'S GOING TO
IMPACT HER.
SO MY RECOLLECTION IS THERE'S NO
DATA TO SUGGEST THERE ARE IN
EFFECTS BECAUSE THAT'S WHAT SHE
WOULD REALLY BE CONCERNED ABOUT.
I JUST WANT TO CLARIFY MY
UNDERSTANDING, WHICH IS THERE'S
NO EVIDENCE TO SUGGEST THERE ARE
ANY KINDS OF THOSE EFFECTS.
THE OTHER REASON THAT'S
IMPORTANT, AS THE OTHER
GENTLEMAN SAID, THE INFANT WOULD
NOT BE ABLE TO RECEIVE
COMPENSATION IF THE MOTHER WAS
VACCINATED.
>> DR. FRIEDLAND.
>> I WAS GOING TO COMMENT ON
THAT.
IN SEPTEMBER OF THIS YEAR,
BOOSTRIX WAS MOVED TO A CATEGORY
"B."
THAT STATES DEVELOPMENTAL
TOXICITY STUDY HAS BEEN
PERFORMED AND THERE'S NO
EVIDENCE OF HARM.
>> I SEE A MOMENT HERE WHERE WE
HAVE --
>> I'M SORRY.
THE STUDY WAS PERFORMED IN
ANIMALS.
>> THANK YOU MUCH.
I SEE A MOMENT HERE WHERE NO
HANDS ARE UP.
I'M WONDERING IF THERE'S ANYONE
WILLING TO CALL TO QUESTION.
OR IF THERE'S SOMEONE WILLING TO
MAKE A MOTION.
I'M SORRY.
>> MOTION FOR APPROVAL OF THE
RECOMMENDATION.
>> IS THERE A SECOND?
ANY FURTHER DISCUSSION?
DOCTOR?
>> SO AS THE RECOMMENDATION HAS
BEEN NOMINATED, IS THERE GOING
TO BE EXPLICIT LANGUAGE THAT'S
GOING TO BE REVISITED WHEN THE
RESULTS OF THE DATA ARE
AVAILABLE?
I WOULD LIKE TO ADD THAT, IF
IT'S NOT.
SAFETY AND EFFECTIVENESS.
>> YES, THAT CAN BE INCLUDED IN
THE STATEMENT.
IT WILL BE.
>> JUST A POINT OF
CLARIFICATION.
YOU WANT A STATEMENT THAT IT
I MEAN, AREN'T ALL OF OUR
SUBJECT TO THE NOTION THAT WE
THE EVIDENCE SHIFTS?
BE IN THE RECOMMENDATION.
COMMENT WITHIN THE
NOT PART OF THE RECOMMENDATION
LANGUAGE.
>> JUST RAISING THE QUESTION
GESTATION IN WHICH WE RECOMMEND
WOULD THAT BE A SEPARATE THING
>> THIS WOULD NOT BE INCLUDED IN
THIS WOULD BE PART OF THE
>> OKAY.
>> ONE LAST QUESTION.
THERE ARE DATA FROM THE CAROL S
BENEFIT?
COST EFFECTIVENESS.
EFFECTIVENESS BASED ON WHAT WE
GUESS.
THAT'S THE COST OF 72% COVERAGE
REGARDLESS OF BIRTH PER QUARTER.
I SEE NO ADDITIONAL COMMENTS.
DR. JENKINS AND GO CLOCKWISE.
>> PLEASE GIVE YOUR NAMES.
THAT WHEN YOU USE THE
TO IT BECAUSE SOME OF THE
HEARING US.
I VOTE YES.
>> KATHY HAIRMAN, YES.
>> ROSENBAUM, YES.
>> VAZQUEZ, YES.
>> SAWYER, YES.
>> YES.
>> YES.
>> IT LOOKS AS THOUGH THE MOTION
I BELIEVE WE NOW NEED TO HAVE
RESOLUTION.