Articles, Blog

February 2015 ACIP-Yellow Fever Vaccine

November 9, 2019


IF WE CAN MOVE ALONG NOW. I STAND CORRECTED.
THIS IS THE SESSION ON YELLOW FEVER. AND IF
DR. BOCCHINI CAN INTRODUCE THEN DR. STAPLES.
>>THANK YOU FOR NOT ALLOWING ANYBODY TO TAKE A BREAK.
IT COULD SHORTEN THE DISCUSSION PERIOD FOR THIS SESSION.
SO TODAY THE YELLOW FEVER VACCINES WORK GROUP WILL PRESENT
FOLLOW-UP INFORMATION RELATED TO YELLOW FEVER VACCINE IN
ANTICIPATION OF AN ACIP VOTE. THESE ARE THE MEMBERS OF THE
WORK GROUP AND I WANT TO THANK EVERYONE FOR THEIR
PARTICIPATION, ESPECIALLY DR. STAPLES FOR HER WORK AS THE
CDs CD LEAD FOR THIS WORK GROUP. SO JUST AS A QUICK REMINDER FOR
EVERYONE, IN APRIL 2013 THE WORLD HEALTH ORGANIZATION’S
STRATEGIC ADVISORY GROUP OF EXPERTS CONCLUDED THAT A SINGLE
DOSE OF YELLOW FEVER VACCINE IS SUFFICIENT TO PROMOTE LIFELONG
PROTECTION AND BOOSTER DOSES WERE NO LONGER NEEDED.
ADDITIONAL DATA, HOWEVER, WAS INDICATED BY WORLD HEALTH
ORGANIZATION FOR IDENTIFYING SPECIFIC RISK GROUPS WHICH MIGHT
BENEFIT FROM SECOND DOSE OR BOOSTER DOSE.
SINCE 1965, INTERNATIONAL HEALTH REGULATIONS ALLOW COUNTRIES TO
REQUIRE YELLOW FEVER VACCINE DOSE WITHIN THE PAST TEN YEARS
FOR ENTRY. IN JUNE OF 2014, THE WORLD
HEALTH ORGANIZATION, WORLD HEALTH ASSEMBLY ADOPTED AN
AMENDMENT TO THE IHR THAT EXTEND YELLOW FEVER PROTECTION TO THE
LIFE OF THE PERSON VACCINATED. THIS NEW CHANGE WILL TAKE EFFECT
IN JUNE OF 2016, SO THERE WILL NO LONGER BE A REQUIREMENT FOR
COUNTRIES TO MAINTAIN THAT TEN-YEAR INTERVAL.
SO BECAUSE OF THOSE CHANGES, THE JE VACCINE WORK GROUP WAS
REFORMED TO INCLUDE YELLOW FEVER VACCINE IN OCTOBER 2013.
WE’VE MET MULTIPLE TIMES TO DISCUSS THE BOOSTER DOSES, AND I
WON’T GO THROUGH THE DATA, BUT AS YOU KNOW, WE’VE HAD THREE
PREVIOUS PRESENTATIONS TO ACIP ON THIS TOPIC, INCLUDING A
PRESENTATION OF GRADE IN JUNE 2014.
AND WE PRESENTED THE INITIAL SET OF RECOMMENDATIONS.
WE RECEIVED FEEDBACK FROM THE ACIP AND SUBSEQUENTLY CONTINUED
TO MEET TO ADDRESS THE ISSUES RAISED BY ACIP.
SO OVERALL AT THE JUNE MEETING, THERE WAS GENERAL SUPPORT TO
REMOVE BOOSTER DOSE REQUIREMENT, BUT QUESTIONS WERE RAISED ABOUT
GROUPS FOR WHOM ADDITIONAL DOSES WOULD BE CONSIDERED.
FIST WAS SOME DISCUSSION ABOUT THE IMMUNE RESPONSE A IN
CHILDREN, THE INTERVAL BETWEEN DOSES IN CERTAIN GROUP, AND WHAT
CONSTITUTES HIGH-RISK SETTINGS FOR EXPOSURE TO YELLOW FEVER.
THE ISSUE RELATED TO CHILDREN, WE WORKED WITH THE COMMITTEE ON
INFECTIOUS DISEASES, A PRESENTATION WAS MADE AT THE
NOVEMBER MEETING, AN UPDATED ANALYSIS ON IMMUNE RESPONSE OF
CHILDREN WAS DISCUSSED, AND IN ADDITION WHETHER CHILDREN’S
IMMUNE RESPONSE TO YELLOW FEVER VACCINE WAS DIFFERENT FROM
ADULTS. DR. STAPLES WILL DISCUSS
RESULTS OF THE FURTHER ANALYSIS AND THE ACIP RECOMMENDATIONS.
THE WORK GROUP DISCUSSED TIME INTERVAL FOR ADDITIONAL DOSES IN
PREGNANT WOMEN, STEM CELL TRANSPLANT RECIPIENT,
HIV-INFECTED INDIVIDUALS AND FURTHER CLARIFIED HIGH-RISK
SETTINGS FOR EXPOSURE FOR THE WILD TYPE YELLOW FEVER VIRUS.
TODAY DR. STAPLES WILL PRESENT A SUMMARY OF THE GRADE REVIEW,
CONSIDERATION FOR SPECIAL POPULATION, PROPOSED
RECOMMENDATIONS FOR CONSIDERATION BY ACIP.
AND WE LOOK FORWARD TO DISCUSSION AND A VOTE.
>>THANK YOU FOR STAYING AND, AND I WON’T BE LONG BECAUSE I
STAND BETWEEN YOU AND LUNCH. I WANT TO START BY SUMMARIZING
GRADE, BOOSTER DOSES BEFORE PRESENTING NEW DATA THAT ADDRESS
ISSUES THAT WERE RAISED DURING THE JUNE ACIP MEETING, AND
FINALLY CONCLUDE ABOUT PRESENTING ABOUT THE PROPOSED
LANGUAGE FOR YELLOW FEVER VACCINE BOOSTER VACCINE DOSES.
JUST TO REMIND PEOPLE, THE PRIMARY POLICY QUESTION AT THAT
THE WORK GROUP STARTED FOR GRADE WAS SHOULD BOOSTER DOSES OF
YELLOW FEVER VACCINE EVERY TEN YEARS CONTINUE TO BE RECOMMENDED
FOR HEALTHY TRAVELERS AND LABORATORY WORKERS.
THE INTERVENTION WOULD BE TO REMOVE CURRENT RECOMMENDATION
VERSUS THE CURRENT OPTION WOULD BE TO CONTINUE THE CURRENT
RECOMMENDATION FOR BOOSTER DOSES.
THE GRADE EVALUATION, THERE WERE FOUR BENEFITS THAT THE WORK
GROUP CONSIDERED TO BE CRITICAL, NAMELY VACCINE EFFICACY, SERA
PROTECTION, VACCINE EFFECTIVENESS, AND SERO
POSITIVITY. HOWEVER, THERE ARE NO DATA ON
THE VACCINE EFFICACY OR SERA PROTECTION.
THERE WERE THREE HARMS CONSIDERED BY THE WORK GROUP TO
BE CRITICAL, INCLUDING SERIOUS ADVERSE EVENTS AND TWO SPECIFIC
TYPES OF YELLOW FEVER ADVERSE EVENTS.
I’LL NOW REVIEW IS MAIN FINDINGS OF EACH CRITICAL OUTCOME
STARTING WITH VACCINE EFFECTIVENESS, WHICH WAS
DESCRIBED AS A LACK OF VACCINE FAILURES.
THERE HAVE BEEN 18 VACCINE FAILURES IDENTIFIED AMONG OVER
540 MILLION DOSES OF YELLOW FEVER VACCINE THAT HAVE BEEN
DELIVERED. ONLY TWO OR 11% OF THE 18
VACCINE AL FAILURES OCCURRED MORE THAN TEN YEARS FROM THE
LAST DOSE OF VACCINE, NAMELY AS 20 AND 27 YEARS.
FOR THE SERA POSITIVITY DATA AT TEN OR MORE YEARS WITH
VACCINATION, THERE WERE 13 OBSERVATIONAL STUDIES WITH DATA
FOR 1,137 PERSONS. THE ESTIMATE OF SERA POSITIVITY
IS 92% USING A RANDOM EFFECT MODEL.
SWITCHING TO 20 YEARS, THERE’S THREE OBSERVATIONAL STUDIES WITH IMMUNOGENICITY DATA FOR 164
PERSONS AT 20 OR MORE YEARS POST VACCINATION, AND THE ESTIMATE
FOR SERA POSITIVITY FOR THIS GROUP IS 80% USING THE RANDOM
EFFECTS MODEL. MOVING TO THE HARMS, THERE WERE
NINE OBSERVATIONAL STUDIES THAT HAD DATA ON 333 MILLION DOSES OF
THE VACCINE DISTRIBUTED. THERE WAS 1,255 SUBJECTS WHO
REPORTED A SERIOUS ADVERSE EVENT FOLLOWING VACCINATION.
OF THE 201 SUBJECTS WHERE THE DOSE TYPE WAS KNOWN, 7% OCCURRED
FOLLOWING A BOOSTER DOSE OF YELLOW FEVER VACCINE.
THE DATA WERE SIMILAR FOR YELLOW FEVER VACCINE ASSOCIATED
NEUROLOGIC AND VISCEROTROPIC. THIS SLIDE IS TO REMIND
EVERYBODY ABOUT THE VARIOUS EVIDENCE YOU’VE HEARD ABOUT, ONE
BEING THE HIGHEST LEVEL OF CONFIDENCE IN THE ESTIMATED EFFECT ON THE OUTCOME AND FOUR BEING THE LOWEST.
SO FOR THE FIVE CRITICAL OUTCOMES ACCESS FOR YELLOW FEVER
VACCINE BOOSTER DOSES, THE QUALITY OF EVIDENCE FOR EACH WAS
FOUR, AS IT ONLY INCLUDED OBSERVATIONAL STUDIES WITH
IMPORTANT LIMITATIONS TYPICALLY RELATED TO BIAS AND
INDIRECTNESS. SO THE OVERALL QUALITY OF
EVIDENCE WAS FOUR. THERE WAS AN ADDITIONAL POLICY
QUESTION CREATED TO ADDRESS PERSONS WHO WERE CONSIDERED BY
THE WORK GROUP NOT TO BELONG TO HEALTHY TRAVELERS AND LABORATORY
WORKERS. AND THAT SPECIFIC QUESTION IS
SHOULD BOOSTER DOSES OF YELLOW FEVER VACCINE EVERY TEN YEARS
CONTINUE TO BE RECOMMENDED FOR TRAVELERS AND LABORATORY WORKERS
WHO HAVE PRECAUTIONS FOR VACCINATIONS THAT MAY HAVE NEGATIVELY IMPACTED THEIR IMMUNE RESPONSE TO PRIMARY DOSE OF
YELLOW FEVER VACCINE SUCH AS PREGNANCY, ASYMPTOMATIC HIV, OR
YOUNG AGE. IN NEXT SLIDE, I’LL GO OVER THE
EVIDENCE FOR FOUR SPECIAL POPULATIONS THAT WERE CONSIDERED
BY THE WORK GROUP RELATED TO THIS ADDITIONAL POLICY QUESTION
AND ALSO ADDRESS CONCERNS RAISED IN JUNE.
THERE ARE TWO OBSERVATIONAL STUDIES THAT PROVIDE IMMUNOGENI-CITY DATA FOR PREGNANT WOMEN. IN THE FIRST STUDY 39% OF
PREGNANT WOMEN VACCINATED DURING THIRD TRIMESTER ZERO CONVERTED
IN COMPARISON TO 94% OF THE GENERAL POPULATION TO RECEIVE
THE VACCINE AT THE SAME TIME IN NIGERIA AS PART OF AN OUTBREAK
RESPONSE. IN THE SECOND STUDY CONDUCTED IN
BRAZIL, 98% OF PREGNANT WOMEN VACCINATED PRIMARILY DURING
THEIR FIRST TRIMESTER, SERA CONVERTED AND DEVELOPED YELLOW
FEVER VIRUS-SPECIFIC ANTIBODIES. FROM THESE TWO STUDIES WE CAN
CONCLUDE THAT THE PROPORTION OF PREGNANT WOMEN WHO DEVELOP
ANTIBODY TITERS FOLLOWING YELLOW FEVER VACCINATION IS VARIABLE,
BUT DAY THAT INDICATE A LACK OF INITIAL SERA CONVERSION FOR SOME
PREGNANT WOMEN. GIVEN THIS, THE WORK GROUP
SUGGESTED REVACCINATING WOMEN WHO RECEIVED THEIR INITIAL DOSE OF YELLOW FEVER VACCINE WHILE PREGNANT ONE TIME PRIOR TO THEIR
NEXT TRAVEL AT RISK. I’M SORRY.
AT-RISK TRAVEL. THERE IS NO IMMUNOGENICITY DATA
FOR RECIPIENT, BUT THE DATA SUGGEST MOST RECIPIENTS BECOME
SERA NEGATIVE TO ANTIGENS ON TRANSPLANTATION.
GUIDELINES RECOMMEND READMINISTERING LIVE VIRAL
VACCINES, SPECIFICALLY MMR, POST TRANSPLANT WHEN THE RECIPIENT IS
NO LONGER IMMUNNOSUPPRESSED. THE WORK GROUP SUGGEST
REVACCINATING ONE TIME BEFORE THEIR NEXT AT-RISK TRAVEL AS
LONG AS THEY’RE IMMUNOCOMPETENT. THREE STUDIES COMPARE. THIS IS COMPARISON TO 74% IN AGE
AND NUTRITIONALLY MATCHED CHILDREN.
IN THE SECOND STUDY, 83% OF HIV-INFECTED TRAVELERS HAD
YELLOW FEVER VIRUS-SPECIFIC ANTIBODIES ONE YEAR POST
VACCINATION AND BEGAN COMPARISONS OF 97% UNAFFECTED
CONTROL. IN THE LAST STUDY, 77% OF HIV
INFECTED TRAVELERS HAD YELLOW FEVER VIRUS SPECIFIC ANTIBODIES
AT ONE TO TEN YEARS POST VACCINATION, AND THIS IS IN
COMPARISON TO 88% OF UNAFFECTED CONTROL.
TO SUMMARIZE THE DATA, THE DATA INDICATE THAT HIV INFECTED
PERSONS ARE LESS LIKELY TO HAVE SUSTAINED YELLOW FEVER VIRUS
SPECIFIC ANTIBODY FIGHTERS FOLLOWING VACCINATION.
GIVEN THIS, THE WORK GROUP SUGGESTS CONTINUING DOSES OF
YELLOW FEVER VACCINE EVERY TEN YEARS FOR PERSONS WHO RECEIVE
YELLOW FEVER VACCINE WHILE INFECTED WITH HIV.
NOW, MOVING TO YOUNG CHILDREN, WHICH WAS A PARTICULAR AREA OF
DISCUSSION FOLLOWING THE GENE PRESENTATION, THERE ARE 12
STUDIES WITH IMMUNOGENICITY DATA ON 4,675 CHILDREN AGED 4 MONTHS
TO 10 YEARS IN ENDEMIC AREAS AT LEAST ONE TO TWO MONTHS POST
VACCINATION. THE ESTIMATE SERA CONVERSION
RATE IS 93% WITH A 95% CONFIDENCE INTERVAL WITH 88% TO
96% USING A RANDOM EFFECTS MODEL.
WE ALSO LOOKED AT DIFFERENCES IN SERA CONVERSION RATES AMONG
DIFFERENT PEDIATRIC AGE GROUPS BECAUSE THE STUDY IRRIGATED THE
RESULT BASE AGE, THERE WERE TWO AGE GROUPS THAT COULD BE READILY
EXPLORED. THE TOP TABLE SHOWS YOU THE SERO
CONVERSION RATE FOR CHILDREN 9 MONTHS AND OLDER COMPARED TO
CHILDREN AGED LESS THAN 9 MONTHS.
THE ESTIMATED SERA CONVERSION RATES WERE SIMILAR AT 92% AND
95% WITH OVERLAPPING CONFIDENCE INTERVALS.
THE BOTTOM TABLE SHOWS DATA FOR CHILDREN 9 MONTHS AND OLDER
COMPARED TO CHILDREN AGED LESS THAN 12 MONTHS AND THE SERA
CONVERSION RATES AGAIN ARE NOT DIFFERENT, AT 89% FOR CHILDREN
OLDER — 12 MONTHS AND OLDER AND 93% FOR CHILDREN LESS THAN 12
MONTHS. AGAIN, WITH OVERLAPPING
CONFIDENCE INTERVALS. TO SUMMARIZE THE PEDIATRIC DATA
AND NOTE OTHER CONSIDERATIONS, THE ESTIMATE FOR PEDIATRIC SERA
CONVERSION RATE WAS 93%, AND UNINGESTED SEROCONVERSION RATE
FOR ADULTS AT THE SAME TIME POINT IS 98% FOR ALL POPULATIONS
AND 97% FOR ENDEMIC POPULATIONS, AN JUST A REMIND THE PEDIATRIC
DATA CAME FROM — WHEN THESE DATA WERE PRESENTED
AND DISCUSSED WITH AAP’S COMMITTEE ON INFECTIOUS DISEASES
OR COID, THEY CONCLUDED THAT YOUNG CHILDREN WERE NOT
IMMUNOLOGICALLY DIFFERENT FROM ADULTS IN THEIR RESPONSE TO
YELLOW FEVER VACCINE. THE WORK GROUP FINALLY
CONSIDERED PERSONS WHO WERE CONSIDERED TO BE AT HIGHER RISK
FOR YELLOW FEVER VIRUS EXPOSURE BASED ON SEASON, LOCATION,
ACTIVITY, AND DURATION OF THEIR EXPOSURE.
THERE WERE THREE SITUATIONS WHERE A PERSON WAS CONSIDERED TO
BE AT HIGHER RISK LOCATION FOR YELLOW FEVER VIRUS EXPOSURE.
THESE INCLUDE WEST AFRICA DURING PEAK TRANSMISSION SEASON WHERE
THE DISEASE RISK IS ESTIMATED TO BE ABOUT TEN TIMES HIGHER THAN
SOUTH AMERICA. ALSO ARIAS WITH ONGOING
OUTBREAKS AND FINALLY REGULAR EXPOSURE TO WILD TYPE YES, MA’AM
YELL VIRUS IN A LABORATORY. THEN FINALLY TRAVEL FOR LONG
PERIODS OF TIME WAS ALSO TO LIKELY INCREASE THE RISK OF
DISEASE. NOW I’D LIKE TO SUMMARIZE THE
DATA AND CONSIDERATIONS RELATED TO YELLOW FEVER VACCINE BOOSTER
DOSES FROM THE VACCINE EFFECTIVENESS DATA, VERY FEW
VACCINE FAILURES NOTED TO CUR FOLLOWING YELLOW FEVER VACCINE
ADMINISTRATION. MOST OR 92% OF VACCINE
RECIPIENTS ARE SERO POSITIVE TEN OR MORE YEARS POST VACCINATION.
SERIOUS ADVERSE EVENTS ARE UNCOMMON FOLLOWING BOOSTER DOSES
OF YELLOW FEVER VACCINE. A HIGH VALUE WAS PLACED BY THE
WORK GROUP ON PREVENTING SERIOUS DISEASE WITH NO TREATMENT AND
POOR OUTCOME. AND FINALLY THE CURRENT
STATEMENT IN THE RECOMMENDATIONS WILL NO LONGER BE RELEVANT WHEN
I REMEMBER HEALTH REGULATIONS ARE UPDATED IN JUNE OF 2016.
GIVEN THESE DATA AND CONSIDERATIONS THE WORK GROUP
CONCLUDED THAT A SINGLE DOSE OF YELLOW FEVER VACCINE PROVIDES
LONG LASTING PROTECTION IN MOST TRAVELERS.
AND THEREFORE THE WORK GROUP WOULD NO LONGER RECOMMEND
BOOSTER DOSES OF YELLOW FEVER VACCINE FOR THOSE TRAVELERS.
HOWEVER, THE WORK GROUP WOULD RECOMMEND YELLOW FEVER VACCINE
BOOSTER DOSES FOR PERSONS WHOSE IMMUNE RESPONSE TO THE PREVIOUS
DOSE MAY HAVE BEEN COMPROMISE AND CONSIDER BOOSTER DOSES IN
PERSONS AT HIGHER RISK SETTINGS FOR EXPOSURE TO YELLOW FEVER
VIRUS. THIS FINALLY LEADS ME TO THE
RECOMMENDATIONS THAT THE WORK GROUP IS PROPOSING FOR ACIP’S
CONSIDERATION AND VOTE. THE RECOMMENDATION FOR MOST
TRAVELERS WOULD BE A SINGLE DOSE OF YELLOW FEVER VACCINE PROVIDES
LONG LASTING PROTECTION AND IS ADEQUATE FOR MOST TRAVELERS.
THIS IS A CATEGORY A RECOMMENDATION.
FOR CERTAIN POPULATIONS NOTED BELOW, THE RECOMMENDATION WOULD
BE ADDITIONAL DOSES OF YELLOW FEVER VACCINE ARE RECOMMENDED
FOR CERTAIN TRAVELERS INCLUDING WOMEN PREGNANT WHEN THEY RECEIVE
THEIR INITIAL DOSE OF YELLOW FEVER VACCINE SHOULD RECEIVE ONE
ADDITIONAL DOSE OF YELLOW FEVER VACCINE PRIOR TO THEIR NEXT
TRAVEL THAT PUTS THEM AT RISK FOR YELLOW FEVER VIRUS
INFECTION. INDIVIDUAL WHO IS RECEIVED STEM
CELL TRANSPLANTS AFTER RECEIVING A DOSE OF YELLOW FEVER VACCINE
AND WHO ARE SUFFICIENTLY IMMUNOCOMPETENT TO BE SAFELY
VACCINATED SHOULD BE REVACCINATED PRIOR TO THEIR NEXT
TRAVEL THAT PUTS THEM AT RISK FOR YELLOW FEVER VIRUS
INFECTION. FOR INDIVIDUALS HIV INFECTED
WHEN THEY RECEIVED THEIR LAST DOSE OF YELLOW FEVER VACCINE,
THEY SHOULD RECEIVE A DOSE EVERY TEN YEARS IF THEY CONTINUE TO BE
AT RISK FOR YELLOW FEVER VIRUS INFECTION. FOR THIS GROUP, WE WANTED TO
KNOW THAT PERSONS SHOULD BE CONSIDERED FOR THE ADDITIONAL
DOSES SHOULD BE ASSESSED FOR CONTRAINDICATIONS AND
PRECAUTIONS. THAT WOULD BE A CATEGORY A
RECOMMENDATION. FOR PERSONS IN HIGHER RISK
SETTINGS THE RECOMMENDATION WOULD BE A BOOSTER DOSE MAY BE
CONSIDERED FOR TRAVELERS WHO RECEIVED THEIR LAST DOSE OF
YELLOW FEVER VACCINE AT LEAST TEN YEARS PREVIOUSLY AND WHO
WILL BE AT A HIGHER RISK SETTING BASED ON SEASON, LOCATION,
ACTIVITY, AND THEIR — DURATION OF TRAVEL. THIS WOULD INCLUDE TRAVELERS
SPENDING LONG TIMES IN HIGHLY ENDEMIC AREAS OR TRAVELING TO
THOSE ARIAS SUCH AS RURAL WEST AFRICA DURING PEAK SEASON OR
THOSE WITH ONGOING OUTBREAK. THIS IS A CATEGORY B
RECOMMENDATION. FINALLY FOR LABORATORY WORKERS
IN HIGHER RISK SETTINGS RECOMMENDATION WOULD BE
LABORATORY WORKER WHO IS ROUTINELY HANDLE WILD TYPE
YELLOW FEVER VIRUS SHOULD HAVE YELLOW FEVER VIRUS SPECIFIC
ANTIBODY NEUTRALIZING TITERS MEASURED AT LEAST EVERY TEN
YEARS TO DETERMINE IF THEY NEED ADDITIONAL DOSES.
FOR THOSE UNABLE TO HAVE THOSE MEASURED, VACCINE SHOULD GIVEN AS LONG AS THEY REMAIN AT RISK. THIS IS A CATEGORY A
RECOMMENDATION. I WOULD LIKE TO NOW TURN IT OVER
THE DR. TEMPTE TO WALK US THROUGH THE NEXT STEP.
THANK YOU. THANK YOU VERY MUCH FOR,
AGAIN, A VERY NICE PRESENTATION WITH LIMITED TIME.
BUT, I THINK YOU PICKED UP ALL THE ISSUES THAT HAD BEEN
PREVIOUSLY RAISED BY THE GROUP SO I APPRECIATE THIS FROM THE
WORKING GROUP. DR. REINGOLD.
>>QUICK QUESTION ABOUT PREGNANT WOMEN.
THE DATA YOU SHOWED SUGGESTS IT’S WOMEN ONLY VACCINATED IN
THE THIRD TRIMESTER WHO NEED AN EXTRA DOSE.
ALL PREGNANT WOMEN JUST BECAUSE YOU DON’T THINK WOMEN WILL KNOW
WHICH TRIMESTER THEY WERE VACCINATED IN?
>>I THINK IT’S MORE THE FACT IT’S ONLY DERIVED FROM TWO
STUDIES THAT THAT I THINK THAT’S INSUFFICIENT TO SAY WITH
CERTAINTY IT’S THE THIRD TRIMESTER.
WHAT ABOUT THE SECOND TRIMESTER. WE DON’T KNOW EXACTLY WHAT THAT
IS. WE ARE BEING PERHAPS A LITTLE
MORE CONSERVATIVE AND JUST SUGGESTING IF YOU’RE VACCINATED
DURING PREGNANCY YOU SHOULD RECEIVE ANOTHER DOSE IF YOU’RE
ABLE TO. DOCTOR?
>>FOR THE LABORATORY WORKERS YOU SUGGESTED ANTIBODY TITERS.
DID YOU CONSIDER THAT POSSIBILITY FOR THE OTHER GROUPS
THAT YOU’RE CONSIDERING REVACCINATING AS AN OPTION?
YOU DID HAVE SOME SERA CONVERSION AMONG ALL THOSE
GROUPS. GIVEN THE ADVERSE REACTIONS THAT
CAN HAPPEN WITH THE VACCINE AND THE SERIOUSNESS OF IT, I’M JUST
WONDERING IF YOU CONSIDERED ANTIBODY TITERS FIRST AND THEN
INSUFFICIENT REVACCINATION. WE DID DISCUSS ANTIBODIES
TITER, AND CURRENTLY THE ONLY PLACE TO GET THOSE PERFORMED IS
AT CDC AND OUR FACILITY. SOMETIMES IT’S LOGISTICALLY
CHALLENGED AND IT’S DONE THROUGH A TEST THAT TAKES ABOUT FOUR
WEEKS TO GET THE RESULTS. AT LEAST FROM OUR TRAVEL
PRACTITIONERS IN THE GROUP THEY DIDN’T THINK IT WAS VERY
PRACTICAL, PARTICULARLY IF PEOPLE ARE RUSHING IN THE DOOR
TO GET THEIR VACCINES AND THEY WON’T HAVE AN ANSWER.
BUT CDC TRADITIONALLY DOES DO ANTIBODY TESTING FOR MANY OF THE
HIGH-RISK GROUPS WE HIGHLIGHTED HERE, RISK GROUPS THAT WOULD BE
CONCERNED. THAT’S SOMETHING ALREADY GOING
ON AND COULD BE MAINTAINED. NUMBER OF LABORATORY WORKERS
THAT REALLY HANDLE WILD TYPE YELLOW FEVER VIRUS ON A REGULAR
BASIS IS QUITE SMALL, AND THEY OBVIOUSLY WOULD BE AWARE AND
SHOULD BE ABLE TO CHANNEL THROUGH AND USE THAT
NEUTRALIZATION TESTING. MISS PELLEGRINI.
>>IF I’M REMEMBERING OUR FALL CONVERSATION CORRECTLY WHEN WE
DISCUSSED CHILDREN, THERE WAS SOME QUESTION ABOUT WHETHER
TRAVELERS WHO WERE VACCINATED AS CHILDREN WOULD, INDEED, HAVE
LIFE-LONG PROTECTION. WAS THE WORK GROUP ABLE TO FIND
ANY DATA THAT WOULD HELP CLARIFY THAT?
>>YES. WE LOOKED AT THE PEDIATRIC DATA
AND I SHOWED YOU PRETTY MUCH ALL OF THE DATA THAT THAT WAS FOR THE INITIAL SERA CONVERSION. THERE’S ONLY ONE STUDY OUT THERE
AND THE DATA ARE NOT PRIMARILY DEALING WITH
YELLOW FEVER. IT WAS DEALING WITH LOOKING AT
CHIRP THAT HAD RECEIVED YELLOW FEVER VACCINE BECAUSE THEY’RE
GOING TO GIVE THEM THAT — VACCINE.
THEY LOOKED AT THOSE CHILDREN BASED ON AGE COHORTS AND SOME OF
THOSE CHILDREN HAD BEEN REVACCINATED SO THE RESULTS ARE
VERY CONFUSING AND NOT — UNFORTUNATELY NOT HELPFUL.
IT IS SOMETHING THAT WHEN WE DISCUSS WITH AAP THEY SAID IT
WOULD BE GREAT TO GET MORE DATA. I DIDN’T HAVE AN OPPORTUNITY DUE
TO THE TIME TO PRESENT FUTURE STUDIES, BUT IT IS ONE OF THE
STUDIES WE’VE HIGHLIGHTED FOR FUTURE WORK.
>>AND DR. ATKINSON AT THE MICROPHONE.
>>I’M WILLIAM ATKINSON. I’M A MESSENGER.
I’M DELIVERING A — I’M ASKING A QUESTION ON BEHALF OF DR. STAN
PLOTKIN, WHO IS NOT HERE BECAUSE OF THE SOUTHERN SEVERE
THUNDERSTORM. DR. PLOTKIN WOULD LIKE TO
INQUIRE ABOUT THE STUDY JUST PUBLISHED IN “VACCINE” SHOWING
17% ZERO NEGATIVE 5 NINE YEARS POST VACCINATION IN NORMAL
PEOPLE. I WOULD HAVE TO SEE
SPECIFICALLY — THERE’S BEEN SEVERAL YELLOW FEVER VACCINE
STUDIES PUBLISHED IN THE LAST SIX MONTHS BUT I’M NOT SURE THE
DATA BEHIND THAT ONE. AND I THINK THE ISSUE THAT WE’VE
ALSO HAD IN THE WORK GROUP IS KNOWING EXACTLY WHAT SERO
PROTECTION THEY USED BECAUSE THERE ARE DIFFERENT CUTOFFS FOR
DETECTABLE ANTIBODIES. SOMETIMES COMPARING ONE STUDY
WITHOUT THOSE RESULTS, IT WOULD BE HARD TO MAKE FURTHER COMMENT
ON THAT. ARE THERE OTHER QUESTIONS OR
COMMENTS? OKAY.
AGAIN, THANKS FOR A VERY NICE PRESENTATION.
I THINK OUR NEXT STEP IS TO MOVE ON AND SEE EMOTION FOR APPROVAL.
AGAIN, I THINK THE QUESTIONS THAT WERE RAISED IN THE PAST
HAVE BEEN ADDRESSED NICELY BY THE WORK GROUPS.
I WILL ENTERTAIN A MOTION FROM DR. RUBEN.
MAKE A MOTION TO APPROVE RECOMMENDATION.
>>OTHER FURTHER COMMENT. THE NOT, DR. KAREN, WE’LL START
WITH YOU AND GO ARNOLD TO YOUR RIGHT.
>>KAREN, YES. REILLY, YES.
>>OKINI, YES. VASQUEZ, YES.
>>CAMPSOCKHALT, YES. RON GOLD, YES.
>>PELLEGRINI, YES. TEMPTE, YES.
>>RUBEN, YES. ROMERO, YES.
>>HARRIMAN, YES. HARRISON, YES.
>>BOLLANGE, YES. THE MOTION CARRIES 13-4.
NO VOTES AGAINST. SO THANKFULLY THERE IS NO VFC
RESOLUTION NEEDED FOR THIS VOTE. AND WE’RE ABLE TO
WISH DR. HARRISON A GOOD TRIP HOME.
DR. BENNETT AND DR. KEMP HAVE ALREADY HAD FLIGHT DELAYS.
I’M JUST GOING TO MOVE LONG VERY QUICKLY WITH PUBLIC COMMENT.
WE HAVE ONE MORE PUBLIC COMMENT HERE.
BUT WARFARE WE GET TO THAT, I WANT TO EXPRESS OUR APPRECIATION
FIRST OF ALL TO EVERYBODY IN THIS ROOM WHO ADAPTED PLANS,
MADE DO WITH NOTHING GOING ON YESTERDAY, AND STILL SHOWED UP
HERE TODAY. WE ALSO APPRECIATE THE WORK
GROUPS WHO GREATLY AND RAPIDLY CHANGED PRESENTATIONS TO TRY AND
CONDENSE THEM DOWN INTO THE TIME AVAILABLE BECAUSE WE DID HAVE
THESE FOUR THINGS WE FELT VERY IMPORTANT TO GET THROUGH.
THAT BEING SAID, WE DID PUT OFF DISCUSSION AND VOLTS ON
INFLUENZA H5N1, SMALLPOX AND RECOMMENDATIONS PLUS OTHER
CONSIDERATIONS FOR MENINGOCOCCAL B AND HPV UNTIL THE JUNE
MEETING. SO KEEP POSTED ON THOSE.
BUT, AGAIN, THANKS TO THE WORK GROUPS FOR ADAPTING TO THIS VERY
LIMITED TIME PERIOD WE HAD. THAT BEING SAID, IS SALLY
LONGBERG HERE? AND IF YOU CAN COME UP TO THE
MICROPHONE? HI.
I’M SALLY GREENBERG AND I’M EXECUTIVE DIRECTOR OF THE
NATIONAL CONSUMERS LEAGUE. I’M HERE TO SUPPORT THE ROUTINE
SCHEDULE OF MENINGITIS B. MY ORGANIZATION’S BEEN AROUND
SINCE 1899. WE ARE THE OLDEST CONSUMER
ORGANIZATION. AND WE ALSO SURVEY CONSUMERS ON
THEIR ATTITUDES ABOUT VACCINES. AND WHAT WE FIND IN OUR LATEST
SURVEY WAS THAT 87% OF PARENTS WANT TO GET THERE AND SUPPORT
GETTING THEIR CHILDREN VACCINATED AND THE DISEASE THEY
FEAR MOST THAT VACCINATING CAN PREVENT IS MENINGITIS.
SO I’M HERE ALSO TO SUPPORT THE MANY PARENTS AND FAMILIES WHO
CAME OUT OF THEIR — AT THEIR OWN EXPENSE.
WE — I COME TO THIS BOTH AS A CONSUMER ADVOCATE AND WEARING
SEVERAL OTHER HATS. ONE IS THAT I HAD AN UNCLE WHO
HAD POLIO, GOT IT THE YEAR BEFORE THE POLIO VACCINE CAME
OUT, AND I WATCHED MY FAMILY SUFFER WITH A — HE CLUNG TO
LIFE IN AN IRON LUNG FOR TWO YEARS THEN WENT ON TO BE A
QUADRIPLEGIC. ONE YEAR LATER HE COULD HAVE
BEEN — THIS TRAGIC CONDITION COULD HAVE BEEN PREVENTED.
BUT I’M ALSO THE PARENT OF A COLLEGE-AGE KID WHO IS A
BASEBALL PLAYER AND LIVES IN THE DORMS.
AS I MEET WITH A LOT OF THE MENINGITIS VICTIMS, WE TAKE A
VERY STRONG STAND IN FAVOR AND IN SUPPORT OF SAFE AND EFFECTIVE
VACCINES. I’M FINDING IT VERY DIFFICULT TO
ACCESS THAT VACCINE FOR HIM. IT WOULD BE WONDERFUL IF THIS
VACCINE BECAME PART OF THE ROUTINE SCHEDULE.
AND IT’S — THEY HAVE TO ORDER IT, THEY’RE NOT SURE WHICH ONE
THEY WANT TO ORDER. THERE’S A WILL THE OF CONFUSION.
I’VE HAD MAYBE TEN PHONE CALLS AND WE STILL HAVEN’T FIGURED OUT
HOW TO GET THIS VACCINE. SO IT REALLY ISN’T FAIR FOR MY
SON TO BE THE ONLY GUY TO GET IT ON HIS CAMPUS, WHICH HE PROBABLY
WILL BE, BUT, YOU KNOW, I REALLY FEEL SO STRONGLY THAT WHEN YOU
HAVE SOMETHING THAT’S SAFE AND EFFECTIVE AND THANKS TO ALL OF
YOU FOR THE CRITICALLY IMPORTANT WORK THAT YOU DO, BUT THERE’S
JUST NO REASON WHY THIS SHOULDN’T BE PART OF THE ROUTINE
SCHEDULE. SO I’M REALLY HERE WITH LOTS
OF HATS ON. BUT I THINK MOST IMPORTANTLY TO
SUPPORT ALL THESE FAMILIES, THE PARENTS WHO CAME FORWARD WITH
THESE DEVASTATING CONDITIONS AS A RESULT OF CONTRACTING
MENINGITIS B AND SOMETHING THAT’S TOTALLY PREVENTABLE.
SO THANK YOU FOR GIVING ME THE CHANCE TO SPEAK, AND APPRECIATE
IT. I THANK YOU FOR YOUR
PATIENCE, TOO, WAITING UNTIL THE END HERE.
BEFORE I FINISH UP, I’M JUST GOING TO FOR THE RECORD SAY —
BECAUSE I DON’T HAVE TIME TO READ ALL THESE AND WE HAVE FOUR
ADDITIONAL LETTERS THAT THE LETTERS HAVE BEEN PROVIDED TO
THE MEMBERS, AND THE LETTERS WILL ALSO BE PLACED IN THEIR
TOTALITY INTO THE MINUTES FROM THIS MEETING.
BUT THE FIRST LETTER IS FROM THE NATIONAL CONSUMERS LEAGUE.
AND ACTUALLY, THE LETTER BY SALLY GREENBERG, WHO JUST SPOKE.
SO THAT WILL BE IN. WE HAVE A LETTER FROM LESLIE
MEYER SPEAKING TO THE ROUTINE RECOMMENDATION FOR SERA GROUP B
IN THE MENINGOCOCCAL VACCINES. AND SHE IS ON THE BOARD OF
DIRECTORS OF THE NATIONAL MENINGITIS ASSOCIATION.
SO THAT WILL BE IN. WE HAVE AN ADDITIONAL LETTER
FROM THE AMERICAN FOR CONSUMER INSTITUTE CENTER FOR CITIZENS RESEARCH. AND, AGAIN, MAKING THEIR PLEA
FOR A UNIVERSAL ROUTINE RECOMMENDATION FOR MENINGOCOCCAL
B. AND FINALLY FROM THE NATIONAL
HISPANIC MEDICAL ASSOCIATION, A LETTER, AGAIN, REQUESTING
CONSIDERATION FOR ROUTINE RECOMMENDATION, MENINGOCOCCAL B
VACCINE. SO WE HAVE A LOT OF WORK AHEAD
OF US COMING UP. BUT I THINK WE HAVE COME TO THE
END OF OUR AGENDA. I’M JUST GOING TO SEE IF THERE’S
ANY ADDITIONAL COMMENT FROM MEMBERS HERE OR DR. SHUCHAT OR
ANYONE ELSE? AND SEEING NONE — AND, AGAIN,
BEFORE WE LEAVE, JUST ONE MORE MENTION OF OUR APPRECIATION TO
DR. PICKERING FOR HIS NINE YEARS OF SERVICE TO ACIP AND OUR BEST
WISHES AS HE MOVES ON FROM HERE. SO WITH THAT, THANK YOU VERY
MUCH, AND TRAVEL WELL. THANK YOU.
[ APPLAUSE ]

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