>>GOOD MORNING. WELCOME TO THE OPEN SESSION OF THE 198th MEETING OF THE COUNCIL OF THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES. DURING THE OPEN SESSION WE'RE JOINED BY REPRESENTATIVES FROM PROFESSIONAL AND LAY ORGANIZATION WHO'S SHARE INTERESTS IN ACTIVITIES IN COMMON WITH THE MISSION OF THE INSTITUTE. AS ALWAYS WE WELCOME THEM. THE FIRST ITEM OF BUSINESS IS TO REVIEW AND APPROVE THE MINUTES FROM THE LAST MEETING. YOU SHOULD ALREADY HAVE SEEN A COPY OF THE MINUTES IN THE ELECTRONIC COUNCIL BOOK. ARE THERE ANY CORRECTIONS TO THE MINUTES? DOES ANYONE HAVE QUESTIONS OR CONCERNS ABOUT THE CONCEPTS PRESENT AT THE PREVIOUS MEETING? IF NOT, MAY I HAVE A MOTION FOR APPROVAL. IS THERE A SECOND. ALL IN FAVOR OF THE MINUTES PLEASE SAY AYE. OPPOSED. THE MINUTES STAND AS APPROVED. I WILL NOW TELL YOU A LITTLE BIT ABOUT APPOINTMENTS AND TRANSITION HAVE OCCURRED SINCE THE LAST COUNCIL. DR. ERIC LANDER HAS BEEN CONFIRMED BY THE SENATE AS DIRECTOR OF THE OFFICE OF TECHNOLOGY OF SCIENCE AND TECHNOLOGY POLICY BETTER KNOWN AS OSDP AND SERVES AS THE PRESIDENT'S SCIENCE ADVISER. THE PRESIDENT'S HAS ELEVATED SCIENCE WITHIN THE WHITE HOUSE BY DESIGNATING THE PRESIDENTIAL SCIENCE ADVISER AS A MEMBER OF THE CABINET FOR THE FIRST TIME IN HISTORY. ERIC WAS A LEADER OF THE HUMAN GENOME PROJECT AND HAS PIONEERED RESEARCH ADVANCES IN GENOMIC MEDICINE. HE'S THE FOUNDING DIRECTOR OF THE BRODE INSTITUTE OF M.I.T. AND HARVARD AND A LONG TIME COLLEAGUE. JAVIER BECERRA HAS BEEN CONFIRMED AS THE SECRETARY OF HEALTH AND HUMAN SERVICES. SECRETARY BECERRA IS A LONG TIME CHAMPION OF EXPANDING ACCESS TO HEALTH CARE. HE'S THE FIRST LATINO TO LEAD THE DEPARTMENT OF HEALTH AND HUMAN SERVICES. AND WE HAVE CONFIRMED THE DEPUTY HHS SECRETARY. PREVIOUSLY SHE HELD POLICY IN OPERATIONAL ROLES AT HHS IN THE OBAMA ADMINISTRATION INCLUDING ACTING ASSISTING SECRETARY FOR LEGISLATION AND SENIOR COUNSELOR TO THE SECRETARY. DR. MURPHY HAS BEEN CONFIRMED AS THE UNITED STATES SURGEON GENERAL. HE PREVIOUSLY SERVED UNDER PRESIDENT OBAMA IN THE SAME CAPACITY BETWEEN 2014 AND 2017. WE HAVE CONFIRMED THE ASSISTANT SECRETARY FOR HEALTH AT HHS. DR. LEVINE WAS PREVIOUSLY PENNSYLVANIA'S SECRETARY OF HEALTH. THE PRESIDENT HAS NOMINATED THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE AT HHS. HE SERVED AS THE SENIOR COUNSELOR TO THE SECRETARY FOR COVID-19 AND COORDINATING THE DEPARTMENT WIDE RESPONSE TO THE PANDEMIC. PRIOR TO THIS ROLE SHE SERVED AS THE DIRECTOR OF THE UNITED STATES OFFICE OF THE COALITION FOR ACADEMIC PREPAREDNESS AND INNOVATION. DURING THE OBAMA ADMINISTRATION, I'VE GOTTEN TO KNOW DAWN WELL AS THE SENIOR COUNSELOR TO SECRETARY AT HHS. DR. BERNARD HAS BEEN SELECTED AS THE NEW NIH CHIEF OFFICER FOR SCIENTIFIC WORKFORCE DIVERSITY. SINCE OCTOBER 2020, SHE HAS SERVED AS THE ACTING CHIEF OFFICER IN THAT POSITION. DR. BERNARD WILL LEAD THE EFFORT FOR DIVERSITY, INCLUSIVENESS AND EQUITY THROUGHOUT THE BIOMEDICAL ENTERPRISE. WE HAVE SEVERAL NEW APPOINTMENTS SINCE WE LAST CONVENED. I'M PLEASED TO ANNOUNCE MORE APPOINTMENTS. PRIOR TO JOINING THE BRANCH IN 2009 AS A PROGRAM OFFICER, JAMES WORKED AT SOUTHERN RESEARCH INSTITUTE WHERE HE MANAGE A LARGE DIVERSE PRE-CLINICAL PURCHASE PROGRAM TO IDENTIFIED AND ADVANCE LEAD HIV THERAPEUTIC CANDIDATES. DR. TAYLOR HAS BEEN NAMED CHIEF OFFICER OF THE CONCEPT PROGRAM FOR VACCINES IN THE OFFICE OF BIODEFENSE AND TRANSLATIONAL RESEARCH. SHE JOINED NIAID IN 2012 AS A PROGRAM OFFICER AND MOST RECENTLY SERVED AS THE PROJECT COORDINATION TEAM LEADER FOR THE JOHNSON COVID-19 VACCINE UNDER OPERATION WARP SPEED. WE ELECTED THE NEW BRANCH CHIEF FOR AIDS RESEARCH CONTRACTS WITH THE OFFICE OF ACQUISITIONS IF THE DIVISION OF EXTRAMURAL AFFAIRS. SHE BEGAN HER GOVERNMENT CAREER IN 2010 AS A PROCUREMENT TECHNICIAN AND WORKED HER WAY UP TO THE POSITIONS OF INCREASING COMPLEXITY AND RESPONSIBILITY. SPECIALIZING IN BIOMEDICAL RESEARCH AND DEVELOPMENT CONTRACTS IN CLINICAL TRIALS. DR. ANDERSON HAS BEEN SELECTED AS THE ASSOCIATE DIRECTOR FOR MANAGEMENT AND OPERATION IN THE VACCINE RESEARCH CENTER. SHE JOINED NIAID IN 2005 AS A POSTDOCTORAL FELLOW AND WORKED AS A RESEARCH FELLOW AND STAFF SCIENTIST IN THE AREA OF MALARIA AND VECTOR RESEARCH. IN 2016, SHE JOINED MY LABORATORY, THE LABORATORY OF IMMUNOREGULATION AS THE SCIENTIFIC OPERATIONS MANAGER. SHE HAS MORE THAN A DECADE OF MANAGING PROGRAMS AT NIAID. THROUGHOUT THE YEAR, NIAID TYPICALLY HOSTS MANY INTERNATIONAL DELEGATIONS WITH WHOM I AND OTHER NIAID STAFFERS MEET. THIS IS CONTINUED IN OUR VIRTUAL WORLD. THIS SLIDE HIGHLIGHTS A FEW OF THESE MEETINGS AS PICTURED IN THE UPPER LEFT I MET SEVERAL TIMES WITH THE CHIEF MEDICAL OFFICER AND THE U.K. GOVERNING CHIEF SCIENTIFIC ADVISER TO DISCUSS THE COVID-19 RESPONSE HERE AND IN THE U.K. I ALSO MET WITH THE ITALIAN MINISTER OF FOREIGN AFFAIRS AND INTERNATIONAL COOPERATION TO DISCUSS VARIOUS COVID-19 ISSUES IN THE UPPER RIGHT. ADDITIONALLY IN THE LOWER RIGHT, I MET WITH THE DIRECTOR OF THE CENTER FOR THE AIDS PROGRAM OF RESEARCH IN SOUTH AFRICA. WE DISCUSSED PLANNED RESEARCH ON HIV BROADLY NEUTRALIZING ANTIBODIES AND ON COVID-19. IN ADDITION, NOT SHOWN AS PHOTOS ON THE SLIDE, I TOOK PART IN VIRTUAL MEETINGS IN FEBRUARY WITH W.H.O. REGIONAL DIRECTOR FOR EUROPE DISCUSSING ISSUES AND WITH U.N. AIDES EXECUTIVE DIRECTORS TO DISCUSS HIV VACCINE AND THERAPY RESEARCH AND NEW TARGETS FOR 2025. IN MARCH PARTICIPATED IN A HOSTED PUBLIC EVENT FOR THE CHIEF MEDICAL OFFICER TO DISCUSS HOW THE AUSTRALIAN AND U.S. GOVERNMENTS ARE REFOCUSSING STRATEGIES IN RESPONSE TO COVID-19 VARIANTS. I ALSO MET IN LATE MARCH WITH THE BRAZILIAN MINISTER OF HEALTH AND HIS BRAZILIAN COLLEAGUES TO DISCUSS THE COVID-19 CRISIS IN BRAZIL AND POTENTIAL OPPORTUNITIES FOR RESEARCH COLLABORATIONS. LET'S MOVE ON TO THE BUDGET. I'D LIKE TO TAKE A FEW MINUTES TO UPDATE YOU ON CLEARLY ONE OF THE MOST IMPORTANT TOPICS WE CAN DISCUSS THE NIH BUDGET. THIS SLIDE COMPARES THE FISCAL 2021 ENACTED BUDGET WITH THE FISCAL 2020 FINAL BUDGET. THE OVERALL INCREASE IN THE LOWER RIGHT FOR NIH IS 3%. HOWEVER, THIS INCREASE IS NOT EVENLY DISTRIBUTED AS YOU CAN SEE. YOU'LL NOTICE MANY I.C.s RECEIVED INCREASES BETWEEN 1% AND 3% OVER THE FINAL 2020 BUDGET. THERE ARE SEVERAL SIGNIFICANT CEPTIONS SUCH AS THE NATIONAL INSTITUTE ON AGING WHICH RECEIVED A 10% INCREASE WITH AN ADDITIONAL $300 MILLION FOR ALZHEIMER'S RESEARCH. ADDITIONALLY THE NIH RECEIVED A 5.6 INCREASE DRIVEN BY $75 MILLION TO SUPPORT THE AGENCY'S EFFORT IN ADVANCING BIOMEDICAL INNOVATION AND COMPUTATIONAL SCIENCES SUCH AS ARTIFICIAL INTELLIGENCE. OTHER INSTITUTES RECEIVED LARGER THAN AVERAGE INCREASED FOR SPECIFIC RESEARCH PROGRAMS SUCH AS THE BRAIN INITIATIVE. NIAID RECEIVED A 3.2% BUDGET INCREASE INCLUDING $20 MILLION FOR THE DEVELOPMENT OF A FLU VACCINE AND TICK BORN DISEASE AND TO SUPPORT THE ENDING THE HIV EPIDEMIC IN THE NIH INITIATIVE AND $40 MILLION TO BE EVENLY DISTRIBUTED AMONG THE 12 REGIONAL BIO CONTAINMENT LABS INITIALLY FUNDED IN 2003 TO RESPOND TO OUTBREAKS. THIS MARKS THE SIXTH CONSECUTIVE YEAR NIH RECEIVED A SIGNIFICANT BUDGET INCREASE. THIS SLIDE SHOWS THE FINANCIAL MANAGEMENT PLAN FOR 2021 THE PAY LINE FOR ESTABLISHED NEW P.I.s ARE THE 14th AND NEW P.I.s FOR THE 14th AND 18th PERCENTILE RESPECTIVELY COMPETING ON SOLICITED REWARDS AS WELL AS NON-COMPETING GRANTS AND THEY'LL INCUR NO PROGRAMMATIC ADJUSTMENTS WHILE COMPETING RESEARCH INITIATIVES HAVE BEEN CUT BY 20% TO SUSTAIN NEW INVESTIGATOR INITIATED AWARDS. WE ESTIMATE AN OVERALL SUCCESS RATES WILL BE 21% TO 23% SIMILAR COMPARED TO THOSE OF 2020. ON MAY 28, PRESIDENT BIDEN SUBMITTED HIS FISCAL 2022 BUDGET REQUEST CALLED A BUDGET FOR AMERICA'S FUTURE. HE PRE OPPOSED AN OVERALL INCREASE FOR NIH OF 21% OR $9 BILLION ABOVE THE FISCAL 2021 ENACTED LEVEL. THIS SLIDE THOSE HOW THE PRESIDENT'S REQUESTED INCREASE IS DISTRIBUTED AMONG THE INSTITUTES AND CENTER. THE MOST SIGNIFICANT INCREASE IS $6.5 BILLION TO ESTABLISH THE ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH OR OFFER H TO DEVELOP TOOLS AND TECHNOLOGIES THAT WOULD DRIVE TRANSFORMATION INNOVATION AND HEALTH RESEARCH AND SPEED APPLICATION AND IMPLEMENTATION OF HEALTH BREAKS THROUGH. THE INITIAL FOCUS AREAS OF ARPA-H WOULD INCLUDE CANCER, DIABETES AND ALZHEIMER'S. YOU'LL NOTICE MOST INSTITUTES RECEIVED INCREASES BETWEEN 2% AND 5%. THERE WERE SEVERAL EXCEPTIONS SUCH AS NIAID WHICH RECEIVED A 21.5% INCREASE TO EXPAND OPIOID AND PAIN RESEARCH AND HELPING END ADDITION LONG TERM OR THE HEAL INITIATIVE. THE INCREASE FOR OTHER I.C.s WAS DRIVEN BY EXPANDING OPIOIDS AND PAIN RESEARCH AS WELL AS FUNDING TO ADDRESS HEALTH DISPARITIES AND THE HUMAN HEALTH IMPACTS OF CLIMATE CHANGE. NIAID PERCENTAGE INCREASE WERE SIMILAR TO MANY I.C.s AND INCLUDED A SINGLE EARMARK OF $10 MILLION FOR THE NIH CENTER FOR AIDS RESEARCH TO SUPPORT THE ENDING THE HIV EPIDEMIC INITIATIVE. THE HOUSE APPROPRIATIONS COMMITTEE SCHEDULED MARK-UPS BEGINNING IN LATE JUNE. THE SENATE APPROPRIATIONS COMMITTEE HAS NOT ANNOUNCED ANY TIMETABLE YET UNTIL THE FINAL FISCAL 2022 BUDGET IS PASSED, WE'LL MAINTAIN A CONSERVATIVE POSTURE IN SETTING PAY LINES AND PROGRAM LEVELS TO MAINTAIN THE FLEXIBILITY TO ADJUST PROGRAMS TO EFFECTIVELY OPERATE WITHIN THE FINAL BUDGET LEVEL. LET ME TAKE A FEW MOMENTS TO PROVIDE UPDATES ON THE FUNDING PROVIDED TO US TO RESPOND TO COVID-19. THIS SUMMARIZES THE FUNDING PROVIDED TO US THROUGH TWO EMERGENCY SUPPLEMENTAL PACKAGES. THE CARES ACT AND THE CORONAVIRUS PREPAREDNESS AND RESPONSE SUPPLEMENTAL APPROPRIATIONS ACT. BOTH OF WHICH WERE ENACTED IN MARCH 2020. THESE ACTS PROVIDED NIAID WITH APPROXIMATELY $1.5 BILLION FOR FUNDING FOR USE UNTIL SEPTEMBER 30, 2024. WE INITIALLY PROVIDED A SPENDING PLAN TO CONGRESSIONAL KATED AS SHOWN IN THE -- CONGRESS ALLOCATED AS SHOWN AND SUPPORTED EXTRAMURAL AND INTRAMURAL INVESTIGATORS ADDRESSING THE SCIENTIFIC AREAS MOST CRITICAL TO UNDERSTANDING AND ADVANCING MEDICAL COUNTER MEASURE FOR SARS COV2 AND COVID-19. THE ALLOCATION OF THE REMAINING $590 MILLION DEPENDS ON MANY FACTORS AND WILL BE AWARDED TO ADDRESS THE MOST URGENT PUBLIC HEALTH NEEDS. NOTE MORE THAN $500 MILLION HAS BEEN COMMITTED TO SUPPORT ONGOING EXTRAMURAL AND INTRAMURAL AND $223 MILLION ALLOCATED TO ADDRESS INFRASTRUCTURE NEEDS AT NIAID'S VACCINE RESEARCH CENTER IN BETHESDA AND ROCKY MOUNTAIN LABS IN HAMILTON, MONTANA. NIAID IS ALSO A KEY PARTNER IN THE NIH'S ACCELERATING COVID-19 INTERVENTION OR VACCINE OR ACTIVE PARTNERSHIP WHICH IS OPERATING IN CONJUNCTION WITH THE U.S. GOVERNMENT'S COUNTER MEASURE'S ACCELERATION GROUP FORMERLY KNOWN AS OPERATION WARP SPEED. TO COORDINATE THE GOVERNMENT'S RESPONSE AND WORK WITH PRICED INDUSTRY TO ACCELERATE THE DEVELOPMENT, MANUFACTURING AND DISTRIBUTION OF COVID-19 VACCINES. THERAPEUTICS AS WELL AS DIAGNOSTICS. SINCE THE BEGINNING OF THE COVID-19 PANDEMIC, HHS HAS PROVIDED NIAID WITH $1.6 BILLION FROM THE FY2020 CARES ACT AND FISCAL 2021 CORONAVIRUS RESPONSE AND RELIEF ACT TO SUPPORT CLINICAL TRIALS. THIS INCLUDES $877 MILLION AWARDED TO EXISTING NIAID CLINICAL TRIAL NETWORKS AND SUPPORT CONTRACTS TO CONDUCT PHASE 3 CLINICAL TRIALS OF FOUR VACCINE CANDIDATES IN VACCINE STUDIES IN SPECIAL POPULATION. THE REMAINING FUNDING SUPPORTS CLINICAL TRIALS FOR EVALUATING THERAPEUTICS SUCH AS ACTIVE TWO, AN ADAPTIVE TRIAL DESIGN TO TEST INVESTIGATIONAL AGENTS IN NON-HOSPITALIZED VOLUNTEERS EXPERIENCING MILD TO MODERATE COVID-19 SYMPTOMS. I USUALLY STOP HERE FOR QUESTIONS BUT SINCE THIS IS VIRTUAL AND NOT HERE PHYSICALLY, AS YOU KNOW I'M IN NEW YORK WITH THE FIRST LADY, PERHAPS HUGH CAN ANSWER QUESTIONS. IF NOT, I CAN MOVE ON WITH MY DISCUSSION AND PROGRAMS WE CAN ANSWER QUESTIONS LATER. I WILL NOW DISCUSS SEVERAL ITEMS OF LEGISLATIVE INTEREST. SINCE WE LAST MET, THERE'S BEEN SEVERAL UPDATES TO COMMIT LEADERSHIP TO THE SENATE OF THE 117th CONGRESS. OF NOTE, OF THE APPROPRIATIONS COMMITTEE SENATOR LEAHY IS CHAIR AND OF THE LABOR HHS APPROPRIATIONS SUBCOMMITTEE SENATOR MURRAY IS THE CHAIR AND SENATOR MURRAY IS NOW ON THE HEATH COMMITTEE WHERE SENATOR BUR IS THE RANKING MEMBER. THE CONGRESS CONTINUES TO TAKE AN OVER ARCHING INTEREST IN NIAID ACTIVITIES REGARDING THE DEVELOPMENT OF COUNTER MEASURES TO ADDRESS SARS COV2. I HAVE TESTIFIED A NUMBER OF HOUSE AND SENATE HEARINGS ON COVID-19 BOTH IN PERSON AND VIRTUALLY OVER THE LAST FEW MONTHS ALONG WITH MY COLLEAGUES FROM THE CDC, FDA AND HHS. THE HEARINGS HAVE BEEN IMPORTANT OPPORTUNITIES TO ENGAGE WITH MEMBERS OF THE SENATE AND HOUSE OF REPRESENTATIVES AND UPDATE THEM ON THE CRUCIAL ROLE NIAID HAS PLAYED IN THE FEDERAL RESPONSE TO ADDRESSING THE COVID-19 PANDEMIC AND ON THE SAFETY AND EFFICACY OF AVAILABLE COVID-19 VACCINES. CONGRESSIONAL MEMBERS HAVE BEEN PARTICULARLY INTERESTED IN WHETHER VARIANTS OF SARS COV2 MAY AFFECT VACCINE EFFICACY AND WHEN IT WOULD BE SAFE FOR VACCINATED INDIVIDUALS IN THE UNITED STATES TO COLLECTIVELY RETURN TO EVERYDAY LIFE AND ACTIVITIES. ANOTHER TOPIC OF ONGOING CONGRESSIONAL INTEREST IS THE ARRAY OF PERSISTENT SYMPTOMS THAT CAN FOLLOW SARS COV2. THE POST ACUTE SEQUELAE OF SARS COV2 OR PASS IS WHAT IT'S CALLED. DURING EACH HEARINGS I'VE DISCUSSED NIAID EFFORTS TO STUDY THE LONG-TERM CLINICAL OUTCOME OF COVID-19 INCLUDING AS PART OF THE NIH RESEARCH IN COVID TO ENHANCE RECOVERY OR AS WE'RE CALLING IT THE RECOVER INITIATIVE. ON MAY 25, I ACCOMPANIED DR. COLLINS TO TESTIFY THAT A VIRTUAL HEARING OF THE HOUSE APPROPRIATIONS HHS SUBCOMMITTEE ON THE PRESIDENT'S FISCAL 2022 NIH BUDGET. I PROVIDED AN UPDATE TO THE APPROPRIATORS ON NIAID RESEARCH ADDRESSING COVID-19 AS WELL AS HIV AIDS, INFLUENZA AND TICK-BORNE DISEASES AND ACCOMPANIED DR. COLLINS TO TESTIFY ON THE HHS SUBCOMMITTEE ON THE FISCAL 2022 NIH BUDGET ON MAY 26. THE SENATORS WERE PARTICULARLY INTERESTED IN TOPICS RELATED TO COVID-19 AND I ALSO DISCUSSED WITH THEM THE POTENTIAL TO EXPAND THE USE OF MRNA VACCINE APPROACHES TO OTHER INFECTIOUS DISEASES SUCH AS HIV AND INFLUENZA. I ALSO HAVE ENGAGED WITH MEMBERS OF THE SENATE AND HOUSE MULTIPLE TIMES SHOWN HERE IN THE SLIDE TO BRIEF THEM ON THE COVID-19 PANDEMIC PARTICULARLY THE EMERGENCE OF SARS COV2 VARIANTS OF CONCERN AND THE SAFETY AND EFFECTIVENESS OF COVID-19 VACCINES. OF SPECIAL INTEREST ON MAY 17, NIAID HOSTED A TOUR OF THE VRC INCLUDING SENIOR ROY BLUNT THE RANKING MEMBER OFF THE APPROPRIATIONS SUBCOMMITTEE AND SENATOR DURBIN WITH FRANCIS AND I THE APPROPRIATIONS SUBCOMMITTEE AND SENATOR DURBIN WITH FRANCIS AND I, WE DISCUSSED AND BRIEFED THE SENATORS ON THE ROLE OF NIAID VRC IN COVID-19 AND ANTIBODY DEVELOPMENT AND THESE ARE UNIQUE OPPORTUNITIES FOR NIAID TO HIGHLIGHT THE GROUNDBREAKING RESEARCH UNDERTAKEN BY OUR INTRAMURAL PROGRAMS OVER TIME AND ARE WELL RECEIVED BY THE ATTENDING CONGRESSIONAL MEMBERS. CONGRESS ALSO CONTINUES TO FOCUS ON NIH EFFORTS TO BETTER UNDERSTAND AND ADDRESS THE DISPROPORTIONATE IMPACT ON COV2 ON MINORITY COMMUNITIES INCLUDING VACCINE ACCESS AND HESITANCY. ON FEBRUARY 26, I DISCUSSED THE IMPACT OF COVID-19 ON AFRICAN AMERICAN POPULATIONS DURING A LIVE TELEVISION SPECIAL WITH REPRESENTATIVES BEATTY AND LAWRENCE. ON APRIL 24 I PARTICIPATED IN ANOTHER TELEVISED SPECIAL EVENT WITH THE CHAIR OF THE HISPANIC CAUCUS REPRESENT RUIZ. WE DISCUSSED ACCESS AND EQUITY IN HISPANIC AND OTHER MINORITY COMMUNITY TO ADDRESS QUESTIONS FROM MEMBERS OF THE PUBLIC. LASTLY, I WOULD BE REMISS IF I DID NOT ACKNOWLEDGE THE NIAID PROGRAM OFFICIALS AND STAFF WHO HAVE PARTICIPATED IN MANY CONGRESSIONAL BRIEFINGS AND EVENTS ON MY BEHALF AS I HAVE WORKED TO FULFILL ADDITIONAL DUTY AS CHIEF MEDICAL ADVISER TO THE PRESIDENT. THE EVENTS ARE OUTLINED ON THE SLIDE. I APPRECIATE THE ASSISTANCE GIVEN THE ONGOING SIGNIFICANT ROLES IN ADDRESSING THE COVID-19 PANDEMIC. I WILL NOW DEDICATE THE REMAINED REMAINDER OF THIS SESSION TO OTHER ISSUES AND EVENT HAVE OCCURRED AND MATTERS WE HAVE DISCUSSED THAT I BELIEVE MAY BE OF INTEREST TO YOU. LET'S FIRST TAKE A LOOK AT AN UPDATE OF THE HIV/AIDS SITUATION. AS YOU CAN SEE THAT WE ARE ALMOST EXACTLY AT THE 40-YEAR ANNIVERSARY OF THE REALIZATION OF THE FIRST FIVE CASES OF PNEUMOCYSTIS PNEUMONIA IN AND THEN 26 GAY MEN FORMERLY HEALTHY BUT DEVELOPED OVER A PERIOD OF TIME NOT ONLY THIS TYPE OF PNEUMONIA BUT OTHER OPPORTUNISTIC INFECTIONS NOT ONLY FROM L.A. TO SAN FRANCISCO AS WELL AS NEW YORK CITY. FAST FORWARD TO THE 40 YEARS WHERE WE ARE RIGHT NOW, 38 MILLION PEOPLE LIVING WITH HIV, 1.7 MILLION NEW INFECTIONS IN THE LAST RECORDED YEAR AND ALMOST 700,000 DEATHS PER YEAR. SINCE THE START OF THE PANDEMIC THERE'S BEEN ABOUT 76 MILLION PEOPLE INFECTED AND OVER 32 MILLION DEATHS. IN THE UNITED STATES WE SUFFERED CONSIDERABLY WITH 1.2 MILLION QUIN EFFECTED AND 13% UNAWARE OF THEIR INFECTION AND 766,000 PEOPLE HAVE DECIDE AND THE NUMBER NUMBER LIVING WITH HIV IS RELATIVELY STABLE AND 14% WERE BETWEEN 13 AND 24 YEARS OLD AND PO% WERE BETWEEN 25 AND 34 AND DISPARITY INFECTION RATE OF AFRICAN AMERICAN AND HISPANIC MEN WHO HAVE SEX WITH MEN. WE HAD SOME ADVANCES THOUGH THIS YEAR HAS BEEN TOTALLY DOMINATED BY COVID-19, TWO RANDOMIZED TRIALS OF NEUTRALIZING ANTIBODIES AND APPING STUDY TO PREVENT HIV ACQUISITION PUBLISHED THOUGH THE MONOCLONAL ANTIBODY DEVELOPED AT THE VACCINE RESEARCH CENTER DID NOT PREVENT ACQUISITION MORE EFFECTIVELY THAN PLACEBO, IT WAS EFFECTIVE AT PREVENTING ACQUISITION OF THOSE STRAINS THAT WERE SENSITIVE TO THE ANTIBODY. IT'S A PROOF OF CONCEPT THAT BROADLY NEUTRALIZING PROPHYLAXIS CAN BE INFECTED AND POINTS TO THE NEEDS FOR COMBINATIONS OF ANTIBODIES USED IN TRANSFER. THE FDA APPROVED THE EXTENDED RELEASE INJECTABLE SUSPENSION AND AN INJECTABLE RELEASE AND A COMPLETE TREATMENT REGIMEN FOR ADULTS FOR TREATMENT OF HIV ONCE A MONTH. LET'S MOVE ON TO WHAT'S GOING ON WITH COVID-19. PRESIDENT BIDEN FEBRUARY 11 VISITED THE VACCINE CENTER AND IS HERE NOW WALKING HE VISITED AND WE EXPLAINED THE IMPORTANT WORK THAT HAD BEEN DONE IN DEVELOPING THE RIGHT CONFIRMATIONAL STABILIZED SPIKE PROTEIN FOR ALMOST ALL THE VACCINES THEY USE. WE WERE PRIVILEGED TO HAVE VICE PRESIDENT KAMALA HARRIS COME TO THE NIH AND RECEIVE HER SECOND DOSE OF HE VACCINE WITH REGARD TO THE EPI I'M TELLING YOU NUMBERS YOU HEAR EVERY DAY, WE'RE IN THE MIDDLE OF THE WORSE PANDEMIC OF THE RESPIRATORY ILLNESS IN THE LAST 102 YEARS WITH NOW OVER 170 MILLION CASES. THE UNITED STATES HAS BEEN HIT PARTICULAR PARTICULARLY HARD WITH 33 MILLION CASES AND 600,000 DEATHS THUS FAR. WE'VE HAD THREE MAJOR SURGES. THE LAST ONE IN THE MOST RECENT LATE FALL AND EARLY WINTER BROUGHT US UP TO 300,000 CASES A DAY AND 3,000 TO 4,000 DEATHS. WE HAVE LOOKED AT THE IR CAT ON THE RIGHT PART OF THE SLIDE AND HAVE VACCINES TO THE TUNE OF HAVING NOW MORE THAN HAVING HALF THE POPULATION BEING FULLY ADULT POPULATION AND THERAPEUTICS WE NOW LOOK AT IT FROM THE STANDPOINT OF TARGETING THE VIRUS BY DIRECT ANTIVIRALS LIKE REMDESIVIR AND MONOCLONAL ANTIBODY WHO'S RECEIVED THE GSK AND VIR MONOCLONAL ANTIBODY AND THERE'S A MODERATING HOST RESPONSE WITH DEXAMETHASONE AND WE NOW HAVE OTHER MODULATORMODULATORS. WE'LL PUT IN AN EFFORT VERY SOON ON THE SARS COV2 REPLICATION CYCLE AND SPECIFICALLY DESIGNING DRUGS TO INHIBIT THE VULNERABLE TARGETS. THIS IS VERY SIMILAR TO WHAT OUR STRATEGY WAS WHICH WAS A SPECTACULARLY SUCCESSFUL STRATEGY FOR THE DEVELOPMENT OF DRUGS FOR HIV AND ANTIRETROVIRAL DRUG BY TARGETING THE VULNERABLE POINTS OF HIV. SIMILARLY WE DID THE SAME THING IN COLLABORATION WITH PHARMA IN DEVELOPING DRUGS FOR HEPATITIS C. THESE ARE SOME OF THE VULNERABLE TARGETS AND SOME OF THE DRUGS THAT ARE BEING PURSUED, PROTEASE INHIBITERS AND POLYMERASE INHIBITERS AND LET'S MOVE ON TO VACCINATES. AS I'VE WRITTEN IN SCIENCE ABOUT TWO MONTHS AGO, THERE IS AN IMPORTANT STORY BEHIND THE COVID-19 VACCINES AND EVEN THOUGH IT WAS DONE QUICKLY THE SPEED AND EFFICIENT WITH THE HIGHLY EFFICACIOUS VACCINES WERE DEVELOPED AND THE POTENTIAL FOR SAVING LIVES IS DUE TO AN EXTRAORDINARY MULTI-DISCIPLINARY EFFORT INVOLVING PRE-CLINICAL AND CLINICAL SCIENCE OUT OF THE SPOTLIGHT FOR DECADES BEFORE THE UNFOLDING OF THE COVID-19 PANDEMIC. SOME IS THE CLINICAL RESEARCH TO DEVELOP VACCINE PLATFORM TECHNOLOGIES PARTICULARLY THE MRNA. THE STABILIZATION AT THE VACCINE RESEARCH CENTER WITH COLLEAGUES FROM OTHER INSTITUTIONS. THE EXTENSIVE NIAID DOMESTIC AND INTERNATIONAL CLINICAL TRIALS NETWORKS FOR HIV AND INFLUENZA PIVOTED TO BE USED FOR COVID-19. THESE ARE THE THREE PLATFORMS, THESE ARE THE SIX COMPANIES THE UNITED STATES GOVERNMENT HAS BASKETBALL INTERACTING WITH WITH THE DEVELOPMENT AND/OR TESTING OF THE PRODUCTS AND AS YOU KNOW THREE MODERNA, BIONTECH AND J&J RECEIVED THEIR EMERGENCY USE AUTHORIZATION. ONE THING THAT'S BEEN NOTEWORTHY IS WHEN LOOK POST-RANDOMIZED CONTROL WHILE AT THE EFFECTIVENESS OF THE VACCINES THE RESULTS ARE BETTER AND HERE ARE REPRESENTATIVE STUDIES AND OBSERVATIONS, 23,000 EMPLOYEES FROM THE UNIVERSITY OF TEXAS SOUTHWESTERN AND VACCINATED VGZ HAVE 0.05% VACCINATION RATE. IN STUDIES LOOKING AT EIGHT LOCATIONS THE CDC SHOWED THE RATE OF POSITIVITY WAS 0.04 PER 1,000 DAYS. ISRAEL HAS DONE EXTRAORDINARY WELL IN THE PAPER IN LANCET LOOKING AT CASES AND HOSPITALIZATIONS AND DEATHS AND SHOWED AGAIN ASYMPTOMATIC AND SYMPTOMATIC AND RATES ALL WITHIN THE 90% EFFECTIVENESS. IT WAS GOOD FOR ALL AGE GROUPS AS SHOWN ON THE SLIDE FROM YOUNG INDIVIDUALS TO THOSE OLDER THAN 85 YEARS OLD. THIS IS WHAT THE CURVE LOOKS LIKE. THE RED BEING CASES, THE BLUE BEING VACCINE DOSES. AS YOU CAN SEE THERE'S A CRITICAL POINT AROUND THE SECOND WEEK IN FEBRUARY WHERE THE CASES WHICH HAD BEEN GOING UP WENT DOWN DRAMATICALLY EVEN AS THEY LIFTED THEIR SHUT DOWN AND CONTINUED TO GO DOWN AND DOWN UNTIL THERE WERE VIRTUALLY NO CASES IN ISRAEL. IMPORTANTLY, THE IMPACT OF THE VACCINES OF THE VIRAL VARIANTS HAVE BEEN QUITE GOOD. THESE THE VARIANTS THAT WE'RE TALKING ABOUT THE 117 OF THE U.K. AND 351 AND SOUTH AFRICA AND CALIFORNIA VARIANTS AND WE NOW HAVE A NEW TECHNOLOGY OF GIVING GREEK LETTERS TO THIS SUCH AS THE U.K. THE GAMMA AND DELTA AND ON AND ON. I HOPE I SAID THAT CORRECTLY. I HAVE TO GET USED TO SAYING IT. ANYWAY, THE IMPORTANT THING IS WHEN WE LOOK AT EFFECTIVENESS THIS IS A STUDY FROM QATAR IN WHICH THERE WAS A 90% EFFICACY AGAINST 117 BUT THE PROGRAMMATIC 351 WAS 75% EFFECTIVE AGAINST ANY DOCUMENTED INFECTION BUT 100% EFFECTIVE FOR SEVERE CRITICAL OR FATAL DISEASE. WHEN WE LOOKED AT THE NEW SARS COV2 SPIKE VARIANCE IT DID IT AGAINST 526, 427, WHICH IS THE CALIFORNIA VARIANT AND 117 INCLUDING THE E VARIANT REMAIN SUSCEPTIBLE TO NEUTRALIZING ANTIBODY. PUBLIC HEALTH ENGLAND LOOKED AT THE VACCINE EFFECTIVENESS AGAINST THE V117 AND SHOWED IT WAS 88% EFFECTIVE AGAINST SYMPTOMATIC DISEASE. I WANT TO POINT OUT SOMETHING JUST AS AN ASIDE FROM THIS STUDY, LOOK AT THE THIRD BULLET, THREE WEEKS AFTER THE FIRST DOSE BOTH VACCINES WERE 33% EFFECTIVE COMPARED TO 88% EFFECTIVE AND ONLY 50% EFFECTIVE AGAINST 117 WHICH MEANS THE SINGLE DOSE DOES NOT DO NEARLY AS WELL AGAINST THE VARIANTS. LOOK AT THE 33% AGAINST 617 VERSUS THE 88% FOLLOWING TWO DOSES WHICH ARGUES STRONGLY FOR THE POSITION THAT WE TOOK ABOUT STICKING WITH GIVING TWO DOSES WITHIN THE TIME FRAME RECOMMENDED BY THE CLINICAL STUDIES. LATE ME ADDRESS NOW VACCINE HESITANCY. WE HAVE, MYSELF INCLUDED, BEEN INVOLVED IN GOING OUT TO THE COMMUNITY TO TALK ABOUT THE IMPORTANCE OF ENHANCING VACCINE CONFIDENCE BY JOINING THE GROUP OF FAITH LEADERS AT A VACCINE COMPETENCE EVENT. I JOIN VICE PRESIDENT KAMALA HARRIS AT A TOUR OF A MASS VACCINATION SITE IN BALTIMORE, MARYLAND. I JOINED THE PRESIDENT IN THE WHITE HOUSE TALKING TO PEOPLE WHO HAVE INSTAGRAMS TO THE TUNE OF MILLIONS SHOWING MY AGE I HAVE NEVER HEARD OF ANY OF THEM. MANNY MUA AND BRAVE WILDERNESS AND JACKIE AINA REACHED OUT PEOPLE ON OUR ENCOURAGEMENT TO GET PEOPLE VACCINATED. I REACHED OUT TO THE CHILDREN'S HOSPITAL OF D.C. WITH DR. JILL BIDEN AND I WENT AROUND AND LOOKED AT THE ACTIVITIES IN CHILDREN WHERE THEY'VE OPENED UP A VACCINATION SITE FOR KIDS 12 TO 15 YEARS OLD. I'VE ALSO MADE MULTIPLE APPEARANCES ON CAPITOL HILL TO TALK ABOUT THE IMPORTANCE OF URGING AMERICANS TO GET THEIR SHOTS. LET ME CLOSE BRIEFLY TALKING ABOUT ALL THE RESEARCH ADVANCES. THE INFLUENZA VACCINE WAS SHOWN TO PRODUCE BROAD PROTECTION. WE'RE VERY MUCH INVOLVED YOU IN TRYING TO DEVELOP THE UNIVERSAL FLU VACCINE THERE WAS A NICE PAPER SHOWING VACCINATION WITH THE STABILIZED FUSION PROTEIN INDUCED THE FIRST ANTIBODY RESPONSES I'LL INTRODUCE DR. JOHN MASCOLA TO PROVIDE AN UPDATE ON THE VRC'S SCIENTIFIC ACTIVITIES. AGAIN I APOLOGIZE FOR NOT BEING THERE AS I MENTIONED I'M ACCOMPANYING THE FIRST LADY TO NEW YORK CITY TODAY TO TALK ABOUT VACCINES. THANK YOU VERY MUCH. >> GOOD MORNING, LADIES AND GENTLEMEN. I'M GOING GIVE A BRIEF UPDATE ON THE MAJOR ACTIVITIES OF THE VACCINES OVER THE LAST YEAR. I'LL BEGIN WITH A COUPLE SLIDES OF INTRODUCTION AND SPEND ABOUT 10 MINUTES REVIEWING SOME OF THE WORK WE'VE DONE ON MRNA THERAPEUTIC ANTIBODIES WITH THE COVID PANDEMIC AND OUR RESPONSE AND SPEND A COUPLE MOMENTS ON UPDATING YOU ON SOME OF THE WORK WE'RE DOING ON TO THE INFLUENZA VACCINES. SO BY WAY OF BRIEF INTRODUCTION, OUR VACCINE CENTER WAS ESTABLISHED IN 2000 AS AN NIH CENTER AND THE IDEA WAS TO DO BASIC RESEARCH THROUGH TO CLINICAL TRIALS UNDER ONE UMBRELLA WITH A VIROLOGIST AND STRUCTURAL BIOLOGY AND BIOENGINEERING AND PRODUCT FORMULATION AND CLINICAL TRIALS AND DR. FAUCI HAS INCREASED OUR SUPPORT AND WE'VE BEEN ABLE TO INCLUDE MAJOR PROGRAMS ON INFLUENZA AND UNIVERSAL INFLUENZA AND EBOLA AND RESPIRATORY VIRUSES AND OTHER PATHOGENS. AND FINALLY TO HIGHLIGHT WE MEFRZ EMPHASIZED DOING FIRST IN HUMAN STUDIES WITH A NEUTRAL OF CLINICS AND WE ALSO EMPHASIZE INDUSTRY PARTNERSHIP FOR ADVANCED DEVELOPMENT AND THAT'S PART OF THE STORY. WITH REGARD TO THE COVID-19 RESPONSE I'LL START WITH THE WORK BY COMBINING VACCINES AND TO REMIND THE GROUP NEW OR EMERGING VIRUSES CAUSING MAJOR OUTBREAKS GOING OR FOR MANY YEARS. THIS IS A PARTIAL LIST HIV/AIDS AND AVIAN FLU AND OTHERS AND THESE TYPES OF EPIDEMICS HAVE EMERGED AND HAVE BEEN CAUSED BY SOME TYPE OF SARS VIRUS AND IT WAS CAUSED BY A FAMILY OF WHICH WE HAVE DETAILED KNOWLEDGE AND SOME VACCINE PREPARATION AND I'LL EXPLAIN WHAT I MEAN BY THAT IN THE NEXT TWO SLIDES. IN OUR CENTER WE EMPHASIZE STRUCTURE BASED VACCINE DESIGN MEANING STUDYING THE ATOMIC LEVEL STRUCTURE OF PROTEINS AND THE VIRUSES YOU SEE HERE, THEY'RE PROW TEENS AND HIV, CORONAVIRUS AND INFLUENZA AND VIRAL ENTRY TO THE HOST CELL. WE TAKE ADVANTAGE OF THE SIMILARITIES IN OUR STUDIES OF THE STRUCTURE. BACK IN 2016 OUR INVESTIGATE EORS DECIDED TO ENDEAVOR TO SOLVE THE STRUCTURE OF THE CORONAVIRUS SPIKE PROTEIN WITH HKU1 IS NOW THE COMMON COLD AND THEY HAD THE FORESIGHT TO APPRECIATE THAT STRUCTURE WOULD LEAD TO OTHER CORONAVIRUS SPIKE PROTEINS. IT EXPLAINS THE INVESTIGATORS WERE ABLE TO STABILIZE CORONAVIRUS PROTEINS AND WHY DID THEY STABILIZE IT? FOR PRE FUSION STRUCTURAL INTEGRITY AND CAN SEE MERS AND PICTURES OF THE SPIKE STABILIZED BY INTRODUCING SPECIFIC SPIKES IN THE PROTEIN AND WE CALL THIS THE S2P COMMUNICATION. WE THEN THE WEN ON THE TO EXPLAIN -- WENT ON TO EXPLAIN THE NEXT YEAR THEY CAME UP WITH A STRATEGY TO REMAIN THE BETACORONAVIRUS S PROTEIN AND WERE ABLE TO EXPRESS AND WORK WITH A STABILIZED CORONAVIRUS SPIKE PROTEIN. SO IT'S NOT TOO HARD TO UNDERSTAND THE COURSE OF EVENTS THAT HAPPENED EARLY IN JANUARY 2020 ONCE THE SEQUENCE OF THE CORONAVIRUS WAS AVAILABLE THE LABORATORIES USED THE SAME TWO MUTATIONS NICELY ASSEMBLED AND THAT PROTEIN WAS PROVIDED WHO BY FEBRUARY WE SAW A HIGH RESOLUTION STRUCTURE OF THE SPIKE TEEN AND WORKING WITH MODERNA WERE ABLE TO ENCODE THAT INTO MRNA AND DO STUDIES. THIS WAS SHOWN IN A PAPER PUBLISHED IN NATURE WITH THE TITLE SARS COV2MRNA VACCINE DESIGN ENABLED BY PROTOTYPE PATHOGEN PREPAREDNESS AND WERE ABLE TO TRANSLATE TO A QUICK VACCINE DESIGN FOR THE CORONAVIRUS AND OTHERS HAVE MENTIONED THIS ALREADY, MOST THE MAJOR VACCINE MANUFACTURERS AT LEAST THOSE WORKING WITH U.S. GOVERNMENT ARE CORONAVIRUS HAVE INCORPORATED THIS MUTATION INTO THEIR SPIKE DESIGN BECAUSE THE SYSTEM WORKED WELL IN THEIR PLATFORM FOR THEIR VACCINE USING A SPECIFIC PLATFORM. THIS SHOWS THE TIME LINE IN WORKING WITH MODERNA AND MAKING A POINT THAT FROM THE TIME OF SEQUENCE TO FIRST NIH CLINICAL STUDY PHASE 3 BEGAN WITH SIX AND A HALF MONTHS FROM THE TIME THE SEQUENCE WAS FIRST AVAILABLE AND THE FINAL PHASE 3 RESULT IN LESS THAN A YEAR FOR MODERNA AND ALSO FOR PFIZER. I JUST WANT TO EMPHASIZE PEOPLE WORKING ON THIS THROUGH THE TIME OF THE PANDEMIC AND FISCAL DISTANCING THE OVERALL EFFORT BY MANY INVESTIGATORS CONTRIBUTED TO THIS. I ALSO WANT TO EMPHASIZE DUE TO THIS MULTI DIVISIONAL U.S. EFFORT MANY INVESTIGATORS ALSO CONTRIBUTED TO THE OPERATION WARP SPEED EFFORT. WE DID THAT BY ASSISTING WITH EARLY STAGE Q&A VACCINE ASSESSMENT, CANDIDATES HELPING OUT WITH ANIMAL STUDIES AN SCIENTIFIC INPUT AND EMPHASIZED THE PHASE 3 TRIAL OVERSIGHT. I DID THAT WITH THE GROUP AND ANALYSES AND AS THE VACCINES BEGAN TO ACCUMULATE EFFICACY DATA IT SHOWED HIGH LEVELS OF EFFICACY THIS IS A SUMMARY OF THE EMERGENCY USE DATES OF GRANTING OF THE APPLICATION SO DECEMBER 11 AND 8 FOR BIONTECH AND MODERNA AND OTHERS. THE PROTEIN PLATFORM WERE FURTHER DOWN STREAM IN GETTING A MANUFACTURING THROUGH PHASE 3 TRIALS BUT WE EXPECT EFFICACY DATA FROM THE U.S. TRIALS QUITE SOON AND THE SANOFI TRIAL HAS START. I WANT TO SAY THERE WAS A COLLABORATION BETWEEN OUR CENTER AND ANOTHER COMPANY AND WE WERE ABLE TO OBTAIN A SAMPLE FROM AN EARLY INFECTED INDIVIDUAL THE STATE OF WASHINGTON AND ISOLATE THE CELLS AND WORKED ON ANTIBODY SCREENING AND CAME UP WITH AN ANTIBODY WE IN THE LABORATORY AND BY JUNE 1 WERE ABLE TO TAKE IT AND INITIATIVE A FIRST IN KIND TRIAL AND SHOWED FOR EARLY OUT PATIENT TREATMENT THERE WAS AN AN ANTIBODY AUTHORIZED AND WE SCREENED A LOT OF ANTIBODIES FROM THIS DONOR AND WE CALLED IT 555 AND IT BECAME COV555. IT'S RARE TO HAVE THE DEVELOPMENT GO THAT FAST BUT THAT WAS THE PACE DURING COVID. AND THERE WAS ANOTHER ANTIBODY THAT BECAME THERAPEUTIC. I WILL NOTE THAT VARIANTS OF CONCERN HAVE BECOME RESISTANT TO THE 555 RECENTLY ISOLATED MAB AND THIS COVERS ALL THE KNOWN VARIANTS OF CONCERN AND OUR INVESTIGATORS CO-DEVELOPED THE VACCINE WITH MODERNA AND THEY MADE THE CLINICAL MATERIAL AND THE STUDY WAS INITIATED IN MARCH 65 DAYS AFTER THE SEQUENCE WAS AVAILABLE AND THE EUA WAS ISSUED IN DECEMBER AND FOR THE MONOCLONAL ANTIBODY WORK PROTEINS WERE PROVIDED AND THEY ISOLATED THE ANTIBODY AND TOGETHER WE SCREENED IT FROM 555. THAT WAS CLINICALLY DEVELOPED AND THE PHASE 1 STUDY STARTED IN JUNE FOLLOWED BY EFFICACY TRIALS AND THE EUA ISSUED NOVEMBER 9. THESE THE TIME LINES 11 AND A HALF MONTHS AND 8 AND A HALF MONTHS FROM THE TIME IT WORKED TO THE EUA SO UNPRECEDENTED TIME LINES. I WANT TO SPEND THE LAST COUPLE MINUTES TALKING ABOUT ONE OF SEVERAL PROGRAMS THAT WAS ABLE TO MAKE PROGRESS DURING THE COVID PANDEMIC. THIS SHOWS SOME PARTICLES WE HAVE BEEN WORKING WITH ON THE RIGHT THE POTENTIAL ADVANTAGE OF NANO PARTICLES IS THEY MIMIC THE SIZE AND SHAPE OF THE VIRUS WITHOUT HAVING TO GROW THE VIRUS AND CONTROL ANTIGENS ON TO THE SURFACE AND ONE CAN CONSTRUCT CONCLUSIONS ON THE SAME PARTICLE. THERE WAS A PARTICLE WITH EIGHT GLY GLYCOPROTEIN TRIMERS AND WE STABILIZED IT FROM GROUP 1 OR INFLUENZA GROUP AND THE MOST RECENT APPROACH HAS BEEN TO LOOK AT THE MOSAIC HELA PARTICLE AND PROTEINS IN AN ARRAY AND WE'LL PUT THE FOUR ALL IN ONE PARTICLE. WITH REGARD TO PHASE 1 TRIAL I WON'T PRESENT THE DATA FOR TODAY'S DISCUSSION BUT THE TRIALS HAVE BEEN RECENTLY COMPLETE COMPLETED AND THE PROTEIN DESIGN WAS DONE AT THE UNIVERSITY OF WASHINGTON AND DECIDED IN THIS KAY TO USE A MIX OF THE ANTIGENS FROM FLU VACCINES IN ONE NANO PARTICLE AND ONE CAN SHOW NICE STRUCTURES OF THE PARTICLES AND WHAT WAS DONE IN THE STUDY WAS TO COMPARE THE NANO PARTICLES THAT CONTAINED THEM ON THEIR OWN AND COMPARED THEM TO ALL AND THEY WERE ABLE TO SHOW YOU GET A BETTER PROTECTION FROM THE MOSAIC NANO PARTICLES AND WHAT HE THINKS IS HAPPENING IS ENGAGING RECEPTORS AND SEE CONSERVED PARTS BY THE VARIOUS NANO PARTICLES. WHAT HE WAS ABLE TO SHOW WAS BETTER PROTECTION AND THIS WORK WAS RECENTLY PUBLISHED IN NATURE. AND JUST TO MAKE THE POINT THAT THIS WAS REALLY EXTRAORDINARILY A NEW EFFORT FOR US TO MAKE FOUR DIFFERENT COMPONENTS WITH THIS TO MAKE A SELF-ASSEMBLY NANO PARTICLE TO DO THE PRODUCT ENGINEERING AND MAKE THE PRODUCT AND RECENTLY FILED AND BROUGHT TO THE CLINIC. I WANT IT END THERE. MANY PEOPLE CONTRIBUTED TO ALL THE WORK BUT THESE ARE SOME OF THE SENIOR STAFF AT THE CENTER WHO CONTRIBUTED TO ALL THE WORK THAT I SHOWED YOU. NOW I'M HAPPY TO COME BACK AND ANSWER ANY QUESTIONS. THANK YOU VERY MUCH FOR YOUR ATTENTION. >> THANK YOU, JOHN. I'M LIVE AND HE'S ON THE CALL AS WELL AND HAPPY TO TAKE ANY QUESTIONS OR REMARKS. >> THIS IS AMITA INCREDIBLE JOURNEY WITH THE VRC AND EXCITING WORK. CURIOUS ABOUT WHERE THINGS ARE WITH COMBINING SOME OF THESE CANDIDATES INTO ONE VACCINE FOR EXAMPLE THE COVID, INFLUENZA OR OTHERS INTO A SINGLE PRODUCT AND IF THAT'S SOMETHING THE VRC'S ALSO WORKING ON? >> THANKS FOR THE QUESTION. IT'S A TOPIC BEING DISCUSSED WITH NIH BROADLY AND THERE'S THOUGH NOT AN ISSUE THERE'S PLANS TO DO CO-ADMINISTRATION STUDIES WITH AUTHORIZED COVID VACCINES AND THE LICENSED INFLUENZA VACCINE AND GENERATE DATA ON THE SAFETY AND IMMUNO-GENESIMMUNO GENESSE -- IMMUNOGENICITY TO MAKE RECOMMENDATIONS ON CO-ADMINISTRATION. >> GREAT TALK. I WANTED TO ASK ABOUT THE FACT THAT ASTRAZENECA HAS THE WILD TYPE PROTEIN COMPARED IT THE OTHERS. DO YOU THINK THAT IS WHY SOME OF THE EFFICACY PARTICULARLY AGAINST THE VARIANTS IS DIMINISHED IN THE ASTRAZENECA OR IS THAT PREMATURE TO SAY THAT. >> WE DON'T HAVE A PERFECTLY CONTROLLED EXPERIMENT. THERE ARE SOME NUANCES. WHEN ONE EXPRESS THE SPIKE AS A TRANS MEMBRANE PROTEIN AS DONE WITH THE VIRAL VECTORS AND MRNA THERE IS SOME INHERENT STABILIZATION AND IF YOU WERE TO TAKE A VOLUBLE PROTEIN THE PROTEINS ARE REQUIRED IN THE CONTEXT OF RNA, YOU'RE EXPRESSING AND ADDING ANOTHER LEVEL OF STABILIZATION PROBABLY IMPROVES THE IMMUNOGENICITY SOMEWHAT. >> THANK YOU FOR THE TALK. THAT WAS BRILLIANT AND SO WAS DR. FAUCI'S. MY QUESTION IS ON THE VACCINE CANDIDATES FOR COVID SPECIFICALLY WHAT'S THE DIFFERENCE BETWEEN HOW THEY ARE [INDISCERNIBLE]. >> WE DON'T REALLY KNOW. TRADITIONALLY THE ACTIVATED VACCINES ON THEIR OWN WITHOUT AN ADJUVANT PRODUCE A CELL RESPONSE. I'M NOT QUITE AS GOOD ON T CELL HELP AS YOU GET WITH THE VIRAL VECTOR. ONE POSSIBILITY IS THAT THE CURRENT FORMULATIONS OF ADJUVANT GIVE A LESS BALANCED AND UNIFORM RESPONSE COMPARED TO MRNA OR THE VIRAL VECTORS. >> ANY ADDITIONAL QUESTIONS? IF NOT, WE'LL NOW TAKE A SHORT BREAK IN ORDER TO PREPARE FOR THE CLOSED SESSION.