>> GOOD MORNING. ON THIS SLIDE ARE THE MEMBERS OF
THE MENINGOCOCCAL WORK GROUP.
I WANT TO THANK YOU THEM.
CURRENTLY FDA LICENSES FOR
INFANTS AND TODDLERS.
THE MEN, LICENSED SEPTEMBER
2010, AS A TWO-DOSE SERIES
STARTING AT NINE MONTHS OF AGE.
THE HIB YTT, WHICH IS A FOUR
DOSE MENINGOCOCCAL VACCINE AT 2
MONTHS OF AGE, LIKELY IN JUNE
2012 AND THE VACCINES WE WISH TO
DISCUSS TODAY, THE MenACWY-CRM
VACCINE LICENSED FOR INFANTS
STARTING AT 2 MONTHS OF AGE IN
AUGUST 2013.
IN TERMS OF ACIP RECOMMENDATIONS
FOR INFANT MENINGOCOCCAL
RECOMMENDATIONS IN THE OCTOBER
2012 MEETING THERE WAS A
RECOMMENDATION FOR VACCINATION
OF PIRATE INFANTS AND THE
PURPOSE OF TODAY'S SESSION IS TO
CONSIDER ADDING MenACWY-CRM TO
THE LIST OF AVAILABLE
MENINGOCOCCAL VACCINES FOR USE
IN HIGH-RISK INFANTS.
THIS VACCINE PROVIDES PROTECTION
AGAINST ADDITIONAL GROUPS AND
MAY BE USED FOR INFANT TRAVELING
TO AREAS WHERE MENINGOCOCCAL
DISEASE IS HYPER ENDEMIC OR
ENDEMIC.
THIS VACCINE IS GIVEN AS 4.50
DOSES INTRAMUSCULARLY ADD 2, 4,
6 AND 12 MONTHS OF AGE AND
AGAINST GROUP A, P, W, AND Y AND
DOES NOT OFFER PROTECTION
AGAINST B.
IN GENERAL YOU'LL HEAR THE
SAFETY PROFILE IS SIMILAR
AGAINST OTHER CHILDHOOD
VACCINES.
IN TODAY'S SESSIONS WE'LL HAVE
SPEAKERS GO OVER THE INMUNOLOGY
AND SAFETY OF THIS VACCINE,
PRESENT A GREAT EVALUATION AND
BE A CONSIDERATION FOR USE OF
THIS VACCINE IN HIGH-RISK
INFANTS.
AND WE ANTICIPATE A VOTE AND VFC
VOTE.
JUST TO SUMMARIZE OTHER
ACTIVITIES OF THE MENINGOCOCCAL
WORK GROUP, IN MARCH 2013, THE
STATEMENT WAS PUBLISHED.
WE REVIEWED AND UPDATED THE DB
VACCINATION AND THERE WILL BE A
RECOMMENDATION REPORT THAT WAS
APPROVED BY THIS COMMITTEE IN
FEBRUARY OF 2013, AND SHOULD BE
PUBLISHED IN EARLY 2014 AND
THEY'RE WORKING ON A AN APPROACH
FOR THE MENINGOCOCCAL VACCINE.
>> THANK YOU, DOCTOR RUBIN.
>> OKAY.
THANK YOU AGAIN FOR THE
OPPORTUNITY TO SPEAK ABOUT
MENVEO.
MY NAME IS PETER, THE HEAD FOR
THE VACCINE CLINICAL FRANCHISE
SO I LEAD THE GROUP THAT
DEVELOPS BOTH THE MENINGOCOCCAL
MenACWY-CRM VACCINE AND WE ALSO
RECENTLY LICENSED THE MEND
VACCINE IN AUSTRALIA.
AND ABCW CLINICAL TRIALS HERE
IN THE U.S. AND ELSEWHERE.
ALSO LEAD THE GROUP THAT LEADS
THE MATERNAL IMMUNIZATION
PROGRAM FOR GROUP B AS WELL.
THE VIRUS.
SO I'M GOING TO KEEP IT
PRETTY NARROW AND TALK ABOUT THE
INCREMENTAL CLINICAL DATA
GENERATED FOR THIS VACCINE SINCE
THE LAST TIME I WAS HERE GIVING
AN OVERVIEW OF THIS VACCINE A
COUPLE YEARS AGO.
GOING TO TALK ABOUT THREE
DIFFERENT STUDIES.
ONE IS THE STUDY IN, PHASE 3
STUDY LOOKING AT 2, 4, 6, 12
MONTH SCHEDULE IN INFANT
VACCINES.
THE STUDY MOST PROMINENTLY
FEATURED IN THE PACKAGE INSERT
THAT WAS PART OF THE U.S.
LICENSURE LABEL.
IT I'M GOING TO TALK ABOUT A
TWO-DOSE TODDLER STUDY OR OLDER
STUDY SIMILAR TO THE OTHER
SCHEDULE ADMINISTERED AT 7 AND 9
MONTHSo )5 AND THE 12 MONTH SCE
ALSO COMMON USE DATA WITH MMRV
AND THAT STUDY AND FINALLY
ONGOING PERSISTENT STUDIES.
I'LL GIVE YOU A FIRST LOOK AT
THE 40-MONTH TIME PERIOD FROM
THE LATE FOLLOW-UP AFTER THE
SERIES.
SO HERE'S THE DESCRIPTION OF
MenACWY-CRM.
YOU CAN SEE AT THE TOP.
IT'S INDICATED NOW FOR
PREVENTION OF INVASIVE DISEASE
CAUGHTED BY MenACWY-CRM GROUPS.
IT'S TAKEN THE LAST FIVE OR SO
YEARS TO CHANGE THAT -- THAT 2
FROM TWO YEARS IN THE LOWER
LIMITS TO 2 MONTHS.
SO, BUT NOW AS INDICATED FROM 2
MONTHS OF AGE TO 55 YEARS OF
AGE, THE SAME SLIDE HAS BEEN
SHOWN THE LAST COUPLE TIMES I'VE
BEEN HERE.
SAME DISEASE.
10 OF A, 5 OF C.
W AND Y COMPONENT.
AND IT'S A LIQUID FORMULATION.
A LIQUID CWY USED TO RESPONSE
STUT A MONTH KNOP LIESED A
COMPONENT.
THE VACCINE CONTAINS NOA AGAGE
AND NO PRESERVATIVE.
HERE'S THE SCOPE OF THE CLINICAL
PROGRAM THAT PROVIDES THE KEY
DATA TO SUPPORT'S LICENSURE FOR
THIS IN INFANTS.
THE TOP TWO STUDIES I'VE
PRESENTED ON PREVIOUSLY THE P5
STUDY SUPPORTED THE DOSE AND
DOSE REGIMEN FINDINGS CONDUCTED
IN UK AND CANADA.
ALSO SHOWED DATA WITH GOOD
ETHNICITY AFTER THE SECOND DOSE
AT 5 MONTHS OF AGE.
THE NEXT IS THE B14 STUDY.
THIS IS A STUDY WITH, WHICH WAS
A PHASE 3 STUDY CONDUCTED IN THE
U.S. AND LATIN AMERICA.
ALSO HAD COMMON USE IN THAT
CASE.
SO WE BOTH STUDIED THE PEDIORIC
AND THAT STUDY PREVIOUSLY I
PRESENTED IN 2011, AND THAT
SHOWED CON COM NANT USE
SUPPORTED FOR THE ANTIGENS
SUPPORTED IN PEDDYRIX AND 7.
TODAY I'LL REVIEW THE BOTTOM
THREE STUDIES.
A LARGE 7,700 SUBJECT SAFETY
STUDY CONDUCTED IN THE U.S.,
LATIN AMERICA AND ASIA.THE UNDE
PROVIDES THE KEY IMMUNOGENICITY
DATA AND THE COMMON ANALYSIS AND
FINALLY THE P 321, TWO DOSE
OLDER INFANT STUDY'S IN TOTAL,
IN THE CLINICAL TRIAL DATABASE
THAT SUPPORTED THE LICENSURE OF
APPROXIMATELY 9,000 INFANTS THAT
RECEIVED THE FOUR-DOSE INFANT
SERIES AND APPROXIMATELY 2000
OLDER INFANTS RECEIVED THE
TWO-DOSE SERIES.
SO HERE'S THE GENERAL DESIGN OF
THOSE TWO INFANT STUDIES I
MENTIONED.
THE P-23 AND THE UNDERSCORE 33.
AND THIS IS A STANDARD INFANT
VACCINATION CON COM NANT YOUTH
STUDY.
ONE ARM WOULD HAVE RECEIVED
MEN
MENVIO KRM THE OTHER A VACCINE
ONLY, ONE OF THE CHALLENGES TO
THIS PROGRAM WAS THE LACK OF A
LICENSED BUT NON RECOMMENDED
KPARTER
COMPARETER IN THE SPACE.
AFTER A DISCUSS WITH FDA ALL OF
THESE STUDIES IN THE INFANT
INDICATION WAS RUN WITH OPEN
LABEL DESIGN.
SO AN INHERENT CHALLENGE TO WHAT
WAS AVAILABLE TO US WHEN WE RAN
THE CLINICAL TRIAL THAT THESE
WERE ALL OPEN LABEL STUDIES.
SO STUDY OBJECTIVES TO SHOW THE
ADEQUACY OF THE RESPONSE AFTER A
FOUR-DOSE SERIES TO A CERTAIN
THRESHOLD NEEDED TO BE MET FOR
ACWY AFTER THE COMPLETION OF THE
SERIES, AND THEN CON COM NENT
USE ANALYSIS WITH ROUTINE
VACCINES.
HERE'S THE IMMUNE GENICITY DATA,
VERY SIMILAR TO THE P-14 STUDY I
PREVIOUSY SHOWED.
SO GOOD RESPONSES AFTER THE
INITIAL PRIMARY SERIES TO THE
CYW, YOU SEE 94% TO 98% OF THESE
KIDS REACHED THE PROTECTIVE
THRESHOLD AFTER THE BOOSTER DOSE
AT 12 MONTHS OF AGE.
95% ACROSS ALL FOUR WITH 89%
AGAINST THIS GROUP A.
YOU SEE A DECLINE PRIOR TO THE
BOOSTER DOSE MORE MARKEDLY WITH
THIS, USE OF THE FDA BUT GOOD
PERSISTENCE IN THE OTHERS.
NOW MOVING ON TO CON COM NANT
USE.
THIS AGAIN WAS BASED ON CON COM
NANT USE STUDY'S WE USED -- IN
THIS CASE IT WAS THE HBV
VACCINE, EITHER THE GFK OR MERCK
VACCINE.
YOU SEE THE TIGHTERS ELICITED
WITH THE PLUS TRIM AND THE
YELLOW BARS THE ROUTINE VACCINES
ALONE AND YOU SEE VERY FLAT
ACROSS THE TOP THERE, SIMILAR
MEAN RESPONSES WHEN GIVEN
COMCOMNANTLY WITH THE SCHEDULE.
FOR THE FOUR COMPONENTS OF THE
PERTUSSIS COMPONENT, TWO
DIFFERENT ANALYSES WERE DONE.
BOTH A SEROUS RESPONSE AND GO 3
RATIO.
I'M SHOWING THE SEROUS RESPONSE
DATA.
FDA HAS INCLINATION TOWARDS THE
SEROUS RESPONSE MORE SO THAN THE
GMC RATIO SO I BRING IN THIS
DATA FIRST.
THE GMC RATIO DATA LOOKED
PERFECT.
THE POINT ESTIMATE OF THE GMCs
IN THE CONCOMNANT USE DATA WERE
HIGHER WHEN MENDIO WAS GIVEN
WITH PENICILLIN IN THIS CASE.
SO ALL FOUR OF THESE PERTUSSIS
ON THE G RATIO IN WCONTRAST YOU
SEE ON THE SEROUS, JUST BELOW,
THE MINUS 10, MISSED FOR BOTH
PERTUSSIS TOXIN AND ON POST
ANALYSES LOOKING AT GROUP AND
CENTER EFFECTS, IT WAS IN FACT
ACHIEVED FOR THE PERTUSSIS TOXIN
AND THE OTHER REMAINED OUTSIDE
THE PRIORITY LIMIT.
MOOSHING ON TO THE PREVNAR 7, AS
BOTH MENVIO AND PREVNAR BOTH
CONTAIN THE SAME PRIM CARRIER
PROTEIN, A TOPIC OF SOME
INTEREST.
AS I MENTIONED EARLIER, NON-
NON-INFERIORITY ACHIEVED IN 13
OF THE 14 TYPE ANALYSES IN THE
TWO DIFFERENT STUDIES.
SO T-14 LOOKED AT POST-THIRD
DOSE.
13 AND 14 ACHIEVED THE
NONINFERIORITY AFTER THE THIRD
DOSE AND ALL ACHIEVED IT AFTER
THE FOURTH DOSE.
THE T-14 STUDY.
IN THIS STUDY, NON-INFERIORITY
RECEIVED IN FIVE OF THE DOSES.
6B AND 23F, IT WAS ACHIEVED.
THE SAME POEFRT-ANALYSIS LOOKED
FOR CENTER EFFECT AND THERE WAS
A STRONG CENTER EFFECT IN
NON- -- WAS ACHIEVED AFTER
ANALYSIS LOOKING WITH THE CENTER
EFFECT TAKEN INTO ACCOUNT.
MORE IMPORTANTLY, POST-BOOST
DOSE, WE LOOK AT A DIFFERENT EN
HIGH, ITS FELT TO BE LET
INTERESTING THAN USING A GMC
RATIO.
THE TYPICAL FDA EXPECTATION IS
THAT A GMC RATIO ANALYSIS IS
VIEWED TO ANALYZE WHETHER THE
TITERS ARE MEANINGFULLY IMPACTED
BY THE CONCOMNANT USE OF A NEW
VACCINE AND THE LOWER LIMIT OF
THE 95% INTERVAL IS EXPECTED TO
BE ABOVE .5 IN THE GMC RATIO AND
HERE YOU SEE AFTER THE BOOST,
THE NUMBERS ARE, HAVE ACHIEVED
THE NON-INFERIORITY ACROSS EACH
OF THE SEVEN ZERO TYPES OF THIS.
THIS IS SIMILAR TO WHAT WAS
SHOWN IN THE T-14 STUDY IN THE
TWO DIFFERENT COHORTS.
14 OF 14 OF THOSE ANALYSES WERE
ALSO ACHIEVED IN
NON-INFERIORITY.
SO YOU CAN SEE THE NUMBER OF
ANALYSES WE'RE TALKING ABOUT.
SO THEY WERE 42 DIFFERENT
ANALYSES FOR PREVNAR 7 BOTH
PRIMARY AND POST-BOOFRT AND OF
THE 42 DIFFERENT ANALYSES, THREE
NON-INFUL FEAR OR THEY WERE
MISSED AFTER POST, ONE OF THE 2
2
WERE MISSED.
IMPORTANTLY, AFTER THE BOOST
DOSE, NO NON-INFERIORITY WERE
MISSED IN EITHER OF THE STUDIES
THAT WE ANALYZED.
MOVING ON TO REACTIVE GENICITY
HERE, YOU CAN SEE, LOOK AT
INJECTION SITE REACTIONS AND IN
THIS CASE WE LOOKED AT THE
INJECTION SITE OF EITHER MENVIO
OR IN THE CONTROL GROUP USING
PREVNAR FOR INJECTION SITE
REACTIONS.
YOU CAN SEE THE RED BAR
GENERALLY SIMILAR IF NOT LOWER
INJECTION SITE REACTIONS WERE
SOLICITED AFTER MENDIO
ADMINISTRATION NOT UNEXPECTED.
IT'S AN AGITANT VERSUS
NON-AGITANT.
NONE SEEN AS OVER REACTIONS.
SIMILAR ANALYSIS WITH SYSTEMIC
REACTIONS.
HERE YOU SEE THE SAME SORT OF
ANALYSIS.
IN THE RED YOU SEE THE SYSTEMIC
REACTION SOLICITED WITHIN SEVEN
DAYS OF VACCINATION WITH EITHER
THIS, WITH ROUTINE OR ROUTINES
ALONE AND SIMILAR READS BOTH OF
ANY REACTIONS OR IN THE GRAY BAR
AT THE BOTTOM OR SEVERE
REACTIONS.
VERY SIMILAR TO MENVEO ON TOP OF
ROUTINE VACCINE.
NOW JUST BRIEFLY ON TO THE P-21
STUDY.
SO THIS IS A LATE TODDLER
VACCINATION OR LATE INFANT
VACCINATION.
IT'S THE FIRST DOSE ADMINISTERED
BETWEEN 7 AND 9 MONTHS OF AGE
WITH A SECOND DOSE ADMINISTERED
AT 12 MONTHS OF AGE.
THE SECOND DOSE ADMINISTERED
EITHER ALONE OR WITH THE MMRV
ADMINISTERED AT 12 MONTHS.
THIS STUDY WAS BEGUN IN 2007 AND
CONDUCTED WHEN MMRV WAS MORE
ROUTINELY GIVEN AT THE 12-MONTH
DOSE.
AND SO THE STUDY OBJECTIVES WERE
AGAIN, RESPONSE AFTER A TWO-DOSE
SERIES.
THE SAME SORT OF THRESHOLD FOR
ACWY NEEDED TO BE MET, AND THEN
NON-INTERFERENCE.
HERE YOU CAN SEE THE RESPONSES
TO THE FIRST DOSE IN THE ORANGE.
SO AFTER THE 7 TO 9 MONTH AGE
DOSE WE TOOK A BLOOD AT 8 TO 10
MONTHS OF AGE AND YOU CAN SEE
LOWER RESPONSES WITH A, W AND Y,
BUT A GOOD RESPONSE TO THE C
COMPONENT AFTER A SINGLE DOSE OF
7 TO 9 MONTHS OF AGE.
AND THEN AFTER THE BOOSTER DOSE,
AGAIN, VERY HIGH RESPONSES
MEETING THE SUFFICIENT CRITERIA
PER THE PRESPECIFIED SUFFICIENCY
OF THE STUDY.
HERE YOU SEE THE
NON-INTERFERENCE STUDY ANALYSIS.
WITH THE MMRV COMPONENT AND
LOWER LIMITS OF THE 95%,
ACQUIRED TO BE ABOVE, MINUS 5%
AND IN EACH CASE, THE CONCOMNANT
USE WAS SUPPORTED AND NON
INFERIORITY REEVED FOR THE MMR.
FINALLY LOOKING AT THE EARLY
LOOK AT THE LONGER TERM.
SO FROM THE EARLIER PHASE 3
STUDY THAT I MENTIONED FROM
T-14, WE ARE NOW FOLLOWING THESE
KIDS OUT AT 3 1/2 YEARS OF AGE
AND WE'RE GOING TO GET MORE DATA
ON THEM LATER THIS YEAR.
AT 5 YEARS OF AGE.
YOU CAN SEE THE RED BAR.
THE PRIMARY RESPONSE AFTER THE
INFANT SERIES, AND THEN IN THE
ORANGE BAR, YOU SEE THE DECLINE.
AGAIN, MOST PROMINENTLY WITH A.
THAT'S WITH GROUP W AND THE Y
AND SOME SEEN BETWEEN.
THIS IS THE 40 MONTH OF AGE,
BETWEEN 34% AND 76% FOR C, W, Y,
PER SI
PERSISTENCE IN THIS.
IN SUMMARY, WELL TOLERATED
IMMUNOGENIC IN INTANTS AND OVER
7,500 INFANTS STUDIED WITH THE
FOUR-DOSE ADMINISTRATION.
NO UNEXPECTED SAFETY SIGNALS
OBSERVED.
SIMILAR IMMUNOGENICITY OBSERVED
FOR ALL CONCOMNANLT VACCINE
ORIGINS ACHIEVED ACROSS EACH OF
THE SEVEN TYPES AFTER THE FOURTH
DOSE OF PREVNAR 7.
I SHOULD MENTION WE ARE
CONDUCTING AS AN ONGOING STUDY
WITH PREVNAR 13, WE SHOULD HAVE
DATA IN EARLY 2014.
ALSO WELL TOLERATED IMMUNOGENIC
7 TO 9 MONTHS OF AGE, SECOND
DOSE AT 12 MONTHS AND RESISTANCE
DATA IS AVAILABLE AT 40 MONTHS
WITH ONGOING STUDIES WITH DATA
AT 60 MONTHS AVAILABLE.
AGAIN, IN EARLY 2014.
THANK YOU VERY MUCH.
>> I THY ITINK IT'S TIME FOR A
COUPLE OF QUESTIONS FOR PEOPLE
REGARDING THE VACCINE
PRESENTATION.
>> DOCTOR?
>> THANK YOU VERY MUCH, FOR THE
PRESENTATION.
HAVE YOU DONE ANY TRIALS WITH
ANY OTHER MA NING MENINGOCOCCAL
VACCINES?
>> IN THE ADOLESCENCE POPULATION
OUR LICENSE CRITERIA WERE IN THE
11 TO 55, 2 TO 10 AGE GROUPS,
THE LICENSURE WAS REQUIRED.
SO NON-INFERIORITY WAS ACHIEVED
FOR THOSE ANALYSIS.
THEY WERE STATISTICALLY HIGHER
AGAINST THREE OF THE FOUR GROUPS
STUDIED VERSUS THE OTHER IN THE
POPULATION.
>> JUST A QUICK QUESTION ON THE
CODE ADMINISTRATION WITH MMRV.
DID YOU SEE ANY SAFETY -- I
DON'T THINK YOU PUT DATA UP
THERE IN TERMS OF THE ADVERSE
EFFECTS, WHAT CAME OUT WITH THE
TODDLER DOSING?
>> YES.
I MEAN, AS FAR AS, WE DO HAVE
THAT DATA AS WELL.
IT'S PUBLISHED, BUT THERE WAS NO
INCREASE IN THE FEVER PROFILE OR
CHANGE IN THE FEVER PROFILE FOR
MMRV AND IT WAS UNDER POWERED TO
HAVE A DISCUSSION ABOUT THESE
PROCEDURES.
>> THANK YOU.
>> DOCTOR?
>> THANK YOU.
JUST A QUICK QUESTION ON YOUR
T-21 SLIDE.
THE 7 TO 9 MONTH CHILDREN.
DO YOU HAVE PRE-VACCINATION
LEVELS?
HIGHER?
DATA POINTS?
>> YES.
I MEAN, I GUESS YOU CAN ALSO
INFER PRE-VACCINATION FROM THE
BASE LINE DATA HERE IN THE U.S.
POPULATION.
SO, AGAIN, WE SEE VERY LOW
HSDAs.
I DON'T SHOW THE CONTROL GROUP
HERE, BUT IT REALLY STAYS QUITE
FLAT.
SO AT LEAST IN OUR HANDS WE SEE
NO BACKGROUND INCREASE WITHOUT
VACCINATION.
THOSE ARE ALL VACCINE INDUCED.
YES.
>> OKAY.
THANK YOU VERY MUCH.
I GUESS WE MOVE ON TO
DR. BRIERE?
>>> GOOD MORNING.
I GUESS ON THE THIRD ANNIVERSARY
UPGRADE I WILL BE TRENTING THE
THIRD GRADE EVALUATION TO THE
MENINGOCOCCAL VACCINE.
I WILL DESCRIBE OUR STUDY
QUESTION AND OUR GRADE
ASSESSMENT OF THE EVIDENCE FOR
THE BENEFITS AND HARMS OUTCOME.
CONCLUDE WITH THE WORKING
GROUP'S DEMOCRATENATION OF
EVIDENCE AND REVIEW THE VALUES
AND PREFERENCES AND ESTIMATED
COSTS OF THE VACCINE USE.
THE FIRST STEP IN THE GRADE
PROCESS IS FORMULATE THE STUDY
QUESTIONS.
INLIGHT OF THE CURRENT
RECOMMENDATIONS FOR
MENINGOCOCCAL VACCINE FOR
INCREASED RISK IN INFANTS, STUDY
QUESTION, WHETHER ACIP SHOULD
BE USED FOR ALL 2, 4, 6 AND 12
MOLDS FOR ALL MENINGOCOCCAL.
IN GRADE, WHEN CONSIDERS, FIRST
EVIDENCE GRADED DURING THE
BALANCE BETWEEN BENEFITS AND
HARMS IN THE OVERALL EVIDENCE.
AND THE CAUSE OF THE VACCINE ARE
ALSO CONSIDERED.
NOW WE'LL DISCUSS THE OUTCOMES
WE GRADE AND OUR DETERMINATION
EVIDENCE TYPE FOR THESE
OUTCOMES.
AFTER DETERMINING THE STUDY
QUESTIONS THE WORK GROUP
SELECTED OUTCOMES THEY FELT WERE
IMPORTANT TO ANSWER THE
QUESTIONS.
THE QUALITY OF THE EVIDENCE FOR
THESE COMES ISN'T EVALUATED.
SHOWING RANKINGS CONSIDERED FOR
MENINGOCOCCAL VACCINE.
ONLY MILD ADVERSE EVENTS.
SO THEY WEREN'T IMPORTANT.
THE FINAL OUTCOMES GRADED
INCLUDING SHORT TERM AND LONG
TERM EFFICACY FOR VACCINATION IN
SERIOUS EVENTS AND INTERFERENCE
IN THE HARNS OF VACCINATION.
IN COMPILING EVIDENCE TO GRADE
FOR EACH OF THESE OUTCOMES WE
USED SEVERAL INCLUSION CRITERIA
INCLUDING U.S. AND NON-U.S.
POPULATIONS.
AS LONG AS THE PROPOSED U.S.
SCHEDULE OF 2, 4, 6 AND 12
MONTHS WAS USED FROM ACIW.
WE COMPILED D CRM AND OUTCOME.
FOUR MET CRITERIA.
ONE PUBLISHED, ONE PRESENTED AT
CONFERENCE.
ONE UNPUBLISHED.
ALL OF THESE STUDIES WERE RCTs.
ONE STUDY DID NOT HAVE A CONTROL
GROUP FOR THE EFFICACY OUTCOME.
OBSERVATIONAL FOR THIS OUTCOME.
DOUG AND I READ THIS AND
SEPARATELY COMPARED RESULTS.
DIFFERENT RESULTS WERE SPECISPE
REACHED.
DUE TO THE LOW INNOCENCE OF MENG
COCKLE DISEASE, THE STUDIES WERE
NOT -- THE BACTERIAL STUDIES
WERE USED FOR PROTECTION.
MULTIPLE STUDIES HAVE SHOWN
HUMAN TITERS 1 TO CORRELATE
INFECTION AGAINST
DISEASE.
THIS ACTIVITY AGAINST -- TITERS
BIGGER THAN 1 PROTECTION FOR
VACCINE FOR OTHER GROUPS.
INDIRECT DATA ADDS TO CONFIDENCE
ARE THIS.
THIS WAS DONE TO CORRELATE WITH
SBA TITORS IN THE U.S. AND IN
THE UK.
AS JUST PRESENTED BY DR. DULL,
SHORT-TERM EFFICACY IS ACHIEVED
FOR ALL GROUPS AFTER THE INFANT
3 DOSE AND THE FULL FOUR-DOSE
SERIOUS.
28 MONTHS FOURTH DOSE VARIED BY
PEER GROUP.
A HIGHER PERCENTAGE OF PATIENT
PROTECTED FOR GROUPS W AND Y AND
A AND C.
THIS WANING IMMUNITY INDICATE
THE VACCINE IS UNLIKELY TO
PROVIDE PROTECTION LONG TERM AND
FOR CHILDREN AT AT RISK LONG
TERM.
IN ALL STUDIES FOR THE ADVERSE
EVENT, EVENTS THE
TIME OF VACCINATION THROUGH SIX
MONTHS POSTVACCINATION AND WERE
PHYSICIAN VERIFIED.
AMONG OVER 5,000 INFANT STUDIED,
AT LEAST ONE SERIOUS ADVERSE
EVENT WAS REPORTED DURING INFANT
SERIES.
AND 2% CONTROLLED.
OF THESE 1 ADVERSE EVENTS
REPORTED ONE MONTH AFTER THE
INFANT SERIES BY 1% OF THOSE
STUDY PARTICIPANTS AND CONTROLS.
AND AT LEAST ONE ADVERSE EVENT
REPORTED SIX MONTHS AFTER THE
SERIES.
11 SERIES ADVERSE I VENTS WERE
CONSIDERED POSSIBLY RELATED TO
MANY C, Y, W, BY
NON-INVESTIGATORS.
TEN DEATHS OCCURRED AMONG
SUBJECTS WHO RECEIVED THIS.
TWO DEATHS OCCURRED AMONG
SUBJECTS IN THE CONTROL ROOM.
NO CLUSTERING OF ANY SINGLE ONE
CAUSE OF DEATH AND NO TEMPORAL
CLUSTERING RELATIVE TO RECEIVING
THE VACCINE.
A 3-1 OR 2-1 RANDOMIZATION USED
IN THE STUDIES.
IN ONE STUDY THE CONTROL ARM
CROSSED OVER AND RECEIVED MANY
AT 12 MONTHS.
AT DIFFERENT TIME POINTS IN THE
STUDIES THERE WERE BETWEEN 7,000
AND 9,000 TOTAL SUBJECTS THAT
RECEIVED THIS CRM, AND DATA
HEAVILY WEIGHTED AND EXPOSURE
TO.
CRM RECIPIENTS.
HOWEVER, NONE OF THESE STEPS
WERE CONSIDERED RELATED TO THE
RECEIPT OF MANY CRMS.
BASED ON THESE WHO ADMINISTERED
VACCINES AND RESPONSES TO
DIPHTHERIA, HEPATITIS AND ALL
POLIO VIRUS MET THE CRITERIA
AFTER CO-ADMINISTRATION WITH
MANY CRMS.
IN TWO OF THE THREE STUDIES,
INFERIORITY SOME WERE NOT MET AS
WEWE JUST HEARD.
IN ONE STUDY, NON-INFERIORITY
WERE NOT MET.
IN THE SECOND STUDY,
NON-INFERIORITY CRITERIA WERE
RATIOS NOT
WHEN USING THE SECONDARY
RESPONSE.
IN SEVERAL STUDIES, POST-DOSE
THREE AFTER THE ADMINISTRATION
DID NOT MEET KI CRITERIA FOR
NON-INFERIORITY.
ALL MENINGOCOCCAL -- IN ALL
STUDIES.
LOOKING AT THE BENEFITS AND
HARMS FOR AN INFANT IN CRM
SERIES THE VACCINE IS SAFE IN
THE SHORT TERM ALTHOUGH DURATION
VARIES BY GROUP.
IN GRADE ALL THE AVAILABLE DATA
FOR EACH OUTCOME ARE EVALUATED
ON THESE FIVE CRITERIA AND FINAL
EVIDENCE TYPE ASSIGNED.
NONE OF THE STUDIES FOR MANY CRM
WERE BLINDED.
THEY FELD BLINDING WAS LIKELY TO
INTRODUCE MORE BIAS FOR A MORE
SUBJECTIVE OUTCOME BUT SERIOUS
ADVERSE EVENTS AND LESS LIKELY
TO INTRODUCE BIAS FOR AN
OBJECTIVE OUTCOME SUCH AS
INTERFERENCE.
THEREFORE WE DOWN GRADED THE
EVIDENCE FOR A SERIOUS OUTCOME
IF THERE IS NO BLINDING BUT
DOWNGRADED THE EF CASEY FOR THE
OUTCOME.
THIS EVIDENCE TABLE LISTS THE
OUTCOMES CREATED ON THE LEFT
COLUMN AND THE FIVE CRITERIA ON
THE TOP ROW.
FOR RISK WE FOUND SERIOUS LIMIT
ACES FOR THE ADVERSE EVENTS
OUTCOME DUE TO NO BLINDING AND
LARGE FOLLOW-UP OR WITHDRAWALS.
NO SERIOUS LIMITATIONS WERE
FOUND FOR IN'S CONSISTENCIES.
LIMITATIONS WERE NOTED FOR
INDIRECTLY FOR ALL OUTCOMES
BECAUSE THE DATA AVAILABLE WERE
HEALTHY INFANTS AND NO DATA ON
HIGH RISK INFANTS WERE
AVAILABLE.
THE RANDOMIZED CONTROL TRIALS --
THE RANDOM CONTROL TRIALS DOWN
GRADED BECAUSE THE SAMPLE SIDES
WAS LESS THAN 300 AND THE LOWER
LIMIT OF THE INTERVAL SHOWED A
SMALL DIFFERENCE IN THE TITERS
IN THE CONTROL GROUP.
AND THERE ARE NO SERIOUS
LIMITATIONS FOR PUBLICATION BIAS
FOR ANY OF THE OUTCOMES.
SO IN SUMMARY, WE DOWNGRADED
EVIDENCE FOR RISK FOR THE SERIES
ADVERSE EVENTS OUTCOME FOR
INDIRECTLY NOR ALL OUTCOME AND
FOR THE LONG-TERM EF CASEY DATA.
WILL DID NOT DOWNGRADE FOR OTHER
ITEM.
THEREFORE THE OVERALL EVIDENCE
IS -- VALUES AND PREFERENCES OF
THE PUBLIC WERE PART OF THE BODY
OF EVIDENCE CONSIDERED DURING
THE JUNE 2011 AND OCTOBER 2012
ACIP DISCUSSIONS ON THE
RECOMMENDATIONS.
IN JUNE 2011, ACIP VOTED TO
RECOMMEND ROUTINE VACCINATIONS
OF TODDLERS 9 THROUGH 23 MONTHS
OF AGE WITH ONLY THE
MENINGOCOCCAL VANN VACCINE
LICENSED FOR THIS TIME.
IN OCTOBER 2012 AFTER LICENSURE
OF THE FIRST INFANT
MENINGOCOCCAL VACCINE, THE ACIP
VOTED TO RECOMMEND VACCINATION
OF INCREASED INFANTS 2 TO 23
MONTHS OF AGE.
WITH THESE TWO VOTES,
VACCINATION WITH THE VACCINE
BETWEEN THE STANDARD OF CARE FOR
HIGH-RISK INFANTS.
MANY AK IP PROVIDE ADDITIONAL
VACCINE OPTIONS FOR THESE
INFANTS.
A COST EFFECTIVENESS ANALYSIS
WAS NOT PERFORMED IN HIGH-RISK
INFANTS.
HOWEVER, BASED ON THE LOW
ESTIMATED NUMBER OF INFANTS PER
YEAR THAT ARE AT RISK FROM
MENINGOCOCCAL DISEASE AND COST
OF THE VACCINE OPTIONS FOR THIS
AGE GROUP, VACCINATING MANY WITH
CRMs HAS A LOW OVERALL COST.
THEREFORE, IN SUMMARY, THE
OVERALL EVIDENCE TYPE FOR THE
MANY CRM Y DATE STA 3.
ED SAFETY OF THE VACCINE AGAINST
GROUP A, C, Y AND W, THE STAND
OF CARE, MANY PROVIDES OPTIONS
FOR THE INFANTS AND HAS A LOW
OVERALL COST.
THE GRADE EVIDENCE TABLES FOR
MenACWY-CRM IN ALL INFANTS
PRESENTED AT PAST ACIP MEETINGS
AND POSTED ON THE WEBSITE.
THOSE PRESENTED TODAY AND
EVIDENCE TABLES FOR THE USE OF
MANY HIGH-RISK INFANTS WILL BE
ADDED TO THE WEBSITE.
I'D LIKE TO THANK YOU ALL WHO
CONTRIBUTED IN THIS EVALUATION
ESPECIALLY DOUG CAMPOS-OUTCALT
AND I'M HAPPY TO TAKE ANY
QUESTION, IF THERE ARE ANY, NOW.
>> ANY QUESTIONS FROM THE
MEMBERS?
YES.
>> I ASSUME IT WILL HAVE SOME
DEFINITION FOR THE PERSONS USING
THE VACCINE ABOUT WHO WE DEFINE
AS AN INFANT OF INCREASED RISK?
>> EXACTLY.
JESSICA WILL GO OVER THAT.
>> OKAY.
>> I JUST HAVE A QUICK QUESTION,
AND GOING BACK TO THE TABLE
OF -- I'M A LITTLE BIT TROUBLED
BY THE NUMBER OF DEATHS IN T
THE -- SLIDE 14 -- IN THE STUDY
GROUP VERSUS THE CONTROL GROUP,
AND JUST -- A LITTLE BIT MORE
EXPLANATION THERE WOULD BE
HELPFUL.
I THINK WE'RE STARTING OUT WITH
HEALTHY CHILDREN.
AND JUST HAVING THAT NUMBER OF
DEATHS IN A RELATIVELY SMALL --
SMALL COHORT, IT IS PRETTY
AMAZING TO ME CARDIAC ARRESTS,
CARDIOPULMONARY FAILURE, LUNG
INFECTIONS AND SO ON.
THESE ARE THINGS WE'RE NOT USED
TO SEEING IN HEALTHY INFANTS.
SO ANY EXPLANATION NOOR?
>> I DON'T THINK I CAN SPEAK
SPECIFICALLY TO THE CAUSES OF
THE DEATH.
I DON'T KNOW IF THE DOCTOR, DR.
DULL WANTS TO ADD TO THAT?
>> I GUESS I COULD AUGMENT THAT
A MAJORITY OF THE SUBJECTS WERE
ENROLLED EED IN THE U.S., BUT
HEALTHY -- I DON'T HAVE THE
NUMBER OFF THE TOP OF MY HEAD,
BUT PROVE SEVEN OF THE EIGHT OF
THE DEATHS WERE EX U.S. BP IN
LATIN AMERICA OR IN TAIWAN.
I THINK THAT ALSO IS AN
IMPORTANT CONSIDERATION OF
INFANT MORTALITY ANY THAT
POPULATION.
>> WAS THERE SIMILAR RECRUITMENT
BETWEEN THE TWO GROUPS, HOWEVER?
FOR THE CONTROL GROUP AND THE
ACTIVE GROUP?
>> RIGHT.
YES.
THE SAME RANDOMIZATION RATIO WAS
APPLIED THROUGHOUT.
SO, YES.
I THINK -- YES.
AGAIN, I THINK THE WAY WE LOOK
AT THESE WHEN WE TRY TO TEASE
OUT IF THERE'S SOMETHING GOING
ON HERE IS I THINK -- ELIZABETH
ALLUDED TO IT.
IS THERE A GROUPING OF TEMPORAL
ASSOCIATION, A MECHANISTIC
RATIONALE WHY THINGS ARE
HAPPENING?
A SET OF SYNDROMES IF AT ALL
RESPIRATORY?
SOME AUTOIMMUNE?
LOOKING AT THIS AND FDA, OF
COURSE, LOOKING AT THIS, WE
DIDN'T SEE A CONCERNING PATTERN
THAT AN OVERALL 3-1
RANDOMIZATION IN TIME YEARS, 5-1
DEATHS, THAT SORT OF SPLIT IS
NOT UNLIKELY, I GUESS IS WHAT
I'M LOOKING AT, IN OUTCOMES.
>> THANK YOU.
>> OTHER QUESTIONS OR COMMENTS?
>> HEARING NONE, LET'S THEN MOVE
ON TO MS. McNEIL.
>>> GOOD MORNING.
TODAY I WILL BE REVIEWING THE
PROPOSED RECOMMENDATION FOR USE
OF MenACWY-CRM IN INFANTS AT
INCREASED RISK OF MENINGOCOCCAL
DECEASE.
AUGUST 1, 2013, FDA EXPANDED FOR
MenACWY-CRM AS A FOUR-DOSE
PRIMARY SERIES TO INFANTS WITH
DOSES AT 2, 4, 6 AND 12 MONTHS
OF AGE.
THIS HAD PREVIOUSLY BEEN
APPROVED FOR CHILDREN AND ADULTS
AGE 2 THROUGH 55 YEARS.
MenACWY-CRM IS A THIRD
MENINGOCOCCAL IN INFANTS.
AT THE TWO-DOSE SERIES AT 9 AND
12 MOSS, A VIRULENT GROUP IS
LICENSED AS A FOUR-DOSE SERIES
AT 2, 4, 6 AND 12 AND 15 MONTHS
OF AGE.
MenACWY-CRM IS THE FIRST QU
QUADRIVALENT VACCINE IN INFANTS
2 THROUGH 12 MONTHS.
CURRENTLY RECOMMENDS VACCINATION
OF INFANTS AGE 2 THROUGH 23
MONTHS AT INCREASE FOR MA NING
KOCH THE DISEASE IN RESPECT IS
NO RECOMMENDATION FOR ROUTINE
VACCINATION OF ALL INFANTS
ALTHOUGH INFANTS LESS THAN 1
YEAR OF AGE ARE HEIGHTENED RISK
OF DISEASE.
INCLUDING THE HIGH PROPORTION IN
THE HIGHEST RATES PRIOR TO 6
MONTHS OF LIFE.
MENINGOCOCCAL DISEASE IS
CURRENTLY AT HISTORIC LOWS IN
THE UNITED STATES.
THEREFORE, ROUTINE INFANT
RECOMMENDATION WERE PREVENT A
LOWER PROR PORTION IN THIS AGE
GROUP.
VERY FEW INFANTS AND YOUNG
CHILDREN ARE CONSIDERED AT
INCREASED RISK FOR MENINGOCOCCAL
DISEASE.
INFANTS AT INCREASED RISK
INCLUDE THOSE WITH
INDEFICIENCIES, INCLUDING THOSE
WITH SICKLE-CELL DISEASE.
THOSE INVOLVED IN A COMMUNITY OR
INSTITUTIONAL OUTBREAK OR
INFANTS TRAVELING TO AN AREA
WHERE THIS DISEASE IS
HYPERENDEMIC.
INCREASED RISK FROM AN
INTRACOCKLE DISEASE IS LIKELY
SOMEWHERE BETWEEN 2,000 AND
5,000 PER YEAR AND A RATE OF 4
MILLION INFANTS.
THE INCIDENT OF THIS CONTINUES
TO DECLINE IN THE UNITED STATES.
IN 2012, 551 CASES WERE REPORTED
AMONG PERSONS OF ALL AGES.
113 OF THOSE CASES WERE REPORTED
AMONG CHILDREN LESS THAN 5 YEARS
OF AGE.
THIS TABLE SHOWS THE AVERAGE
ANNUAL NUMBER OF CASES OF
MENINGOCOCCAL DISEASE CALLED BY
THE FAGER GROUPS FOR CHILDREN
LESS THAN 5 YEARS OF AGE DURING
2010 TO 2012.
50% OCCURRED IN CHILDREN 0 TO 8
MONTHS OF A AGE AND OVERALL 54%
CHILDREN LESS THAN FIVE YEARS
CAUSED IN GROUP B.
AS WE SAW IN THE EARLIER
PRESENTATION, VACCINATION WITH
THREE DOSES OF MenACWY-CRM
RESULTED IN A PROTECTIVE
IMMUNORESPONSE FOR ALL GROUPS.
ALTHOUGH A LOWER RESPONSE FROM
GROUP A.
FOLLOWING A FULL SERIES OVER 89%
OF INFANTS ACHIEVE PROTECTIVE
ANTIBODIES TO ALL FOUR GROUPS.
MenACWY-CRM IS ALSO IMMUNOGENIC
BETWEEN 7 AND 12 MONTHS OF AGE.
TWO YEARS AFTER A COMPLETE
FOUR-DOSE SERIES ANTIBODY LEVELS
WANE ESPECIALLY FOR GROUPS A AND
C ININDICATING IT IS UNLIKELY TO
PROVIDE PROTECTION UNTIL THE 11
DOSE AND CAN MAINTAIN
PROTECTION.
WHEN THE FOUR DOSE SERIES WAS
ADMINISTERED CONCOM NANLT THELY
WITH THE VACCINE, NO OTHERS
OBSERVED FOR THE HEPATITIS C
ANTIGENS.
WITH A TWO-DOSE SERIES IN OLDER
INFANTS, NOT OBSERVED WHEN IT
WAS ADMINISTERED AT 12 MONTHS OF
AGE.
SEVERAL STUDIES, RESPONSE TO THE
PNEUMOCOCCAL, 6B AND 23F LOWERED
WHICH IT WAS CO-ADMINISTEREDRY
MenACWY-CRM.
THE TYPE 6B AND 23F DID NOT MEET
THE PHYSICAL CRITERIA FOR
HING
SEEN FOR THE OTHER FIVE PCB
TYPES.
NON INFERIORITY MET IN ALL TYPES
INCLUDING 6B AND THECWY-CRM
THESE DATA SHARED WITH BOTH THE
MENINGOCOCCAL AND PNEUMOCOCCAL
WORKERS.
THE CONSENSUS, MenACWY-CRM MAY
BE ADMINISTERED WITH PCB 13
INCLUDING IN CHILDREN BECAUSE
THE IMMUNE RESPONSE WAS
SUFFICIENT.
THE FINAL DOSE AT 12 MONTHS OF
AGE.
MenACWY-CRM APPEARS TO BE WELL
TOLERATED AND SAFE, RECORDED
ADVERSE EVENTS SIMILAR BETWEEN
INFANTS RECEIVING MenACWY-CRM
WITH ROUTINE CHILDHOOD VACCINES
AND CONTROL INFANTS RECEIVING
ROUTINE CHILDHOOD VACCINES
ALONE.
11 SERIOUS ADVERSE EVENTS, WHICH
MEANS VACCINES WERE REASONABLY
RELATED IN TIME TO THE ADVERSE
EVENT COULD BE EXPLAINED BY
CAUSES OTHER THAN THE VACCINE.
NO DEATHS WERE ATTRIBUTED TO THE
VACCINE.
WITH THE LICENSURE OF
MenACWY-CRM, INFANTS AT
INCREASED RISK FROM THE
INTERCOCKLE DISEASE HAVE A THIRD
OPTION FOR THIS.
BASED ON IMMUNOGENICITY, THERE'S
NO PREFERENCE FOR ANY OF THE
LICENSES VACCINATING
FORMULATIONS FOR INCREASED RISK
FOR MENINGOCOCCAL DISEASE EXCEPT
FOR TWO XAGSS.
FIRST, DOES NOT PROVIDE
PROTECTION AGAINST GROUP A AND
W.
IT'S NOT RECOMMENDED FOR USE IN
INFANTS TRAVELING TO THE
MENINGITIS BELT OR HAJJ.
SECOND, IT IS NOT RECOMMENDALED
FOR INFANTS 9 THROUGH 23 MONTHS
OF AGE WITH FUNCTIONAL OR
ANATOMIC -- IN ORDER TO AVOID
POTENTIAL INTERFERENCE WITH THE
FOURTH DOSE OF THIS.
GUIDANCE FOR USE OF MenACWY-CRM
IN INF INCREASED RISK
WILL ARE INTEGRATED WITH
EXISTING GUIDANCE.
THIS TABLE SUMMARIZES THE THREE
OPTIONS FOR TODDLERS AT
INCREASED RISK FOR MENINGOCOCCAL
DISEASE.
IT'S THE ONLY VACCINE LICENSED
FOR USE IN INFANTS 2 THROUGH 8
MONTHS IN AGE.
THIS TABLE HIGHLIGHTS THE
RECOMMENDATIONS AND INDICATIONS
FOR USE OF MENINGOCOCCAL VACCINE
IN INFANTS AND CHILDREN 2
THROUGH 23 MONTHS OF AGE AT
INCREASED RISK FOR MENINGOCOCCAL
DISEASE.
THESE RECOMMENDATIONS ARE PART
OF A LARGER TABLE OF
RECOMMENDATIONS WHICH ARE
INCLUDED IN THE RESOLUTION FOR
CHILDREN 18 YEARS OF AGE AND
YOUNGER.
THE PORTION OF THIS THABL WILL
BE UPDATED BASED ON TODAY'S VOTE
IS HIGHLIGHTED HERE.
IN ORDER TO IMPLEMENT THE
PROPOSED RECOMMENDATIONS INTO
THE FOLLOWING LAG WILL BE
INCLUDED.
INFANT 29 THROUGH 23 MONTHS OF
AGE AT INCREASED RISK SHOULD BE
VACCINATED WITH AGE APPROPRIATE
VACCINES.
MenACWY-CRM IS AN ADDITIONAL
OPTION FOR VACCINATING INFANTS 2
THROUGH 23 MOSS OF AGE AT
INCREASED RISK FOR MENINGOCOCCAL
DISEASE.
LANGUAGE SHALL BE INCLUDED IN
THE POLICY NOTE AS GUIDANCE FOR
YOU INCLUDES THOSE WHO REMAIN AT
INCREASE RISK FROM MA NINS
COCKLE DISEASES SHOULD RECEIVE A
DOSE THREE YEARS AFTER THE
PRIMARY SERIOUS AND DISHES
BOOSTS EVERY FIVE YEARS
THEREAFTER.
IF IT'S USED TO ACHIEVE
PROTECTION, A QUAD DRALANT
VACCINE SHOULD BE USED TO
COMPLETE THE SERIES.
THE PROPOSED RECOMMENDATIONS TO
THE VOTED ON TODAY ARE -- N BE
PROTECTION AGAINST GROUPS A, C,
W AND Y AND INCREASED GROUP AGE
2 THROUGH 23 MONTHS.
INFANTS 2 THROUGH 8 MONTHS WHO
TRAVEL TO COUNTRIES IN WHICH
MENINGOCOCCAL DISEASE IS
HYPERENDEMIC OR EPIDEMIC ARE
RECOMMENDED TO RECEIVECWY-CRM P
PROVIDE PROTECTION AGAINST
GROUPS A AND W.
MenACWY-CRM MAY BE ADMINISTERED
WITH PB-13 INCLUDING IN --
CHILDREN.
BEFORE I OP-- OPEN UP THIS FOR
CONFESS I WANTED TO THANK THOSE
WHO WORKED IN THE GROUP AND ALSO
WANTED TO THANK ELIZABETH BRIERE
FOR KEEPING OUR WORK GROUP
ACTIVITIES MOVING FORWARD IN THE
LAST FEW WEEKS AND HER
INSTRUMENTAL ROLE IN PREPARING
FOR TODAY'S SESSION.
I NOW WELCOME ANY QUESTIONS OR
COMMENTS ON THE PROPOSED
RECOMMENDATIONS.
>> THANK YOU HAVE.
I SEE A NUMBER OF HANDS GOING
UP.
DOCTOR?
>> SO I WANTED TO FOCUS ON THE
RECOMMENDATIONS FOR TRAVEL AND
SPECIFICALLY ON THE
MENINGOCOCCAL A RESPONSES, AND I
WAS REALLY WONDERING HOW THIS
COMPARES TO THE A, C, Y, W, D,
WITH RESPECT TO A, AND ALSO DO
WE HAVE ANY DATA, DO WE HAVE
DATA IMMEDIATELY AFTER
VACCINATION, AND DATA AT 40
MONTHS?
DO WE HAVE DATA AT INTERMEDIATE
TIMES?
BECAUSE MY CONCERN IS OBVIOUSLY
WANING TO A AND THEN IN
TRAVELING.
>> INFANDS THAT ARE 2 TO 8
MONTHS OF AGE THIS IS THE ONLY
VACCINE AVAILABLE THAT HAS GROUP
A IN IT.
TO THAT GROUP, THIS IS THE OM
VACCINE WE WOULD RECOMMEND.
THAT'S WHAT WE'RE VOTING ON
TODAY.
I CAN LET PETER TALK ABOUT IT IF
THERE'S ADDITIONAL DATA.
I DON'T THINK THERE IS, IN
BETWEEN.D
>> YEAH.
I'M CERTAINLY -- CERTAINLY NO
COMPARATIVE DATE THAT THAT WE
COMPARED TO THIS IN OLDER AGED
POPULATIONS AND LOOKED AT LATER
TIME POINTS IN 11 TO 18 YEARS
AND HAVE COMPARABLE WHEN LOOKING
AT TIME POINTS FOR THE
MenACWY-CRM, VERSUS MENVIO
SUBPOENA THAT YOUR -- NOTHING
FOR --
>> WHAT I'M WONDERING, I
UNDERSTAND THE 2 TO 8 MONTH AGE
GROUP BUT AM WOND ERG FROM THE 8
TO 23 MONTH AGE GROUP, THE OLDER
AGE, IN THE OLDER INFANT AND
TODDLER AGE GROUP WHERE THERE IS
AN ALTERNATIVE.
I'M JUST WONDERING ABOUT WHAT
THE RESPONSE AND DURABILITY OF
ANTIBODIES A AND A, C, Y, W, D
AND VERSUS CRM.
ANY DATA ON THAT?
OR DATA WE KNOW THAT COULD BE --
>> WE HAVE NOT FOLLOWED THAT.
SO WE CAN JUST, I GUESS, INFER
SOMETHING FROM THE DATA DERIVED
IN OLDER AGED POPULATIONS AND
HOW THEY MIGHT COMPARE IN A
YOUNGER AGE POPULATION.
IMPERFECTLY.
YEAH.
>> CAN I SAY SOMETHING, DOCTOR?
>> IN GENERAL, IF YOU COMPARE
MENACWY AND MENZIO, FORTUNATELY
WITH THE USE, THE RISK FOR GROUP
A DISEASE AMONG INFANTS WHO
TRAVEL IS GETTING CONSIDERABLY
SMALLER.
IN FACT, WE'VE ACTUALLY -- THE
RISK FROM GROUP A FOR TRAVELING
HAS NEVER BEEN AS WELL
ESTABLISHED.
THERE'S NEVER BEEN A CASE OF
MenACWY-CRM TRAVELING TO THE
MENINGITIS BELT.
WHILE IT'S A RECOMMENDATION, WE
FELT LIKE THE IMMUNE RESPONSE
FOR INFANTS IN THE 2 TO 8 MONTH
RANGE, WHERE THERE'S NO OTHER
OPTIONS IS SUFFICIENT, AND THE
DIFFERENCES BETWEEN MENACWY AND
THE OLDER GROUPS AREN'T SPECIFIC
TO PREFER IT OVER MENVIO.
>> THANK YOU.
DOCTOR?
>> THANKS.
I JUST HAVE A COUPLE OF COMMENTS
FOR THE WORKING GROUP AND THEN
ONE GENERAL COMMENT.
SO ALTHOUGH IT WASN'T PRESENTED
TODAY, COST EFFECTIVENESS DATA
HAVE BEEN PRESENTED BEFORE, AND
TO MY KNOWLEDGE, THOSE
EVALUATIONS DID NOT INCLUDE ANY
INDIRECT BENEFITS OF THE VACCINE
IN THE SENSE OF THE IMMUNITY
BENEFIT DUE TO DECREASED
CARRIAGE, WHICH, OF COURSE,
OTHER COUNTRIES DATED FROM THE
UK AND ELSEWHERE HAVE SHOWN
DRAMATIC IMPACTS OF THIS
IMMUNITY.
SO I WOULD ASK IF THE WORKING
GROUP COULD DO THAT KIND OF COST
EVALUATION?
THAT WOULD BE ONE COMMENT.
AND THE SECOND COMMENT IS, AS
FAR AS I CAN TELL, THERE ARE 35
COUNTRIES AROUND THE WORLD
OUTSIDE OF THE MENINGITIS BELT
THAT HAVE A ROUTINE
RECOMMENDATION FOR MENINGOCOCCAL
VACCINES AND 28 OF THESE HAVE AN
INFANT OR TODDLER DOSE SCHEDULE.
USUALLY ONE TO THREE DOSES
TOTAL.
AND IT'S USUALLY MONOVALIANT
VACCINE.
NOW THAT WE HAVE INFANT AND
TODDLER VACCINES LICENSED IN THE
UNITED STATES, WOULD THE WORKING
GROUP BE WILLING TO LOOK AT
ALTERNATE SCHEDULES FOR THE
MENINGOCOCCAL VACCINE?
FOR EXAMPLE, COMMON IN OTHER
COUNTRIES IS ONE DOSE AT AGE 12
TO 14 MONTHS AND THEN A BOOSTER
DOSE AT MID-ADOLESCENCMID-ADOLE.
MY NEIGHBOR IN CANADA COULD
PROBABLY GIVE US A LOT OF
INFORMATION ABOUT THAT.
SO THAT WOULD BE MY SECOND
QUESTION FOR THE GROUP.
AND THEN JUST MY GENERAL COMMENT
IS --
YOU KNOW, IF WE'RE NOT GOING TO
HAVE A ROUTINE RECOMMENDATION
FOR ALL HEALTHY INFANTS, I WOULD
JUST HARKIN BACK TO AN EDITORIAL
WRITTEN TEN YEARS AGO BY PAUL
OFFUTT AND PETER FROM "NEW
ENGLAND JOURNAL OF MEDICINE."
AT THAT TIME NOTHING FOR
VACCINES.
THERE'S A DIFFERENCE TWEENS
PUBLIC HEALTH POLICY AND
INDIVIDUAL CARE.
INN THAT EDITORIAL THEY STRESS
IF WE WEREN'T GOING TO HAVE
ROUTINE USE OF THESE VACCINES
POLICIES AND PRACTICES SHOULD BE
ESTABLISHED TO INFORM PARENTS,
PARENTS OF INFANTS AND TODDLERS,
AT THAT TIME IT WAS ALL AGES,
ABOUT THE EXISTENCE AND
POTENTIAL BENEFITS OF THE
VACCINE AND I WOULD ASK THE
WORKING GROUP AND I GUESS
OTHERS, ARE THERE PLANS TO --
TO -- MAKE SURE THAT PARENTS ARE
AWARE OF THIS VACCINE AND THAT
GOES FOR PROVIDERS, TOO.
BECAUSE AS WE KNOW, IF
SOMETHING'S NOT RECOMMENDED BY
ACIP, THEY THINK PERHAPS THERE'S
A REASON THEY SHOULDN'T BE
GIVING IT, ET CETERA.
SO I'LL STOP THERE.
>> DO YOU WANT TO COMMENT?
>> THANK YOU.
>> SURE.
SO WITH REGARD TO THE INMUNTY
QUESTION.
THE HERD INMUNTY SEEN IN THE
UNITED STATES KINGDOM HASN'T
BEEN SEEN WITH THE QUAD DRA
VALANCE VACENESES IN THE UNITED
STATES.
WE HAVEN'T BEEN ABLE TO SHOW A
REDUCTION IN CARRIAGE IN THE SAY
THEY'VE SHOWN A REDUCTION WITH
THE MEN C VACCINES AND IMMUNITY
WAS SUBSTANTIALLY GREATER.
THE PROGRAM INTRODUCED IN THE UK
WAS VERY DIFFERENT FROM THE
PROGRAM INTRODUCED IN THE UNITED
STATES AS WELL.
SO THE ACTUAL IMPACT ON THE
PROGRAMS ARE HARD TO COMPARE.
BUT EVEN IF YOU JUST LOOK AT
CARRIAGE DATA ALONE, THE WORK
GROUP DID NOT FEEL THERE WAS
SUFFICIENT DATA FOR THESE
VACCINES TO INCORPORATE HERD
IMMUNITY SBI MENINGOCOCCAL
VACCINE AFFECTING THE STUD IS.
SHE HAVE LOOKED AT THAT IN TERMS
OF SENSITIVITY AND IT DOES NOT
BRING DOWN THE COST EFFECTIVE
NIZ SUBSTANTIALLY IN THE SAME
WAY IT DID IN THE UK WITH THE
PROM THAT HE IMPLEMENTED.
>> I GUESS I WOULD STILL REQUEST
THAT THAT BE LOOKED AT, BECAUSE,
TO ME, I THINK I'VE READ UP A
THE PAPERS NOW, AND I THINK THAT
THERE IS SOME PRETTY STRONG
EVIDENCE OF A HERD EFFECT, AND
IT DOES CHANGE THE COST
EFFECTIVENESS OF THE EVALUATION.
>> DOCTOR?
>> YES.
I JUST WANT TO MAKE A COMMENT
FOR A NUMBER OF THE MEMBERS WHO,
YOU KNOW, JOINED THE COMMITTEE
WITHIN THE PAST TWO YEARS, I
THINK.
MUCH OF THE RUN-UP TO EVALUATING
MENINGOCOCCAL EFFECTS BEING IN
AGES UNDER 11 WAS BASED ON THE
EPIDEMIOLOGY OF THE DISEASE IN
THE U.S. RATHER THAN THE
VACCINE'S PERFORMANCE, BECAUSE
MANY OF THE COUNTRIES THAT HAVE
ROUTINE RECOMMENDATIONS HAVE
MUCH HIGHER RATES OF THE DISEASE
THAN WE HAVE.
WE'VE HAD THIS VERY SURPRISING
AND INTERESTING DECLINE IN
MENINGOCOCCAL DISEASE IN THE
U.S., AND I THINK IT WAS HANDED
OUT THAT THERE IS MUCH LESS
DISEASE TO PREVENT, OR EVEN TO
DOCUMENT A HERD EFFECT OR
SOMETHING, AND THEN THE OTHER
THING THAT THE COMMITTEE DEALT
WITH IN THE PAST FEW YEARS WAS
THE SURPRISING AND SOMEWHAT
DISAPPOINTING WANING OF
PROTECTION OF THE 11-YEAR-OLD
ADOLESCENT DOSE THAT THROWEDLED
SECOND DOSE IN TEENAGE YEARS.
PRESUMABLY HE CONTINUE TO LOOK
AT THE EPIDEMIOLOGY ANDN dB
PERFORMANCE OF VACCINES BUT MUCH
OF THE DECISION-MAKING THE PAST
COUPLE YEARS THAT WENT INTO NOT
HAVING A ROUTINE INFANT OR
TODDLER DOSE WAS, SCHEDULE, WAS
THE VERY LOW DISEASE, DIFFERENT
FROM MANY OTHER COUNTRIES THAT
HAVE ROUTINE VACCINATION.
ON THE OTHER HAND, OF COURSE,
THE U.S. HAS ROUTINE VACCINATION
FOR DISEASES THAT OTHER
COUNTRIES THAT HAVE BEEN USING
THE TODDLER DOSES OF MENIG FOR
YEARS HAVEN'T INTRODUCED YET.
WE'VE INTRODUCED SOME VACCINES
EARLIER AND SOME NOT BECAUSE OF
THE EPIDEMIOLOGY HERE.
>> THANK YOU.
OTHER DISCUSSION?
DOCTOR?
>> ONE OF THE THINGS I'M
WONDERING.
WE'RE RECOMMENDING THE VACCINE
IN CHILDREN WHO ARE AT HIGH RISK
FOR MENINGOCOCCAL DISEASE YET
THE STUDIES ARE ALL DONE IN
HEALTHY CHILDREN.
WILL THERE BE ANY STUDIES FOR US
TO FEEL COMFORTABLE THAT WE'RE
GETTING SIMILAR IMMUNE RESPONSES
IN CHILDREN WHO ARE IMMUNE
COMPROMISED?
OBVIOUSLY THE CHILDREN WHO ARE
RECEIVING IT FOR TRAVEL, ET
CETERA.
WE SHOULD ASSUME THEY'LL HAVE --
I WOULD BE CONCERNED THAT AS WE
FOUND IN OTHER IMMUNE DEFICIENT
POPULATIONS WHO ARE OLDER, WE
NEEDED TO HAVE ADDITIONAL DOSES
GIVEN IN ORDER TO ASSURE
ADEQUATE LEVELS.
>> IT'S HARD TO -- WITH THE
CONDITIONS THAT THEY WOULD BE
RECOMMENDED TO RECEIVE AS IF
THEY HAD DEFICIENCIES AT 3 YEARS
AFTER THE PRIMARY SERIES AND
THEN EVERY FIVE YEARS THEREAFTER
TO MAIN PATAIN PROTECTION.
>> THE QUESTION, ADEQUATE LEVELS
BY PROTECTION.
>> YES.
>> DOCTOR?
>> YES.
WITH AMERICA OSTEOPATHIC
ORGANIZATION.
I HAVE A QUESTION IN THE SECOND
BULLET.
THE LAST SENTENCE, IT SAYS,
PRIOR TO TRAVEL TO PROVIDE
PROTECTION AGAINST MENINGOCOCCAL
GROUPS A AND W, WHY NOT JUST END
IT AT THE END OF, TO TRAVEL.
RATHER THAN ADDING -- BECAUSE IT
MAKES IT LOOK LIKE IT DOESN'T
PROTECT AGAINST THE OTHER TWO AT
ALL.
>> I THINK WE CAN MAKE THAT
CHANGE.
WE WERE TRYING TO HIGHLIGHT THE
REAL RISK.
BUT CERTAINLY WE CAN CHANGE
THAT.
>> DOCTOR PIR. PICKERING?
>> A FOLLOW-UP TO THE QUESTION
THAT DEALS WITH 14 TO 16 AS
PETER DULL PRESENTED.
GROUP A IN THE UNITED STATES, I
BELIEVE, IN THE UNITED STATES IS
RARE.
BUT TRAVEL STILL IS A CONCERN
FOR MASS GATHERINGS.
YOU LOOK AT THE DATA HERE IN
MAKING THE RECOMMENDATION IT
COULD BE USED FOR TRAVEL IN
INFANTS.
BUT YOU LOOK AT THE DATA AND IT
SHOWS THAT POOEFT POST-7 TO 9
MONTH, DROPS DOWN TO 25 OR SO.
RUB
RUTH POINTED OUT, OLDER GROUPS
AT 40 MONTHS.
SO IT IS THE BEST, ONE OF BEST,
OR THE ONLY VACCINE LICENSED IN
THIS AGE GROUP FOR TRAVEL, BUT
SHOULDN'T THERE BE A QUALIFIER
THAT THIS IS NOT A PERFECT
VACCINE?
WE'RE TALKING ABOUT LEVELS LESS
THAN 50% AS A CORE OF
PROTECTION.
DO YOU PLAN TO PUT A QUALIFIER
IN THERE TO LET PHYSICIANS AND
PARENTS KNOW THAT?
>> I THINK THAT'S A GOOD POINT
AND WE CAN CERTAINLY DISCUSS
THAT MORE IN THE BACKGROUND
SECTION OF THE DOCUMENT.
WE CAN ALSO, WE DO HAVE
ANTICIPATEDATIONS IN THE INFANT
STATEMENTS THAT WERE RECEIVED
PRIOR TO TRAVEL AND THAT THEY
CAN BE GIVEN THIS INSTEAD OF
MAKING THEM WAIT UNTIL THE 12
WEEKS OR IN THIS CASE IT WOULD
BE THE SECOND YEAR OF LIFE TO
GET THAT SECOND DOSE.
WE DO RECOMMEND GIVING TWO
DOSES.
WE COULD ALSO ADD LANGUAGE ABOUT
TRYING TO RECEIVE THE VACCINE
CLOSE TO THAT TRAVEL, WHICH MAY
PROTECT INFANTS DURING THE
PERIOD OF TRAVEL.
INFANTS WHO ARE LIVING IN THE
MENINGITIS AREA, FOR EXAMPLE,
WOULD BE IN A DIFFERENT
SITUATION.
THEY WOULD REQUIRE LONGER TERM
PROTECTION.
BUT FOR AT LEAST TRAVELING, THAT
WOULD BE A --
>> DR. BAKER?
>> I DON'T DISAGREE WITH DR.
CAIRN OR D
KARRON OR DR. PICKERING.
IT IS IMPERFECT.
WE DON'T COUNSEL PARENTS ABOUT
OTHER IMPERFECT VACCINES AND WE
CERTAINLY HAVE THEM.
FLU BEING ONE.
WITH REGARD TO THE DOCTOR'S
COMMENTS, THAT WOULD BE GREAT IN
A PERFECT WORLD, BUT THE FAMILY
PRACTITIONER HAS LIMITED TIME TO
TALK ABOUT ROUTINE VACCINES AND
EDUCATING PARENTS ABOUT A VERY
LOW PREVALENCE INCIDENCE
DISEASE.
IT'S NOT PRACTICAL IN TERMS OF
MAKING SURE ROUTINELY
RECOMMENDED VACCINES HAPPENS.
>> DR. KARRON?
>> I GUESS JUST TO FOLLOW-UP, I
WONDER IF THERE COULD BE IN
GUIDANCE LANGUAGE SOME
INDICATION THAT THIS IS,
PERHAPS, PREVENTIVE FOR THE
SHORT TERM BUT FOR AN INFANT
THANTS GOING RESIDE IN THE
COUNTRY, THIS MAY BE INADEQUATE
AGAINST MEN A.
>> I BELIEVE IT'S DOCTOR --
>> THANK YOU VERY MUCH.
AGAIN, I WANT TO AT THIS POINT
ASK THAT -- WELL, THERE'S A REAL
CONCERN ABOUT THE USE OF THE
TERM ROUTINE VACCINATION FOR
HIGH-RISK INFANTS.
I'M SURE THAT WAS PART OF THE
CONFUSION FOR SOME OF THE
MISREPRESENTATION OF THE LETTER
SENT TO THE ACIP.
IN FACT, THE STAFF.
A CONTRACTOR DID NOT REALLY
UNDERSTAND THE IMPLICATION OF
ROUTINE IN THE APPLICATION.
THIS IS SOMETHING WE NEED TO
LOOK AT.
WE'RE TALKING ABOUT IMMUNIZING
HIGH-RISK INFANTS.
TO SAY -- THIS COULD BE A
QUESTION.
IT FULLY SUPPORT IMMUNIZING
HIGH-RISK INFANTS AND CHILDREN,
AND, AGAIN, AS WE FULLY DESCRIBE
THE EVIDENCE-BASE APPROACH.
AT THIS TIME I DO WANT TO
RETRACT THE ERROR THAT WAS
SENT -- IS THIS THE TIME, DR.
PICKERING, TO TELL YOU THAT?
>> I JUST MENTIONED THAT A
LETTER WAS SENT TO DR. PICKERING
FROM THE NATIONAL MEDICAL
ASSOCIATION REGARDING THE USE OF
MENINGOCOCCAL VACCINE IN
CHILDREN.
AND SO THAT WILL BE, LETTER,
WILL BE PLACED IN THE OFFICIAL
MINUTES OF THIS MEETING.
BUT IF WANT TO CONTINUE FROM
THERE --
>> YES.
WE REALLY URGENTLY WANT TO
RETRACT THAT LETTER AS A
PEDIATRICIAN AND FORMERLY ASON
TO THE ACIP BACK IN THE DAY,
LARRY, CONGRATULATIONS, BY THE
WAY.
BUT WE REALLY -- OUR PRESIDENT
AND CHAIRMAN OF THE BOARD, DR.
GEORGE SANS IS SENT ME HERE
SPECIFICALLY TO ASSURE THAT THE
ACIP KNOW THAT WE REPORT OUR
REPRESENTATIVE, SHE BROUGHT TO
OUR ATTENTION THE INACCURACIES
REFLECTED IN THE LETTER.
INDEED, WE DON'T HAVE
DISPARITIES.
I THINK DR. COHEN'S PAPER HAD
YOU BEFORE YOU FULLY SHOWS
DECREASE OF DISPARITIES.
AND HOPE THAT WE ARE PART OF THE
SOLUTION IN THAT.
SO WE REALLY APOLOGIZE FOR ANY
MISREPRESENTATION THAT WE'RE
TRYING TO PUT SOMETHING
CONFLICTUAL IN THE RECORD, BUT
WE DO SUBSCRIBE AND
EVIDENCE-BASED APPROACH TO
DEVELOPING CLINICAL GUIDELINES.
SO AT THIS TIME, I WANT TO
EMPHASIZE THAT WE SUPPORT THE
RECOMMENDATION AS, THAT IS HERE
NOW, WHICH IS SPECIFICALLY
DEPORTING IMMUNIZATION OF
HIGH-RISK CHILDREN.
NOT AS INCORRECTLY STATED IN
THAT LETTER, WHICH WE'RE ASKING
TO BE RETRACTED, THAT WE TALK
ABOUT ROUTINE IMMUNIZATION.
OKAY?
I SEE THAT AS A TYPO, AND PEOPLE
THAT DIDN'T UNDERSTAND THE
DIFFERENCE.
SO, AGAIN, WE LOOK FORWARD TO
REALLY CONTINUE TO WORK WITH CDC
AND CLOSE THE GAPS.
IT'S SO EXCITING TO HEAR DR.
FRIEDEN'S COMMENTS, AND WE FULLY
SUBSCRIBE AND WILL HAVE ALL OF
OUR RESOURCES AVAILABLE TO YOU,
TO MOVE FORWARD.
>> THE LETTER HAS BEEN
RETRACTED.
LET THE RECORD SHOW.
AND THE COMMENTS HERE GO WITH --
>> RIGHT.
AND AGAIN, THE AUTHORITY TO
REALLY, FROM THE VERY ROBUST AND
ELOQUENT PRESENTATION HERE TODAY
SO WE CAN ADD ANY COMMENTS TO
THE RECORD.
THANK YOU.
>> THANK YOU VERY MUCH.
OTHER COMMENTS?
OH.
DR. REINGOLD?
>> THANKS.
I HAVE TWO QUESTIONS AND THEN
REFLECT MY OPINION, A NEW
MEMBER.
ONE GOES BACK TO THE DOCTOR'S
PRESENTATION AND GRADING OF THE
EVIDENCE.
I'M FULLY AWARE OF THE NEED TO
BRIDGE FROM THE IMMUNOGENICITY
STUDIES TO MAKE INFERENCES ABOUT
EFFECTIVENESS BUT I WONDER IF
THE IS RIGHT TO TALK ABOUT
EFFICACY WHEN ALL WE HAVE IS
IMMUNOGENICITY DATA?
I'M CURIOUS IN GENERAL FOR A
GENERAL PERSPECTIVE ON THIS
WHETHER THE LANGUAGE IS
BETTER -- STATING EFFICACY WHEN
IN FACT ALL WE REALLY KNOW IS
BRIDGING FROM THE IMMUNOGENICITY
DATA.
THE OTHER QUESTION I HAVE FROM
THE WHOLE RECOMMENDATIONS FOR
TRAVELERS AND WHAT WE KNOW ABOUT
THE DYNAMICS OF IMMUNORESPONSE
FOLLOWING IMMUNIZATION AND HOW
QUICKLY ANTIBODY LEVELS RISE.
MY CONCERN AS A FREQUENT
TRAVELER, MANY PEOPLE RUSH TO
GET THEIR SHOTS RIGHT BEFORE
THEY LEAVE.
AND WHILE I TAKE THE POINT WE
DON'T WANT PEOPLE GETTING
VACCINATED TOO NAR ADVANCE.
I'M NOT SURE WE WANT THEM
VACCINATED RIGHT BEFORE THEY
LEAVE EITHER.
I'M WONDERING HOW PRECISE THE
RECOMMENDATIONS ARE FOR
TRAVELERS REGARDING THE TIMING
OF THESE DOSES?
>> SO WE ACTUALLY DON'T GIVE ANY
RECOMMENDATIONS WITH REGARD TO
TIMING FOR DOSES.
I THINK THERE MAY BE TWO WEEKS
PRIOR TO TRAVEL.
AT LEAST, IN THE OLDER AGE
GROUPS.
THE ONLY RECOMMENDATION WE HAVE
SPECIFICALLY IS THAT THE TWO
DOSES MAY BE GIVEN AT A SHORTER
PERIOD OF TIME TO GET THE TRAVEL
IN THIS AGE GROUP.
>> AND I THINK THERE ARE
REQUIREMENTS FOR THE HOJ FOR
GETTING THE VISA TO DOCUMENT AND
THEN FOR AFRICA.
AS WAS SAID BEFORE, WE HAVE NO
REAL DOCUMENT OF CASES FOR
TRAVELERS TO AFRICA.
>> DR. KEMPE.
>> ACTUALLY IT'S KEMPE.
THAT WILL MAKE IT EASIER.
>> I'VE BEEN WRONG ALL OF THESE
YEARS.
>> I ASK THAT -- I HAVE -- I
HAVE A QUESTION ABOUT POTENTIAL
CONFUSION ABOUT THE ISSUE OF MEN
ACWY AND WHETHER THERE'S NEEDS
TO BE A CLARIFICATION ABOUT
WHETHER IT'S OKAY, THEN TO CROSS
OVER AND USE MENVIO IN THAT
INSTANCE?
I'M FEELING LIKE THAT'S GOING TO
BE A POINT OF CONFUSION AND
WONDER IF THAT SHOULD BE
CLARIFIED?
>> SO WHEN THE, THESE
RECOMMENDATIONS WILL BE
INTEGRATED WITH THE
RECOMMENDATIONS FOR MEN ACWY AND
WE WILL MAKE IT CLEAR IT IS NOT
RECOMMENDED UNTIL AFTER AGE 2
YEARS OF AGE BUT MAY BE USED UP
THROUGH AGE 2 YEARS AND BEYOND.
AFTER AGE 2 YEARS, THE
RECOMMENDATIONS FOR MEN ACWY
THAT YOU GET IT ONE MONTH AFTER
YOUR LAST PB DOSE IN CASE YOU
HAVEN'T RECEIVED IT PRIOR TO AGE
2 YEARS.
SO WE HOPE WHEN WE INTEGRATE THE
LANGUAGE, AND YOU'LL RECEIVE THE
NOTICE TO READERS PRIOR TO
PUBLICATION THAT -- YOU HAVE AN
OPPORTUNITY TO COMMENT ON THAT.
THAT IT WILL BE CLEAR.
>> DOCTOR?
>> JUST A REMINDER THAT THIS IS
A VERY RARE SITUATION.
PROBABLY LESS THAN 1 IN 1,000
KIDS.
AS A PRACTICING FAMILY PHYSICIAN
I'M GOING TO HAVE TO LOOK THIS
UP EVERY SINGLE TIME AND READ
THE BOOK.
THIS ISN'T SOMETHING I WILL HAVE
IN MY MEMORY AT ALL.
>> ANY ADDITIONAL COMMENTS?
I THINK THERE ARE SOME PUBLIC
COMMENTS OUT THERE, AND IF I MAY
CALL ON JOHN BECKER.
AND WE'D LIKE YOU TO STATE YOUR
AFFILIATION AND ANY CONFLICTS OF
INTEREST.
>> GOOD MORNING.
GOOD MORNING.
I'M AN INDEPENDENT LGBT ACTIVIST
AND ADVOCATE FOR OUR COMMUNITY
AND I'M HERE ON MY OWN WITH JUST
AS A CONCERNED CITIZEN.
I REPRESENT GAY, LESBIAN
BISEXUAL AND TRANSGENDER
AMERICANS CONCERNED ABOUT THE
GROWING THREAT OF BACK MATERIAL
MENINGITIS IN OUR COMMUNITY.
AN OUTBREAK IN SEVERAL AMERICAN
CITIES IN RECENT YEARS WITH
SEVEN DEATHS IN NEW YORK CITY
ALONE AND OTHER DEATHS REPORTED
IN CALIFORNIA AND UTAH.
WE BELIEVE THE BEST WAY TO
ENSURE THAT BACTERIAL MENINGITIS
DOESN'T KILL MORE PEOPLE EXPAND
THE VACCINATION IN THE UNITED
STATES AS WIDELY ADD POSSIBLE
AND ASKING TO EXPAND BACTERIAL
MENINGITIS TO INCLUDE CHILDREN
AND INFANTS AS YOUNG AS 6 MONTHS
OLD.
EXTENDING THE VACCINES WOULD
PROTECT SAME-SEX COUPLES WITH
CHILDREN.
ESTIMATES ARE THAT THERE ARE AT
LEAST 115,000 SAME-SEX COUPLES
IN THIS COUNTRY THAT ARE RAISING
CHILDREN.
AND IT EXPANDS THE
RECOMMENDATIONS TO ALSO INCREASE
THE COMMUNITY TO PROTECT THOSE
WITH COMPROMISED IMMUNE SYSTEM
AND OURS IS
I RECENTLY LAUNCHED A CAMPAIGN
CALLING ON THE CDC AND ACIP TO
HELP PROTECT THE LIVES OF LGBT.
SO FAR THE CAMPAIGN HAS RECEIVED
MORE THAN 14,000 SIGNATURES.
WE SHOULD PROBABLY REACH THE
15,000 THRESHOLD TAKE.
WE WILL CONTINUE TO PUSH THE
VACCINE TO BE EXPANDED BECAUSE
WE BELIEVE IT OFFERS THE BEST
CHANCE TO MAKE SURE THE DISEASE
NEVER THREATENS OUR COMMUNITY.
WE'RE INCREDIBLY FORTUNATE TO
HAVE A SAFE AND EFFECTIVE
VACCINE AVAILABLE AND ITS
POTENTIAL CAN BE EXPANDED TO
PREVENT THE DISEASE FROM
SPREADING.
THANK YOU VERY MUCH.
>> AND LET THE RECORD SHOW ALSO
THAT THE LETTER -- OR THE
PETITION HAS BEEN DISTRIBUTED TO
ACIP MEMBERS AND WILL BE PLACED
INTO THE MINUTES OF THIS
MEETING.
FOR THE RECORD I'LL MENTION
DR. BAGETCH
BAGET IS A SPEAKER --
>> YES, ALSO PROFESSOR AT
HARVARD UNIVERSITY COLLEGE OF
MEDICINE.
>> THANK YOU SO MUCH.
AND TO WE HAVE CHRIS BOONE?
CH.
>> I'M CHRIS BOONE.
THIS IS MY WIFE, HEATHER, AND MY
SON.
I'M NOT A PUBLIC SPEAKER.
I'M PROBABLY GOING TO GET
EMOTIONAL.
I'M SORRY.
ON JUNE 15th, 2008, MY HEALTHY 7
MONTH OLD LITTLE BOY STARTED
RUNNING A FEVER.
30 HOURS FROM RUNNING THAT
FEVER, HIS HEART STOPPED.
13 DAYS LATER, THEY AMPUTATED
ALL FOUR OF HIS EXTREMITIES.
SOMETIME AFTER THAT, HIS FACE.
AFTER 65 DAYS OF BEING IN THE
HOSPITAL AND FIVE OPERATIONS --
HIS LITTLE BODY WAS DESTROYED.
HE'S HAD SURGERY EVERY SUMMER TO
RECONSTRUCT HIS FACE.
AND I THINK IT WOULD BE
IRRESPONSIBLE NOT VACCINATE
CHILDREN.
THANK YOU.
[ APPLAUSE ]
>> THANK YOU, MR. BOONE, FOR
YOUR WILLINGNESS TO SHARE THAT
PERSONAL STORY.
WE HAHAVE FRAPNKIE MILEY.
>> HI, I'M THE NATIONAL DIRECTOR
OF MENINGITIS ANGEL AND I'M THE
MOTHER OF A TAUGDAUGHTER WHO DIT
18.
I WANTED TO YOU MEET JEREMIAH.
HIS FIRST GRADE CLASS IN
OKLAHOMA HAD AN OUTBREAK.
SIX CHILDREN IN THAT CLASS
WITHIN 48 HOURS CONTRACTED
MENINGOCOCCAL IT DISEASE.
TWO OF THEM DIED.
JEREMIAH HAD MASSIVE FACE
CONSTRUCTION.
THE DAMAGE TO HIS BODY IS
MASSIVE, BUT I'M PROUD TO TELL
YOU HE HAS A 12th GRADE READING
AND LANGUAGE SKILL.
[ APPLAUSE ]
I WENT TO ALL THE ACIP SUMMERS
AFTER TIME I HEARD IT'S NOT COST
EFFECTIVE, INCIDENT RATE IS NOT
HIGH ENOUGH.
YET EVERY PARENT WHO WAS THERE
VOTED WHEN THE VOTE CAME DOWN TO
VACCINATE INFANTS AGAINST THIS
DISEASE EVEN THOUGH PARENTS WHO
WERE AGAINST IT.
YOU KNOW, WE EDUCATE PARENTS IN
THIS COUNTRY WHO HAVE
ANTI-VACCINE, WE SPEND A LOT OF
MONEY AND A LOT OF TIME DOING
THAT.
BUT WE'RE NOT EDUCATING PARENTS
ON A DISEASE THAT CAN DO THIS TO
A BABY OR KILL MY SON IN 14
HOURS, MY PERFECTLY HEALTHY SON.
HAD BLOOD COMING FROM EVERY OR
PHYSICAL O
ORIFICE OF HIS BODY IN 14 HOURS.
WE WORRY ABOUT COST
EFFECTIVENESS.
IS THIS COST EFFECTIVE?WE WORRY
EFFECTIVENESS.
IS THIS COST EFFECTIVE?
HUNDREDS OF CHILDREN WITHIN OUR
NETWORK ARE NOT AT HIGH RISK.
I SAY TO YOU ONE BABY, ONE
CHILD, ONE TEEN IS TOO MANY.
ESPECIALLY WHEN IT COMES TO
YOURS.
I'M STANDING HERE TODAY AND I'M
SO -- I WANT TO TELL YOU, I HAVE
THE UTMOST RESPECT AND
ADMIRATION AND GRATITUDE TO
THESE PEOPLE RIGHT HERE BECAUSE
THEY DEDICATE THEIR LIVES TO
MAKING SURE OUR KIDS ARE
VACCINATED.
AND I'M REALLY IT IS APPOINTED,
THOUGH, THAT WE'RE ONLY LOOKING
AT THIS FOR HIGH RISK.
WHAT IS HIGH RISK?
YOU LOOK AT STATISTICS.
I LOOK AT REAL LITTLE PEOPLE,
REAL LITTLE FACES.
I LISTEN TO PARENTS EVERY DAY OF
MY LIFE WHO WATCH THEIR KIDS
HAVE SEIZURES SO BAD THEY HAVE
TO HAVE PARTS OF THEIR BRAIN
DISSECTED, WHOEVER TIME THEY
TAKE THEM TO THE DOCTOR, THEY
GET REVISIONS ON AMPUTATIONS.
WHO DEVELOP JOINT DISEASE.
WHO HAVE ONCE THEY REACH
PUBERTY, THEY DEVELOP EMOTIONAL
PROBLEMS.
AND ANGER ISSUES.
WE'VE SEEN SUICIDE WITHIN OUR
FAMILIES, HIGH DIVORCE RATES.
MY GOD, PLEASE, THIS SHOULD BE A
ROUTINE AT LEAST PERMISSIVE
RECOMMENDATION
INFANTS.
LET OUR PARENTS BE EDUCATED, LET
OUR HEALTH CARE PROVIDERS BE
EDUCATED.
GIVE US THAT.
I'M DISAPPOINTED THAT THIS IS
ONLY FOR HIGH RISK.
I THINK THEY'RE ALL HIGH RISK
AND THEY'RE ALL WORTH BEING
PROTECTED.
THANK YOU.
>> THANK YOU VERY MUCH FOR YOUR
COMMENTS.
[ APPLAUSE ]
ARE THERE ADDITIONAL COMMENTS?
IS THERE IT NIP WANYONE WHO IS
WILLING TO MAKE A MOTION FOR THE
CURRENT PROPOSAL?
>> I'D MAKE A MOTION TO ACCEPT
THE CURRENT PROPOSAL WITH THE
ADDITION OF LANGUAGE THAT WOULD
EXPAND UPON CONSIDERATION FOR
TIMING OF VACCINE FOR TRAVELERS
WHO NEED PROTECTED AGAINST THE
MENINGITIS SERVERBANK.
>> WOULD THAT BE APPROPRIATE TO
PLACE IN THE COMMENTARY SECTION?
>> YES, I THINK THAT COULD BE AN
ANNOTATED PART OF THE
RECOMMENDATION.
>> FURTHER DISCUSSION?
I SEE NONE.
WHY DON'T WE START WITH VOTING
AND WE'LL GO COUNTER CLOCKWISE
FROM DR. VAZQUEZ.
>> YES.
>> COIN BEASLEY, YES.
BUT I WOULD LIKE TO LOOK INTO
MAKING IT A PERMISSION SIF
RECOMMENDATION.
>> RUBIN YES.
>> NO.
>> YES.
>> RON GOLD YES.
>> YES.
>> KEMP YES.
>> KAREN YES.
>> TEMTE YES.
>> YES.
>> ABSTAIN.
>> YES.
>> EMERSON YES.
>> THE MOTION IS PASSED.
AND I BELIEVE WE ARE AT THE
BREAK LIFE-NO, WE HAVE THE VFC
RESOLUTION.
SORRY ABOUT THAT.
SO DR. SANTOLI.
>> HI, THERE.
THE PURPOSE OF THE RESOLUTION,
THE VAET FOR TODAY'S REP
INDICATION THE RESOLUTION TO
INCLUDE USE OF A MENINGOCOCCAL
VACCINE RECENTLY LICENSED IN A
NEW AGE GROUP AND SIMPLIFY THE
LANGUAGE WITHIN THE RECOMMENDED
VAK SIP NATION SCHEDULE AND
INTERVAL SECTION.
THE ELIGIBLE GROUPS FOR THE
VACCINE REMAIN UNCHANGED.
YOU SEE A SLIDE THAT WILL BE
FAMILIAR TO YOU FROM THE LAST
PRESENTATION FOR THE HIGH RISK
CHILDREN TWO MONTHS TO TEN YEARS
OF AGE.
AND THIS SUMMARIZES WHICH
VACCINES ARE RECOMMENDED FOR
WHICH GROUPS.
THE SECOND IS THE
RECOMMENDATIONS FOR THE 11 TO
18-YEAR-OLDS WHICH DIDN'T TALK
ABOUT TODAY, THIS IS FROM THE
PRIOR RESOLUTION.
ALTHOUGH IT'S BEEN REARRANGED
AND STREAM LINED TO BE MORE
SUCCINCTLY PRESENTED.
BUT THERE AREN'T SUBSTANTIVE
CHANGES.
AND THEN THE TABLE NOTES, AND I
CAN GO BACK, I'M FWG THROUGH
QUICKLY, BUT I CAN GO BACK, THE
FIRST THREE FOOTNOTES JUST TALK
ABOUT THE DIFFERENT GROUPS OF
HIGH RISK AND HOW THOSE GROUPS
ARE DEFINED.
AND THEN FOR THE RECOMMENDED
DOSAGE AND THE CONTRAINDICATIONS
AND PRECAUTIONS, THERE ARE NO
CHANGES.
AS ALWAYS THERE IS A STATEMENT
THAT THERE COULD BE A URL
REFERENCED RATHER THAN NEEDING
TO MAKE CHANGES TO THIS
DOCUMENT.
AND THAT'S THE RESOLUTION.
>> DISCUSSION?
>> I THOUGHT I SAW HIV ON THE
HIGH RISK GROUP.
TWO MORE.
I THINK THAT'S DIFFERENT THAN
SOME OF THE OTHER HIGH RISKS
DEFINED IN
PRESENTATIONS.
>> I'LL TAKE YOU TO WHERE THAT
COMES INTO PLAY.
HERE.
HERE, IF ANOTHER INDICATION FOR
VACCINATION EXISTS.
SO THAT LANGUAGE WASN'T IN THE
FRONT, BUT IT WAS HERE IN TERMS
OF HOW TO USE THE VACCINE.
>> I THINK IN THE ACTUAL
LANGUAGE THE INFECTION IS NOT
INCLUDED.
I THINK A COUPLE OF YEARS AGO
THAT WAS CLARIFIED AND I BELIEVE
IT'S NOT IN THE ELIGIBLE GROUP.
BUT THE RECOMMENDATION IS THAT
CHILDREN -- THE CHILD WITH HIV
DOES HAVE ANOTHER INDICATION,
THAT THEY SHOULD RECEIVE TWO
DOSES.
>> SO IF FOLKS WOULD LIKE TO
REMOVE IT FROM THE ELIGIBLE
CHILDREN'S SECTION, YOU'RE
SAYING IT'S THE NOT IN THE
RESOLUTION THAT WE HAVE ON THE
WEB?
I'LL CHECK.
I THOUGHT IT WAS, BUT WE CAN
CERTAINLY REMOVE IT IF THAT'S
THE REQUEST.
FROM THIS SECTION OF THE
RESOLUTION AND KEEP IT LISTED AS
IT IS IN THE TABLE?
I'M HAPPY TO MAKE THAT CHANGE IF
FOLKS WOULD LIKE THAT.
SO THAT IT WOULDN'T BE CONFUSING
IN THE ELIGIBLE GROUP SECTION
JUST TO DELETE THE LINE.
>> I THINK IF SOMEBODY COULD
CHECK THE LANGUAGE THAT'S
ACTUALLY PUBLISHED.
I THOUGHT WE DID MAKE THIS
CHANGE TWO YEARS AGO.
>> I CAN MAKE IT NOW.
I'M HAPPY TO TAKE IT OUT.
BUT I'M ASSUMING YOU MEAN STILL
TO KEEP IT IN THE TABLE IF
ANOTHER INDICATION EXISTS?
OTHER QUESTIONS OR COMMENTS?
>> JUST TO CLARIFY THAT, I THINK
THAT IT SHOULD BE DELETED FROM
THIS SLIDE.
I THINK WE WANT TO RECEIVE ALL
HIV CHILDREN SHOULD BE
VACCINATED YOU CAN THUNLESS THE
ANOTHER HIGH RISK KAEGS.
THEY DO GET THE A TWO DOSE
REGIMEN.
>> ANY OTHER DISCUSSION?
>> YES.
I JUST HAVE A COMMENT, AND I
HATE TO BRING IT UP, BUT IT
LOOKS TO ME LIKE TRAVELLERS IN
THIS CASE WOULD BE COVERED.
TYPICALLY TRAVEL IMMUNIZATIONS
ARE NOT, BUT I'M ASKING
CLARIFICATION HERE.
>> YES, THAT'S WHAT IS INCLUDED
IN THE CURRENT RECOMMENDATION
AND WAS --
>> I'M YAD TO SGLAD TO SEE IT.
JUST SURPRISED.
>> ANY OTHER DISCUSSION?
SEEING NONE, ANYOYONE WILLING
TO -- I'LL CALL FOR THE
QUESTION.
OKAY.
DO WE HAVE A SECOND?
FURTHER DISCUSSION?
OKAY.
AND WE'LL GO CLOCKWISE FROM DR.
KEMP.
>> KEMP, YES.
>> YES.
>> TEMTE, YES.
>> YES.
>> ABSTAIN AGAIN.
>> YES.
>> HARRISON YES.
>> VAZQUEZ YES.
>> COYNE-BEASLEY YES.
>> RUBIN YES.
>> YES.
BUT I THINK YOU SAY RIGHT TO
LEFT INSTEAD OF COUNTER
CLOCKWISE.
>> POINT TAKEN.
>> YES.
>> YES.
>> YES.
>> AND THE RESOLUTION PASSES.
WE WILL TAKE IT LOOKS LIKE ABOUT
A 25, 30 MINUTE BREAK,
RECONVENING AT 10:45.