June 2014 ACIP Meeting: Influenza


>>>SO WE ARE GOING TO START THE
INFLUENZA SECTION AND DR. KAREN IF YOU COULD LEAD US OFF PLEASE.
>>GOOD MORNING EVERYBODY. I’M VERY PLEASED TO BE ABLE TO
BRING YOU SOME OF THE DELIBERATION THAT’S THE
INFLUENZA WORK GROUP HAS BEEN INVOLVED IN OVER THE PAST
SEVERAL MONTHS. I WOULD LIKE TO ACKNOWLEDGE OUR
WORK GROUP MEMBERS. WE HAVE VERY DEDICATED AND VERY
ACTIVE WORK GROUP AND THEN HAVE HAD A LOT TO DO IN THE LAST FEW
MONTHS. I’D LIKE TO PARTICULARLY
ACKNOWLEDGE OUR CDC LEAD, LISA. WHAT WE HAVE BEEN WORKING ON,
THE PRIMARY ACTIVITY, IS TO REVIEW THE SAFETY LLB AND IIB
FOR USE IN CHILDREN. WE HAD ADDITIONAL CONSIDERATION
OF THE LANGUAGE FOR USE OF LAIB AND IIIB WHEN BOTH ARE
AVAILABLE. WE HAVE ALSO REVIEWED SOME DATA
ON USE OF THE TWO ON CHILDREN WITH RISHIGH RISK CONDITIONS.
WE ALSO DISCUSSED THE DOSAL GOOR RHYTHM FOR CHILDREN WITH DOSES
SIX MONTHS TO EIGHT YEARS, PARTICULARLY IN THIS YEAR WHERE
THERE IS NOT A STRAIN CHANGE. AND WE HAVE FINALIZED THE
2014-15 INFLUENZA STATEMENT. THE FIRST PRESENTATION TODAY
THERE IS A PARALLEL GROUP, THE NOVEL VACCINE WORK GROUP,
CHAIRED BY DR. DOUG CAWHO WILL GIVE THE FIRST PRESENTATION.
WE WILL PLEASED TO HAVE MELISSA STOCKWELL FROM COLUMBIA
UNIVERSITY WHO UNDER A FIFA GRANT WILL ASSESS WORK ON WORK
FOR RATES ON CHILDREN FOLLOWING LAIB AND IIB.
AND LISA WILL PRESENT DATA FOR CHILDREN TWO FOR EIGHT YEARS
FOLLOWED BY THE PROPOSED RECOMMENDATION.
SO DOUG. ALL RIGHT.
THANK YOU. GOOD MORNING.
THIS IS GOING TO BE A REAL QUICK PRESENTATION.VE HADK GROUP ON
NOVEL IN FLUFLUNZ OUR CHARGE IS REDUCE VACCINE DURING AN INTERER
PANDEMIC PERIOD. THERE ARE FOUR DIFFERENT H 51
VACCINES TWO HAVE BEEN LICENSED FOR GENERAL USE ONLY ONE, THE
GSK VACCINE WILL BE AVAILABLE FOR USE.
THE USE OF THE STOCK PILE SAC FLY VACCINE IS LIMITED TO A PAN
OF AND THEM PANDEMIC. 100,000 DOSES OR SO WILL BE
PRODUCED AND SOMEWHERE, PROBABLY AT NIH AND THE MANUFACTURER
ITSELF. THESE DOSES WILL BE AVAILABLE TO
HIGH-RISK INVESTIGATORS AND OTHER HIGH-RISK GROUPS AND WE
WILL FOCUS ON MAKING RECOMMENDATIONS FOR THAT LIMITED
GROUP OF PEOPLE. WE WILL FOCUS ON THAT ONE
VACCINE AND IDENTIFY THE HIGH-RISK GROUPS AND DRAFT SOME
RECOMMENDATIONS. NOW OUR PLAN WAS TO BRING
RECOMMENDATIONS TO THE GROUP IN OCTOBER BUT HAVING HEARD THE
PREVIOUS DISCUSSION OF YELLOW FEVER WE WILL PROBABLY COME BACK
WITH GRADE RECOMMENDATION, SOME LANGUAGE TO DISCUSS AND COME
BACK WITH THE GRADE RECOMMENDATIONS.
THAT’S OUR PLAN CURRENTLY. THANK YOU.
ONE OTHER THING I DO WANT TO ACKNOWLEDGE SONIA OLSON, WHO IS
THE STAFF PERSON. I DID NOT DO THAT LAST TIME AND
I REGRETTED IT. NOT THAT SHE MADE ME REGRET IT.
I JUST FELT BAD NOTOK ACKNOWLEDGING HER BECAUSE SHE
DOES ALL THE WORK. SO SONIA, THANK YOU VERY MUCH
FOR ALL YOUR WORK. GOOD MORNING.
GOOD MORNING. I’LL BE PRESENTED THE END OF
SEASON FLU VACCINE SEASON UPDATE FOR 2013-14. THE END OF
SEASON FLU VACCINE SEASON UPDATE FOR 2013-14. THE END OF
SEASON FLU VACCINE SEASON UPDATE FOR 2013-14.I THE END OF
SEASON FLU VACCINE SEASON UPDATE FOR 2013-14.N THE END OF
SEASON FLU VACCINE SEASON UPDATE FOR 2013-14.G THE END OF
SEASON FLU VACCINE SEASON UPDATE FOR 2013-14. UPDATES FROM
VACCINE ADVERSE EVENT REPORTING SYSTEM AND LINK SURVEILLANCE.
HOWEVER, BEFORE I PRESENT THE RESULTS I WOULD LIKE TO GO OVER
THE STRENGTHS AND LIMITATIONS. MOST OF YOU HAVE SEEN THE SLIDE
IN PREVIOUS PRESENTATIONS. SOME — OF THE LIMITATIONS ARE
REPORTING BIAS, INCONSISTENT DATA QUALITY AND COMPLETENESS.
ANOTHER LIMITATION OF THEIRS IS ILLUSTRATED ON THIS SLIDE, OF
THE TOTAL POPULATION, ONLY INDIVIDUALS WERE VACCINED AND
HAD ADVERSE EVENTS THAT WERE REPORTED, INCLUDED AND SHOWN IN
THE PINK CELL. DATA DO NOT INCLUDE THOSE IN THE
WHITE CELLS WHICH ARE UNVACCINE ATED COMPARE SEASON GROUP, THOSE
VACCINATED ARE HAD NO ADVERSE EVENT OR HAD NOT REPORTED.
GIVEN THIS LIMITATION, NOT ABLE TO — DETERMINE INCREASE RISK OR
CALCULATE VACCINE COVERAGE. THIS TABLE WHICH I PRESENTED IN
FEBRUARY SUMMARIZES THE LICENSED FLU VACCINES THAT BECAME
AVAILABLE DURING THE CURRENT SEASON.
THERE WAS A COMPLETE SWITCH IN FLU VACCINE THIS SEASON.
SO COMPARISON BETWEEN TWO FORMS WILL BE BETWEEN SEASONS.
FOR THE INACTIVATED FLU VACCINE BOTH VACCINES ARE AVAILABLE AND
COMPARISON CAN BE MADE. THE SECOND COLUMN SHOWS THE
ABBREVIATION, WHICH I WILL REFER TO DURING THIS PRESENTATION.
THE LAST COLUMN SHOWS RECOMMENDED ANCIENT GROUPS FOR
THE VACCINES LISTED. SURVEILLANCE INCLUDES U.S.
REPORTS AFTER LAIB AND IBANIB SIGNS ARE CODED INTO THE
DATABASE, COMMONLY REFERRED TO AS MET RAW.
AS METRA. TERMS ARE NOT MUTUALLY
EXCLUESIVE. BEING REVIEWED MEDICAL RECORDS
FOR ALL SERIOUS REPORTS AFTER THE RECENTLY VACCINE THAT I LIS
PREVIOUS TABLE. AND FLU DOME, INTERDETERMIRMAL.
ALSOED SERIOUS AND ALL REPORTS WITH A HISTORY OFEGG
ALLERGY. — THIS PROP PORTIONAL REPORTING
IN THE DATABASE. THIS SLIDE SUMMARIZES U.S.
REPORTS — FOLLOWING IIB FOR ALL AGES.
THIS IS THE COMPARISON BETWEEN IIB 4 SHOWN IN THE LAST COLUMN
WITH IIB 3, THIS SEASON AND THE PREVIOUS SEASON WHICH ARE SHOWN
IN THE MIDDLE COLUMNS. THERE WERE 493IIB 4 AND
APPROXIMATELY 700 OR SO FOR IIB 3.
MOST OF THE REPORTS WERE CLASSIFIED AS NONSERIOUS.
IT IS IMPORTANT TO LOOK AT THE PERCENTAGES RATHER THAN THE
ACTUAL NUMBERS WHEN COMPARING THE RESULTS.
GBS WAS COMPARABLE FOR IIB 3 AND IIB 4.
AN FLAX HIGHER FROM 4 TO 3 FROM THE PREVIOUS AND CURRENT SEASON
HOWEVER THERE WAS NO DISPROPORTIONAL REPORTING IN THE
DATA MINING FOR GBS AND 4 AN FLAXIES FOR THE LAST SEASON AND
THE CURRENT SEASON. SUMMARIZES RESULTS FOR LAIB.
THIS IS THE COMPARISON BETWEEN — LAIB 4 THIS
SEASON TO LAIB 3FROM LAST SEASON.
THERE WERE TOTAL REPORTS FOR LAIB 3.
COMPARED TO FOR LAIB 4. THE PERCENTAGES OF
REPORTS AND AN FLAXIES WERE HIGHER FOR LAIB 3.
GBS WASPARABLE FOR BOTH LAIB 3 AND LAIB 4.
THERE WAS NO REPORTING IN DATA MINING FOR GBS
AND AN FLAXIES. THE NEXT SHOWS A SUMMARY
OF THE RESULTS FOR FLU ZONE 243REPORTS WITH 3% CLASSIFIED AS
SERIOUS. 20% IN MALES.
MEDIAN AGE 44 YEARS WITH MEDIAN ONSET INTERVAL OF ONE DA
THE TOP FIVE MED RA TERMS LISTED AND MOSTLY INJECTED SITE.
THERE WAS NO NEW DATA MINING FINDINGS FOR FLU ZONE
INTERDERMAL THIS SEASON. THIS SLIDE SHOWS THE RESULTS FOR
FLU SO VACCINE. A CELL FLU VACCINE.
THERE WERE A TOTAL OF 67 REPORTS 3% WERE SERIOUS.
46% WERE IN MALES, MEDIAN AGE OF 36 YEARS WITH MEDIAN ONSET
INTERVAL ON THE DAY OF VACCINATION.
THE MOST COMMON MET DRA TERM WAS DRUG ADMIN IS ITERED AT
INAPPROPRIATE AGE. THE RECOMMENDED AGE IS 18 OR
OLDER. HOWEVER 37 OF THE REPORTS WERE
IN LESS THAN 18 YEARS OF AGE. OTHER COMMON ADVERSE EVENTS WERE
PAIN IN THE EXTREMITTY, INJECTION SITE PAIN, AND FLU
NAUSEA. THERE WERE 20 VARIOUS REPORTS
NONE CONSIDERED SERIOUS. ALL WERE IN FEMALES WITH A
MEDIAN AGE OF 47 YEARS AND ONSET INTERVALS, THE MEAN WAS ON THE
DAY OF VACCINATION. PROVIDED WITH THE MOST COMMON
REACTION 37% FOLLOW DS BY THE RASH 18% EACHE DS BY THE
RASH 18% EA DS BY THE RASH 18% EA BY THE
RASH 18% EACH. THERE WERE 61 REPORTS
FOLLOWING IIB. AND AGE WAS 30 YEARS WITH MEDIAN
AGE OF 18 WEEKS. THE PREGNANCY SPECIFIC OUTCOME
DS ARE LISTED WITH FIVE CASES OF SPONTANEOUS ABORTION.
31 OR APPROXIMATELY 51% WERE NON-PREGNANCY SPECIFIC REPORTS.
19 OF THE REPORTS HAD NO ADVERSE EVENT.
THERE WERE 22 REPORTS WITHOUT ANY ADVERSE EVENT AFTER LAIB 4
AND ONE SERIOUS REPORT WHICH WAS A CASE OF PULMONARY HYPER
TENSION IN AN INFANT WHO’S MOTHER RECEIVED LAIB 4.
THERE WAS ONE CASE AN FLAXIES REPORT IN BARES FLU
VACCINATION IN A PERSON WITH EGG ALLERGY.
A 40-YEAR-OLD MALE SNEEZING AND WATERING EYES AND VOMITING
WITHIN 15 MINUTES OF IIB 3. HE IS ALLERGYESTING SKIN TESTS
AND ARM TEST FOR EGG WHITE AND B O
BOEF IVINE GEL. EGG WHITES AND INCREASED
SALVATION, ABDOMINAL PAIN. THE AUTHORS CONCLU THE
ACTION WAS MOST LIKELY RELATED TO GELATIN RATHER THAN EGG
PROTEIN IN THE VACCINE. I WILL NOW PRESENT THE FINDINGS
FROM THE DATA LINK FOR THE SEASON.
THIS IS THE SIXTH SEASON THAT REALTIME RAPID CYCLE ANALYSIS
HAS BEEN CONDUCTED WITHIN BFD. RCA FOR THE AGE GROUP INDICATED
FOR THE PRESPECIFIED OUTCOMES USING THE CODES LISTED ON THE
SLIDE. THE OUTCOMES ARE NEURO LOGICAL
ADVERSE EVENT. FOR 2013-14 FLU VACCINE RCA USE
AUTOMATED DATA FROM APPROXIMATELY 9 MILLION PATIENT
RECORDS. THIS SLIDE SHOWS THE DATA FOR
RCA FOR THE CURRENT SEASON. THERE WERE APPROXIMATELY
3,800,000 ADMINSTERED. DOES INCLUDE CELL CULTURE BASE
AND IIB STRAIN. THERE WERE APPROXIMATELY 219
DOSES OF LAIB 4 DOSE ONE ADMINISTERED.
THERE HAVE BEEN VERY LIMITED UPTAKE OF IIB 4, CELL CULTURE
BASE AND TRY VEILENT VACCINE. THERE WERE NO SIGNALS DURING RCA
FOR ANY PRESPECIFIED OUTCOMES. IN SUMMARY THERE WERE NO NEW
SAFETY CONCERNS DETECTED FOR AN ACTIVATED OR LIVE ACTIVATED FLU
VACCINES DURING THE SEASON IN BAIRZ AND SURVEILLANCE WILL
INCLUDE SAFETY MONITORING, THE CELL CULTURE BASE AND PREGNANCY
REPORTS, LOOKING SPECIFICALLY AT THE COMPLICATIONED I MENTIONED
EARLIER. AN FLAXIES FOR PEOPLE WITH
HISTORY OF ALLERGY AFTER THE FLU VACCINE AND FINALLY WHEEZING
AFTER LAIB 4. I WOULD LIKE TO THANK THOSE ON
THE PREVIOUS SLIDE, THOSE WHOASSISTED IN THE PREPARATION
OF THIS PRESENTATION. AND ALSO FOR HELP WITH THE
AUTOMATIC MATED EMBARRASS AND BSB DATA.
THANK YOU. THANK YOU VERY MUCH.
I THINK WE WILL MOVE ON TO DR. STOCKWELL ON A DISCUSSION ON
FEVER AND THEN HAVE QUESTIONS AFTER THESE TWO PRESENTATIONS.
>>THANK YOU FOR INVITING ME HERE TODAY.
I WILL TELL YOU ABOUT A STUDY WE CAN LOOK AT AT FEVER RATES IN
CHILDREN 24 MONTHS TO FIVE YEARS OLD AFTER RECEIVING THE VACCINE
DURING THE 2013-14 SEASON. I WOULD LIKE TO ACKNOWLEDGE OUR
INVESTIGATORS AND TEAM FROM COLUMBIA AND THE CDC.
AND SO — [ READING ].
MAY HELP INFORM NATIONAL POLICIES — INCLUDING A — OF
VACCINES AS THEY ARE INTRODUCED. ONE STUDY SUGGESTED HIGHER FEVER
RATES IN 50 TO 10 PERIOD AFTER RABING IIB — THOSE RECEIVING
LAIB AND THOSE RECEIVING IIB AND THEREFORE THE RISK INTERVAL WAS
THOUGHT TO BE TWO DAYS. IN A PREVIOUS STUDY WAS SHOWN TO
BE VACCINATION DAY OR THE DAY AFTER OR THE 0 TO 1 DAY PERIOD.
SO TEXT MESSAGING CAN BE USED TO PREVENT.
WE HAVE USED IT TO ASSESS FEVER AFTER SIMULTANEOUS VACCINATION
WITH IIB 3 ANDCINE AND DECIDED TO EMPLOY THIS
METHOD IN THIS STUDY AS WELL. THE PRIME OCTOBERIBJECTIVE IS T
COMPARE FENWAY THOBETWEEN THOSE LAIB AND IIB.
WITH DAY TWO BEING VACCINATION DAY AND FIRST TWO DAYS OF
VACCINATION. WE SELECTED THAT WINDOW BASED ON
THE PREVIOUS TWO STD STUDIES I MENTION
MENTIONED. DAY THREE THROUGH TEN WINDOW,
NOT SIGNIFICANT. A NUMBER OF OBJECTIVES, ONE TO
ASSESS WHETHER FEVER RATES ARE HIGHER IN THOSE RECEIVING IIB 4
VERSUS IIB 3. [ READING ].
I WON’T BE FOCUSSING ON THAT OBJECTIVE.
OBSERVATIONAL OBJECTSIVE COHORT STUDY CONDUCTED 2013-14
[ READING ]. WE DID NOT RANDOMIZE THEM TO
WHICH VACCINE TO RECEIVE. [ READING ].
TO ABOUT ELIGIBLE CHILDREN HAD TO BE 24 TO 9 MONTHS OLD.
[ READING ]. WE HAVE A NUMBER OF EXCLUSION
CRITERIA. I WILL FOCUS ON THE FIRST THREE.
IF THE CHILD HAD A MEDICAL CONDITION THEY WERE NOT ENROLLED
OF THE EXCEPTION FOR CHILDREN WITH HISTORY OF ASTHMA OR
WHEEZING [ READING ].
YOU CAN SEE THE OTHER EXCLUSION CRITERIA HERE.
FAMILIES WERE SENT A TEXT MESSAGE ON THE DAY OF
ENROLLMENT, AT 8:00P.M. THAT NIGHT AND SUBSEQUENTLY FOR THE
NEXT TEN DAYS AT 8:00 P.M. EACH NIGHT WE COLLECTED TEMPERATURE
RANGE, AND TIME TAKEN. IF ANY MEDICINE WAS TAKEN, AS
WELL AS CARE THOUGHT AT THE DEPARTMENT.
I WILL FOCUS ON THE MEDICAL EXTRACTION.
HERE’S AN EXAMPLE OF THE FIRST TEXT MESSAGE THAT WE SEND.
WE REVIEW EACH RESPONSE THE NEXT MORNING.
[ READING ]. WE ALSO ASK FAMILIES TO USE A
PAPERS DIARY AND SEND IT TO US AFTER TEN DAYS.
[ READING ]. WE ABSTRACT COMPLAINTS AND S
SYMPTOMS [ READING ].
FOR DEFINITIONS, DAY ZERO IS THE DAY IMMEDIATELY AFTER THE
VACCINATION TO THE RESPONSE TEXT SPENT ON VACCINATION DAY.
DAY ONE IS THE [ READING ].
ASSESS MODERATE FEVER OF 102.2. LOOK AT DAY 0 THROUGH 2 AND DAY
3THROUGH 10. [ READING ].
EVAN RE[ READING ]. THIS IS THE AGE OF OUR ENROLLEN.
—EN ROLLE ENROLL EENROLLEE. [ READING ].
THIS IS OUR TEXT MESSAGES AND YOU CAN SEE OUR INFORMATION CAME
PRIMARILY FROM THE TEXT MESSAGE AND HAD A GOOD RESPONSE RATE
PARTICULARLY DAY 0 TO 2 PERIOD. LOOKING NOW AT ASSESS RATES [
READING ]. OF NOTE OF THE 22 FEVERS FOUR
WERE GREATER THAN 102. NONE IN THE IIB GROUP.
LOOKING AT 9.9% OF CHILDREN RECEIVED IIB FEVERING COMPARED
THOSE REEFI THOSE RECEIVING LAIB.
IT WAS NONSIGNATURE. IT WAS NONSIGNIFICANT.
[ READING ]. NOW LOOKING AT CORE
ADMINISTRATIVE VACCINES. IN ALL THE GROUPS THE MAJORITY
OF CHILDREN RECEIVE IT FROM THE VACCINE ALONE — THE MOST COMMON
IN 82.6% WHO RECEIVED THE VACCINE, OTHERS RECEIVED IT WITH
COMBINATION OF A VACCINE OR AS A TYPE A.
LOOKING AT THE RISK WINDOWS. [ READING ].
SO THIS IS THE MOST COMMONLY CODED AND ADMINSTERED VACCINES.
ALSO [ READING ] OTHER VARIABLES THAT
WE CONSIDERED BUT DIDN’T CONCLUDE
[ READING ]. SO LOOKING AT THE ADJUSTED
MODEL. RISK WINDOW
[ READING ]. WE ASSESSES CHILDREN WHO
RECEIVED ONE VACCINE ALONE. REMOVED THOSE WHO HAD MEDICINE
WITHIN EIGHT HOURS FROM WHEN THE REPORT WAS TAKEN.
WE LOOKED AT ONLY THOSE [ READING ].
OUR MEDICAL RECORD REVIEW FIRST LOOKING AT ALL PARTICIPANTS FROM
DAY ZERO THROUGH DAY TEN. [ READING ].
LOOKING AT THOSE 22 CASE THERE’S WERE TWO CHILDREN WHO HAD AN
EMERGENCY ROOM VISIT. THIS IS CORRECTION FROM THE
PAPERS THEY WERE BOTH IIB 4 IN ONE CASE AND IIB 3 IN THE OTHER
CASE. SO IN SUMMARY.
THERE WERE NO SIGNIFICANT DIFFERENCES IN FEVER RATES
GREATER THAN 104 IN THE FIRST TWO DAYS WITH VACCINATION IIB 4.
THAT NON-SIGNIFICANCE CONTINUED EVEN AFTER ADJUSTING THE MODELS.
[ READING ]. OUR ANALYSIS ARE STILL ONGOING.
THANK YOU. THANK YOU VERY MUCH.
ARE THERE ANY QUESTIONS? DR. HARRISON.
>>I’M NOT SURE IF I MISSED THIS.
CAN YOU COMMENT ON THE STATISTICAL POWER OF YOUR STUDY
TO DEFINE DIFFERENCES. I DIDN’T INCLUDE THAT.
WE ARE POWERED TO FIND A TWO-FOLD DIFFERENCE BETWEEN THE
STUDIES. SO EVEN WITH THE DIFFERENCE OF
TWO% WE WOULDN’T HAVE BEEN POWERED TO FIND THE DIFFERENCE.
BUT I THINK CONSIDERING THE RATES ARE SO SMALL —
>>NOW, DR. KEMP. JUST FOLLOWING UP ON THAT.
YOU BROKE IT DOWN BY HIGH FEVER FOR THE FIRST TWO DAYS BUT NOT
FOR T TEN AND IT LOOKED LIKE IT WAS AVERSUS A HA
THROUGH TEN. I’M WONDERING IF YOU COULD
SPECIFICALLY — OKAY, SO IT IS 6 OUT OF 14.
>>RIGHT. SO, THE ALLIED GROUP WOULD HAVE
BEEN 6 OUT OF 14 VERSUS 4 OUT OF 19.
>>OAK. OKAY.
I THINK THE ISSUE IS WHETHER YOU HAVE ENOUGH STATISTICAL —
>>WE ACTUALLY DIDN’T.
PARTICULARLY FOR THE 102.2 ONE WE WEREN’T LOOKING AT — I DON’T
HAVE THE SLIDE HERE, BUT IF WE LOOK AT GREATER THAN 102.2 WE
DON’T HAVE ENOUGH CELLS TO BE ABLE TO LOOK AT THAT AND SO
THAT’S WHAT WE’RE REPORTING THE RAW CRUDE DATA, RATHER THAN
SHOWING THAT STATISTICAL CHANGE FOR THE MODERATE FEVER.
SO FOCUSSING ON THE 104.4 FEVER. ANY QUESTIONS?
THANK YOU VERY MUCH. DR. RUBEN.
>>FROM THE PREVIOUS SPEAKER, I JUST WANTED CLARIFICATION, IS
THAT POSSIBLE. AND THE QUESTION WAS FOR THE
BELL — THEER 18 YEARS OLD THEY WERE REPORTED NOT
BECAUSE THEY HAD ADVERSE EFFECTS.
>>NO THEY DID HAVE SOME ADVERSE EVENTS SO THAT WAS — WHEN WE
LOOKED AT THE DEMOGRAPHICS, THE INFORMATION ON THE BARES FORM
THEY WERE LESS THAN 18 YEARS OF AGE XG.
SO I DON’T HAVE THE SPECIFIC. I DON’T KNOW IF DR. MOORE HAS
MORE DETAILS ON THOSE SPECIFIC CASES.
HE’S STEPPING UP TO THE MICROPHONE SINCE HE HAD REVIEWED
THOSE SPECIFIC CASES. ACTUALLY, THOSE THAT RECEIVED
SHOULD NOT HAVE RECEIVED FLU VACCINE WERE LESS THAN 18 YEARS
OF AGE, THE MAJORITY DID NOT HAVE A ADVERSE EVENT 240EZ THOSE
DID, MAINLY LOCAL SITE REACTIONS.
THE REASON FOR REPORTING IT WAS INCORRECT H FOR ADMINISTERING
THE VACCINE. ANY OTHER QUESTIONS?
>>THANK YOU. OKAY.
WE’LL MOVE ALONG. I’M SUPPOSED TO ALSO REMIND OUR
PRESENTERS THAT WE HAVE SPANISH TRANSLATION GOING ON SO SPEAKING
CLEARLY AND SLOWLY IS WORTH WHILE.
>>I SHALL DO MY BEST. GOOD MORNING.WORTHWHILE.
>>I SHALL DO MY BEST. GOOD MORNING. SO THIS PRESENTATION IS IN
TWO PARTS. THE FIRST PART IS GOING TO GO
OVER SOME INFORMATION PERTAINING TO LAIB AND IIB FOR CHILDREN WHO
ARE NOT HEALTHY THAT IS CHILDREN WHO HAVE HIGH RISK CONDITION
THAT CONFER HIGHER RISK OF BAD OUTCOMES OR SERIOUS RISK OF
INFLUENZA AND AFTER THAT I WILL BRIEFLY REVIEW SOME OF THE
MATERIAL WE WENT OVER IN THE MEETING RELATED TO THE ANALYSIS
IN THESE VACCINES AMONG HEALTHY CHILDREN.
I WANT TO THANKS FOLKS WHO GOT THIS PREPARED.
REALLY APPRECIATE ALL YOUR EFFORTS.
SO AS MENTIONED AND AS MANY REMEMBER BACK IN FEBRUARY WE HAD
A NUMBER OF PRESENTATION FOR ANALYSIS BETWEEN LAIB AND IIB IN
HEALTHY CHILDREN, CHILDREN WHO DON’T HAVE CHRONIC MEDICAL
CONDITIONS THAT WILL HAVE A HIGHER RISK FOR FLU INFECTIONS.
WE HAVE FOCUSED PRIMARILY ON CHILDREN TWO THROUGH EIGHT YEARS
OF AGE. THE RATIONAL IS LINEBACKAIB IS
LICENSED FOR CHILDREN UNDER TWO AND THE UPPER LIMIT IS CONSIDER
WHETHER ONE OR TWO DOSES ARE NEEDED — THAT WAS SELECTED
PRIOR TO THE VIA VIEW FOR PROGRAM CONSISTENCY THAT WE
WOULD EVENTUALLY FORMA LATE. THE GREAT ASSESSMENT WAS
PRESENTED FOR HEALTHY CHILDREN AT THE FEBRUARY 2014 ACIP.
DURING THAT PRESENTATION THERE WERE QUESTION THAT’S AROSE FOR
THE USE OF LAIB FOR CHILDREN WITH CHRONIC MEDICAL CONDITIONS.
WHEN WE INITIALLY PLANNED OUR WORK WE DECIDED WE WILL TACKLE
THE LITERATURE ON HEALTHY CHILDREN FIRST BUT SINCE, WE
HAVE DONE A BIT OF REVIEW T, TH IS STILL SOMETHING OF A WORK IN
PROGRESS BUT BECAUSE THESE QUESTIONS WERE ASKED I WANT TO
GO OVER SOME OF IT WITH YOU. ACIP CURRENTLY DOES NOT
RECOMMEND THE USE OF LAIB, V, [ READING ].
THIS IS NOW FLU VEILENT THAT WAS LICENSE IN 2014.
CHILDREN YOUNGER THAN FIVE [ READING ].
THOSE JUST COME FROM THE WARNINGS AND PRECAUTIONS
SECTIONS, THAT’S WHERE THAT INFORMATION ARE.
SO IN REVIEW OF COMPARATIVE STUDIES, WE AGAIN, SIMILAR TO
WE THOUGHT TOHY STUDIES THAT COMPARED THE TWO
VACIVACCINES, STUDIES HAD LAIV ARM AND ARM.
WE HAVE THREE STUDIES. TWO A FAMILIAR BECAUSEWE DISCUS
DURING THE HEALTHY CHILDREN REVIEW.
THEY ARE STUDIES OF HERELATIVEL YOUNG CHILDREN.
THEY DIDN’T HAVE THE CRITERIA THAT THE CHILD HAVESTHMA OR W T
STUDIES. IN ADDITION, FLEMING PUBLISHED
IN 2006, A STUDY OF CHILDREN WITH ASTHMA DIAGNOSE, IT IS
OLDER CHILDREN 6 THROUGH 17 YEARS AND FOR THAT REASON SINCE
FOR THE TIME BEING WE ARE FOCUSSING ON THE YOUNGER AGE
GROUP WE WON’T PRESENT INFORMATION FOR THAT TRIAL BUT
WILL PROBABLY RETURN TO IT LATE. I’M GOING TO PRESENT JUST A FEW
SLIDES FROM SOME OF THE GRADE AND QUAD INFORMATION ON THE
INFORM FORGETS FOR THESE CHILDREN WITH HISTORY OF ASTHMA
OR WHEEZING. WE ARE DEALING WITH TWO STUDIES
THAT CHA OF COMPARED LAIV AND IIV.
ONE AN OPEN STUDY, THE OTHER A BELL A LARGER STUDY.LINDED STUD.
THE DATA FOR THESE TWO STUDIES, SUBSETTED OUT FOR THE CHILDREN
BETWEEN 24 AND 59MONTHS OF AGE AND ALSO WHO HAD HISTORY OF
ASTHMA AND/OR WHEEZING ARE BROKEN DOWN NICELY IN A PAPERS
IN 2012 WHICH IS WHERE THE INFORMATION YOU WILL SEE COMES
FROM. THE FIRST SLIDE IS PRIMARY
EFFICACY, CRITICAL OUTCOME FOR US.
WE DIDN’T DOWNGRADE FOR RISK OF BIAS OR INPRECISION.
WE HAVE A RELATIVE RISK OF 0.53CAN WHICH IS 0.53N
WHICH IS SIGNIFICANT. AND0.53WHICH IS SIG
[ READING ]. 0.53
WHICH IS SIGNIFICANT. AND
[ READING ]. IT ISELATIVELY COMPARABLE TO
THE REPORT IN FEBRUARY. OVERALL QUALITY IS HIGH.
THE NEXT COUPLE OF SLIDES HAVE TO DO WITH WHEEZING OUTCOMES AND
THE BELL PAPERS IS THE ONE WE’RE LOOKING AT HERE.
THE DEFINITION FOR THE WHEEZING OUTCOMES DIFFER SOME WHAT
BETWEEN THE TWO. WE WILL STICK WITH BELL FOR NOW.
FOR THIS PAPERS MEDICALLY SIGNIFICANT AND MEDICALLY
ATTENDED OUTCOMES WERE REPORTED. THEY LOOKED PRETTY SIMILAR.
THIS IS MEDICALLY SIGNIFICANT ON THE NEXT COUPLE SLIDES.
THIS IS SIGNIFICANT WHEEZING UP TO 59 MONTHS OLD FOLLOW A PERIOD
OF TWO DAYS. [ READING ].
WE HAVE A RISK RATIO OF 0.69 WITH CONFIDENCE INTERVAL THAT IS
NOT SIGNIFICANT AT THE 95% LEVEL.
AND WE HAVE OVERALL EVIDENCE QUALITY OF TWO OR MODERATE FOR
DOWN GRADING FOR IMPRECISION. THIS IS THE SAME SCENARIO, 42
DAYS FOLLOW UP. 24 THROUGH 59 MONTHS.
AGAIN IT IS BELL. THIS TIME IT IS CHILDREN WITH
ASTHMA AND OR WHEEZING BUT FURTHER SUB DIVISION CHILDREN
WHO HAVE NOT WHEEZED IN LAST 12MONTHS.
THAT’S AONE. AND THESE ARE THE CHILDREN WHO
HAVE WHEEZED IN LAST 12 MONTHS. [ READING ].
THE LAST ONE IS THE CHILDREN THAT HAD AN ASTHMA DIAGNOSE.
THIS IS THE SMALLEST SUBSET. WE ARE NOW DOWN TO 120 TO 130
KIDS PER ARM. YOU CAN SEE HOW THIN IT GETS.
THIS IS THE ONE INSTANCE WHERE THE POINT DEFICIT IS ON THE
OTHER SIDE OF ONE. BUT IT STILL ALSO IS NOT
SIGNIFICANT 0.29 TO 1.88 BECAUSE OF THE DOWN GRADE
WE ESTIMATED IT AS MODERATE QUALITY EVIDENCE.
WE ALSO TRIED TO FIND STUDIES INVOLVING HEAD TO HEAD
COMPARISON OF THE TWO VACCINES FOR KIDS WITH CHRONIC CONDITIONS
BUT WE HAVE TO FIND A LOT.
WE HAVE FOUR PAPERS, ONE WITH CHILDREN WITH CANCER, WITH
SIS TICK FIE BROESIES AND CHILDREN WITH HIV INFECTION.
WE ARE TALKING ABOUT FAIRLY SMALL STUDIES SO THINGS WILL
LOOK DIFFERENT WHEN WE SUMMARIZE THIS.
WE DON’T HAVE THE SAME SITUATION WITH THE COUPLE LARGE STUDIES AS
WE DID PREVIOUSLY. THIS IS SOMETHING WE WILL LIKELY
BE COMING BACK TO LATER. AT THIS POINT WE DIDN’T FEEL
THERE WAS SUFFICIENT EVIDENCE TO MOVE FORWARD WITH ANYTHING FOR
CHILDREN WITH HIGH RISK MEDICAL CONDITIONS OR ASTHMA.
SOME LIMITATIONS, STUDIES ARE NOT POWERED TO PROTECT WHEEZING
[ READING ]. THE DATA, IF ONE LOOKS THE
DEFINITIONS FOR HOW THE CRITERIA FOR WHEEZING AND AS MAY WERE
DESCRIBED IN THE STUDIES AND HOW THE DATA REPORTED, THEY REALLY
DON’T SEEM TO CLEARLY INDICATE A DEGREE OF ASTHMA SEVERITY FOR
WHICH LAIV BENEFITS WOULD OUTWEIGH RISKS.
THIS IS IMPORTANT FOR RECOMMENDATIONS BECAUSE WE WANT
TO SAY PLEASE OR SEVERE USE THIS VACCINE
FOR THIS CONTEXT AND WE WANT TO BE CLEAR ABOUT THE WORDING WHAT
IS SEVERE WHEEZING. RIGHT NOW IT IS A LITTLE
DIFFICULT TO DO THAT.OUTCOMES. WE HAVE FEW COMPARATIVE DATA FOR
OTHER CHRONIC MEDICAL CONDITIONS.
SO WITH THAT BEING SAID, WE’RE GOING TO MOVE FORWARD AND I’M
GOING TO GO TO THE NEXT PART OF THE PRESENTATION NOW WHICH
INVOLVES HEALTHY CHILDREN. WE HAVE NOT PROPOSED ANY
LANGUAGE CHANGES FOR THE UPCOMING SEASON, ANY SIGNIFICANT
ONES FOR HIGH-RISK MEDICAL CONDITIONS.
SO WITH THAT SAID, I KNOW WE WENT OVER A LOT OF THIS LAST
TIME. BUT I’M GOING TO REVIEW OF THE
TABLES AND GIVE A SUMMARY AT THE END FOR WHAT WE’VE DONE FOR THE
ANALYSIS FOR HEALTHY AGE 2 TWO 8 YEARS.
WE WILL FOCUS ON 2 THROUGH YEARS HERE.
THIS IS JUST A REMINDER OF THE OUTCOMES CONSIDERED.
ALL OF THEM ARE LISTED HERE. WE HAVE EFFICACY
OUTCOMES AND THE HARMS, THE SAFETY OUTCOMESE FOR OUR BENEFI
LABORATORY CONFIRMED INFLUENZA. INFLUENZA ASSOCIATED MORTALITY,
HOSPITALIZATIONS AND MEDICALLY ATTENDED RESPIRATORY WERE VAL
YUD AS CRITICAL. WE WERE NOT ABLE TO FIND
EVIDENCE FROM OUR STUDIES ON INFLUENZAOCIATED MORTALITY.
SO THAT’S NOT PRESENTED. INAND
INFLUENZA ASSOCIATED ACUTE WERE CONSIDERED IMPORTANT.
WE HAVE DATA FOR THOSE. HARMS, WE HAVE A BIT MROR OF A
LIST. MEDICALLY ATTENDED WHEEZING WAS
ONE OF THE CRITICAL ONES. WE ADDED MEDI SIGNIFICANT
WHEEZING BECAUSE THERE WERE DATA ON THAT AND WE THOUGHT THAT
MIGHT BE USEFUL. THAT’S PART OF WHY YOU SAW THAT
EARLIER. THEN ALSO, IMMEDIATE
HYPERSENSITIVITY ANA IF A LAXIC. THAT WAS KRIT KAG.
FOR IMMEDIATE HYPERSENSITIVITY, FEBRUARY RIGHT SEIZURE, THESE
ARE RARE YOUT COMES THAT WE WER NOT ABLE TO MAKE AN ASSESSMENT.
RESPIRATORY SYMPTOMS, OTHER NEUROLOGIC SYMPTOMS AND FEVER.
WE INCLUDED RESPIRATORY AND OTHER NEUROLOGIC OUTCOMES.
WE DID NOT INCLUDE IN THE EVIDENCE PROFILE THEY WERE NOT
REALLY DEFINED SPECIFICALLY ENOUGH TO REALLY MAKE IT
FEASIBLE TO ASSESS AND ALSO THEY WERE IMPORTANT AND WE HAD MANY .
THEY WEREN’T CONSIDERED CRITICAL.
WE DID NOT USE THOSE. BECAUSE WE HAD A COUPLE OF
SERIOUS OUTCOMES THAT WERE RATED CRITICAL THAT WE COULDN’T REALLY
ASSESS, WE DID INCLUDE ANY RELATED SAE.
I HAVE NOT INCLUDED A VALUE FOR THIS BECAUSE THIS IS QUITE A S
DESPAIR IT BAG THAT OCCUR. IT’S DIFFICULT TO ASSIGN A VALUE
TO IT. BUT WE DID ASSESS THAT.
I’M NOT GOILL OF THE TABLES AND CHARTS THAT WE
DID LAST TIME, BECAUSE THAT — THAT’S PROBABLY NOT NECESSARY.
AT THE BACK OF LOT OF TIME. THE SET FOR EXTRA SLIDES SHOULD
ANYONE WANT TO SEE SOMETHING IN PARTICULAR.
BUT I’M GOING TO GO OVER THE ONES THAT THAT WERE CRITICAL
SAFETY CONCERNS. A CRITICAL OUTCOME, THIS IS DATA
FROM ASHKENAZI AND BELSHE. AS MENTIONED EARLIER, ONE IS
OPEN LABEL. THE BELSHE WAS BLINDED.
THIS IS DATA THAT’S RESTRICTED TO THOSE IN BOTH STUDIES THAT
WERE OVER 24 MONTHS OF AGE. SO WE DON’T HAVE THE 6 THROUGH
23 MONTH OLDS IN HERE. WE DID NOT DOWNGRADE FOR SERIOUS
CONCERNS. THE RISK RATIO IS 0.7.
A OVERALL EVIDENCE QUALITY WE TERMED HIGH.
RISK DIFFERENCE IS ESTIMATED TO BE 46 FEWER CASES PER 1,000.
THERE WE GO. OKAY.
THE OTHER OUTCOME THAT WAS — SHOWED A SIGNIFICANCE DIFFERENCE
IN FAVOR OF LAIV WAS INFLUENZA ASSOCIATED OTITUSMEDIA.
RISK RATIO 0.47,0.3 TO USE CONFIDENCE RATIO.
WE RATED THIS AS HIGH QUALITY EVIDENCE.
THE OTHER CRITICAL OUTCOMES, MEDICALLY ATTENDED RESPIRATORY
AND INFLUENZA LIKE ILLNESS DID NOT SHOW SIGNIFICANT
DIFFERENCES. WE WILL SEE THEM A LITTLE BIT ON
THE SLIDE AT THE END. THIS IS ONE OF SLIDES.
WE HAVE SEVERAL OF THEM ON MEDICALLY SIGNIFICANT WHEEZING.
WE ARE USING BELSHE ONLY BECAUSE OF BEING ABLE TO KEEP THE
DEFINITIONS OF THE WHEEZING YOIT COMES CONSISTENT.
THIS IS THE MEDICALLY SIGNIFICANT OUTCOME.
AGAIN, FOLLOW A TIME OF 42 DAYS. THIS IS 24 THROUGH 59 MONTHS FOR
THE AGE OF THE CHILDREN. WE STILL HAVE EVEN THOUGH WE
HAVE A SLIGHTLY LARGER GROUP OF KIDS IN THIS PARTICULAR SLIDE, A
DOWNGRADED FOR CONFIDENCE IMPRECISION, OVERALL QUALITY IS
MODERATE. I SHOULD HAVE MENTION ALSO THAT
LAST SLIDE — LET ME BACK UP WAS AFTER DOZE ONE.
CHIFRN IN THE BELSHE SHOULD HAVE FOR VACCINE OR NOT.
PREVIOUSLY VACCINATED CHILDREN HERE AND VACCINE NAIVE CHILDREN
WHICH HERE. SIMILARLY, WE DOWNGRADED FOR
IMPRECISION AND CALLED IT AS MODERATE QUALITY EVIDENCE.THIS
O WE MORTALITY IN SEVERAL
OF THE SAFETY OUTCOMES HAVE ADE. THE TWO LINESIN
GREEN FLU TIE TUESDAY ARE FOR WHICH ERENCE INLAIV.
THE OTHER ODIFFERENCE. AND THEY ARE ALL THERE.IF WE TAT
EVIDENCE OF THE CRITICAL AS OUR OVQUALITY, THAT BEOSPITA
ELECTED TO TAKE THE QUALITY THE AS
MARI RATHER THAN HOSPITALIZATION.
NG ONE AND TWO INFLUENZA ASSOCIATED
HOSPITALIZATIONS BUT THE HOSPITALIZATION DATA THAT WE HAD
WASOT HOSPITALIZATIONS.
SO WE DON’T GRADED THAT FOR INDIRECTNESS.
WE HAD THAT AT THE WHICH WE HAVE A OUTC NOTNG H OU
LOWEST. THE LOWEST OF THE WHOLE GROUP
EING MARI, WHICH AVE MED
WHEEZING, FEVER AND ANY RELATED SAE, ALL OF WHICH
HAD MODERATE QUALITY OF EVIDENCE.
MOVING AWAY BRIEFLY FROM EVIDENCE QUALITY, WE HAD, OF
COURSE, SOME OTHER ISSUES TO DISCUSS.
ONE IS, VACCINE SUPPLY. WE DID HAVE A PRESENTATION AT
THE FEBRUARY ACIP ABOUT SUPPLY ISSUES.
SO I WON’T GO INTO THAT HERE. ANOTHER ISSUE IS COST.
AS SOON AS THE RELATIVE COST OF LAIV AND IIV, WE HAVE NOT
CONDUCTED A COST ANALYSIS FOR THIS PARTICULAR EFFORT.
IT’S LIKELY THAT THAT WOULD BE A VERY COMPLEX UNDERTAKING AT THIS
POINT DUE TO THE VERY LARGE NUMBER OF DIFFERENT INFLUENZA
PROBE DUKTSS, THE DIFFERENT PRESENTATIONS.
WE ALSO HAVE TRIVALEINE. IT’S PROBABLY A COUPLE OF YEARS
BEFORE SOMETHING LIKE THAT COULD BE DONE AND WE HAVE A BETT WHAT
WHAT THE RATIO OF IIV TO IIV-4 USE IS AND WHETHER IT REACHES A
EQUAL INYUM. THEY FELT IT WAS NOT NEZ TO HAVE
A FORMAL COST-EFFECTIVENESS TO MOVE FORWARD.
WE DID LOOK UP THE COMPARATIVE U.S. PRICES PER DOSE.
THE DA DA THAT WE HAVE COMES FROM THE 2014/2015 PRIVATE
SECTOR COST FROM THE VFC, VACCINES FOR CHILDREN TABLE.
THAT’S THE ONLY LAIV WE HAVE.
IS QUADRIVALENT. THE SUPPLY IS STARTING THIS
SEASON. WE HAVE A PRICE OF $22.70 PER
DOSE. FOR INACTIVATED VACCINES,
THERE’S A BROAD RANGE OF VARIABILITY.
IIV-3 AND WE HAVE MULTIPLE PRESENTATIONS
FOR EACH OF THEM. SO WE HAVE A RANGE OF PRICES
GIVEN FOR THE TRIVALENT, $7.65 TO $14.81 AND QUADRIVALENT, $14
TO $21.09. WE ARE AWARE OF ONE MODEL WHICH
ESTIMATED COST SAVINGS OF $45.80 WITH LAIV.
BUT IT’S UP CLEAR WHAT TH APPLICABLE BUILT OF THIS
PARTICULAR MODEL WOULD BE GIVEN THE CURRENT RANGE OF PRODUCTS,
INCLUDING QUAD VAL ENTERS WHICH WERE NOT AROUND IN 2008.
SO SUMMARY, CONSIDERATIONS FOR FORMULATING RECOMMENDATIONS,
EVIDENCE TYPE PREVENTATIVES AND HARMZ.
OVERALL EVIDENCE WAS TWO OR MODERATE FOR EFFICACY ON SAFETY.
EVIDENCE IS LACKING FOR SOME CRITICAL OUTCOMES SUCH AS INFLEW
ENDA RELATED MORTALITY, FEBRILE SEAR U.S., IMMEDIATE
HYPERSENSITIVITY. STUDIES MIGHT NOT BE POWERED TO
DETECT SOME RARE BUT SERIOUS EVE
EVENTS. BALANCE BETWEEN BENEFITS AND
HARMS, BENEFITS OUT WEIGH HARMS. 47 FEWER CASES OF LAB-CONFIRMED
FLU PER 1,000. NO SIGNIFICANT DIFFERENCES
OBSERVED IN THE DATA WE WERE ABLE TO GLEAN IN TERMS OF
WHEEZING OR FEVER. VALUE, THE INFLEW ENDA GROUP
PLACED A HIGH VALUE ON LAB-CONFIRMED FLU.
UNCERTAINTY AT PRESENT REGARDING RELATIVE COST BENEFIT GIVING
CURRENTLY AVAILABLE RANGE OF VACCINES.
SOME LIMITATIONS TO ALL OF THIS. FOR ONE, ALL OF THE PUBLISHED
STUDIES USE TRIVALENT VACCINE INSIDE THE QUADRIVALENT.
QUADRIVALENT WERE AVAILABLE. NOW AT PRESENT WE HAVE A
COMPLETE SUPPLY OF QUADRIVALENT FOR LAIV.
WE HAVE A MIXTURE OF IIV 3 AND 4.
THE QUADRIVALENTS WERE LICENSED AS BEING NON-INFERIOR.
FROM A SAFETY STANDPOINT, THE SAFETY PROFILE SEEMS SIMILAR.
IT IS POSSIBLE THERE COULD BE RARE BUT SERIOUS ADVERSE EVENTS
THAT COULD TURN UP OVER THE COURSE OF THE YEARS IN POST
MARKETING THAT WOULD NOT HAVE ADEQUATE POWER TO DETERMINE ON
PREMARKETING STUDIES. THIS IS SOMETHING THAT’S GOING
TO HAVE TO BE FOLLOWED, OF COURSE.
ANOTHER THING IS THAT IT’S UNCLEAR WHETHER THE GREATER
RELATIVE EFFICACY OF LAIV IS SUSTAINED EITHER WITH REPEATED
VACCINATION OVER YEARS OR WITH INCREASING AGE.
STUDIES IN ADULTS HAVE NOTED SIMILAR EFFICACY BETWEEN THE TWO
VACCINES OR SLIGHTLY GREATER EFFICACY OF THE INACTIVATED
VACCINE. SO IT DOES SEEM THAT THERE’S A
POINT WHERE SOMETHING CHANGES. BUT WHERE THAT IS, WE’RE NOT
CERTAIN. SO THAT IS WHAT I HAVE FOR THE
FIRST PRESENTATION. DR. TEMTE, I DON’T KNOW IF YOU
WANT TO DO QUESTIONS. WE HAVE TIME FOR A FEW BRIEF
QUESTIONS. OR NOT.
WHY DON’T YOU GO AHEAD AND MOVE ALONG THEN.
>>OKAY. ALL RIGHT THEN.
OKAY. PROPOSED RECOMMENDATIONS FOR THE
2014/2015 SEASON. THIS PRESENTATION IS A LITTLE
SHORTER, I PROMISE. THE DISCUSSION MIGHT NOT BE.
FEWER CHARTS. THE ACKNOWLEDGEMENTS I WOULD
LIKE TO MENTION FIRST. WE HAVE A VERY BIG GROUP IN THE
INFLUENZA WORK GROUP. OF COURSE, I’M THANKFUL TO THEM
AND RUTH AND ALSO ALL MY CDC COLLEAGUES WHO ASSIST IN PUTTING
ALL OF THIS TOGETHER. I WOULD LIKE TO GIVE THANKS TO
MY TEAMMATES. I CAN SAY WE’RE NEVER BORED.
PROPOSED RECOMMENDATIONS. THE MMWR JUST A LITTLE
BACKGROUND WILL BE IN THE POLICY NOTE FORMAT AGAIN.
WE HAD A FULL MMWR FOR THE FIRST TIME IN TWO SEASONS OR THREE
SEASONS. FOR CURRENT SEASON, THAT’S JUST
PASSED. WE WILL MOVE BACK TO THE SHORTER
FORMAT. AN UN VACIZATION IS RECOMMENDED
FOR ALL PERSONS SIX MONTHS AND OLDER.
WE HAVE FOUR NEW ITEMS THAT I WANT TO HIGHLIGHT IN THE NEXT
FEW SLIDES THAT ARE NEW AND/OR REVISED.
THOSE INCLUDE THE INFLUENZA VACCINE COMPOSITION, A MINOR
CHANGE TO THE EGG ALLERGY LANGUAGE, MINOR CHANGE IN THE
PEDIATRIC DOZING, NEW RECOMMENDATION REGARDING LAIV
AND IIV FOR YOUNG CHILDREN WHERE EITHER IS AVAILABLE AND
APPROPRIATE. I HAVE LISTED THESE IN THE ORDER
WHICH I BELIEVE THEY APPEAR IN THE DRAFT FLU STATEMENT.
BECAUSE WE JUST COVERED THE LAST TOPIC, I’M GOING TO MOVE TO THAT
FIRST. SO GIVEN THE INFORMATION THAT I
JUST PRESENTED AND THAT WE’VE BEEN DISCUSSING WITHIN THE WORK
GROUP FOR THE LAST SEVERAL MONTHS, WE HAVE SOME NEW
PROPOSED LANGUAGE REGARDING — PERTAINING TO THE USE OF LAIV
AND IIV FOR HEALTHY YOUNG CHILDREN AGE 2 THROUGH 8 YEARS.
AND THE THREE BULLETS OUTLINE THIS LANGUAGE.
FIRST, WE DO EMPHASIZE ALL INDIVIDUALS GREATER THAN OTHER
EQUAL TO SIX MONTHS OF AGE SHOULD RECEIVE FLU VACCINE.
IT SHOULD NOT BE DELAYED IN ORDER TO PROCURE A SPECIFIC
VACCINE PREPARATION IF AN APPROPRIATE ONE IS AVAILABLE.
NEXT, WHEN BOTH LAIV AND IIV ARE AVAILABLE, LAIV SHOULD BE USED
FOR HEALTHY CHILDREN AGES 2 THROUGH 8 YEARS WHO HAVE NO
CONTRAINDICATIONS OR PRECAUTIONS.
GAT GORY A. LAST, IF LAIV IS NOT IMMEDIATELY
AVAILABLE, IIV SHOULD BE USED. VACCINATION SHOULD NOT BE
DELAYED IN ORDER TO PROCURE LAIV.
THAT’S THE LANGUAGE FOR THAT PARTICULAR CHANGE.
DR. TEMTE, WOULD YOU LIKE ME TO MOVE ON TO THE OTHER POINTS AND
WE CAN COME BACK TO THESE ONE BY ONE?
>>GOOD QUESTION. I THINK WHY DON’T WE PAUSE HERE
AND JUST HAVE SOME DISCUSSION REGARDING THIS PARTICULAR ISSUE.
BECAUSE I THINK THIS IS THE LARGEST CHANGE.
WE HAVE SEEN THIS NUMEROUS TIMES AT PREVIOUS MEETINGS WITH GRADE
PRESENTATIONS. BUT OPEN IT UP FOR ANY COMMENT
OR QUESTION. THIS UNDOUBTEDLY REFLECTS MY
IGNORANCE. CAN YOU EXPLAIN THE DIFFERENCE
BETWEEN THE FIRST AND THIRD STATEMENT?
>>THERE IS NOT A LOT OF DIFFERENCE, BUT WE FELT IT WAS
IMPORTANT TO EMPHASIZE THIS POINT.
I WILL ADMIT, THERE IS REDUNDANCY.
>>DOCTOR? WHAT DOES THIS DO FOR THE
SECOND DOSE? IF THE FIRST DOSE IS ONE VACCINE
AND THEN THAT SAME VACCINE IS NOT AVAILABLE IN A TIMELY
FASHION FOR THE SECOND DOSE, IS THAT INCLUDED IN THAT OR IS THAT
A SEPARATE STATEMENT? WE CAN CLARIFY THAT, IF NEED
BE. THAT’S SOMETHING TO THINK ABOUT.
WE’RE NOT PROPOSING A CHANGE IN THE CURRENT RECOMMENDATION WHICH
IS THAT EACH DOSE CAN BE EITHER. YOU DON’T ARE TO HAVE BOTH LAIV
OR BOTH IIV. IT COULD BE ONE OR THE OTHER.
SO THIS WOULD APPLY EQUALLY TO BOTH THOSE FOR THOSE CHILDREN
WHO NEED IT. DR. GRADY.
>>I DISCUSSED THIS PREVIOUSLY. ONE OF THE CONCERNS THIS THAT
PROVIDERS HAD ALREADY GIVEN THEIR ORDERS IN FEBRUARY FOR THE
DOSES. AND WE WERE A LITTLE BIT
UNCOMFORTABLE WITH TWO THINGS. ONE, IF YOU HAVE THIS KIND OF
PREFERENTIAL LANGUAGE WHICH SHOULD BE USED, THERE COULD BE
SOME ISSUES RELATED TO HOW FAMILIES MIGHT RESPOND IF THE
PEDIATRICIANS RUN OUT OF THE VACCINE THAT SHOULD BE USED.
AND THE OTHER SITUATION IS, AS YOU MENTIONED, WE HAVE BEEN
FORTUNATELY CAPABLE OF IMNIEZING LARGER PROPORTIONS OF INFANTS.
NOW WHEN YOU GET TO THE FIVE, SIX, SEVEN, EIGHT-YEAR-OLD, WE
WILL HAVE CHILDREN WHO HAVE HAD MULTIPLE DOSES AND IT MAY BE
THAT LAIV MAY NOT BE NECESSARILY A MORE EFFECTIVE VACCINE IN THAT
AGE GROUP. THE DRAFT RECOMMENDATIONS THAT
WE ARE SENDING TO THE BOARD, INSTEAD OF USING LAIV SHOULD BE
USED, WE’RE GOING TO USE THE LANGUAGE LAIV SHOULD BE
CONSIDERED FOR HEALTHY CHILDREN TO KIND OF MAKE IT A LITTLE BIT
LESS KIND OF PREFERENTIAL. DR. HAHN?
>>I THINK THE SECOND BULLET COULD JUST SAY WHEN LAIV IS
AVAILABLE IT SHOULD BE USED. BECAUSE IT ALMOST SOUNDS LIKE
DON’T USE LAIV UNLESS YOU HAVE BOTH ON HAND.
IT’S A LITTLE ODD. I THINK IT COULD JUST SAY WHEN
LAIV IS AVAILABLE IT SHOULD BE USED KIND OF THINK.
IF YOU’VE GOT IT, USE IT. DR. ENGLAND.
>>JANET ENGLAND. THE FIRST BULLET ACTUALLY MIGHT
BE APPLICABLE THIS YEAR AND THE NEXT YEAR AS WE STILL HAVE
TRIVALENT VACCINES AVAILABLE. WE HAVE HAD CONFUSION OVER THE
PAST YEAR ABOUT WITHHOLDING TO GET QUADRIVALENT IF YOU ONLY
HAVE TRIVALENT. I THINK IT’S MORE LAIV AND IIV.
I LIKE THAT FIRST BULLET. I THINK IT’S HELPFUL TO HAVE IT
THERE. ANY OTHER DISCUSSION?
MISS BELGRINI? I’D LIKE TO RAISE THE ISSUE
HERE OF FAMILIES WHO ARE GOING TO BE SENSITIVE TO THE PRICE
POINT. WHILE THE LANGUAGE REQUIRING
INSURANCE COVERAGE OF THESE VACCINES IS VERY HELPFUL,
THERE’S STILL A SIGNIFICANT NUMBER OF FAMILIES WHO AREN’T
COVERrd BY THOSE PROTECTIONS FOR ONE REASON OR ANOTHER.
EITHER ON GRANDFATHER PLANS OR OTHER PLANS.
SO I’M NOT SURE I ACTUALLY HAVE A PROPOSAL.
BUT I DO WANT US TO MAKE SURE WE’RE THINKING ABOUT THE
STRENGTH OF THIS RECOMMENDATION. HOW STRONGLY DO WE REALLY,
REALLY WANT TO PUSH THOSE FAMILIES TOWARDS LAIV WHEN FOR
SOME OF THEM THAT $10 PRICE DIFFERENCE OR ROUGHLY ESTIMATING
MAY BE MAY PLAY A ROLE IN THEIR DECISION.
>>DR. BENNETT? AREN’T FAMILIES COVERED?
>>NOT NECESSARILY. I’M THINKING ABOUT FAMILIES WITH
PRIVATE COVERAGE WHO AREN’T COVERED.
MORE THAN MEDICAID, DEDUCTIBLES AND ALL OF THAT.
>>DR. DUSHAN? ON THAT POINT, SOMEWHAT
RELATED IS THE FACT THAT WE TRIED TO EMPHASIZE THAT BOTH VAC
SEENZ ARE EXCELLENT AND EFFECTIVE AND THAT WHEN
POSSIBLE, LAIV IS PREFERENTIAL. BUT NOT GETTING LAIV IS NOT A
MAJOR DISADVANTAGE. ANY OTHER COMMENT?
IF NONE, DR. GROHSKOPF, YOU COULD MOVE ALONG TO THE OTHER
POINTS OF DISCUSSION. THANK YOU.
THERE IS SOME ADDITIONAL LANGUAGE RELATED TO LAIV.
THESE INCLUDE THAT A BIT OF A CHANGE TO REFLECT THE FACT THAT
SOME CONDITIONS FOR WHICH WE HAVE RECOMMENDED THAT LAIV NOT
BE USED ARE TO CLARIFY THAT FOR THE PACKAGE INSERT THOSE ARE
PRECAUTIONS. THAT ADDITIONAL LANGUAGE SPELLS
OUT THAT LAIV SHOULD NOT BE ADMINISTERED TO THOSE UNDER TWO
YEARS OR GREATER THAN 49 YEARS OF AGE, THOSE WITH
CONTRAINDICATIONS AS PER THE PACKAGE INSERT WHICH INCLUDE
THOSE RECEIVING CHILDREN 2 THROUGH 17 WHO ARE RECEIVING
ASPIRIN THERAPY AND PERSONS WHO HAVE HAD SEVERE ALLERGIC
REACTIONS TO THE VACCINE OR ITS XOE NANTS, PREGNANT WOMEN,
PERSON WITH EGG AIRLINE GI, ROU HAVE HAD A WHEEZING EPISODE IN
THE MEDICAL RECORDS OR WHOSE PARENTS REPORT THEY HAD ONE
WITHIN THE LAST 12 MONTHS AND MEDICATIONS WITHIN THE ANTI
PREVIOUS 48 HOURS. THE GUIDANCE NOTES THAT OTHER
CHRONIC MEDICAL CONDITIONS CONFERRING HIGHER RISK OF
COMPLICATIONS ARE PRECAUTIONS TO THE USE OF LAIV AND PER THE
PACKAGE INSERT THE SAFETY HAS NOT BEEN ESTABLISHED.
THE NEXT, VACCINE STRAIN SELECTION FOR 2014-2015.
THIS HAS NOT YET BEEN DECIDED BY THE FDA AS OF THE LAST TIME WE
MET IN FEBRUARY. THAT COMMITTEE CONVENED ON
FEBRUARY 28, 2014. FOR THE ’14-’15 SEASON
RECOMMENDED THE SAME, A TEXAS 2012 H 3 N 2 VIRUS, B
MASSACHUSETTS, 2012 VIRUS AND FOR THE QUADRIVALENT, IN
ADDITION TO THOSE THREE, A BBRISBON 62 LIKE VIRUS.
THIS IS PRESENTED FOR INFORMATION AS THIS IS WHAT THE
COMPOSITION OF THE VACCINE WILL BE FOR THIS YEAR.
SHOULD I MOVE ON? YES, PLEASE.
>>OKAY. NOW WE MOVED ON TO THE LAST TWO
ISSUES WHICH ARE RELATIVELY MINOR CHANGES.
ONE HAS TO DO WITH THE ALGORITHM FOR DETERMINES THE NUMBER OF
DOSES NEEDED FOR SIX MONTHS THROUGH EIGHT YEARS.
CHILDREN, ACCORDING TO A COUPLE OF STUDIES, NEED TWO DOSES OF
VACCINE INSTEAD OF ONE THE FIRST TIME THEY ARE VACCINATED TO
ACHIEVE OPTIMAL IMMUNE RESPONSE. THIS WAS AN UNCOMPLICATED SEASON
UNTIL THE 2009 PANDEMIC WHERE WE HAD TO COUNT THE DOSES.
FOR 2013 — 2012-2013 AND 2013-2014 WE HAD THE SAME
APPROACH. BOTH ACCEPTABLE.
SIMPLIFIED WHICH CONSIDERED DOSES JULY 2010 AND A SECOND
APPROACH BUT GOOD FOR THOSE IN SETTINGS WITH GOOD REGISTRY DA
DA THAT CONSIDERED ALL VACCINATION HISTORY.
FOR 2014-2015, WE ARE PROPOSING KEEPING BOTH APPROACHES, THE
SIMPLIFIED AND COMPLICATED APPROACH.
BUT WITH THEL INFORMATION THAT CHILDREN IN
THIS AGE GROUP WHO RECEIVED AT LEAST ONE DOZE OF THE 2013-2014
VACCINE NEED ONLY ONE DOSE IN ’14-’15.
THIS IS DONE BECAUSE VIRUSS ARE HE REMAINING UNCHANGED.
IT’S ANALOGOUS TO A CHANGE THAT WAS MADE FOR 2011-2012 WHICH WAS
THE LAST TIME THAT THE STRAINS WERE UNCHANGED FROM THE PREVIOUS
SEASON. IS THERE ANY DISCUSSION
REGARDING — OR QUESTIONS REGARDING THIS?
>>NOT NECESSARILY DISCUSSION POINT BUT CERTAINLY JUST A
COMMENT. I KNOW YOU SAID IT WAS A MINOR
CHANGE. FOR THOSE OF US TRYING TO
PROGRAM THIS IN TO HAVE THIS DISCUSSION COME IN JUNE, IT’S
VERY CHALLENGING. WE WANT TO INCORPORATE IT
BECAUSE IT WILL REDUCE THE NUMBER OF CHILDREN WHO NEED TWO
DOSES. I’M WONDERING IF IN THE FUTURE
SOMETHING COULD BE INCLUDED IN THE RECOMMENDATION SO IF THERE
ISN’T A STRAIN CHANGE WE CAN ALL ASSUME THAT ONLY ONE DOZE WOULD
BE MADE AND MOVING FORWARD WE COULD ANTICIPATE THIS SOONER.
>>DEFINITELY APPRECIATE THAT. UNFORTUNATELY, SINCE THE WHO
MEETINGS TEND TO OCCUR IN FEBRUARY, WE’RE SOMEWHAT STUCK
AS FAR AS KNOWING WHAT’S GOING TO HAPPEN WITH THE STRAINS.
IT MAY OR MAY NOT BE AN ISSUE GOING FORWARD BECAUSE ONE THING
THAT’S UNDER DISCUSSION — I CAN’T SAY WHAT’S GOING TO HAPPEN
IN FUTURE SEASONS. BUT AS WE GET INCREASINGLY
FARTHER OUT FROM THE PANDEMIC YEAR, THIS BECOMES LESS AND LESS
OF AN ISSUE. SO AT SOME POINT IN THE NEAR
FUTURE, WE WILL PROBABLY DISCUSS WHETHER WE CAN MOVE BACK TO THE
SIMPLEST APPROACH OF ALL, WHICH WAS LAST APPLICABLE IN 2009,
WHICH WAS IF IT’S YOUR FIRST TIME, GET TWO.
IT DIDN’T REQUIRE AN ALGORITHM, WHICH WAS LOVELY.
IT JUST NEEDED A SENTENCE. I UNDERSTAND THAT POINT.
WE DID HAVE SOME DISCUSSION IN THE WORK GROUP.
I DON’T KNOW IF DR. KARRON WISHES TO COMMENT REGARDING THE
CHANGE AND DIFFICULTIES THAT POSES FOR REGISTRY PROGRAMMING.
>>I DON’T HAVE A COMMENT OTHER THAN WHAT YOU SAID.
I AGREE THAT WE MAY BE GOING BACK TO A SIMPLER ALGORITHM AS
THOSE KIDS FROM THE PREPANDEMIC TIME AGE UP.
>>DR. GORMAN? GO BACK TO THE SLIDE
PREVIOUS? NUMBER SIX — FIVE.
OME OF THE THINGS THIS LIST THAT THAT THE FDA LISTS AS
PRECAUTIONS OR WARNINGS TO CONTRAINDICATIONS.
I WOULD LIKE THOSE TO BE SEPARATED OUT AS YOU GO FORWARD.
>>WOULD THINGS SUCH AS UNDER THE FIRST BULLET, THE SUB
BULLETS AS PR IMMUNOSUPPRESSED PERSONS?
>>I DON’T HAVE THE LIST IN FRONT OF ME.
THERE ARE PROVIDERS WHO, IN ALL FAIRNESS, ARE USING LAIV IN SOME
OF THOSE CONDITIONS. WE RECOGNIZE THAT.
WE MADE AN EFFORT IN THE 2013-2014 STATEMENT TO MAKE A
DISTINCTION BETWEEN THOSE CONDITIONS THAT ARE PACKAGE
INSERT SPECIFIED CONTRAINDICATIONS OF WHICH THERE
ARE ONLY TWO AND THOSE CONDITIONS WHICH ACIP RECOMMENDS
AGAINST USE OF LAIV FOR. AND THERE HAS BEEN A DICHOTOMY
OF THOSE CONDITIONS. FOR EXAMPLE, THE
RECOMMENDATION — IT’S PROBABLY THE LARGEST IS RECOMMENDATION
AGAINST USE IN PERSONS WITH CHRONIC MEDICAL CONDITIONS WITH
HIGHER RISK OF COMPLICATIONS FROM FLU.
AND WE ATTEMPTED TO MAKE THAT SAME DISTINCTION HERE BY CITING
THAT THE FIRST BULLET IS OF COURSE THE REFLECTS AGE.
THE SECOND REFLECTS THE PACKAGE INSERTS THAT ARE PACKAGE INSERT
TO FIND CONTRAINDICATIONS. THE REMAINING BULLETS UNDER THE
FIRST MAIN BULLET SHOULD NOT BE ADMINISTERED TO ARE CONDITIONS
THAT ACIP DOES NOT RECOMMEND USE FOR.
>>THEN PERHAPS I WOULD LIKE TO MAKE A RECOMMENDATION FOR
LANGUAGE. PERSONS WHO THE ACIP DOES NOT
RECOMMEND RECEIVE LAIV AS OPPOSED TO SHOULD NOT.
>>DR. MIDDLEMAN. MY QUESTION IS SIMILAR IN THAT,
THE BULLET REGARDING THE TWO TO FOUR-YEAR-OLDS WHO HAVE HAD A
WHEEZING EPISODE, THAT MAKES IT SEEM LIKE ADOLESCENTS WHO HAVE A
DIAGNOSIS OF ASTHMA AREN’T INCLUDED IN THAT, UNLESS I’M
READING IT WRONG. IT SORT OF IMPLIES THAT THOSE
WHO ARE FIVE AND OLDER WHO DO HAVE ASTHMA OR WHO HAVE HAD
WHEEZING, IT COULD BE ADMINISTERED TO THEM.
AM I — CHANGED? AM I MISTAKEN?
>>NO, ACTUALLY, THAT’S A GOOD POINT.
I THINK THERE’S AN ADDITIONAL BULLET I SHOULD HAVE INCLUDED
HERE. THE DRAFT GUIDANCE THAT THE ACIP
MEMBERS HAVE SEEN ACTUALLY DOES INCLUDE A BULLET ON PERSONS OF
ANY AGE WITH ASTHMA. IT LOOKS LIKE I’VE NEGLECTED TO
INCLUDE THAT ON THE SLIDE. THANK YOU.
>>MY QUESTION OR COMMENT IS ON THE SAME LINES HERE.
IT’S RELATED TO THOSE WHO WRITE THE VACCINE INFORMATION
STATEMENTS. SOMETIMELESS THAT IS THE ONLY
DOCUMENT THAT CLINICIANS LOOK AT.
SO WE I THINK IN THE PAST HAVE OVERSTATED WHO SHOULD NOT GET
LAIV AND THE CURRENT VIEW IS YOU SHOULD GET A FLU SHOT INSTEAD OF
NASAL SPRAY IF YOU HAVE LONG-TERM HEALTH CONDITIONS.
NOW THAT WE SEPARATED THIS OUT INTO PRECAUTIONS, I WANT TO MAKE
SURE THAT THE WRITERS CARRY THAT OVER AND NOT OVERSTATE IT THERE.
>>WE WILL — WE HAVE HELD OFF ON THE LANGUAGE FOR NEXT SEASON.
BUT BECAUSE WE KNEW SOME THINGS MIGHT BE HAPPENING.
SO WE WILL LOOP BACK. DR. MOORE? BACK TO THE FIRST
SLIDE WE TALKED ABOUT. NOW THAT YOU HAVE BROKEN OUT WHO
LAIV SHOULD BE ADMINISTERED TO AND THE PRECAUTIONS THAT ARE
LOWER ON THE ORIGINAL WORDING OF WHEN BOTH LAIV AND IIV ARE
AVAILABLE, USE THE LAIV IF THERE IS NO PRECAUTION OR CONTRA
CONTRAINDICATION. AND WE TALKED ABOUT SIMPLMENT.
I WOULD LIKE TO INFOFORMATION WT THE INTENTION OF THE WORKING
GROUP IS RELATED TO THE USE OF LAIV WHERE THERE IS APRECAUTION
AND IT IS NOT A CONTRAINDICATION.
ARE YOU SAYING IF THERE’S A PRECAUTION FOR LAIV YOU SHOULD
AND YOU HAVE IIV AND YOU SHOULD NOT USE IT BUT IF YOU DIDN’T
HAVE IIV, YOU JUST CONSIDER THAT A PRECAUTION?
I’M UNCLEAR ABOUT THAT. DOES THAT MAKE SENSE?
>>YES. I THINK — I WILL DO MY BEST.
LET ME KNOW IF I MISS THE THREAD ANYWHERE.
I SEE SORT OF TWO LEVELS TO THE ISSUE.
ONE, I WANT TO CLARIFY THAT AS FAR AS PREFERENCE OR ANY
PREFERENTIAL LANGUAGE IS CONCERNED, THAT AT THIS POINT IS
STRICTLY FOR HEALTHY CHILDREN AND NOT THOSE WITH CHRONIC
MEDICAL CONDITIONS. WITH REGARD TO BASICALLY THE
ACTION STEP FOR PRECAUTIONS OR CONDITIONS THAT WOULD BE DEEMED
A PRECAUTION AND AREN’T LISTED UNDER THE SHOULD NOT BE
ADMINISTERED TO SECTION, FOR PRECAUTIONS, THOSE ARE
SITUATIONS THAT GENERALLY REQUIRE CLINICAL JUDGMENT AND
FOR WHICH THE BENEFITS AND HARMS HAVE TO BE WEIGHED.
IT’S A DIFFICULT THING TO MAKE A STATEMENT ABOUT THE RELATIVE
BENEFITS AND HARMS IN THIS PARTICULAR CASE BECAUSE FOR A
LOT OF GROUPS THERE ARE INSUFFICIENT DATA.
SO AT THIS POINT, IT’S DIFFICULT TO HAVE A RECOMMENDATION IN A
DOCUMENT INTENDED TO COVER EVERY POSSIBLE SCENARIO IN THE ABSENCE
OF THAT DATA. SO NO PREFERENCE IF THERE IS
ANY PRECAUTION OR CONTRAINDICATION IN THE PATIENT.
BUT IF THEY HAPPEN TO HAVE ONE OR THE OTHER ON HAND, THEY CAN
USE THEIR CLINICAL TO WHAT THE CLINICIAN PREFERS TO
USE IN THAT CASE? BY THE DEFINITION OF
PRECAUTION, THAT WOULD INVOLVE CLINICAL JUDGMENT.
>>DR. KIMBERLAND? COULD YOU BACK UP ONE SLIDE,
PLEASE? IF THE LANGUAGE IS APPROVED AS
IN THE SECOND BULLET, SHOULD BE USED FOR HEALTHY CHILDREN, WOULD
THAT GO ON TO THE IMMUNIZATION SCHEDULE FOOTNOTE AS SUCH?
THE REASON I ASK IS THAT IF THE BOARD OF DIRECTORS APPROVES
LANGUAGE OF SHOULD BE CONSIDERED AND THE ACIP HAS SHOULD BE USED,
WE HAVE A DIVERGENCE OF SCHEDULES THAT FOR MANY YEARS
ARE TRYING TO HAR MONIZE. I DON’T KNOW IF THERE’S
ANYONE WHO WORKS ON THE PEDIATRIC SCHEDULE.
>>DR. SHOOKEN? I THINK IF A PREFERENCE VOTE
GOES FORWARD THE SCHEDULE WILL REPRESENT THAT.
THE SCHEDULE IS SUPPOSED TO BE CLEAR FOR PEOPLE.
THE FOOTNOTES WOULD CLARIFY ALL THE DETAILS.
IT WOULDN’T BE LEFT INVISIBLE, BECAUSE THAT’S THE PRIMARY TOOL
THAT CLINICIANS HAVE. SO AS YOU WELL KNOW, YOU’VE BEEN
FOLLOWING FORMAL EVIDENCE DISCUSSION TO MAKE A DECISION OF
WHETHER THE EVIDENCE IS GOING TO GO FORWARD.
YES, IT WOULD BE REFLECTED IN THE SCHEDULE.
>>I WOULD PUT A PLEA THAT IF APPROVED BY
THE TWO DIFFERENT ORGANIZATIONS ARE NOT IDENTICAL, WE SHOULD
HOPEFULLY BE VERY CAREFUL ABOUT THAT.
AGAIN, MANY, MANY YEARS HAVE GONE TO GETTING US TO THE POINT
WHERE WE ARE COMPLETELY IN SYNC. IT WOULD BE A SHAME IN MY
OPINIO OF LOCK STEP WITH EACH OTHER.
>>DOCTOR, IS MY UNDERSTANDING CORRECT THAT THE RECOMMENDATION
IS BASED ON THE FACT THAT WE’RE OUST SYNC WITH PEDIATRICIANS
ORDERING SCHEDULES FOR VACCINES? SO OUR LANGUAGE WOULD ONLY BE
OUT OF SYNC FOR ONE YEAR? I THINK THAT, YES, THAT’S
PART OF THE DISCUSSION. AND IT WOULD POTENTIALLY BE OUT
OF SYNC FOR ONLY ONE YEAR IF THERE’S NO ADDITIONAL
INFORMATION TO SUGGEST THAT THERE MAY BE A NEED TO
RECONSIDER THAT. FOR THOSE WITH A LONG MEMORY,
I WANT TO REMIND YOU THAT ACIP MOVED AWAY FROM USING THE TERM
SHOULD BE CONSIDERED BASED ON THE AAP’S STRONG RECOMMENDATION
THAT WE DO THAT. THATAS BASED ON
WHETHER OR NOT SOMETHING WAS GOING TO BE A VACCINE THAT WAS
PERMISSIVE OR NOT. BUT THIS IS MORE TRYING TO NOT
WHERE FAMILIES MIGHT CONSIDER THAT IF YOU’RE NOT DOING IT,
THAT YOU’RE NOT DOING WHAT’S BEST FOR THEIR CHILD.
>>HARRISON? MY BIGGEST CONCERN IS FOR A
CLINISH TRYING TO FIGURE OUT WHAT TO DO, I’M NOT SURE WHAT
SHOULD BE CONSIDERED. THE OTHER POINT IS, I’M NOT
SURE WHEN THE RIGHT TIME IS. IF IT’S IN FEBRUARY, PEOPLE HAVE
ALREADY ORDERED. IN JUNE, PEOPLE HAVE ALREADY ‘R
THE SEASON. IF IT’S OCTOBER, WE’RE WELL INTO
THE SEASON. THERE REALLY ISN’T A GOOD TIME.
AS PART OF THE WHOLE DISCUSSION WE HAD WITH MAKING
RECOMMENDATIONS AND TRYING TO CODIFY THE LANGUAGE, WE TRIED TO
MOVE AWAY FROM SHOULD BE CONSIDERED WHICH IS CONFUSING TO
CLINICIANS. SO, FIRST OF ALL, AS A —
FROM A MANUFACTURING PERSPECTIVE, A MID-SEASON
RECOMMENDATION LIKE THIS IS PRETTY DISRUPTIVE.
NOT ONLY HAVE THEY ORDERED, BUT WHAT CAN HAPPEN IS WHEN THIS
GOES OUT, PEOPLE WILL CALL AND AND CANCEL.
WE’RE WELL INTO AND ALMOST FINISHED WITH THE MAJOR PART OF
THE MANUFACTURING PROCESS. I THINK THERE’S NOT WITHOUT
PRECEDENT BEFORE THAT ACIP HAS GIVEN A FOREWARNING THAT
SOMETHING IS COMING IN AN OUTGOING YEAR.
I THINK IT WAS DONE WITH SWITCHING.
IT WAS DONE WHETHER WE FIRST MADE THE INFLUENZA
RECOMMENDATIONS DOWN TO SIX MONTHS OF AGE.
I THINK THAT THIS IS PRETTY DISRUPTIVE TO A NUMBER OF STAKE
HOLDERS. IT WILL COMPLICATE THINGS FOR US
AND WE WILL HAVE FINANCIAL IMPACTS WITH MANUFACTURERS AND
EVEN HEALTHCARE PRACTITIONERS. I WAS HAVING DEJA VU HERE
FROM OUR CONVERSATION WHEN WE WENT TO A UNIVERSAL FLU VACCINE
FOR EVERYONE SIX MONTHS OF AGE AND OVER.
I THINK IT WAS THE SAME TIME OF YEAR.
WE JUST ADDED A TERM AS FEASIBLE.
SO IF YOU CAN ROLL THIS THIS YEAR, GO AHEAD.
IF NOT, NEXT YEAR. BUT NOT TO AGONIZE OR WAIT FOR A
COMING YEAR. IN TERMS OF COMMENT, IF
OUR VACCINE RATES WERE IN THE 80s, 90S PERCENT, I WOULD WORRY
ABOUT THE DISRUPTION. BUT WE HAVE A LONG WAY TO GO TO
VACCINATE PEOPLE FOR WHOM IIV IS AVAILABLE AND THEY ARE ELIGIBLE
FOR. I DON’T SEE THE NEED TO HOLD.
>>THANK YOU FOR THE HISTORIC PERSPECTIVE.
ALSO, WHEN I LOOK AT MY OWN STATE, ESPECIALLY IN CHILDREN
FIVE THROUGH 17, WE HIT ABOUT 30% TO 32%.
THAT’S THE PROBLEM OUT THERE. DR. DECKER?
>>MICHAEL DECKER. AAP PARTICIPANTS HAVE NOTED THAT
THE STUDIES COMPARING LAIV AND TIV ARE OLD AND PRACTICE HAS
CHANGED SINCE THEN THAT IT’S NOT ENTIRELY CLEAR THE BENEFIT IN
THOSE STUDIES OBTAINED. IN THAT REGARD, I KNOW YOU KNOW
THAT THE MANUFACTURER OF LAIV HAS AN FDA OBLIGATION TO CONDUCT
AN EFFICACY TRIAL IN THE GROUP THAT YOU ARE PROPOSING MAKING
THIS RECOMMENDATION FOR, TWO TO EIGHT YEARS OLD.
MY QUESTION TO YOU IS, DO YOU KNOW WHEN THE RESULTS OF THAT
STUDY WILL BE AVAILABLE? I DO NOT.
>>DR. FREEDLAND. I THINK THE LANGUAGE THAT
PROVIDERS WOULD LIKE TO SEE WOULD BE FOR CLARITY AND
UNDERSTANDING OF THE RECOMMENDATION.
I THINK THERE WOULD BE VALUE IN THE LANGUAGE TO SAY THAT WHEN
IIV VACCINES ARE USED, THEY ARE SAFE AND EFFECTIVE IN THE
POPULATION. THIS LANGUAGE DOESN’T
NECESSARILY SAY THAT. SO CLARITY THAT IIV VACCINES ARE
SAFE AND EFFECTIVE WOULD BE VALUABLE FOR THE PROVIDER.
>>JUST TO ADDRESS THE LAST POINT FIRST, I BELIEVE THE TEXTS
DOES DESCRIBE BOTH VACCINES AS SAFE AND EFFECTIVE AND VERY
DESIRABLE. WITH RESPECT TO THE TIMING, THIS
IS AN ISSUE WE HAVE DISCUSSED AT MULTIPLE MEETINGS, THAT THERE IS
NO GREAT TIME. WE DID SIGNAL OUR INTENT
AT THIS AT MULTIPLE ACIP MEETINGS.
THIS IS THE THIRD ON DISCUSSED THIS AND GIVEN AN
INDICATION WE ARE MOVING IN THIS DIRECT.
IF YOU ARE SURPRISED BY THIS, I’M SORRY.
BUT YOU MAY NOT HAVE BEEN TRYING TO PAY ATTENTION TO WHAT WE HAVE
BEEN TRYING TO SIGNAL. WOULD YOU LIKE TO MOVE ON TO
THE LAST POINT HERE WITH EGG ALLERGY?
>>I WOULD BE HAPPY TO. VACCINATION OF PERSONS WITH
SEVERE EGG ALLERGY. WE HAVE I BELIEVE A MINOR CHANGE
TO THIS LANGUAGE. JUST A LITTLE BACKGROUND.
SINCE 2011, 2012 WHEN WE HAD THIS DICHOTOMY BETWEEN WHAT TO
DO WITH PERSONS WHO HAVE MILD ALLERGY, WHICH WE DEFINE AS
HIVES IN RESPONSE TO EGG EXPOSURE VERSUS SEVERE ALLERGY
WHICH WE DEFINE FOR OUR PURPOSES AS ANYTHING OTHER THAN HIVES,
ANY OTHER SYMPTOMS. FOR THE MOST RECENT ROUND OF THE
RECOMMENDATIONS THAT WE DISCUSSED A YEAR AGO, WE ALSO
HAD RIV COME INTOI ISEXISTENCE. PERSONS WITH SYMPTOMS OTHER THAN
HIVES ARE RECOMMENDED TO RECEIVE RIV IF IT’S AVAILABLE.
IF THEY ARE WITHIN THE AGE INDICATIONS, WHICH IS 18 TO 49,
OR BE REFERRED TO A PHYSICIAN WITH EXPERTISE IN THE MANAGEMENT
OF ALLERGIC CONDITIONS. WE HAVE NEVER SPECIFIED
ALLERGIST. SOMEBODY WITH EXPERTISE IN THE
MANAGEMENT OF ALLERGIC CONDITIONS.
THIS WAS A CONSCIOUS DISCUSSION OUT OF THE DISCUSSION THAT
OCCURRED OUT OF THE ACIPIN JUNE. SINCE WE LAST SPOKE ABOUT ALL
THIS, THE JOINT TASK FORCE ON PRACTICE PARAMETERS, WHICH IS A
BODY THAT COORDINATES RECOMMENDATIONS BETWEEN THE
AMERICAN COLLEGE OF ASTHMA ALLERGY AND IMMUNOLOGY AND THE
ACADEMY ACADEMY OF AS AS MA ALLERGY, IN 2013 TWO MEN
AUTHORED A VERY BRIEF PAPER WHICH CITES A 2012 REVIEW WHICH
IS ONE WE DISCUSSED AT OUR LAST MEETING LAST YEAR OF OVER 4,000
PATIENTS, INCLUDING 513 WITH A HISTORY OF SEVERE ALLERGIC
REACTION TO EGG. NO OCCURRENCES OF AN IF A LAXIC
WERE NOTED. THERE WERE MILDER REACTIONS THAT
OCCURRED. THAT PARTICULAR DOCUMENT
RECOMMENDS THAT SPECIAL PRECAUTIONS REGARDING MEDICAL
SETTING AND WAITING PERIODS AFTER ADMINISTRATION OF IIV TO
EGG ALLERGIC RECIPIENTS BEYOND THOSE RECOMMENDED FOR ANY
VACCINE ARE NOT WARRANTED. WE HAD DISCUSSION OF THIS
DOCUMENT WITHIN OUR WORK GROUP. THERE WERE A COUPLE OF CONCERNS
WHICH EMERGED. ONE IS THAT WE ARE STILL SEEING
CASES OF ANAPHALAXIS. THE AUTHERS BELIEVED IT WAS DUE
TO GEL CONTIN EGG. WE HAD ONE CASE FOR
HYPERSENSITIVITY THAT WAS BELIEVED TO BE DUE TO EGG IN AN
EGG ALLERGIC CHILD. THERE WAS ALSO CONCERN THAT WE
HAVE, OF COURSE, A VERY WIDE RANGE OF SETTINGS IN WHICH
INFLUENZA VACCINES ARE GIVEN THESE DAYS.
NOT ALL SUCH SETTINGS, EVEN THOUGH THEY SHOULD AND IT’S IN
THE RECOMMENDATIONS THAT THEY REALLY SHOULD HAVE APPROPRIATE
EQUIPMENT AND PERSONNEL AVAILABLE AND READY TO GO IN THE
EVENT OF REACTIONS TO ANY VACCINE, REGARDLESS OF A
PATIENT’S HISTORY, THERE WAS CONCERN THIS MIGHT NOT BE THE
CASE IN ALL SITUATIONS. SO THE NEW LANGUAGE SEEKS TO
CLARIFY THAT A REFERRAL IS NOT STRICTLY NECESSARY, ASSUMING THE
PERSON WHO IS GOING TO BE ADMINISTERING IS A PHYSICIAN
WITH EXPERTISE IN PREVENTING ALLERGIC CONDITIONS AND DOES
MAINTAIN THE 30-MINUTE WAIT PERIOD.
WE HAVE NOT MADE A CHANGE TO THAT.
I’M GOING TO VIEW THE SPECIFIC LANGUAGE.
THE PROPOSED CHANGE IS THAT PERSONS WHO GOING FROM PERSONS
WHO REPORT HAVING HAD REACTIONS TO EGG INVOLVING SUCH RESPIRATO
LIGHT-HEADEDNESS OR REQUIRE EMERGENCY MEDICAL INTERVENTION,
CCURRED IMMEDIATELY OR WITHIN A SHORT
PERIOD OF TIME, MINUTES TO HOURS AFTER EGG EXPOSUREXPOSURE, MAY
RIV IF AGE 18 THROUGH 49 AND THERE ARE NO OTHER TIONS.
IF RIV IS NOT AVAILABLE OR THE RECIPIENT IS NOT WITHIN THE
INDICATED AGE RANGE, THIS IS WHERE THE CHANGE C THE
CURRENT GUIDANCE IS SUCH PERSONS SHOULD BE REFERRED TO A
PHYSICIAN WITH EXER IN THE MANAGEMENT OF ALLERGIC REACTION.
WE PROPOSE CHANGING THAT TO IIV SHOULD BE ADMINISTERED WITH A
PHYSICIAN WITH EXPERIENCE IN THE MANAGEMENT OF SEVERE ALLERGIC
CONDITIONS. I BELIEVE THAT’S THE LAST
CHANGE. THANK YOU.
FURTHER DISCUSSION HERE? DR. JENKINS?
>>IT’S A MINOR EDIT. SHOULD BE ADMINISTERED B
>>THE BY IS MISSING. ADMINISTERED BY.
SORRY FOR THAT ERROR. IT SHALL BE CORRECTED.
DR. DUSHON IS MAKING A MOTION TO — WOULD THIS BE INCLUDING
THE ANTIGEN, THE LANGUAGE HERE IN ALLERGY, THE RECOMMENDATIONS
FOR ALIVE ATTENUATED AND HOPEFULLY I’M PAYING ATTENTION
HERE, AND THE DOSING FOR CHILDREN?
>>YES. WE HAVE A MOTION AND — CLA
ACIP RECOMMENDED CONT CONTRAINDICATIONS AND IONS.
>>DR. KIM? AND THE PERHAPS DIFFERENT
WORDING ABOUT THE FACT THAT IIV IS SAFE BUT LAIV MAY BE MORE
EFFECTIVE. DO WE HAVE A SECOND?
>>YES. DR. HARRISON?
>>FURTHER DISCUSSION? DR. RUBIN?
>>IF WE COULD GO BACK TO THESL. I JUST WANT TO — GIVEN SOME OF
THE COMMENTS RELATED TO THE SECOND BULLET AND THE FIRST —
CHANGING THE FIRST PHRASE TO SAY WHEN FEASIBLE, LAIV SHOULD BE
USED RATHER THAN — TAKE CARE OF SOME OF THE CONCERNS WITH PRICE
AVAILABILITY. THAT WOULD MAKE IT CONSISTENT
WITH WHAT WE HAD MENTIONED ABOUT THE SWITCH TO UNIVERSAL.
IS THAT ALL ACCEPTABLE TO — MAY I ASK FOR CLARIFICATION?
>>TO CHANGE WHEN BOTH LAIV AND IIV ARE AVAILABLE TO SAY WHEN
FEASIBLE. IN THE SECOND BULLET. I WOULD S
IMPLIED. ALL OF OUR RECOMMENDATIONS ARE
WHEN FEEDZABLE. NONE OF THEM CAN BE IMPLEMENTED
WHEN NOT FEASIBLE. DR. KIM?
>>THAT’S TRUE, JEFF. BE HELPFUL IN THAT PARTICULAR
LIEU OF THE FACT THAT PEOPLE MIGHT FIND THEMSELVES IN A BIND
FOR THE NEXT YEAR OR SO. I DON’T THINK IT HURTS.
>>W PUTTING THAT INTO THE RECOMMENDATION, AN
TATING THE GUIDANCE WITH THAT TYPE OF INFORMATION AS IS
FREQUENTLY DONE WHEN THE RECOMMENDATION COMES OUT?
THERE’S A STATEMENT THAT CAN IT INTO CONTEXT THAT WOULD
EXPLAIN THE ORDERING ISSUES AND THE FACT THAT THIS
MIGHT BE A LITTLE CHALLENGING THE FIRST YEAR BUT SHOULDN’T —
PEOPLE SHOULDN’T FEEL BAD ABOUT THAT.
>>ALONG THAT LINE, A STATEMENT TO EXTENT THAT UNDERSTANDING
THAT ORDERS ARE IN PLACE AND SO ON, THIS IS A RECOMMENDATION AS
IS FEASIBLE AND THEN GO INTO THE RECOMMENDATION.
DR. BENNETT? I THINK THE OBJECTION TO THAT
WAS THAT IT COULD HAVE IMPLIED HAD YOU TO HAVE BOTH IN THE
OFFICE BEFORE YOU GAVE LAIV. I THINK THAT’S WHAT WE WERE
TRYING TO GET AWAY FROM, JUST PHRASING THAT A LITTLE
DIFFERENTLY. DR. KERN?
>>I THINK THE FRAYING SUGGESTED FOR THAT WAS WHEN LAIV IS
AVAILABLE. THAT DOES NOT — WHICH I AGREE
WITH, BECAUSE I THINK IT MAKES IT MUCH CLEANER AND SIMPLER.
IT DOES NOT GET TO THE FEASIBILITY ISSUE.
I AGREE WITH JEFF THAT PERHAPS THAT COULD BE ANNOTATED RATHER
THAN GOING INTO THE PRIMARY LANGUAGE.
>>I’M GOIN A LITTLE BIT HERE.
THERE ARE MULTIPLE HERE TO FEASIBILITY.
IN FACT, I ARE PROBABLY SOME WE HAVEN’T TALKED
ABOUT HE GOES BACK TO THE CORE QUESTION OF JUST HOW STRONG IS
THIS PREFERENTIAL RECOMMENDATION?
ARE WE LIMITING IT TO A SMALL UNIVERSE OF FEASIBILITY ISSUES
OR ARE WE BROADENING IT TO THINGS LIKE FAMILY PREFERENCE,
ECONOMIC CONSIDERATIONS? T ARE
GOING TO BE SHORT-TERM. OTHER ISSUES THAT ARE GOING TO
BE LONGER TERM. THERE’S A LARGER QUESTION HERE.
>>DR. KIM? I THINK THAT’S VERY TRUE AND
IN FACT I CAN THINK ABOUT A LOT OF CHILDREN WHO FOR SOME STRANGE
REASON PREFER THE INJECTION. I AS A DOCTOR ARE NEVER GOING TO
SAY NO BECAUSE I WANT THEM TO GET IT.
I THINK THOSE THINGS WILL ALWAYS BE THERE.
BUT I THINK MAYBE IT WOULD HELP TO WORD THESE IN TERMS OF THE
DATA. FIRST OF ALL, BOTH LAIV AND IIV
ARE EFFICACIOUS AND ARE EFFECTIVE AND SAFE.
THANK YOU. AND SECONDLY, DATA SUGGESTS LAIV
MAY BE MORE EFFECTIVE IN HELPING — THAT SHOULD BE A
PREFERENCE. I’M NOT GETTING THE WORD
EXACTLY RIGHT. LET’S STICK WITH THE FACTS.
I THINK SHOULD BE USED IS A LITTLE ENCOMPASSING AND
DOESN’T REALLY INCORPORATE WHAT WE’RE TRYING TO DO, WHICH IS
EVIDENCE SHOWS THIS. I GUESS I WOULD — I WOULD
LIKE TO COMMENT THAT THE ADDITIONAL LANGUAGE IN THE
RECOMMENDATION ACTUALLY GOES THROUGH THE EVIDENCE AND TALKS
ABOUT THE DATA. I THINK IT’S RATHER CUMBERSOME
TO ACTUALLY INCLUDE THAT HERE. I CAN JUST TELL YOU FROM THE
WORK GROUP PERSPECTIVE, THIS HAS BEEN A LONG TIME COMING AND
THERE’S BEEN A LOT OF DISCUSSION IN THE WORK GROUP.
I THINK THE FEELING OF THE WORK GROUP WAS THAT THE LANGUAGE
WAS — WE SPECIFICALLY CHOSE THE LANGUAGE SHOULD BE USED AFTER A
LOT OF DELIBERATION AND REVIEW OF THE DATA.
>>THAT’S BASED ON MODERATE TO HIGH-QUALITY EVIDENCE.
FURTHER DISCUSSION? I’M GOING TO GO DR.
DUSHON WHO MADE THE ORIGINAL MOTION.
WE TALKED ABOUT SOME SUBTLE CHANGES TO THAT.
ARE THOSE ACCEPTABLE TO YOU? YEAH.
MAYBE — WHICH ONE? I THINK THAT THE ISSUE OF
FEASIBILITY AND THE ISSUES AROUND TIMING CAN BE DISCUSSED
OUTSIDE OF THE RECOMMENDATION ITSELF.
THE SUGGESTION TO MODIFY THE SECOND BULLET TO WHEN LAIV IS
AVAILABLE, IT SHOULD BE USED, IS ACCEPTABLE.
>>THAT CORRESPONDS FOR THE THIRD BULLET, WHEN IT IS NOT
IMMEDIATELY THOSE DOVETAIL NICELY TOGETHER.
IT MAY — DR. HAD A GOOD POINT.
IT MIGHT BE NICE TO HAVE THIS WRITTEN ON THE SCREEN SO WE KNOW
EXACTLY WHAT WE HAVE. DR. SAVOY?
>>WOULD PEOPLE FEEL BETTER IF THERE WERE AN AID SIMILAR TO
WHAT WE WERE SHOWN EARLIER TODAY UT
WHAT THE TABLES THAT ARE THE ARROWS, IF YOU HAVE THIS, GIVE
THIS, IF YOU HAVE THIS, GIVE THAT.
I THINK IF I HAD JUST READ THE TEXT OF WHAT WAS WRITTEN, I
WOULD HAVE ASSUMED THAT IF I HAD BOTH, THAT I’M SUPPOSED TO GIVE
THE LIVE VACCINE AND IF I DON’T HAVE BOTH AND I GIVE WHICHEVER
ONE I HAVE. BUT IF OTHER PEOPLE WEREN’T
GOING TO ASSUME THAT, IF OUR WORRY WAS THAT PEOPLE WOULD GET
CONFUSED ABOUT WHICH ONE ORHEY ANYTHING THEY GOT LIVE IN,
SOMETHING LIKE THAT MIGHT CLARIFY WITHOUT HAVING TO CHANGE
YOUR RECOMMENDATION. I JUST WANT TO SAY
VERY RESPECTFULLY WE’RE 25 MINUTES OVER.
I WANT TO MAKE SURE THAT OUR ADULT WORK GROUP DOES NOT GET
BUMPED AGAIN. IT WILL INCLUDE A DISCUSSION —
I’M GLAD FOR THE LAUGHTER, REA SURE THAT OUR INDIVIDUALS GET AN
OPPORTUNITY TO PRESENT. IT WILL INCLUDE INFLUENZA ALSO.
>>LET THE RECORD SHOW THAT AT LAST MEETING, I PROMISED THAT
WOULD NOT HAPPEN AND YOU WILL HAVE YOUR TIME THIS AFTERNOON.
DR. BRADY? I WOULD AGREE THAT PROBABLY
FROM THE PERSPECTIVE OF WHAT I MENTIONED BEFORE, IF THAT SECOND
WAS CHANGED TO IF LAIV WAS AVAILABLE AND DIDN’T INCLUDE
BOTH, THEN IF A PEDIATRICIAN DIDN’T HAVE ANY LAIV, THEN THAT
WOULD KIND OF GIVE THEM AN EASIER OUT.
>>THANK YOU FOR THAT CLARIFICATION.
>>I WILL AGREE WITH WHAT DR. BRADY SAID.
THIS IS A ONE-YEAR STATEMENT. LIKE THE AAP STATEMENT, THIS IS
ONLY YEAR. IT’S OKAY TO MAKE AN INTEREST
RUM CHANGE WITH THE LANGUAGE THAT WAS MENTIONED AND THEN
CHANGE IT AGAIN NEXT YEAR BASED ON THE FACT THAT PEOPLE ARE MORE
READY FOR ORDERING IN A DIFFERENT WAY.
>>OKAY. WITH WHAT YOU SEE UP THERE, DR.
DUSHON, ARE YOU — IF THE MAKER OF THE MOTION — IS THAT
ACCEPT YES, IT IS ACCEPTABLE.
>>I’M TRYING TO RECALL, WAS IT DR. HARRISON WHO SECONDED IT?
>>YES. THE ACTUAL LA
IIV AND LAIV ARE CONSIDERED SAFE AND EFFECTIVE, PERIOD.
WHEN AVAILABLE LAIV SHOULD BE USED.
THAT WAS THE SUGGESTION. THAT’S FROM THE PRELUDE TO
THE RECOMMENDATION. THAT WILL STILL BE IN THE
STATEMENT. OKAY.
WE HAVE A MOTION AND SECONDED. OKAY.
READING INTO THE MINUTES, USE OF LAIV AND IIV FOR HEALTHY
CHILDREN AGE TWO THROUGH EIGHT YEARS, ALL INDIVIDUALS GREATER
THAN SIX MONTHS OF AGE SHOULD RECEIVE INFLUENZA VACCINE.
INFLUENZA VACCINATIONS SHOULD NOT BE DELAYED TO PROCURE A
SPECIFIC VACCINE PREPARATION IF AN APPROPRIATE ONE IS ALREADY
AVAILABLE. WHEN AVAILABLE, LAIV SHOULD BE
USED FOR HEALTHY CHILDREN AGE TWO THREE EIGHT YEARS.
WE HAVE NO CONTRAINDICATIONS OR PRECAUTIONS, CATEGORY A.
AND THEN IF LAIV IS NOT IMMEDIATELY AVAILABLE, IIV
SHOULD BE USED. VACCINATIONS SHOULD NOT BE
DELAYED IN ORDER PROCURE LAIV.
>>IN THE THIRD BULLET, IT SHO LAIV IS NOT
IMMEDIATELY AVAILABLE, THERE’S AN IT
BE THERE. THANK YOU FOR CATCHING THAT.
MY MIND WENT IMMEDIATELY OVER THAT.
FURTHER DISCUSSION? I SEE NONE.
WE WILL START WITH DR. HARRISON. PROCEED IN PAY COUNTER CLOCK —
A COUNTERCLOCKWISE YES. YES.
>>YES. YES.
>>RIENGOLD, YES. KARRON, YES.
>>TEMTE, YES. PELL DEGREE KNEE, YES.
>>LUGAN, YES. THE MOTION IS CARRIED
UNANIMOUSLY. IT’S AMAZING HOW TIME — HOW
FIVE HOURS CAN PASS WHEN YOU ARE HAVING FUN.
BUT WE STAND FOR A BREAK.

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