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>> 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 *** 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 ***
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
*** 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.