NVAC l February 2020 l Day 1, Pt 1: Welcome, Updates and Ebola Vaccine Implementation

NVAC l February 2020 l Day 1, Pt 1: Welcome, Updates and Ebola Vaccine Implementation


>>GOOD MORNING. MY NAME IS ANN AIKIN THE ACTING
DESIGNATED OFFICER FOR NVAC. I’LL LIKE TO CALL THE MEETING TO
ORDER AND WOULD LIKE TO START BY THANK OUR MEMBERS HERE TODAY. THERE’S A LOT OF WORK THAT GOES
IN TO THIS MEETING AS WELL AS THE SUBCOMMITTEES THAT HAPPEN
THROUGHOUT THE YEAR. I’D ALSO LIKE TO THANK THE OIDP
STAFF WHO SUPPORTED TODAY’S MEETING. [LISTING NAMES]
SO THIS IS THE FIRST MEETING OF 2020. THE AGENDA’S GOING TO FOCUS ON
SEVERAL PRESSING TOPICS AROUND VACCINE IMMUNIZATION AND
CONFIDENCE AND I’M EXCITED TO HEAR THE PRESENTATIONS AND THE
DELIBERATION COME FROM COMMITTEE MEMBERS TODAY AND WE’LL HAVE
PUBLIC COMMENT AT THE END OF BOTH DAYS. BEFORE WE GO ON I DO HAVE A FEW
HOUSEKEEPING ISSUES. FIRST, IT’S A PUBLIC MEETING AND
ALL STATEMENTS ARE ON THE RECORD. THE ADVISORY COUNCIL IS GOVERNED
BY THE FEDERAL ADVISORY COMMITTEE ACT IT PROVIDES THE
RULES BY WHICH AGENCIES OR OFFICES BY THE FEDERAL
GOVERNMENT CAN CONTROL COMMITTEE OR GROUPS LIKE THIS ONE TO
OBTAIN ADVICE OR RECOMMENDATION. THE MEMBERS ARE SUBJECT TO
CONFLICT OF INTEREST LAWS AND THE EX-OFFICIO MEMBERS HAVE BEEN
VETTED FOR CONFLICTS OF INTEREST. THESE ARE REGULAR GOVERNMENT
EMPLOYEES AND THEY’RE SUBJECT TO ETHIC REGULATIONS AND ISSUES BY
THE U.S.�GOVERNMENT OF ETHICS INCLUDING ANNUAL FINANCIAL
DISCLOSURE AND ETHICS TRAINING. REVIEWED AND RECEIVED
INFORMATION FROM THE LIAISON OR SPECIAL GOVERNMENT EMPLOYEES AND
THE REGULAR GOVERNMENT EMPLOYEE THEIR PERSONAL, PROFESSIONAL
ABOUT CONFLICTS OF INTEREST THAT COULD COMPROMISE A PERSON’S
OBJECTIVE AT THE MEETING. WITH THAT I’LL PROCEED WITH ROLL
CALL. [ROLL CALL]
>>OKAY. WITH THAT I’M PLEASED TO INTRODUCE MY BOSS DR. TAMMY
BECKHAM THE DIRECTOR OF THE DISEASE AND AIDS POLICY AND WILL
GIVE AN UPDATE ON THE ACTIVITIES THIS MORNING. THANK YOU.>>GOOD MORNING, EVERYBODY. THANK YOU, ANN. I WANT TO WELCOME EVERYONE HERE
THIS MORNING. IT’S GREAT TO SEE YOU. WELCOME TO EVERYBODY AND THE NEW
MEMBERS JOINING AND BACK FOR THE FIRST TIME AS WELL. SO IT’S AN HONOR TO BE HERE
TODAY AND HAVE THE OPPORTUNITY TO PROVIDE YOU AN UPDATE
REGARDING OIDP’S ACTIVITIES SINCE SEPTEMBER. I’LL GIVE YOU AN OVERVIEW OF
SOME ACTIVITIES AND ONGOING ACTIVITIES IN HHS EARLIER THEY
NAMED THE CORONAVIRUS TO REPRESENT CORONAVIRUS 2019 AND
IT DESIGNATED THE DISEASE AS RESPIRATORY SYSTEM. IT DEMONSTRATES THE CONTINUING
IMPACT AND GLOBAL INFLUENCES ON U.S.�GLOBAL HEALTH AND TRADE AND
WILDLIFE SPECIES HAVE CAUSED A CONSEQUENCE TO HUMAN HEALTH. THE OCCURRENCE OF SARS DID NOT
OCCUR WITHOUT WARNING WE HAD ACUTE RESPIRATORY ISSUES AND
SARS AND AS A RESULT WHO PLACED SARS AND MERS ON THE PRIORITY
LIST TO LOOK AT COUNTERMEASURES AGAINST CORONAVIRUS. THIS WEEK THE WHO ACTED IN
RESPONSE TO THE NEW CORONAVIRUS AND THROUGH HHS THE WHITE HOUSE
HAS PRIORITIZED THE NEED FOR INNOVATION AND RESPONSE TO THE
THREAT AND IN JANUARY THE PRESIDENT ANNOUNCED THE
FORMATION OF A TASK FORCE LED BY SECRETARY AZAR TO MONITOR AND
COORDINATE EMERGENCY RESPONSE EFFORTS FOR THE OUTBREAK. AS A RESULT OF BARTA THE OFFICE
OF THE SECRETARY FOR PREPAREDNESS AND RESPONSE HAS
CALLED FOR COUNTERMEASURES AND R&D AND RAPID RESPONSE
CAPABILITIES AND NIH IS PURSUING TECHNICAL APPROACHES FOR NOVEL
CORONAVIRUS TEST RESEARCH AND EVALUATION. THE APPROACHES AT THE GLOBAL AND
NATIONAL LEVEL ARE NECESSARY TO DRIVE THE INNOVATION TO RESPOND
AND PREFERABLY ANTICIPATE EMERGING DISEASE THREATS SUCH AS
THE 2019 NOVEL CORONAVIRUS. THE MISSION OF THIS COMMITTEE
HELPS SHAPE POLICIES TO CONTRIBUTE TO OUR PREPAREDNESS
AND HELP DRIVE POLICIES THAT WILL SHAPE FUTURE REQUIREMENTS
FOR INNOVATION AND MANUFACTURING IN THE U.S.
THANK YOU FOR THE WORK THAT YOU DO ON THAT. MOVING ON, SOME OF THE WORK YOU
HAVE DONE PREVIOUSLY ON THE NATIONAL VACCINE PLAN I WANT TO
GIVE YOU AN UPDATE WHERE WE ARE IN DEVELOPING THE NEXT ITERATION
OF THE NATIONAL VACCINE PLAN. IN ADDITION TO THE
RECOMMENDATIONS YOU PROVIDED, THE OFFICE INFECTIOUS DISEASE
POLICY SOLICITED FEEDBACK AND THIS CONSISTED OF 26, ONE-HOUR
MEETINGS AND WE RECEIVED FEEDBACK FOR INFORMATION. MUCH OF THE FEEDBACK WE RECEIVED
ALIGNED CLOSE WITH THE RECOMMENDATIONS OF THIS
COMMITTEE. THE FEEDBACK FURTHER SUPPORTED
GOALS AND PRIORITY AND PREVAILING THEMES ALIGNING WELL
WITH THE WORK UNDERTAKEN INCLUDING BUT NOT LIMITED TO
VACCINE HESITANCY AND CONFIDENCE AND THE WORK YOU’RE DOING IN THE
IMMUNIZATION SUBCOMMITTEE. WE’RE IN THE PROCESS OF
INTEGRATING ALL THAT FEEDBACK TO A CONCISE FIVE-YEAR PLAN TO
PROVIDE VACCINE STRATEGIES ACROSS THE LIFE SPAN, GUIDE
PRIORITY ACTIONS FROM 2020 TO 2025 AND IDENTIFY INDICATORS TO
MAKE SURE WE HOLD OURSELVES ACCOUNTABLE AND CAN MEASURE
PROGRESS TOWARD THAT PLAN. SO WE’RE ON TRACK TO RELEASE
THAT PLAN IN LATE 2020 AND WILL CONTINUE TO UPDATE YOU AS THE
PLAN GETS DEVELOPED. AS WE DEVELOP THE VACCINE PLAN
THE VACCINATION INNOVATION CONTINUES TO BE A PRIORITY AT
HHS AND RECOGNIZE THE CRITICAL ROLE OF INNOVATION IN THE
VACCINATION ENTERPRISE. IT’S PUTTING IT INTO PRACTICE IN
MULTIPLE WAYS AND IN ORDER TO IMPROVE VACCINE PERFORMANCE WE
RECENTLY CONVENED A SCIENTIFIC POLICY AND EXPERT MEETING TO
DISCUSS THE ETHICS, FEASIBILITY AND REGULATORY CONSIDERATIONS OF
A CONTROLLED HUMAN CHALLENGE MODEL TO BETTER UNDERSTAND THE
IMMUNE SYSTEM’S RESPONSE TO INFECTION INCLUDING COLONIZATION
AND PERTUSSIS. IT WILL SERVE TO GUIDE
TEMPERATURE POLICY AND WORK IN THE AREA. AS YOU ALSO KNOW, HPV REMAINS A
PUBLIC HEALTH CHALLENGE WITH COMPLETION RATES FOR ADOLESCENTS
BARELY ABOVE 50%. AS YOU KNOW, THE ASSISTANT
SECRETARY FOR HEALTH HAS PRIORITIZED INCREASING THE RATES
NATIONALLY TO REDUCE VACCINE PREVENTIBLE CANCERS. AS A RESULT, WE’RE WORKING WITH
PARTNERS AND IMPLEMENTING APPROACHES TO IMPROVE
VACCINATION RATES WITHIN THE NEXT FIVE YEARS. IT’S BEING ACHIEVED THROUGH
ACTIVITIES. WE’RE WORKING WITH CDC, THE
AMERICAN MEDICAL GROUP ASSOCIATION AND THE AMERICAN
CANCER SOCIETY ROUNDTABLE TO ESTABLISH A COLLABORATIVE AMONG
DELIVERY NETWORKS AND OTHER LARGE HEALTH SYSTEMS SO ENSURE
THE SYSTEMS PRIORITIZE INTEGRATING EVIDENCE-BASED
PRACTICES SUCH AS REDUCING MISSED OPPORTUNITIES AND
REMINDER CALLS AND TREATING HPV AS A ROUTINE VACCINE THROUGH
BUNDLING ULTIMATELY INCREASING RATES FOR THE LARGE PATIENT
POPULATIONS AND COMMUNITIES THE HEALTH SYSTEMS SERVE. WE’VE ALSO RECENTLY LAUNCHED THE
MILLION CANCER PREVENTING CONGREGATIONS PROGRAM. A FAITH-BASED INITIATIVE THAT
EMPOWERS OF LEADERS OF PARTICIPATING RELIGIOUS
ORGANIZATION TO PRIORITIZE HPV VACCINATION AND PREVENTION AND
PROVIDE CATCH-UP CLINICS FOR COMMUNITY MEMBERS. IT FOCUSES ON SAFE COMMUNITIES
IN THE SOUTHEASTERN STATES IS A REGION WHERE VACCINATION RATES
ARE LOWEST IN THE UNITED STATES. IN ADDITION FOR CERVICAL HEALTH
AWARENESS MONTH, LAST MONTH, THE TEAM PROMOTED CANCER PREVENTION
AND DURING HPV PREVENTION WEEK WHICH ALSO OCCURRED LAST MONTH
WE RELEASED NEW GRAPHICS WHERE A SURVIVOR SHARED HER STORY AS A
MECHANISM TO INSPIRE ACTION AMONG VIEWERS AMONG INDIVIDUALS
AN FAITH-BASED LEADERS. I’LL UPDATE YOU ON OTHER
ACTIVITIES WITHIN OUR OFFICE. AS YOU KNOW, WE’RE RESPONSIBLE
FOR DEVELOPING SEVERAL OTHER STRATEGIES IN ADDITION TO THE
NATIONAL VACCINE PLAN. SO WE’RE IN THE PROCESS OF
DEVELOPING UPDATES TO THE NATIONAL HIV/AIDS STRATEGY AND
THE NATIONAL HEPATITIS VACCINATION PLAN AND THE
NATIONAL ANTI-HEPATITIS VIRAL PLAN ACHIEVES A COORDINATED… TO HEPATITIS A, B AND C AND WILL
PRIORITIZE HEPATITIS VACCINES. OIDP IS ALSO ADVANCING THE FIRST
STI ACTION PLAN. AS YOU KNOW DATA SHOWS RATES OF
STIs HAVE REACHED AN ALL-TIME HIGH IN 2018. RATES OF CONGENITAL SYPHILIS
HAVE INCREASED 185% AND CASES OF GONORRHEA HAVE INCREASED SINCE
2014. WE’RE DEVELOPING THE FEDERAL
ACTION PLAN WITH FEDERAL PARTNERS AND LIKE ALL OF OUR
PLANS WE’VE GONE OUT FOR STAKEHOLDER INPUT AND HAVE
STEERING COMMITTEES CONSISTING OF FEDERAL GOVERNMENT EMPLOYEES
HELPING PUT THE PLAN TOGETHER. THE STI PLAN WILL FOCUS ON THE
FOUR MOST COMMON STIs, CHLAMYDIA, GONORRHEA, SYPHILIS
AND HPV AND EMPHASIZING HPV AS A CANCER-FIGHTING PLAN. AN ACT WAS PASSED RECENTLY AND
THE OFFICE OF THE ASSISTANT SECRETARY OF HEALTH WILL BE
LEADING A NEW NATIONAL STRATEGY FOR VECTOR-BORN DISEASES. IT’S UNDERWAY WITH THE FORMATION
OF A STEERING COMMITTEE AND WE’LL BE WORKING ON THAT IN THE
NEXT YEAR AS WELL THERE’S SEVERAL ACTIVITIES IN THE OFFICE
WITH A BROAD PORTFOLIO THAT ALL HAVE RELEVANCE TO EACH OTHER AND
THE IMMUNIZATION ENTERPRISE. HAPPY TO UPDATE YOU ON THOSE
ACTIVITIES AND WE’RE WORKING TO INTEGRATE EVERYTHING IN THE
OFFICE ACROSS THE NATIONAL PLANS AND STRATEGIES AND SO I JUST
WANTED TO HAVE THE OPPORTUNITY TO UPDATE YOU ON THAT. THANKS FOR THE OPPORTUNITY TO
UPDATE YOU. THE WORK OF THE COMMITTEE IS
CRUCIAL IN SUPPORTING OUR ABILITY TO POSITIVELY IMPACT THE
U.S.�PUBLIC HEALTH AND ADDRESS ONGOING CHALLENGES WE FACE
TODAY. YOU HAVE A GREAT TWO DAYS COMING
UP. I LOOK FORWARD TO SITTING
THROUGH AND HEARING UPDATES FROM THE SUBCOMMITTEES AND A GREAT
PROGRAM ALIGNED AND BEFORE I CLOSE I WANT TO THANK ANN WHO
JUST DOES A TREMENDOUS JOB PUTTING THIS MEETING TOGETHER
BUT NOT ONLY ANN BUT ALL THE OTHER PEOPLE AT OIDP LISTED
EARLIER THAT WORKED TIRELESSLY TO PUT THE MEETING TOGETHER. ALL OF OUR FACAs AND FOLKS DO A
GREAT JOB AND ANN KNOCKS IT OUT OF THE PARK. THANKFUL SHE’S HERE AND THE REST
OF EVERYONE AND GREAT TWO DAYS AND LIKE FORWARD TO THE MEETING. THANK YOU.>>NEXT UP WE’LL HAVE ADMIRAL
BRETT GIROIR THE ASSISTANT SECRETARY FOR HEALTH AND
DIRECTOR OF THE NATIONAL VACCINE PLAN.>>GOOD MORNING, EVERYBODY. THANKS FOR BEING HERE THIS
MORNING. AS USUAL, IT IS REALLY AN HONOR
FOR ME TO BE HERE. I TRY TO BE AT EVERY MEETING AND
LISTEN IN AS MUCH AS I CAN. IT’S MY SWEET SPOT. ONE OF THE REASONS I REALLY
WANTED THIS POSITION WAS TO PROMOTE VACCINE UPTAKE AND
INNOVATION AND THE NEW FRONTIERS OF VACCINES SO THANK YOU FOR
HAVING ME HERE. AS WE TOGETHER MOVE IN TO A NEW
DECADE, I THINK THERE’S BOTH REASONS FOR HOPE AND REASONS FOR
CONCERN. IMMUNOLOGY IS AFFECTING OUR
ABILITY TO COMBAT INFECTIOUS DISEASES AND CANCER EXCITING NEW
VACCINES AND SUBSTANCE USE DISORDER AND METHAMPHETAMINES
AND FENTANYL AND ALZHEIMER’S. AMERICA JUST EXPERIENCED OUR
WORSE MEASLES OUTBREAK SINCE OFFICIAL ERADICATION IN SINCE
2014 MANY LOST THEIR LIVES TO THIS COMPLETELY PREVENTIBLE
DISEASE. SO FAR THIS FLU SEASON CDC
ESTIMATES THERE’S BEEN HOSPITALIZATIONS AND DEATHS FROM
FLU INCLUDING TRAGICALLY 78 CHILDREN. IF ALL THE REASONS WERE NOT
ENOUGH TO EMPHASIZE THE CRITICAL IMPORTANCE OF THIS COMMITTEE AND
THE HEALTH OF OUR NATION’S VACCINE ENTERPRISE LET’S TALK
WITH THE NOVEL CORONAVIRUS. AS MANY ARE AWARE, THE WHO
DECLARED THE NOVEL CORONAVIRUS A PUBLIC HEALTH EMERGENCY OF
INTERNATIONAL CONCERN AND ON JANUARY 31, SECRETARY AZAR
DECLARED IT PRESENTS A PUBLIC HEALTH EMERGENCY IN THE UNITED
STATES AND SEVERAL HOURS OF MY DAY ARE SPENT ON THIS ISSUE
EVERY SINGLE DAY. LAST WEEK AS PART OF THE STATE
OF THE UNION ADDRESS THE PRESIDENT ADDRESSED THE PUBLIC
IN PROTECTING THEM FROM THE DISEASES AND HHS IS TAKING
PRUDENT AND TARGETED ACTION TO ENSURE THE RISK PROPOSED BY THIS
VIRUS TO THE AMERICAN PUBLIC REMAINS LOW. WE ARE WORK AGGRESSIVELY TO
MONITOR THIS CONTINUALLY EVOLVING SITUATION AND KEEP THE
PUBLIC INFORMED. AND THE U.S.�PUBLIC HEALTH
SERVICE COMMISSION CORPS HAVE ALSO ANSWER THE CALL. WHEN I WROTE IT OVER THE WEEKEND
WE HAD 150 DEPLOYED AND NOW WE’RE OVER 220 DEPLOYED WITH THE
CONTINGENCY I WAS ABLE TO ADDRESS BEFORE THEY GET ON THE
PLANE GOING TO TOKYO GOING TO JAPAN. WE’RE SUPPORTING ALL ASPECTS,
CDC, ASPER AND CUSTOMS AND BORDER PROTECTION. THE GLOBAL CORONAVIRUS EMERGENCY
IS A RESOUNDING REMINDER OF THE CRITICAL NEED TO CONTINUE
VACCINE DEVELOPMENT AND VACCINE MANUFACTURING IN PREPARATION FOR
AND IN RESPONSE TO EMERGING DISEASE EVENTS. THOUGH THERE ARE CURRENTLY NO
VACCINES AVAILABLE TO PROTECT AGAINST THE NEW NOVEL
CORONAVIRUS I THINK WE ALL UNDERSTAND SIGNIFICANT ADVANCES
IN TECHNOLOGY HAVE OCCURRED SINCE THE SARS OUTBREAK. AS A RESULT THE VACCINE
DEVELOPMENT TIME LINE HAS BEEN COMPRESSED SIGNIFICANTLY. FOR EXAMPLE, THE SARS VACCINE
NEEDED 20 MONTHS TO REACH EARLY STAGE TESTING. TONY FAUCHI HAS PUBLICLY STATED
HE BELIEVES PHASE 1 CLINICAL TRIALS WILL OCCUR WITHIN THREE
MONTHS AND ALL THE PRELIMINARY STAGES FOR THE GENETICALLY-BASED
VACCINE ARE GOING VERY SMOOTHLY. I THINK THIS IS A CLEAR
TESTAMENT TO WHY INVESTMENT IN THE VACCINE ENTERPRISE IS SO
CRITICALLY IMPORTANT. THIS IS POSSIBLE BECAUSE WE HAD
SHARING OF GENETIC SEQUENCES OF THE VIRUS EARLY IN THE OUTBREAK
AND WE’VE BEEN ABLE TO ADAPT APPROACHES USED FOR
INVESTIGATIONAL STARS AND MERS VACCINE TO IMPROVE THE TIME
LINE. YOU’LL HEAR MORE ABOUT THE
ONGOING CORONAVIRUS OUTBREAK AND CURRENT VACCINE AND MEDICAL
COUNTERMEASURE DEVELOPMENT DURING THIS MEETING. INCLUDING TO EMERGING INFECTIOUS
DISEASES CONDITIONS SUCH AS VIRAL HEPATITIS AND INFLUENZA
REMAINS THE LEADING CAUSES OF DEATHS IN THE UNITED STATES. THE TREMENDOUS COST AND BURDEN
OF INFLUENZA UNDERSCORES THE NEED FOR IMPROVEMENT IN
INFLUENZA VACCINES. AS WE BEGIN THE NEW DECADE, A
NUMBER OF UNIVERSAL VACCINE PROGRAMS ARE SHOWING PROGRESS IN
CLINICAL TRIALS. I APPLAUD PRESIDENT TRUMP’S
LEADERSHIP ON MODERNIZING FLU VACCINES WITH HIS EXECUTIVE
ORDER TO BETTER PROTECT AMERICANS FROM THE EVOLVING
THREAT OF INFLUENZA VIRUS. I WAS PRIVILEGED TO BE IN THE
OVAL OFFICE WHEN HE SIGNED IT AND I GRABBED THE PEN HE SIGNED
WITH AND IT’S IN MY OFFICE. WE HAVE RESPONDED WITH A BOLD
RESPECT TO ACTION. IN ADDITION YOUR AGENDA INCLUDES
DISCUSSIONS INVOLVING ONGOING WORK WITH UNIVERSAL FLU VACCINE
AND IMPROVED MEDICATIONS AND DIAGNOSTICS. ON OTHER TOPIC, HOW CAN I BE
MORE EMPHATIC ABOUT OUR COMMITMENT AND RESOLVE TO ENABLE
FULL USE OF LIFE-SAVING VACCINES BOTH IN AMERICA AND AROUND THE
WORLD. MANY WHO QUESTION VACCINES ARE
CONCERNED PARENTS WHO ARE TRYING TO DO THE BEST FOR THEIR
FAMILIES IN THE MIDST OF MISINFORMATION. IT IS OUR DUTY TO WORK
COLLABORATIVELY WITH THOSE WHO QUESTION VACCINE AND PROVIDE THE
BEST MEDICAL INFORMATION AVAILABLE TO ENHANCE DECISION
MAKING AND RESPOND CREDIBLY TO QUESTIONS. TO ACCOMPLISH THIS, WE MUST
CONTINUE TO IMPROVE OUR DATA SYSTEM, EDUCATE PROVIDERS ON
VACCINE COUNSELING APPROACHES, SUPPORT APPROACHES FOR VACCINE
COUNSELING, BUILD IN QUALITY METRICS THAT SUPPORT CHANGES AND
WORK WITH PARTNERS TO COUNTER THE VAST AMOUNTS OF VACCINE
INFORMING THAT EXIST ON SOCIAL MEDIA SITES. BUT EVEN IF WE ARE SUCCESSFUL AT
MANY ABOVE MANY PROPONENTS OF VACCINES HAVE NOT FULLY
UNDERSTAND OR PERHAPS PURPOSELY IGNORED THE SCIENCE AND DECADE
OF DATA THAT DRIVES OUR SOUND RECOMMENDATIONS ABOUT PREVENTING
DISEASE THROUGH IMMUNIZATION. OF COURSE, WE KNOW THERE’S
SIGNIFICANT AMOUNT OF MISINFORMATION THAT IS AMPLIFIED
BY FOREIGN AGENT TO FOMENT MISINFORMATION AND WE MUST STOP
THIS MEDDLING. AMERICA REMAINS ON TRACK GIVEN
90% OF PARENTS ADHERE TO VACCINES. YOUR REPORT WILL ENHANCE OUR
ABILITY TO IMPROVE CONFIDENCE IN ALL RECOMMENDS VACCINES THROUGH
THE LIFE STAN. THANK YOU FOR YOUR WORK ON THE
EFFORT. I ALSO WANT TO THANK YOU FOR
WORKING THE ACCESSIBILITY AND AFFORDABILITY OF VACCINES FOR
ALL AND WHILE THIS MEETING IS NOT FOCUSSED ON THE TOPIC, I
KNOW YOU ARE WORKING VERY HARD IN THE IMMUNIZATION SUBCOMMITTEE
TO DEVELOP REPORTS FOR THIS AS WELL. LET ME SWITCH TO HPV. ANOTHER CLEAR EXAMPLE ON
PREVENTION IS THE SIGNIFICANT, SUBSTANTIAL WORK HAPPENING TO
IMPROVE HPV VACCINE RATES. IT WAS ONE OF THE FIRST BULLET
POINTS, MY FIRST CHART I PRESENTED WHEN I BECAME THE ASH
WAS NOT ONLY ABOUT HIV LIKE WHY DO WE STILL HAVE 40,000 CASES OF
HIV AND WE HAVE TO FIX THIS BUT WE HAVE TO DO SOMETHING ABOUT
HPV. WE HAVE A VACCINE THAT CAN
PREVENT 30,000 CANCERS A YEAR IS WHAT WE’VE ALWAYS DREAMED ABOUT,
WHY DON’T WE USE IT SO EVERY COMMITTEE SINCE THE COMMITTEE
RELEASED ITS REPORT SINCE 2018, I’VE STOOD TO SHARE THE STEPS TO
IMPLEMENT THE RECOMMENDATIONS AND THAT’S TRUE TO DIRECTLY
IMPLEMENT YOUR RECOMMENDATIONS. IN THE PAST YEAR WE MADE
SIGNIFICANT STRIDES INCLUDING RECENTLY ENGAGING A LARGE NUMBER
OF INTEGRATED HEALTH DELIVERY NETWORKS AND SYSTEMS LAUNCHING A
FAITH-BASED INITIATIVE THROUGHOUT THE SOUTHEASTERN
STATES AND PROMOTING HPV VACCINATION THROUGH
COMMUNICATION AND I’D LIKE TO SHARE THE ONGOING WORK BECAUSE
I’M PERSONALLY COMMITTED TO THIS. LAST MONTH I MET WITH A CERVICAL
CANCER SURVIVOR AND FOUNDER OF C-E-R-V-I-V-O-R. SHE WAS DIAGNOSED WITH CERVICAL
CANCER AT 25 AND HAS BECOME A VOCAL CHAMPION FOR PREVENTING
CERVICAL CANCER THROUGH VACCINATION AND SCREENINGS. SHE’LL BE HERE TOMORROW TO SHARE
HER STORY AND IT’S AN IMPORTANT MOMENT AND I AM REALLY SO HAPPY
SHE’S GOING TO BE HERE BECAUSE SHE CAN COMMUNICATE IN A WAY
THAT I CERTAINLY CAN’T OR FEW OF US CAN. DURING CERVICAL HEALTH AWARENESS
MONTH IN JANUARY WE FILMED VIDEOS TO SHARE HER STORY AND
DISCUSSED THE POTENTIAL OF HPV VACCINE TO ELIMINATE CERVICAL
CANCER IN OUR LIFE TIME AND CONSIDER WAYS TO WORK WITH THE
FAITH COMMUNITY TO PREVENT HPV CANCERS. THE VIDEO’S AVAILABLE ON
VACCINES.gov ON THE HHS YOUTUBE CHANNEL. I ASKED A COUPLE QUESTIONS AND
LET HER GO AND WAS INFORMATIVE AND THE MOST PERSUASIVE PERSON
I’VE SEEN. I ALSO PERSONALLY SENT LETTERS
TO PROFESSIONAL ASSOCIATIONS AND ACADEMIC INSTITUTIONS,
INTEGRATED DELIVERY NETWORK AND LARGE HEALTH SYSTEMS LEADERSHIP
TO PRIORITIZE BEST PRACTICE MODELS TO INCREASE VACCINATION
RATES IN THE COMMUNITY THEY SERVE. THOUGH THE FOCUS IS ON
ENCOURAGING HPV VACCINATION AT 11 AND 12 WITH 51% OF
ADOLESCENTS FULLY VACCINATED MANY ARE LEFT VULNERABLE. LESS THAN 40% OF YOUNG ADULTS 18
TO 26 RECEIVED ONE OR MORE DOSES OF THE HPV VACCINE. MY LETTERS WENT TO 20 COLLEGES
AND UNIVERSITIES IN THE SOUTHEASTERN UNITED STATES WHERE
WE KNOW THE BURDEN OF HPV IS THE HIGHEST. I URGED UNIVERSITY LEADERS WHO
REPRESENT NEARLY 1 MILLION TOTAL STUDENT ENROLLEES TO HELP END
HPV CANCERS ON THEIR CAMPUS BY IMPROVING VACCINE RATES. I ALSO ON INTEGRATED SOCIETIES
AND NETWORKS AND HEALTH SYSTEMS TO PRIORITIZE INCREASING HPV
VACCINATION RATES FOR THE COMMUNITY AND POPULATIONS THEY
SERVE. IN ADDITION TO THIS DURING HPV
PREVENTION WEEK, I SPOKE ON A WEBINAR HOSTED BY THE HPV
ROUNDTABLE TO KICK OFF A NEW INITIATIVE CALLED WE’RE IN 2020
FOR CANCER PREVENTION. IT SUPPORTS NVAC3.1 OF THE
REPORT TO WORK WITH HEALTH SYSTEMS AND ORGANIZATIONS AND
OTHERS TO PRIORITIZE THE HPV VACCINE AND CALLED ON ALL
SYSTEMS TO SAY WE ARE IN AND CONTINUE OR BEGIN TO MAKE HPV
VACCINATION A PRIORITY AND IT’S AVAILABLE ON THE ROUNDTABLE
WEBSITE. I LOOK FORWARD TO CONTINUING TO
BUILD ON THE MOMENTUM AND MAKING A LASTING IMPACT IN PREVENTING
HPV CANCERS. I’M ALSO PLEASED TO WELCOME AND
I HAD THE DISTINCT HONOR OF SWEARING IN NEW MEMBERS TO THE
NVAC. WELCOME MEETING. I THINK YOU ALL KNOW EACH OTHER
BUT DR. DEBORAH BLOG AND MS. MOLLY HOWELL AND DR. SCHECHTER. DR. HOPKINS WILL BE PROVIDING A
FORMAL INTRODUCTION AND I WANTED TO TAKE A MOMENT TO ACKNOWLEDGE
AND THANK EACH YOU FOR BECOMING PART OF THIS COMMITTEE. THIS COMMITTEE TAKES A
COMPREHENSIVE VIEW OF OUR COUNTRY’S SYSTEM AND LOOK AT
PROGRESS FOR AREAS RANGING FROM VACCINE INNOVATION TO
ACCEPTANCE. I KNOW YOU’LL FIND THE NEW
MEMBERS EXPERTISE TO BE IMPACTFUL AT THE NATIONAL LEVEL
FOR DECADES TO COME. I’D LIKE TO THANK OUR OUTGOING
MEMBER DR. ANN GINSBURG FOR HER
TREMENDOUS CONTRIBUTIONS TO THIS COMMITTEE. WITH THAT I WANT TO THANK EACH
YOU AGAIN FOR YOUR SERVICE. ONE REASON I’M SO COMMITTED TO
AT LEAST BEING HERE AT PARTS OF THESE MEETINGS IS THAT AS I SAY
THAT WHAT YOU DO REALLY DOES MATTER. NOT ONLY DOES TAMMY BECKHAM AND
HER OFFICE READ IT, DIGEST IT. I READ THE RECOMMENDATIONS AND
PERSONALLY INVITE THE CHAIRS OF THE COMMITTEE LEADS TO BRIEF ME
AND AND WE TRY TO TAKE YOUR RECOMMENDATION. YOU’RE NOT A DECISION-MAKING
BODY BUT WE WILL DO OUR BEST TO IMPLEMENT THEM AND HOPEFULLY
WE’VE DONE THAT WITH HPV. IF WE NEED TO DO BETTER OR
CHANGE COURSE OR SOMETHING WE’RE MISSING WE NEED YOUR FEEDBACK. WHAT YOU DO IS VERY IMPORTANT TO
ME AND TO THE SECRETARY AND I WANT TO TURN IT OVER TO TAMMY
BECKHAM AND CONGRATULATE HER AND IF YOU LOOK AT THE TOP 10
THREATS TO HEALTH SEVEN ARE LOCALIZED IN HER OFFICE AND
DOING A FEW IMPORTANT THINGS LIKE RUNNING AND ENDING THE HIV
INITIATIVE AND SPEARHEADING THE TICK BORN STRATEGY AND VECTOR
AND TICK BORN DISEASES IN THE U.S.�AND I THINK AT THE HEART OF
IT THIS COMMITTEE REPRESENT THE CORE OF PUBLIC HEALTH AND
IMMUNIZATIONS HAS DONE MORE TO PROTECT LIVES THAN ANY OTHER
INTERVENTION. THANK YOU VERY MUCH.>>NEXT WE’LL HAVE DR. HOPKINS
THE CHAIR OF THE NATIONAL VACCINE ADVISORY COMMITTEE AND
WILL WELCOME YOU NOW.>>GOOD MORNING. WE APPRECIATE YOU JOINING US AND
LOOK FORWARD TO THE DECADE AHEAD IN IMMUNIZATION. I’D LIKE TO START BY
ACKNOWLEDGING ANN AIKIN AND OTHER MEMBERS OF THE STAFF HERE
OR HAVE PUT THEIR EFFORT IN TO GETTING US HERE. THIS MEETING WILL PRIMARILY
FOCUS ON VACCINE INNOVATION AND CONFIDENCE. TWO TOPICS WITH INDICATIONS FOR
THE SYSTEM. LET’S START WITH HOUSEKEEPING
ITEMS. IN TERMS OF HOUSEKEEPING I WANT
TO MAKE SURE EVERYONE IS AWARE THIS SAY PUBLIC MEETING PEOPLE
CAN WATCH ONLINE OR DIAL IN TO. ALL SPEAKERS ENSURE YOU USE A
WORKING MICROPHONE AND IDENTIFY YOURSELF BEFORE SPEAKING IF I
DON’T ACKNOWLEDGE YOU BY NAME. TURN OFF YOUR MICROPHONES WHEN
NOT UP USE. MEMBERS OF THE PUBLIC WILL HAVE
AN OPPORTUNITY TO GIVE PUBLIC COMMENT AT THE END OF EACH
MEETING DAY. THEY REPRESENT AN OPPORTUNITY
FOR INDIVIDUALS WHO WOULD LIKE TO MAKE A STATEMENT TO DO SO NOT
A QUESTION AND ANSWER PERIOD. IF YOU WOULD LIKE TO SPEAK LIMIT
YOUR COMMENTS TO THREE MINUTES IN LENGTH AND WRITTEN COMMENTS
TO THREE PAGES AND WE’RE LIMITED TO 15 MINUTES OF PUBLIC COMMENT
PER DAY AND YOU CAN SUBMIT THEM ONLINE AND NEXT WE NEED TO
APPROVE MINUTES FROM THE SEPTEMBER MEETING AND THEY’RE
ALSO AVAILABLE ON THE NVAC WEBSITE. DO ANY MEMBERS HAVE CORRECTIONS
TO MAKE TO THE MINUTES FROM THE LAST MEETING? IF NOT, CAN I HAVE A MOTION TO
APPROVE.>>MOTION TO APPROVE.>>THANK YOU DR. SWAMY. A SECOND? THANK YOU DR. PICKERING. ALL IN FAVOR? ANY DISSENT? THE MINUTES ARE NOW APPROVED. THANK YOU. AS A REMINDER THE FUTURE DATES
ARE DETERMINED AND PLEASE NOTE THE DATES. I’D LIKE ABOUT THE MEETING
HIGHLIGHTS TODAY. WE’LL START WITH GOING OVER THE
AGENDA BRIEFLY. AFTER OUR UPDATES THIS MORNING
FROM DR. BECKHAM AND ADMIRAL
GIROIR WE’LL FOCUS ON VACCINE INNOVATION AND IMPLEMENTATION
AND IMPLEMENTING THE EBOLA VACCINE IN THE DEMOCRATIC
REPUBLIC OF CONGO AND THE FIRST SESSION WILL FOCUS ON
TUBERCULOSIS VACCINE ADMINISTRATION, MEASLES
INFECTION AND MEMORY LOSS AND NEW USE FOR PLANT, INSECTS AND
ANIMALS IN VACCINE DEVELOPMENT AND THEN HEAR A NUMBER OF
PRESENTATIONS ABOUT THE NOVEL CORONAVIRUS AND RESEARCH USED IN
THE DEVELOPMENT OF POTENTIAL VACCINE AND FUTURE MEDICAL
COUNTERMEASURES AND WILL SUPPORT THE RECENT ORDER TO MODERNIZE
INFLUENZA VACCINES AND HEAR UPDATES ON THE VACCINE
SUBCOMMITTEE AND REPRESENTATIVES AND WE’LL END THE DAY WITH
PUBLIC COMMENT. FOR TOMORROW, WE’LL RECONVENE
WITH A FOCUS ON VACCINE CONFIDENCE AND AS ONLINE
CONFIDENCE HAS EMERGED AS UPTAKE WE’LL BEGIN WITH TWO ROBUST
PANEL DISCUSSIONS ON PROMISING STRATEGIES TO ACCESS TO CREDIBLE
VACCINE INFORMATION ONLINE AND IN THE AFTERNOON WE’LL HERE FROM
HAWAI’I’S DEPARTMENT OF HEALTH FOR NEW VACCINES FOR SCHOOL
ENTRY INCLUDING THE REQUIREMENT FOR SIXTH GRADERS AND HOLD A
PANEL TO HIGHLIGHT THE POTENTIAL OF STORY TELLING AS A MEANS OF
ENCOURAGING TIMELY VACCINE. THE DAY WILL CONCLUDE WAY
PRESENTATION ON NEW CODING CHANGES FOR REIMBURSEMENT ON
VACCINE COUNSELING AND PUBLIC COMMENT. I’M THRILLED TO KICK OFF THE
YEAR WITH THREE NEW MEMBERS AND THE APPOINTMENT OF FOUR EXISTING
MEMBERS. I’D LIKE TO BRIEFLY INTRODUCE
THE MEMBERS. FIRST IS DR. DEBORAH BLOG. THE DIRECTOR OF EPIDEMIOLOGY AT
THE NEW YORK STATE DEPARTMENT OF HEALTH. THIRD LEADERSHIP INCLUDES
OVERSEEING DISEASE SURVEILLANCE AND EXPERT TECHNICAL ASSISTANCE
AND COLLABORATIONS WITH LOCAL HEALTH DEPARTMENTS AND
PROFESSIONALS SHARING EXPERTISE AND KNOWLEDGE TO CONFRONT A
VARIETY OF NEW AND COMMUNICABLE DISEASES. WE APPRECIATE YOU JOINING US. NEXT IS MOLLY HOWELL. SHE’S FROM THE NORTH DAKOTA
DEPARTMENT OF HEALTH AND HER CURRENT ROLE SHE OVERSEES
IMMUNIZATION POLICIES AND ACTIVITIES IN NORTH DAKOTA
INCLUDED INCREASE IMMUNIZATION COVERING, HEALTH CARE PROVIDER
IMPLEMENTATION AND ONE OF THE CDC’S SITES. OUR THIRD NEW MEMBER IS DR. ROBERT SCHECHTER. HE’S A MEDICAL OFFICER AND CHIEF
OF CLINICAL AND POLICY SUPPORT SECTION FOR THE CALIFORNIA
DEPARTMENT OF PUBLIC HEALTH IMMUNIZATION BRANCH AND OFFERS
EXPERIENCE IN PROGRAM IMPLEMENTATION AND MANAGEMENT,
VACCINE SAFETY AND POST-MARKETING SURVEILLANCE,
VACCINE COMMUNICATION AND HEALTH INFORMATION TECHNOLOGY,
IMMUNIZATION INFORMATION SYSTEM AND VACCINE AND DEVELOPMENT. HE’S HELD MANAGERIAL AND
CONSULTATIVE ROLES INCLUDING THE
CALIFORNIA VACCINE FOR CHILDREN PROGRAM AND THE FEDERAL 317
IMMUNIZATION FOR THE UNINSURE. WE’RE PLEASED TO REAPPOINT
CERTAIN MEMBERS FOR THREE YEAR TERMS. [LISTING NAMES]
AND I HOPE YOU FIND THE TIME MEANINGFUL AND I’D LIKE TO THANK
ANN GINSBURG. SHE’S STEADILY CONTRIBUTED TO
MANY MEETINGS DURING HER TENURE AND I’VE ENJOYED HER
CONTRIBUTIONS RECENTLY AT THE NATIONAL VACCINE DEVELOPMENT
SUBCOMMITTEE. I HOPE YOU’LL ALL JOIN ME IN
WISHING HER WELL AND SHARING HER LEADERSHIP SKILLS AND EXTENSIVE
EXPERIENCE. LET’S GIVE HER A ROUND OF
APPLAUSE EVEN IN HER ABSENCE. IN CLOSING, I’LL TURN IT OVER TO
OUR NEXT SPEAKER. ANN, WOULD YOU MAKE HER
INTRODUCTION, PLEASE.>>NEXT UP WE HAVE ROSALIND
CARTER FOR THE CENTER FROM DISEASE CONTROL AND PREVENTION. SHE’LL BE TALKING ABOUT EBOLA
VACCINE IMPLEMENTATION.>>I WANT TO THANK THE
ORGANIZATION FOR OPPORTUNITY TO PRESENT TO YOU TODAY. I’M DELIGHTED TO SHARE CDC’S
EXPERIENCES WITH EXPERIMENTAL EBOLA VACCINES I HOPE WILL
PROVIDE GROUNDING FOR THE DISCUSSION ABOUT THE PROCESS OF
GETTING EXPERIMENTAL VACCINES OUT OF THE LAB AND IN TO THE
PLACES THEY NEED THEM. DISTURB TODAY’S PRESENTATION
I’LL GIVE AN EVERY VIEW OF THE EBOLA TRANSMISSION, THE
LANDSCAPE OF VACCINES AND OUR EXPERIENCE WITH IMPLEMENT IN
CONGO AND BORDERING COUNTRIES. I’LL COVER TOPICS OF SPECIAL
INTEREST TO THE GROUP VACCINE EQUITY AND CONFIDENCE AND
DESCRIBE LESSONS LEARNED AND NEXT STEPS. THE FIRST EBOLA SPECIES WAS
FOUND IN WHAT IS THE DEMOCRATIC REPUBLIC OF CONGO AND THERE ARE
FOUR SPECIES THAT CAUSE HUMAN ILLNESS. [LISTING]
AND FROM 1976 TO 2014 SEVERAL OUTBREAKS OCCURRED IN AFRICA AND
ALL IN REMOTE AREAS. THEN IN 2014 THE WEST AFRICA
OUTBREAK OCCURRED WITH MORE THAN 28,000 CASES AN 11,000 DEATHS TO
COMPARE THE CURRENT CORONAVIRUS NUMBERS. THE CURRENT OUTBREAK WHICH
STARTED IN AUGUST OF 2018 IS THE TENTH AND LARGEST OUTBREAK IN
DRC. AN OUTBREAK IS FROM AN INFECTED
WILD ANIMAL SUCH AS A FRUIT BAT, MONKEY, CHIMPANZEES FOLLOWED BY
HUMAN TO HUMAN TRANSMISSION BY BODILY FLUID SUCH AS BLOOD,
VOMIT OR SWEAT OR WASHING BODIES BEFORE BURIAL AND IN SOME CASES,
UNPROTECTED SEX THROUGH AN EBOLA SURVIVOR AND IT’S SPREAD AND
IT’S PART OF WHAT MADE THE OUTBREAK DEVASTATING AND ALSO
CHALLENGING TO CONTROL. SO WHERE TO VACCINES FIT IN
RESPONSE?>>THERE’S CONTACT TRACING. COMMUNITY ENGAGEMENT AND
COMMUNICATION, INFECTION CONTROL AND BURIALS AND
CASE MANAGEMENT, LABORATORY, BORDER HEALTH AND
VACCINE. IT’S IMPORTANT TO NOTE WHILE THE
VACCINE IS NEW, IT’S COMPLEMENTARY TO RESPOND TO AN
OUTBREAK AND NEEDS TO BE DONE WITH CURRENT OUTBREAKS. NOW A BIT MORE ABOUT EBOLA
VACCINES SPECIFICALLY. IN SEPTEMBER 2014 THERE WAS A
WHO CONSULTATION ON POTENTIAL EBOLA THERAPIES AND VACCINES. PARTICIPANTS INCLUDED
REPRESENTATIVES OF AFFECTED COUNTRIES AND AGENCIES LIKE NIH
AND CDC AND COUNTERPARTS IN OTHER COUNTRIES AND INCLUDED
THERE WAS AN URGENT NEED FOR A VACCINE AND MOUNT A COORDINATED
EFFORT TO REMOVE UNNECESSARY OBSTACLES. AND MOVING FROM PRE-CLINICAL
TESTING CAN BE EASILY 10 YEARS THE MULTIPLE ORGANIZATIONS BEGAN
PLANNING THE CLINICAL TRIALS AND FORGING PARTNERSHIPS NECESSARY
TO CONDUCT THE TRIALS. ALL THE VACCINES IN TRIALS ARE
VECTOR VACCINES IN WHICH THE GENETIC MATERIAL CODING HAS BEEN
INSERTED IN TO ANOTHER CARRIER VIRUS. THERE’S NINE VACCINES IN
CLINICAL TRIAL PHASE 1 THROUGH 3. WHAT I HAVE HERE IS NOT AN
EXHAUSTIVE LIST OF REGIMENTS. THERE’S STUDIES PLANNED TO
EVALUATE OTHER REGIMENTS. THERE’S ALSO CANDIDATES FOR
OTHER EBOLA SPECIES SUCH AS EBOLA SUDAN AND FEWER VIRUSES
BUT WHAT I’M GOING DO TODAY IS TO FOCUS PRIMARILY ON THE VIRAL
VACCINE STUDIED IN TRIALS IN WEST AFRICA AND HAS EFFICACY
AVAILABLE AND THE ONLY VACCINE WHERE WE HAVE EFFICACY. SO THE VIRUS TYPICALLY CAUSES
LIVESTOCK DISEASE. HUMAN INFECTIONS ARE RARE AND
TYPICALLY ASYMPTOMATIC AND NOT IN DEMOCRATIC IN AFRICA IN
EUROPE SO THERE WAS LITTLE PRE-EXISTING IMMUNITY ASSOCIATED
WITH RESPONSE AND THIS SHOWS THE WILD TYPE PROTEIN ON THE LEFT
HAS BEEN REPLACED FOR THE GENE OF THE EBOLA VIRUS SHOWN IN RED. THIS IS DEVELOPED BY THE PUBLIC
HEALTH AGENCY OF CANADA EVENTUALLY LICENSED TO NEW AND
GENETIC AND FINALLY TO MERCK. THERE WAS NO DETECTABLE TOXIC
EFFECT AND THE VACCINE WAS GIVE AS A SINGLE DOSE WHICH IS AN
ADVANTAGE AND THE DOSE SELECTED AFTER THE PHASE 1 TRIALS WAS TWO
TIMES TEN TO THE SEVEN AND THE
STRINGENT SHELF REQUIREMENT NEEDS TO GET IT QUICKLY TO TRIAL
AND WE ARE LEFT WITH A VACCINE WITH VERY CHALLENGING COLD
STORAGE. AND FINALLY THE VACCINE CANNOT
CAUSE EBOLA BECAUSE IT DOES NOT CONTAIN THE ENTIRE VIRUS. SO THE STUDIES WERE CONDUCTED IN
INFRASTRUCTURE, EUROPE AND THE U.S.�AND SAFETY MONITORING
SHOWED THE VACCINE WAS QUITE REACTIVE WITH ADVERSE EVENT IN
50% OF PARTICIPANTS INCLUDING LOCAL AND SYSTEMIC EVENTS SUCH
AS FEVER, HEADACHE AND MUSCLE ACHE. THEY APPEARED EARLY AS YOU CAN
SEE IN THE GRAPH FROM THE STUDY. THERE’S A VERY STRONG INCREASE
IN RNA FROM THE VACCINE IDENTIFIED ONE TO THREE DAYS
AFTER VACCINATION IN MOST PARTICIPANTS. WHILE IT APPEARS ONE TO THREE
DAYS POST-VACCINATION THEY SUBSIDE RAPIDLY AND MANAGED WITH
OVER THE COUNTER ANALGESICS. THERE’S NO CORRELATION WITH THE
VIREMIA OR THE INTENSITY OF ADVERSE EVENT. I’LL SPEND A MOMENT DESCRIBING
THE WHO RING TRIAL KNOWN AS EBOLA [INDISCERNIBLE]. IT DEMONSTRATED EFFICACY AND
IT’S BASED ON THE RING VACCINE APPROACH USED SUCCESSFULLY TO
ELIMINATE SMALLPOX AND THE ENTIRE CLUSTER WAS RANDOMIZED TO
AN IMMEDIATE OR DELAYED VACCINATION OF ELIGIBLE
CONTACTS. THE DELAYED GROUP RECEIVING THE
VACCINE 21 DAYS LATER AND IT CONFIRMED EBOLA VIRAL DAYS WHEN
WE THOUGHT IT WOULD HAVE PRODUCED EFFECTIVE IMMUNE
RESPONSE. HOW’S THE VACCINATION WORK? IT STARTS WITH A LABORATORY
CONFIRMED PERSON INFECTED WITH EBOLA. THE CONTEXT OF THAT PERSON ARE
IDENTIFIED. THESE ARE INDIVIDUALS WHO IN THE
LAST 21 DAYS LIVED IN THE SAME HOUSEHOLD AND WERE VISIT THE
INDEX CASE AFTER DEVELOPING SYMPTOMS OR WERE IN CLOSE
PHYSICAL CONTEXT WITH BODIES, LINENS, ETCETERA. WE VACCINE THE CONTACTS BUT
DON’T EXPECT PROTECTION AGAINST THE GROUP WILL BE COMPLETE
BECAUSE VACCINE IS OFTEN BROUGHT IN MORE THAN 10 DAYS AFTER
EXPOSURE. NEXT THE TEAM SIGNS THE CONTEXT
AND NOW IT BECOMES WORDY. THE CONTACTS OF CONTACTS ARE
NEIGHBORS, FAMILY, EXTENDED FAMILY MEMBERS LIVING NEARBY. AND NOW WE VACCINATE THEM. IF THERE’S SECONDARY
TRANSMISSION FROM THE ORIGINAL CASE TO THE CONTACT IT’S THE
CONTACTS OF CONTACTS THAT WILL BE PROTECT FROM THE SECONDARY
CASES. THE LAST PIECE OF RING
VACCINATION IS TO PROTECT HEALTH CARE WORKERS OR ANY FACILITIES
THE CASE MAY HAVE GONE AND VACCINATES EN ROUTE .
IT FORMS A THIRD PROTECTIVE LAYER FROM ONWARD TRANSMISSION
FROM THE ORIGINAL CASE. AND AND THIS WAS TAKEN FROM
RESULTS AND IF WE LOOK AT THE FIRST COLUMN, THE SPECIFIED
OUTCOME WAS EBOLA MORE THAN 10 DAYS AND NO CASES IN THE
IMMEDIATE GROUP AND 16 CASES IN THE DELAYED GROUP WITH VACCINE
EFFICACY ESTIMATION OF 70% AND CONFIDENCE FOUND OF 75% AND IT
DOES NOT MEET THE PRE-SPECIFIED LEVELS FOR SIGNIFICANCE BUT
NONETHELESS THEY’RE IMPRESSIVE RESULTS. SO FOLLOWING THE WEST
INFRASTRUCTURE OUTBREAK AND THE SUCCESSFUL EFFICACY RESULTS FROM
THE NEW GUINEA TRIAL SHOULD AN EBOLA OUTBREAK OCCUR ABOUT THE
VACCINE IS LICENSED IT SHOULD BE PROMPTLY DEPLOYED WITH INFORMED
CONSENT AND IN COMPLIANCE WITH GOOD CLINICAL PRACTICE AND THE
FRAME WORK WAS NEW AND ALLOWS SOMEONE WITH AN IMMEDIATE LIFE
THREATENING DISEASE OR PREVENTION TO GAIN ACCESS TO AN
INVESTIGATIONAL MEDICAL PRODUCT OUTSIDE OF A CLINICAL TRIAL WHEN
THERE’S NO THERAPY OPTION AVAILABLE. WE KNEW WE WOULD USE THAT ONLY
ABOUT A YEAR LATER. AND ON TO 2018 AND THE
STRATEGIES THAT WERE USED TO BRING VACCINE TO THIS OUTBREAK
WERE BOTH AS WE SAID IN THE CONTEXT OF HAVING A LABORATORY
CONFIRMED EBOLA CASE AND DID RE-VACCINE OF CONTACTS OF
CONTACTS AND HEALTH CARE WORKERS AND CONSIDERED THE CASE OF
WHETHER WHERE THERE IS NO EBOLA. IT INVOLVES PREVENTIVE
VACCINATION OF HEALTH CARE WORKERS AND FRONTLINE WORKERS IN
AREAS OF RISK AND MIGHT BE AFFECTED BY A SPREADING
OUTBREAK. IT’S A RATIONALE TO VACCINE IN
HEALTH CARE FACILITIES ACROSS THE BORDER FROM DRC. SO WHERE ARE WE NOW? FEBRUARY 10 THIS IS THE CURVE
THROUGH THE END OF JANUARY. THERE’S BEEN EBOLA CASES WITH A
66% FATALITY RATIO AND MORE THAN 292,000 INDIVIDUAL CONTACTS OF
CONTACTS AND HEALTH CARE WORKERS HAVE BEEN VACCINATED IN THE DRC.
59 OF THOSE HAVE BEEN HEALTH CARE WORKERS. SO LOOKING AT THE MAP OF DRC
RELATIVE TO ALL OF ITS NEIGHBORS, THE CURRENT OUTBREAK
ORIGINALLY WAS AND CONTINUES TO BE FOCUSSED IN THE
[INDISCERNIBLE] PROVINCES AND WE LOOKED AT THE AREAS ACROSS THE
BORDER IN UGANDA AND SOUTH SUDAN AND RWANDA AND BURUNDI AND
WITHIN THE HIGH-RISK DISTRICTS IS WHERE WE IMPLEMENTED THIS FOR
WORKERS AND IN TOTAL 16,000 HEALTH CARE WORKERS HAVE BEEN
VACCINATED IN THE BORDERING COUNTRIES AND THAT’S WHAT I’LL
TALK ABOUT IN THE NEXT PIECE. HOW DOES THIS START? FIRST WE DE SENSITIZED THOSE WE
WERE WORKING WITH. THERE’S SIGNIFICANT REGULATORY
APPROVES THAT NEEDED TO HAPPEN, LOGISTICS, TRAINING STAFF,
MICROPLANNING, COMMUNITY ENGAGEMENT AND FINALLY
IMPLEMENTING VACCINATION AND SAFETY FOLLOW-UP AND MONITORING
AND EVALUATION. I’M GOING TO HIGHLIGHT A FEW OF
THESE AND LESSONS LEARNED FOCUSSING ON THINGS THAT MIGHT
BE USEFUL CONSIDERING VACCINES AND OTHER OUTBREAKS. WHEN WE FIRST APPROACH COUNTRIES
WE SPEND A LOT OF TIME SENSITIZING THE GOVERNMENT AND
THIS IS PRIOR TO SUBMITTING THIS TO THE REGULATING COMMITTEES. EVERYONE WAS GIVEN A COPY OF THE
PROTOCOL AND FEW HAD TIME TO DIGEST IT AND HAD TO WALK THEM
THROUGH THE SCIENCE AND WITH THE U.S.�EMBASSY AND WITH LEADERS IT
WAS TIME WELL SPENT. IN TERMS OF THE REGULATORY
APPROVAL AS WE’RE GOING BACK NOW AND TALKING TO PEOPLE ABOUT WHAT
THE EXPERIENCE WAS WHEN WE STARTED A YEAR AGO, ONE OF THE
COMMENTS WAS THAT THE ACCESS WAS A NEW CONCEPT FOR THE REGULATORY
AGENCIES THEY UNDERSTAND AND APPROVE THEM AND HAVE A LOT OF
EXPERIENCE. GIVING SO MANY DOSES OF AN
EXPERIMENTAL VACCINE WIDELY ACROSS THE COUNTRY WAS SOMETHING
THAT TOOK THEM A WHILE TO UNDERSTAND AND APPRECIATE AND
GOES TO A CLINICAL TRIAL AND WHAT WE WERE ASKING THEM TO DO
WAS SOMETHING OUTSIDE OF THAT. IN THE FUTURE I THINK WE NODE TO
THINK ABOUT HOW WE BEST SUPPORT THE REGULATORY AND ETHICAL
AGENCIES AND HOW TO REVIEW THE
PROTOCOLS. IN RETURN FOR LOGISTICS, THERE
WERE MANY IMPLEMENTATION CHALLENGES. WE’RE TALKING ABOUT COUNTRIES
WITH LIMITED INFRASTRUCTURE AND STEADY ELECTRICAL SUPPLIES MEANT
WE HAD TO HAVE MULTIPLE GENERATORS AND MANY BACK-UP
SYSTEMS. AGAIN, TO STORE VACCINE AS SUCH
A LOW TEMPERATURE OF MINUS 16 WE NEEDED SPECIAL ULTRA LOW
FREEZERS SHOWN ON TOP AND WERE NOT AVAILABLE IN THESE COUNTRIES
AND HAD TO BE PROCURED IN EUROPE AND SHARED BY AIR AND IT WOULD
TAKE TWO WEEKS TO GET THE FREEZERS AND THE COLD CHAIN HAS
TO BE SET UP BEFORE THE VACCINE CAN BE SHIPPED AND REQUIRED
STEADY ELECTRICAL SUPPLY REQUIRING REFURBISHMENT OF
CURRENT COLD CHAIN OR THINKING CREATIVELY. WE LEARNED WELL IN SIERRA LEONE
HAVING THREE REDUNDANT SYSTEMS WAS NOT ENOUGH AND ALL THREE
FAILED AT SOME POINT. THOUGH WE HAD NO PROBLEM WITH
THE VACCINE WE WERE SURPRISED WE NEEDED EVERY BIT OF OUR BACK UP. ONE OF THE KEYS TO SUCCESSFUL
IMPLEMENTATION IN WEST INFRASTRUCTURE THAT CONTINUES
NOW IS THE DEVELOPMENT OF THESE [INDISCERNIBLE]. ON TOP THE GREEN ONES IF FROZEN
WATER IS PLACED INSIDE THE DRUMS IT KEEPS VACCINE AT 0 TO 8
DEGREES WHICH IS HELPFUL AND IN USING [INDISCERNIBLE] ALCOHOL WE
WERE ABLE TO OBTAIN MINUS 16 DEGREES FOR UP TO SIX DAYS. THIS IS A GAME CHANGER IN
GETTING VACCINE FROM A CENTRAL DEPOT IN THE CAPITAL CITY OUT TO
THE FIELD. WE TOOK IT A STEP FURTHER IN
SOUTH SUDAN AND WERE ABLE TO GET THEM ON PLANES SAFELY BECAUSE
THE MATERIAL’S NOT FLAMMABLE. THE OTHER GOOD THING RECENTLY IN
THE DRC OUTBREAK IS STABILITY INFORMATION FROM THE
MANUFACTURER THAT ALLOWED US TO [INDISCERNIBLE] VACCINE AND WE
COULD STORE IT FOR 14 DAYS IN A REGULAR EPI COLD CHAIN. IT’S A GAME CHANGER WHEN YOU
TAKE IT LONG DISTANCES BUT THE PROGRAMS HAVE SOME COLD CHAIN
AVAILABLE TO SUPPORT FOR A SHORT PERIOD OF TIME. ONE THING TO CONSIDER IN THE
TEMPERATURE THIS IS SHOWING THE VACCINE CARRIER IN SOUTH SUDAN
AND WHILE IT WAS PUT IN THE CARRIERS WHERE WE COULD USE IT
UP TO FIVE HOURS WHEN YOU TALK ABOUT A BACKGROUND TEMPERATURE
OF 112 DEGREES THE NUMBER TIMES YOU’RE OPENING THE VACCINE
CARRIER MAKES A DIFFERENCE. THIS IS AN EXAMPLE OF MANY
PEOPLE WANTING TO MEASURE THE TEMPERATURE INSIDE THE VACCINE
CARRIER TO THE EXTENT IT WAS BEING OPENED EIGHT TO 10 TIMES A
DAY MAKING IT DIFFICULT TO MAINTAIN THE TEMPERATURE AND WE
FIXED THAT WITH ADDITIONAL TRAINING. AND FOLLOWING THE NEW GUINEA
TRIAL THE ENTIRE ACTIVITY WAS PORTABLE. WE BROUGHT UP THE SUPPLIES WITH
US IN TO FIELD AND MOVED AROUND WITH IT BUT THE TEAMS CARRIED
SUPPLIES THAT FIT NEATLY INTO THE FIVE BLACK BOXES. EVERY NIGHT THEY WENT OUT TO THE
FIELD AND EVERY NIGHT THEY CAME BACK AND WERE REPLENISHED. IT MADE US QUITE NIMBLE AND
SHOWED THE IMPORTANCE OF HAVING TRUCKS AND VEHICLES TO TRANSPORT
PEOPLE AS WELL AS THE SUPPLIES. AND IN TERMS OF LESSONS LEARNED
FROM LOGISTICS YOU NEED TO PLAN FOR THE PROCUREMENT AND
INSULATION OF SPECIALIZED EQUIPMENT AND NEED TO CONSIDER
ELECTRICITY AVAILABILITY AND NEEDS. OUR TEXT CAN BE HELPFUL WITH THE
VACCINE AND THE FIELD REQUIRES STRONG LOGISTIC SUPPORT. IN HIRING AND TRAINING A VACCINE
TEAM THIS IS THE EASY PART. THERE’S NO END TO THE NUMBER OF
TALENTED PEOPLE JUST WAITING FOR AN OPPORTUNITY AND APPRECIATE
LEARNING MORE. I FEEL POSITIVE ABOUT THE
CAPACITY BUILT IN TERMS OF THE WORK. THEY WERE BASICALLY MADE OF 10
TO 12 MEMBERS SERVING UNDER A TEAM LEADER IN AREAS OF SOCIAL
MOBILIZATION AND DESIGNING THE RING OF THE CONTACTS OF CONTACTS
AND INFORMED CONSENT THE ACTUAL VACCINE WORK AND MEDICAL
PHYSICIAN WHO COULD PERFORM ANY NECESSARY THINGS FOR 30-MINUTE
FOLLOW UP AND IT WAS ORIGINALLY PART OF THE PROTOCOL IN DAY
THREE AND 41 DAYS AFTER VACCINATION. THE INVESTMENT AND CAPACITY
BUILDING WILL PROVIDE RETURNS FOR MANY YEARS TO COME. A PART OF THIS WAS THE MICRO
PLANNING. THE COUNTRIES DESIGN THE
HIGH-RISK AREAS BASED ON PROXIMITY TO THE DRC AND WE ONLY
HAD 3,000 DOSES TO COVER HEALTH CARE WORKERS IN THOSE PLACES AND
WE HAD TO CHOOSE HEALTH FACILITIES BASED ON CRITERIA
SUCH AS THOSE CROSSING THE BORDER TO OBTAIN HEALTH CARE AND
AN IMPORTANT PART WAS DEFINING THE TARGET GROUPS. ON A DAILY BASIS WE TRIED TO
TRACK PROGRESS. WE OFTEN HAVE A LIST OF CONTACTS
OR WORKERS AT THE FACILITY AND WE NEED TO MAKE SURE WHERE WE
VACCINATING THE RIGHT PEOPLE. THE PHOTO HERE SAYS
[INDISCERNIBLE] AFTER WE DID THE MAIN PRESENTATION HE WALKED TO
THE BACK OF THE HOSPITAL WITH NICE FRESH LAUNDRY AND WENT TO
THE LAUNDRY ROOMS BECAUSE HE NOTICED THE LAUNDRY WORKERS
WEREN’T PART OF OUR PRESENTATION AND WENT TO TALK TO THEM WITH
THE OPPORTUNITY AND WHAT I’VE SEEN FOLLOWING THE CASES IN
UGANDA AND JULY WAS ALL OF A SUDDEN A HUGE VACCINE DEMAND AND
WE’VE COME TO A HUGE NUMBER OF VACCINE DOSES AND HAD 100 PEOPLE
CLAMORING FOR VACCINE INCLUDING MANY MEDICAL AND NURSING
STUDENTS AND WE HAD TO WORK TOGETHER TO DECIDE WHO WOULD BE
THE PEOPLE THEY THOUGHT SHOULD BE VACCINATING BASED ON THEIR
EXPOSURE AND THE AMOUNT OF TIME SPENT DOING PATIENT CARE. THE STORY THERE IS BY 2:00 IN
THE AFTERNOON WE TOOK A BREATH, LOOKED AT WHO WE HAD VACCINATED
AND LOOKED AROUND TO SEE ARE WE MISSING ANYONE. THERE WAS AN ISOLATION UNIT AT
THE HOSPITAL THERE WERE TWO SUSPECT CASES IN THE UNIT SO THE
TEAM TAKING CARE OF THESE PATIENTS WERE WORKING THEIR
SHIFT AND HAD NO IDEA WE WERE THERE. IN THIS CASE, WE STOPPED AND
HELD BACK SOME VACCINES AND WAITED UNTIL THEIR SHIFT WAS
OVER AND TALKED TO THEM ABOUT THE OPPORTUNITY AND THEY TOOK
THE VACCINE. THIS IS AN ONGOING PROCESS. IT BEGINS DESENSITIZING THE
GOVERNMENT WORKERS AND ONCE THE
ACTIVITY BEGINS WE’RE PROVING CONSTANT INFORMATION IN BOTH
LARGE AND SMALL GROUPS AND DOING ACTIVE LISTENING. I’LL SPEAK MORE ABOUT THIS. THIS IS AN ISSUE THAT COULD USE
MORE WORK AND IMPROVEMENT FOR THE FUTURE. FINALLY JUST TO DESCRIBE QUICKLY
WHAT ACTUALLY HAPPENED AT THE SITE, SO THE SURVEILLANCE TEAMS
AND VACCINE NAMES ENUMERATE THE PEOPLE AT RISK AND CONTACTS AN
HEALTH CARE WORKERS. THEY WERE THEN SCREENED FOR
ELIGIBILITY AND INFORMED CONSENT HAPPENED
AND WAITED 30 MINUTES FOR OBSERVATION. AND THIS GIVES AN IDEA WHAT
INFORMED CONSENT LOOKS LIKE IN THE DRC. THERE WERE ACTIVE CASES AND THE
EVENT TEAM IS WEARING THEIR PPE AND YOU CAN UNDERSTAND HAVING A
DISCUSSION WHILE USING FACE MASKS AND GLOVES. PEOPLE WERE ABLE TO WORK THROUGH
IT BUT THERE ARE CHALLENGES WITH THIS APPROACH. FINALLY, JUST TO TALK A LITTLE
BIT ABOUT SAFETY MONITORING. EVEN WITH EXTENDED ACCESS,
SAFETY MONITORING AND REPORTING FROM THE DATA SAFETY MONITORING
BOARD WAS PART OF THE PROTOCOL THAT WENT THROUGH IRB REVIEW. ALL RECIPIENTS OF THE VACCINE
WERE OBSERVED FOR 30 MINUTES FOR ANY OF SIGNS AND SYMPTOMS OF
ANAPHYLAXIS AND
BECAUSE THERE WERE FEW SAFETY EVENTS INSTEAD
OF HAVING A DIRECT ACTIVE MONITORING UP TO 21 DAYS AFTER
VACCINATION IT THEN MOVED TO PASSIVE REPORTING EXCEPT FOR
INFANTS UNDER 12 MONTHS OF AGE AND PREGNANT WOMEN. SO THERE’S A QUESTION WHETHER
THAT HAD IMPACT ON SAE DETECTION. FINALLY IN TERMS OF MONITORING
AND EVALUATION I THINK THIS IS AN ANOTHER AREA THAT CAN BE
STRENGTHENED. WE COLLECTED INFORMATION FROM
EACH PARTICIPANT ELECTRONICALLY ON TABLETS. THE DATA WAS SENT VIA THE
INTERNET VIA A SERVER ON EUROPE AND AVAILABLE AT THE LOCAL LEVEL
FOR ANALYSIS AND THERE WAS NO INFORMATION ON VACCINE COVERAGE
BY HEALTH FACILITY OR AMONG HIGH-RISK CONTACTS READILY
AVAILABLE. IT COULD BE CALCULATED IN
RETROSPECT BUT SOMETHING THAT FREQUENTLY CAME UP IN
DISCUSSIONS WITH WHAT ARE WE DOING, DO WE NEED TO GO BACK AND
RE-VACCINE DURING THE HEIGHT OF THE EPIDEMIC AND DRC IN MARCH
THROUGH MAY. FINALLY THE DATA SYSTEMS WE USED
FOR CASE REPORTING FOR EBOLA IS NOT NECESSARILY HARMONIZED WITH
THE SYSTEMS COLLECTING INFORMATION ON PERSONS
VACCINATE. IT WAS OFTEN DIFFICULT TO KNOW
WHETHER PEOPLE THAT WERE EBOLA CASES IN FACT HAD BEEN
VACCINATED. I’LL GIVE YOU A QUICK SENSE OF
WHAT THIS LOOKS LIKE. THE VACCINATION ACTIVITY CAN
TAKE PLACE WITHIN A HEALTH FACILITY SETTING SUCH AS IN THIS
HOSTEL IN UGANDA AND CAN BE DONE IN THE OPEN AIR AT A HEALTH
FACILITY OR WITHIN THE COMMUNITY AND THIS HAS IMPACT FOR THE NEXT
POINT WHICH IS WE NEED TO CONSIDER THE UNIQUE CONDITIONS
OF DRC AND THE INSECURE CONFLICT SETTINGS. NOT ONLY DID THIS IMPACT THE
ABILITY OF TEAMS TO REACH AFFECTED AREAS OF THE VACCINE,
WE HAVE TO CONSIDER THE TRAUMATIZING EFFECT ON THE
STAFF. I CAN SAY IT’S DIFFICULT TO WORK
IN THE SETTING BUT YOU CAN IMAGINE HOW MUCH HARDER IT IS TO
WORK IN A HUMANITARIAN SETTING WHICH ADDS TO THE DANGER OF THE
WORK. WE’VE SEEN NEWS REPORTS ABOUT
THE EBOLA TREATMENT CENTERS THAT WERE BURNED AND THE DOCTOR THAT
WAS ATTACKED AND KILLED AND LATER A VACCINATOR AND HER
DRIVER WERE KILLED IN A COMMUNITY ACTIVITY AGAINST THE
EBOLA RESPONSE. AND POINTS TO NECESSARY
COORDINATION WITH SECURITY AND ACCESS GROUPS AGAIN WHICH THE
HUMANITARIAN COMMUNITY IS FAMILIAR WITH BUT WE IN PUBLIC
HEALTH HAVE MORE TO LEARN ON THIS ISSUE. I WANT TO MOVE NOW TO ADDRESS A
FEW ISSUES THEY KNOW OF PARTICULAR INTEREST TO THIS
GROUP AROUND VACCINE EQUITY. ORIGINALLY PREGNANT AND
LACTATING WOMEN WERE INCLUDED FROM VACCINATION AND CLINICAL
TRIALS AND AT THE BEGINNING OF THE DRC OUTBREAK. THERE WAS PRESSURE TO RECONSIDER
THE CRITERIA AND IN EARLY 2019 THEY REVIEWED THE AVAILABLE DATA
ON PREGNANCY OUTCOMES FOLLOWING VACCINATION BUT FOUND THE DATA
WAS LIMITED AND INCONCLUSIVE AND THE ETHICAL REVIEW BOARDS NEEDED
TO MAKE THEIR OWN DETERMINATION ABOUT THE ISSUE AND SO THEY
PRESENTED THIS TO THE IRBs AND IN FACT DRC THEY PASSED AN
AMENDMENT TO THE PROTOCOL TO ENROLL PREGNANT WOMEN AND FOUND
1500 WOMEN WERE VACCINATED. THE ISSUE OF AN ACTIVE
TRANSMISSION SETTING THE RISK/BENEFIT RATIO CHANGES SO
YOU’RE BALANCING THE RISK OF PREGNANCY OUTCOMES VERSUS THE
RISK OF EBOLA VIRUS DISEASE. AND ALMOST CERTAIN
[INDISCERNIBLE]. NOW I’LL TALK ABOUT VACCINE
CONFIDENCE. THERE’S BEEN MANY BEHAVIORAL
SOCIAL STUDIES IN DRC I DON’T HAVE TIME TO GO IN TO BUT
THERE’S A JOINT PROJECT BETWEEN THE INTERNATIONAL FEDERATION OF
THE RED CROSS SUPPORTED BY CDC WHERE THEY GO IN TO THE
COMMUNITY AND RECORD INFORMATION THEY HEAR THROUGH COMMUNITY
DIALOGUE AND FOCUS ON DIFFERENT COMMUNITIES DEPENDING ON WHERE
THE OUTBREAK IS AT THE MOMENT. THEY’VE BEEN CONSISTENT ON THE
TOPIC OF VACCINATION. THERE’S A LOT OF CONFUSION AND
OPPOSITION TO SELECTIVELY VACCINATING PEOPLE, WHY NOT
EVERYONE. A SENSE OF CONSPIRACY AND
MISTRUST OF GOVERNMENT AND HEALTH CARE WITH THE THOUGHT
THAT RICH PEOPLE ARE GETTING THE AFFECTED VACCINE AND THE POOR
PEOPLE GET A DIFFERENT INEFFECTIVE VACCINE. THERE’S CONCERN ABOUT SIDE
EFFECTS, FEAR THE VACCINE WILL GIVE YOU EBOLA AND CONCERNS
THESE ARE EXPERIMENTAL. SOME OF THE DIRECT QUOTES ARE
WHY NOT VACCINATE EVERYONE AND IN PARTICULARLY AROUND PREGNANT
WOMEN. THIS IS AT A TIME BEFORE THEY
WERE INVITED. THEY REFUSED TO GIVE THE VACCINE
TO PREGNANT WOMEN BUT WE KNOW PREGNANT WOMEN ARE ALWAYS
VACCINATED TO PROTECT BABIES AND YOU CAN IMAGINE THE EFFORTS THAT
NEED TO GO INTO COMMUNITY ENGAGEMENT TO GO TO THE ISSUES
THAT COME UP. YOUR VACCINE CAN MAKE YOU
STERILE AND WE DON’T WANT THE VACCINE ANYMORE ARE THOUGHTS AND
THERE’S POSITIVE FEEDBACK SUCH AS THANK YOU FOR THE VACCINATORS
FOR COMING AND HELPING US BUT FOR MANY THERE’S MANY NEGATIVE
VIEWS THAT NED TO BE ADDRESSED. AND SOME OF THE LESSONS LEARN
FROM THE COMMUNITY FEEDBACK INCLUDES INVESTING TIME IN THAT
COMMUNITY ENGAGEMENT TO BUILD TRUST. AGAIN, THIS OUTBREAK IS AN AREAS
WITH MISTRUST AND INSECURITY. THEY DON’T KNOW WHO TO TRUST. THAT MAKES IT ALL MORE
COMPLICATE. THEY HAVE TO ADDRESS
COMMUNICATION ONCE WE HAVE THE COMMUNITY FEEDBACK. IT’S BEEN CHALLENGING IN DRC
BECAUSE OF THE PROCESSES THEY HAVE FOR FORMING
MISCOMMUNICATION MESSAGES AN DATA COLLECT SHOULD BE DONE IN A
WAY THAT ADDRESSES PUBLIC HEALTH NEEDS AND WE NEED TO LEARN FROM
OUR HUMANITARIAN PARTNERS HOW TO WORK BEST IN THESE ENVIRONMENTS. THIS INCLUDES NOT JUST IN DRC
BUT I FACED THE SAME ISSUES IN TRYING TO DELIVER VACCINES IN
SOUTH SUDAN WORK CLOSELY WITH THE GROUPS AND WORKING TO
DELIVER VACCINATIONS AND WE DID IT IN JULY AND THREE WEEKS AFTER
WE WERE ABLE TO VACCINATE AT THE BORDER CROSSING AND HEALTH
FACILITIES CLOSE TO THE DRC BORDER THREE SCREENERS WERE
KILLED AND EVERYTHING SHUT DOWN. WE HAD A SMALL OPPORTUNITY, WE
WERE ABLE TO TAKE ADVANTAGE OF IT BUT THE OPPORTUNITY IS NO
LONGER. SO WHAT’S NEXT? IN MAY OF 2019, THERE WERE
ADDITIONAL VACCINE CANDIDATES BE EVALUATED IN THE CONTEXT OF THE
STUDY AND THEREFORE THE LONDON SCHOOL AND NSF ALL LAUNCHED A
NEW ACTIVITY USING THE JENSON TWO DOSE VACCINE IN RWANDA AND
DRC. THEY’RE NOT IN THE HOT ZONES BUT
[INDISCERNIBLE] ON THE RWANDA BORDER PROVIDING ADDITIONAL
OPPORTUNITIES FOR VACCINATION AND THE GOAL WAS TO LOOK IF
THERE’S ADDITIONAL CASES IN THE AREAS POSSIBLY LOOKING AT
EFFICACY. IT’S BEEN WELL RECEIVED. THE EMERGENCY LICENSURE
PRE-QUALIFIED THE VACCINE IN NOVEMBER 2019 AND THE USDA
GRANTED LICENSURE WHICH WAS A LOVELY CHRISTMAS PRESENT. IT WILL TAKE TIME FOR MERCK TO
PRODUCE THE LICENSED PRODUCT AND LABEL IT SO WE DON’T EXPECT THAT
FOR ANOTHER FEW MONTHS. DESPITE HAVING A LICENSED
VACCINE FOR THE FORESEEABLE FUTURE WE CONTINUE TO USE THE
IND PRODUCT AVAILABLE IN COUNTRIES. FORTUNATELY, I KNOW MANY MEMBERS
OF THE U.S.�GOVERNMENT HAVE WORKED HARD TO MAKE SURE THERE
HAVE BEEN ADEQUATE SUPPLIES OF THIS VACCINE. MY GREAT APPRECIATION TO THEM. THE REGULATORY FORUM HAS BEEN
WORK VERY HARD WITH THE AFFECTED COUNTRIES AND POTENTIAL AT-RISK
COUNTRIES TO LOOK AT LICENSURE AND DRC HAS OFFICIALLY
REGISTERED THE VACCINE. WE HOPE MORE COUNTRIES WILL JOIN
IN THE FUTURE. POST LICENSURE ACCESS AND
THERE’S A 500,000 DOSE EMERGENCY STOCKPILE OF THE VACCINE MADE
AVAILABLE TO ALL COUNTRIES DURING THE EBOLA OUTBREAK AND
MAY BE AVAILABLE FOR PREVENTING VACCINATION. THERE’S GOING TO BE NO
CO-FINANCING OBLIGATION FOR ELIGIBLE COUNTRIES AND FUNDING
WILL BE AVAILABLE FOR OPERATIONAL COSTS WHICH CAN BE
SUBSTANTIAL. AND FINALLY THE U.S.�ADVISORY
COMMITTEE ON IMMUNIZATION PRACTICES HAS LOOKED AT THE
TARGET POPULATION FOR VACCINATION IN THE U.S.�AND THAT
INFORMATION SHOULD BE AVAILABLE AT THE END OF THE MONTH. IT’S IMPORTANT TO KEEP IN MIND
THERE ARE SOME CRITICAL QUESTIONS UNANSWERED AND THEY
APPLY TO OTHER VACCINE WORK. WE KNOW LITTLE ABOUT THE
DURABILITY OF PROTECTION OF THIS VACCINE OR ANY OF THE OTHER
CANDIDATES FOR THAT MATTER. WE HAVE INFORMATION ON IMMUNO
GENICITY AND THERE’S INFORMATION THAT IS NOT AVAILABLE. WE TALKED MOSTLY ABOUT THE
VACCINES AIMED AT THE EBOLA IN ZAIRE AND THERE’S OTHER PLACES
LIKE SUDAN AND WE’RE STILL LOOKING AT THE FUTURE OF
VACCINES WHICH WOULD BE USEFUL IN SOUTH SUDAN AND UGANDA. ULTIMATELY, IF WE DO HAVE
MULTIPLE LICENSED VACCINES WE NEED TO FIGURE OUT WHAT ARE THE
BEST STRATEGIES. FOR EXAMPLE, WE MAY HAVE A
VACCINE WITH A RAPID ONSET OF PROTECTION, WHICH WOULD BE
FAVORED FOR OUTBREAKS AND OTHER VACCINES FOR THE LONGER DURATION
OF PROTECTION BETTER FOR THE PREVENTIVE VACCINATION. WE’RE WAITING TO SEE WHAT IS
GOING TO BE AVAILABLE. I JUST WANT TO GIVE FOOD FOR
THOUGHT ON THE DISCUSSION THIS AFTERNOON IN THE NOVEL
CORONAVIRUS. IN THE SOUTH AFRICA OUTBREAK WE
LEARNED IT’S DIFFICULT TO SCALE UP CLINICAL TRIALS QUICKLY. PLANNING FOR THE EBOLA VACCINE
STUDIES WAS DONE REMARKABLY FAST. LESS THAN FIVE MONTHS OF WORK
THAT WOULD NORMALLY TAKE YEARS BUT BY THE TIME THE VACCINE
TRIALS LAUNCHED IT WAS LATE IN THE EPIDEMIC AND WE EXPECT THE
DYNAMIC WILL CONTINUE. BY THE TIME THE TRIALS ARE
LAUNCHED THE OUTBREAK WILL BE WANING AND CASES WILL BE SCARCE. THINK ONE OF THE LESSONS LEARN
FROM THE TRIALS IS THE TRIAL DESIGNS NEED TO BE ABLE TO TAKE
ADVANTAGE OF CASES STILL OCCURRING. BEING MOBILE AND BRINGING THE
VACCINE TO WHERE THE CASES ARE AND PROVIDING PREVENTIVE VACCINE
ALONG THE PATH OF THE EXTENDING OUTBREAK THOUGH IT’S IMPERFECT
CONTINUES TO BE A SUCCESSFUL MODEL FOR RESPONDING TO THE
CURRENT OUTBREAK IN DRC AND OPPORTUNITIES LIKE THIS SHOULD
BE CONSIDERED. FINALLY, I WISH TO THANK
EVERYONE FOR THE OPPORTUNITY AND I’M HAPPY TO ANSWER QUESTIONS.>>THANK YOU, DR. CARTER. ANY QUESTIONS OR COMMENTS FROM
THE COMMITTEE? DR. PICKERING.>>I KNEW THIS WAS GOING TO BE
ON THE AGENDA I HAD A WHOLE SERIES OF QUESTIONS I WANTED TO
ASK AND YOU’VE ANSWERED EVERY ONE OF THEM. THANK YOU. YOU’RE AN AMAZING PERSON AS ARE
ALL MEMBERS OF YOUR STAFF. THIS IS PHENOMENAL. THANK YOU.>>THANK YOU VERY MUCH.>>OTHER COMMENTS OR QUESTIONS? [INDISCERNIBLE] SEEING NONE. THANK YOU VERY MUCH DR. CARTER. AT THIS TIME WE WILL TAKE A
BREAK AND COME BACK AT PROMPTLY AT 10:30 TO START THE NEXT
SESSION.

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