Novel Influenza and Pertussis


I THINK WE ARE READY TO CALL
THINGS BACK IN SESSION. I HAVE THE PLEASURE OF
INTRODUCING THE NOVEL INFLUENZA WORK GROUP.
WE ARE THINKING OF DOUG HERE. THE RATIONALE FOR THE NOVEL
INFLUENZA RECOMMENDATIONS ARE THAT THERE ARE TWO FDA LICENSED
VACCINES FOR THE HIGHLY PATHOGENIC H5N1 AND THERE IS A
NEED FOR RECOMMENDATIONS FOR USE DURING PANDEMIC PERIODS AND FOR
THOSE PEOPLE WHO HAVE INCREASED RISK OF EXPOSURE.
THIS GROUP HAS FORMED BEYOND THE SEASONAL INFLUENZA GROUP BECAUSE
THERE IS A LOT THAT THEY NEED TO DO AND HAVE ENOUGH ON THEIR
PLATE FOR THIS TO BE DONE IN A SEPARATE GROUP.
THIS GROUP FORMED IN FEBRUARY OF 2014 CHARGED WITH DEVELOPING
RECOMMENDATIONS FOR USE OF H5N1 VACCINE DURING INTERPANDEMIC
PERIOD. A NUMBER OF OUR LIAISONS,
CONSULTANTS AND MEMBERS, AS WELL.
THE POLICY QUESTION IS SHOULD H5N1 VACCINE BE RECOMMENDED TO
ADULTS WITH INCREASED EXPOSURE, IF YES DETERMINE EXPOSURE AND
RECOMMENDATIONS. THE PROGRESS TO DATE IS WE HAVE
BEEN MEETING AT LEAST MONTHLY AND SOMETIMES MORE FREQUENTLY
THAN THAT. WE HAVE HAD 11 WORK GROUP
MEETINGS SO FAR. AT THIS MEETING DR. SONJA OLSEN
WHO IS THE LEAD FOR THE WORK GROUP WILL BE PRESENTING DATA ON
INFLUENZA A H5N1 AND VACCINE AND PRESENT ON OPTIONS FOR H5N1
VACCINE. WE ANTICIPATE HAVING THIS
RECOMMENDATIONS FOR POTENTIAL VOTE IN THE FEBRUARY 2015 ACIP
MEETING. I WILL HAVE DR. SONJA OLSEN COME
UP. THANK YOU.
AS JOHN SAID I WILL BE GIVING TWO TALKS.
THIS IS FIRST ON THE BACKGROUND. INFLUENZA H5N1 IS A HIGHLY
PATHOGENIC INFLUENZA VIRUS THAT CAUSES RESPIRATORY DISEASE IN
BIRDS. THE VIRUS IS ENDEMIC IN POULTRY
IN AT LEAST SIX COUNTRIES, BANGLADESH, CHINE, VIETNAM,
CAMBODIA. OUTBREAKS OCCUR FREQUENTLY IN
THESE COUNTRIES AND ALSO NEIGHBORING COUNTRIES.
INFECTIONS HAVE OCCURRED IN HUMANS, THE FIRST OF WHICH WERE
RECOGNIZED IN HONG KONG IN 1997. AT THAT TIME THERE WERE 18 CASES
IN HUMANS AND HONG KONG THE VIRUS REMERGED
IN ASIA IN 2003. THE NUMBER OF CASES HAVE PEAKED
AROUND 2006, HOWEVER EVERY WREER INCLUDING THIS YEAR THERE HAVE
BEEN SPORADIC CASES WITH HIGH MORTALITY.
BETWEEN 2003 AND SEPTEMBER 2014 THERE HAVE BEEN 667 CASES IN 16
COUNTRIES. 393 OF THESE HAVE DIED FOR
MORTALITY OF 59%. MOST CASES OCCUR FROM CLOSE
CONTACT WITH INFECTED LIVE OR DEAD BIRDS OR H5N1 VIRUS
CONTAMINATED ENVIRONMENTS. HUMAN-HUMAN TRANSMISSION IS
EXTREMELY RARE. THIS SLIDE SHOWS THE NUMBER OF
CASES OF H5N1 INFECTION IN HUMANS BETWEEN 2004 AND 2014 ON
THE X AXIS IS TIME AND Y AXIS IS NUMBER OF CASES.
EACH COLOR REPRESENTS A CASE FROM A DIFFERENT COUNTRY.
SO AS I SAID THERE HAVE BEEN 667 CASES FROM 16 COUNTRIES.
I WILL JUST HIGHLIGHT IN 2004, 20 CASES HERE, NINE WERE IN
CAMBODIA, FOUR IN EGYPT, THREE IN CHINA AND TWO EACH IN VIETNAM
AND INDONESIA. THE H5N1 VIRUS CONTINUES TO
EVOLVE AND THE EVOLUTION IS MONITORED USING SEQUENCE OF THE
HEMO GLUTENNEN GENE. THEY ARE CLAVED.
KNOWLEDGE OF WHAT IS CURRENTLY CIRCULATING IN THE ANTIGENIC
DISTANCE FROM EXISTING VIRUSES IS RELATIVE TO UPDATING
PREPANDEMIC VACCINE RECOMMENDATIONS.
THIS SLIDE SHOWS H5N1 CLADES ALL FROM 1996 UNTIL 2014.
THOSE WITH THE RED STAR HAVE NOT BEEN DETECTED SINCE 2008 AND
THERE ARE 13 OF THOSE. THE CLAVE HIGHLIGHTED IN COLORS
INDICATE COUNTRIES WHERE THEY HAVE BEEN DETECTED.
ASTERISKS REPRESENT PLACES WHERE IT WAS REPORTED RECENTLY IN
2014. THE PURPLY RED COLOR HERE IS
2.1.3 WHICH OCCURS IN INDONESIA AND THE STAR MEANS CASES
OCCURRING THIS YEAR. THE NEXT TWO SLIDES HIGHLIGHT
THE GLOBAL VACCINE RECOMMENDATIONS FOR H5N1.
THE WORKING GROUP ON INFLUENZA VACCINES AND RECOMMENDATIONS
DEVELOPED FOR LICENSE DURING INTERPANDEMIC PERIODS.
THESE RECOMMENDATIONS WERE DRAFTED IN 2009 AND REEVALUATED
AND REAFFIRMED IN 2013 WITH NO CHANGES.
THE CURRENT RECOMMENDATIONS ARE OUTLINE HERE.
AND THEY ARE STRONGLY RECOMMENDED VACCINATION OF
LABORATORY WORKERS INVOLVED IN HIGH RISK GROUPS SUCH AS LARGE
SCALE PRODUCTION OR WORK WITH DRUG RESISTANT VIRUSES.
THE SECOND GROUP IS RECOMMENDED. THOSE INCLUDE FIRST RESPONDERS
TO HUMAN OR ANIMAL CASES OR OUTBREAKS OR HEALTH CARE WORKERS
WHO EVALUATE OR MANAGE PATIENTS. AND THEN NOT RECOMMENDED INCLUDE
PERSONS WHO MAY ONLY POTENTIALLY COME IN CONTACT WITH INFECTED
ANIMALS, ESSENTIAL WORKERS IN AREA [ INAUDIBLE ] OR GENERAL
POPULATION. THESE ARE NOT SPECIFIC TO ANY
VACCINES. BECAUSE EACH VIRUS CONTINUES TO
EVOLVE THIS NECESSITATE FREQUENT DEVELOPMENT OF REPRESENTATIVE
CANDIDATE VACCINE VIRUSES. W.H.O. RECOMMENDS THAT COUNTRIES
CONSIDER VIRUSES FOR PREPAREDNESS BASED ON PUBLIC
HEALTH NEEDS AND RISKS. CURRENTLY GLOBALLY THERE ARE 26
VACCINE VIRUS CANDIDATES FOR H5N1 IN DEVELOPMENT AND FOUR IN
PREPARATION. I’LL JUST SHIFT TO TALK ABOUT
H5N1 VACCINES IN THE UNITED STATES.
IN THE UNITED STATES H5N1 VACCINES ARE NOT MADE
COMMERCIALLY. THE U.S. GOVERNMENT HAS
SUPPORTED THEIR DEVELOPMENT. CANDIDATE VACCINE VIRUSES ARE
CHOSEN FOR VACCINE DEVELOPMENT HERE USING A STANDARDIZED
INFLUENZA RISK ASSESSMENT TOOL. CURRENTLY THERE ARE FOUR
VACCINES IN THE STOCK PILE AND THIS TABLE SHOWS THOSE FOUR
VACCINES. AND THE FIRST COLUMN IS THE
VIRUS. AND THE SECOND IS THE CLADE
REPRESENTED AND THE THIRD IS THE LICENSURE STATUS.
YOU CAN SEE THE FIRST TWO ARE LICENSED VACCINES.
VACCINES IN THE STOCK PILE ARE FOR USE DURING A PANDEMIC OR FOR
CLINICAL STUDIES OF THE VACCINE. STRAIN CHANGES MUCH LIKE FOR
SEASONAL FLU ARE PERMITTED BUT ONLY DURING AN EMERGENCY.
THESE VACCINES ARE NOT MEANT TO BE USED DURING INTERPANDEMIC
TIMES. ONE OF THESE VACCINES IS BEING
PRODUCED POST LICENSURE. THE U.S. GOVERNMENT IS
SUPPORTING THIS ADDITIONAL VACCINE PRODUCTION AND THE
MANUFACTURER IS PRODUCING ONE LOT OF APPROXIMATELY 100,000
DOZES. IT IS CURRENTLY ANTICIPATED TO
BE READY IN EARLY 2015 AND IT’S SET UP SO THAT A PORTION OF THIS
WILL BE STORED AT N.I.H. AND MADE AVAILABLE TO INVESTIGATORS
AND THE REST WILL BE IN THE STOCK PILE.
THIS VACCINE IS MADE BY MEDICAL CORPORATION OF QUEBEC WHICH IS A
SUBSID YARE OF GSK. IT IS AN EMULSION WHICH CONSISTS
OF VIRUS CHAIN A INDONESIA ’05 AS WELL AS ASO 3 A WHICH USES
THE FULL DOZE OF THIS. SO THE VACCINE IS ADMINISTERED
INTERMUSCULLERLY AND IT IS APPROVED FOR USE IN PERSONS 18
YEARS OF AGE OR OLDER AT INCREASED RISK OF EXPOSURE TO
INFLUENZA A VIRUS H5N1. IT IS THE FIRST VACCINE TO BE
LICENSED IN THE UNITED STATES. THERE ARE NO [ INAUDIBLE ]
LICENSING IN THE UNITED STATES. IT IS AN OIL IN WATER EMULSION
AND THERE ARE SEVERAL REASONS TO USE THE ADJUVANT.
FIRST IS INCREASED. AND THEN INFLUENZA CROSS STRAIN
AND INABILITY TO PRODUCE RESPONSE TO OTHER STRAINS.
USED IN MONOVALENT PANDEMIC VACCINES.
THE TWO ARE LISTED HERE. ONE MADE BY GSK IN GERMANY AND
ONE MADE IN QUEBEC. THERE HAVE BEEN REPORTS OF ASO 3
VACCINES ASSOCIATED WITH NARCOLEPSY.
SEVERAL STUDIES IN EUROPEAN COUNTRIES HAVE F
INCREASED RISK OF NARCOLEPSY IN ALL AGES.
THIS IS HIGHEST IN CHILDREN AND ADOLESCENTS.
THERE HAVEN’T BEEN STUDIES TO DATE WITH NEGATIVE FINDINGS.
AND THE ATTRIBUTABLE RISK HAS BEEN AS HIGH AS SIX CASES PER
100,000 PERSONS VACCINATED. THERE IS A STUDY CONDUCTED IN
CANADA OR BRAZIL. IT WAS A POPULATION-BASED STUDY.
IT FOUND A RELATIVE RISK SIMILAR TO THOSE FOUND IN EUROPEAN
STUDIES. THE RISK WAS LOWER.
MILLION DOSES. OVERALL THE INCIDENTS OF
NARCOLEPSY WAS LOWER THAN WAS FOUND IN EU
ADJUVANT WAS NOT USED IN THE UNITED STATES BUT BECAUSE OF THE
FINDINGS CDC HAS SPONSORED AN INTERNATIONAL STUDY ON
ADJUVANTED VACCINES AND THE RESULTS ARE EXPECTED IN LATE
2015. SO THE LICENSE FOR INCREASED
RISK OF EXPOSURE BUT WHO IS THIS GROUP OF PEOPLE IN THE UNITED
STATES? THIS TABLE DEFINES THOSE PERSONS
AT INCREASED RISK. I WILL JUST WALK YOU THROUGH THE
TABLE. SO IN THE FIRST COLUMN WE HAVE
OCCUPATIONAL EXPOSURE GROUP. SO FOR EXAMPLE LABORATORY
WORKERS THAT MIGHT INCLUDE VACCINE MANUFACTURERS, ANTIVIRAL
DRUG DEVELOPERS, LABORATORY T H TECHNICIANS WHO WORK WITH LIVE
VIRUS AND THE RISKS CONTEMPLATED MAY INCLUDE MECHANICAL
MALFUNCTIONS, HUMAN ERROR, ACCIDENTS, ET CETERA.
SO THE GROUPS THAT WE HAVE OUTLINED AT INCREASED RISK
INCLUDE LABORATORY WORKERS, EXPERIMENTAL ANIMALS, STUDY
WORKERS WHICH INCLUDE VETERINARIANS, PUBLIC HEALTH
RESPONDERS WHICH MIGHT BE CDC, EPIDEMIOLOGISTS OR OTHER
RESPONDERS IN THE FIELD, PUBLIC HEALTH RESPONDERS FROM THE
ANIMAL HEALTH PERSPECTIVE AND THEN OTHER WHICH MAY INCLUDE
ANCILLARY STAFF ENTERING A LABORATORY WITH WORKING ON H 5
VIRUS. GIVEN THAT PERSONS AT INCREASED
RISK OF EXPOSURE OF H5N1 VIRUS ARE NARROWLY DEFINED WE WANT TO
HIGHLIGHT THE POPULATION. THIS SLIDE IS AN EFFORT TO DO
THAT WHERE WE ESTIMATE THE SIZE OF THE POPULATION AT INCREASED
RISK OF EXPOSURE. FOR LAB WORKERS WE KNOW THAT IN
2014 THERE ARE 173 PRINCIPLE INVESTIGATORS THAT HAVE A USDA
LICENSE TO WORK WITH VIRUSES. TALKING TO THE THREE PIs AT CDC
WE KNOW EACH HAS ABOUT 15 LAB STAFF.
THERE IS ABOUT TOTAL OF ABOUT 3,000 PEOPLE LABORATORY WORKERS
THAT MIGHT HAVE INTEREST IN BEING VACCINATED AND THEN PUBLIC
HEALTH RESPONDERS, ANOTHER GROUP.
YOU CAN SEE THE TOTAL POPULATION WE ARE TALKING ABOUT AT
INCREASED RISK OF EXPOSURE IS FAIRLY LOW AT ABOUT 3,000
PERSONS AND TWO DOSES PER VACCINE, 6,000 DOSES OF VACCINE.
WE ALSO WANTED TO QUANTIFY THE RISK OF AN EX EXPOSURE OF H5N1
VIRUS TO WEIGH THE RISKS AND BENEFITS.
IN THE UNITED STATES HIGHLY PATHOGENIC INFLUENZA VIRUSES ARE
REGULATED AND THEY REQUIRE ENTITIES IN THE UNITED STATES TO
DO THE FOLLOWING, AN INDIVIDUAL OR ENTITY MUST IMMEDIATELY
NOTIFY USDA OR CDC [ INAUDIBLE ] OR RELEASE OF SELECT AGENT OR
TOXIN OUTSIDE BARRIERS OF BIO CONTAINMENT AREA.
BETWEEN 2007 AND 2013 A REVIEW OF THE DATA SHOW THERE ARE 44
REPORTED INCIDENTS FOR AN AVERAGE OF SIX PER YEAR.
AND THE TYPES OF REPORTS INCLUDED THINGS LIKE NEEDLE
STICKS, ANIMAL BITES, LEAK, WORK OUTSIDE A CONTAINMENT FACILITY
OR SOME SORT OF EQUIPMENT OR PERSONAL PROTECTIVE EQUIPMENT
FAILURE. BUT I THINK IT IS IMPORTANT TO
COMMENT THTHAT AN INCIDENT DOEST NECESSARILY EQUATE TO AN
EXPOSURE. SO LOOKING AT THE DATA AND WHAT
WE KNOW ABOUT THE NUMBER OF LABORATORY WORKERS WE ESTIMATE
AN ANNUAL FREQUENCY OF LESS THAN 1% PER YEAR.
NONE OF THE REPORTED INCIDENTS RESULTED IN INFECTION.
NO PEOPLE GOT H5N1. SO TO SUMMARIZE THIS FIRST
PRESENTATION BACKGROUND H5N1 REMAINS A GLOBAL CONCERN AND HAS
HIGH MORTALITY. IN THE UNITED STATES THERE ARE
TWO LICENSED VACCINES, ONE OF WHICH IS BEING MADE POST
LICENSURE. THE TOTAL POPULATION AT
INCREASED RISK OF OCCUPATIONAL EXPOSURE IS SMALL.
THE DATA WE HAVE IS RISK OF TRANSMISSION IS 0 TO EXTREMELY
LOW. THERE ARE SOME LIMITATIONS.
LABORATORY EVENTS CERTAINLY COULD HAVE GONE UNREPORTED WHICH
WOULD HAVE UNDER ESTIMATED THE NUMBER OF INCIDENTS.
THAT REPORTING IS NOT RESTRICTED TO H5N1.
IT IS TO ALL HIGHLY PATHOGENIC. WE DON’T HAVE ANY SYSTEMATIC
DATA COLLECTION ON PUBLIC HEALTH RESPONDERS BUT WE KNOW THERE
HAVEN’T BEEN ANY INFECTIONS IN THOSE PUBLIC HEALTH RESPONDERS
IN THE UNITED STATES. SO I WOULD LIKE TO THANK A FEW
PEOPLE FOR HELPING TO PUT TOGETHER THE DATA.
AND I THINK I’LL JUST PAUSE HERE BEFORE WE GO ON TO THE NEXT SET. POINT OF CLARIFICATION OR
QUESTION? I WAS UNCLEAR ABOUT THE ISSUE
OF THE ADJUVANT VACCINES AND THE ISSUE OF NARCOLEPSY AND WHETHER
YOU WERE IMPLYING IT IS A VACCINE RELATED ISSUE.
>>I THINK WE DON’T KNOW WHAT THE ISSUE IS.
I DON’T KNOW IF ANYBODY FROM IMMUNIZATION SAFETY WANTS TO
ADDRESS THAT QUESTION. IMMUNIZATION SAFETY OFFICE.
SO THE FINDINGS HAVE REALLY BEEN OBSERVED IN THE MONOVALENT H1N1
VACCINE WIDELY USED IN EUROPE AND THEN THE ONE STUDY THAT DR.
SONJA OLSEN MENTIONED IN QUEBEC. THERE IS ADDITIONAL WORK GOING
ON LOOKING AT THE CDC SPONSORED STUDY LOOKING AT BOTH ASO 3
VACCINES THAT IS IN PROGRESS. WE SHOULD HAVE PRELIMINARY
RESULTS LATER IN 2015. I MAY HAVE MISSED IT.
IT SEEMS TO ME IN TERMS OF THE RECOMMENDATIONS HOW ONE MIGHT
VIEW THE VACCINE IT MAY BE IMPORTANT TO KNOW WHETHER IT IS
IN BULK AND WHAT THE SHELF LIFE CONTINUING TO HAVE STOCKPILES OF
THE VACCINE IS. CAN YOU COMMENT ON THAT?
>>SURE. RIGHT NOW EVERYTHING IS KEPT IN
BULK AT THE MANUFACTURER SEPARATED ANTIGEN AND ADJUVANT.
I THINK THERE IS STILL SOME IN TERMS OF THE SUPPLY AND I THINK
THERE ARE SOME THINGS THAT NEED TO BE WORKED OUT.
I WILL SAY THERE IS ALSO A PRECEDENT FOR THIS IN SOME OF
THE CLINICAL TRIALS THAT THE VACCINE HAS GONE TO NIH AND THEY
HAVE PREPARED THE VACCINE THERE AND DISTRIBUTED IT FROM NIH AND
AS I UNDERSTAND A MECHANISM IN PLACE THROUGH NIH FOR SOME OF
THE DELIVERY. I THINK SOME OF THE DELIVERY
ISSUES STILL NEED TO BE WORKED OUT.
>>JUST TO CLARIFY, MAYBE BRUCE CAN COMMENT ON THIS BUT I’M NOT
CLEAR WHAT THE COMMITMENT IS TO CONTINUING TO HAVE VALUABLE
VACCINES, WHAT THE SHELF LIFE IS AND WHETHER IT WILL BE REPLACED.
>>SO AS MENTIONED THE WAY THAT THE PANDEMIC STOCK PILE IS MADE
IS IN BULK SO THAT FORMULATION CAN OCCUR AT THE RIGHT
QUANTITIES WHEN THAT NEEDS TO HAPPEN.
THAT IS THE PLAN GOING FORWARD AND THERE IS NO END POINT TO
THAT RIGHT NOW. YOU HEARD THERE ARE A NUMBER OF
CLADES IN THAT STOCK PILE NOW HANDLED IN THE SAME WAY.
>>I THINK IF I RECALL CORRECTLY THAT THEY HAD SAID THAT IT’S
APPROXIMATELY LIKE A 12-MONTH SHELF LIFE BUT THEY REEVALUATE.
>>IN BULK IT DOESN’T HAVE A SHELF LIFE.
>>IT DOESN’T? SO IT IS ANTIGEN THAT CAN BE
THEN FORMULATED BASED ON THE CONTENT THAT IS NEEDED
AFTERWARDS. ONCE IT IS IN A VIAL THEN THE
CLOCK STARTS BUT WHAT’S IN THERE IS EVALUATED FOR STABILITY OVER
TIME. GIVEN THE NUMBER OF CLADES
AND WE ARE TALKING ABOUT ONE CLADE NOW, ARE THERE DATA ON
EITHER IN ANIMAL STUDIES OF CROSS PROTECTION OR ANT BODY
AGAINST DIFFERENT CLADES? WOULD THIS VACCINE FOR EXAMPLE
INDUCE ANTIBODY AS WELL AS ITS OWN CLADE?
>>IN THE NEXT PRESENTATION I WILL PRESENT SOME DATA.
ACTUALLY, THE DATA ON THE IMUNI
IMMUNITY IS IN EXTRA SLIDES THAT I WON’T BE PRESENTING.
THERE IS DATA. YES, THERE IS A RESPONSE, A
DIMINISHED RESPONSE. BUT IF YOU LOOK IN THE EXTRA
SLIDES YOU CAN SEE SOME OF THE DATA.
>>IT JUST DEPENDS WHICH VIRUS YOU ARE LOOKING AT.
>>JUST CURIOUS ABOUT THE ESTIMATE OF 2,600 LAB WORKERS
POTENTIALLY AND I WASN’T CLEAR, 2,600 PEOPLE WHO ARE ROUTINELY
ON A DAILY BASIS SORT OF HANDLING THIS PATHOGEN, WHAT IS
THE ESTIMATE AS FAR AS LEVEL OF EXPOSURE THESE PEOPLE HAVE?
>>THAT’S A GOOD QUESTION. WE ARE TRYING TO LOOK INTO THAT
A LITTLE BIT MORE. THESE ARE SORT OF ROUGH
CALCULATIONS BASED ON PEOPLE THAT AT SOME POINT WOULD HAVE —
WE JUST LOOKED AT THE THREE WHAT WE KNOW ABOUT THE PIs AT CDC.
WE HAVEN’T SURVEYED EVERYONE OR ANYTHING.
I THINK THERE IS A VARIABILITY IN TERMS OF HOW MUCH SOMEBODY
WORKS IN A LABORATORY. WE DON’T HAVE THAT INFORMATION
AT THIS POINT. THIS IS JUST A ROUGH
CALCULATION. I THINK WE CAN PROBABLY MOVE
ALONG TO THE DISCUSSION ON THE GRADING OF THE EVIDENCE.
>>THANK YOU. SO JUST TO RESTATE THE POLICY
QUESTION, SHOULD LICENSE INFLUENZA A H5N1 BE INTRODUCED.
THE FIRST THING THE WORK GROUP DID WAS DEFINE OUTCOMES OF
INTEREST. WE ENUM RATED OUTCOMES OF
INTEREST. AND THEN EACH MEMBER SCORED THE
OUTCOMES USING A NUMERIC SCORE WITH THE HIGHEST NUMBERS
ASSOCIATED WITH OUTCOMES THAT WERE CRITICAL DECISION MAKING,
LOWER THAT WERE IMPORTANT OR NOT IMPORTANT.
AND THEN WE SUMMARIZED THESE RANKINGS.
SO THESE ARE FIRST SAFETY OUTCOMES.
AND YOU SEE HERE WE HAVE SIX CRITICAL OUTCOMES ANY VACCINE
RELATED SERIOUS EVENTS. MORTALITY.
AND THEN IMPORTANT WERE GENERAL SYMPTOMS AND FEVER.
AND THEN LOW WHICH WE DON’T ADDRESS AGAIN WAS INJECTION SITE
REACTIONS. THESE ARE THE OUTCOMES.
I WILL JUST — THIS IS A LITTLE COMPLICATED.
THERE WERE IN TERMS OF THE TIME PERIOD THERE WAS 21 DAYS POST
SECOND VACCINATION OR SIX MONTHS POST SECOND VACCINATION AND THEN
OUTCOMES WHICH AS WE SORT OF MENTIONED EVENTS TO THE SAME
VIRUS IN THE VACCINE. AND IMMUNE RESPONSES TO A
DIFFERENT VIRUS. AND WE LOOKED AT SERO PROTECTION
WHICH IS SINGLE ANTIBODY. THESE ARE DEFINED USINGK
CRITERIA THAT THEY USE FOR LICENSURE.
SO THE TOP TWO WERE OUTCOMES THE GROUP THOUGHT WERE CRITICAL.
THE OUTCOMES AT THREE WEEKS POST SECOND VACCINE AND THE OTHERS
WERE ALL CONSIDERED IMPORTANT. SO THE NEXT STEP WAS TO DEFINE
WHAT DATA WE COULD REVIEW. TO DO THIS I THINK IT IS HELPFUL
TO UNDERSTAND WHAT VACCINES THERE ARE.
THESE ARE THE GSK H5N1 VACCINES. THEY ARE MANUFACTURED IN TWO
DIFFERENT PLACES. IT WOULD BE DIFFICULT TO
EXTRAPOLATE DATA FROM OTHER VACCINES FOR SEVERAL REASONS.
ONE IS WE HAVE A DIFFERENT MANUFACTURING PROCESS AND WE
DON’T KNOW WHAT IT MEANS IN TERMS OF INTERPRETING RESULTS.
THE ADJUVANT DIFFERS. FOR THOSE REASONS WE CHOSE TO
FOCUS ON THE VACCINE THAT WAS SPECIF
SPECIFIC, MAN AND WE ENDED UP WITH FOUR
STUDIES THAT WE LOOKED AT IN DETAIL.
SO THIS SLIDE I’LL TELL YOU THAT IN RED IS WHAT IS THE DEFINITION
OF THE LICENSURE CRITERIA. FULL DOSE OF ADJUVANT
ADMINISTERED AT DAY 0 AND 21. THE FULL CONTROL TRIAL WITH NO
PLACEBO LOOKING AT DIFFERENT DOSES, FULL VERSUS HALF AND
DIFFERENT MANUFACTURING SITES. THE SECOND IS THE RANDOMIZED
CONTROL TRIAL THAT DID HAVE THE PLACEBO.
THE THIRD IS A RANDOMIZED TRIAL WITH NO PLACEBO THAT WAS
COMPARING DIFFERENTDIFFERENT DO SCHEDULES.
YOU CAN SEE THEY ONLY LOOKED AT SAFETY.
REVIEWED THE DATA FROM ALL FOUR PAPERS.
EACH HAS A DIFFERENT QUESTION SO IT MAKES IT A LITTLE CONFUSING.
THE ONE STUDY THAT WAS DESIGNED TO ANSWER THE QUESTION WHICH WAS
VACCINE YES OR NO WAS THE PLACEBO CONTROLLED ONE.
THIS IS THE STUDY THAT WE HAVE GONE ON TO GRADE THE EVIDENCE.
I WILL PRESENT, HOWEVER, IN CASE YOU ARE INTERESTED, THE DATA
FROM ALL FOUR STUDIES ARE PRESENTED IN YOUR EXTRA SLIDES.
I’M NOT GOING TO GO THROUGH THOSE.
SO THE OUTCOMES, THIS SLIDE SHOWS OUTCOMES AVAILABLE FROM
THE ONE CONTROL TRIAL. YOU CAN SEE WE ARE MISSING
CRITICAL SAFETY OUTCOMES AND WE HAVE DATA ON ONLY THE IMMUNE
OLOGIC OUTCOMES. I WILL GO THROUGH THE FIRST
SLIDE IN MORE DETAILS TO ORIENT YOU TO THE TABLES AND THEN THEY
ARE THE SAME. WE ARE STARTING WITH TWO SAFETY
OUTCOMES THAT ARE CRITICAL. THESE ARE ANY VACCINE RELATED
AND MORTALITY. IN THE FIRST COLUMN IS STUDY
DESIGN. THESE ARE ALL RANDOMIZED CONTROL
TRIAL WITH ONE STUDY. AND THEN THERE ARE FOUR BIASES
THAT WE RATE EITHER NOT SERIOUS, SERIOUS OR VERY SERIOUS.
WHEN THEY ARE DOWNGRADED, FOR EXAMPLE HERE IS SERIOUS, WE PUT
THE REASON HERE. FOR ANY SERIOUS ADVERSE EVENT WE
DOWNGRADE BECAUSE THE SAMPLE SIZE IS TOO SMALL TO DETECT RARE
ADVERSE EVENTS. AND THEN HERE YOU HAVE THE
RELATIVE RISK AND THE RISK DIFFERENCE.
THIS IS VERSUS PLACEBO. AND THEN QUALITY OF EVIDENCE
DETERMINED BASED ON DOWNGRADINGS.
HERE IS ACTUAL DATA. IN THIS CASE THERE WERE ZERO IN
BOTH GROUPS. WE COULDN’T ESTIMATE THE DATA.
AND THEN THE QUALITY OF EVIDENCE WAS RATED MODERATE BECAUSE WE
DOWNGRADED HERE. SO FOR MORTALITY YOU CAN SEE
THERE WERE FEWER DEATHS IN THE VACCINATED GROUP THAN PLACEBO
GROUP. REDUCED RELATIVE RISK WITH FIVE
FEWER DEATHS PER 1,000 WITH QUALITY EVIDENCE OF HIGH.
EACH SLIDE WILL BE SIMILAR AND I WILL JUST GO THROUGH THEM FAIRLY
FAST. SO THESE ARE THE SAFETY OUTCOMES
THAT WERE LISTED AS IMPORTANT, FATIGUE, HEADACHE, JOINT PAIN.
THERE ARE THREE SLIDES OF THESE. IMPORTANT SAFETY OUTCOMES.
IN THIS CASE ALL OF THESE VACCINATED GROUP HAD A SLIGHTLY
ELEVATED RISK FOR THESE SAFETY OUTCOMES.
AND FOR EACH OF THESE WE FELT THAT THE DATA WERE GOOD AND THAT
THE QUALITY OF EVIDENCE WAS HIGH.
THIS SLIDE GOES ON TO SHOW MUSCLE ACHES, SHIVERING AND
SWEATING. FOR MUSCLE ACHES AND SHIVERING
YOU CAN SEE, AGAIN, IT WAS SIGNIFICANTLY INCREASED RISK BUT
WE FELT THAT THE QUALITY OF THE EVIDENCE WAS HIGH.
FOR SWEATING WE DOWNGRADED IT BECAUSE IT WAS INCLUDING ONE.
THERE WAS NO DIFFERENCE FOUND HERE BETWEEN THE TWO GROUPS.
AND CONSIDERED THE EVIDENCE AS MODERATE.
AND THEN THE LAST OF THE IMPORTANT SAFETY OUTCOMES,
SYNCOPE AND FEVER. WE DOWNGRADED SYNCOPE FOR VERY
SERIOUS BECAUSE OF THE INABILITY TO DETECT RARE EVENTS WITH A
RELATIVE RISK OF ONE AND BECAUSE WE DOWNGRADED THE EVIDENCE THE
QUALITY WAS RANKED AS LOW. AND THEN FOR FEVER NO DIFFERENT.
YOU CAN SEE THE FREQUENCY OF FEVER AND THE EVIDENCE WAS RATED
AS MODERATE. SO MOVING ON TO THE IMMUNEOLOGIC
OUTCOMES. YOU WANT TO SEE RELATIVE
ELEVATED RISK. THIS IS THE 21 DAY CONVERSION.
WITH BOTH OF THESE WE DIDN’T HAVE ANY CONCERNS ABOUT THE
QUALITY OF THE DATA. YOU CAN SEE THE ELEVATED
RELATIVE RISK AND THE FREQUENCY OF PROTECTION AND CONVERSION.
YOU CAN SEE VERSUS THE PLACEBO. WE VOTED THE QUALITY OF EVIDENCE
AS HIGH. AND THEN THE OUTCOMES THAT WERE
RANKED AS IMPORTANT, THESE ARE JUST THE SAME TWO BUT AT THE
SIX-MONTH TIME POINT. THESE WERE A SUBSET OF THE
ORIGINAL SAMPLE SIZES. WE HAVE DOWNGRADED BECAUSE WE
HAVE A SMALLER SAMPLE SIZE HERE WE GET A WIDE INTERVAL.
YOU CAN SEE IN THE GROUP HERE AND HERE THAT AT SIX MONTHS YOU
HAVE A DIMINISHED IMMUNE RESPONSE BY BOTH MEASURES.
SO OVERALL THE QUALITY OF EVIDENCE WE RATED AS MODERATE.
SO THE NEXT TWO TABLES JUST SUMMARIZE THE DATA SO YOU CAN
SEE THEM ALL TOGETHER. AGAIN, THIS IS THE SAFETY, THE
HARM COMPARISON VERSUS PLACEBO. OF THE SIX CRITICAL OUTCOMES WE
ONLY HAD DATA ON TWO. OVERALL THE EVIDENCE TYPE IS
RATED BASED ON THE CRITICAL OUTCOMES FOR WHICH YOU HAVE
DATA. SO YOU LOOK AT THESE TWO AND SO
THE OVERALL EVIDENCE TYPE IS MODERATE.
YOU CAN SEE WE ARE MISSING DATA ON ALL OF THE OUTCOMES.
HERE YOU CAN SEE THE IMPORTANT ONES AND JUST THE SUMMARY OF HOW
THEY WERE RANKED. SIMILARLY, THIS IS THE EVIDENCE
TABLE FOR THE BENEFITS. WE ARE MISSING ANY OF THE
OUTCOMES. WE HAVE INCREASED RESPONSE TO
THE VACCINE FOR BOTH THE TWO CRITICAL AND TWO IMPORTANT
OUTCOMES. BECAUSE THESE WERE RANKED AS
HIGH EVIDENCE TYPE OVERALL WE SAY THE QUALITY OF EVIDENCE WAS
HIGH. SO IN ADDITION TO THESE GRADE
DATA THERE ARE ADDITIONAL CONSIDERATIONS FOR FORMULATING
ANY RECOMMENDATIONS. SO THE FIRST IS TO CONSIDER THE
BALANCE BETWEEN THE BENEFITS AND THE HARMS.
I HAVE LISTED POINTS HERE THAT THE WORK GROUP CONSIDERED THAT
THESE — WE BASED ALL OF THIS ON A SINGLE STUDY.
THE BENEFITS MAY NOT BE GENERALIZABLE AS WAS MENTIONED
BEFORE BECAUSE OF CLADE EVOLUTION.
THERE IS NO DATA ON EFFICACY. IT IS NOT POSSIBLE.
AND WE KNOW THAT THERE IS A LOW EXPOSURE RISK AND A LOW OR ZERO
TRANSMISSION RISK. THESE ARE THINGS THAT THE WORK
GROUP WEIGHED. OVERALL THE EVIDENCE TYPE WAS
LOW FOR SAFETY AND HIGH. WE DON’T HAVE DATA ON HOW THE
TARGET GROUP VALUES THE OUTCOMES BUT WE DOKNOW THAT THE TARGET
GROUP IS A FEW PEOPLE. IT’S PROBABLY AN ESTIMATE OF
LESS THAN 3,000 PEOPLE IN THE UNITED STATES.
AND THEN USUALLY THESE ANALYSIS TAKE INTO ACCOUNT HEALTH
ECONOMICS DATA WHICH ISN’T REALLY RELEVANT HERE BECAUSE THE
U.S. GOVERNMENT IS PAYING FOR THE VACCINE SO IT WASN’T
CONSIDERED. SO THIS IS THE LAST SLIDE.
THIS IS WHAT THE WORK GROUP PUTS FORWARD FOR CONSIDERATION.
IT’S JUST FOR DISCUSSION TODAY, BUT A — THIS SHOULD BE ACTUALLY
18 OR OLDER THERE SHOULD BE A LINE UNDER HERE.
SO THE GROUP RECOMMENDS A CATEGORY B RECOMMENDATION ADULTS
WITH INCREASED RISK MAY RECEIVE INFLUENZA A H5N1 FOR INCREASED
PROTECTION. THE INTERVENTION BEING TWO DOSES
ADMINISTERED 21 DAYS APART AND OCCUPATIONAL EXPOSURE DEFINED AS
LABORATORY WORKERS WHO HAVE CONTACT OR WORK WITH LIVE VIRUS
OR CLINICAL SAMPLES FROM SUSPECTED CASES, EXPERIMENTAL
ANIMAL WORKERS WITH CONTACT. PUBLIC HEALTH RESPONDERS
INVESTIGATING OR MANAGING SUSPECTED OR CONFIRMED CASES,
PUBLIC HEALTH RESPONDERS INVESTIGATING OR MANAGING
SUSPECTED AVIAN OR OTHERS WHO WORK IN LOCATIONS WHERE EXPOSURE
TO H5N1 VIRUS COULD OCCUR. OPEN IT FOR QUESTIONS.
>>COULD YOU CLARIFY WHEN THE ADDITIONAL SAFETY DATA WILL BE
AVAILABLE AND WHETHER IT WILL CONTAIN ALL OF THE CRITICAL
ELEMENTS THAT WE LACK RIGHT NOW? WE DON’T ANTICIPATE ANYMORE
DATA BEING AVAILABLE. THERE WILL BE DATA FROM THE CDC
SPONSORED NARCOLEPSY STUDY. THAT WILL BE READY IN 2015.
THERE IS NOT ENOUGH — TO GET TO SEE MOST OF THE RARE OUTCOMES
YOU HAVE TO VACCINATE A LOT OF PEOPLE.
THAT’S NOT GOING TO HAPPEN. WE DON’T ANTICIPATE MORE DATA.
>>YOU CLARIFY WHAT THE ADDITIONAL DATA — THE CDC WILL
BE GETTING? SPECIFICALLY WITH RESPECT TO
ASO 3 DATA? I DON’T UNDERSTAND WHAT THE
ADDITIONAL DATA THAT WAS DISCUSSED THAT THE CDC IS
COLLECTING REGARDING SAFETY IS ABOUT.
>>SO I THINK THAT ESSENTIALLY THERE ARE NO OTHER DATA SPECIFIC
TO THIS VACCINE THAT WE WILL GET, THAT WE ANTICIPATE AT ANY
POINT. THERE WILL BE ADDITIONAL DATA
FROM THE CDC SPONSORED STUDY LOOKING AT VACCINES FROM THE
PANDEMIC THAT WERE ADJUVANTED WITH THE SAME AND THOSE ARE
EXPECTED IN 2015. THERE WON’T BE MORE DATA
SPECIFICALLY WITH H5N1 VACCINES. SO THE CDC SPONSORED STUDY ON
NARCOLEPSY IS LOOKING AT 2009 MONOVALENT H1N1 VACCINE.
THAT IS GOING BACK AND LOOKING AT OTHER COUNTRIES OUTSIDE OF
EUROPE THAT USED ADJUVANTED VACCINES.
THAT DATA WILL BE AVAILABLE PROBABLY TOWARDS THE END OF
2015. THAT’S NOT THE VACCINE THAT SHE
IS DISCUSSING. THAT’S PANDEMIC VACCINE.
>>THANK YOU. TWO FOR CLARIFICATION.
IN THE MAIN TRIAL IS THE PLACEBO RECIPIENTS DID THEY RECEIVE
ADJUVANT AS PART OF PLACEBO. IS THIS PURIFIED VACCINE WITH
THE AMOUNT INDICATED? I CAN’T REMEMBER WHAT WAS IN
THE PLACEBO. AND PERHAPS THE MANUFACTURER
WILL HAVE TO CALL IN THAT. IT’S — YOU WANT TO COMMENT ON
THAT? YES.
THE PLACEBO DID NOT RECEIVE ANY ADJUVANT.
THIS IS A SPLIT VACCINE SIMILAR TO SEASONAL VACCINES USED IN
THIS CASE FOR H5N1. DR. ART REINGOLD.
>>AS I UNDERSTAND CORRECTLY IN THE FEBRUARY MEETING WE WILL BE
ASKED TO VOTE ON THIS IN TERMS OF RECOMMENDATION FOR USE OF THE
VACCINE? IS THAT CORRECT?
>>YES. I’M CURIOUS IF THESE ARE
DRAFT RECOMMENDATIONS I’M SURE YOU KNOW SAGE FOR W.H.O. WENT
THROUGH A LENGTHY SIMILAR PROCESS IN TERMS OF PANDEMIC
VACCINE AND I WAS ON THE WORKING GROUP AND I FOUND THIS A
DIFFICULT DISCUSSION. ONE OF THE THINGS DISCUSSED WAS
STORAGE OF THE VACCINE IN HUMANS, LARGE NUMBERS OF
INDIVIDUALS WITH FIRST DOSE IF THERE WAS A PANDEMIC YOU ONLY
GIVE ONE ADDITIONAL DOSE TOSE I PROTECTION AS OPPOSED TO HAVING
TO DISPOSE OF LARGE QUANTITIES OF VACCINE WHEN IT REACHED THE
END OF THE SHELF LIFE. I’M CURIOUS WHETHER ANY — AND
THERE IS DISCUSSION ABOUT POTENTIALLY OTHER POPULATIONS
WHO MIGHT WANT TO PROTECT IN THE EVENT OF A PANDEMIC, NOT JUST
THIS VERY LIMITED GROUP BUT A MUCH LARGER GROUP OF
INDIVIDUALS. I’M CURIOUS, IT SOUNDS LIKE AS A
POLICY YOU GUYS HAVE ALREADY PRETTY MUCH FOCUSED ON THIS
GROUP. I’M CURIOUS IF THERE WAS A WIDER
DISCUSSION ABOUT THE POTENTIAL USE OF THE VACCINE AND WHETHER
WE WILL BE HAVING THAT DISCUSSION OR NOT.
>>IT WAS ONLY CONDITIONALLY DISCUSSED BECAUSE WE WERE
FOCUSED ON THIS QUESTION AND DIDN’T WANT TO GET SIDE TRACKED.
I THINK MAYBE ADDITIONAL QUESTION FOR THE GROUP.
AS YOU KNOW I THINK ULTIMATELY THE SAGE RECOMMENDATIONS AT
LEAST AT THAT TIME THERE WASN’T ENOUGH DATA TO RECOMMEND
PRIMING. SO THIS IS SORT OF COMING
BACK TO MY PREVIOUS QUESTION GIVEN THIS IS LIKELY TO COME UP
AS RECOMMENDATION THERE IS A SPECTRUM OF POTENTIAL EXPOSURE,
PEOPLE WHO HAVE RARE EXPOSURE OR FREQUENT EXPOSURE.
I THINK GIVEN THE UNCERTAINTIES AND THE LIMITED AMOUNT OF DATA
AVAILABLE RIGHT NOW REGARDING SAFETY IT WOULD BE HELPFUL TO
CLARIFY THAT YOU ARE LOOKING AT PEOPLE WHO HAVE REPEATED
FREQUENT. THERE AREN’T ANY DATA TO LOOK
AT AND THERE ARE NO TRANSMISSION EVENTS.
IT IS HARD TO PUT DATA AROUND THAT.
AND THE W.H.O.’S RECOMMENDATIONS DO TALK ABOUT WORK WITH LARGE
AMOUNTS OF VIRUS OR EXTENDED PERIOD OF TIME BUT DON’T
QUANTIFY ANY OF THAT. SO OUR GROUP DECIDED IT WAS TOO
NEBULOUS AND WOULD BE CLEARER TO JUST SAY YOU WORK WITH IT OR
DON’T WORK WITH IT. IT IS SOMETHING THE WORK GROUP
CAN DISCUSS AGAIN AND CONSIDER. I WANT TO GO BACK TO THE
QUESTION ABOUT THE SIZE OF THE SAFETY DATABASE.
I WANT TO MAKE SURE THAT WE HAVE MADE KNOWN WHEN WE APPROVED THE
MANUFACTURER IS REQUIRED TO EVALUATE THE VACCINE IN
CHILDREN. SO THERE ARE REQUIREMENTS FOR
ADDITIONAL STUDIES AND MAYBE THE COMPANY CAN COMMENT ON WHAT
ADDITIONAL SAFETY DATAS ARE AVAILABLE FOR THOSE
REQUIREMENTS. THANK YOU.
GO AHEAD. IF YOU COULD CLARIFY A LITTLE
MORE ABOUT WHAT YOU MEAN BY PUBLIC HEALTH RESPONDERS.
WE HAVE ONE COLLEAGUE ON MY CAMPUS WHO EMERGING
VIRAL DISEASES. I DON’T KNOW IF HE WORKS WITH
H5N1 BUT LET’S ASSUME HE DOES OUR POLICY IS IF ONE OF THOSE
WORKERS BECOMES ILL THEY WILL COME TO OUR HOSPITAL EMERGENCY
DEPARTMENT AND BE EVALUATED. WOULD THAT INCLUDE OUR 300
MEMBERS IN OUR EMERGENCY DEPARTMENT CARE TEAM TO TAKE
CARE OF HIM. CAN YOU SHARE FOCUS ON WHAT YOU
MEAN BY PUBLIC HEALTH RESPONDERS.
>>WHAT THIS GROUP INCLUDES ARE PEOPLE WHO ARE U.S. PEOPLE WHO
GO TO A PLACE TO INVESTIGATE. SO IF YOU ARE GOING TO INDONESIA
TO INVESTIGATE A CLUSTER OF ILLNESS IN HUMANS OR A POULTRY
DIE OFF THAT IS H5N1 THOSE ARE THE TYPES OF PEOPLE WE ARE
TALKING ABOUT. BECAUSE THERE ARE NO CASES IN
THE UNITED STATES WE ARE NOT TALKING ABOUT HEALTH CARE
WORKERS OR FIRST RESPONDERS IN THE UNITED STATES.
WE ARE ONLY TALKING ABOUT THOSE WHO MIGHT GO TO A SITUATION.
WE UNDERSTAND IT IS A FLUID SITUATION AND THAT IN THE FUTURE
COULD CHANGE. THANK YOU.
>>I HAVE DR. BENNETT, MS. PELIGRINI.
>>I WANTED TO CLARIFY ONE THING.
I WAS INTRIGUED BY THE FIVE FOLD REDUCTION IN MORTALITY IN THE
VACCINATED GROUP THAT WAS SIGNIFICANT.
I PRESUME YOU THINK THAT IS A STATISTICAL ARTIFACT OF MULTIPLE
THINGS. IS THERE ANY BIOLOGIC
PLAUSIBILITY TO THAT? AND THE SECOND IS A NUMBER OF US
INVOLVED IN RESEARCH STUDIES DOING SURVEILLANCE FOR INFLUENZA
BOTH DOMESTICALLY AND ABROAD. UNLESS IT IS HIGH RISK H5N1
THOSE PEOPLE WOULD NOT FIT INTO THE RISK CATEGORY FOR GETTING
THE VACCINE, IS THAT CORRECT? RIGHT.
THE SECOND ANSWER, THAT IS CORRECT.
WHAT WAS THE FIRST ONE AGAIN? THE FIRST ONE IS AS I READ
YOUR DATA YOU HAVE A FIVE FOLD REDUCTION IN MORTALITY THE
VACCINATED GROUP. THESE ARE NOT VACCINE
ASSOCIATED DEATHS. THESE ARE JUST MORTALITY THAT
HAPPENED IN THE STUDY. MOST OF THESE ARE OLDER PERSONS.
WE CAN’T SAY FOR SURE THAT IT IS — IT DIDN’T RAISE CONCERNS
IN THE WORK GROUP. IT SHOULD DO THE OPPOSITE.
THE QUESTION IS THERE — DR. BENNETT.
>>TO FOLLOW THE QUESTIONS THAT WERE PREVIOUSLY ASKED.
I WANT TO POINT OUT THAT NOT THAT LONG AGO WE VACCINATED A
LOT OF PEOPLE IN THIS COUNTRY AGAINST SMALLPOX.
THE SIMILAR. I DON’T THINK YOU INTEND THAT
BUT IT MAY BE USEFUL TO MORE DEEPLY DESCRIBE WHAT YOU MEAN BY
PUBLIC HEALTH RESPONDERS. I THINK THERE IS A LOT OF
OPPORTUNITY FOR MISINTERPRETING THAT THE WAY IT IS WRITTEN.
>>THANK YOU. THANK YOU.
THINKING ABOUT THE PUBLIC HEALTH RESPONDERS THAT MAY GO OUT TO
SEVERAL OUTBREAKS AND LABTORIANS THAT HAVE FREQUENT AND REPEATED
EXPOSURES I AM CONCERNED OR INTERESTED IN THE ANTICIPATED
DURATION OF IMMUNITY. ARE YOU THINKING ABOUT A
ONE-TIME IMMUNIZATION OR PEOPLE WHO HAVE FREQUENT AND REPEATED
EXPOSURES OVER TIME, WILL THEY BE REIMMUNIZED?
>>I THINK THAT’S A GOOD QUESTION AND IT IS NOT ONE THE
GROUP ADDRESSED. YOU KNOW, WE DID LOOK AT
INTENTIONALLY AT THE SIX MONTH OUTCOMES.
WE SEE THE IMMUNE RESPONSES DIMINISH
DIMINISHED. WE DON’T HAVE LONGER OUTCOMES TO
LOOK AT SO WE DON’T HAVE DATA TO ASSESS THAT.
SO WE DIDN’T — WE HAVEN’T ADDRESSED IT.
>>AND IF I’M NOT MISTAKEN I THINK THE COMPANY REPRESENTATIVE
MAY HAVE ADDRESSED THAT. COULD WE HEAR MORE ABOUT THAT
FOR A MOMENT? PEDIATRIC STUDY UP TO THE 17
YEARS OF AGE HAS BEEN CONDUCTED. THE COMPANY HAS SHARED THE
INFORMATION RECENTLY WITH THE FDA AND DISCUSSIONS ARE IN PLACE
TO AMEND IN THE FUTURE TO INCLUDE LICENSE INDICATION DOWN
BELOW THE CURRENT AGE OF 18. ONE COMMENT AND ONE QUESTION.
THE COMMENT WHEN YOU SAID THAT THE HEALTH ECONOMIC ANALYSIS IS
NOT RELEVANT, PAID FOR BY THE U.S. GOVERNMENT I WOULD DISAGREE
WITH THAT. IT IS THE COST OF THE VACCINE
WITH $10 A DOSE THAT DOES COME DOWN TO RELEVANCE FOR ME, AT
LEAST. THE OTHER QUESTION IS THE GROUPS
YOUOU HAVE HERE, IF WE DON’T HA ANY EVIDENCE OF LABORATORY
TRANSMISSION, WE ONLY HAVE 46 EXPOSURES, DO LABORATORY WORKERS
NEED IT. IT HAS NEVER BEEN DONE, DO WE
NEED TO BE PROTECTING THEM OR IS THERE THEORETICAL RISK?
ARE ANIMALS WORKERS MORE AT RISK THAN LABORATORY WORKERS?
THOSE THINGS HAVEN’T BEEN WORKED OUT.
>>I THINK THE WORK GROUP CAN DISCUSS THE COST EFFECTIVENESS.
I APPRECIATE WHAT YOU ARE SAYING THERE.
YOU’RE CORRECT. THERE ARE NO CASES, KNOWN CASES
OF TRANSMISSION IN EITHER PUBLIC HEALTH RESPONDER OR LABORATORY
WORKER. AND I THINK THAT’S WHAT
CONTRIBUTED TO THE RECOMMENDATIONS OF CATEGORY B AS
OPPOSED TO A. CERTAINLY SOMETHING THE GROUP
CAN DISCUSS FURTHER. FOLLOWING UP ON THAT I DON’T
REMEMBER DISCUSSION BUT DO YOU KNOW IF FOR THE LABORATORY
BREACHES IF THERE IS JUST ROUTINE ADMINISTRATION OF
ANTIVIRAL? IS THERE REPORT OF THAT?
>>I CAN’T SPEAK FOR ALL OF THEM.
I DO KNOW AT LEAST RECENT ONES I HAVE HEARD ABOUT THAT DOES
HAPPEN. SOME PEOPLE LOOKED FOR
GUIDANCE. THIS DOES NOT APPEAR TO PROVIDE
MUCHGOIDANCE. IT JUST SAYS MAY BE SEEN.
I’M NOT SURE WHAT THAT MEANS. HAS THERE BEEN CONSIDERATION TO
MAKING CLEAR DOCUMENT IN TERMS OF WHAT WE ARE RECOMMENDING?
>>IF I CAN RESPOND, WE HAD THE OPTION OF THE CATEGORY A
RECOMMENDATIONS WHICH USE LANGUAGE SUCH AS IT SHOULD
RECEIVE. IN THIS ONE IT WAS AN AREA OF A
LOT OF DELIBERATION WITH THE WORK GROUP AND FELT THAT
CATEGORY B WAS APPROPRIATE FOR INDIVIDUAL CLINICAL DECISION
MAKING BASED ON ONE’S OWN EXPOSURE, ONE’S OWN CONCERN
ABOUT THAT EXPOSURE AND COMING DOWN WITH THIS.
AND PLUS ALL OF THE UNKNOWNS IN TERMS OF THE RISKS AND LONG TERM
BENEFITS. WE FELT IT CAME DOWN IN THE
CATEGORY B. SUFFICE IT TO SAY THAT WE
DESTAIN THE CATEGORY B RECOMMENDATIONS WE FELT THIS ONE
WAS ACTUALLY APPROPRIATE HERE. SO JUST FOLLOWING UP ON THAT,
THE KEY HERE IS GOING TO BE THE RISK BENEFIT INFORMATION GIVEN
TO PEOPLE. THIS IN ITSELF JUST ALLOWS
PEOPLE TO GET IT. BUT THE KEY WILL BE GETTING THE
RISKS AND BENEFITS DOWN TO SOME KIND OF A REASONABLE ONE PAGER.
>>WE APPRECIATE THE DISCUSSION HERE BECAUSE THAT IS ALL
INFORMATION THAT CAN GO BACK TO THE WORK GROUP FOR FURTHER
DISCUSSION AND MODIFICATION PRIOR TO FEBRUARY.
ARE THERE ANY OTHER COMMENTS OR QUESTIONS?
WE WILL MOVE ON TO THE PERTUSSIS DISCUSSION AND DR. ART REINGOLD.
>>SO WE WILL TRY TO KEEP THIS BRIEF AND KEEP BEING BACK ON
TIME. FIRST TO ACKNOWLEDGE THE WORK OF
THE WORKING GROUP MEMBERS. I KATHIE IS WORKING IN EBOLA IN
WEST AFRICA. I HOPE SHE HAS THE WISDOM TO
RETURN TO CALIFORNIA RATHER THAN OTHER POSSIBLE AIRPORTS.
WE MAY SEE HER SOONER IN THAT EVENT.
I WANT TO ACKNOWLEDGE THE WORK OF JENNIFER LIANG WHO DOES THE.
THERE ARE A NUMBER OF STATEMENTS ABOUT THE USE OF PERTUSSIS
VACCINES. FOUR OF THEM AT THE MOMENT AND
THE WORKING GROUP IN CHARGE OF CONSOLIDATING THEM INTO A SINGLE
STATEMENT IN ADDITION TO REVIEWING NEW DATA.
TO REVIEW AND UPDATE IN THE UNITED STATES.
THEY ARE BOTH LICENSED FOR SINGLE USE.
THE CURRENT RECOMMENDATIONS FOR TDAP ARE FOR A SINGLE DOSE FOR
AGES 11 AND OLDER. PREGNANT WOMEN ARE RECOMMENDED.
AND THIS IS OBVIOUSLY DESIGNED TO PROVIDE PASSIVE PROTECTION TO
THE NEWBORN BABY. AND THEN ADDITION.
THESE ARE DATA ABOUT COVERAGE WITH TDAP.
WE ACHIEVE HIGH LEVELS OF COVERAGE WITH INFANT
IMMUNIZATION. WE DO FAIRLY WELL WITH
ADOLESCENT DOSE BUT WE ARE NOT DOING VERY WELL IN TERMS OF
COVERAGE ADULTS. THE GREEN LINE SHOWS WE ARE NOT
DOING VERY WELL WITH THE RECOMMENDATION.
MY UNDERSTANDING FROM JENNIFER IS 15%.
SO WE ARE NOT DOING WELL AT THE MOMENT WITH ACHIEVING COVERAGE
IN THAT GROUP EITHER. THIS IS SOMETHING THAT THE
OFFICE HAS BEEN FOLLOWING FOR QUITE SOME TIME.
BASICALLY THE DATA SINCE THE UPDATE IN FEBRUARY.
THERE HAVE BEEN A NUMBER OF REPOR
REPORTS. I KNOW THAT I THINK SOMEONE IS
HERE FROM THE SAFETY OFFICE WHO CAN COMMENT MORE ON THIS.
BASICALLY AS I SEE IT THERE ARE NO SIGNALS.
WE CAN CERTAINLY TALK MORE ABOUT THAT.
THERE ARE OTHER ACTIVITIES GOING ON TO MONITOR SAFETY IN THE
CONTEXT. IN ADDITION TO THE SYSTEM IT IS
INVOLVED IN CONTINUING ANALYSIS THE SESA PROJECT IS ALSO DOING A
STUDY OF SAFETY IN PREGNANT WOMEN.
I THINK THE WORKING GROUP HAS ALSO ASKED TO SEE WHETHER OR NOT
THERE MIGHT BE OTHER SOURCES OF DATA POTENTIALLY WITHIN THE
MILITARY OR OTHER GROUPS THAT MIGHT HAVE A LARGE EXPERIENCE
WITH USE OF THE VACCINE IN PREGNANCY, AND WE’RE TRYING TO
MAINTAIN AS MUCH AWARENESS OF WHAT’S HAPPENING IN PREGNANCY AS
POSSIBLE. NOW, IN JUNE OF 2013, WHICH WAS
BEFORE I JOINED THE GROUP, THIS WAS PRESENTED TO THE ACIP.
THERE WAS A RECOGNITION OF AN INCREASING BURDEN OF PERTUSSIS.
YOU ALL ARE AWARE OF THE FACT THAT WE HAVE A SUBSTANTIAL
BURDEN OF PERTUSSIS NATIONALLY. PRETTY GOOD EVIDENCE THAT THE
SECOND DOSE OF TDAP IS FACING IMMUNOGENIC, VERY GOOD EVIDENCE
THAT PROTECTION WANES AFTER A NUMBER OF YEARS, CLINICAL
PROTECTION DOES WANE. BUT IN FACT, AT LEAST ONE MODEL
THAT HAS NOT YET BEEN PUBLISHED, BUT A MODEL THAT’S SHOWED THAT A
SECOND DOSE OF TDAP WOULD REALLY HAVE ONLY A VERY, VERY LIMITED
EFFECT IN TERMS OF REDUCING DISEASE BURDEN.
AND THIS IS JUST ONE GRAPH TAKEN FROM THAT.
THIS IS YET UNPUBLISHED, ALTHOUGH THERE IS A MANUSCRIPT.
AND WHAT IT BASICALLY SHOWS IS THAT WHILE ONE DOSE OF TDAP AT
11 OR 12 YEARS OF AGE HAS A SUBSTANTIAL IMPACT ON THE NUMBER
OF PERTUSSIS CASES, THAT ADDING A SECOND DOSE EITHER AT 16 YEARS
OF AGE OR 21 YEARS OF AGE, THOSE ARE THE — BASICALLY, YOU CAN
SEE THAT THE THREE BOTTOM LINES ARE VIRTUALLY SUPERIMPOSABLE,
AND THAT THERE, IN FACT, WOULD BE VERY LIMITED BENEFIT TO
ADDING ADDITIONAL BOOSTERS AFTER THE BOOSTER AT — THE DOSE AT
11. SO, AT LEAST AT THE JUNE 2013
MEETING, IT WAS CONSIDERED THAT A SECOND DOSE OF TDAP WOULD HAVE
LIMITED PUBLIC HEALTH IMPACT. NO CHANGE WAS RECOMMENDED IN
TERMS OF THE RECOMMENDATION, EXCEPT TO FOCUS ON PREVENTING
PERTUSSIS IN INFANTS BY MAKING SURE THAT PREGNANT WOMEN RECEIVE
A DOSE IN EVERY PREGNANCY, BUT THAT IN ADDITION, THERE WAS
CLEARLY A NEED TO CONTINUE TO LOOK AT THE ISSUE OF USE OF THE
VACCINE, BOTH IN HEALTH CARE WORKERS IN THE CONTEXT OF
OUTBREAKS IN PARTICULAR, AND PERHAPS AMONG CLOSE CONTACTS OF
INFANTS. SO, IN TODAY’S SESSION, JENNIFER
IS GOING TO PRESENT SOME INFORMATION AROUND TDAP VACCINE,
ABOUT THE ISSUE OF PERTUSSIS IN HEALTH CARE PERSONNEL, ABOUT THE
POTENTIAL IMPACT OF VACCINATING HEALTH CARE PERSONNEL AND WHERE
THE WORKING G AT THE MOMENT WITH REGARD TO ITS
CONSIDERATIONS OF THESE ISSUES. SO, LET ME TURN IT OVER TO
JENNIFER. THANK YOU.
>>THANK YOU. SO, AS DR. REINGOLD NOTED, ACIP
MADE CONSIDERATIONS OVER A YEAR AGO FOR A SECOND DOSE OF TDAP TO
THE GENERAL POPULATION BUT DID NOT MAKE CHANGES TO THE CURRENT
RECOMMENDATION. SO, SINCE THEN, THE WORK GROUP
CONSIDERED TDAP VAC FACE OF HEALTH CARE PERSONNEL AND
EVALUATED THE NEED FOR AND POTENTIAL IMPACT OF ADDITIONAL
DOSES OF TDAP. FOR TODAY’S DISCUSSION, I WILL
PRESENT A SUMMARY OF THESE DATA AND THE WORK GROUP’S
CONCLUSIONS. CURRENTLY, BOTH TDAP VACCINES
ARE LICENSED ONLY FOR A SINGLE DOSE, AND AS PREVIOUSLY REVIEWED
BY ACIP, A SINGLE DOSE OF TDAP IS SAFE AND IMMUNOGENIC.
THERE ARE SEVERAL PUBLISHED CLINICAL TRIALS FROM OTHER
COUNTRIES ON A SECOND DOSE OF TDAP AT FIVE OR TEN YEARS AFTER
THE FIRST DOSE. REPORTED ADVERSE EVENTS WERE
GENERALLY COMPARABLE TO THOSE AFTER THE FIRST TDAP.
THE MAJORITY OF LOCAL AND SYSTEMIC ADVERSE EVENTS WERE
MILD TO MODERATE AND SELF-LIMITED.
A FEW SERIOUS ADVERSE EVENTS REPORTED.
NONE WERE DETERMINED TO BE RELATED TO THE RECEIPT OF THE
SECOND TDAP. SAFETY PROFILES WERE COMPARABLE
AT THE FIVE AND TEN-YEAR INTERVAL.
FOR IMMUNOGENICITY AFTER RECEIPT OF A SECOND TDAP, TETANUS AND
DIPTHERIA ARE ESSENTIALLY 100% PROTECTED.
FOR PERTUSSIS, RESPONSES ARE SIMILAR AT FIVE AND TEN-YEAR
INTERVALS AND RESPONSES ARE COMPARABLE TO HISTORIC AND
CONTEMPORANEOUS FIRST DOSE. AFTER A SINGLE DOSE OF BOOSTRIX,
SIMILAR CURVES ARE OBSERVED FOR THREE YEARS FOR THE THREE
PERTUSSIS AN JENS. RESPONSE TO A SECOND BOOSTRIX
AFTER A TEN-YEAR INTERVAL IS ALSO SHOWN.
RESPONSE TO THE SECOND DOSE WAS SIMILAR TO THE RESPONSE AFTER
THE FIRST AT A TEN-YEAR INTERVAL, AND ALTHOUGH NOT
SHOWN, A SECOND DOSE OF ADACEL AT A TEN-YEAR INTERVAL ALSO
SHOWED SIMILAR RESPONSE AFTER A FIRST DOSE.
FOR ADACEL, AFTER A FIVE-YEAR INTERVAL, RESPONSE TO A SECOND
TDAP WAS ROBUST BUT WAS LOWER COMPARED TO THE RESPONSE AFTER
THE FIRST DOSE. BUT AT FIVE YEARS, PLEASE NOTE
THE BASELINE FOR PERTUSSIS ANTIBODIES BEFORE A SECOND TDAP
WERE HIGHER. IN THE UNITED STATES, BOTH
PHARMACEUTICAL COMPANIES ARE CONDUCTING CLINICAL TRIALS OF A
SECOND DOSE OF TDAP. THE U.S. STUDY FOR ADACEL IS
COMPLETE AND WAS PRESENTED TO THE WORK GROUP AND SUMMARIZED TO
ACIP IN FEBRUARY 2013. A REVACCINATION STUDY IN CANADA
WILL FINISH LATER THIS YEAR, AND SANOFI PLANS TO SUBMIT TO FDA
CONSIDERATIONS OF LABEL UPDATES FOR ADACEL.
TSK’S REVACCINATION PROGRAM FOR BOOSTRIX IS ALSO UNDER WAY.
ONE REVACCINATION STUDY OF YOUNG ADULTS WHO RECEIVED THEIR FIRST
TDAP AS ADOLESCENTS TEN YEARS EARLIER IS COMPLETE.
AND A REVACCINATION STUDY IN ADULTS IS UNDER WAY.
GSK PLANS TO SUBMIT DATA TO FDA FOR CONSIDERATION OF LABEL
UPDATES TO BOOSTRIX, WHICH WILL BE DEPENDENT ON THE PERTUSSIS
EPIDEMIOLOGY AND PERTUSSIS RECOMMENDATIONS.
TDAP IS EFFECTIVE, BUT PROTECTION STARTS TO WANE WITHIN
THREE YEARS. PREVIOUS ESTIMATES OF TDAP
VACCINE EFFECTIVENESS RANGE BETWEEN 66% TO 78%.
HOWEVER, ALL OF THESE STUDIES INVOLVED ADOLESCENTS WHO
RECEIVED SOME WHOLESALE VACCINES AS PART OF THEIR CHILDHOOD
SERIES. AT THE TIME, THE EFFECTIVENESS
OF TDAP AMONG ADOLESCENTS WHO HAD RECEIVED ALL ACELLULAR
VACCINES IN CHILDHOOD WAS UNKNOWN.
DURING THE 2012 EPIDEMIC IN WASHINGTON, THE CDC IN
CORROBORATION WITH THE WASHINGTON STATE DEPARTMENT OF
HEALTH CONDUCTED A LARGE VACCINE STUDY IN ADOLESCENTS WHO ONLY
RECEIVED ACELLULAR PERTUSSIS VACCINES.
ESTIMATED TDAP VACCINE EFFECTIVENESS WAS 65%, WHICH IS
CONSISTENT WITH PREVIOUS STUDIES.
THIS STUDY ALSO LOOKED AT THE DURATION OF PROTECTION.
IN 2012, WISCONSIN ALSO EVALUATED TDAP VACCINE
EFFECTIVENESS AND DURATION OF PROTECTION IN THEIR ADOLESCENT
POPULATION THAT ALSO ONLY RECEIVED ACELLULAR VACCINES.
DESPITE THE METHODOLOGIES BEING DIFFERENT, BOTH STUDIES
DEMONSTRATED SUBSTANTIAL WANING OF PROTECTION OVER TIME.
IN WASHINGTON, THE INITIAL EFFECTIVENESS WITHIN 12 MONTHS
OF TDAP VACCINATION WAS 73%. FOLLOWING THIS, THE
EFFECTIVENESS DECLINED SUBSTANTIALLY.
BETWEEN TWO AND FOUR YEARS POST VACCINATION, EFFECTIVENESS WAS
ONLY 34%. THIS WANING IN PROTECTION IS
CONSISTENT WITH THE OBSERVED EPIDEMIOLOGY.
WISCONSIN PUBLISHED RESULTS VERY SIMILAR TO CDC’S FINDINGS.
TDAP VACCINE EFFECTIVENESS DECREASED WITH INCREASING TIME
SINCE RECEIPT. FOR INDIRECT PROTECTION, IT IS
UNCLEAR WHAT THE EFFECT OF TDAP VACCINATION IS ON PREVENTING
PERTUSSIS TRANSMISSION. FOR PEOPLE VACCINATED WITH
ACELLULAR PERTUSSIS VACCINES, SYMPTOMS ARE NOT AS SEVERE AND
PRESUMABLY LESS LIKELY TO TRANSMIT.
AN AUSTRALIAN COCOONING CAYCE STUDY FOUND A MODEST DECREASE IN
THE RATE OF PERTUSSIS IN INFANTS WHOSE MOTHERS WERE VACCINATED AT
A SUFFICIENT TIME TO BOOST THEIR IMMUNE RESPONSE RELATIVE TO THE
INFANT’S PERTUSSIS INCUBATION PERIOD.
THIS EFFECT WAS ALSO SEEN IN INFANTS WHOSE MOTHERS WERE
VACCINATED POSTPARTUM, BUT IT’S UNCLEAR WHETHER THE LOWER RISK
OF INFANTS WAS ATTRIBUTABLE TO A SHORT-TERM IMPACT ON
TRANSMISSION FOR RECENTLY VACCINATED MOTHERS OR THE LACK
OF EXPOSURE TO INFANTS. AN ANIMAL MODEL SHOWED THAT
ACELLULAR PERTUSSIS VACCINATED BABOONS WERE PROTECTED AGAINST
DISEASE BUT NOT INFECTION. BACTERIAL COLONY COUNTS FROM THE
WASHES WERE COMPARABLE TO THOSE OBSERVED IN UNVACCINATED
ANIMALS. INFECTED BUT ASYMPTOMATIC
BABOONS TRANSMITTED PERTUSSIS TO OTHER CO-HOUSED BABOONS.
ALTHOUGH THE RESULTS ARE STRIKING, IT IS UNCLEAR IF THIS
ANIMAL MODEL REPRESENTS WHAT HAPPENS WITH HUMANS, VACCINES
AND INFECTION. THERE IS CURRENTLY NO HUMAN
CHALLENGE MODEL. PERTUSSIS OCCURS IN HEALTH CARE
PERSONNEL BUT IS PROBABLY NOT A SIGNIFICANT CONTRIBUTION TO THE
OVERALL BURDEN OF DISEASE. OCCUPATIONAL EXPOSURES TO
PERTUSSIS OCCURS IN HEALTH CARE SETTINGS.
THE FREQUENCY AND PROXIMITY OF PATIENT INTERACTION PUTS HEALTH
CARE PERSONNEL AT INCREASED RISK FOR PROTECTION WITH POTENTIAL TO
EXPOSE MANY. THOSE INFECTIONS IN HEALTH CARE
SETTINGS HAVE BEEN DOCUMENTED. THE INDEX CASE HAS BEENIDENTIFI
PERSONNEL, PATIENT OR HOSPITAL VISITOR.
THERE HAVE BEEN NUMEROUS PUBLISHED REPORTS OF PERTUSSIS
OUTBREAKS IN A VARIETY OF HEALTH CARE SETTINGS.
ANECDOTALLY, STATES RECENTLY HAHARD HIT WITH PERTUSSIS HAVE T
IDENTIFIED OR REPORTED HEALTH CARE OUTBREAKS, INCLUDING
CALIFORNIA, WISCONSIN AND WASHINGTON.
THE LAST ONE REPORTED TO CDC WAS IN 2011.
THE MEASURED RISK AND BURDEN OF DISEASE IN HEALTH CARE PERSONNEL
ARE NOT WELL DEFINED. NATIONAL SURVEILLANCE DOES NOT
COLLECT HEALTH CARE PERSONNEL STATUS FOR PERTUSSIS CASES.
THERE ARE A FEW POPULATION-BASED ESTIMATES ON THE RELATIVE RISK
OF PERTUSSIS FOR HEALTH CARE PERSONNEL.
ONE STUDY IN THE PROVINCE OF QUEBEC ESTIMATED A 1.7-FOLD
INCREASED RISK FOR HEALTH CARE PERSONNEL COMPARED TO THEIR
ADULT POPULATION. THIS WAS BASED ON 384 REPORTED
ADULT PERTUSSIS CASES, 32 WHICH WERE HEALTH CARE PERSONNEL.
ANOTHER STUDY FOUND 1.3 TO 3.6% ANNUAL INCIDENTS IN EMERGENCY
DEPARTMENT RESIDENCE NURSING AND PATIENT CARE STAFF.
SOME OF THE INFECTIONS WERE ASYMPTOMATIC.
PUBLISHED STUDIES NOTE YEARLY INFECTION RATES AMONG
ADOLESCENTS AND ADULTS VARY FROM 1% TO 6%, BASED ON SEROLOGIC
STUDIES. SO, IN GENERAL, THE RISK AMONG
HEALTH CARE PERSONNEL AND THE GENERAL POPULATION IS
COMPARABLE. PERTUSSIS EXPOSURE MANAGEMENT IN
HEALTH CARE SETTINGS IS COMPLICATED, TIME-CONSUMING, AND
COSTLY. SEVERAL STUDIES HAVE ESTIMATED
THE COST OF INVESTIGATION AND CONTROL MEASURES, WHICH ARE
SUBSTANTIAL. HOWEVER, TDAP VACCINATION WOULD
NOT CHANGE THAT. CURRENT GUIDANCE ON
POST-EXPOSURE PROPHYLAXIS FOR HEALTH CARE PERSONNEL IS BASED
ON LIKELY CONTACT WITH PATIENTS AT RISK FOR SEVERE DISEASE AND
NOT TDAP VACCINATION STATUS. ONE STUDY LOOKED AT THE NEED OF
POST-EXPOSURE PROPHYLAXIS FOR TDAP VACCINATED HEALTH CARE
PERSONNEL, BUT RESULTS WERE INCONCLUSIVE.
VERY FEW EXPOSED HEALTH CARE PERSONNEL, WHEN AFFECTED,
REGARDLESS OF POST-EXPOSURE PROPHYLAXIS OR NOT.
INFECTION WAS BASED ON SEROLOGIC EVIDENCE, AND NONE WERE
SYMPTOMATIC. THESE HEALTH CARE PERSONNEL WERE
VACCINATED WITHIN FOUR YEARS PRIOR TO THEIR EXPOSURE.
SINCE 2006, HEALTH CARE PERSONNEL HAVE BEEN RECOMMENDING
A SINGLE DOSE OF TDAP AND ROUTINE TD BOOSTER EVERY TEN
YEARS. HOSPITAL-BASED TDAP COVERAGE
RATES VARY, AND A LOT OF EFFORT HAS BEEN PUT INTO INCREASING
COVERAGE FROM CAMPAIGNS TO HOSPITAL MANDATES.
AS WE APPROACH TEN YEARS SINCE THE INTRODUCTION OF TDAP,
NATIONAL HEALTH CARE PERSONNEL COVERAGE FOR THE FIRST DOSE IS
31%. THE BENEFITS AND COSTS OF
VACCINATING HEALTH CARE PERSONNEL WITH TDAP WERE MODELED
PREVIOUSLY TO LOOK AT PREVENTING THE PERTUSSIS OUTBREAK.
VACCINATING HEALTH CARE PERSONNEL WAS SHOWN TO
SUBSTANTIALLY REDUCE THE RISK OF HOSPITAL-BASED OUTBREAKS AND WAS
COST-EFFECTIVE COST SAVINGS. BUT MODEL INPUTS INCLUDED TDAP
VACCINE EFFICACY ESTIMATES HIGHER THAN CURRENT ESTIMATES,
AND ASSUMED VACCINATION WOULD DECREASE TRANSMISSION AND
PREVENT SECONDARY CASES. AT THIS TIME, THERE IS NO DIRECT
EVIDENCE, AND THE ROLE OF VACCINATION IN TRANSMISSION AND
PREVENTION IS UNCLEAR. THERE ARE PLANS TO UPDATE THE
CDC’S M THE WORK GROUP HAS STRUGGLED
WITH THE LACK OF UPDATED DISEASE AND VACCINE-SPECIFIC DATA,
SPECIFIC TO HEALTH CARE PERSONNEL, AND ARE LEFT WITH A
NUMBER OF UNCERTAINTIES. OVER THE PAST SEVERAL YEARS,
MORE HAS BEEN LEARNED ABOUT ACELLULAR PERTUSSIS VACCINES.
IN ACELLULAR PRIMED ADOLESCENTS, TDAP IS EFFECTIVE, BUT
PROTECTION WANES SUBSTANTIALLY WITHIN A FEW YEARS.
FOR ADULTS WHO ARE VACCINATED WITH WHOLESALE PERTUSSIS
VACCINES, TDAP PROVIDES PROTECTION BUT WOULD BE
DIFFICULT TO STUDY OR BETTER CHARACTERIZE.
AND AS THE POPULATION AGES, THERE WILL SOON BE MORE ADULTS
WHO RECEIVED ONLY ACELLULAR PERTUSSIS VACCINES.
IS THE ASSUMPTION VALID THAT TDAP VACCINATION PROTECTS
CONTACTS? THE EVIDENCE IS UNCLEAR.
ALSO, WITH THE TIMING OF ANY POTENTIAL INDICATION ON
ADDITIONAL DOSES OF TDAP, DOES THE COMMITTEE WAIT, OR ARE WE
COMPELLED TO MAKE AN OFF-LABEL RECOMMENDATION?
AFTER MUCH DISCUSSION, THE WORK GROUP HAS MADE THE FOLLOWING
ASSESSMENTS REGARDING PERTUSSIS AND VACCINATING HEALTH CARE
PERSONNEL. THE WORK GROUP RECOGNIZES THAT
PERTUSSIS TRANSMISSION OCCURS IN HEALTH CARE SETTINGS AND THAT
THE FREQUENCY AND PROXIMITY OF PATIENT INTERACTION PUTS HEALTH
CARE PERSONNEL AT INCREASED RISK OF EXPOSURE TO PERTUSSIS.
HOWEVER, IT IS UNCLEAR HOW MUCH PERTUSSIS EXPOSURE RESULTS IN
DISEASE. THERE IS A LACK OF UPDATED DATA
SPECIFIC TO HEALTH CARE PERSONNEL.
THE WORK GROUP ALSO RECOGNIZES THAT IT IS NO SMALL THING TO
IMPLEMENT RECOMMENDATIONS FOR HEALTH CARE PERSONNEL.
AND THERE IS NO SUPPORTIVE EVIDENCE THAT ADDITIONAL DOSES
WOULD BE BENEFICIAL IN PREVENTION OF DISEASE AND
TRANSMISSION IN A HEALTH CARE SETTING.
AND EVEN IF ADDITIONAL TDAP DOSES ARE RECOMMENDED, THERE
WOULD BE NO CHANGE TO RISK MANAGEMENT OF PERTUSSIS
EXPOSURE. AT THIS TIME, THE ACIP PERTUSSIS
VACCINE WORK GROUP DOES NOT PROPOSE CHANGES TO THE CURRENT
TDAP RECOMMENDATION FOR HEALTH CARE PERSONNEL.
WITH A RECORD OF MORE THAN 48,000 PERTUSSIS CASES REPORTED
IN 2012 AND 2014 NUMBERS ALREADY HIGHER THAN AT THIS TIME LAST
YEAR, THE WORK GROUP DOES ACKNOWLEDGE THE CURRENT
RESURGENCE OF PERTUSSIS AND THE BURDEN THIS PLACES ON STATE AND
LOCAL HEALTH DEPARTMENTS AND PROVIDERS.
THE WORK GROUP HAS EXPRESSED A DESIRE FOR CDC TO CONSIDER
AGENCY GUIDANCE ON THE ROLE OF REPEAT TDAP DOSES FOR HEALTH
CARE PERSONNEL IN RESPONSE TO OUTBREAKS IN HEALTH CARE
SETTINGS. THE CDC IS CONSIDERING POTENTIAL
GUIDANCE LANGUAGE FOR THE CDC PERTUSSIS WEBSITE THAT WOULD
INCLUDE ENCOURAGING CONSULTATION WITH THEIR STATE PUBLIC HEALTH
AND CDC DURING OUTBREAKS IN HEALTH CARE SETTINGS.
SINCE EACH OUTBREAK IS UNIQUE AND THE GUIDANCE SHOULD BE
CATERED TO THE SITUATION. THE FOCUS SHOULD BE ON THE
CURRENT TDAP PROGRAM. IMPROVE ADULT COVERAGE,
INCLUDING AMONG HEALTH CARE PERSONNEL, AND TO VACCINATE
PREGNANT WOMEN DURING EVERY PREGNANCY TO PROTECT INFANTS.
TO END THIS SESSION, I WOULD LIKE TO MENTION SOME
PERTUSSIS-RELATED PROJECTS UNDER WAY WITH OUR COLLABORATORS THAT
WOULD HELP ADDRESS SOME DATA GAPS.
RESULTS FROM THESE STUDIES WILL BE PRESENTED AT FUTURE ACIP
MEETINGS. THERE ARE SEVERAL VACCINE
EFFECTIVENESS STUDIES UNDER WAY, INCLUDING D TAP AND TDAP VACCINE
EFFECTIVE FACE WITH THE EMERGENCE OF PROTECTIVE NEGATIVE
STRAIN. THROUGH THE ENHANCED PERTUSSIS
SURVEILLANCE, WE WILL BE LOOKING AT THE CLINICAL CHARACTERISTICS
OF VACCINATED AND UNVACCINATED PERTUSSIS CASES.
ALSO, THROUGH EIP’S ENHANCED PERTUSSIS SURVEY LENS, WE ARE
REPORTING CASES OF PERTUSSIS WHO WORK IN A HEALTH CARE SETTING,
AND THERE ARE PLANS TO UPDATE THE COST-EFFECTIVENESS MODEL FOR
VACCINATING HEALTH CARE WORKERS. FOR THE TDAP PREGNANCY
RECOMMENDATION, THERE IS A COCOONING AND PREGNANCY TDAP
EVALUATION AND AN INFANT BLOOD SPOT STUDY TO MEASURE THE
EFFECTIVENESS OF MATERNAL TDAP AGAINST PERTUSSIS.
AND FINALLY, I WANTED TO HIGHLIGHT ADDITIONAL CDC
ACTIVITIES RELATED TO THE TDAP PREGNANCY RECOMMENDATION.
MEASURING TDAP COVERAGE AMONG PREGNANT WOMEN, THE SAFETY
MONITORING ACTIVITIES, INFORMATIVE RESEARCH THAT IS
UNDER WAY TO DEVELOP A MATERNAL TDAP VACCINATION CAMPAIGN.
THANK YOU. THANK YOU, DOCTOR.
A QUICK QUESTION FROM MY END, AND IT’S MORE IN TERMS OF
EPIDEMIOLOGY, BUT HOW TRANSMITTABLE IS PERTUSSIS FOR
SOMEONE WHO IS ASYMPTOMATIC, SOMEONE WHO’S INFECTED BUT NOT
SICK WITH IT? SO, THEY DON’T HAVE THE
CHARACTERISTIC OR PARATYSMAL PHASE.
IS THAT A RISK? SO, PEOPLE WHO HAVE BEEN
EXPOSED TO PERTUSSIS AND MAY DEVELOP UNCOLONIZED OR
ASYMPTOMATIC, IT’S HIGHLY UNLIKELY OR LESS LIKELY FOR THEM
TO TRANSMIT BECAUSE THEY’RE NOT COUGHING, SO THEY’RE NOT
ACTIVELY SPREADING THE BACTERIA. THANK YOU.
OTHER QUESTIONS? DR. BENNETT?
>>JUST CURIOUS ABOUT WHAT THE POTENTIAL IS FOR DEVELOPING
MANDATORY TDAP AMONG HEALTH CARE WORKERS?
I MEAN, THE RATES, 31%, ARE REALLY STRIKING, BUT THAT IS
WHERE WE WERE PROROBABLY FIVE T TEN YEARS AGO WITH INFLUENZA
VACCINE, AND NOW WE’RE REALLY SEEING A BIG UPTICK DUE TO
MANDATORY PROGRAMS. I SAW DR. WEBER.
>>DR. WEBER? SO, AT MY HOSPITAL, TDAP IS A
REQUIRED VACCINE ALONG WITH MUMPS, MEASLES, RUBELLA AND
PERTUSSIS, AND BECAUSE IT’S REQUIRED, WE ARE 100% COMPLIANT,
EXCEPT FOR A FEW PEOPLE WITH MEDICAL CONTRAINDICATION.
PERTUSSIS REMAINS ONE OF OUR MOST COMMON EXPOSURES TO OUR
HEALTH CARE PERSONNEL, SO OVER THE LAST FIVE YEARS, ROUGHLY 1
OUT OF 200 OF OUR HEALTH CARE PERSONNEL EACH YEAR HAS BEEN
EXPOSED TO PERTUSSIS. WE DO OFFER ALL OF THEM POST
EXPOSURE PROPHYLAXIS, AND VIRTUALLY ALL OF THEM ACCEPT IT.
SO, WE’VE HAD NO HEALTH CARE WORKERS IN THE LAST FIVE YEARS
WHO HAVE DEVELOPED PERTUSSIS. THERE WERE SEVERAL — AND I DID
DISCUSS THE RECOMMENDATION. I APPRECIATE THE COMMENTS OF THE
WORKING GROUP, AND I’M ON THE WORKING GROUP, AND THEIR
WILLINGNESS TO LISTEN. AND CERTAINLY, I THINK AT THIS
TIME, THE EVIDENCE REALLY DOESN’T ALLOW US TO MAKE AN
EVIDENCE-BASED RECOMMENDATION FOR A REVACCINATION.
THAT SAID AND DONE, A NUMBER OF THE CONCERNS RAISED BY THE SHEA
BOARD WHEN I DISCUSSED THIS WITH THEM IS JUST THE LOGISTICAL
PROBLEMS THAT THE ACIP NOW RECOMMENDS NO REVACCINATION AND
WE PASS A HIGH PERIOD SHORTLY WHEN TEN YEARS HAVE PASSED —
ONE, WE’LL LOSE THE BUDGETING. WE’VE ALREADY BUDGETED, MANY OF
US, IN THE FUTURE FOR THE VACCINE.
AND AS WE ALL KNOW, IT’S HARD TO RECAPTURE MONEY ONCE YOU’VE
GIVEN IT AWAY. SECOND, OUR HEALTH CARE
PERSONNEL AT TEN YEARS WILL BEGIN GETTING THEIR TEN-YEAR TD
SHOTS. AND IF SOME TIME IN THE FUTURE,
A FEW YEARS LATER, THE EVIDENCE SUPPORTS A BOOSTER, THAT WILL
MAKE IT MORE DIFFICULT, AND THEY’LL BE UNHAPPY ABOUT NEEDING
AN EXTRA VACCINE. AND THEN FINALLY, IT’S A BIT
CONTRADICTORY THAT WE’RE GOING TO REQUIRE OR RECOMMEND THAT
HEALTH CARE WORKERS — AND WE GIVE ALL OF OUR VACCINES, WE
REQUIRE IT FOR THE INCOMING MEDICAL STUDENTS, NURSING
STUDENTS. WE’VE ALREADY HEARD HOW THE
VACCINE WANES, SO WE’RE, IN FACT, IMMUNIZING PEOPLE WHO ARE
RELATIVELY LOW RISK, MEANING FIRST-YEAR NURSING, MEDICAL
STUDENTS. THE VACCINE WILL WANE.
AND YET, WE’RE GOING TO CONTINUE RECOMMENDING TDAP FOR THAT
GROUP. BUT AT TEN YEARS, WHEN THEY’RE
NOW JUNIOR ATTENDINGS OUT ON THE WARDS, WE’RE GOING TO TELL THEM
THEY DON’T NEED A BOOSTER SHOT. SO, THAT’S A BIT DIFFICULT TO
SELL, PARTICULARLY AS A REQUIREMENT FOR INITIAL WORK.
SO, THOSE WERE SOME OF THE CONCERNS RAISED AMONG THE BOARD,
AND THEIR FEELING WAS, IF THERE IS GOING TO BE DATA IN THE NEXT
FEW YEARS THAT BOTH MODELING AND, OBVIOUSLY, LICENSURE OF
BOOSTER SHOTS, IT WOULD BE BETTER TO AT LEAST INITIALLY
RECOMMEND A BOOSTER AND THEN STOP THAN TO RECOMMEND NO
BOOSTER NOW AND THEN TRY AND REINSTITUTE ONE IN A FEW YEARS.
THANK YOU VERY MUCH. THANK YOU.
DR. FRYHOFER. THANK YOU.
I’M SPEAKING AS THE LIAISON, THE ACIP.
WE’RE MEETING NEXT WEEK WITH THE HOUSE OF DELEGATES AND THERE’S
BEEN A RESOLUTION INTRODUCED BY THE OREGON STATE DELEGATION.
THAT ACTUALLY EXPRESSES CONFUSION ABOUT MEDICARE
COVERAGE OF TDAP VACCINATIONS. SO, I WONDERED IF YOU COULD
CLARIFY FOR THE RECORD MEDICARE COVERAGE FOR TDAP?
>>SO, THIS IS FOR MEDICARE, THIS IS FOR THE 65 AND OLDER.
SO, RIGHT NOW, TDAP COVERAGE IN MEDICARE IS A — I BELIEVE PLAN
“D,” SO, MEANING THAT IT’S NOT PART OF THE ROUTINE PLAN “B”
SERIES. SO, IT’S NOT COVERED UNDER
MEDICARE, FROM MY UNDERSTANDING. I DON’T KNOW IF THERE’S ANY
OTHER COMMENTS — WELL, THE SPECIFIC QUESTION
IS ABOUT HOW TO ADMINISTER TDAP WITHIN THE OFFICE AND GET IT
COVERED. COULD PERHAPS THE CMS
REPRESENTATIVE CLARIFY THAT FOR US?
>>SURE. THIS IS RIGHT OFF HAND.
AS SHE SAID, IT IS COVERED NUMBER MEDICARE PART “D.”
LET ME FOLLOW UP AND SEE IF I CAN GET SOME SPECIFIC
INFORMATION FROM MY MEDICARE COLLEAGUES DURING OUR BREAK TO
ANSWER YOUR QUESTION, SEE IF THERE’S ANYTHING ELSE THEY WANT
TO SHARE. I THINK A FOLLOW-UP QUESTION
FOR THAT PERTAINS TO ALL THE ACIP RECOMMENDED IMMUNIZATIONS
FOR OUR PATIENTS ON MEDICARE AND WHAT TYPE OF REAL CHANGES WOULD
BE POSSIBLE TO ALLOW COVERAGE FOR ALL OF THESE RECOMMENDATIONS
UNDER PART “B.” I HAVE DR. PICKERING.
>>YEAH, JENNIFER, YOU MENTIONED THAT ONLY 15% OF PREGNANT WOMEN
ARE RECEIVING TDAP. SO, I WONDERED, WITH DR. AULT,
OUR NEW LIAISON FROM ACOG AND DR. LOEHR, TWO OF THE
ORGANIZATIONS THAT ADMINISTER IMMUNIZATIONS TO WOMEN, WHAT ARE
YOU DOING TO TRY TO INCREASE COVERAGE?
>>DR. RILEY AND I ARE BOTH PART OF A COGNITIVE IMMUNIZATION
WORKING GROUP, AND ONE OF OUR STRATEGIES, AND I THINK ONE OF
OUR MOST SUCCESSFUL STRATEGIES HAS BEEN TO PROVIDE WHAT WE CALL
TOOL KITS TO OB/GYN PHYSICIANS, AND THAT INCLUDES SCRIPTS AND
OTHER INFORMATION THAT WOULD HELP PROVIDERS.
WE’RE ALSO DOING A SERIES OF WEBINARS AS KIND OF A MULTIMEDIA
EXERCISE TO INFORM OB/GYN PROVIDERS AND OFFICE PERSONNEL
THAT WORK IN OBJESTETRICAL OFFIS ABOUT TDAP VACCINATIONS.
I’M LOOKING AT MS. RILEY TO SEE IF I’M MISSING ANYTHING.
APPARENTLY NOT. THE RECOMMENDATIONS ARE PRETTY
NEW. LAST TIME YOU PUT ME ON THE
SPOT, I SAID WE HAVE CHANGED THE RECOMMENDATIONS EVERY SIX MONTHS
OR A YEAR, BUT NOW THEY’VE BEEN IN PLACE FOR 15 OR 16 MONTHS, IF
I’M DOING THE MATH RIGHT. DR. LOEHR?
>>THE AAFP IS ALSO TRYING TO PASS ON THIS INFORMATION TO AS
MANY FAMILY PHYSICIANS AS POSSIBLE.
AND SO, IT’S DISAPPOINTING THAT THE RATE IS ONLY 15%.
>>I HAVE DR. BAKER, DR. HARRISON, DR. KEMPE.
>>WELL, I WANT TO CONGRATULATE ACOG, AND DON’T THINK I’M SAYING
SOMETHING NICE ABOUT OBSTETRICIANS.
THEY’VE DONE A WONDERFUL JOB IN COLLABORATION WITH THE CDC MEDIA
PEOPLE AND EDUCATION, BUT NOT JUST HEALTH CARE PROVIDERS, BUT
PREGNANT WOMEN. JUST SHOUT OUT CONGRATULATIONS.
FOLLOWED BY THE CONTINUATION BARRIER IS REIMBURSEMENT.
AND I’LL GIVE JUST ONE EXAMPLE. CALIFORNIA PHYSICIANS DELIVER A
LOT OF BABIES. IT’S A BIG STATE.
CALIFORNIA MEDICAID DOES NOT PAY FOR TDAP.
SO, ASIDE FROM THE PROBLEM OF BUYING THE VACCINE, STORING IT
IN, YOU KNOW, YOUR OFFICE, ALL OF THE OTHER PRACTICAL BARRIERS,
TO HAVE SOMETHING THAT WOULD PREVENT DEATH — AND THE UK HAS
SHOWN US THAT IF YOU IMMUNIZE PREGNANT WOMEN, YOU HAVE OVER
90% VACCINE EFFECTIVENESS IF YOU GIVE IT BASICALLY SOME TIME IN
THE THIRD TRIMESTER. I MEAN, THAT’S INCREDIBLE WHAT
THEY DID. SO, I’M SAYING SOMETHING NICE
ABOUT THE BRITS, TOO. TOO BAD DR. DAVID SALZBERG’S NOT
HERE. SO, THIS IS SOMETHING THAT HAS
TREMENDOUS BENEFIT. I LOVE THE INCREASED SAFETY
VIGILANCE THAT’S GOING ON. I HAVE AN OPINION OF WHAT IT
WILL SHOW, BUT I THINK IT’S WONDERFUL TO BE ABLE TO GET THIS
KIND OF DATA WHEN WE STUCK OUR NECKS OUT AND MADE THE
RECOMMENDATION FOR EVERY PREGNANCY.
SO, MY ISSUE HERE IS BACK ON CMS, I GUESS.
YOU KNOW, I HOPE YOU HAVE A TO-DO LIST.
TDAP REIMBURSEMENT FOR PREGNANT WOMEN IS AN IMPORTANT ISSUE FOR
THOSE WELL-MEANING HEALTH CARE PROVIDERS WHO ACTUALLY KNOW IT’S
A RECOMMENDATION, HAVE THE ABILITY TO GIVE IT, AND YET,
THEY WON’T BE REIMBURSED AT ALL. THANK YOU, DR. BAKER.
AND LET THE RECORD SHOW THAT DR. BAKER DID SAY SOMETHING NICE
ABOUT OBSTETRICIANS AND BRITS. WE HAVE DR. HARRISON.
>>SO, THIS SEEMS LIKE A DIFFICULT BATTLE WITH THE
CURRENT VACCINES. COULD WE GET A SENSE FOR WHAT’S
GOING ON IN TERMS OF DEVELOPMENT OF NEXT-GEN VACCINES FROM THE
MANUFACTURERS? I THINK I’VE ADDRESSED THIS
HERE BEFORE. THERE WE GO.
YOU KNOW, I CAN SHRINK, IT CAN GROW.
I THINK ALL THE MANUFACTURERS ARE LOOKING TO SEE WHAT CAN BE
DONE ABOUT IMPROVED PERTUSSIS VACCINES, BUT THE STRUCTURAL
BARRIERS ARE FORMIDABLE. TO GIVE ONE EXAMPLE, I DON’T
THINK ANYBODY’S FIGURED OUT A WAY TO LICENSE A NEW PERTUSSIS
VACCINE, CERTAINLY NOT A NEW INFANT VACCINE.
THE REGULATORY AUTHORITIES WOULD REQUIRE A CLINICAL TRIAL.
EVERYBODY KNOWS THERE’S NO ACCEPTED GENERIC CORRELATIVE
IMMUNITY FOR PERTUSSIS. IT’S VERY SPECIFIC.
EVERY PERTUSSIS VACCINE, ACELLULAR VACCINE LICENSED
AROUND THE WORLD WAS LICENSED ON THE BASIS OF A SPECIFIC EFFICACY
TRIAL. YOU CAN’T CONDUCT THOSE ANYMORE
IN ANY PRACTICAL WAY BECAUSE THERE’S NO PLACE IN THE WORLD
THAT DOESN’T RECOMMEND PERTUSSIS VACCINE.
THE EFFICACY OF THE VACCINE IN THE PRIMARY SERIES IS IN THE
HIGH 90%s. SO, THE SAMPLE SIZE NEEDED TO
MEET THE REQUIREMENTS IS LARGER THAN THE POPULATION OF ANY
SINGLE COUNTRY. THESE ARE PROBLEMS THAT HAVE TO
BE FIGURED OUT. IN ADDITION, ALTHOUGH SOME WORK
IS BEING DONE ON PERFECTING ANIMAL MODELS, THERE’S NO ANIMAL
MODEL THAT’S PROVEN TO BE A VALID CORRELATIVE TO THE HUMAN
RESPONSE. AND SO, EVEN ANSWERING THE
QUESTION WHAT CHANGES NEED TO BE MADE IS FORMIDABLE.
SO, DO THE BEST YOU CAN WITH THE VACCINES YOU HAVE, BECAUSE I
CAN’T TELL YOU WHEN YOU’RE GOING TO HAVE NEW ONES.
>>LEONARD FREED. IN ADDITION TO OUR GROUP LOOKING
AT DEVELOPING NEW AND POTENTIALLY PRODUCTIVE PERTUSSIS
VACCINES, OUR FOCUS IS EXACTLY WHAT’S ON THIS SLIDE.
IT’S DOING WHAT WE CAN TO HELP THE HEALTH CARE COMMUNITY
UNDERSTAND HOW TO IMPROVE ADULT COVERAGE AND ELDERLY COVERAGE OF
TDAP VACCINES, AND WE’RE COMMITTED TO GENERATING DATA
WITH MATERNAL IMMUNIZATION WITH TDAP VACCINES SO THAT GROUPS
LIKE YOURSELVES CAN MAIM INFORMED DECISIONS ON HOW TO USE
THE VACCINES SAFELY AND EFFECTIVELY IN PREGNANT WOMEN.
THAT’S OUR FOCUS. DO YOU HAVE ANYTHING?
>>TO REITERATE WHAT LEN JUST SAID, I THINK I WAS HEARTENED TO
SEE WE HAVE A FOCUS ON IMPROVING ADULT COVERAGE, INCLUDING HEALTH
CARE PROVIDERS. YOU KNOW, HEARING THAT
IMMUNIZATION RATES IN PREGNANT WOMEN ARE ONLY AT ABOUT 15%,
THAT’S GOING TO TAKE A LOT OF WORK TO RAISE THOSE.
SO, IN THE MEANTIME, LET’S USE THE TOOLS THAT WE HAVE AND MAKE
SURE THAT WE ARE FOCUSING ON IMMUNIZING THOSE WHO DO TAKE
CARE OF THE INFANTS. SO, THAT INCLUDES DAD, THAT
INCLUDES GRANDPARENTS, THAT INCLUDES HEALTH CARE PROVIDERS,
THAT INCLUDES DAYCARE. SO, WE CAN’T LOSE THAT.
WE’RE SO FOCUSED ON MATERNAL IMMUNIZATION, AND THAT’S GREAT,
BECAUSE IT’S VERY TARGETED, LOOKS TO BE VERY EFFECTIVE.
HOWEVER, IT’S GOING TO TAKE A WHILE TO GET TO 80%, 90%, SO
LET’S USE THE TOOLS THAT WE HAVE.
>>I’M GOING TO GET OFF CYCLE HERE A LITTLE BIT AND CALL ON
MS. HAHN FROM CMS. THANK YOU.
I WANTED TO RESPOND TO MR. DAYCA
BAKER’S COMMENT ON HEALTH CARE COVERAGE IN CALIFORNIA ON TDAP.
UNFORTUNATELY, THE WAY THE MEDICAID PROGRAM DOES THIS NOW
IS THERE IS SOME DISCONNECTS IN COVERAGE FOR VACCINE IN GENERAL
FOR ADULTS, AND IT IS AN AREA THAT CMS IS AWARE OF.
UNDER THE MEDICAID EXPANSION, ALL ACIP-RECOMMENDED VACCINES
ARE COVERED. SO, IF YOU HAVE AN ADULT IN
MEDICAID, THROUGH THE MEDICAID EXPANSION, THEY HAVE COVERAGE OF
ALL ACIP-RECOMMENDED VACCINES. SINCE THERE ARE SOME WOMEN WHO
ARE PREGNANT WHO ARE UNDER AGE 21, THEY ALSO WOULD HAVE
COVERAGE OF THE ACIP-RECOMMENDED VACCINES THROUGH THE EARLY AND
PERIODIC SCREENING TREATMENT PROGRAM THROUGH THE TRADITIONAL
MEDICAID PROGRAM. WHERE YOU HAVE A GAP IS PEOPLE
WHO ARE IN MEDICAID IN THE TRADITIONAL MEDICAID PROGRAM WHO
DID NOT HAVE COVERAGE THROUGH THE MEDICAID EXPANSION.
THIS IS A GAP THAT WAS CREATED WITH THE AFFORDABLE CARE ACT,
AND IT IS A GAP THAT CMS IS AWARE OF.
IT REQUIRES LEGISLATIVE CHANGE. AND THIS IS SOMETHING THAT IS ON
OUR AGENDA AND HAS BEEN INCLUDED IN A COUPLE OF BILLS THAT
PROBABLY AREN’T GOING TO BE ACTED ON RIGHT NOW.
BUT THIS IS ON OUR RADAR SCREEN. SO, BUT LUCKILY, WHILE NOT
EVERYONE HAS COVERAGE THAT’S AN ADULT IN MEDICAID, THERE ARE
LARGER NUMBERS OF ADULTS IN MEDICAID.
THE OTHER PIECE OF THE MEDICAID PROGRAM IS THAT IT IS AN OPTION.
SO, WHILE NOT ALL STATES CHOOSE TO COVER VACCINES — AND THEY
CAN CHOOSE. IT IS NOT AN ALL-OR-NOTHING
CHOICE FOR STATES. THERE ARE A NUMBER OF STATES WHO
HAVE CHOSEN TO COVER SOME VACCIN
VACCINES. AND SO, EVEN IF THEY DON’T COVER
TDAP, THEY MAY COVER OTHER VACCINES RECOMMENDED BY THE
ACIP. SO, AGAIN, THIS IS AN AREA WE
ARE AWARE OF. WE’RE HOPING THAT AT SOME POINT,
WE WILL GET TO MORE ACROSS-THE-BOARD COVERAGE.
AND UNFORTUNATELY, THIS IS AN EXAMPLE WHERE THERE JUST ISN’T
COVERAGE FOR A CERTAIN SECTION OF THE POPULATION.
>>THANKS FOR THAT CLARIFICATION.
DR. KEMPE. I WAS JUST GOING TO —
RELATED TO OUR PREVIOUS DISCUSSION — ALSO SHOUT OUT TO
ACOG IN THAT I’M AN IMPLEMENTATION SCIENTIST AND
THERE ARE HUGE IMPLEMENTATION ISSUES TO ACOG, TO OB/GYNs
BEGINNING TO DELIVER A LOT OF VACCINES, NOT JUST THE PAYMENT
ISSUES, BUT THE WHOLE SYSTEM DEVELOPMENT, ET CETERA.
AND ACOG HAS RECENTLY AGREED AND CDC IS FUNDING A SURVEY UNIT
WITHIN ACOG TO REALLY TRY TO GET AT LOOKING AT THE PROCESSES THAT
ARE LACKING AND WHAT OB/GYNs NEED TO MORE EFFECTIVELY DELIVER
AND WHAT KIND OF SYSTEMS THEY CAN ADOPT FROM OTHER
SPECIALITIES. SO, I JUST WANT TO SHOUT OUT TO
ACOG. THANKS FOR HELPING US WITH THAT.
>>MS. PELLEGRINI. THANK YOU.
I WAS GOING TO MAKE ALMOST THE IDENTICAL POINT.
I THINK THE NVAC REPORT THAT CAME OUT NOT LONG ON ON MATERNAL
VACCINATION ENCAPSULATED THESE CHANGES BEAUTIFULLY AND SHOWED
THAT FOUR OB/GYNs WHO DO NOT HAVE A LONG HISTORY OF
CONSIDERING THEMSELVES VACCINATORS, THERE IS A
SUBSTANTIAL INVESTMENT REQUIRED UP FRONT IN EQUIPMENT, IN THE
VACCINE ITSELF. THERE’S A TREMENDOUS LEARNING
CURVE, STORAGE ISSUES, AND THIS IS A REALLY DAUNTING PROSPECT
FOR A LOT OF PRACTICES. SO, WE NEED TO HELP THEM ADDRESS
THOSE OBSTACLES. DR. MIDDLEMAN.
>>HI, AMY MIDDLEMAN FROM SOCIETY FOR HEALTH AND MEDICINE.
THANK YOU FOR THOSE GREAT PRESENTATIONS.
I WAS WONDERING IF THE WORKING GROUP IS CONSIDERING MAKING THE
TEN-YEAR, THE EVERY TEN-YEAR BOOSTER DOSE A TDAP FOR EASE OF
PHYSICIAN IMPLEMENTATION, AND YOU KNOW, STOCKING ISSUES AND
CONFUSION. I’M NOT FULLY AWARE OF ALL OF
THE COST-EFFECTIVENESS ISSUES, BUT I’M WONDERING IF THAT’S
BEING CONSIDERED? I’M SORRY, DR. MIDDLEMAN,
IT’S HARD TO HEAR. COULD YOU REPEAT THE QUESTION?
SORRY. I’M JUST WONDERING IF THERE’S
ANY DISCUSSION AT THE WORKING GROUP LEVEL ON WHETHER OR NOT
THE EVERY-TEN-YEAR BOOSTER COULD BE A TDAP RATHER THAN TD IN
TERMS OF, YOU KNOW, STOCKING DOSES AND PHYSICIAN
IMPLEMENTATION AND EASE OF RECOMMENDATION.
>>I MEAN, SO, WITH REGARDS TO JUST THE SWITCH FROM A TETANUS
BOOSTER — A DICENNIAL TD TO A DICENNIAL TDAP, THIS IS WHAT THE
WORKING GROUP HAS BEEN CONSIDERATION, BUT REALLY
LOOKING AT ADDING A SECOND DOSE, THIS IS TAGGING ON TO BACK IN
JANUARY OF 2013, WHEN THE WORK GROUP FIRST PRESENTED
CONSIDERATIONS ON THE GENERAL POPULATION OF ADDITIONAL DOSES.
BECAUSE TDAP IS ONLY LICENSED FOR SINGLE USE, THE GUIDANCE
THAT WE GOT FROM ACIP WAS TO CONSIDER JUST ADDING A SECOND
DOSE AND NOT MOVING BEYOND AND EXPANDING IT TO A DICENNIAL
TDAP. SO, THE CONCLUSIONS FOR THE
SECOND DOSE FOR THE GENERAL POPULATIONS WAS TO NOT MAKE ANY
CHANGES. AND SIMILARLY WITH THE HEALTH
CARE PERSONNEL, WE’RE NOT MAKING ANY CHANGES TO THE
RECOMMENDATIONS. DR. BAKER.
>>JUST A QUICK QUESTION FOR JENNIFER.
BECAUSE THIS QUESTION COMES UP ALL THE TIME.
YOU MAY BE FAMILIAR THAT WOMEN SOMETIMES HAVE MORE THAN ONE
PREGNANCY, AND WE KNOW WE’RE SUPPOSED TO VACCINATE THEM EVERY
TIME, BUT THEY SEEM TO HAVE FAMILY MEMBERS, GRANDPARENTS, ET
CETERA, AROUND THE BABY. SO, IF THEY COCOONED THE FIRST
TIME, WHAT’S THE CDC — I KNOW THE ANSWER, IT’S FOR THE
PUBLIC — WHAT’S THE CDC POSITION ON REVACCINATING FOR
THE COCOON? SO, CURRENTLY — SO, THIS IS
SOMETHING THAT THE WORKING GROUP HAS BEEN DISCUSSING AND WE
PLANNED AND HOPED TO PRESENT THIS AT THE FEBRUARY ACIP
MEETING. BUT WHEN THESE CALLS COME IN TO
CDC, OUR GUIDANCE REALLY IS, BECAUSE IT’S ONLY LICENSED FOR
SINGLE USE, JUST TO MAKE SURE THAT ALL FAMILY MEMBERS ARE UP
TO DATE WITH THEIR TDAP VACCINATION.
>>OTHER COMMENTS OR QUESTIONS? AFTER I MADE MY COMMENTS, I
REALIZED I HAD THE ACOP APP ON MY PHONE.
AND ON THE ACOG APP, SINCE WE ALL LIVE IN THE 21st CENTURY
NOW, YOU CAN DOWNLOAD ALL THE THINGS I MENTIONED PREVIOUSLY,
IF YOU DOWNLOAD IT TO YOUR ANDROID OR iPHONE.
>>AND OTHER QUESTIONS? OK. I THINK WE ARE TO THE END OF
PERTUSSIS.

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