NVAC Day 2 Part 2


>>OUR NEXT PANEL IS PROPS TO
PREVENT FLU PROPERLY. IN THIS PANEL PRESENTATION WE
WILL LOOK AT EVIDENCE BASED TOOLS FOR IMPROVING INFLUENZA
VACCINATION EFFORTS AS WELL AS TOOLS AND RESOURCES CLINICIANS
CAN USE TO IMPROVE VACCINATION AND ENSURE VACCINATION IN
SATELLITE, TEMPORARY AND OFF SITE LOCATIONS ARE DONE SAFELY. OUR SPEAKERS INCLUDE KELLY
MCKENNA FROM THE AMERICAN ACADEMY OF HOSPICE AND
PALLIATIVE MEDICINE, TOOLS FOR SAFE VACCINATION CLINICS. DIANE PETERSON FROM THE
IMMUNIZATION ACTION COALITION GETTING VACCINE ADMINISTRATION
RIGHT. AND DR. AMY BEHRMAN, UNIVERSITY
OF PENNSYLVANIA RESOURCES FOR TRACKING EVALUATING AND
PROMOTING INFLUENZA VACCINATION CAMPAIGNS. MCKENNA.>>GOOD MORNING. THANK YOU FOR HAVING ME. I’M KELLY MCKENNA. I’M ONE OF THE CO-LEADS OF THE
INFLUENZA WORKING GROUP, THE NATIONAL ADULT AND INFLUENZA
IMMUNIZATION SUMMIT ALONG WITH DR. AMY BEHRMAN AND AMY PARKER AND TODAY I WILL TALK ABOUT SOME
TOOLS WE CREATED IN ORDER TO PROMOTE SAFETY AND
NON-TRADITIONAL CLINIC SETTINGS. SO SURE MOST OF YOU ARE FAMILIAR
WITH THE SUMMIT BUT FOCUSING ON THE WEBCAST WHO ARE NOT, THE
SUMMIT IS ORGANIZED BY THE CDC IMMUNIZATION ACTION COALITION
AND THE NATIONAL VACCINE PROGRAM OFFICE. THEIR MISSION IS DEDICATED TO
ADDRESSING RESOLVING ADULT INFLUENZA IMMUNIZATION ISSUES
AND IMPROVING VACCINES RECOMMEND BY ADVISORY COMMITTEE ON
IMMUNIZATION PRACTICES. THE INFLUENZA WORKING GROUP OF
THE SUMMIT WAS RELAUNCHED IN 2015 WITH MISSION TO IMPROVE
VACCINATION COVERAGE AND PROMOTE BEST PRACTICES AND ONE OF THE
MAIN GOALS OF THIS WORKING GROUP IS CREATE TOOLS THAT ENCOURAGE
SAFE VACCINATION ADMINISTRATION. SO WE WILL BE TALKING ABOUT
THOSE TOOLS TODAY. ESPECIALLY AS THEY RELATE TO
CLINICS IN SATELLITE TEMPORARY OFF SITE LOCATIONS. SO WE WILL DISCUSS THOSE
LOCATIONS AND THEN THE TOOLS THAT WERE CREATED. SO LITTLE BACKGROUND ON THIS
SATELLITE TEMPORARY OFF SITE LOCATION. WE KNOW THEY PLAY A VERY
IMPORTANT ROLE IN IMPROVING ACCESS TO VACCINATION BECAUSE
THEY OPTIMIZE CONVENIENCE FOR RECIPIENTS OF VACCINES. WE ALSO KNOW THAT OF ADULTS THAT
RECEIVE VACCINATION, 17% CURRENTLY RECEIVE THOSE WITHIN
THE WORKPLACE AND WE CAN ANTICIPATE THAT NUMBER TO GROW
AS WE SEE ACCESS BEYOND TRADITIONAL PRIMARY CARE
PROVIDER OFFICES. GREAT FOR INCREASED ACCESS BUT THERE ARE CHALLENGES SO WE HAVE
OUTLINED A FEW CHALLENGES HERE. HIRING AND TRAINING OF STAFF
EMPLOYEES. MAINTAINING TEMPERATURE CONTROL
AND STERILITY, MONITORING PROPER VACCINE ADMINISTRATION. AND MANAGING DOCUMENTATION FOR
LARGE GROUP OUTSIDE TRADITIONAL OFFICE SETTING WITHEH, ARE. SO THESE CONCERNS ARE NOT MERELY
THEORETICAL, SOME MAY REMEMBER DURING THE FALL OF 2015 THERE
WAS A CLINIC IN WORK MACE BASED CLINIC IN NEW JERSEY THAT
EXEMPLIFIED THESE CONCERNS AND CHALLENGES ON SEPTEMBER 30,
2015, A WELLNESS COMPANY HIRED A NURSE TO PROVIDE VACCINATION
CLINIC AT WHAT WILL REFER TO AS COMPANY B.
THE NURSE WENT TO THE COMPANY TO PROVIDE VACCINES SHE CHANGED THE
NEEDLE BETWEEN EACH PATIENT BUT USED THE SAME SYRINGE ON 67
PATIENTS. WHICH WE KNOW CAN
CERTAINLY BE AN ISSUE WITH BLOOD BORN PATHOGEN TRANSMISSION WHICH
IS NOT GOOD. ONE EMPLOYEE WHO WAS THERE TO
RECEIVE VACCINATION AT CLINIC NOTICED THAT THE SAME SYRINGE
WAS REUSED AND HE REPORTED BACK TO HIS EMPLOYER COMPANY B.
WHO REPORTED IT TO THE WELLNESS COMPANY WHO REPORTED IT TO THE
NEW JERSEY DEPARTMENT OF PUBLIC HEALTH WHICH IS APPROPRIATE. THE NEW JERSEY DEPARTMENT OF
HEALTH DID LOOKED INTO THIS AND FOUND A FEW OTHER ISSUES WITH
THE CLINIC. WHICH INCLUDED INADEQUATE DOSING
SO THE WRONG AMOUNT OF EACH DOSE IS BEING DRAWN UP AS WELL. ISSUES WITH TRANSPORTATION
STORAGE HANDLING AND TEMPERATURE EXCURSION. SO THEY’D DID A COORDINATED
EFFORT WITH CDC, HAD TO DO EXTENSIVE TESTING FOR BLOOD BORN
PATHOGENS, THE HEPATITIS B VACCINATION, HAD TO OFFER REVAX
WITH INFLUENZA, SINCE THOSE VACCINATE DID NOT RECEIVE THE
FULL DOSE AT THE TIME. THEY HAD TO FOLLOW-UP WITH NEW
JERSEY BOARD OF NURSING AND ANSWER QUITE A BIT OF MEDIA
ATTENTION. IF YOU ARE INTEREST IN MORE
INFORMATION ABOUT THIS IT WAS PUBLISHED IN DECEMBER 2015 MMWR
REPORT. THERE WAS QUITE A BIT OF MEDIA
COVERAGE, THE COVERAGE MOSTLY IN NEW JERSEY NEW YORK AND
PENNSYLVANIA BUT DID RECEIVE NATIONAL ATTENTION. WHICH DOES PROMOTE CONCERNS
AROUND IMMUNIZATION INFLUENZA. THERE’S OTHER DOCUMENTED CASES,
OF SAFETY ISSUE, SO SOME ARE AROUND TEMPERATURE EXCURSION,
BUT ALSO THERE WAS A CASE WHERE THERE WAS A VACCINATION CLINIC. AT A SCHOOL MEANT TO VACCINATE
TEACHERS WITH INFLUENZA VACCINE AND THEY MISTAKENLY VACCINATED
THEM WITH INSULIN FOR STUDENTS WITH DIABETES SO OBVIOUSLY NOD
IDEAL. THE INFLUENZA WORKING GROUP
REVIEWED THE DIFFERENT INCIDENTS AND REALIZED THAT THERE REALLY
WAS NO GOLD STANDARD. AT THE TIME FOR MOW TO HAVE BEST
PRACTICE IN TERMS OF A SAFE VACCINATION CLINIC AND THESE
NON-TRADITION AL SETTINGS. SO WE HAD THE WORKING GROUP
DECIDED TO PUT TOGETHER A CHECKLIST AS WE HAVE SEEP FROM
OTHER AREAS OF THE HEALTHCARE SPACE, AS WELL AS OTHER
INDUSTRIES CHECKLISTS CAN REALLY HELP MITIGATE ANY RISK SO WE
THOUGHT THIS WOULD BE A REALLY USEFUL AND HELPFUL TOOL. ALONG WITH THE CHECKLIST CREATED A FEW OTHER RESOURCES BUT I WILL
ALSO GO OVER WITHIN THE SLIDE SET. WE WILL START WITH THE CHECKLIST
OF BEST PRACTICES. AND SO THIS IS REALLY MEANT TO
BE A STEP BY STEP GUIDE FOR CLINIC COORDINATORS, SUPERVISORS
THAT ARE OVERSEEING THESE NON-TRADITION AL CLINICS. AND THE CHECKLIST IS DIVIDED
INTO THREE SECTIONS. SO YOU HAVE A BEFORE THE CLINIC
SECTION, A DURING THE CLINIC SECTION AND AFTER THE CLINIC
SECTION. THEN I WANT TO GO OVER AS WE GO
THROUGH THE CLINIC YOU WILL SEE SEVERAL OF THESE STOP SIGN
ICONS, THE STOP SIGN ICONS ARE PLACED IN AREAS THAT WE FELT
LIKE WERE OF CRITICAL IMPORTANCE. THAT IF A — SOMEONE FILLING OUT
THE FORM WERE TO CHECK NO IN ONE OF THE ROWS THAT IS INDICATED
WITH A STOP SIGN, THEY WOULD THEN NEED TO CONSULT THEIR
ORGANIZATION PROTOCOLS AND CONTACT STATE DEPARTMENT OF
PUBLIC HEALTH BEFORE PROCEEDING TO THE NEXT ROW SO THESE ARE
REALLY CRITICAL STEPS. THIS IS THE TITLE PAGE OF THE
CHECKLIST. MOST OF THE PAGE ON THE SCREEN
IS INSTRUCTION FOR HOW TO USE THE CHECKLIST THEN THIS IS SPACE
BELOW BLANK LINE WHERE IS THE COORDINATOR OF THE CLINIC SHOULD
FILL IN THEIR NAME, THE DATE LOCATION AND TIME OF THE CLINIC. AND THEN THAT’S A SPACE FOR THE
SUPERVISOR TO SIGN THAT INFORMATION. YOU CAN SEE THAT THE CDC LOGO IS
ON THIS RESOURCE, IT’S BEEN CLUE CDC CLEARANCE. SO THIS IS THE BEFORE SECTION OF
THE CHECKLIST AND GOES THROUGH VACCINE SHIPMENT TRANSPORT
STORAGE AND HANDLING. NOTICE THERE IS A FEW STOP SIGNS
THROUGHOUT HERE, THESE ARE MOSTLY AT MAKING SURE THAT THE
CLINIC WILL HAVE AN EMERGENCY MEDICAL KIT ON SITE AND THEY
ALSO WILL HAVE STAFF TRAINED IN CPR AND ABLE TO RESPOND TO
EMERGENCY SITUATIONS, THAT’S WHERE YOU WILL SEE MOST OF THE
STOP SIGNS IN THE BEFORE CLINIC SECTION. THIS IS ZOOMED IN SO YOU CAN SEE
HOW THE DOCUMENT IS LAID OUT. SO THE SECOND SECTION OF THE
CHECKLIST IS THE DURING THE CLINIC SECTION. SO THIS IS JUST A LITTLE BIT OF
A CLOSER LOOK AT THAT. AND THIS SECTION IS MEANT TO BE
COMPLETED DURING THE CLINIC AND REVIEWED AT THE END OF THE
SHIFT. SO THIS IS THE SECOND SUBSECTION
OF THE DURING THE CLINIC. WE HAVE A FEW STOP SIGNS HERE
MAKING SURE THE VACCINE IS NOT EXPIRED. MAKING SURE NOTHING IS OUT OF
THE TEMPERATURE RANGE AFTER BEING DRAWN UP. THIRD SUBSECTION IS VACCINE
ADMINISTRATION. SO THIS IS MAKING SURE THAT
CORRECT DOSE BEING GIVEN TO CORRECT PATIENT. SO YOU WILL SEE STOP SIGNS
THERE. THERE’S AN ADMINISTRATION OF
INJECTABLE VACCINE SECTION AS WELL DURING THE CLINIC. THIS IS THE FINAL STOP SIGN HERE
MAKING SURE MEDICAL INFORMATION IS PLACED IN A SECURE LOCATION. THE FINAL PAGE OF THE CHECKLIST
INCLUDES RESOURCES WE THOUGHT WOULD BE HELPFUL SHOULD SOMEBODY
HAVE ADDITIONAL QUESTIONS ABOUT ANY OF THE ROWS ON THE CHECKLIST. WE BELIEVE THE CHECKLIST IS
CERTAINLY USEFUL RESOURCE BUT ONLY USEFUL IF ACTUALLY BEING
USED SO WHENEVER WE GIVE PRESENTATIONS AROUND THE
CHECKLIST WE MAKE SURE TO ENCOURAGE FOLKS USING THE
CHECKLIST IF APPROPRIATE OR ENCOURAGE OTHERS TO ALSO USE THE
CHECKLIST. I WILL GO THROUGH THE
SUPPLEMENTAL MATERIALS HERE QUICKLY. SO WE HAVE A PLEDGE, A
SUPPLEMENTAL RESOURCE TO THE CHECKLIST, IT’S MEANT TO BE
SIGNED BY ORGANIZATION EXECUTIVES, WHO ARE AGREEING TO
ADHERE TO CDC GUIDELINES AND BEST PRACTICES FOR IMPLEMENTING
INFLUENZA CLINICS. AND ADHERING TO THE CHECKLIST
EVERY VACCINATION CLINIC. SO THAT THE PLEDGE IS MEANT TO
BE REVIEWED AND SIGNED ANNUALLY. WE ALSO RECOGNIZE THOSE THAT
SIGN THE PLEDGE ON THE SUMMIT WEBSITE YOU CAN SEE AN IMAGE OF
THAT HERE. WE ENCOURAGE THOSE ORGANIZATIONS
TO ALSO POST INFORMATION ON THEIR WEBSITE. INDICATING THEY FOLLOW THE GOLD
STANDARD VACCINATION SAFETY. THIS SHOWS YOU WHAT THE PLEDGE
LOOKS LIKE, IT’S JUST ONE PAGE. THERE’S INSTRUCTIONS HERE AT THE
BEGINNING AND THERE’S SECS THAT COVER FOLLOWING BEST PRACTICES
THAT VACCINATION CLINICS AND INCLUDING USING THE CHECKLIST,
ADHERING TO MANUFACTURE STORAGE AND HANDLING GUIDELINE, HAVING A
PLAN TO REPLACE EXPIRED OR DAMAGED VACCINES, SOME ADDITION
ANTIBODY REQUIREMENTS MAKING SURE VAX NAYTORS ARE ALLOWED TO
ADMINISTER VACCINES AND MAKE SURING THEY ARE TRAINED AND DEMONSTRATE COMPETENCIES AND
THERE’S PLACE FOR ORGANIZATIONAL EXECUTIVE TO SIGN AND DATE AT
BOTTOM OF THE DOCUMENT. ADDITIONAL TOOLS INCLUDE
FREQUENTLY ASKED QUESTIONS DOCUMENT, THIS IS JUST REALLY A
ZOOMED IN LOOK AT THE DOCUMENT SO YOU CAN SEE THE FIRST
QUESTION HERE, BUT THIS GREW OUT OF MANY QUESTIONS WE HAVE
RECEIVED SINCE PUBLISHING THE MATERIALS. SO THAT ALSO EXISTS. THEN WE PUT TOGETHER A ONE PAGE
SUMMARY RESOURCE, THIS IS NOT MEANT TO REPLACE THE CHECKLIST
BUT REALLY TO SUPPORT IT AND IT GOES THROUGH IN A SLIMMED
VERSION THE TEN KEY BULLET POINTS IN THE CHECKLIST WHEN WE
ORIGINALLY CREATED THIS WE THOUGHT IT WOULD WORK WELL LIKE
A POSTER FORMAT. THEN WHERE TO FIND RESOURCES,
THE WEBSITE YOU CAN SEE THE GRAY BAR AT TOP OF THE SCREEN, IT
SAYS HOME, WORK GROUP, CLICK ON WORK GROUP IT PROVIDE A DROP
DOWN MENU WITH INFLUENZA WORKS GROUP, CLICK ON THAT, IT WILL
TALK YOU TO THESE RESOURCES IN ADDITION TO OTHERS. YOU CAN ALSO GET TO IT THROUGH
THE HOME PAGE, THERE’S A ROTATING PICTURE ON THE HOME
PAGE, CLICK ON IT WHEN IT LOOKS LIKE THIS IT WILL TAKE YOU TO
RESOURCES AS WELL. I ALSO INCLUDED JUST DIRECT
LINKS IN THE SLIDE IF HELPFUL, WE ASK AGAIN FOLKS HELP SPREAD
THE WORD HERE BUT THEY ARE ALSO MEANT TO BE LIVING DOCUMENTS SO
WE WELCOME FEEDBACK. ENCOURAGE FEEDBACK AND QUESTIONS
WE UPDATE WHEN APPROPRIATE, IZSUMMITPARTNERS.ORG OR WE
ACCEPT FEEDBACK ON IT OR ALSO PROVIDE IT TO MYSELF OR DR. BEHRMAN TODAY. FINALLY I WANT TO THANK ALL OF
OUR WORK GROUP MEMBERS WHO HELPED CREATE DOCUMENTS AS WELL
AS MANY SUBJECT MATTER EXPERTS INSTRUMENTAL IN THE CREATION OF
THESE DOCUMENTS. I INCLUDED THE CONTACT
INFORMATION FOR ALL THE WORKING GROUP LEADS ON THIS SLIDE. THANK YOU.>>THANK YOU. [APPLAUSE]>>THANK YOU. MY NAME IS DIANE PETERSON, AS
DR. HOPKINS SAID I’M
REPRESENTING THE IMMUNIZATION ACTION COALITION THIS MORNING. AND THANK YOU TO THE COMMITTEE
FOR INVITING ME TO DO THIS. IF YOU ARE NOT FAMILIAR WITH THE
IMMUNIZATION ACTION CO-LUGS I KNOW MOST OF YOU — COALITION,
MOST MIGHT BE BUT SOME MIGHT NOT BE. WE ARE A 501C 3 NON-PROFIT
ORGANIZATION FOUNDED IN 1991. IN SAINT PAUL, MINNESOTA, AS A
GRASSROOTS ORGANIZATION TO AT THAT TIME VACCINATE REFUGEE
CHILDREN IN SAINT PAUL MINNESOTA. WE HAVE GROWN SINCE THAT TIME. WE NOW HAVE 30 STAFF MEMBERS,
MANY ARE IMMUNIZATION EXPERTS FROM ACROSS THE UNITED STATES,
SEVERAL RETIRED FROM CDC, WE SNATCH THEM UP QUICKLY IF WE
CAN. AND RETIRED FROM STATE HEALTH
DEPARTMENTS. ACTUALLY LJ DOESN’T REPRESENT
EITHER OF THOSE BUT WE HAVE LJ TAN AS ONE OF OUR PRIMARY
EXPERTS. THIS IS OUR MAIN WEBSITE, IMMUNIZE.ORG. THIS HAS BEEN IN EXISTENCE SINCE
1995. WE AVERAGE 25 VISITS A DAY —
25,000 VISITS A DAY. WHEN WE FIRST CHOSE OUR URL YOU
CAN SEARCH USING THE FOUR MOST SEARCH ENGINE AT THAT TIME WHICH
WAS ALTA VISTA. ON IMMUNIZE AND 11 ITEMS WOULD
COME UP. AND WE WERE AT THE TOP OF THE
LIST. NOW A GOOGLE SEARCH YIELDS
1.6 MILLION WEBSITE IS CURRENTLY STILL NUMBER ONE WHEN YOU SEARCH
ON HUE RECOGNIZE FOR THIS PRESENTATION I HAVE BEEN ASKED
TO TALK EDUCATIONAL MATERIALS THAT WE HAVE DEVELOPED AND TOOLS
THAT HELPED MEDICAL PRACTICES IMPLEMENT COMPLICATED LENGTHY
ACIP RECOMMENDATIONS AND HOW IT IS THAT THEY CAN FIND THEM ON
OUR WEBSITE. HERE IS THE OVERALL WEBSITE FOR
ALL OF OUR HAND OUTS AND WE HAVE OVER 300 HAND OUTS THAT ARE
WRITTEN FOR HEALTHCARE PROFESSIONALS. TO USE THEMSELVES OR GIVE TO
PATIENTS. ALL AVAILABLE IN PDF FORMAT
AVAILABLE FOR DOWNLOAD. MANY ARE JUST ONE PAGE. MAKE IT SIMPLE. WE HAVE DOWNLOADS NUMBERING MORE
THAN 7 1/2 MILLION PDF DOCUMENTS FROM OUR SITE EVERY YEAR. AND WHILE THESE DOCUMENTS ARE
PRIMARILY FROM THE U.S., ABOUT 12% ARE VISITS FROM OUT OF THE
UNITED STATES. MANY MATERIALS ARE AVAILABLE IN
OTHER LANGUAGES. WHILE THERE ARE MULTIPLE WAYS
YOU CAN GET TO MANY OF THESE HAND OUTS I WILL WALK YOU
THROUGH WHAT MIGHT BE THE EASIEST FOR TODAY’S DISCUSSION. IF YOU CHOOSE AS THIS ARROW
SHOWS, INFLUENZA, IT WILL TAKE YOU TO THE PAGE THAT LISTS
MATERIALS FOR INFLUENZA. I WILL START WITH OUR SCREENING
CHECKLIST. THIS IS A SELF-ADMINISTERED
CHECKLIST THAT CAN BE GIVEN TO THE PATIENT WHILE THEY ARE
WAITING IN THE CLINIC WAITING ROOM. THIS PAGE HAS FOUR SIMPLE
QUESTIONS, FOR THE INACTIVATED INFLUENZA VACCINE. OPT RIGHT YOU SEE AWE COMPANYING
PAGE FOR THE HEALTHCARE PROVIDER. IT EXPLAINS THE RATIONALE AND
THE NEXT STEPS FOR ANY QUESTIONS TO WHICH THE PATIENT WOULD
ANSWER YES OR DON’T KNOW. THE FOUR SIMPLE QUESTIONS COVER
ARE YOU SICK TODAY, DO YOU HAVE AN ALLERGY TO A VACCINE
COMPONENT, DO YOU HAVE A HISTORY OF GIOM BERET SYNDROME, SO
THERE’S THE EXPLANATION THE PAGE IS RATHER SIMPLE AND THE
RESPONSES ARE PRETTY STRAIGHT FORWARD TO TOO. THIS IS THE SCREEN QUESTION
THEIR FOR THE LIVE VIRUS VACCINE, INTRANASAL VACCINE. AS YOU CAN SEE IT HAS MORE
QUESTIONS IN IN ADDITION TO BASIC QUESTIONS I MENTIONED FOR
IIV, IT TALKS ABOUT HAVE YOU HAVE OTHER, ISSUES RECEIVING
ANTIVIRAL OR THINGS OF THAT TYPE WHICH WOULD BE A FLAG FOR THE
LIVE VIRUS VACCINE. OUR STANDING ORDERS ARE POPULAR,
THIS IS ARE THE TEMPLATES FOR INFLUENZA VACCINE. ON THE LEFT IS DESIGNED FOR
CHILDREN AND TEENS AND COVERS BOTH VACCINES, THE ONE ON THE
RIGHT IS FOR ADULTS. IT IS ACTUALLY ABOUT THREE PAGES
NOW. LITTLE MORE COMPLICATED. BUT IT COVERS SEVEN DIFFERENT
STEPS, ASSESS THE NEED FOR VACCINE, DO THEY FIX IN– FIT
INTO THE CRITERIA WHO SHOULD BE VACCINATED. OBVIOUSLY INFLUENZA IS SIMPLE. THE SCREENING, PRECAUTIONS THE
CONTRAINDICATIONS, PROVIDE VIS TO THE PATIENT, PREPARE TO
ADMINISTER THE VACCINE, IS IT IM, IS IT SUBQ, INTRANASAL. ADMINISTER THE VACCINE AND HOW
IS THAT DONE. DOCUMENT IT AND BE PREPARED TO
MANAGE ANY MEDICAL EMERGENCY AND IF NECESSARY, REPORT IT TO VARES
OR FOR CERTAIN REMIND THE PATIENT TO REPORT TO VARES. THESE ARE TWO DIFFERENT
EDUCATIONAL TOOLS, ONE ON THE LEFT IS A GUIDE FOR DETERMINING
THE NUMBER OF DOSES FOR YOUNG CHILDREN. IT GETS COMPLICATED AND
ALGORITHMS ARE A NICE WAY TO GO. THIS IS ACTUALLY TAKEN PRETTY
MUCH VERBATIM FROM THE ACIP RECOMMENDATIONS BUT IT’S ON JUST
ONE PAGE. THE SECOND ONE IS THE ISSUE OF
INDIVIDUAL EGG ALLERGY AND PRECAUTIONS IF ANY. HOW TO ADMINISTER INTRAMUSCULAR
AND INTRANASAL INFLUENZA VACCINE WITH DIAGRAM. ON THE LEFT SIDE AND THE RIGHT
SIDE IS ACTUALLY DESIGNED FOR HEALTHCARE PROFESSIONALS WHO
DECLINE TO BE VACCINATED. I CAN SPEAK A LITTLE MORE ABOUT
THAT ISSUE LATER ON. BE PREPARED TO MANAGE MEDICAL
ADVERSE EVENTS THAT MIGHT OCCUR DURING THE CLINIC. THIS IS CALLED MEDICAL
MANAGEMENT FOR REACTIONS IN IN CHILDREN AND TEENS IN A
COMMUNITY SETTING AND WE HAVE ONE ALSO FOR ADULTS, IT TALKS ABOUT THE MORE COMMON TYPES OF
REACTIONS THAT MIGHT OCCUR. AND SERIOUS REACTIONS SUCH AS
ANAPHYLAXIS AND HOW TO FOLLOW-UP WITH THAT. THESE TWO ARE VERY GENERAL TYPES
OF FLYERS FOR PARENTS, THE ONE ON THE LEFT JUST TALKS ABOUT THE
IMPORTANCE OF VACCINATING EVERYONE IN YOUR FAMILY AGAINST
INFLUENZA ON AN ANNUAL BASIS. THE ONE ON THE RIGHT IS ACTUALLY
TO HELP PARENTS RECOGNIZE EARLY SIGNS OF A CHILD THAT MAY HAVE
INFLUENZA AND MAY HAVE A TRIGGER THAT IS — COULD LEAD TO MORE
SERIOUS CONSEQUENCES INCLUDING DEATH. THIS PIECE THIS PAGE SHOWS ONE
OF OUR MORE POPULAR HAND OUTS AND IT’S IN RED BECAUSE AT THE
TIME I SUBMITTED IT FOR THE PRESENTATION HERE IT WAS STILL
IN DRAFT FORM. BUT WE DO THIS ANNUALLY IN TERMS
OF WHAT VACCINES ARE GOING TO BE AVAILABLE FOR THE COMING SEASON. HOW ARE THEY GOING TO BE
SUPPLIED THE MERCURY CONTENT, CERTAIN STATES HAVE CERTAIN
QUANTITIES OF DIMERYTHOL, THE AGE RANGE FOR THE VACCINE
PRODUCT WHICH CHANGES AND NEW THIS YEAR WE ADDED CVX CODES
BECAUSE THAT WAS REQUESTED BUT WE ALSO HAVE CPT CODES. THE ONE OTHER ASPECT OF OUR WEB
SO IT IS WHAT WE CALL ASK THE EXPERTS AND THERE YOU SEE PHOTOS
OF OUR EXPERTS. MANY OF WHOM I’M SURE YOU WOULD
RECOGNIZE BUT IF YOU CLICK ON INFLUENZA YOU WILL GET TO MORE
IN DEPTH DISCUSSION OF PROBABLY SITUATIONS THAT ARE NOT COMMONLY
ADDRESSED IN THE ACIP RECOMMENDATIONS THERE’S 92
QUESTIONS AND ANSWERS, THIS IS JUST UPDATED. AND JUST BEING ANNOUNCE TODAY AS OUR OTHER INFLUENZA HAND OUTS
THAT HAVE BEEN REVISED BASED ON THE ACIP RECOMMENDATIONS THAT
WERE PUBLISHED ONLY A FEW WEEKS AGO. BUT YOU WILL SEE QUESTIONS, I
HAVE A PATIENT WITH MULTIPLE SCLEROSIS. THEY GET A LITTLE PANICY REQUEST
THEY DON’T SEE IT IN THE RECOMMENDATIONS AND WHO DO THEY
CALL OR WHERE CAN THEY FIND IT SO I WOULD SAY GO HERE FIRST. NEW THIS YEAR IS THAT WE HAVE
BUTTONS AND STICKERS THAT WE ARE DISTRIBUTING FOR CLINICIANS TO
HOPEFULLY DISTRIBUTE THROUGHOUT THEIR STAFF DURING THE CLINIC
SEASON. GOOD REMINDER FOR PATIENTS TOO
IF THEY HAVEN’T HAD THEIR VACCINATION YET THAT THIS IS THE
TIME TO GET IT. WE HAVE RUN OUT OF THE FIRST
ISSUANCE OF THESE, SO THEY ARE CURRENTLY BEING REODDERRED SO
PLEASE CONSIDER — REORDERED SO CONSIDER THE VACCINE INFORMATION
STATEMENTS ONE ON THE LEFT IS FOR INACTIVATED VACCINE, ONE ON
THE RIGHT FOR INTRANASAL VACCINE, YOU CAN SEE WE ALWAYS
GET MANY, MANY REQUESTS FOR THESE AND HAVE QUITE A FEW OTHER
LANGUAGES THAT THEY COME IN AS WELL. THE HONOR ROLL FOR MANDATORY FLU
VACCINATION WE STARTED A FEW YEARS AGO TO PROVIDE A INVENTORY
YAW TO HONOR THOSE CHAMPIONS WHO HAVE TAKEN THE LEAD AND
MANDATING INFLUENZA VACCINATION WITHIN THEIR ORGANIZATION OR
INSTITUTION. TO BE INCLUDED IN THE HONOR ROLL
THE ORGANIZATION MANDATE MUST REQUIRE VACCINATION FOR
EMPLOYEES AND INCLUDE SERIOUS MEASURES TO PREVENT TRANSMISSION
OF INFLUENZA FOR THOSE WHO REFUSE. THOSE MEASURES MIGHT INCLUDE A
MASS REQUIREMENT THROUGHOUT THE INFLUENZA SEASON, REASSIGN TO
NEW PATIENT CARE DUTIES OR DISMISSAL. SO THOSE ARE THE CRITERIA, WE
HAVE OVER 800 CLINICS HOSPITALS AND HEALTHCARE SYSTEMS AND
OTHERS THAT HAVE MET THE CRITERIA FOR THE HONOR ROLL. IF YOU ARE INTERESTED IN YOUR
OWN STATE, YOU CAN SORT BY STATE AND YOU CAN SEE WHICH ARE THE
CLINICS ARE HEALTHCARE SYSTEMS IN YOUR STATES THAT HAVE
ACHIEVED THIS GOAL. WE HAVE UNPROTECTED PEOPLE
STORIES, SOMETIMES PUTTING THE STORY BEFORE A PATIENT IS
NECESSARY TO SEE THIS IS THE CONSEQUENCE. THIS WAS A HEALTHY PERSON,
HEALTHY CHILD, HEALTHY ADULT WHO ACQUIRED INFLUENZA AND DIED FROM
THE DISEASE. A LITTLE MORE ABOUT THE SUMMIT
WEBSITE THAT IS ONE OF THE ACTIVITIES THAT I MANAGE
INFLUENZA VACCINE AVAILABILITY TRACKING SYSTEM. A LITTLE WHILE AGO LIAISON
MEMBERS ASKED SUPPLY OF INFLUENZA VACCINE THIS YEAR. IT LOOKS TO BE GOOD THIS YEAR
BUT IT WAS I CAN’T REMEMBER HOW MANY YEARS AGO THAT THERE WAS A
REALLY SERIOUS SUPPLY ISSUE SO THE SUMMIT TOOK IT UPON HERSELF
TO CREATE THIS TRACKING SYSTEM. WHAT WE DO IS WE HAVE THE
MANUFACTURERS AND THE DISTRIBUTORS THAT REGISTER THAT
THEY HAVE VACCINE AVAILABLE, THIS WOULD BE FOR CLINICS NOW
THAT PERHAPS NEGLECTED TO REPREORDER OR THEY ARE RUNNING
OUT. SO THEY REGISTER ON THAT AND
THEY SUBMIT TO US THEIR — WHAT IS AVAILABLE AT THAT TIME. THEN I PUT TOGETHER A
SPREADSHEET WHICH THE CLINIC CAN CLICK ON THE BOTTOM PURPLE BAR
AND GET TO THIS SPREADSHEET WHICH LISTS ALL OF THE
MANUFACTURES AND DISTRIBUTORS THAT HAVE WHICH PRODUCT
AVAILABLE ON HAND AT THE MOMENT. THAT CONCLUDES MY PRESENTATION [APPLAUSE]>>THANK YOU SO MUCH FOR HAVING
US HERE TODAY. AMY BEHRMAN APPEARED AT THE
RIGHT TIME. I’M GOING TO SLIGHTLY SWITCH THE
FOCUS AND TALK TO YOU ABOUT HEALTHCARE PERSONNEL AND
INFLUENZA VACCINE SPECIFICALLY. HOPEFULLY BUILDING ON THE
PRESENTATIONS THAT YOU JUST HEARD. I WON’T SPEND TIME DESCRIBING
THE INFLUENZA WORKING GROUP AND THE, PANAL ADULT IMMUNIZATION
SUMMIT BECAUSE YOU ALREADY KNOW ABOUT THAT. I WILL SAY ONE OF OUR MOST
RECENT LARGEST PROJECTS HAS BEEN TO FOCUS ON THE ISSUE OF
INFLUENZA VACCINATION COVERAGE OPTIMIZATION AND LONG TERM CARE
FACILITY. THAT’S WHAT I’M GOING TO TALK
ABOUT TODAY. I WON’T TALK ABOUT THE SLIDE
MUCH BECAUSE YOU ARE HERE BECAUSE YOU KNOW HOW SERIOUS
THIS VACCINE PREVENTABLE DISEASE IS. BUT I DO WANT TO JUST EMPHASIZE
THAT OF ALL THE MANY INFECTION CONTROL MODALITIES IN PATIENTS
SETS THAT HELP DECREASE INFLUENZA, VACCINATION IS THE
SINGLE MOST EFFECTIVE. THAT’S PROBABLY BECAUSE IT’S
PASSIVE ONCE YOU ARE IMMUNIZED, AND YOU DON’T HAVE TO REMEMBER
TO DO ANYTHING. YOUR IMMUNE SYSTEM WILL DO IT
FOR YOU. WE KNOW THAT VULNERABLE PATIENTS
IN MANY GROUPS FROM NEONATES TO ELDERLY TO THOSE WITH CHRONIC
DISEASE ARE MORE LIKELY TO SUFFER SERIOUS CONSEQUENCES,
HOSPITALIZATION AND DEATH FROM INFLUENZA. WE ALSO KNOW THOSE PEOPLE HAVE
THE WEAKEST RESPONSE TO INFLUENZA VACCINES. WE ALSO KNOW THAT HEALTHCARE
PERSONNEL OFTEN WORK SICK OFTEN HAVE YOUNG HEALTHY ADULTS WITH
ROBUST IMMUNE SYSTEMS. THEREFORE WE THINK ARE ONE OF
THE PRIME GROUPS WE SHOULD BE CONCENTRATING ON FOR EXCELLENT
IMMUNIZATION COVERAGE SEASONALLY FOR INFLUENZA. THAT’S IN THE HOPE THAT THIS
WILL NOT ONLY PROTECT THEM, BUT ALSO DECREASE TRANSMISSION RISK
TO THEIR PATIENTS IN MULTIPLE SETTINGS. SO A PICTURE OF TWO VULNERABLE
PATIENTS, WE WILL FOCUS TON RIGHT. THIS IS MY DAD, IN USED WITH HIS
PERMISSION. JUST DRIVE HOME TO ME HOW
IMPORTANT THIS IS. NO SURPRISE, THE VAST MAJORITY
OF INFLUENZA SERIOUS CASES INFLUENZA HOSPITALIZATIONS AND
DEATH ALMOST EVERY YEAR ARE CONCENTRATED IN THE ELDERLY AND
EVEN IN THE VERY OLD. IN FACT WITHIN LONG TERM CARE
FACILITIES CASE FATALITY RATES CAN BE HIGH AS 55%. BIG, BIG ISSUE. OUTBREAKS WITHIN LONG TERM CARE
FACILITIES ARE NOT RARE. I PUT UP A COUPLE OF EXAMPLES
FROM A COUPLE OF STATES AND THESE PROBABLY UNDERESTIMATE THE NUMBER OF TRUE OUTBREAKS SINCE
THEY ARE LABORATORY PROVEN AND REPORTED TO PUBLIC HEALTH
AUTHORITIES WHEREAS MANY OUTBREAKS MAY HAVE NEITHER OF
THOSE CRITERIA. NO SURPRISE YOU HAVE A LOT OF
VULNERABLE PEOPLE LIVING IN CLOSE PROXIMITY WITH EACH OTHER
AND CARED FOR BY HEALTHCARE PERSONNEL WHO HAVE VERY CLOSE
PHYSICAL CONTACT WITH THEIR PATIENTS AS THEY NECESSARILY
ASSIST IN ACTIVITIES OF DAILY LIVING AS WELL AS HEALTHCARE. SO IT’S KIND OF A SETUP. IT IS THEREFORE IMPORTANT TO
KNOW NOT SURPRISING THAT SOMETIMES OUTBREAKS IN LONG TERM
CARE FACILITIES HAVE ACTUALLY BEEN ASSOCIATED WITH PROVEN
DOCUMENTED LOW VACCINATION RATES AMONG HEALTHCARE PERSONNEL. I WILL SAY AS AN ASIDE THAT I’M
USING THE TERM LONG TERM CARE FACILITY TO BE A LITTLE BIT
CONCISE, WE INCLUDE IN THAT ASSISTED LIVING FACILITIES AND
POST ACUTE CARE FACILITIES. SO I APOLOGIZE FOR USING SHORT
CUT BUT THAT’S WHAT IT MEANS. HERE IS REALLY THE THING THAT I
THINK SHOULD DRAW OUR ATTENTION MOST. THERE’S BEEN STUDIES, SOME ARE
RANDOMIZED CONTROL STUDIES. SHOWING THAT INCREASING
INFLUENZA VACCINATION RATES AMONG HEALTHCARE PERSONNEL IN
LONG TERM CARE FACILITIES HAS LED TO SUBSTANTIAL DECREASES IN
INFLUENZA LIKE ILLNESS AND ALL CAUSE MORTALITY. YOU MIGHT NOTICE I SAID
INFLUENZA LIKE ILLNESS, THAT’S PRIMARILY BECAUSE INFLUENZA
DIAGNOSTIC OR NOT ROUTINELY AVAILABLE IN THESE SITES WHERE
THESE STUDIES ARE CARRIED OUT AT THE TIME. AND ALL CAUSE MORTALITY REFLECTS
WHAT WE NOW KNOW WHICH IS INFLUENZA INFECTION CANNOT ONLY
KILL DIRECTLY CANNOT ONLY KILL BY INCREASING DEATH IN PEOPLE
WITH UNDERLYING RESPIRATORY DISEASE BUT IS ALSO PARTICULARLY
DANGEROUS AND LIKELY TO CAUSE DEATH IN PEOPLE WITH CARDIAC
DISEASE AND OTHER UNDERLYING CHRONIC ILLNESS. SO THE CKC RECOMMENDS ACROSS THE
BOARD AND COMPLETELY APPROPRIATELY THAT ALL
HEALTHCARE PERSONNEL SHOULD BE VACCINATED ANNUALLY FOR
INFLUENZA. WE WOULD SAY THE INFLUENZA
WORKING GROUP REASON THIS WAS PARTICULARLY IMPORTANT FOR LONG
TERM CARE FACILITY STAFF. WE ALSO NOTE IN ADDITION TO THE
DIRECT POSITIVE EFFECTS ON THE HEALTHCARE PERSONELL AND THEIR
PATIENTS FROM DECREASING INFLUENZA RISK YOU CAN ALSO SHOW
DECREASE ABSENTEEISM WITH WORKPLACE INFLUENZA VACCINATION
TO SAY QUALITY OF CARE FOR OTHER METRICS SUCH AS PHYSICAL
RESTRAINT USE, URINARY CATHETER USE, INADEQUATE PAIN MANAGEMENT
AND PRESSURE SORES MAY ALSO BE HELPED BY DECREASING ABSENTEEISM
INCREASING IMMUNOGEN. IS IS IT’S A WIN WIN WIN. .
DESPITE EVERYTHING I HAVE JUST SAID AND DESPITE THE FACT THAT
LET ME EMPHASIZE THE DATA THE STUDIES SHOWING BENEFIT TO
PATIENTS FROM HEALTHCARE WORKERS VACCINATION ARE STRONGEST AND
EXIST IN PRIMARY CARE SETTINGS. DESPITE THIS, THE IMMUNIZATION
RATES OVER THE LAST DECADE IN THE U.S. FOR STAFF FROM LONG
TERM CARE FACILITIES HAVE LAGGED SUBSTANTIALLY BEHIND AND BELOW
OTHER H WORKERS SO THE RED DOTTED LINE ON THE BOTTOM IS
VACCINATION RATES FOR LONG TERM CARE FACILITY STAFF AND IT’S
JUST REALLY NOWHERE NEAR THE GOAL, THE HEALTHY PEOPLE 2020
GOAL OF 90% FOR HEALTHCARE PERSONNEL AND HONESTLY NOWHERE
NEAR LEVELS WHERE YOU WOULD EXPECT TO SEE POSITIVE EFFECT ON
RESIDENTS FROM THOSE FACILITIES. SO WHY IS THIS? PROBABLY A LOT OF REASONS AND
CERTAINLY LONG TERM CARE FACILITIES HAVE CHALLENGES IN
TERMS OF STAFFING AND MARGINS THAT ARE TO SOME EXTENT
CONCENTRATED IN THAT SPHERE. THERE ARE ALSO STUDIES SHOWING
HEALTHCARE PERSONNEL IN THOSE SETTINGS OFTEN HAVE VERY
INACCURATE BELIEFS TO THAT INFLUENZA VACCINATION, BELIEVING
THAT IT MAY BE HARMFUL AND CERTAINLY INEFFECTIVE ON — AND
THEY ALSO VOID FOR OTHER REASONS INCLUDING NEEDLINGS AND WANTING
NOT NO TO PUT UNNECESSARY FOREIGN SUBSTANCES INTO THEIR
BODIES. THESE COME UP OVER AN OVER ON
SURVEY. THERE’S BEEN A LOT OF WORK DONE
ON SOME BY PEOPLE IN THIS ROOM TO HELP BLUNT THAT EFFECT OF
MISBELIEF ABOUT INFLUENZA VACCINE IN THIS SPHERE. THEY WORK TO A LIMITED EXTENT. VACCINATION RATES IN THIS
SETTING AMONG HEALTHCARE PERSONNEL WILL IMPROVE WITH
EDUCATION AND SOMEWHAT MORE WITH INTEGRATED STRATEGIES THAT
INCLUDE OTHER INFECTION CONTROL TECHNIQUES AND TECHNIQUES TO
ENGAGE EMPLOYEES IN THE PRINCIPLES AND CONCEPT OF
INFLUENZA VACCINATION. BUT IT’S PRETTY NOTICEABLE THAT
ALMOST NO VOLUNTARY EFFORTS IN THIS SPHERE HAVE LED TO VACCINATION RATES OF ABOVE 90%. THAT IS A SAD FACT. AND WE ALSO KNOW, I WILL
INTRODUCE AT THIS POINT, THAT VACCINE — ALL THOSE PROBLEMS
EXISTED IN ACUTE CARE AND VACCINE DATES OR VACCINE
EMPLOYER REQUIREMENTS IN HOSPITALS AND OTHER ACUTE CARE
SETTINGS HAVE BEEN TO INCREASE IMMUNIZATION RATES AMONG
HEALTHCARE PERSONNEL PRETTY DRAMATICALLY. AT THIS POINT I WILL STOP
SHOWING THAT KIND OF SLIDE AND SEGUE INTO A NARRATIVE. THERE ARE MANY PUBLICATIONS THAT
WILL TELL YOU, I HAVE THEM REFERENCED WHAT I’M GOING TO
SAY, THIS IS HOW IT PLAYED OUT IN REAL LIFE AT A TYPICAL LARGE
ACADEMIC MEDICAL CENTER THE ONE I WORK AT, UNIVERSITY OF
PENSACOLA. SO — UNIVERSITY OF
PENNSYLVANIA. IN 2004 I HAD THE SAME DAY JOB,
LARGELY FOCUSED ON CONTROLLING THOSE INFECTIONS FOR HEALTHCARE
PERSONNEL IN THIS LARGE TERTIARY ACADEMIC SETTING. WE HAD ALL THE HEALTHCARE
VACCINES THE CDC RECOMMENDS AN WE WERE DOING GREAT WITH MOST OF
THEM, SO THE TOP HALF OF THE SLIDE MEASLES MUMPS RUBELLA
VARICELLA REQUIRED, WE ADDRESSED HIGHER, YOU DON’T THANKFULLY
HAVE TO DO THEM ANNUALRY AND WE HIT A HUNDRED PERCENT THOUGH
THERE ARE SOME MEDICAL CONTRAINDICATIONS TO THESE LIVE
VIRUS VACCINES. WE HAD EXACTLY THE SAME
RECOMMENDATION FOR INFLUENZA VACCINE, VERY SAFE KILL VACCINE
AS Y’ALL KNOW AND WE WERE DOING EVERYTHING YOU ARE SUPPOSED TO
DO TO GET GOOD ACCEPTANCE. WE MADE IT FREE, SUPER CONVENIENT, I WON’T BELABOR THE
POINT BUT WE MADE IT AVAILABLE TO PEOPLE. AT THAT POINT EMPHASIZE 15 YEARS
AGO THIS WAS NOT ATYPICAL, OUR VACCINATION RATES BARELY
APPROACHED 50%. CLEARLY INEFFECTIVE. WE ASKED OURSELF IT IS SAME
QUESTION EVERYBODY ELSE IS ASKING WHY ARE PEOPLE SAYING NO? SO WE SENT OUT DECLINATION
FORMS. THESE ARE ACTUAL QUOTE FROM OUR
DECLINATION FORMS, 2006, 2007. I WON’T READ THEM BECAUSE YOU
CAN READ THEM. BUT THEY SHOULD LOOK FAMILIAR
BECAUSE THEY ARE THE SAME THINGS THE LONG TERM CARE FACILITIES
STAFF SAY ON THEIR DECLINATION. THE SAME THING OTHER ACUTE CARE
INSTITUTIONS SEE IN DECLINATION FORMS. THIS IS GLOBAL. YOU GET THE SAME ANSWERS MANY
MULTIPLE COUNTRIES. SO IT’S A BIG PROBLEM. WE DID NOT REALIZE HOW
POTENTIALLY LIMITED EDUCATION — THOUGH IMPORTANT HOW POTENTIALLY
LIMITED EDUCATIONAL OUTREACH WAS. WE WENT GUNNING HO ON THIS, WE
REVED UP OUR PROGRAM AND TRIED TO RESPOND TO ALL THOSE
RESPONSES. WE HAD MULTI-MEDIA OUTREACH IN
EVERY FORM WE CAN THINK OF ELECTRONIC AND PAPER. WE EVENTUALLY MADE A MUSIC VIDEO
THAT ADDRESSED WITH ITS LYRICS ALL THE CONCERNS. IT’S STILL ON YOUTUBE. PEOPLE LOVE THIS VIDEO AND
PEOPLE IN IT ARE OUR STAFF, PEOPLE PLAYED IT ALL THE TIME,
THEY STILL PLAY IT BUT GUESS WHAT, WE DID SIGNIFICANTLY BUT
COMPLETELY INADEQUATELY BUMP OUR IMMUNIZATION RATES, 50% CLINICAL
STAFF AND LESS THAN THAT FOR EVERYBODY ELSE. UNFORTUNATELY WE WERE FORCED TO
CONSIDER THIS A FAILURE IN TERMS OF REACHING ACCEPTABLE LEVELS. WE BEGAN TO THINK ABOUT WHETHER
AGAIN NOT ALONE IN THIS, OTHER ACUTE CARE INSTITUTIONS WERE
DOING THE SAME THING AT EXACTLY THE SAME TIME. AND BEGINNING TO PUBLISH IT. WE THOUGHT ABOUT THE REASONS
AGAINST VACCINE MANDATE OR EMPLOYER REQUIREMENT, THOSE
APPLY TO LONG TERM CARE JUST AS MUCH. NOBODY LIKES BEING TOLD WHAT
THEY HAVE TO DO. I DON’T.
ESPECIALLY NOT EVERY YEAR. WE WORRIED IT WOULD MAKE STAFF
RECENT THE WHOLE PROGRAM AND POTENTIALLY THREATEN IT FROM ITS
CURRENT — ITS THEN CURRENT LEVEL AND WE KNEW SOME VOLUNTARY
PROGRAMS ARE DOING BETTER. WE ALSO KNEW MOST VOLUNTARY
PROGRAMS WEREN’T DOING BETTER AND COUPLE OF PARENTS
INSTITUTIONS REFERENCED BOTTOM OF THE SLIDE, HAD ESSENTIALLY
DOUBLED THEIR IMMUNIZATION RATES FROM BASICALLY 50% TO ALMOST
100%, WITH THE IMPLEMENTATION OF EMPLOYER REQUIREMENTS. WITH IMPLEMENTED A MANDATE WELL
RESOURCE WITH EDUCATIONAL MATERIALS BROAD IN SCOPE
COVERING EVERYBODY WHO COMES IN AND BREATHES THE AIR IN THE
INSTITUTION. THIS IS WHAT HAPPENS. THAT’S THE SAME GRAPH ON — FROM
THE CDC, HASN’T BEEN UPDATED THIS YEAR BUT YOU CAN SEE THE
DIFFERENT SETTINGS WITH LONG TERM CARE ON THE BOTTOM BUT THAT
RED LINE ON THE TOP IS US. WE ARE — THAT’S EXCLUDING 1%, 1.2% EXEMPTION RATE. WE HAVE BEEN OVER 98%
VACCINATION RATE SINCE WE IMPLEMENTED THIS MANDATE. THAT IS COMMONLY OBSERVED AMONG
PEER INSTITUTIONS. SO THE BOTTOM LINE IS DOES
HEALTHCARE PERSONNEL EFFECTIVELY ARE DEUCE RISK FOR PATIENTS IN
OTHER STAFF? IT IS HARD TO TELL THAT IN THE
LITERATURE BECAUSE FLU SEASONS VARY BECAUSE THERE’S ILLNESS
CURRENT ILLNESSES THAT RESEMBLE FLU AND IMPACT ABSENTEEISM BUT
IN LONG TERM CARE FACILITIES WE KNOW THIS WORK. I THINK IT WORKS EVERYWHERE BUT
I KNOW IT WORKS IN LONG TERM CARE. MANDATES, AKA EMPLOYER
REQUIREMENTS WORK TO RAISE IMMUNIZATION RATES, THEY
ABSOLUTELY DO. IN MULTIPLE SETTINGS IN ACUTE
CARE. SO WE REASONED THAT THIS SHOULD
WORK IN LONG TERM CARE AS WELL. IN FACT, RELATIVELY FAIRLY
RECENT STUDY IN THE BOTTOM HALF OF THE SLIDE CONFIRMED THAT EVEN
IN LONG TERM CARE, WHERE THERE’S A LITTLE BIT LESS EVIDENCE THAN
EMPLOYER REQUIREMENTS BROUGHT VACCINATION RATES IN THE STUDIED
INSTITUTIONS UP TO NEAR 90% WERE AS NEARLY PROMOTING IT OR DO
NOTHING OR DOING NOTHING ON THE PART OF THE EMPLOYER LED TO
COMPLETELY INADEQUATE IMMUNIZATION RATES. VACCINATION REQUIREMENTS ARE
SUPPORTED BY MULTIPLE PROFESSIONAL ASSOCIATIONS,
INCLUDING IN RED AMDA, THE MEDICAL DIRECTORS ASSOCIATION
FOR LONG TERM POST ACUTE CARE ORGANIZATIONS. SO OUR DELIVERABLE WAS TO CREATE
A TOOL THAT WOULD ASSIST LEADERSHIP LONG TERM CARE
FACILITIES MOVING FORWARD WITH EMPLOYER REQUIREMENT SHOULD THEY
WISH TO DO SO. IN DOING THIS WE PARTNERD WITH
THE GERANTO LOGIC SOCIETY OF AMERICA. THANK YOU, ELIZABETH, AND ON
MULTIPLE FRONTS MOST HOPEFULLY MEETING WITH THEM IN MID-YEAR
2018. WE PARTNERED WITH CMS AND
PRESENTED THESE CONCEPTS ON MULTIPLE OCCASIONS TO THEIR
QUALITY IMPROVEMENT NETWORKS AND ORGANIZATIONS. FINALLY, WE PARTNERED WITH, AMDA
MEDICAL DIRECTORS GROUP AND SPONSORED A 2018 MEETING FOR
SELECTED STAKEHOLDERS AND EXECUTIVES FROM LONG TERM CARE
ORGANIZATIONS. AND MOST RECENTLY WE HAVE THE
PRIVILEGE OF PRESENTING TO Y’ALL TODAY. THANK YOU AGAIN FOR THE
INVITATION. THIS IS A SCREEN SHOT OF THE
DOCUMENT ITSELF, AVAILABLE FOR FREE FOR ANYBODY ON THE WEBSITE
AND ALL THE WAYS THAT KELLY INDICATED. IT INCLUDES A SECTION WHICH ARE
MODULAR AND HYPERLINKED ON THE RATIONALE FOR SUCH A PROGRAM,
OPERATIONAL TIPS FOR IMPLEMENTING IT AND SAMPLE
DOCUMENTS INCLUDING A SAMPLE POLICY. AND EXEMPTION FORM TO BE USED IF
HELPFUL FOR ANY ORGANIZATION. BUT SPECIFICALLY LONG TERM CARE
FACILITIES. ONE OTHER THING TO TELL YOU,
BEAUTIFULLY INTRODUCED OR SET UP BY THE PRIOR SPEAKER. AS YOU KNOW, THE IMMUNIZATION
ACTION AS OWE NOW KNOW THE IMMUNIZATION ACTION COALITION
HAS A WONDERFUL HONOR ROLL FOR FACILITIES TO IMPLEMENT
INTEGRATED VACCINE REQUIREMENTS FOR HEALTHCARE PERSONNEL AND
INFLUENZA. IN OCTOBER OF 2018 JUST BEFORE
WE HAD THAT MEETING WITH THE AMDA REPRESENTATIVES, THERE WERE
SIX LONG TERM CARE FACILITIES RECOGNIZED ON THE HONOR ROLL. NOT ONLY WAS THAT A TINY NUMBER
THEY WERE BURIED IN THE 800 PEOPLE, INSTITUTIONS THAT WERE
HER THERE. SO I AM THRILLED TO TELL YOU
RIGHT NOW SEPTEMBER 2019, THERE ARE 130 LONG TERM CARE
FACILITIES RECOGNIZED ON THAT HONOR ROLL. THANKS TO THE IAC WE HAVE
DEDICATED HONOR ROLL FOR LONG TERM CARE FACILITIES TO SEE
THEMSELVES AND PATIENTS, CLIENTS, FAMILY MEMBERS,
HEALTHCARE PERSONNEL, POLICY MAKERS CAN ALSO EASILY SEE WHICH
FACILITIES AND WHICH STATES IN THE LONG TERM CARE SPHERE HAVE
JUMPED IN TO THIS VERY EFFECTIVE INTERVENTION. SO I WON’T BELABOR THE POINT
EXCEPT TO EMPHASIZE WE DO HAVE A RELATIVELY NEW TOOL WHICH WE
URGE YOU TO LOOK AT, TO COMMENT ON, TO ASK US ABOUT AND TO SHARE
WITH ANY STAKEHOLDERS YOU MAY BE INVOLVED WITH, FOR ASSISTING
LONG TERM CARE FACILITIES WITH EMPLOYER REQUIREMENTS. WE DO HAVE A NEW INCENTIVE,
THANKS TO THE IMMUNIZATION ACTION COALITION WHICH IS A
DEDICATED HONOR ROLL WHICH I BELIEVE IS GOING TO EXPLODE
AGAIN WITH ANOTHER SIGNIFICANT INCREASE IN INSTITUTIONS WITHIN
THE MONO. AND NEW OPPORTUNITIES SPEAKING
TO YOU TODAY. THANK YOU VERY MUCH.>>ANY COMMENTS OR QUESTIONS?>>THANK YOU FOR ALL THREE
SPEAKERS FOR THE INFORMATIVE PRESENTATION. QUESTION REGARDING THE
INTRODUCTION OF MANDATORY OR REQUIRED INFLUENZA VACCINATION
FOR HEALTHCARE PROFESSIONALS. WE DO KNOW AS YOU MENTION SOME
DATA ON OF DATA ON DECREASING ABSENTEEISM AN RANDOMIZE TRIALS
AND WHAT NOT, HAVE YOU IMPLEMENTED OR STUDIED AT YOUR
INSTITUTION THE BEFORE AN AFTER EFFECT, BEFORE MANNED TOWER
VACCINATION REQUIREMENT AND AFTER THE MANDATORY VACCINATION
REQUIREMENT AN ABSENTEEISM OR INFECTION RATES.>>WONDERFUL AND COMPLEX
QUESTION. THERE IS — THERE’S A FEW NEW
PUBLICATIONS OUT INDICATING ABSENTEEISM AMONG HEALTHCARE
PERSONNEL IN ACUTE CARE SETTINGS IS DECREASING. IT’S NOT AN ENORMOUS LITERATURE
AND I PERSONALLY BELIEVE THAT IS BECAUSE OF THE CHALLENGINGLY
COMPLEX EPIDEMIOLOGY OF INFLUENZA IN GENERAL. BUT LOOK FOR A NEW PUBLICATION
OUT FROM MD ANDERSON FOLLOWING THEIR IMPLEMENTATION OF VACCINE
INFLUENZA VACCINE MANDATE. THEY DID A BEFORE AND AFTER
STUDY OPPOSED TO A CLUSTER STUDY SUCH AS YOU PREVIOUSLY
REFERENCED. I DON’T HAVE OTHER ONES AT THE
TIP OF MY TONG BUT A GOOD QUESTION AND VERY DIFFICULT
THING TO STUDY. PUBLICATIONS THAT I FIND MOST
CONVINCING IN LONG TERM CARE ARE NOT THAT NEW. THEY ARE FROM THE DECADE
PRECEDING THIS ONE ABOUT 2010 ONWARD. MANY GUN OUTSIDE THE COUNTRY BUT
I THINK IN SETTINGS THAT COMPLETELY ANALOGOUS TO LONG
TERM CARE SETTINGS ANYWHERE. IS THAT HELPFUL?>>THANK YOU.>>JOB DONE. I LIKE TO THANK YOU ALL ALSO,
ALL TERRIFIC QUESTIONS. MY QUESTION ALSO HAS TO DO WITH
MANDATORY FLU VACCINATION. IT WAS MOSTLY TO SEE WHAT YOUR
EXPERIENCE HAD BEEN REGARDING SOMETHING SPECIFIC OUT IN
SEATTLE, SEVERAL HOSPITAL SYSTEMS AND HEALTHCARE LARGE
HEALTHCARE SYSTEMS OVER THE LAST DECADE HAVE ALL MOVED TO EXACTLY
THIS TYPE OF THING. WITH STRIKINGLY SIMILAR SUCCESS,
COMPARED TO WHAT YOU SHOW. THERE WERE — THAT WAS STARTED
BY A FEW ISOLATED ORGANIZATIONS AND THEY HAD A DIFFICULT TIME
EARLY ON. IN FACT ALL THE ORGANIZATIONS
EXPERIENCED A LOT OF RESISTANCE TO PEOPLE DOING THIS. IT WAS SOMEWHAT EASIER FOR THOSE
ORGANIZATIONS THAT CAME IN THE SECOND WAVE BECAUSE AFTER THE
FIRST HOSPITAL AND CLINIC SYSTEM HAD DONE IT, A WHOLE BUNCH OF US
FRANKLY ALL DID IT TOGETHER. ONCE THERE WAS CRITICAL MASS IT
WAS EASIER BECAUSE THAT WAS AMONG HEALTHCARE WORKER, IT WAS
MORE OR LESS COMMUNITY STANDARD, EVERY PLAY THEY LOOKED IN TOWN
THEY WERE SEEING SOMETHING ANALOGOUS. WITH LONG TERM CARE FACILITIES,
WHICH MAY BE LITTLE INDEPENDENT OR MAYBE OWNED BY LARGE
ORGANIZATIONS, HAVE YOU RUN INTO THE SAME CHALLENGE, HAVE YOU
FOUND IT DIFFICULT TO CONVINCE PLACES TO DO THIS WITHOUT THE
COVER OF HAVING EVERYBODY ALL DOING IN LOCK STEP? IF SO, WOULD THERE BE BENEFIT TO
HAVING EVERYBODY TRY TO DO THIS AS A SINGLE UNIT AT THE SAME
TIME IN NEW AREAS YOU TRY TO HAVE THIS IMPLEMENT.>>FIRST I AM SURE YOU ARE
RIGHT. SECONDLY, A SHOUT OUT TO SEATTLE
WHERE I BELIEVE THE FIRST EMPLOYER MANDATE AT THE FIRST
HOSPITAL WAS IMPLEMENTED AND PUBLISHED WHICH WAS VERY
INSPIRING TO EVERYBODY NOT JUST PACIFIC NORTHWEST. I THINK THE CHALLENGES FOR LONG
TERM CARE FACILITIES ARE ENORMOUS. IN MANY WAYS AND IN TERMS OF
IMPLEMENTING PROGRAM WITH FIXED EXPENSES AND VACCINE AND
STAFFING AND PROVIDING THE SAFE EFFECTIVE OPERATIONS MY
COLLEAGUE KELLY MCKENNA DESCRIBED. I THINK MARGINAL PROFIT MARGINS
AND ENORMOUS STAFF TURN OVER ARE ADDITIONAL CHALLENGES. I AM HUMBLED WHAT THEY MANAGE TO
ACHIEVE. THAT’S THE REASON IN ADDITION TO
LACK OF PUBLICITY AND FOCUS THEY HAVE LAGGED FAR MIND. WE HOPE TO HELP ADDRESS THAT. A LOT OF MY OPINION A LOT OF
POTENTIAL IN CREATING A NORM FOR THIS AMONG LONG TERM CARE
FACILITIES AS IT HAS BECOME AS YOU SAID, A NORM IN ACUTE CARE
SETTINGS IS HAVING LARGE INFLUENTIAL GROUPS TAKE THIS ON,
COMMIT TO IT, AND PUBLICIZE IT AND HOPEFULLY PUBLICIZE IT IN
WAY THAT IS VISIBLE TO PATIENTS AND FAMILY MEMBERS MAKING
DECISIONS AN PEER GROUPS IN TERMS OF C SUITE AND PEOPLE WHO
WORK IN THESE FACILITIES. THAT TRANSPARENCY HERE, THE
WONDERFUL JUMP IN TERMS OF MOVING FROM SIX TO 130
FACILITIES ON THE IAC DEDICATED HONOR ROLE, THOSE ARE ALMOST
ENTIRELY FROM ONE GROUP WITH MULTIPLE FACILITIES, BUT THE
ABILITY TO HAVE A CENTRALIZED POLICY. ANOTHER LARGE GROUP, I DON’T
KNOW IF I CAN SAY THEIR NAME THOUGH THEY PROBABLY WANT ME TO
WILL DO SO THIS MONO. IN A FASCINATING WAY INTEGRATE
REQUIREMENT, I DON’T KNOW EXACTLY HOW THEY ARE GOING TO
RUN IT OR WHAT DETAILS OF THE POLICY MAYBE BUT THEY MADE IT A
COMPREHENSIVE APPROACH NOT ONLY TO STAFF BUT PATIENTS WHICH
SURELY MUST BE FROM A LOGICAL SCIENTIFIC POINT OF VIEW THE
BEST WAY TO GO. SO I HOPE IN SUMMARY, THAT
HAVING LARGE GROUPS EVEN IF NOT ACADEMIC GROUPS, MOVE IN THIS
DIRECTION WILL IN FACT MOVE THE NEEDLE AND EVENTUALLY ACCELERATE
IT.>>THANK YOU VERY MUCH.>>MELODY BUTLER.>>THANK YOU VERY MUCH FOR THE
PRESENTATION. I AM VERY APPRECIATIVE FOR THE
HARD WORK AN DEDICATION FROM THE NATIONAL ADULT AND INFLUENZA
IMMUNIZATION SUMMIT AND FOR IMMUNIZATION ACTION COALITION. AS A NURSE I’M CONSTANTLY GOING
TO THE WEBSITES USING IT FOR PATIENT EDGE CASE AND STAFF
EDUCATION, IT WILL EASY TO USE RESOURCES AND TOOLS YOU PROVIDE
ARE FUNDAMENTAL FOR SAFE WORKING PRACTICES. WHAT ARE YOUR CHALLENGES IN
GETTING THE INFORMATION YOU PROVIDE, TO CURRENT HEALTHCARE
PROVIDERS WORKING AND THE NEW INCOMING MEMBERS OF THE NURSE
AND COMMUNITY AND MEDICAL COMMUNITY?>>IT’S ON. CHALLENGES TO GET THE MATERIALS
OUT WHILE ALL OF YOU WE DEPEND ON TO BE ACTIVE ON OUR WEBSITE,
TODAY IS WHEN WE ARE — YOU WOULD RECEIVE OUR WEEKLY EMAIL
NEWS LETTER UPDATE WHICH INDICATE ALL THE NEW MATERIALS
WE HAVE. SO IF YOU HAVEN’T SUBSCRIBED GO
TO IMMUNIZE.ORG/SUBSCRIBE AND SIGN UP FOR IAC EXPRESS. SO GET THE WORD OUT. BUT FOR YOUNGER HEALTHCARE
PROFESSIONALS NOT FAMILIAR WITH US, THAT IS A CHALLENGE. WE DO EVERYTHING — WE USED TO
MAIL OUT NEEDLE TIPS. ANYBODY REMEMBER THAT? WE HAD HUGE SUBSCRIPTION LISTS
AND IT WENT TO RESIDENCY PROGRAMS AND WHAT NOT BUT WE
DON’T DO THAT ANY MORE. WE DEPEND ON PEOPLE TO SUBSCRIBE
TO US TO GET THAT TYPE OF INFORMATION TO GET ASKED THE
EXPERTS WHEN UPDATED TO GET THE NEW STANDING ORDERS AND WHAT
NOT. BUT WE ARE PROMOTING OURSELVES
AS MUCH AS WE CAN. AS OFTEN AS WE CAN. I’M WEARING A BUTTON RIGHT NOW
THAT SAYS VACCINE SAVES LIVES AND IN SMALL PRINT,
IMMUNIZE.ORG. I WE ARE IT ALL THE TIME, THIS
IS SOMETHING NEW, IT’S A PIECE OF JEWELRY ACTUALLY, IT’S KIND
OF GOLD. BUT I WILL WALK DOWN THE FILE OF
THE PLANE AND I HAVE PEOPLE SAY I LIKE YOUR BUTTON. IT’S PROBABLY MORE TO DO WITH THE CURRENT CONTROVERSY ABOUT
VACCINE HESITANCY AND ALL OF THAT BUT NICE TO GET THE WORD
OUT TO THE PUBLIC BUT BACK TO THE PROVIDERS. I DON’T HAVE ANY EASY ANSWER, I
GUESS I JUST DEPEND ON ALL OF YOU TO SPREAD THE WORD. THEN FOR THE INFLUENZA WORKING
GROUP WE DON’T HAVE A NEWS LETTER OR A LIST SERVE THAT WAY
SO WE REALLY RELIED ON PARTNERSHIPS AND OPPORTUNITIES
TO SPEAK AND PROVIDE THE INFORMATION. ONE OF OUR PIGGEST CHALLENGE
WITH BOTH OF THESE RESOURCES, HAVE BEEN PROVIDING ACCURATE
INFORMATION IN A CONCISE USABLE FORMAT, THAT’S CERTAINLY BEEN A
BIG CHALLENGE BUT I THINK WE HAVE FOUND WAYS TO OVERCOME
THAT.>>JOHN DOUGLAS. SO FIRST THANKS. THESE ARE GREAT PRESENTATIONS,
VERY THOUGHT PROVOKING. I HAD MORE MANDATE QUESTIONS. WHAT EXPERIENCE HAS THERE BEEN,
JUST LOOKING TO SEE WHAT’S HAPPENING IN COLORADO RIGHT NOW,
WHERE MANDATES ARE AT LEAST SOME REQUIREMENT PUT FORTH IN SEVEN
OR EIGHT YEARS AGO WHAT EXPERIENCE WE KNOW OF WITH
STATES STRONGLY ENCOURAGING MEASURING MANDATING, ET CETERA,
PARTICULARLY IN LTCS. I HAVE TO SAY THAT WE USE THE
COLORADO DOCUMENT AS A BASIS FOR OUR GUIDANCE DOCUMENT, I SHOULD
HAVE SAID THAT DURING MY PRESENTATION. WE ARE GRATEFUL TO THE COLORADO
DEPARTMENT OF HEALTH FOR JUMP STARTING US, THANK YOU. I AM NOT AN EXPERT ON THIS BUT I
DO KNOW THERE HAS BEEN A — AS ONE WOULD EXPECT SOMEWHAT VARIABLE RESPONSE FROM STATE
DEPARTMENTS OF HEALTH AND STATE LEGAL STRUCTURES IN TERMS OF
WHAT IS AND ISN’T ALLOWABLE IN THIS SPHERE OF EMPLOYER MANDATES
FOR VACCINES. WE ALSO KNOW THAT MANDATE CAN
MEAN A LOT OF DIFFERENT THINGS, EVEN HAVE A MANDATE WHERE THE
CONSEQUENCE OF NOT BEING VACCINATED IS IF THEY NEED TO
SIGN A DECLINATION FORM YOU CAN HAVE MANDATES NOT BEING
VACCINATED THAT YOU DON’T HAVE A JOB ANY MORE AND EVERYTHING IN
BETWEEN. ALL OF THEM HELP, THE MORE
RIGOROUS ONES HELP MORE BUT THEY ALL HELP. PROBABLY NOT EXACTLY WHAT YOU
ARE ASKING. I DO KNOW THERE HAS BEEN —
THERE HAVE BEEN LAWSUITS BROUGHT IN MULTIPLE STATES, AND THE
OUTCOMES HAVE VARY AD LITTLE BIT. BUT TO A LARGE EXTENT, I’M BEING
GENERAL BECAUSE I DON’T KNOW THE SPECIFIC ANSWERS, STATES HAVE
TENDED TO UPHOLD THE RIGHT OF HEALTHCARE ORGANIZATIONS TO
REQUIRE THIS. WITH APPROPRIATE SAFEGUARDS FOR
MEDICAL CONTRAINDICATIONS AND SOME CASES CONTRAINDICATIONS. I KNOW PENNSYLVANIA HAS AS FAR
AS I KNOW ALMOST UNIVERSALLY UPHELD GRIEVANCES UNLESS THEY
REALLY APPEARED TO HAVE A COMPONENT OF BIAS.>>THEN, IS THERE A ROLE FOR CMS
GIVEN PROBABLY 98% PLUS INHABITANTS OF THESE FACILITIES
ARE BEING SUPPORTED BY MEDICARE. MAYBE LOTS ARE ALREADY GOING ON
IN TERMS OF INCENTIVES IF YOU ARE COVERED BY MEDICARE OR
FACILITY IS COVER TO DO THIS BUT THAT WOULD BE A MAJOR CARROT ENTERPRISE.>>THE INFLUENZA WORKING GROUP
WOULD LOVE TO SEE CMS CONSIDER THIS AN ACTIONABLE ITEM IN TERMS
OF GRADING AND APPROVAL. AS PERHAPS EVERYONE IN THIS ROOM
KNOWS, HOSPITALS ARE ALREADY REQUIRED TO SUBMIT THEIR STAFF
INFLUENZA RATES TO CMS I’M EMBARRASS TO SAY I BELIEVE THAT
IS TRUE FOR LONG TERM CARE BUT NOT HUNDRED PERCENT SURE. WE WILL FIND THAT OUT. WE WILL FIND THAT OUT. BUT WE WOULD LOVE TO PARTNER
FURTHER WITH CMS ON ALL LEVELS INCLUDING THE QUALITY GROUPS TO
BRING THIS TO PEOPLE’S ATTENTION, TO BRING TO PATIENT
AND FAMILY MEMBERS ATTENTION, TO MOVE IT TOWARDS BECOMING A NORM.>>RELATED TO THAT, DID YOUR
GROUP LOOK — DO YOU HAVE ANY SENSE AS TO THE PROPORTION OF
FLU HOSPITALIZATIONS IN A GIVEN SEASON THAT MAY ARISE FROM
INFECTION ACQUIRED IN LONG TERM CARE FACILITIES? IS IT A 10% BURDEN, 20? THAT STRIKES ME WOULD BE QUITE
INSTRUMENTAL WHETHER LOCAL SETTING OR FOR CMS POLICY MAKING
TO UNDERSTAND THAT.>>THANK YOU FOR THESE
INCREDIBLY USEFUL QUESTIONS. I DON’T KNOW THE ANSWER TO THAT
ONE. I DON’T KNOW IF THERE’S ANYONE
— I’M LOOKING AT DAVID BUT IT IS A GREAT QUESTION AND IF NOT
KNOWN IT WOULD BE A WONDERFUL THING TO KNOW ADDITIONAL DRIVER
OR NOT DEPENDING ON THIS. MY GUESS WOULD BE THAT IT WOULD
BE RELATIVELY HIGH JUST BECAUSE OF THE SHARE LIVING SITUATION. IT’S LIKE A BARRACKS OR A COLLEGE DORM IN TERMS OF
OUTBREAKS OF MEASLES OR MUMPS OR ME ANYONECOCCUS. I’M SORRY I — MENINGOCOCCUS.>>MARY BETH DO YOU HAVE A
COMMENT?>>THE COMMENT I WAS GOING TO
MAKE THOUGH I’M FROM CMS I HAVE TO CONFESS I’M FROM MEDICAID
SIDE OF CMS. IF I GET ANY UPDATED INFORMATION
I WILL BE HAPPY TO SHARE IT.>>I WOULD MENTION THE CDC AND
PUBLIC HEALTH PROFESSIONALS GATEWAY HAS DATA ON WHAT
LEGISLATION IS OUT THERE BY STATE ON BOTH NURSING HOME
EMPLOYEES AND PATIENT MANDATES FOR INFLUENZA AND OTHER
VACCINATIONS. IT’S A BIT DATED, IT’S A YEAR
AND A HALF OLD BUT STILL IMPORTANT INFORMATION THAT MAY
HELP ANSWER SOME OF THOSE QUESTIONS.>>ANY OTHER QUESTIONS OR
COMMENTS?>>THIS IS MORE OF A BRIEF
COMMENT AND SORT OF SYNTHESIZING WHAT WE HEARD IN JUNE IN THE
SCHOOL SITUATION ESPECIALLY IN COLORADO AND CALIFORNIA. THE ISSUE OF HEALTHCARE
FACILITIES, WHICH IS WHENEVER THERE’S ROOM FOR A POLICY OR
REQUIREMENT TO BE IN PLACE, A LOT OF ISSUES AROUND HESITANCY
AND FINDING OPT OUT BECOME LESS IMPORTANT. SO AS NVAC GUIDING ON POLICIES,
I THINK THAT THIS WOULD BE AN IMPORTANT THING TO CONSIDER. WHICH IS WHEREVER WE THINK A
PARTICULAR MANDATE OR REQUIREMENT BECOMES ACROSS THE BOARD, AND CAN BE IMPLEMENTED IT
WILL BE SORT OF PROBABLY MORE ADVANTAGEOUS FOR COVERAGE RATES
COMPARED TO LEAVING IT UP TO INDIVIDUALS OR TO INSTITUTIONS
OR TO SCHOOL DISTRICTS, TO CARRY THE BURDEN.>>LYNN.>>FOR CONSIDERATION I FOUND IN
THE – FEW YEARS THE INFO GRAPHU THAT HAVE BEEN CREATED FROM HHS
CDC AND OTHER ORGANIZATIONS HAVE BEEN VERY IMPACTFUL BECAUSE THEY
ARE SHOWING THE IMPACT OF DISEASE, PERHAPS GIVEN THIS
PARTICULAR TARGET AUDIENCE WITH HIGH RATES OF MORBIDITY AND
MORTALITY THAT COULD BE CREATED INFO GRAPH SPECIFICALLY TO THIS
AND OTHER GROUPS RATHER THAN TO THE POPULATION AT LARGE. THOSE INFO GRAPHICS CAN BE
EASILY USED, THEY ARE ALL OPEN SOURCE SO MANY PEOPLE WILL
REPOST THEM, ET CETERA. SO I THINK THAT MIGHT BE
SOMETHING FOR CONSIDERATION GIVEN THE INFORMATION TODAY.>>YES. JUST A COUPLE OF COMMENTS,
PARTICULARLY REGARDS TO THE MANDATORY PROGRAM. FOR HEALTHCARE PRACTICE, I’M
HESITANT ABOUT MANDATORY, THAT IS PART OF OUR FOUNDATION. BUT FOR OUR — FOR A HEALTHCARE
PRACTICE, THERE’S ONE THING IN OUR MEDICAL TREATMENT FACILITY
THAT IS VERY USEFUL IS HAVING THAT RESOURCE GROUP LOOK AT
EXEMPTIONS AND HAVING THAT ESTABLISHED WITHIN THE MEDICAL
TREATMENT FACILITIES, USUALLY THAT CONSISTS OF IMMUNIZATION
EXPERTS WHO CAN LOOK AT EXEMPTION, ET CETERA, ET CETERA. I WOULD LOOK TO MAKE SURE THAT THAT’S CONSISTENT IN YOUR
FACILITIES THAT ARE LUGGING AT ENHANCE THEIR HEALTHCARE
PRACTITIONER PROGRAMS. THEN THE ONLY OTHER COMMENT IN
REGARDS TO RESOURCES ESPECIALLY THE IDEA GAVE THE FIRST
PRESENTATION, THE DEPARTMENT OF DEFENSE SAYS THAT A LONG TERM
ACTIVITIES IN REGARDS TO MOVING VACCINE COLD STORAGE HANDLING
HAVE A LOT OF RESOURCES IN THAT REGARD AND EXPERIENCES WITH THAT
AND REALLY ROBUST EDUCATION PROGRAM FOR OUR EVER EVOLVING
CYCLE OF MEDICAL CORPSMEN RESPONSIBLE FOR GIVING
INFORMATION SO I WOULD ENCOURAGE YOU TO PERHAPS LOOK AT SOME OF
THE WEBSITES AND PARTICULARLY SOME OF OUR COLD STORAGE AND
HANDLING ACTIVITIES THAT ARE AVAILABLE. TO REVIEW. AND MAYBE HELPFUL FOR YOU.>>THAT’S GREAT TO KNOW. THE TRANSPORTATION PIECE WAS
DEFINITELY A BIG CHALLENGE FROM PUTTING TOGETHER THE CHECKLIST. SO THANK YOU.>>THANK YOU ALL FOR VERY
HELPFUL PANEL. [APPLAUSE]
OUR LAST PRESENTATION FOR THE MEETING IS NIH HIGHLIGHT, FIRST
IN HUMAN TRIAL OF THE UNION VERSAL INFLUENZA VACCINE
CANDIDATE. IT WILL BE PRESENTED BY
DR. GRACE CHEN, DEPUTY CHIEF OF
THE CLINICAL TRIALS PROGRAM AT THE NIH VACCINE RESEARCH CENTER. SHE WILL HIGHLIGHT THE FIRST IN
HUMAN CLINICAL TRIAL UNIVERSAL FLU VACCINE CANDIDATE. THANK YOU FOR BEING HERE, DR. CHEN.>>THANK YOU FOR THE INHAVE
IATION TO PRESENT AND UPDATE FROM THE VACCINE RESEARCH
CENTERS PHASE 1 CLINICAL STUDY OF A UNIVERSAL VACCINE
CANDIDATE. THE VACCINE RESEARCH CENTER IS
LOCATED IN BETHESDA, IT’S PART OF NIAID AND PART OF NIH. WE ARE AN INTRAMURAL RESEARCH
DIVISION. BEFORE I PRESENT MY UPDATE, I
WOULD LIKE TO PROVIDE ADDITIONAL BACKGROUND AND CONTEXT TO
DEVELOPMENT OF THIS UNIVERSAL INFLUENZA VACCINE CANDIDATE AND
I WILL START BY TALKING MORE A LITTLE BIT ABOUT THE INFLUENZA
VACCINE DEVELOPMENT THAT OCCURRED AT VRC AND THE PLATFORM
WE HAVE EVALUATED IN DEVELOPING THIS UNIVERSAL INFLUENZA VACCINE
CANDIDATE. FINALLY I WILL PRESENT SOME VERY
BRIEF UPDATES ON THIS TRIAL AS IT IS REALLY JUST STARTED
ENROLLING AND ACCRUING. AS WE KNOW AND HAVE HER
REINFORCED INFLUENZA REMAIN AS PUBLIC HEALTH CHALLENGE, IT HAS
A SIGNIFICANT MORBIDITY AND MORTALITY IMPACT, UNDERLYING
THIS IS REALLY SOME UNIQUE VIROLOGIC CHARACTERISTICS OF THE
VIRION. ANGIOGENIC DRIFT ACCOUNTS FOR
SEASONAL EPIDEMICS, AND IS SMALLER VARIABILITY DUE TO
ACCUMULATION OF MINOR POINT MUTATIONS IN THE GENOME. ANGIOGENIC SHIFT BY GENETIC
ASSORTMENT OCCURS UNDERLIE THE INFLUENZA PANDEMICS THAT
OCCURRED AN THESE HAVE EVEN MORE SIGNIFICANT IMPACT ON MORBIDITY
MORTALITY. IN THE MOST DEVASTATING IMPACT
THAT HAS BEEN RECORD IN THE 20th CENTURY THE 1918
PANDEMIC, 40 TO 100 MILLION DEATH OCCURRED. MILLION DEATH OCCURRED. THE RECURRENCE OF SEASONAL
EPIDEMICS AS WELL AS INFLUENZA PANDEMICS UNDERSCORE THE NEED
FOR UNIVERSAL INFLUENZA VACCINE. OUR CURRENT LICENSED INFLUENZA
VACCINES HAVE MANY LIMITATIONS. INCLUDING A MANUFACTURING
PROCESS THAT RELIES HEAVILY ON EGGS WHICH IS NOT OFTEN AGILE
SYSTEM IN RESPONSE TO AN EMERGING PANDEMIC. IN ADDITION DURING SEASONAL
EPIDEMICS, DEPENDING ON THIS STRAIN MATCH FROM CIRCUMSTANCE
MITTING STRAINS TO VACCINE STRAINS CONTAINED WITHIN THE
VACCINE EFFECTIVENESS IN GOOD YEARS CAN BE ONLY AS HIGH AS 50
TO 60%. IN ADDITION AS WE KNOW INFLUENZA
— YOU SEE INFLUENZA VACCINES NEED TO BE REFORMULATED ON
ANNUAL BASIS AND ADMINISTERED ON ANNUAL BASIS WITH EACH FLU
SEASON AS WELL. THE SEASONAL INFLUENZA VACCINES
CURRENTLY LICENSED DO NOT HAVE PROTECTION AGAINST POTENTIAL
PANDEMIC STRAINS THAT WOULD EMERGE. SO THEREFORE THE NEED FOR A
BROADER UNIVERSAL INFLUENZA VACCINE IS NEEDED. SO THIS SLIDE IS MEANT TO
HIGHLIGHT THIS POINT THAT THE CHALLENGE IS POSED BY INFLUENZA
FOR VACCINE DEVELOPMENT HAVE BEEN OUTWEIGHED BY TRADITIONAL
APPROACHES UP UNTIL NOW. HOWEVER, THE LANDSCAPE FOR
VACCINE TECHNOLOGY HAS BEEN CHANGING RECENTLY, IN THE LAST
TEN YEARS THERE HAVE BEEN NEW OPTIONS AN TECHNOLOGIES THAT
HAVE BECOME AVAILABLE FOR VACCINE DEVELOPMENT AS WELL AS THERAPEUTIC AND OTHER
INTERVENTIONAL DEVELOPMENTS THAT WE HAVE UTILIZED AND DEVELOPING
OUR VACCINE PLATFORM FOR OUR CANDIDATES. SO THESE NEW TECHNOLOGIES HAVE
REALLY REINVIGORATED THE EFFORTS TO DEVELOP A UNIVERSAL VACCINE
CANDIDATE. THE GOAL OF DEVELOPING A
UNIVERSAL INFLUENZA VACCINE CANDIDATE ENCOMPASSES A NUMBER
OF GOALS, SO DIFFERENT GROUPS MAY HAVE DIFFERENT GOALS,
HOWEVER FOR VRC OUR STRATEGIC GOALS ALIEN WITH NIAID STRATEGIC
GOALS AND INCLUDE A CONSISTENT EFFICACY FOR THE VACCINE
TARGETING GREATER THAN 75%, AGAINST MEDICALLY ATTENDED
ILLNESS CAUSED BY SEASONAL PANDEMIC STRAINS OF INFLUENZA. SEASONAL PRODUCT OR EXCUSE ME A
SINGLE PRODUCT THAT WOULDN’T REQUIRE ANNUAL REVISION, AND
FINALLY MORE DURABLE IMMUNITY GREATER THAN A YEAR. BEYOND THE CHALLENGING THAT I
OUTLINED PREVIOUSLY THERE’S ADDITIONAL BIOLOGIC CHALLENGES
FOR UNIVERSAL INFLUENZA VACCINE. THESE INCLUDE SOME OF THE
VARIABILITIES THAT I DISCUSSED EARLIER AND GENETIC PLASTICITY. IN ADDITION, THERE’S AN
EXTENSIVE ZOONOTIC RESERVOIR FOR MANY INFLUENZA STRAINS AN INDIAN
RESERVOIRS IN PARTICULAR THAT ADD TO THE BIOLOGIC CHALLENGES
AND COMPLEXITY OF INFLUENZA. AND THERE’S ALSO THE BUY LODGE
INC. CHALLENGE OF PRE-EXISTING IMMUNE ACTIVITY THE
IMMUNODOMINANCE OF CERTAIN SEROTYPE SPECIFIC EPITOPES ON
THE HA HEAD. AND TESTIMONY IMMUNODOMINANCE OF
ANTIBODY LINEAGE WITH LIMITED BREADTH. SO IN ORDER TO OVERCOME BIOLOGIC CHALLENGES, VRC IS LEARNING
TECHNOLOGICAL ADVANCES AND STRUCTURE GUIDED APPROACHES TO
DESIGN ANTIGENS INCLUDING NATURAL DESIGNER NANOPARTICLES
AS WELL AS DIFFERENT DELIVERY TECHNIQUES TO DEVELOP VACCINE
PLATFORMS. IN ADDITION, THE VRC INFLUENZA
PROGRAM IS ALSO FOCUSED ON MAKING ADVANCEMENTS IN ASSESSING
IMMUNE RESPONSE TO VACCINATION. INFLUENZA VACCINE DEVELOPMENT AT
VRC HAS BEEN ONGOING SINCE ABOUT 2006 WHEN WE FIRST SUBMITTED OUR
FIRST IND AND CONDUCTED OUR FIRST CLINICAL TRIAL IN
INFLUENZA VACCINE. HOWEVER, MORE RECENT YEARS, AS
YOU CAN SEE IN RED, HIGHLIGHTED WE HAVE SHIFTED — WE HAVE
FOCUSED MORE ON DEVELOPING A UNIVERSAL INFLUENZA VACCINE
CANDIDATE, AGAIN LEVERAGING THE NEWER TECHNOLOGIES THAT HAVE
BECOME AVAILABLE. I WILL TALK ABOUT TWO OF THESE
TRIALS THAT WE HAVE DUCKED TODAY. THE FIRST VRC 316 UTILIZE A NEW
PLATFORM, FIRST IN HUMAN TRIAL THAT WE HAVE CONDUCTED UTILIZING
THIS NEW PLATFORM. AND THIS PLATFORM WAS USED FOR
VRC 321, THE TRIAL THAT IS EVALUATING THE UNIVERSAL
INFLUENZA VACCINE CANDIDATE. SO THIS GRAPHIC IS TO
DEMONSTRATE MORE IN DETAIL WHAT THE VACCINE DEVELOPMENT PATHWAY
AT VRC IS, AND REALLY WHAT I ARE HIGHLIGHT IS JUST WE ARE ABLE TO
WITHIN THE CONTEXT OF OUR DECISION GO FROM A VACCINE
CONCEPT THAT HAS BEEN DESIGNED DEVELOPED AND TESTED IN
PRE-CLINICAL STUDIES, IN OUR LABS AT VRC ON THE NIH CAMPUS,
ALL THE WAY INTO PHASE 1 AND SOMETIMES PHASE 2 CLINICAL TRIALS USUALLY CONDUCTED AT THE
NIH BUT SOMETIMES PARTNERSHIP WITH EXTERNAL SITES IN TRIALS —
SITES WITHIN THE U.S. AND ALSO SOMETIMES EVEN OUTSIDE THE US. SO SHOWN HERE IS THE UNIVERSAL
INFLUENZA VACCINE CANDIDATE ON THE LOWER BOX THAT WE TESTED IN
VRC 321, COMPOSED OF H 1 INFLUENZA VIRUS STEM WHICH HAS
MORE CONSERVED EPITOPES. FUSE TO AN H PYLORI FERRITIN
PLATFORM, PRIOR TO TESTING THAT VACCINE CANDIDATE, I MENTIONED
WE TESTED THE PLATFORM IN AN EARLIER TRIAL VRC 316 AND THAT
VACCINE IS BOX ABOVE IT AND WE LOOK AT H 2 HA HEAD FUSED TO
THIS PLATFORM. I WILL DISCUSS BOTH OF THESE
TRIALS IN DETAIL. WE TESTED THE FIRST H PYLORI
PLATFORM WITH H 2 INFLUENZA HA HEAD. THIS WAS FOLLOWING PRE-CLINICAL
STUDIES DEMONSTRATING SAFETY AS WELL AS IMMUNOGENICITY IN ANIMAL
MODELS OF THIS VACCINE CANDIDATE. UTILIZING H 2 INFLUENZA
CANDIDATE HAVE SEVERAL ADVANTAGES. FIRST THOUGH H 2 IS NOT
CIRCULATED IN HUMANS SINCE 1968, IT STILL CIRCULATES IN AVIAN
RESERVOIRS AND REPRESENTS PANDEMIC PATHOGEN. IN ADDITION, AS YOU WILL SEE IN
THE NEXT SLIDE OF THE TRIAL DESIGN, WE WERE ABLE TO ASSESS
THE IMPACT ON NAIVE VERSUS EXPERIENCE INDIVIDUALS UTILIZING
H 2 INFLUENZA THUS HOPEFULLY GIVING US INSIGHT TO THE IMPACT
OF PRE-EXISTING IMMUNITY IN IMMUNE RESPONSE. SO I WON’T GO INTO THE STUDY
DESIGN OF THE FIRST TRIAL H 2 INFLUENZA TRIAL IN DETAIL ONLY
TO SAY THAT IT WAS FOR US TO ASSESS THIS PLATFORM IN A FIRST
IN HUMAN STUDY, WE HAVE COMPLETED ENROLLMENT IN THIS
STUDY. AND WHAT WE HAVE SEEN IN
PRELIMINARY DATA IS IT’S SAFE AND WELL TOLERATED. IN IN HOPES OF LEADING TO
IMPROVE BREADTH OF RESPONSE NOT ONLY AGAINST THE STRAIN
CONTAINED WITHIN THE VACCINE BUT OTHER POTENTIALLY RELATED OR
BROADER STRAINS. AND THAT VRC
TESTED A FERRITIN BASED PLATFORM IN ITERATIVE PHASE 1 CLINICAL
TRIALS, INCLUDING TESTING A POTENTIAL UNIVERSAL INFLUENZA
VACCINE CANDIDATE. I WOULD LIKE TO END WITH
ACKNOWLEDGMENTS OF THE INCREDIBLE WORK THAT TAKES TO
CONDUCT A CLINICAL TRIAL. THE CLINICAL TRIALS PROGRAM IS
SHOWN HERE AT VRC AND WE WORK IN CLOSE COLLABORATION WITH
DR. GRAHAM’S LAB IN VIRAL
PATHOGENESIS LABORATORY WHO DEVELOPED THIS VACCINE
CANDIDATE. THANK YOU. [APPLAUSE]>>THANK YOU, DR. CHEN. ANY COMMENTS OR QUESTIONS FROM
THE COMMITTEE? NOTHING FROM MY PERSPECTIVE, I
THINK THIS IS A GREAT STEP FORWARD. WE HAVE A WIDE LANDSCAPE IN
FRONT OF US BUT GIVES US GREAT HOPE THAT WE MAY HAVE A BETTERED
FUTURE FOR PREVENTION OF INFLUENZA DOWN THE ROAD.>>– INFLUENZA DOWN THE ROAD.>>I SECOND THAT. SO TO GET AN UNDERSTANDING OF THE PATH THAT YOU AND TEAM AT
VRC WILL BE TAKING WITH THIS VACCINE WILL YOU BE LOOKING AT
IMMUNOLOGIC RESPONSES IN TERMS OF ANTIBODIES FROM VACCINEES
NEUTRALIZING SAY DIVERGENT STRAIN ARRAY OF FLU STRAINS, IS
THAT THE GOAL? AND WOULD THAT BE THE POSITIVE
SIGNAL SO YOU CAN MOVE THIS FORWARD?>>WE WILL BE LOOKING NOT ONLY
AT THE VACCINE STRAIN CONTAINED WITHIN THE VACCINE TO ASSESS
IMMUNOGENICITY BUT ALSO OTHER VACCINE STRAINS, PROBABLY BOTH
WITHIN GROUP ONE WHICH IS WHERE THE H 1 VIRUS IS ROW KATEED AND
POSSIBLY ALSO WITHIN GROUP 2.>>THE ASSAY WILL BE
NEUTRALIZING ANTIBODY ASSAY, IS THAT —
>>THAT’S ONE OF THE ASSAYS, AS YOU CAN IMAGINE BECAUSE WE CAN’T
USE AN HAI ASSAYS SINCE THERE’S NO HEAD. WE ARE USING NEUTRALIZATION
ASSAYS AND DIFFERENT BINDING ASSAYS AS WELL.>>THANK YOU.>>SURE.>>JOHN.>>
>>JUST A BACKGROUND QUESTION. THE VALUE OF THE H PYLORI
FERRITIN CORE, WHATEVER THE TERM IS, IS WHAT? WHY IS THAT USEFUL?>>ONE USEFUL ASPECT OF USING H
PIE ORRY FERRITIN IS IT ALLOWS PRESENTATION OF THE ANTIGEN IN A
FAIRLY ANTIGENICALLY REALISTIC PRESENTATION TO HOPEFULLY GENERATE AN IMMUNE RESPONSE,
PRONOUNCE IMMUNE RESPONSE, SO THAT’S ONE ASPECT. ACTUALLY PROBABLY THE PRIMARY
ASPECT. AND WHY WE CHOSE THE FERRITIN H
PYLORI FERRITIN.>>SEEING NO OTHER COMMENT. THANK YOU DR. CHEN.>>THANK YOU. [APPLAUSE]>>WE HAVE REACHED THE TIME FOR
OUR SECOND DAY PUBLIC COMMENT. IF YOU WOULD LAKE TO MAKE A
PUBLIC COMMENT TODAY AND YOU ARE ON THE PHONE, PLEASE DIAL “*1”
TO BE PLACED IN THE PUBLIC COMMENT QUEUE. IF YOU ARE HERE IN THE ROOM,
WOULD LIKE TO MAKE A COMMENT PLEASE COME TO THE GREEN
MICROPHONE TO MY LEFT. PLEASE MAKE SURE THAT YOUR LINE
IS UNMUTED. IS THERE ANYONE IN THE ROOM THAT
YOU WOULD LIKE TO MAKE A PUBLIC COMMENT? NOT SEEING ANY OPERATOR, DO WE
HAVE ANY CALL IN FOR PUBLIC COMMENT ON THE LINE?>>WE DO NOT.>>SO NOT HAVING ANY ON THE LINE
OR IN THE ROOM FOR PUBLIC COMMENT I WOULD LIKE TO THANK
ALL OF YOU FOR PARTICIPATION IN OUR SEPTEMBER NATIONAL VACCINE
ADVISORY COMMITTEE MEETING. I LOOK FORWARD TO SEEING EACH OF
YOU AND TALKING TO YOU AT OUR NEXT MEETING FEBRUARY 13 AND
14th, 2020. THIS MEETING IS NOW FORMALLY
ADJOURNED.

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