February 2015 ACIP-Influenza


>>I THINK AT THIS POINT WE CAN MOVE ALONG TO INFLUENZA AND I AND I BELIEVE DR. KARRON,
YOU COULD INTRODUCE?>>I THOUGHT IN THE INTEREST OF
TIME I WOULD DO IT RIGHT FROM MY SEAT.>>THANK YOU.
>>ACTUALLY, WE HAVE A REQUEST — IF YOU CAN DO IT
WITHOUT THE SLIDES, DR. SMITH IS GOING TO TRY TO SWAP OUT
COMPUTERS TO SOMETHING THAT RUNS A LITTLE MORE EFFICIENTLY.
>>I ABSOLUTELY CAN DO THAT. I FIRST ACTUALLY JUST WANTED TO
THANK OUR WORKING GROUP FOR A VERY TREMENDOUS EFFORT,
PARTICULARLY OVER THE LAST COUPLE OF MONTHS, AS WE
CONSIDERED A LOT OF VERY LATE-BREAKING DATA.
SINCE OCTOBER OF 2014, WE’VE HAD CONTINUED DISCUSSION OF THE
EFFECTIVENESS OF LAIV, LIVE ATTENUATED INFLUENZA VACCINE FOR
THE 2014, AND 2014-15 FLEW SEASON.
WE’VE ALSO REVIEWED DATA PERTAINING TO THE RECENTLY
APPROVED INTRADERMAL INFLUENZA VACCINE. IN THE INTEREST OF TIME WE’RE
TRUNCATING SOME OF OUR PRESENTATIONS.
WHAT YOU’RE HEARING IS THE UPDATED VACCINE EFFECTIVENESS
FOR THE 2014 SEASON FROM THE CDC, UPDATED ON LIVE ATTENUATED
INFLUENZA VACCINE AND PROPOSED RECOMMENDATIONS FOR 2015, 2016
INFLUENZA SEASON FROM LISA GROHSKOPF.
OTHER INFORMATION YOU WON’T RECEIVE WHICH IS INFORMATION
ABOUT THE INTRADERMAL FLU VACCINE.
THANK YOU. THANK YOU, DR. KARRON.
AND THEN WE’RE GOING TO MOVE ALONG TO DR. FLANNERY, ON AN
UPDATE UPDATED VACCINE EFFECTIVENESS
AND ASSESSMENT. I’LL PRESENT AN UPDATE ON THE
EFFECTIVENESS AS ARE WELL AS LIVE ATTENUATED VACCINES.
THERE’S MORE DETAIL IN THE SLIDES THAT WERE HAND-OUTS.
OKAY. SO THESE UPDATES ARE BASED ON
4,913 PATIENTS WITH ACUTE RESPIRATORY ILLNESS.
ENROLLED FROM NOVEMBER 10th TO JANUARY 30th OF THIS YEAR.
STUDY USE IS A TEST NEGATIVE DESIGN THAT YOU’RE FAMILIAR
WITH. ALL PATIENTS ARE TESTED FOR
INFLUENZA AND VACCINATION AMONG INFLUENZA POSITIVE CASE IS CONTRACTED WITH INFLUENZA NEGATIVE PATIENTS.
67% OF ENROLLEES WERE NEGATIVE. 33% WERE POSITIVE.
94% OF POSITIVE CASES WERE TYPE A.
ALL TYPE A VIRUSES WERE H3N2. 764 VIRUS OR MORE THAN HALF WERE
CHARACTERIZED AT CDC USING NOVEL PIRACY SEEKING ASSAY WHICH
ANTIGENIC PROPERTIES CAN BE INFERRED. THIS IS THE FIRST FROM THIS
SEASON. I’LL PRESENT DATA.
85% OF THE VIRUSES FROM THE FLU PARTICIPANTS BELONG TO GENETIC
GROUP THAT ARE GENERALLY LOW REACTORS WITH THE 2012 VACCINE,
H3N2 VIRUS WHILE ONLY 15% OF VIRUSES WERE GENETICALLY
VACCINE LIKE. AMONG THE CASES, MOST WERE THE B
LINEAGE QUADRIVALENT VACCINE. THIS IS FROM THE REPORT, H3N2
RESULTS WERE SHOWN BECAUSE THEY ARE SIMILAR TO ALL INFLUENZA AND
ADJUSTED THE ESTIMATE AGAINST INFLUENZA ILLNESS OVERALL FOR
ALL AGES WAS 18%. OKAY?
WITH THE CONFIDENCE INTERVAL FROM 6% TO 29%.
NONE OF THE AGE-SPECIFIC ESTIMATES WERE STATISTICALLY
SIGNIFICANT. ALL OF THE INTERVALS SUGGESTING
THE POSSIBILITY OF NO EFFECTIVENESS.
THERE WAS EVIDENCE OF HIGH HER VACCINE EFFECTIVENESS AGAINST
INFLUENZA V, ALTHOUGH SMALL NUMBERS WERE ONLY ABLE TO
PREVENT THE ESTIMATE FOR ALL AGES.
THE ESTIMATE WAS 45% FOR ALL AGES WITH 95% CONFIDENCE
INTERVAL FROM 14% TO 65%. SO, THESE ARE THE NEW DATA FOR
THIS SEASON. THE NUMBERS OF GENETICALLY
CHARACTERIZED H3N2 VIRUSES WERE SUFFICIENT TO PROVIDE INTERIM
ESTIMATES OF VACCINE EFFECTIVENESS AGAINST PRE
DOMINANT GENETIC GROUPS OF H3N2 VIRUSES.
THE FIRST ROW SHOWS PATIENTS SIX MONTHS AND OLDER.
THE ROW HIGHLIGHTED IN WHITE THROWS 115 H3N2 VIRUSES IN
GROUPS OF 3 C 3 OR 3 B. 39% OF THESE PATIENTS WERE
VACCINATED COMPARED TO 57% OF INFLUENZA NEGATIVE PATIENTS.
ADJUSTED AGAINST VACCINE LIKE H3N2.
WITH FROM 18% TO 69% SUGGESTING THE VACCINES PERFORM BETTER
AGAINST VACCINE-LIKE VIRUSES. THE BOTTOM TWO ROWS, BOXED IN
RED, WITH 624 CASES DUE TO GROUP 3 C 2 A AND 25 CASES DUE TO
GROUP 3 C 3 A. INDICATES NO EFFECTIVE AGAINST
VIRUSES IN THE LOW REACTOR GROUPS ALL BE IT WITH WIDE
CONFIDENCE INTERVALS AND OF NOTE THE REFERENCE VIRUS FROM THE 3 C
CA GROUP WAS SELECTED, FOR THE 15-16 INFLUENZA VACCINE.
AND THERE’S CROSS REACTIVITY FROM THE MORE COMMON VIRUSES
FROM THE 3 C 2 A GROUP. NOW I’LL QUICKLY PRESENT THE
GROUP AMONG CHILDREN AND ADOLESCENTS.
BRIEFLY, FOR THESE METHODS ONLY INCLUDED IN THIS ANALYSIS.
CHILDREN WHO RECEIVED AT LEAST ONE DOSE OF CURRENT SEASON
VACCINE WERE CONSIDERED VACCINATED.
VACCINE TYPE WAS DETERMINED FOR MEDICAL RECORD IF AVAILABLE BUT
WE USED PARENT RECORD OR PARENT REPORT OF VACCINE TYPE IF NO
MEDICAL RECORD DOCUMENTATION OF VACCINE TYPE WAS AVAILABLE.
AND 12 PEOPLE WITH UNKNOWN VACCINE TYPE WERE EXCLUDED.
VACCINE EFFECTIVENESS WAS CALCULATED SEPARATELY FOR LIVE
ATTENUATED VACCINE WHERE PATIENTS UNVACCINATED THIS
SEASON ARE THE REFERENCE GROUP. THIS TABLE SHOWS INTERIM
ADJUSTED VE ESTIMATES AGAINST H3N2 CASES FOR ONE OR MORE DOSE
OF VACCINE BY VACCINE TYPE ALTHOUGH THE FIRST THREE ROWS
SHOW AGE GROUP FOR ANY INFLUENCE OF VACCINE, ADJUSTED VE FOR ONE
OR MORE DOSE OF VACCINE AMONG 2 TO 17-YEAR-OLDS WITH 7% WITH
CONFIDENCE INTERVALS THAT INCLUDED ZERO OR NO EFFECTIVENESS. ESTIMATES FOR YOUNGER CHILDREN
WERE SIMILAR. ANALYSIS FOR LAIV EXCLUDED
CHILDRENS WHO RECEIVED ACTIVE VACCINE.
SIMILAR WERE POSITIVE AND INFLUENZA NEGATIVE.
PATIENTS RECEIVED AT LAIV THIS SEASON.
ADJUSTED RANGE 20 TO 24%. AND ZERO SUGGESTING NO EFFECTIVE
AGAINST H3N2 VIRUSES SO FAR THIS SEASON.
ANALYSES FOR INACTIVATED VACCINE EXCLUDE CHILDREN WHO RECEIVED
LAIV. ADJUSTED VE ESTIMATES RANGE FROM
15% TO 19% WITH CONFIDENCE INTERVALS INCLUDING NO EFFECT
AND OVERLAPPING WITH CONFIDENCE INTERVALS FOR VE ESTIMATES FOR
LAIV. MEDIMMUNE IS CONDUCTING A STUDY
AT FOUR SITES IN THE U.S. THIS SLIDE WITH 2014-15 RESULTS
WAS PREPARED THE THEM AND SHARED WITH US FOR COMPARISON WITH
RESULTS FROM THE U.S. FLU VE NETWORK.
THE STUDY ENROLLS PAINS FROM 2 TO 17 YEARS OF LESS THAN FIVE
DAYS DURATION PRESENTING WITH ILLNESS.
VACCINE STATUS DETERMINED BY MEDICAL RECORD OR REGISTRY AND
INFLUENZA IS CONFIRMED AS FOR THE FLU VE NETWORK AND INFLUENZA
PCR NEGATIVES ARE THE COMPARISON GROUP.
THIS ANALYSIS INCLUDES 988 ENROLLEES, THIS TABLE SHOWS THE
NUMBER OF INFLUENZA POSITIVE AND NEGATIVE CONTROLS IN EACH GROUP
OF CHILDREN AND ADOLESCENT. ADJUSTED VACCINE EFFECTIVENESS
IS PRESENTED IN THE THREE COLUMNS ON THE RIGHT.
ADJUSTED VE FOR ANY VACCINE AGAINST ANY INFLUENZA WITH 27%
WITH CONFIDENCE INTERVAL FROM NEGATIVE 1 TO 27%.
ADJUSTED VACCINE EFFECTIVE WAS 19% AND FOR ACTIVATED VACCINE AT
31% WITH INTERVALS THAT INCLUDED NO EFFECT AND
OVERLAPPED. ADJUSTED VE AGAINST H3N2 WAS 16%
FOR LAIV AND 33% FOR AN ACTIVATED VACCINE WHICH REACHED
STATISTICAL SIGNIFICANCE. THERE WERE TOO FEW TO REACH
RELIABLE ESTIMATE OF THE VACCINE IN CHILDREN AND ADOLESCENTS.
IN CONCLUSION LOW VE ESTIMATES ARE CONSISTENT WITH THE H3N2
VIRUSES. H3N2 ACCOUNTED FOR 95 FIRST OF
ALL POSITIVE CASES AND MORE THAN 80% OF GENETICALLY CHARACTERIZED
H3N2 CASES WERE FROM THE INFLUENZA VIRUS.
WE SAW NO EFFECTIVENESS DRIFTED H3N2 VIRUSES.
THERE WERE NO H3N2 AND B VIRUSES WHICH EFFECTIVENESS WAS HIGHER.
INTERIM EVIDENCE FROM THE TWO STUDIES PROVIDE NO EVIDENCE FOR
LAIV IN THE 2014-15 SYSTEM WITH PREDOMINANCE OF DRIFTED VIRUSES.
WE PLAN TO COMPLETE THE GENETIC CHARACTERIZATION OF INFLUENZA
VIRUSES AND NAME DATE ESTIMATES FOR LAIV AND IIV WITH PRIOR
VACCINATION AND COMORBIDITIES AND FURTHER ANALYSES OF
DIFFERENCES IN CIRCULATING VIRUSES BY SITE THE AND FINALLY, I WOULD LIKE TO ACKNOWLEDGE THE FIVE
PARTICIPATING SITES AND COLLEAGUES AND INVESTIGATORS WHO
SHARED THE PRELIMINARY DATA FOR THIS PRESENTATION.
THANKS. THANK YOU VERY MUCH.
>>YES QUESTIONS FROM THE COMMITTEE?
OKAY.>>I, THANK YOU FOR THIS OPPORTUNITY TO GIVE AN UPDATE ON
THE EFFECTIVENESS OF LAIV. THE RESULTS OF OUR INVESTIGATION
INTO THE EFFECTIVENESS OF LAIV IN 2013 & 14 AGAINST THE STRAIN.
AND THE ACTIONS TO ENSURE THE HIGH EFFECTIVENESS OF LAIV.
WE DISCUSSED OUR FINDINGS IN DETAIL AND AT THEIR REQUEST
WE’RE SHARING AN ABBREVIATED SUMMARY TODAY.
THIS IS THE SUMMARY. GOOD EFFECTIVENESS OF LAIV IN
CHILDREN IS OBSERVED FOR H 3 N 2 BUT LOW EFFECTIVENESS IN THE
U.S. IN 2010-11 AND 2013-14. WE CONCLUDED THIS IS RESTRICTED
TO THE A CALIFORNIA LAIV STRAIN AND MAY BE RESTRICTED TO THE
LAIV USE IN THE U.S. THE H1N1 STRAIN HAS UNIQUE
STRAIN THAT MAKES THE STRAIN LESS FIT AND MORE VULNERABLE TO
HEAT DEGRADATION. IT APPEARS LINKED TO THE
EFFECTIVENESS OF THE CALIFORNIA STRAIN BECAUSE DETAILED ANALYSIS
OF THE AVAILABLE EFFECTIVENESS DATA, SHOWS VACCINE SHIPPING
WHEN TEMPERATURES ARE 80 DEGREES CORRELATES TO THE EFFECTIVENESS
OF THE CALIFORNIA LAIV, BUT NOT OTHER STRAINS.
TO REMEDY THIS WE’LL REPLACE THE CALIFORNIA STRAIN WITH A MORE
STRAIN WITH A MORE STABLE HA. SO — OKAY.
SO, FIRST A QUICK REVIEW OF THE DATA FROM RECENT STUDIES IN THE
U.S. AND CANADA. THIS SLIDE SHOWS VE AGAINST H 3
AND THESE STRAINS IN CHILDREN 8 YEARS OF AGE IN STUDIES IN FOUR
RECENT SEASONS. LAIV EFFECTIVENESS IS IN BLUE
AND IIV IS IN GRAY. LAIV EFFECTIVENESS WAS
CONSISTENTLY MODERATE TO HIGH IN STRAINS IN EVERY SEASON.
THIS SLIDE SHOWS THE EFFECTIVENESS AGAINST H1N1
STRAIN AND THIS STRAIN CONTAINED IN THE LAIV WAS ALWAYS THE A
CALIFORNIA STRAIN IN ALL OF THE STUDIES.
LAIV WAS EFFECTIVE AGAINST H1N1 IN THE 2010 SEASON BUT NOT 2011,
2012, 13, 14 SEASON. TO SUMMARIZE IN THE LSU.
LAIV WAS EFFECTIVE FENCE H 2 N 3 STRAINS BUT LITTLE EFFECTIVENESS
IN THE 9 STRAINS. THIS DATA IS FROM THE DOCTOR WHO
SHARED THEM WITH US. LAIV WAS HIGHLY EFFECTIVE IN
CANADA AGAINST ANY INDIVIDUALS UNDER 2 YEARS OF AGE.
WHICH WAS SIGNIFICANT. AS NOTED 59% OF THE STRAINS IN
THIS STUDY WERE H1N1. RESULTS WERE SIMILAR LOOKING AT
PDM STRAINS ONLY, HOWEVER, DUE TO CASES, THESE ESTIMATES HAD
WIDE CONFIDENCE INTERVALS AND WAS NOT SIGNIFICANT.
THESE RESULTS WERE RECORDED BY RESULTS OF A SECOND CANADIAN
STUDY. THIS SHOWS THE STUDY PRESENTED
BY JEFFERY KONG FROM DECEMBER. THIS IS I CLUSTER RANDOMIZED
TRIAL IN ON TAIRIA. THE INCIDENCE OF INFLUENZA WAS
LOWER FROM LAIV RECIPIENTS INDICATING IT DID PROTECT
AGAINST THE H1N1 STRAIN IN CANADA IN 2014.
THESE RESULTS SUPPORT THE CONCLUSION THAT THE LOW
EFFECTIVENESS AGAINST THE H1N1 STRAIN MAY HAVE BEEN
U.S.-SPECIFIC. I WOULD LIKE TO NOW FOCUS ON THE
HYPOTHESIS CONSISTENT WITH ALL OF THE DATA I JUST SHOWED YOU
AND THE MOST BIOLOGICAL POSSIBLE EXPLANATION OF THE EFFECTIVENESS
OF THE A CALIFORNIA STRAIN IN TWO INCIDENTS IN THE U.S.
WE BELIEVE THAT THE UNIQUE A CALIFORNIA SEQUENCE EXPLAINS THE
LOW LAIV EFFECTIVENESS IN H1N1 IN SOME STUDIES.
LAIV AS E-47, IN THE HA STOCK THAT REDUCES THE STABILITY AND
VIRAL FITNESS. E-47 IS NOT PRESENT IN SEASONAL
VIRUSES AND NOT PREVALENT IN THE CURRENT H1N109 STRAIN.
WHEN WE PRE REPLACE THE A CALIFORNIA STRAIN WITH THE
UPCOMING SEASON WITH THE MORE RECENT N 1 STRAIN THAT WILL NOT
POSITION E-47 AND HAVE ENHANCE HAD STABILITY IN VIRAL FITNESS.
WE’VE SHOWN THE E-47 SEQUENCE REDUCES ACTIVITY AND REDUCES
VULNERABILITY IN HEAT DEGRADATION INCREASING
TEMPERATURE 120 TO 160 DEGREES. THE WAY TO THINK ABOUT IT IT
TAKES MORE HEAT TO PULL APART AN UNSTABLE HA — STABLE HA THAN IT
DOES TO PULL APART AN UNSTABLE HA THE CALIFORNIA LAIV STRAIN WAS E-47 AND ITS STOCK WAS READY
DIFFERENTIATED FROM HER LAIV STRAIN, INCLUDING LAIV STRAIN
WAS KNOWN EFFICACY. GIVEN THE A CALIFORNIA STRAINS
INCREASED VULNERABILITY TO HEAT DEGRADATION.
WE HYPOTHESIZE MINOR AND ROUTINE EXPOSURE TO TEMPERATURES ABOVE
THE RECOMMENDED STORAGE TEMPERATURE COULD LEAD TO
POTENCY LAW WHICH IN TURN COULD LOWER THE REAL WORLD EFFECTIVE. IN THE NORMAL U.S. DISTRIBUTION
PROCESS, EXPOSURES TO TEMPERATURES OVER 70 DEGREES CAN
OCCUR AT MULTIPLE POINTS AFTER LEAVING THE CHAIN OF CONTROL.
STANDARD PROCESSES PERMIT VACCINE EXPOSURE TO ROOM
TEMPERATURE UP TO 79 DEGREES FOR UP TO TWO HOURS AFTER UNLOADING
FROM REFRIGERATED TRUCKS AND DISTRIBUTORS AND WHILE
PACKING OUT SHIPMENTS TO CUSTOMERS.
WE DOCUMENTED THAT ONE OF THE LOTS MOST FREQUENTLY USED IN THE
STUDIES IN 2013-14 WAS OUTSIDE OF THE REFRIGERATED WAREHOUSE
FOR 1 HOUR AND 15 MINUTES AT THE DISTRIBUTOR.
WE RECENTLY SHOWED THE A CALIFORNIA POTENCY OCCURS AT 91
DEGREE. WE’RE STUDYING SHORTER TERM
EXPOSURES ON POTENCY. IN THIS GRAPHIC THE PORTION OF
THE RECIPIENTS IN THE STUDIES WHO HAD H1N1 ILLNESS IS ON THE
VERTICAL ACCESS AND ON THE HORIZONTAL AXIS IT’S TEMPERATURE
AT THE SITE OF DATE AND TIME OF TRUCK UNLOADING.
EACH CIRCLE REPRESENTS A SEPARATE LOT AND THE SIZE OF THE
CIRCLE CORRESPONDS TO THE NUMBER OF SUBJECTS RECEIVING A LOT THE
ACTUAL NUMBER OF RECIPIENTS IS GIVEN BY THE CIRCLE.
THERE’S A STRONG CORRELATION BETWEEN LOT EFFECTIVENESS AND
OUTDOOR TEMPERATURE WHEN THE TRUCK WAS UNLOADED AT THE DISTRIBUTOR WITH CUT POINT OF 80
DEGREES. THIS SUGGESTS THE TEMPERATURE
MAY AFFECT THE PERFORMANCE AND INCREASED VULNERABILITY TO HEAT
DEGRADATION. THIS SAID SLOWS SIMILAR
ASSOCIATION DUE TO SHIPPING IN HOTTER WEATHER BEFORE SEPTEMBER.
LAIV EFFECTIVENESS WAS LOW IN 2010, 2010-11 AND 2013-14 IN THE
U.S. WHEN MOST OF THE DOSES WERE SHIPPED DURING WARMER WEEKS
BEFORE MID-SEPTEMBER. IN CONTRAST, LAIV EFFECTIVENESS
AGAINST H1N1 WAS HIGH IN THE U.S. AND IN CANADA, WHEN
DOSES WERE SHIPPED IN THE COOLER WEEKS AFTER SEPTEMBER.
THIS IS CONSISTENT WITH THE HYPOTHESIS OF THE FITNESS
STRAIN. VULNERABILITY TO HIGHER
TEMPERATURES AND EXPOSURES ABOVE 36 TO 46 DEGREE DURING
DISTRIBUTION REDUCE THE EFFECTIVENESS OF THE A
CALIFORNIA LAIV STRAIN. ALL OF THIS BROUGHT US UP TO OUR
LEAD HYPOTHESIS THAT THE REDUCED FITNESS AND INCREASED
VULNERABILITY OF THE A CALIFORNIA LAIV DUE TO HEAT
DEGRADATION COULD EXPLAIN THE VARIABLE EFFECTIVENESS OF LAIV
AGAINST THE H1N1 STRAIN. CRITICAL FROM THIS HYPOTHESIS,
WE KNOW FROM PREVIOUS RANDOMIZED TRIALS THAT LAIV EFFICACY CAN BE
SIGNIFICANTLY REDUCE D THE KEY POINT IS THE PRIMARY DEFICIENCY
IS THE UNIQUE CHARACTERS I IS OF A CALIFORNIA.
THE 2 AND 3 STRAINS DO NOT HAVE THE UNIQUE VULNERABILITY OF THE
CALIFORNIA STRAINS, CONSISTENT WITH OUR MULTIPLE PREVIOUS
RANDOMIZED CONTROL STUDIES. I WOULD NOW LIKE TO TURN TO THE
PLANS FOR THE 2015-16 PLANS FOR THE FUTURE.
THE PRIMARY REMEDY IS PLACE A CALIFORNIA STRAIN AND 2015-16
STRAIN WITH A MORE STABLE HA. THE STRAIN WILL NOT CONTAIN THE
E-47 RESIDUE AND WILL HAVE A HEAT TOLERANCE SIMILAR TO
STRAINS WITH DEMONSTRATED EFFECTIVENESS.
AS I SHOWED YOU AT THE START OF THE PRESENTATION, NONE OF THE
OTHER LAIV STRAINS HAS BEEN INEFFECTIVE EVEN THOUGH ALL WERE
SUBJECT TO THE SAME DISTRIBUTION PROCESS AND POTENTIAL
TEMPERATURE EXPOSURES AND THIS HIGHLIGHTS THAT THE NORMAL LAIV
STRAINS REALLY QUITE RESILIENT AND A CALIFORNIA IS AN OUTLYER
IN THIS RESPECT. NEVERTHELESS WE’RE WORKING WITH
OUR U.S. DISTRIBUTORS TO ELIMINATE ANY SIGNIFICANT
EXPOSURE ABOVE THE RECOMMENDED STORAGE TEMPERATURE OF 46 DEGREE
DURING SHIPPING AND HANDLING. GOING FORWARD, MEDIMMUNE HAS AN
ONGOING TRIAL IN JAPANESE CHILDREN 15 TO 18 YEARS OF AGE
WHICH WE EXPECT EFFICACY DATA EARLIER THIS YEAR.
THIS CLOSING WE’RE CONFIDENT REPLACEMENT OF A CALIFORNIA H1N1
STRAIN WITH A MORE ROBUST STRAIN.
WILL RESULT IN A MORE ROBUST STRAIN THAT WHAT WE’VE SEEN IN
RANDOMIZED CONTROL TRIAL AND WHAT WE’VE SEEN IN OTHER STRAINS
IN THE RECENT OBSERVATIONAL STUDIES.
>>THANK YOU. DR. KARRON?
>>THANK YOU VERY MUCH, KATHY, FOR THAT CLEAR PRESENTATION.
I KNOW YOU MENTIONED IT BUT IT WENT BY VERY QUICKLY.
CAN YOU SAY, IN THE 2013-2014 SEASON, WE WERE USING
QUADRIVALENT VACCINES HERE. I BELIEVE IN CANADA THEY WERE
USING TRIVALENT. IS THAT CORRECT?
>>YES. GOING FORWARD, WE WILL BE
ABLE TO COMPARE QUADRIVALENT TO QUADRIVALENT BECAUSE ALL
COUNTRIES OF USING QUADRIVALENT. THAT’S CORRECT.
GLOBALLY EVERYTHING WILL BE QUADRIVALENT.
>>THERE WILL BE DATA FROM THIS SEASON, 2014-15 AS YOU MENTIONED
IN THE SLIDE FROM OTHER COUNTRIES USING QUADRIVALENT.
>>DR. ROMERO — EXCUSE ME, THE QUESTION I
HAVE FOR YOU ALL, WHAT MEASURES IN PLACE TO CHECK FOR THERMAL
ABILITY OR STABILITY, IF YOU WILL, OF FUTURE STRAINS?
THIS IS PROBABLY NOT JUST AN ANOMALY.
IT HAPPENS MORE FREQUENTLY IN NATURE THAN WE REALIZE.
>>GOOD QUESTION. I’M GLAD YOU ASKED THAT.
WE, ROUTINELY, AS YOU PROBABLY KNOW, WE MAKE OUR OWN STRAIN.
SO WE’RE RESPONSIBLE FOR ENSURING THAT WE CHOOSE THE
ABSOLUTE BEST, MOST OPTIMAL STRAIN.
SO, IN THE PAST WE HAVE NOT SEEN THIS PHENOMENON, SO WE — THIS
SCREENING FOR HA STABILITY WAS NOT PART OF OUR ROUTINE
SCREENING OF STRAINS WE’RE CONSIDERING FOR INCLUSION IN THE
VACCINE. BUT IT NOW IS.
I THINK THERE’S BACKUPS IN YOUR HANDOUTS THAT CAN SHOW THAT YOU
CAN VERY NICELY AND QUITE RELIABLY NOW IN THE LABORATORY,
DISCRIMINATE BETWEEN STRAINS THAT HAVE THIS UNIQUE
CHARACTERISTIC AND DON’T HAVE HEAT STABILITY. SO, WE’LL SCREEN BY SEQUENCE BUT IT’S MORE IMPORTANT TO SCREEN BY ACTUAL FUNCTION, TO ACTUALLY PRESSURE TEST IT IN THE LAB AND SEE WHICH STRAINS MIGHT
BE MORE OPTIMAL THAN OTHERS AND HAVE A BETTER HA STABILITY.
>>DOCTOR REINGOLD? THIS IS SOMETHING I HADN’T
THOUGHT ABOUT. WORKING WITH DISTRIBUTOR TO WORK
IN HIGHER TEMPERATURES BUT WHAT DO WE KNOW IN TERMS OF BEING ADD
MINNEAPOLIS SISTERED. BEING LEFT OUT, HOW LONG IT SITS
THERE, BEING IT IS GIVEN MORE AND MORE IN PHARMACISTS AND
VARIETY OF PLAYS. DO WE KNOW ANYTHING ABOUT HOW
IT’S HANDLED IN THESE VARIOUS SETTINGS?
WHAT WE DO KNOW, THE AVERAGE — THE LAIV IS QUITE STABLE EVEN AT
25 DEGREE — AT WHAT IT WOULD CALL ROOM TEMPERATURE, SO IF
YOU’RE HANDLING IT IN A CLINIC, FOR EXAMPLE, IT IS VERY — YOU
KNOW, IT’S RESILIENT TO LEAVING IT, YOU KNOW, FOR, SAY, A DAY.
BUT AS FAR AS, I THINK YOU’RE ASKING THE WRONG PERSON ABOUT
HOW IT’S ACTUALLY HANDLED. BY PRACTITIONER.
THAT’S WHAT YOU’RE ASKING? SO, I’M SURE THERE’S AN ENTIRE
RANGE OF PRACTICES, AND WHAT WE TRY TO DO, YOU KNOW, IN OUR
STABILITY PROGRAM, IT’S ALWAYS MONITORED AT THE RECOMMENDED
STORAGE TEMPERATURE OF 2 TO 8 DEGREES OR FRENCH RACIAL
TEMPERATURE, BUT ANYWAY, OUR STABILITY PROGRAM MONITORS THAT
RECOMMENDED STORAGE BUT WE ALSO GO OUTSIDE BECAUSE WE KNOW THAT
SOME PEOPLE LIKE TO GET PREPARED FOR A BIG CLINIC AND THEY DON’T
YOU THAT THEM ONE BY ONE. SO THAT’S WHY WE’RE VERY, YOU
KNOW, CAREFUL TO MAKE SURE THAT IT WOULD BE TABLE UNDER THOSE
KIND OF CONDITION, TOO. DR.?
>>THANK YOU. FOR THAT EXPLANATION.
YOU DEMONSTRATED THE EFFECTIVENESS OF 2 THROUGH
8-YEAR-OLDS. COULD YOU REMIND US FOR THE
2013-14 SEASON, WHAT WAS THE EFFECTIVE FROM THE 9 THROUGH
17-YEAR-OLDS? MY RECOMMENDATION WAS FROM THE
OBJECT MEETING THERE WAS EFFECTIVENESS THERE.
>>THERE WAS. IT TRENDED HIGHER THAN IN 92 TO
8 WHICH WAS A SURPRISING FINDING.
>>STATISTICALLY SIGNIFICANT THERE WAS
EFFECTIVENESS IN THE 9 THROUGH 17-YEAR-OLDS?
>>NO, IT WASN’T. IT WAS NOT SIGNIFICANT.
OKAY. THANK YOU.
>>>ANY OTHER COMMENTS –? YES, DR. LAIR.
>>YOU SAID IT WAS A H 1 N 1.
BUT YOU SHOW LAIV IS NOT WORKING WELL THIS YEAR.
I WONDER IF YOU CAN COMMENT ON THAT?
>>THANKS FOR THAT QUESTION, ACTUALLY, BECAUSE WHAT I
PRESENTED TO YOU TODAY SHOWS THE OCCURRENCE IN 2013-14 THAT WAS
RELATED TO THE STOCK SEQUENCE, AND, YOU KNOW, SO THAT’S ONE
THING. IT’S AN ENTIRELY DIFFERENT
SITUATION WHAT WE HAVE GOT GOING ON IN THE CURRENT SEASON WHERE
THE MISMATCH IS REALLY BAD. SO, AS YOU PROBABLY RECALL, FOR
H3N2 STRAIN, WE’VE SHOWN IN THE PAST THAT WE HAVE PROVIDED
REALLY GOOD PRODUCTION AGAINST SOME OF THOSE MISMATCHED
STRAINS. FOR EXAMPLE, IN 1979 THERE WAS
SYDNEY WUHAN AND THE COMPARISON FROM THE STUDY IN 2004-05 THERE
WAS A MISMATCH AND EFFICACY WAS HIGH IN THE ’80s.
I THINK MY OWN THOUGHT IS IF YOU HAVE THE KIND OF PROTECTION
AGAINST A STRAIN OF ANY THAT YOU SEE DURING THE VACCINE IS
DEPENDENT ON DEGREE OF MATCH OR MISMATCH AND THERE ARE LIMITS
FOR EVERY VACCINE WHAT DEGREE OF MISMATCH IT STILL WORKS AGAINST.
AFTER ALL, WE CHANGE THE VACCINE EVERY YEAR TO TRY TO MATCH IT
AND THERE’S A REASON WHY WE DO THAT.
>>OKAY. THANK YOU VERY MUCH.
DR. GROHSKOPH? AS DR. GROHSKOPF IS GETTING
TRADE. I SUGGEST WE TAKE A BREAK — I
KNOW A COUPLE OF PEOPLE WITH COMMENTS ON MENINGOCOCCAL
DISEASE HAVE TO LEAVE BECAUSE OF FLIGHTS.
AFTER WE’RE DONE WITH INFLUENZA, WE CAN TAKE TWO OF THOSE
COMMENTS THAT ARE MOST URGENTLY NEEDING TO GO AND WE’LL TRY TO
ADJUST AS WE CAN. SO, THANKS.
>>ONE MOMENT, PLEASE. WE GOOD?
GOOD MORNING, EVERYONE. THANKS VERY MUCH.
IN THE INTEREST OF TIME, I’M NOT GOING TO SAY AS MUCH AS I WANTED
TO SAY HERE BUT THIS IS A SLIDE THAT WOULD HAVE APPEARED IN
DR. KARRON’S PRESENTATION, WHO I WANTED TO ACKNOWLEDGE AS WELL AS
MANY OTHER PEOPLE THE WORK GETTING AWFUL THIS TOGETHER AND
I WANTED TO SAY MORE, BUT I WANTED TO SAY HOW MUCH I
APPRECIATE IT. THANK YOU.
SO, MOVING ON TO THE DETAILS FOR THE CURRENT MEETING, WE HAVE TWO
PROPOSED RECOMMENDATIONS FOR NEXT SEASON, THE FIRST, AS IN
PREVIOUS YEAR, DURING FEBRUARY, THE FIRST THING WE PROPOSE IS
REITERATION OF THE CORE RECOMMENDATIONS THAT ANNUAL
INFLUENZA VACCINATION IS RECOMMENDED FOR ALL PERSONS 6
MONTHS OF AGE AND OLDER. AGAIN WE’VE DONE THIS DURING THE
LAST SEVERAL FEBRUARY MEETINGS JUST TO REMIND EVERYBODY OF
THAT. AS IN PREVIOUS SEASON, A
LICENSED AID APPROPRIATE VACCINE SHOULD BE USED.
THE RECOMMENDATIONS FOR DIFFERENT VACCINE TYPES AND
DIFFERENT VACCINATIONS WILL BE DISCUSSED AS IN PREVIOUS SEASONS
WITHIN THE CORE RECOMMENDATIONS CURRENTLY ONE CHANGE IN LANGUAGE
IS PROPOSED RIGHT NOW WHICH BEGIN ON THE NEXT SLIDE.
IF THERE ARE ANY FURTHER CHANGES TO BE PROPOSED THE WORK GROUP
WILL BRING THEM TO THE JUNE ACIP MEETING.
I WOULD LIKE TO PAUSE NOW TO SEE IF THERE ARE ANY QUESTION ABOUT
THIS ASPECT? WE’RE GOOD TO GO?
OKAY. MOVING ALONG. A REVISION TO THE
GUIDANCE FOR THE USE OF LAIV FOR HEALTHY CHILDREN 2 THROUGH 8
YEARS IS PROPOSED FOR CONSIDERATION.
IN JUNE 2014, THE ACIP VOTED TO RECOMMEND FOR THE 2014-2015
SEASON THAT WHEN IMMEDIATELY AVAILABLE IT SHOULD BE USED FOR
CHILDREN 2 THROUGH 8 YEARS WITH NO CONTRAINDICATIONS.
AS PLANNED AND DISCUSSED AFTER THAT RECOMMENDATION WAS MADE IN
JUNE, EMERGING DATA WERE REVIEWED AND THE PRODUCTS OF
WHICH YOU’VE SEEN PRESENTED EARLIER IN THE SESSION AS WELL
AS AT THE OCTOBER 2014 MEETING. ON THE BASIS OF THIS
INFORMATION, THIS LANGUAGE IS PROPOSED TO BE REVISED AS
FOLLOWS — FOR 2015-2016, FOR HEALTHY CHILDREN AGE 2 THROUGH 8
YEARS WHO HAVE NO CONTRAINDICATIONS OR
PRECAUTIONS, EITHER LAIV OR IIV IS AN APPROPRIATE OPTION.
NO PREFERENCE IS EXPRESSED FOR EITHER FOR ANY PERSON AGE 2
THROUGH 49 YEARS FOR WHOM EITHER VACCINE IS APPROPRIATE.
THIS WOULD BE A CHANGE OF ONE BULL NET THE LIST OF
RECOMMENDATIONS RELATED TO LAIVs EARED LAST YEAR.
I HAVEN’T REPRODUCED THE WHOLE LIST IN THIS SLIDE OUT OF THE
INTEREST OF TIME AND SPACE. I DO HAVE SOME SLIDES THAT
FOLLOW THAT PUT IT INTO CONTEXT. THE BULLET THAT IMMEDIATELY
FOLLOWS OUTLINES WHICH GROUPS SHOULD NOT RECEIVE LAIV AND
THERE ARE NO CHANGES TO THOSE RECOMMENDATIONS.
THIS IS THE ONLY ASPECT OF THE RECOMMENDATIONS FOR WHICH A
REVISION IS PROPOSED. AND I’LL PAUSE HERE.
>>SO WE’ OPEN TO ANY QUESTIONS OR COMMENTS.
IT APPEARS THAT YOU’VE COVERED IT WELL.
>>OKAY. IF ONE WOULD LIKE TO SEE THE
CONTEXT FOR THE NEW BULLET, WHICH IS IN THIS SLIDE IN RED,
THE FIRST BULLET WILL REITERATE THAT ALL PERSONS AGED AT LEAST 6
MONTHS SHOULD RECEIVE INFLUENZA VACCINE ANNUALLY.
VACCINATIONS SHOULD NOT BE DELAYED FOR VACCINE PREPARATION
IF AN APPROPRIATE ONE IS ALREADY AVAILABLE.
THIS IS A CONCEPT THAT WAS — APPEARED AS WELL LAST YEAR.
THEN THERE IS THE PROPOSED REVISION BULLET.
IMMEDIATELY FOLLOWING IS THE LIST THAT APPEARED LAST SEASON
OF GROUPS FOR WHOM LAIV SHOULD NOT BE USED.
NO REVISIONS ARE PROPOSED HERE AT PRESENT.
IF THERE’S ANYTHING TO BE DISCUSSED IN THIS LIST, WE WILL
BRING IT IN JUNE. AND FINALLY, LAST SEASON, THERE
WAS LANGUAGE ALSO WHICH WAS NOT PROPOSED FOR CHANGE WHICH HAS TO
DO WITH GROUPS FOR WHICH LAIV IS A PRECAUTION AS OPPOSED TO A
CONTRAINDICATION. I WON’T SPEND TIME ON THIS
UNLESS DESIRED SINCE I KNOW WE’RE RUNNING SHORT OF TIME.
IN A NUTSHELL, AGAIN, IN SUMMARY, OUR TWO PROPOSALS ARE
TO HAVE — IF THE ACIP HAS A VOTE ON REITERATION OF THE CORE
RECOMMENDATION AS WELL AS AN OPINION ON ANY CHANGE IN
LANGUAGE FOR LAIVs FOR HEALTHY CHILDREN 2 TO 8 YEARS.
AND I’LL CLOSE THERE. THANK YOU.
>>THANKS, LISA. IS THERE FURTHER DISCUSSION
HERE? I THANK THE WORK GROUP FOR A
VERY SUCCINCT PRESENTATION HERE, BUT IF THERE ARE NO FURTHER
QUESTIONS DO WE HAVE ANY MOVE FOR THE DOCTOR?
>>MOVE THE ACCEPT THE — ACCEPT THE RECOMMENDATIONS OF THE WORK
GROUP. AND ANY SECOND?
DR. BENNETT. SO WE HAVE A MOTION, A SECOND.
ANY FURTHER DISCUSSION? SEEING NONE,I WILL START WITH YOU,AND WE CAN WORK TO YOUR RIGHT. YES.
>>BRIAN GOLD, YES. PELLEGRINI, YES.
>>DR. TANTA YES. ENNIS, YES.
>>RUBEN, YES. YES.
>>HARRIMAN, YES. HARRISON, YES.
>>ABSTAINED. KAREN, YES.
>>KEMP, YES. REILLY, YES.
>>LOCKINI, YES. RASKAS, YES.
>>THE MOTION PASSES, ONE ABSTENTION.
THANK YOU VERY MUCH. I’D JUST LIKE TO POINT OUT THAT
DESPITE THE FACT THAT WE MADE A RECOMMENDATION IN JUNE USING
GRADE PROCESS WITH MODERATE EVIDENCE WE MADE A STRONG
RECOMMENDATION, ACIP CAN CHANGE AS EVIDENCE CHANGES.
I SEE THIS AS THE REAL POWER OF BOTH TRANSPARENCY AND HAVING A
FORMAL PROCESS BY WHICH WE CONSIDER ALL THE EVIDENCE AND
CHANGE AS APPROPRIATE. AS WE ARE MOVING TO THE HPV
SECTION, I’M GOING TO TAKE THE OPPORTUNITY TO HAVE THREE OF THE
PUBLIC COMMENTS COME UP JUST OUT OF RESPECT FOR THEIR TRAVEL AND
THEIR TIME. SO WE HAVE ANDY, SCOTT, AND
FRANKIE. IF YOU CAN COME UP TO THE
MICROPHONE. AND, AGAIN, MY APOLOGY BUT WE
WANT TO TRY TO KEEP THE STATEMENTS BRIEF.
AND, AGAIN, IF THERE’S ANY CONFLICTS OF INTEREST, PLEASE
LET US KNOW. THANK YOU.
FRANKIE. THERE WAS NO RECOMMENDATION.
THERE WAS NO ACCESSIBILITY, SO HE DIED.
PERMISSIVE RECOMMENDATIONS NOW WHAT IS STILL MEANT BECAUSE I
STILL WOULDN’T HAVE KNOWN ABOUT IT.
YOU KNOW, TO ME, THIS IS LIKE, IF YOU HAVE A SHIP WITH 100
PASSENGERS ON BOARD, YOU HAVE 100 LIFE VESTS AND THAT SHIP IS
SINKING, YOU HANDLE OUT 50 OF THOSE LIFE VESTS AND THE OTHER
50 PEOPLE WATCH THEIRS HANGING IN THE CLOSET AS THEY DROWN.
WE CAN’T — YOU’VE DONE A GREAT JOB IN PROTECTING THESE KIDS SO
FAR FROM THIS DISEASE. WE’VE GOT HALF OF THE PUZZLE
THERE. WE NEED TO FINISH THE PUZZLE.
SO I AM REALLY ENCOURAGING YOU AS YOU MOVE FORWARD TO WORK FAST
ON THIS BECAUSE I REALLY BELIEVE A PERMISSIVE RECOMMENDATION IN
AN OUTBREAK, SOMEBODY’S GOING TO DIE BEFORE THAT HAPPENS OR BE
LEFT DEBILITATED. THAT’S WRONG.
WE SHOULDN’T HAVE TO HAVE A SACRIFICIAL LAMB.
I WOULD ENCOURAGE YOU TO MOVE AWAY FROM THOSE LIVING IN DORMS.
WE’VE BEEN FIGHTING THIS TEN YEAR, AND WE STILL ARGUE WITH
PHYSICIANS EVERY DAY THAT THEY DON’T HAVE TO LIVE IN A DORM TO
GET THIS. FIVE OF OUR KIDS WERE TOLD YOU
DON’T LIVE IN THE DORMS, YOU DON’T GET THE VACCINE, AND ALL
FIVE OF THEM DIED. SO I JUST WANT TO ENCOURAGE YOU
TO REALLY THINK ABOUT MOVING FAST ON THIS ISSUE SO OTHER KIDS
DON’T DIE. THANKS AGAIN.
>>THANK YOU, FRANKIE. IS THIS SCOTT?
>>YES. MR. PARKHURST?
>>HI. THANK YOU FOR LETTING ME SPEAK.
MY NAME IS SCOTT PARKHURST. FROM PORTLAND, OREGON.
MY SON JAKE IS THE YOUNGEST OF TWO OF MY BOYS.
HE WAS AN A STUDENT, JUNIOR IN HIGH SCHOOL.
HE LOVED GOLF. HE SKIED, SNOWBOARD, RIDE
MOTORCYCLES, HE WAS INTO BASEBALL.
I GOT A CALL SUNDAY NIGHT ABOUT A YEAR AGO TO THE DATE THAT HE
WASN’T FEELING WELL. HE WAS WITH HIS MOM.
AND I SAID DRINK YOUR FLUIDS AND WE’LL SEE HOW YOU FEEL IN THE
MORNING. THE NEXT MORNING I TEXTED HIM TO
FOLLOW UP HOW HE WAS FEELING AND HE SAID HIS MOM WAS TAKING HIM
TO URGENT CARE. 10:30 MONDAY MORNING I TEXTED
HIS MOM AND SHE SAID HE WAS BEING PUT IN AN AMBULANCE AND
BEING TAKE ON THE HOSPITAL. I DROVE TO THE HOSPITAL.
I WAS IN THE E.R. AND THE DOCTOR PULLED ME AND HI
MOM ASIDE AND SAID HE MAY NOT MAKE IT.
AND I ASKED HIM, I SAID FIGHT FOR YOUR LIFE, AND HE NODDED HIS
HEAD, AND THEY TOOK HIM TO ICU AND HE WAS IN A MEDICALLY
INDUCED COMA. THEY COULDN’T — THEY HAD TO
HELP HIM FIGHT THE ANTIBIOTICS. I’M SORRY.
I’M — LATE THEY’RE EVENING, THEY NOTICED ONE OF HIS PUPILS
WAS DILATED AND THEY THOUGHT THERE MIGHT BE SOME BRAIN
ISSUES, AND SO THEY STARTED TO WEAN HIM OFF THE MEDICATION.
AND HE WASN’T SHOWING ANY RESPONSIVENESS, SO THEY DID AN
EEG AND DETERMINED THAT HE WAS BRAIN-DEAD.
JAKE WAS DEAD IN 36 HOURS, CAUSE OF DEATH, MENINGITIS B.
I TOOK MY OLDEST BOY TO CANADA TO GET HIM VACCINATED FOR
MENINGITIS B. AND I SHOULDN’T HAVE HAD TO TAKE
HIM TO CANADA. AND I BELIEVE A PERMISSIVE
RECOMMENDATION WOULD BE THE DEATH OF JAKE ALL OVER AGAIN.
THANK YOU. THANK YOU VERY MUCH FOR YOUR
COMMENT. AND ANDY, MARSO?
>>YES. I’M FROM TOPEKA, KANSAS.
I PREPARED SOME REMARKS BUT OBVIOUSLY I JUST KEPT PARING
THEM DOWN AND PARING THEM DOWN. IN THE INTEREST OF TIME, I WROTE
A 270-PAGE BOOK ABOUT MY EXPERIENCE, IF YOU WANT IT,
DR. PICKERING HAS A COPY. REALLY THE TIME ELEMENT HERE
DOESN’T NECESSARILY MATTER BECAUSE NO MATTER HOW MUCH TIME
I HAD I WOULDN’T HAVE BEEN ABLE TO CONVEY TO ALL OF YOU FROM
GOING FROM A COMPLETELY HEALTHY COLLEGE STUDENT TO WITHIN 24
HOURS BEING LIFE FLIGHTED ON A HELICOPTER TO A LEVEL ONE TRAUMA
CENTER WITH MY LUNGS FAILING, STRUGGLING TO BREATHE.
I WOULDN’T BE ABLE TO CONVEY TO YOU WHAT MY PARENTS FELT WHEN
THEY ARRIVED THAT NIGHT AND I WAS ALREADY UNCONSCIOUS AND THE
DOCTORS TOLD THEM I MIGHT NOT SURVIVE.
I WOULDN’T BE ABLE TO CONVEY TO YOU THE DEEP DISTRESS OF WAKING
UP FROM THAT COMA THREE WEEKS LATER AND REALIZING I COULDN’T
MOVE MY HANDS AND FEET AND HAVING DOCTORS REMOVE BANDAGES
TO SHOW ME THAT MY ARMS AND LEGS WERE ROTTING WHILE STILL
ATTACHED TO MY BODY. I WOULD NOT BE ABLE TO CONVEY TO
YOU THE PAIN OF THE NEXT THREE MONTHS, BOTH PHYSICAL AND
EMOTIONAL, THAT I SPENT IN THE BURN UNIT AT KU MEDICAL CENTER
HAVING MY ARMS AND LEGS DEBRIDED DAILY.
I WOULD NOT BE ABLE TO CONVEY TO YOU THE POST SURGICAL PAIN OF
AMPUTATIONS THAT WERE STILL NECESSARY TO MY FEET AND HANDS.
I WOULD NOT BE ABLE TO CONVEY TO YOU THE FRUSTRATION OF THE YEAR
OF PHYSICAL AND OCCUPATION GNAT THEY A
THERAPY TO BE ABLE TO WIPE MYSELF AND FEED MYSELF AS A
23-YEAR-OLD MAN. NO MATTER HOW MUCH TIME YOU
COULD GIVE ME, IT WOULD NOT REPAY MY FATHER’S INSURANCE
COMPANY FOR THE $2 MILLION IN MEDICAL BILLS THAT WE BILLED
THEM THAT FIRST YEAR. IT WOULD NOT COMPENSATE ME FOR
ALL OF THE THOUSANDS IN OUT-OF-POCKET COSTS I HAVE PAID
EVERY YEAR SINCE FOR MY MEDICAL NEEDS INCLUDING MY PROSTHETICS
TO WALK AND STAND. THOSE COSTS WILL BE WITH ME FOR
THE REST OF MY LIFE. WHEN YOU CONSIDER THESE
RECOMMENDATIONS, PLEASE CONSIDER NOT JUST THE COST BUT THE COST
BURDEN. MASS VACCINATION SPREADS THAT
COST BURDEN EQUITABLY AMONG A LARGE POPULATION, NEGLECTING TO
VACCINATE LARGE POPULATIONS CONCENTRATES THE COST BURDEN FOR
THIS DISEASE ON FAMILIES LIKE MINE.
AND IT IS ENORMOUS. TODAY IS A START, BUT IT’S
BARELY A START. WHAT IT BASICALLY SAYS IS THAT
IF YOU GO TO A SCHOOL LIKE THE UNIVERSITY OF MISSOURI, WHERE
THEY JUST HAD A CONFIRMED MEN-B CASE, YOU’VE GOT TO WAIT FOR TWO
MORE PEOPLE TO GET SICK BECAUSE THAT’S A BIG SCHOOL SO, THEY’RE
NOT GOING TO BRING IN THE VACCINE UNTIL AT LEAST TWO MORE
PEOPLE ARE CRITICALLY ILL. THAT’S NOT ACCEPTABLE.
THAT’S NOT PREVENTIVE MEDICINE. THAT’S CRISIS MANAGEMENT, AND
IT’S NOT EVEN VERY EFFECTIVE CRISIS MANAGEMENT.
I WOULD MUCH RATHER SEE US PREVENT IT BEFORE IT HAPPENS.
SO I URGE YOU ALL TO DO IS BE BOLD AND CONSIDER YOUR LEGACY.
YOU HAVE A CHANCE TO WIPE OUT A DISEASE THAT CAUSES INCALCULABLE
HUMAN SUFFERING AND ONE OF THE MOST IMPORTANT PIECES OF THAT
PUZZLE IS YOUR RECOMMENDATION. THANK YOU.
>>AND THANK YOU VERY MUCH FOR YOUR ELOQUENT WORDS.
DO WE STILL HAVE SOME COMPUTER ISSUES GOING ON?
>>YES. SO I’M WONDERING IF THERE ARE
SOME ADDITIONAL OF THE PUBLIC THAT ARE WILLING TO COME UP AT
THIS POINT IN TIME. AGAIN, PLEASE STATE YOUR NAME,
YOUR ASSOCIATION. THANK YOU SO MUCH.
>>THIS IS LYNN BOZOK AT THE NATIONAL MENINGITIS ASSOCIATION,
AND NO DISCLOSURE. YOU KNOW, AS MANY OF YOU KNOW,
NMA WORKS WITH SURVIVORS AND THOSE WHO HAVE SUFFERED FROM
THIS DISEASE. IN JANUARY, NMA HOSTED A
ROUNDTABLE WITH SURVIVORS, THEIR FAMILY MEMBERS, INFECTIOUS
DISEASE SPECIALISTS, COLLEGE HEALTH OFFICIALS, AND OTHERS WHO
COULD ALL OFFER A UNIQUE PERSPECTIVE AND KNOWLEDGE ABOUT
IN THIS DISEASE. WE WOULD LIKE TO SHARE THE
OUTCOME FROM THAT MEETING WHICH IS IN YOUR PACKET AND ALSO
AVAILABLE ON THE BACK TABLE. IT GIVES VOICE TO THE CONCERNS
AND WORRIES ABOUT THE PARTICIPANTS.
THE REPORT POINTS OUT THE LONG-TERM IMPACT ON SURVIVORS,
THE LIFE-ALTER CHANGES FOR ALL THEIR FAMILY, AND THE AFFECTS ON
AN ENTIRE COMMUNITY LONG AFTER THE IMMEDIATE IMPACT.
SO, AS OTHERS HAVE SAID, AS YOU CONSIDER GROUP B RECOMMENDATIONS
IN LIGHT OF ALL CASES AND OUTBREAKS THAT HAVE OCCURRED
RECENTLY, PLEASE CONSIDER THESE LIFE-ALTERING AND LIFE-CHANGING
PERSPECTIVES. I’VE HEARD FROM SO MANY FAMILIES
WHO HAVE LOST CHIRP TO THE B-SERA GROUP WHO THOUGHT THEIR
CHILDREN HAD BEEN PROTECTED BECAUSE THEY HAD BEEN VACCINATED
ACCORDING TO CDC RECOMMENDATIONS.
WE NOW HAVE THE TOOLS TO PROTECT AGAINST THE MOST COMMON STRAINS
OF THIS DISEASE. WE NEED TO DO THE RIGHT THING
AND ROUTINELY RECOMMEND VACCINATION FOR ADOLESCENTS AND
TEENS. IT’S THE ONLY WAY THAT PARENTS
WHO RELY ON PHYSICIAN RECOMMENDATIONS CAN HAVE THE
OPPORTUNITY TO FULLY PROTECT THEIR CHILDREN.
THANK YOU. AND WE HAVE A SHORT PS ACTION TO
SHOW. I DON’T KNOW IF YOU’RE READY TO
SHOW THAT OR IF YOU WANT TO SHOW THAT LATER.
>>I THINK WE’RE HAVING TROUBLE WITH THE VISUALS.
BUT WE WILL MAKE SURE WE GET THAT ON UP.
THANK YOU VERY MUCH. ACTUALLY, DO WE HAVE IT?
AND THE QUESTION IS — I’M SORRY TO INTERRUPT.
>>PROTECT YOUR CHILDREN. YOU TEACH THEM HOW TO BRUSH
THEIR TEETH. HOW TO WASH THEIR HANDS.
>>TO LOOK BOTH WAYS WHEN CROSSING THE STREET.
>>YOU TAKE THEM TO THE DOCTOR WHEN THEY’RE SICK.
>>AND YOU VACCINATE THEM. AND YOU VACCINATE THEM.
>>AND YOU VACCINATE THEM. THERE WASN’T A VACCINE TO
PROTECT AGAINST STRAIN B WHEN MY DAUGHTER DIED.
>>WHEN MY DAUGHTER DIED. WHEN MY DAUGHTER DIED.
>>BUT NOW THERE IS. LEARN ABOUT VACCINES FOR
MENINGOCOCCAL MENINGITIS. GET THE FACTS AND VACCINATE
IS THE RIGHT THING TO DO. VISIT THE NMA WEBSITE.
NMAUS.ORG. I’M GLAD WE COULD DO THAT.
WE’LL MOVE ON TO THE NEXT COMMENT.
>>HELLO. MY NAME IS PATTY AND I’M HERE
REPRESENTING THE NATIONAL MENINGITIS ASSOCIATION.
IN 2012, MY BEAUTIFUL DAUGHTER, 17-YEAR-OLD KIMBERLY, A HEALTHY
HIGH SCHOOL SENIOR IN NEW YORK, DIED OF SERA GROUP B
MENINGOCOCCAL DISEASE JUST ONE WEEK BEFORE GRADUATING.
WE BURIED HER IN HER PROM DRESS JUST TWO DAYS BEFORE SHE WOULD
HAVE BEEN ABLE TO WEAR IT AT HER PROM.
I’M A NURSE, AND WHEN KIM GOT SICK, I WAS SURE IT WASN’T
MENINGITIS BECAUSE SHE’D BEEN VACCINATED.
I ASSUMED THAT THE RECOMMENDED VACCINE COVERED IT ALL AND I
THOUGHT SHE WAS SAFE. AFTER LOSING KIM, I DEDICATED
MYSELF TO LEARNING MORE. THERE WERE NO APPROVED SERA
GROUP B OPTIONS THEN BUT THERE ARE NOW.
PLEASE TRY TO THINK ABOUT THE MESSAGE THAT PARENTS WILL HEAR.
THE CDC RECOMMENDED THAT YOUR CHILD WILL VACCINATED AGAINST
MENINGOCOCCAL DISEASE, BUT THIS VACCINE WON’T PROTECT AGAINST
ALL STRAINS OF THE DISEASE. THERE IS AN ADDITIONAL VACCINE
THAT PROTECTS AGAINST THE STRAIN MOST COMMON IN ADOLESCENTS.
IT’S NOT RECOMMENDED, BUT YOUR CHILD CAN GET IT IF YOU WANT IT
AND IF YOU’RE ABLE TO OBTAIN IT. AS A HEALTH CARE PROFESSIONAL,
THIS IS AN EXTREMELY COMPLICATED MESSAGE TO DELIVER, AND MORE
IMPORTANTLY, IT’S A HARD MESSAGE FOR A PARENT TO HEAR AND
UNDERSTAND. WE CANNOT EXPECT PARENTS TO KNOW
THAT THEIR CHILDREN ARE NOT PROTECTED AGAINST SERA GROUP B
AND WE CANNOT EXPECT HEALTH CARE PROVIDERS TO ACT WITHOUT STRONG
GUIDANCE FROM THIS COMMITTEE. THAT’S WHY I’M ASKING YOU TO
CONSIDER BROAD RECOMMENDATIONS FOR THIS VACCINE.
A RECOMMENDATION WOULD MAKE IT EASY FOR PARENTS TO DO THE RIGHT
THING TO VACCINATE THEIR CHILDREN.
THE BOTTOM LINE IS KIMBERLY WOULD BE ALIVE TODAY IF SHE HAD
HAD THE OPPORTUNITY TO HAVE BEEN PROTECTED BY THE B VACCINE.
INSTEAD, AS HER MOTHER, I AM STANDING HERE LITERALLY IN KIM’S
SHOES, THE VERY SHOES SHE SHOULD BE WEARING RIGHT NOW IN HER
THIRD YEAR OF NURSING SCHOOL, FULFILLING HER DREAMS TO BECOME
A PEDIATRIC NURSE. PLEASE HELP ENSURE ALL CHILDREN
GET THE PROTECTION THEY NEED SO THAT WHAT HAPPENED TO MY FAMILY
AND TO KIMBERLY DOES NOT HAPPEN AGAIN.
THANK YOU. THANK YOU VERY MUCH.

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