>>WELCOME TO THE OPEN
SESSION OF THE 201 MEETING OF
THE COUNCIL OF THE NATIONAL
INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES.
WE ARE JOINED BY REPRESENTATIVES
FROM PROFESSIONAL AND LAY
ORGANIZATIONS WHO SHARE
ACTIVITIES IN COMMON WITH THE
INSTITUTE AND WE WELCOME THEM.
I WOULD LIKE TO WELCOME THREE AD
HOC MEMBERS WHO ARE JOINING US
TODAY.
Dr. JAMES GERN, CHIEF OF THE
DIVISION OF ALLERGY IMMUNOLOGY
AND VICE-CHAIR OF RESEARCH IN
THE DEPARTMENT OF PEDIATRICS AT
UNIVERSITY OF WES CON SIN AND
Dr. CAROLE OBER FROM THE
DEPARTMENT OF HUMAN GENETICS AT
THE UNIVERSITY OF CHICAGO AND
Dr. MATTHEW ATHMAN FROM THE
DEPARTMENT OF MEDICINE, DIVISION
OF ALLERGY AND INFECTIOUS
DISEASES AND HEAD OF THE ALLERGY
SECTION.
AND ASSOCIATE SCIENTIST IN THE
RESEARCH INSTITUTE AT THE
VIRGINIA MAYSON MEDICAL CENTER
IN SEATTLE.
WE'RE DELIGHTED TO HAVE THEM
WITH US TODAY.
THE FIRST ITEM OF BUSINESS IS
APPROVE THE MINUTES FROM THE
LAST MEETING.
YOU SHOULD ALREADY HAVE BEEN
SEEN A COPY OF THE MINUTES IN
THE ELECTRONIC COUNCIL BOOK.
ARE THERE ANY CORRECT TO THE
MINUTES?
DOES ANYONE HAVE ANY QUESTIONS
OR CONCERNS ABOUT THE CONCEPTS
PRESENTED IN THE PREVIOUS
MEETING?
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL?
IS THERE A SECOND?
>> AYE.
>> ALL IN FAVOR OF THE MINUTES
SAY AYE.
ANY OPPOSED?
THE MINUTES STAND AS APPROVED.
I WILL TELL YOU ABOUT SEVERAL
APPOINTMENTS AND TRANSITIONS
THAT OCCURRED SINCE THE LAST
COUNCIL MEETING.
ON FEBRUARY 28th, THE SENATE
VOTED TO CONFIRM Dr. ROBERT
ROB CALIFF AS FDA COMMISSIONER.
HE IS A LEADING EXPERT HEALTH
DIS AARTI, EQUALITY AND
CARDIOVASCULAR MEDICINE.
HE SERVED AS FDA COMMISSIONER
FROM 2017 TO 2017 AND IS BEEN A
LONG-TERM PROFESSOR OF MEDICINE
AT THE DUKE UNIVERSITY SCHOOL OF
MEDICINE.
WITH ROB'S CONFIRMATION, THE KEY
HHS LEADERS, WITH WHOM WE INTER
AGENT ARE NOW IN PLACE.
JAVIER BASARA AND PALM DEPUTY
SECRETARY AND MURTHY SURGEON
GENERAL, DAWN OWE CON HE WILL,
ROB AS FDA COMMISSIONER AND
Dr. WALENSKY AS CDC DIRECTOR.
DR. TABAK IS ACTING NIH DIRECTOR
AS THE SEARCH FOR A PERMANENT
NIH DIRECTOR CONTINUES.
AT THE WHITE HOUSE, Dr. JA
HUAWEI HAS HELD THE COORDINATE.
BEFORE HIS APPOINTMENT TO THE
WHITE HOUSE, HE WAS DEAN OF THE
BROWN SCHOOL OF PUBLIC-HEALTH
AND PROFESSOR OF HEALTH POLICY
AND PRACTICE AND JEFF DID AN
EXTRAORDINARY JOB AS THE
COVID-19 RESPONSE COORDINATOR
AND ASHISH PICKED OFF WHERE HE
LEFT OFF AND BRINGS HEALTH AND
COMMUNICATION SKILLS TO THE JOB.
AT THE END OF THE LAST MOT, ASK
BACERRA ANNOUNCED THE FORMAL
ESTABLISHMENT OF THE RESEARCH
PROJECT FOR HELP OR AARPA-H.
AS WELL AS THE APPOINTMENT OF
Dr. ADAM RUSSELL AS ACTING
DEPUTY DIRECTOR.
MOST RECENTLY, Dr. RUSSELL WAS
THE CHIEF SCIENTIST OF THE
UNIVERSITY OF MAR LAND APPLIED
RESEARCH LABORATORY FOR IN TELL
AGAINST AND SECURITY.
BEFORE THAT, HE SPENT MORE THAN
A DECADE AS PROGRAM MANAGER AT
THE INTELLIGENCE ADVANCE
RESEARCH PROJECTIVE TEE AND AT
THE DEFENSE ADVANCE RESEARCH
PROJECT AGENCY OR DAPR.
I WILL SAY MORE ABOUT ARPA-H AND
THE BUDGET SECTION OF MY
REMARKS.
IN APRIL, Dr. NIPSHAW STEPPED
DOWN AS THE DIRECTOR A POSITION
HE HAS HELL SINCE 2017.
NCI PRINCIPLE DEPUTY DIRECTOR IS
SERVING AS NCI WHILE THE SEARCH
FOR A PERMANENT DIRECTING.
>> RepPERM DIRECTOR.DOUG AS THEM
APRIL 2015 TO OCTOBER 2017.
FOLLOWING THE RESIGNATION OF
Dr. VAUGHN AND IN 2019 WHILE
NED SERVED AS ACTING
COMMISSIONER, OF THE FDA.
IN APRIL, Dr. JOHN MA COLA
RETIRED AS DIRECTOR OF OUR
VACCINE RESEARCH CENTER AND
CHIEF OF THE VCR VIROLOGY
LABORATORY.
JOIN JOINED THE VRC IN 2000.
HE DEVELOPED VACCINE RESEARCH
FOR DISEASES OF PUBLIC-HEALTH
IMPORTANCE, INCLUDING HIV,
INFLUENZA, EBOLA, MALARIA AND
COVID-19 AND DISCOVERED IN
DEVELOPED NUMEROUS HIV BROADLY
REACTIVE ANTIBODIES CURRENTLY
BEING STUDIED FOR HIV PREVENTION
AND THERAPY.
Dr. RICK K OUTAOUAIS KOUP.
HE IS THE CHIEF OF THE VRC
IMMUNE GEE LAB AND SERVED AS
DIRECTOR OF THE VRC SINCE 2013.
Dr. JULIE LEDGEWOOD AND CHIEF
MEDICAL OFFICER ALSO HAS
DEPARTED.
JULIE LED NUMEROUS CLINICAL
TRIALS AND CLINICAL
COLLABORATIONS FOR THE VRC AND
SHE SERVED AS PRINCIPLE
INVESTIGATIVE PROTOCOL CHAIR OR
ASSOCIATED INVESTIGATOR FOR MORE
THAN 60 PHASE 1 AND PHASE 2
CLINICAL TRIALS STUDYING
VACCINES AND MONOCLONAL
ANTIBODIES FOR HIV, INFLUENZA,
EBOLA, MALARIA, ZIKA, AND NOW
COVID-19.
Dr. KARIN BOK IS SERVING AS
THE ACTING DEPUTY DIRECTOR.
IN ADDITION, KARIN CONTINUES HER
ROLE AS VRC DIRECTOR OF PANDEMIC
PREPAREDNESS AND EMERGENCY
RESPONSE.
Dr. BOB SEDER IS ACTING CHIEF
MEDICAL OFFICER AND ASSOCIATE
DIRECTOR.
BOB IS ALSO CHIEF OF THE VRC
CELLULAR IMMUNOLOGY SECTION.
I AM PLEASED TO ANNOUNCE THAT
MARIE PARKA IS NIAID NEW
ASSOCIATE DIRECTOR FOR SCIENCE
MANAGEMENT.
MARIE ALSO SERVED AS THE DEPUTY
EXECUTIVE OFFICER FOR NIAID.
SHE HAS MORE THAN 20 YEARS'
EXPERIENCE WORKING AT NIAID.
MOST RECENTLY, AS THE ACTING
DIRECTOR OF THE OFFICE OF
STRATEGIC PLANNING.
THROUGH INITIATIVE DEVELOPMENT
ANALYSIS.
IN THAT CAPACITY, MARIE PROVIDED
LEADERSHIP TO THE PLANNING,
EVALUATION, INITIATIVE
DEVELOPMENT, PORTFOLIO ANALYSIS
AND SCIENTIFIC CODING AND
REPORTING ACTIVITIES.
TWO KEY PEOPLE HAVE JOINED MY
STAFF IN THE IMMEDIATE OFFICE
THE DIRECTOR.
Dr. JANE NICELY SPECIAL
ASSISTANT FOR SCIENTIFIC
PROJECTS AND HELPS COORDINATE
ASPECTS OF NIAID'S RESPONSE TO
THE COVID-19 PANDEMIC.
FROM 2009 TO 2021, JANE WAS A
PROGRAM OFFICER IN THE BACTERIA
AND HIGH COL GEE BRANCH OF DIMD
WHERE SHE OVERSAW SCIENTIFIC
PROGRAMS RELATED TO ANTIBIOTIC
RESISTANT BACTERIA.
Dr. IAN SIMON PROVIDES ADVICE
AND EXPERT ANALYSIS ON A WIDE
RANGE OF ISSUES RELATE TODAY
EMERGING INFECTION AND PANDEMIC
PREPAREDNESS PLANING AND
MANAGEMENT.
HE IS THE FORMER ASSIST A ANT DR
FOR THE INSTITUTE OF SCIENCE AND
TECHNOLOGY POLICY.
Dr. KELLY POE HAS BEEN
APPOINTED DEPUTY DIRECTOR OF THE
NIAID DIVISION OF EXTRAMURAL
ACTIVITIES.
A VIROLOGIST BY TRAINING, KELLY
JOINED NIAID IN 2011 AS A
SCIENTIFIC REVIEW OFFICER.
SHE BECAME THE DEPUTY DIRECTOR
OF THE SCIENTIFIC REVIEW PROGRAM
IN 2018 AND SERVED AS THE ACTING
DEA DEPUTY DIRECTOR FOR NINE
MONTHS PRIOR TO HER OFFICIAL
APPOINTMENT IN MARCH.
Dr. JENNIFER MYERS IS THE
DIRECTOR OF NIAID SCIENTIFIC
REVIEW PROGRAM AND IMMUNOLOGIST
BY TRAINING, Dr. MYERS JOINED
THE PROGRAM AS A SCIENTIFIC
REVIEW OFFICER IN 2017 AND
BECAME DEPUTY CHIEF THE
IMMUNOLOGY REVIEW BRANCH IN
2021.
Dr. PRETI MAYROTRAA OF REVIEW
BRANCH A.
IN THE NIAID SCIENTIFIC REVIEW
PROGRAM AND IMMUNOLOGIST BY
TRAINING, Dr. MEHROTRA JOINED
IN 1998 AS A SCIENTIFIC REVIEW
OFFICER.
SHE WAS BRANCH CHIEF IN THE
NIAID SCIENTIFIC REVIEW PROGRAM
FOR 15 YEARS AND THEN SHE JOINED
THE AGENCY FOR HEALTHCARE
RESEARCH AND QUALITY AS A
DIRECTOR OF DIVISION OF
SCIENTIFIC REVIEW BEFORE
RETURNING TO NIAID.
Dr. SONIA BEST IS THE NEW
CHIEF OF THE INVIRAL DISEASES AT
OUR ROCKY MOUNTAIN LABS.
SONIA IS CHIEF OF THE I AM EIGHT
IMMUNITY AND PATHOGENESIS IN THE
LABORATORY OF VIROLOGY AND
SERVED AS THE DEPUTY CHIEF OF
THAT LABORATORY.
SONIA HAS MADE CONTRIBUTIONS TO
OUR UNDERSTANDING OF THE INNATE
IMMUNE RESPONSE TO EMERGEING AND
REEMERGING INFECTIOUS DISEASES
BY UNCOVERING NOVEL CELLULAR
PROTEIN INVOLVED IN HOST DEFENSE
AGAINST INFECTION.
THE MEMBER STATES OF THE WORLD
HEALTH ORGANIZATION HAVE
RE-ELECTED Dr. TED ROSE WHO WE
ALL KNOW SIMPLY FOR OBVIOUS
REASONS, AS Dr. TEDROS.
TO SERVE AS SECOND FIVE-YEAR
TERM, AS DIRECTOR GENERAL OF THE
W.H.O.
WE HAVE HAD MANY POSITIVE
INTERACTIONS WITH TEDROS AND HIS
TEAM.
HE HAS LED W.H.O.'S RESPONSE TO
THE COVID-19 PANDEMIC OUTBREAKS
OF EBOLA IN THE DEMOCRATIC
REPUBLIC OF THE CONGO, AND TO
HELP IMPACTS OF MULTIPLE
HUMANITARIAN CRISIS.
BEFORE FIRST BEING APPOINTED,
W.H.O. DIRECTOR GENERAL, HE
SERVED AS THE MINISTER OF
FOREIGN AFFAIRS OF ETHIOPIA FROM
2012 TO 2016 AND AS THE MINISTER
OF HEALTH OF ETHIOPIA FROM 2005
TO 2012.
THROUGHOUT THE YEAR, NIAID HOSTS
MANY INTERNATIONAL DELEGATIONS
WITH WHOM I, AND OTHER NIAID
STAFFERS MEET.
THE PAST FIVE MONTHS HAVE BEEN
NO EXCEPTION.
AS WE HAVE MET WITH
INTERNATIONAL VISITORS FROM
EUROPE, AFRICA, ASIA, AND SOUTH
AMERICA.
THIS SLIDE HIGHLIGHTS A FEW OF
THESE MEETINGS.
AS PICTURED IN THE CENTER OF THE
SLIDE AT THE TOP, I HAVE HAD
SEVERAL REGULAR VIRTUAL MEETINGS
WITH THE U.K.'S CHIEF MEDICAL
OFFICER PROFESSOR CHRIS WOODY,
ALONG WITH THE GOVERNMENT'S
CHIEF SCIENTIFIC OFFICER Dr.
PATRICK SIR PATRICK VERRANCE.
ON THE LOWER LEFT IN FEBRUARY
FIRST, I MET WITH THE VICE
PRESIDENT OF H EQUADOR AND THE
MINISTER OF PUBLIC-HEALTH, WE
DISCUSSED THE CURRENT COVID-19
SITUATION IN EQUADOR AND SOUTH
AMERICA AND POTENTIAL VIRUS MUTS
AND THE VARIANTS AND THE
VARIANT.
WITH LEADERS FROM SEVERAL NIAID
DIVISIONS I MET IN APRIL WITH
THE LEADERSHIP OF THE CAREER
NATIONAL INSTITUTE OF INFECTIOUS
DISEASES TO SIGN A LETTER OF
INTENT TO ENHANCE COOPERATION
WITH SOUTH KOREA ON IMMUNOLOGY
AND INFECTIOUS DISEASES
RESEARCH.
IN MAY, I MET WITH THE ITALIAN
MINISTER OF HEALTH ROBERTO HE IS
SPERANZA TO DISCUSS COVID-19,
ITALY'S PLANS FOR PANDEMIC
PREPAREDNESS, AS WELL AS AREAS
FOR POTENTIAL COLLABORATION.
WE ARE PICTURED SHAKING HANDS IN
THE PHOTO AT THE BOTTOM CENTER
OF THE SLIDE.
FINALLY, AS PICTURED IN THE
LOWER RIGHT, LEADERS FROM OUR
INSTITUTE DIVISIONS NIA, LET IN
LATE MAY WITH THE FOUNDER AND
CHAIRMAN OF THE INSTITUTE OF
INDIA, Dr. PUNAWALA AND HIS
SON, ADAL A AND C.E.O. OF THAT
COMPANY.
OUR DISCUSSIONS TOPICS INCLUDED
DANGY VACCINES, TB VACCINES,
MALARIA RESEARCH, MRNA VACCINES,
ANTIBODIES AND RESEARCH.
THE INSTITUTE IS THE WORLD'S
LARGEST VACCINE MANUFACTURER BY
A NUMBER OF DOSES PRODUCED AND
SOLD.
ABOUT 65% OF THE CHILDREN IN THE
WORLD RECEIVE AT LEAST ONE
VACCINE MANUFACTURED BY THE
INSTITUTE.
NOW I WOULD LIKE TO TAKE A FEW
MINUTES TO UPDATE YOU ON ONE OF
OUR FAVORITE SUBJECTS, THE NIH
BUDGET.
THIS SLIDE COMPARES THE FISCAL
2002 ENACTED BUDGET WITH THE
FISCAL 2021 ENACTED BUDGET.
THE OVER ALL INCREASE FOR NIH IS
7.5% AS SHOWN ON THE
LOWER-RIGHT-HAND PART OF THE
SIDE.
THIS IS NOT EVENLY DISTRIBUTE.
MANY I.C.s RECEIVED INCREASES
BETWEEN 3% TO 5% OVER THE FISCAL
2021 ENACTED BUDGET.
THERE ARE SEVERAL SIGNIFICANT
EXCEPTIONS.
SUCH AS THE NATIONAL INSTITUTE
ON AGING, WHICH RECEIVED AN 8.2%
INCREASE IN AN ADDITIONAL
$289 MILLION FOR ALZHEIMER'S
RESEARCH AND NIADA THAT RECEIVED
$345 MILLION FOR OPIOID AND
STIMULANT RESEARCH.
ADDITIONALLY, THE NIH RECEIVED A
9.5% INCREASE DRIVEN BY
$41 MILLION MORE TO SUPPORT THE
ALL OF US INITIATIVE, 40 MILLION
FOR CYBERSECURITY, AND 156 MORE
FOR OD OPERATIONS TO SUPPORT THE
AGENCY'S EFFORTS IN THE
ADVANCING BIOMEDICAL INNOVATION
WITH COMPUTATIONAL SCIENCES,
SUCH AS ARTIFICIAL INTELLIGENCE.
NIAID RECEIVED A 4.2% INCREASE
HIGHLIGHTED IN YELLOW.
ON MARCH 28th, PRESIDENT JOE
BIDEN SUBMITTED HIS FISCAL 2023
BUDGET REQUEST TO CONGRESS.
FOR FISCAL 2023, THE PRESIDENT
PROPOSED AN OVER ALL INCREASE
FOR NIH OF 9.3%.
OR $4.3 BILLION ABOVE THE FISCAL
TO 22 ENACTED LEVEL.
NOW MANY I.C.s ON THIS SLIDE
SHOW A DECREASE IN FUNDING.
BUT THIS IS SIMPLY BECAUSE
CONGRESS PROVIDED GENEROUS
INCREASES IN THE FISCAL 2022
ENACTED BUDGET WHICH WERE ABOVE
THE FISCAL 2022 CONTINUING
RESOLUTION THAT WERE USED AS THE
BASIS TO DEVELOP THE PRESIDENT'S
BUDGET.
AND SO IT WAS NEVER THE INTENT
OF THE ADMINISTRATION TO DOUGH
CREASE NIAID OR OTHER IC BUDGETS
IN 20236789 THIS 2023.
THIS IS A MISTAKE OR
MISREPRESENT SENSATION OF TIMING
WHERE THE BUDGET OF 2023 WAS
BASED ON A LOWER STARTING
BUDGET, WHICH WE HAD MUCH MORE
THAN THAT ORIGINAL BUDGET
SHOWED.
SO IT LOOKS LIKE A DECREASE WHEN
IT'S NOT.
THE PRESIDENT BUDGET ALSO
REQUESTS AN ADDITIONAL
$4 BILLION TO CONTINUE THE
ADVANCE RESEARCH PROJECT AGENCY
FOR $4 BILLION TO CONTINUE THAT
ARPA-H TO DEVELOP STATE OF THE
ART TOOLS AND TECHNOLOGIES THAT
WILL DRIVE TRANSFORMATIONAL
INNOVATION IN HEALTH RESEARCH
AND SPEED APPLICATION AND
IMPLEMENTATION OF HEALTH
BREAKTHROUGHS.
THE INITIAL FOCUS AREAS OF
ARPA-H WILL INCLUDE CANCER,
DIABETES AND ALZHEIMER'S.
ALSO NOTE, AT BOTTOM OF THE
TABLE, THE MANDATORY BUDGET
REQUEST FOR FUNDS AVAILABLE OVER
FIVE YEARS TO SUPPORT
PREPAREDNESS AT NIH AND NIAID,
INCLUDED IN THIS $12 BILLION
MANDATORY PACKAGE, IS
$10.6 BILLION TO SUPPORT
PANDEMIC PREPAREDNESS
ACTIVITIES, MANAGED BY NIAID
WHICH INCLUDE RESEARCH ON
VACCINES AND VACCINE PLATFORMS,
MONO CONAL ADDIE BODIES AND
PROVIDING PROTECTION AGAINST PRO
PRO TYPE AND COLLECT INTERESTEDF
20 VIRAL FAMILIES OF CONCERN.
THESE FUNDS WILL SUPPORT
DEVELOPMENT OF CLINICAL TRIALS
OF ADDITIONAL THERAPEUTIC
CANDIDATES, INCLUDING HOST
TISSUE DIRECTED THERAPIES AS
WELL AS BIOMEDICAL RESEARCH
INFRASTRUCTURE TO ADDRESS FUTURE
PANDEMICS, INCLUDING BSLA3, 4
LABS AND EXPANDED CAPACITY TO
MANUFACTURE PILOT LIGHTS OF
PROTOTYPE, MEDICAL
COUNTERMEASURES.
I KNOW THIS LOOKS LIKE A LOT OF
COMPLICATIONS HERE, BUT THIS IS
WHAT WE HAVE RIGHT NOW WHEN YOU
ARE DEALING WITH MULTIPLE
BUDGETS THAT ARE OVERLAPPING AT
THE SAME TIME.
THIS SLIDE SHOWS THE NIAID
FINANCIAL MANAGEMENT PLAN FOR
FISCAL 2022.
OUR RO1 PAYLINES WERE
ESTABLISHED A NEW PI WERE AT THE
12th AND 16th PERCENT
RESPECTIVELY.
COMPETING UNSOLICITED AWARDS AND
NON COMPETING GRANTS, NRND
AWARDS WILL INCUR NO PRAG ATTICA
JUSTMENTS AND COMPETING RESEARCH
INITIATIVES HAVE BEEN CUT BY UP
TO 20% IN ORDER TO SUSTAIN NEW
INVESTIGATOR-INITIATED AWARDS.
WE ESTIMATE THAT OVER ALL
SUCCESS RATES WILL BE BETWEEN
18% TO 22%.
NOW, AN IMPORTANT ASPECT OF OUR
APPROPRIATION, IS TO SUMMARIZE
THE PREPORTION THAT CONGRESS
EARMARKED FOR NIAID TO SPEND ON
SPECIFIC DISEASES ACTIVITIES.
WE'RE APPRECIATIVE OF THE
ADDITIONAL FUNDING, HOWEVER, IT
LIMITS OUR FLEXIBILITY TO
ALLOCATE ADDITIONAL FUNDS TO
SUPPORT INVESTIGATOR INITIATED
PROJECTS AND OTHER NIAID
PRIORITIES.
THE SLIDE YOU ARE LOOKING AT
RIGHT NOW, SHOWS THE COMPONENTS
OF THE NIAID EARMARKED BUDGET
FROM FISCAL 2021 TO 2022.
IN 2022, NIAID RECEIVED ONE
BILLION IN EARMARKED FUNDS AND A
9.3% INCREASE OVER FISCAL 2021.
THESE INCREASES INCLUDED AN
ADDITIONAL 10 MILLION FOR NIH
CENTERS FOR AIDS RESEARCH TO
SUPPORT THE ENDING THE HIV
EPIDEMIC IN THE UNITED STATES
INITIATIVE.
A $25 MILLION INCREASE FOR THE
DEVELOPMENT OF UNIVERSAL
INFLUENZA VACCINES, $18 MILLION
FOR RESEARCH ON-LINE AND OTHER
TICK-BORN DISEASES.
A 15 MILLION-DOLLAR INCREASE FOR
AN MICROBIAL RESEARCH AND
$3 MILLION FOR THE FOOD ALLERGY
RESEARCH AND A $12 MILLION
INCREASE TO BE EVENLY DIVIDED
AMONG THE 12 REGIONAL BIO
CONTAINMENT LABS THAT NIAID
INITIALLY FUNDED IN FISCAL 2003
TO CONTINUE EFFORTS TO PREVENT,
PREPARE FOR, AND RESPOND TO
INFECTIOUS DISEASES OUTBREAK.
ALSO, THERE'S A NEW
5 MILLION-DOLLAR EARMARKED FOR
SARS-CoV-2 IMMUNITY PROFILING.
LET ME TAKE JUST A FEW MOMENTS
TO PROVIDE A BRIEF UPDATE ON THE
FUNDING THAT HAS BEEN PROVIDED,
SPECIFICALLY TO RESPOND TO
COVID-19.
THIS SLIDE SUMMARIZES THE FUND
PROVIDE TODAY NIAID.
THE CARES ACT, AND THE
CORONAVIRUS PREPAREDNESS AND
RESPONSE SUPPLEMENTAL
APPROPRIATIONS ACT, BOTH ENACTED
IN MARCH OF 2020.
THESE ACTS PROVIDED NIAID WITH
$1.5 MILLION IN FUNDING
AVAILABLE FOR USE UNTIL
SEPTEMBER OF 30th, 2024.
WE INITIALLY PROVIDED A SPENDING
PLAN TO CONGRESS ALLOCATED AS
SHOWN IN THE SECOND COLUMN.
SO FAR WE HAVE $1.28 BILLION FOR
EXTRA AND INTRAMURAL
INVESTIGATORS ADDRESSING THE
SCIENTIFIC AREAS THAT ARE MOST
CRITICAL TO UNDERSTANDING AND
ADVANCING MEDICAL
COUNTERMEASURES AND FOR
SARS-CoV-2 AND COVID-19.
MOST OF THE REMAINING
$248 MILLION, IS COMMITTED TO ON
GOING EXTRAMURAL AND INTRAMURAL
PROJECTS WITH A SMALL REMAINING
BALANCE THAT WILL BE AWARDED TO
ADDRESS THE MOST URGENT,
PUBLIC-HEALTH AND SCIENTIFIC
RESEARCH NEEDS RELATED TO
COVID-19.
AND WE HAVE 26 MILLION LEFT TO
SPEND ON FACILITY PROJECTS AT
NIAID'S VACCINE RESEARCH CENTER
IN BETHESDA AND OUR RML LABS IN
HAMILTON, MONTANA.
AND NIAID WAS ALSO A KEY PARTNER
IN THE NIH'S ACCELERATING
COVID-19 THERAPEUTIC
INTERVENTION AND VACCINES OR
ACTIVE PARTNERSHIP.
WHICH IS OPERATING IN
CONJUNCTION WITH THE UNITED
STATES HHS COORDINATION
OPERATIONS AND RESPONSE ELEMENTS
REFERRED TO AS HCORE KNOWN AS
THE COUNTERMEASURES ACCELERATED
GROUP AND OPERATION WARP SPEED.
THIS PARTNERSHIP COORDINATES THE
GOVERNMENT'S RESPONSE AND WORKS
WITH PRIVATE INDUSTRY TO
ACCELERATE THE DEVELOPMENT,
MANUFACTURING, AND DISTRIBUTION
OF VACCINES, THERAPEUTICS, AND
DIAGNOSTICS FOR COVID-19.
SINCE THE BEGINNING OF THE
COVID-19 PANDEMIC, HHS HAS
PROVIDED NIAID WITH
$3.06 BILLION AS SHOWN ON THIS
SLIDE FROM COVID-19 SUPPLEMENTAL
FUNDS TO SUPPORT CLINICAL
TRIALS.
THIS INCLUDES $1.3 BILLION
AWARDED TO EXISTING NIAID
CLINICAL TRIAL NETWORKS AND
SUPPORT CONTRACTS TO CONDUCT
PHASE 3 CLINICAL TRIALS OF FIVE
VACCINE CANDIDATES AND VACCINE
STUDIES AND SPECIAL POPULATIONS.
THE REMAINING FUNDING SUPPORTS
CLINICAL TRIALS, FOR EVALUATING
THERAPEUTICS SUCH AS ACTIVE 2.
AND ADAPTIVE TRIAL DESIGN TO
TEST INVESTIGATIONAL AGENTS IN
NON HOSPITALIZED ADULT
VOLUNTEERS EXPERIENCING MILD TO
MAMODERATE SYMPTOMS.
WE JUMP STOP THE ADMINISTRATION
ANTIVIRAL PROGRAMS FOR PANDEMICS
BY AWARDING CLOSE TO
$600 MILLION TO NINE ANTIVIRAL
DRUG DISCOVERY CENTERS TO
CONDUCT INNOVATIVE
MULTI-DISCIPLINARY RESEARCH TO
DEVELOP CANDIDATE COVID-19
ANTIVIRALS ESPECIALLY THOSE THAT
CAN BE TAKEN IN AN OUT PATIENT
SETTING.
AS WELL AS SPECIFIC VALUE
FAMILIES WITH HYPO TEN SHALL TO
CAUSE A PANDEMIC IN THE FUTURE.
I WILL NOW BRIEFLY PROVIDE THE
LEGISLATIVE AND CONSTITUENCY
GROUP UPDATE.
CONGRESS IS INTERESTED IN
MEDICAL COUNTERMEASURES TO
COMBAT CURRENT AND FUTURE
VARIANTS OF SARS-CoV-2.
AS WELL AS OUR LONGSTANDING
EFFORTS TO ADDRESS PANDEMIC
INFLUENZA AND BETTER
UNDERSTANDING, TREAT, AND
ULTIMATELY PREVENT INFECTIOUS
IMMUNE LOGIC DISEASES.
ON MAY 11th, I ACCOMPANIED DR.
TABAK AND SEVERAL OTHER NIH
INSTITUTE DIRECTORS TO A HEARING
OF THE HOUSE APPROPRIATIONS
LABOR HHS SUBCOMMITTEE ON THE
PRESIDENT'S FISCAL YEAR 2023 NIH
BUDGET REQUEST.
I UPDATED THE APPROPRIATORS ON
THE NIAID PANDEMIC PREPAREDNESS
PLAN AS WELL AS OUR ON GOING
RESEARCH TO BETTER UNDERSTAND
AND TREAT COVID-19, DEVELOP
UNIVERSAL INFLUENZA VACCINES,
AND ADVANCE OUR UNDERSTANDING OF
THE ADVANTAGES OF AND POTENTIAL
BARRIERS TO ZENO
TRANSPLANTATION.
ON MAY 17th, I ALSO
ACCOMPANIED DR. TABAK TO A
HEARING OF THE SENATE
APPROPRIATIONS LABOR HHS
SUBCOMMITTEE ON THE PRESIDENT'S
FISCAL 2023 BUDGET REQUEST.
THE SENATORS WERE INTERESTED IN
TOPICS RELATED TO COVID-19,
INCLUDING NIH EFFORTS TO BETTER
UNDERSTAND AND TREAT LONG COVID.
I DISCUSSED THE NEED TO DEVELOP
CANDIDATE THERAPEUTICS AND
VACCINES FOR VIRAL FAMILIES OF
CONCERN IN PREPARATION FOR THE
NEXT PANDEMIC THREAT.
AS YOU WILL RECALL, SENATOR
PATTY MAR A IS LEADING
CONGRESSIONAL EFFORTS TO DEVELOP
LEGISLATION TO ENHANCE PANDEMIC
PREPAREDNESS.
BY CONTINUING TO ENGAGE WITH
MEMBERS OF THE SENATE AND THE
HOUSE OF REPRESENTATIVES,
INCLUDING CONGRESSIONAL
LEADERSHIP, THROUGH REGULAR
BRIEFINGS, NOT OFFICIAL
HEARINGS, BUT BRIEFINGS, THESE
EVENTS REMAIN IMPORTANT
OPPORTUNITIES TO PROVIDE
CONGRESS WITH ACCURATE AND
UP-TO-DATE INFORMATION ON OUR
EFFORTS TO BETTER UNDERSTAND
SARS-CoV-2 VARIANTS AND TO
DEVELOP AND TEST ADDITION ALONG
MEDICAL COUNTERMEASURES FOR
COVID-19.
OUR INTERACTIONS UNDERSCORE HOW
CONGRESSIONAL SUPPORT FOR
NIAID'S LONGSTANDING RESEARCH ON
CORONAVIRUSES HAS FACILITATED
THE TIMELY DEVELOPMENT OF
CRITICALLY NEEDED COVID-19
VACCINES, SUSTAINED
CONGRESSIONAL INVESTMENTS IN
NIAID DEVELOPMENT OF INNOVATIVE,
UNIVERSAL INFLUENZA VACCINES AND
ALSO IS INFORMING OUR EFFORTS ON
NEXT GENERATION MORE BROADLY
PROTECTIVE AND DURABLE
CORONAVIRUS VACCINES.
SUCH VACCINES WOULD TARGET
HIGHLY CONCERNED VIRAL ANTIGENS
FOR UTILIZING ALTERNATIVE ROUTES
OF INOCULATION SUCH AS THE INTRA
NASAL ROUTE.
ON FEBRUARY 24th, I
PARTICIPATED AGAIN IN THE ANNUAL
DOUGH MINUTE TIN ON THE HILL
EVENT -- DOMINICAN ON THE HILL
EVENT.
DEMOCRAT OF NEW YORK RESPONDED.
THIS EVENT WAS IMPORTANT
OPPORTUNITY TO DIRECTLY CONNECT
WITH DOMINICAN AMERICANS AND THE
DIASPORA TO DISCUSS THE
IMPORTANCE OF COVID-19 ISSUES
AROUND VACCINE HESITANCY AND THE
ON GOING COVID-19 PANDEMIC.
FINALLY, I WANT TO THANK THE
NIAID STAFF WHO HAVE
PARTICIPATED IN MANY
CONGRESSIONAL EVENTS, INCLUDING
BRIEFINGS OF CONGRESSIONAL
APPROPRIATION STAFF ON MY
BEHALF.
THESE EVENTS ARE OUTLINED ON
THIS SLIDE.
I WILL NOW DID DEDICATE THE REMF
THIS SESSION ON EVENTS THAT HAVE
OCCURRED, FOLLOW UPS OF MATTERS
WE HAVE PREVIOUSLY DISCUSSED,
THAT MAY BE OF INTEREST TO YOU.
NOW, WE ALL KNOW THAT I HAVE
SAID MANY TIMES, THAT NIAID
RESEARCH HAS A DUEL MANDATE.
ONE THAT ALL OF THE OTHER HAVE
TO MAINTAIN AND GROW A ROBUST
BASIC AND APPLIED RESEARCH
PORTFOLIO IN WHATEVER THE AREA
OF RESPONSIBILITY IS FOR US,
OBVIOUSLY, IT'S MICROBIOLOGY
INFECTIOUS DISEASES, IMMUNOLOGY
AND IMMUNE MEDIATED DISEASES,
HOWEVER, WE ALSO HAVE ANOTHER,
WHAT I CALL, DUEL MANDATE.
RESPONDING RAPIDLY TO EMERGEING
AND REEMERGING DISEASE THREATS.
THIS IS A SLIDE I HAVE SHOWN
HUNDREDS OF TIMES ALWAYS ADDING
ONE OR TWO OR THREE PER YEAR OF
NEW EXAMPLES OF EMERGEING AND
REEMERGING INFECTIONS.
SOME ARE JUST CURIOSITY AND SOME
IMPACT THE GLOBAL HEALTH.
LET'S TAKE A LOOK AT SOME
EXAMPLES OF ON GOING INFECTIOUS
DISEASE OUTBREAKS IN 2022.
MONKEY POX WHICH WE'RE DEALING
WITH NOW, COVID-19, WHICH HAS
COMPLETELY TRANSFORMED OUR WAVE
LIFE OVER THE LAST TWO AND A
HALF YEARS.
ACUTE HEPATITIS OF UNKNOWN
ETIOLOGY IN CHILDREN, ON GOING
EBOLA IN THE DEMOCRATIC RELICK
OF THE CONGO AND I'VE YAN
INFLUENZA A IN CHINA AND THE
UNITED STATES.
WHAT ARE WE DOING TO PREPARE FOR
FUTURE PANDEMIC?
THE NIAID HAS A PANDEMIC PRE
PAIDNESS PLAN WHICH TARGETS
PROTOTYPE AND PRIORITY PATHOGENS
WHICH WE'VE BEEN WORKING ON FOR
SOME TIME NOW.
WE PICK OUT PULL TOLL FAMILIES
OF PATHOGENS IN THIS CASE ALL
VIRAL DISEASES IN WHICH WE DO
THE KIND OF BASELINE WORK ON
EACH OF THESE TO PREPARE US TO
DEVELOP COMMONALITIES WITHIN THE
FAMILY TO ALLOW US TOKL MOVE THN
OUTBREAK WITHIN THAT FAMILY.
THIS SERVED US VERY WELL AS WE
HAD PRIOR EXPERIENCE WITH
CORONAVIRUSES NOT ONLY WITH THE
COMMON COLD CORONAVIRUS BUT ALSO
WITH SARS-CoV-2 AND MARES AND
WE HAVE DEVELOPED A PROGRAM FOR
MANDELMAN WHIPANDEMIC TO COMBATY
COVID-19 BUT TO PREPARE US FOR
OTHER PANDEMIC THREATS.
IN THIS REGARD, WE RECENTLY
ANNOUNCED ANTIVIRAL DRUG
DEVELOPMENT AWARDS OF
$577 MILLION TO ESTABLISH OURIDG
DISCOVERY CENTERS FOR PATHOGENS
OF CONCERN TARGETING CORONAVIRUS
AS WELL AS OTHER VIRUSES SUCH AS
TOGA, AND NAIN' VIRUSES AND THE
AWARDS SHOWN HERE ON THIS SLIDE
OF THE UNITED STATES.
QUICKLY, MONKEY POX UPDATE.
WE ARE CLEARLY NOW HAVING AN
EMERGING THREAT OF MONKEY POX IN
NON ENDEMIC COUNTRIES WITH NOW
THE SLIDE IS LIKELY ALREADY
OUTDATED WITH 653 CONFIRMED CASE
THIS IS 32 COUNTRIES AS OF
JUNE 1st, 2022.
THE OUTBREAK IN NON ENDEMIC
COUNTRIES IS SHOWN HERE ON THIS
GLOBAL MAP WITH A DISTRIBUTION
AMONG THE VARIOUS COUNTRIES.
AS US CAN SEE, THE U.K. APPEARS
TO BE THE MOST SEVERELY HIT AT
THIS PARTICULAR TIME.
BUT REMEMBER, THIS IS A MOVING
TARGET.
IN THE UNITED STATES THERE ARE
19 CONFIRMED CASES SHOWN ON THIS
SLIDE.
WE DO HAVE COUNTERMEASURES WHICH
WE HAVE DEVELOPED SOME TIME AGO
IN PREPARATION FOR BIO TERROR
ATTACKS WITH SMALL SOX AND THE
COUNTERMEASURES FOR SMALLPOX DO
HAVE CROSS REACTIVITY AND ARE
EFFECTIVE AGAINST MONKEYPOX.
IN THE AREA OF TREATMENT, THE
NIAID WAS INVOLVED IN MANY OF
THE DEVELOPMENT OF THESE
COUNTERMEASURES INCLUDING
TECOVIRIMAT OR TPOXX OR VESTIDE
AND SO PREVENTION FOR PRO AND
POST EXPOSURE PROPHYLAXIS, THE
DEFICIENT AND MVA STRAIN AS WELL
AS THE ORIGINAL ACAM200 WHICH IS
A LIVE VACCINIA VIRUS VACCINE,
THE NIAID HAS BEEN WORKING ON
THESE COUNTERMEASURES ON THE
NATIONAL STOCKPILE.
ALSO THERE'S A LOT OF ON GOING
AS WELL AS PREVIOUS RESEARCH AND
FUTURE PLANS FOR RESEARCH.
I ALREADY MENTIONED OUR KEY ROLE
IN DEVELOPING CURRENTLY
AVAILABLE COUNTERMEASURES, FROM
THE STANDPOINT OF FUNDING WE
FUND ABOUT $20 MILLION IN FISCAL
2021 FOR POX VIRUSES AND
MONKEYPOX.
FOR MONKEYPOX SPECIFICALLY IT'S
$11.9 MILLION.
WE DO WORK ON BIOINFORMATICS AND
GENOMICS AND AND ANTIVIRAL
SCREENING, ANTIBODY DEVELOPMENT.
DIAGNOSTIC AS SAYS AND THE
REPUBLIC OF CONGO AND WE ARE
PLANNING OUR RANDOMIZED CONTROL
TRIAL OF T POX FOR MONKEYPOX
WITH THE DEMOCRATIC REPUBLIC OF
THE CONGO AND WE HAVE VIRAL ICE
ISOLATES AND THE WORLD REFERENCE
CENTER FOR EMERGING VIRUS AND
ARBO VIRUSES.
I'LL GIVE YOU SOME SNIPPETS OF
THIS BECAUSE WE CAN SPEND THE
ENTIRE TIME TALKING ABOUT THIS
CHALLENGE THAT WE ARE LIVING
THROUGH.
WITH REGARD TO THE EPIDEMIOLOGY
AS YOU KNOW, WE NOW HAVE A HALF
A BILLION CASES THAT HAVE BEEN
REPORTED.
THAT IS REPORTED AND LIKELY MANY
MORE SAME TRUE FOR THE DEATHS
GLOBALLY.
6 MILLION BUT AN ESTIMATE IS
THAT IT IS VERY LIKELY CLOSER TO
12 TO 15 MILLION.
REPORTED CASES IN THE UNITED
STATES OVER 84 MILLION AND WE
HAVE REACHED A TERRIBLE LANDMARK
OF 1 MILLION DEATHS IN OUR
COUNTRY SINCE THE BEGINNING OF
THIS OUTBREAK.
WE ARE CURRENTLY DEALING NOW
WITH A VARIANT CALLED OMICRON.
I SHOW THIS FAMILY TREE WHICH
INCLUDES ALL THE VARIANTS WE'VE
DEALT WITH FROM THE ORIGINAL
WA-1 WHICH IS THE STRAIN TO THE
BA AND NOW OMICRON NOW RECENTLY
HAS SHOWN THE EVOLUTION INTO
MULTIPLE SUB LINEAGES AS SHOWN
AN THIS SLIDE.
AND IN FACT IT'S BEEN
EXTRAORDINARY HOW EACH LINEAGE
HAS HAD A GREATER TRANSMISSION
ADVANTAGE AND LITERALLY PUSHED
THE OTHER VARIANTS OFF THE SCENE
AS IT TOOK OVER AS SHOWN ON THIS
SLIDE GLOBALLY HOW DELTA CAME IN
AND PUSHED ALPHA AND BETA AND
GAMMA OFF AND THEN OMICRON BEGAN
TO DOMINATE.
IF YOU LOOK AT WORLD, THIS IS
THE WAY THAT THE SURGES COINCIDE
WITH THE VARIOUS VARIANTS'
APPEARANCE AND AGAIN, LOOK AT
THE DIFFERENCE MASSIVELY, IN
CASES WITH OMICRON COMPARED TO
THE OTHERS.
BUT THERE'S A LITTLE BIT OF A
COMPLICATIONS IN THE POSITIVE
SENSE IN SOME RESPECTS WHERE THE
DEATHS ASSOCIATED WITH WHAT
WE'RE GOING THROUGH RIGHT NOW,
ARE LESS THAN THE PREPORTION AT
OF DEATHS THAT WE SEEN WITH
OUTBREAKS SUCH AS WITH DELTA.
SO RIGHT NOW, IF YOU LOOK AT THE
UNITED STATES, IN JANUARY, THERE
WERE CLOSE TO 900,000 CASES PER
DAY.
WE NOW ARE IN A SPRING TO SUMMER
INCREASE IN CASES AND WE'VE GONE
FROM AROUND 25,000 A MONTH OR SO
AGO UP NOW AS SHOWN ON THE
RIGHT-HAND SIDE OF THE SLIDE TO
100,000 PER DAY WITH DEATHS THAT
HAVE GONE FROM 3,000 DURING THE
WORSE PART OF THE SURGE, MONTHS
AGO, TO 300 A DAY NOW.
SO WE'RE SEEING A LOT OF CASES.
THE PROPORTIONAL AMOUNT OF THOSE
CASES THAT RESULT IN
HOSPITALIZATION AND DEATH IS
LESS.
WE TOO HAVE SEEN THAT GRADUAL
PUSHING OFF THE SCENE OF ONE
VARIANT BY ANOTHER.
IF YOU LOOK AT BA1.1 IN ORANGE,
HOW IT THEN WAS PUSHED OFF BY
BA.2 WHICH GOT PUSHED OFF BY
WHAT WE'RE CURRENTLY SEEING IS
BA.2.12.1 WHICH WENT FROM A
PERCENT OR TWO UP TO 60% OF THE
ISOLATES.
THE IMPORTANCE OF THIS EVOLUTION
OF NEW VARIANTS IS SHOWN ON THIS
SLIDE.
EACH OF THESE VARIANTS HAD A BIT
OF A TRANSMISSION ADVANTAGE OVER
THE PRIOR ONE EXCEPT FOR OMICRON
WHICH HAD A MAJOR TRANSMISSION
ADVANTAGE OVER DELTA AND AS YOU
WENT FROM OMICRON TO BA.2.1 AND
BA4 AND BA.5 IN SOUTH AFRICA BUT
A LOW LEVEL IN THE UNITED
STATES.
SO, WHAT IS HAPPENING NOW, AS
WE'RE SEEING INCREASE IN
COVID-19 CASES THAT WE ARE
EXPERIENCING IN THE NUMBERS THAT
I JUST SHOWED YOU.
IT'S DUE TO THE INCREASE
TRANSMISSIBILITY ON THE PRIOR
SLIDE.
TWO THERE'S WAINING IMMUNITY TO
PRIOR INFECTION AND OR
VACCINATION.
WAINING IMMUNITY WITH REGARDS TO
INFECTION BUT RATHER HOLDING
GOOD WITH IMMUNITY TOWARDS
PROTECTION AGAINST SEVERE
DISEASE AND DEATH.
AND THEN AGAIN, WE ALL KNOW,
LOOK AROUND US, THROUGHOUT THE
COUNTRY, THERE'S RELAXATION OF
MITIGATIONS.
PEOPLE NOT WEARING MASKS, AND
PEOPLE INDOOR CON G CONGREGATIN.
I SHOWED THIS SLIDE MULTIPLE
TIMES IN THE PAST, IT'S THE
PORTFOLIO OF VACCINES THAT WE
HAVE AVAILABLE.
WE KNOW NOW WE HAVE A FULL
APPROVAL OF THE BIOEN TICK AND
MOW DANA AND EMERGENCY USE FOR
SEVERAL OF THE OTHERS.
I'M GOING TO TALK MORE ABOUT
THAT MOMENTARILY.
THERE'S NO DOUBT THAT
VACCINATION HAS A MAJOR, MAJOR
IMPACT ON PREVENTING DISEASE,
HOSPITALIZATIONS AND DEATHS.
IT'S ESTIMATED THAT FROM
DECEMBER 2020 TO MARCH 2022,
OVER 2 MILLION DEATHS WERE
AVERTED OVER 17 MILLION
HOSPITALIZATIONS WERE AVERTED,
AND OVER 66 MILLION INFECTIONS
WERE AVERTED, AND HEALTHCARE
COSTS OF $900 BILLION WERE
SAVED.
NOW, THAT'S THE FUNDAMENTALS OF
THE VACCINE EFFECT.
WHAT ABOUT BOOSTER SHOTS IN
NUMEROUS STUDIES OF REAL WORLD
HE CAN TIVENESS ON VACCINES HAVE
SHOWN THAT DESPITE THE
EXTRAORDINARY EFFECTIVENESS OF
94 AND 95% IN PREVIOUS
PRESENTATIONS, BOOSTED DOSES
RECONSTITUTE THE WAINING OF
IMMUNE PROTECTION FOR AT LEAST
SEVERAL MONTHS.
THE EFFECT OF BOOSTER DOSES MOST
PRONOUNCED AGAINST SEVERE
DISEASE, HOSPITALIZATION, AND
DEATH, PARTICULARLY IN THE ERA
OF OMICRON.
WHICH ABSOLUTELY REQUIRES A
BOOSTER DOSE.
IF YOU LOOK AT THIS SLIDE, IN
THE UNITED STATES, FROM
OCTOBER 2021 TO JANUARY 2022,
AND LOOK AT HOSPITALIZATIONS PER
100,000 AND LOOK AT THE
DIFFERENCE BETWEEN UNVACCINATED
IN RED AND FULLY VACCINATED
WITHOUT A BOOST IN DARK BLUE AND
FULLY VACCINATED WITH AN
ADDITIONAL BOOST IN LIGHT BLUE.
THIS SAME HOLDS TRUE FOR DEATHS.
HERE WE ARE DEATH RATE PER
100,000 AND LOOK AT UNVACCINATED
IN RED AND FULLY VACCINATED
WITHOUT A BOOSTER AND DARK BLUE
AND FULLY VACCINATED WITH A
BOOSTER IN LIGHT BLUE.
BECAUSE OF THIS, THE FDA HAS NOW
EXPANDED ELIGIBILITY TO GO
BEYOND THAT ORIGINAL POPULATION
AND NOW BOOSTERS ARE ELIGIBLE IN
CHILDREN FIVE THROUGH
11-YEARS-OLD WITH THE BIONTECH.
NOW WE'RE CONSIDERING FOR A
SECOND BOOSTER SHOT, NAMELY THE
FOURTH SHOT OF AN MRNA REGIMENT.
WHY IS THAT?
THE FIRST BOOSTER DOSES AS I
SHOWED YOU RESTORE THE WAINING
IMMUNITY EFFECTIVENESS OF THE
PRIMARY VACCINE SERIES,
INCLUDING AS I SHOWED YOU,
AGAINST SEVERE DISEASE AND
HOSPITALIZATION AND THE FACTS
THAT WE'RE DEALING WITH OMICRON.
HOWEVER, THE EFFECTIVENESS OF A
FIRST BOOSTER DOSE DOES WAIN
OVER TIME, CHARACTER IS TICK OF
CORONAVIRUS, GROWING EVIDENCE
SAYS A SECOND BOOSTER CAN
RESTORE VACCINE EFFECTIVENESS TO
CERTAIN POPULATIONS IN THE SHORT
TERM.
BECAUSE OF THIS NOW, THE CDC
ORIGINALLY MADE ELIGIBLE WITH
THE FDA THE CDC RECOMMENDED
BOOSTERS FOR CERTAIN INDIVIDUALS
BUT NOW THE CDC STRENGTHENS THE
RECOMMENDATIONS AND EXPANDS
ELIGIBILITY AND RECOMMENDATIONS
FOR BOOSTER SHOTS.
THIS IS A SUMMARY OF THE VACCINE
DOSE ELIGIBILITY BY AGE.
SO, THE RED Xs MEANS NOT
ELIGIBLE AND THE GREEN CHECK
MARKS MEAN ELIGIBLE.
IF YOU LOOK AT CHILDREN 0-4
WE'RE STILL WAITING ON THE FDA'S
DETERMINATION, WHAT THEIR
ADVISORY COMMITTEE FOR DOSES FOR
CHILDREN.
IF YOU GO FIVE TO 11, THE FIRST,
SECOND AND THIRD BOOSTER DOSE AS
I MENTIONED, IS AVAILABLE FOR
THOSE CHILDREN.
NOT THE FOURTH DOSE AS SHOWN IN
THE RED X.
WHEN YOU GO FROM 12 TO 17, 18 TO
49 AND 50 PLUS, THIRD DOSE
BOOSTERS FOR ALL OF THOSE AGES
BUT FOR THE 50 PLUS, FOURTH DOSE
BOOSTERS ARE RECOMMENDED.
FOR THE YOUNGER GROUP, THE
FOURTH DOSE BOOST IF PEOPLE ARE
MODERATELY OR SEVERELY
IMMUNOCOMPROMISED.
NOW, IN PREPARATION FOR BOOSTING
AS WE GET INTO THE COMING FALL
AND EARLY WINTER, WHICH WE WOULD
EXPECT UNDERSTANDABLY A SURGE OF
CASES, WE ARE DOING STUDIES NOW
DOING MULTIPLE ARMS OF STUDIES
IN A TRIAL CALLED COVAIL OF
PROTOCOL AND VACCINES ALONE AND
IN COMBINATIONS WITH BUY VAL
ANTS TO RECEIVE WHO HAVE
RECEIVED ONE BOOSTER DOSE.
I WANT TO MENTION SOMETHING
THAT'S REALLY IMPORTANT AND A
RECENT STUDY CALLED HEROES,
STANDING FOR HUMAN EPIDEMIOLOGY
AND RESPONSE TO SARS-CoV-2
STUDY, AND IN OVER A THOUSAND
HOUSEHOLDS, WHERE IT SHOWED AS
ASTHMA DID NOT INCREASE THE RISK
OF SARS-CoV-2 INFECTION, EVEN
THOUGH PEOPLE WITH ASTHMA CAN
HAVE A MORE SEVERE EVENT
ASSOCIATED WITH INFECTION, BUT
FOOD ALLERGY FOR REASONS THAT WE
DON'T FULLY UNDERSTAND, WAS
ASSOCIATED WITH A LOWER
INFECTION RISK AND OBESITY WITH
A HIGH BMI WAS ASSOCIATED WITH
AN INCREASE RISK OF INFECTION
NOT ONLY JUST ADVANCED DISEASE.
AND YOUNG CHILDREN WERE SHOWN TO
BE VERY EFFICIENT TRANSMITTERS
WITHIN THE HOUSEHOLD.
WE HAVE A THERAPEUTIC TOOLKIT
IMPORTANTLY AIMED AT KEEPING NON
HOSPITALIZED PATIENTS OUT OF THE
HOSPITAL AND AS I MENTIONED, WE
HAVE PAXLOVID AND AN TANI BODY
IS BEBTELOVIMAB.
ON AN HIV-AIDS UPDATE, SEAN IS
THE NEW AIDS GLOBAL AIDS
COORDINATOR FOR PEPFAR AND
PEPFAR RESULTS CONTINUE TO SHOW
AN EXTRAORDINARY POSITIVE EFFECT
WITH 21 MILLION LIVES SAVED AND
ALMOST 3 MILLION UNINFECTED
CHILDREN BORN TO MOTHERS WITH
HIV.
OVER 19 MILLION PEOPLE RECEIVED
ART AND THE MILLION NEWLY
ENROLLED ON PREP.
AS WELL AS ALMOST 3 MILLION
ADOLESCENT GIRLS AND YOUNG WOMEN
RECEIVING PREVENTION SERVICES.
INTERESTINGLY, HIV DIAGNOSIS IN
THE UNITED STATES HAVE DECREASED
BY 17%.
THIS IS LIKELY A SKEWED RESULT
DUE TO DISRUPTIONS IN CLINICAL
CARE SERVICES AND HESITANCY IN
ACCESSING HEALTHCARE AND
SHORTAGES IN MATERIALS TO HIV
TEST DURING THE COVID-19
PANDEMIC.
WE ARE NOW LAUNCHING THREE
CLINICAL TRIALS OF THREE
MRNA-HIV VACCINES USING WHAT
WE'VE LEARNED FENM THEOF MRNA ID
TO SEE IF WE CAN GET BETTER
RESULTS WITH VACCINES FOR HIV.
AND IMPORTANTLY NOW, ONE ADVANCE
THAT I REALLY NEED TO MENTION TO
YOU, IS THAT THE FDA APPROVED
THE FIRST EXTENDED RELEASE
INJECTABLE DRUG REGIMENT FOR
RESULTS LIVING WITH HIV, NAMELY
CABOTEGRAVIR AND RILPIVIRINE AND
INJECTED ONCE EVERY FOUR WEEKS.
LET ME STOP THERE AND I WILL
ANSWER ANY QUESTIONS.
>>YES, HI.
THANK YOU, AGAIN FOR A FANTASTIC
OVERVIEW.
I'M INTERESTED IN YOUR THOUGHTS
ABOUT THE MONKEYPOX OUTBREAK AND
YOUR SORT OF UNDERSTANDING OF
WHETHER YOU THINK THAT THE VIRUS
HAS EVOLVED OR WHY YOU THINK
WE'RE SEEING THE NUMBER OF CASES
WE ARE AND WHAT WE SHOULD BE
DOING TO SORT OF RESPOND GIVEN
THE CURRENT SITUATION?
>>Dr. Anthony Fauci: WELL, I'D
HAVE TO SAY HONESTLY I DON'T
KNOW EXACTLY WHAT HAPPENED.
WHETHER THERE'S BEEN SOME CHANGE
IN THE VIRUS OR IF WE'VE SEEN
NOW, GIVEN WHICH WAS LIKELY OVER
TIME THE EVOLUTION OF A DEM
KNEWION OF IMMUNITY AGAINST
SMALLPOX WHICH WE STOPPED WE HAD
A SMOLDERING MONKEYPOX GOING ON
IN AFRICA WHERE THEY HAD CASES,
NOT A TRIVIAL NUMBER OF CASE
THAT'S THE DEVELOPED WORLD
DIDN'T KNOW THAT MUCH UNTIL THEY
GOT EXPORTED AND WE KNOW THE
FIRST ONES GOT EXPORTED AND IT'S
LIKELY MULTIPLE INTRODUCTIONS
AND FROM THE NUMBERS, IF YOU
LOCK AT THE PREPORTION OF THE
CASES THAT WE'RE RECOGNIZING,
THEY'RE OVERWHELMINGLY STRONGLY
SKEWED TOWARDS THE GAY-MEN
POPULATION.
SO, I MEAN, I BELIEVE THERE WAS
ONE WOMAN BUT MOSTLY GAY MEN.
SO, WE DON'T KNOW WHY THAT IS
HAPPENING.
LIKELY MULTIPLE INTRODUCTIONS
BUT WE'RE GAY PRIDE THAT TOOK
PLACE IN THE CANARY ISLANDS AND
IN BELGIUM AND OTHER PLACES THAT
WERE BELIEVED TO BE THE PART OF
THAT AND THERE WAS A RECENT
STUDY THAT CAME OUT YESTERDAY
FROM THE U.K. AND THE
OVERWHELMING MAJORITY OF THE
CASES WERE AMONG GAY MEN, MOST
OF THEM, NOT ALL, TRAVELED TO
AFRICAN COUNTRIES AND CAME TO
THE U.K. AND THEN SPREAD WITHIN
THE U.K.
SO, IT'S ANNIE INVOLVING
SITUATION.
WHAT ARE WE GOING TO DO ABOUT
IT?
YOU KNOW IT HARKINS BACK TO THE
DAYS OF NIH.
THIS IS THE NOT HIV OR COVID.
LET'S MAKE THAT CLEAR.
BUT WHAT WE NEED TO DO IS TO
ALERT THE GAY POPULATION TO BE
CAREFUL WHEN YOU ARE DEALING
WITH SITUATIONS OF SEXUAL
CONTACT, TO MAKE SURE THAT YOU
ARE AWARE IF PEOPLE ARE ILL OR
IF THEY HAVE LESIONS,
PARTICULARLY AROUND THE GENITALE
AREA TO ALERT DOCTORS AT
TRANSMITTED INFECTION CLINICS,
THINGS THAT WE MAY HAVE BEEN
CALLING HER PEES OR SECONDARY
SYPHILIS, VERY WELL MIGHT HAVE
BEEN MONKEYPOX SO WE JUST NEED
TO BE A HIGH ALERT THAT WE MAY
BE DEALING WITH THE TIP OF AN
ICEBERG OR NOT.
WE DO KNOW THAT.
WE JUST NEED TO STAY ALERT.
THAT'S WHAT WE NEED TO DO UNTIL
WE GET FURTHER INFORMATION.
WE'RE GOING TO BE TAKING A LOOK
AT SOME STORED CERA WE HAVE FROM
COHORTS FROM YEARS AGO TO SEE IF
THERE WAS A LEVEL, A LOW LEVEL
OF THIS IN SOCIETY THAT WE
DIDN'T PICK UP VERY MUCH.
IT WAS BELOW THE RADAR SCREEN.
I'M NOT SURE IT HAPPENED, BUT WE
WANT TO MAKE SURE WE DON'T MISS
THAT.
THERE ARE A NUMBER OF THINGS
THAT WE CAN DO.
>> THANK YOU FOR THAT.
>> Dr. GANDHI HAS A QUESTION.
>> THANK YOU VERY MUCH FOR ALL
YOUR WORK DURING THE PANDEMIC
AND ALSO PAYING ATTENTION TO
THESE OTHER INFECTIOUS DISEASES.
I HAVE TWO QUESTION, THE HIV
SETBACK THAT WAS REPORTED BY THE
CDC LAST WEEK, WHICH IS TOTALLY
UNDERSTANDABLE, WE HAD LOWER
NUMBER OF NEW INFECTIONS BUT
IT'S LIKELY BECAUSE OF TESTING.
LOWER NUMBER OF TESTING DURING
THE PANDEMIC.
I SAW THE MOST SUPPORT IN NIAID
INCREASING FOR HIV.
IS THAT TRUE?
AND WILL IT BE PUT TOWARDS END
THE HIV EPIDEMIC INITIATIVES IN
TERMS OF RESEARCH FROM THE NIH,
PRESUMABLY IMPLEMENTATION
SCIENCE BECAUSE WE KNOW HOW TO
END IT, BUT JUST GETTING IT TO
HAPPEN?
AND THEN ACTUALLY MY -- I WAS
DELIGHTED TO SEE THE SUPPORT FOR
NIAID AND MY SECOND QUESTION WAS
NOT A QUESTION BUT A COMMENT, WE
WERE REALLY EXCITED TO SEE THE
K23 PAY LINES GO UP FOR NIAID.
ESPECIALLY KO8 AND K23 PAYLINES
JUST BECAUSE WE'VE LOST THAT
RESEARCH WORKFORCE DURING THE
PANDEMIC.
SO, WE KEEP ON ENCOURAGING THE
KP LINES TO GO UP SO THANK YOU.
>> Dr. Anthony Fauci: THANK YOU,
MONICA FOR THOSE COMMENTS.
THE ANSWER TO YOUR QUESTIONS AND
I'LL BE MORE EXPLICIT, THE SHORT
ANSWER IS YES, YES, YES.
WE'RE GETTING NEW MONEY AND THE
MONEY IS GOING TO BE VERY
HEAVILY WEIGHTED TOWARDS THE END
THE HIV EPIDEMIC ACTIVITIES,
PARTICULARLY THE IMPLEMENTATION
SCIENCE THROUGH THE CFARS AND
OTHERS.
THERE'S NO DOUBT THAT WE WANT TO
GET -- I MEAN, WE'RE NOT THROUGH
WITH COVID BUT WE'VE REALLY GOT
TO RECHARGE THE EFFORT ON
HIV/AIDS BECAUSE YOU KNOW, WE
START OFF-THE-RECORD IN 2020 AND
IT'S A 10-YEAR PLAN, HOPEFULLY
BY 2030 WE'LL DECREASE THE
NUMBER OF CASES BY 95%, HALFWAY
THROUGH WE SHOULD BE DOWN BY
70%.
WE WANT TO GET THERE.
WE DON'T WANT THE UNDERSTANDABLE
CHALLENGE THAT WE'RE BEING FACED
WITH WITH COVID-19 TO DETER US
FROM DOING BOTH THINGS AT THE
SAME TIME.
WE CAN DO BOTH.
>> THANK YOU.
>> Dr. Anthony Fauci: ALL RIGHT.
IF THERE ARE NO MORE QUESTIONS,
I'D LIKE TO INTRODUCE THE NEXT
PART OF THE PROGRAM Dr. RICK
KOUP THE ACTING DIRECTING OF THE
NIAID RESEARCH VACCINE CENTER
WILL UPDATE US ON THE LATEST
RESEARCH ACTIVITIES AND
ACCOMPLISHMENTS AT THE VRC.
RICK, TAKE OVER.
>> HI, IT'S MY PLEASURE TO
UPDATE YOU TODAY ON OUR
ACTIVITIES AND PROGRESS OVER THE
LAST YEAR.
I WILL COVER THREE AREAS IN MY
PRESENTATION.
FIRST I WILL GIVE A QUICK
OVERVIEW OF THE VRC, WHO WE ARE
AND WHAT WE DO.
I WILL THEN PROVIDE AN UPDATE ON
OUR ON ON GOING EFFORTS AS PART
OF THE NATIONAL RESPONSE TO
COVID-19.
FINALLY I WILL GIVE YOU AN
UPDATE ON CURRENT VRC RESEARCH
ACTIVITIES.
I WILL NOT BE ABLE TO TOUCH ON
ALL THE RESEARCH WE ARE
CURRENTLY DOING, BUT I WILL
PROVIDE SOME UPDATES ON OUR
UNIVERSAL FLU VACCINE PROGRAM
AND OUR EFFORTS IN PANDEMIC
PREPAREDNESS.
THE VACCINE RESEARCH CENTER WAS
ESTABLISHED IN 2000 AS A CENTER
DEDICATED TO RESEARCH AND
DEVELOPMENT ON HIV VACCINES.
IT WAS DESIGNED TO BE ABLE TO
COVER ALL ASPECTS OF RESEARCH
AND DEVELOPMENT, WITHIN A SINGLE
CENTER, ALLOWING FOR BASIC
RESEARCH TO DISCOVERIES TO BE
TRANSLATED TO FIRST IN HUMAN
CLINICAL TRIALS.
THE DEDICATED TEAM OF SCIENTISTS
INCLUDES EXPERTS IN IMMUNOLOGY,
VIROLOGY, STRUCTURAL BIOLOGY,
BIO ENGINEERING, PRODUCT
FORMULATION, MANUFACTURING, AND
CLINICAL TRIALS.
IN THE 21 YEARS SINCE ITS
INCEPTION, AS AN AIDS VACCINE
CENTER, THIS SCOPE OF THE VRC
HAS EXPANDED.
AND WE LIKE TO SAY NOW WE COVER
EVERYTHING FROM AIDS TO ZIKA.
IN FACT, THE LIST ON THIS SLIDE
GIVES YOU AN IDEA OF THE SCOPE
AND BREADTH OF ACTIVE VACCINE
RESEARCH AT OUR CENTER.
WE HAVE DEVELOPED VACCINES IN
MONOCLONAL ANTIBODIES TO THE
PATHOGENS ON THIS LIST AND
SEVERAL HAVE BEEN LICENSED TO
PHARMACEUTICAL PARTNERS.
THIS SLIDE PROVIDES A QUICK
OVERVIEW OF THE FACILITIES IN
CAPABILITIES OF THE VRC WHICH
INCLUDES THE UNIQUE PRODUCT
ENGINEERING GROUP AND THE PILOT
PLAN WHICH ALLOW US TO TRANSLATE
BASIC SCIENTIFIC DISCOVERIES
INTO MANUFACTURE OF CLINICAL
GRADE MATERIALS FOR USE IN HUMAN
TRIALS.
WHILE WE CAN AND HAVE PRODUCED
CLINICAL MATERIALS, AND
COMPLETED HUMAN CLINICAL TRIALS
FOR MANY PRODUCTS, INCLUDING
THOSE ON THE LIST ON THE RIGHT,
WE DO NOT AND CANNOT ACTUALLY
LICENSE PRODUCTS FOR CLINICAL
USE.
FOR THAT WE PARTNER WITH
INDUSTRY AND WHO CAN TAKE THE
PRODUCTS WE DEVELOP THROUGH FULL
PRODUCT DEVELOPMENT AND
LICENSURE.
LET ME NOW SHIFT GEARS AND TELL
YOU ABOUT OUR ON GOING EFFORTS
AS PART OF THE NATIONAL RESPONSE
TO THE COVID-19 PANDEMIC.
MOST PEOPLE ARE AWARE OF THE
SUPPORT THE U.S. GOVERNMENT
PROVIDED TO THE SUCCESSFUL
EFFORT TO DEVELOP TEST AND
DEMONSTRATE EFFICACY OF THE SIX
VACCINES LISTED HERE.
FORMALLY CALLED OPERATION WARP
SPEED AND NOW CALLED THE HCORE,
SCIENTISTS WERE INVOLVED IN ALL
ASPECTS OF THIS EFFORT AND
BARNEY GRAHAM WERE INSTRUMENTAL
IN DISCOVERING THE S2P MUTATION
THAT STABILIZES THE SPIKE
PROTEIN OF THE SARS-CoV-2 AND
USED IN FIVE OF THE SIX U.S.
GOVERNMENT SUPPORTED COVID-19
VACCINE PRODUCTS LISTED HERE.
FORMER DIRECTOR JOHN MASSTOLA
WAS CO-LEAD OF THE VACCINE
DEVELOPMENT TEAM.
FORMER DEPUTY DIRECTORS BARNEY
GRAHAM AND JULIE LEDGERWOOD HELP
LEAD VARIOUS EFFORTS IN THE
CLINICAL TRIALS OF THESE
VACCINES.
I CONTINUE TO BE CO-LEADER OF
THE IMMUNE ASSAY TEAM THAT HAVE
ANTIBODIES THAT BIND TO THE
SPIKE PROTEIN AND NEUTRAL LIES
SARS-CoV-2.
AND OUR CURRENTLY BEING USED TO
EXPANSION OF THE CURRENTLY
LICENSED VACCINES INTO
ADDITIONAL POPULATIONS.
WITHIN THAT EFFORT, ADRIAN
McDERMOTT WHO HEADS THE
PROGRAM AT THE VRC HAD THE
BINDING ANTIBODY ASSAY USED IN
THIS EFFORT AND NANCY SULLIVAN
HELD WITH THE EFFORT TO EVALUATE
THE SARS-CoV-2-SPECIFIC
MONOCLONAL A ANTIBODIES AS
THERAPY.
I CAN GO ON BUT TIME DOES NOT
PERMIT SO SUFFICE IT TO SAY I'M
PROUD OF THE VRC'S CONTRIBUTION
TO THIS NATIONAL EFFORT.
UNFORTUNATELY THE REALIZATION
THAT THE VIRUS IS UNIQUELY
CAPABLE OF MUTATING ITS SPIKE
PROTEIN TO STAY SOMEWHAT BUT AS
I WILL HOPEFULLY SHOW YOU NOT
COMPLETELY AHEAD OF OUR VACCINE
EFFORT.
MULTIPLE VARIANTS OF CONCERN
HAVE A RISEN AROUND THE GLOBE,
THE MOST RECENT BEING THE
OMICRON ON THE RIGHT.
WITH FAR MORE MUTATIONS THAN THE
PRIOR VARIANTS.
AND WHICH IS LED TO THE
SUBSEQUENT WAVES OF SUB VARIANTS
INCLUDING BA.1, 2, 2.12.1, 4 AND
5.
EACH NEW VARIANT HAS REPLACED
PRIOR VARIANTS AND THEY'RE PRO
RESISTANT TO LICENSED ANTIBODY
THERAPY AND VACCINES.
THE VRC IS INVOLVED IN TWO
IMPORTANT EFFORTS TO COMBAT
THESE NEW VARIANTS.
FIRST, WE FORMED A PIPPY LIE
LILLY TO ISOLATE AND CHARACTER
EYES MONOCLONAL ANTIBODIES
AGAINST SARS-CoV-2.
USING BLOOD MONO NUCLEAR CELLS,
BEFORE THERE WERE ANY VARIANTS
OF CONCERN, THIS PARTNERSHIP LED
TO THE DEVELOPMENT AND LICENSE
OF LIVE COV555 OR USED AS A
AGENT IN COVID PATIENTS AND WHEN
IT WAS CLEAR THAT SUBSEQUENT
WAVES OF VARIANTS WERE RESISTANT
TO THIS AND OTHER ANTIBODIES,
ADDITIONAL ANTIBODY FROM THE
ORIGINAL SCREENING AND
CHARACTERIZATION WERE EVALUATED
AT THE VRC AGAINST OMICRON AND
THE OTHER VARIANTS.
AMAZINGLY, ANTIBODY LYCOV1404
FROM THAT SAME DONOR WAS HIGHLY
ACTIVE AGAINST ALL OMICRON
VARIANTS AND THIS LED TO THE
RAPID TESTING AND LICENSURE OF
BEBTELOVIMAB BY ELI LILLY.
THIS SLIDE SHOWS DATA GENERATED
AT THE VRC -- LISTED As CROSS
THE TOP OF THE TABLE.
THE REDDER THE BOX THE MORE
SENSITIVE THE STRAIN IS TO THE
ANTIBODIES ON THE LEFT.
AS YOU CAN SEE, BEBTELOVIMAB IS
THE ONLY ANTIBODY WITH BROAD
ACTIVITY AGAINST ALL OMICRON SUB
VARIANTS AND IT'S THE ONLY
ANTIBODY CURRENTLY BEING USED
FOR TREATMENT OF COVID-19.
BUT BEYOND THE DEVELOPMENT OF AN
IMPORTANT PRODUCT, THE DISCOVERY
OF ANTIBODIES WITH BROAD
ACTIVITY AGAINST OMICRON, IN AN
INDIVIDUAL INFECTED WITH THE
ORIGINAL WASHINGTON STRAIN, LONG
BEFORE OMICRON AROSE, INDICATES
THAT THE PEOPLE INFECTED WITH
EARLY STRAINS OF SARS-CoV-2
MAY HAVE MEMORY B CELLS CAPABLE
OF RESPONDING WITH STRONG
ACTIVITY AGAINST NEW VARIANTS AS
THEY A ARRIVE.
AS THIS IS A VERY HOPEFUL RESULT
WITH IMPLICATIONS FOR HOW PEOPLE
MAY DEAL IMMUNE LOGICALLY WITH
FUTURE VARIANTS OF SARS-CoV-2.
IN THE SPRING OF LAST YEAR, WE
WERE FACED WITH A VACCINE POLICY
ISSUE.
WHEN THE BETA STRAIN OF COVID-19
ARRIVED AND WE DIDN'T KNOW HOW
THE POPULATION WOULD RESPOND TO
THE BETA STRAIN AND WHETHER WE
COULD BOOST WITH THE EXISTING
STRAIN OR INTRODUCE THE BETA
STRAIN INTO THE VACCINE BOOST IN
ORDER TO STIMULATE PROTECTIVE
RESPONSES AGAINST BETA.
LUCKILY, Dr. BOB SEDER WAS
POISED AND READY TO DO CRITICAL
EXPERIMENTS THAT HELPED FORM THE
BASIC SCIENTIFIC BASIS OF OUR
BOOST STRATEGY SO FAR.
Dr. SEDER HAD MONKEYS THAT
WERE VACCINATED WITH MODERNA AND
WAS BASED ON THE ORIGINAL
WASHINGTON STRAIN.
AS SHOWN IN THE TOP PANEL, HE
SIMPLY BOOSTED THOSE MONKEYS
EITHER WITH THE ORIGINAL 1273
VACCINE OR A SIMILAR MRNA
VACCINE FROM MODERNA ENCODING
THE BETA STRAIN.
HE MEASURED NEUTRALIZING
ANTIBODY RESPONSES AGAINST THE
ORIGINAL OR THE BETA STRAIN OF
VIRUS AND CHALLENGED THE MONKEYS
WITH THE BETA STRAIN.
HE FOUND NEUTRALIZING THE
RESPONSE S WITH SIMILAR ACROSS
ALL VARIANTS AFTER BOOSTING WITH
EITHER STRAIN AND BOOSTING WITH
EITHER STRAIN INCREASES
PROTECTION AGAINST BETA.
THEREFORE, THE EXISTING VACCINE
WAS CAPABLE OF BOOSTING
PROTECTIVE RESPONSES AGAINST THE
BETA STRAIN.
WE DIDN'T HAVE TO DEVELOP NEW
VACCINES AGAINST BETA IN ORDER
TO INDUCE SPECIFIC-SPECIFICS
PROTECTION.
AS SHOWN IN THE BOTTOM PANEL, A
SIMILAR EXPERIMENT WITH SIMILAR
RESULTS WAS PERFORMED BY Dr.
SEDER WHEN THE OMICRON VARIANT
AROSE.
AGAIN, INDICATING THAT THE
EXISTING VACCINES WHEN BOOSTED
BY EXISTING VACCINES, COULD
INDUCE PROTECTIVE RESPONSES
AGAINST NEWLY ARISING STRAINS
THAT WERE QUITE DIFFERENT FROM
THE VACCINES ENCODED
STRAINS.
THIS DATA, PUBLISHED IN SCIENCE
LAST YEAR, WERE PRESENTED TO THE
ISRAELI GOVERNMENT ON
JULY 29th OF 2021.
JUST AS THEY WERE FACING A
DECISION ON HOW TO RESPOND TO A
RAPID RISE IN DELTA VIRUS
INFECTIONS.
THAT SAME DAY, THEY APPROVED THE
PLAN TO BOOST THEIR POPULATION
WITH EXISTING VACCINES.
LIKELY BASED AT LEAST PARTIALLY
ON Dr. SEDER'S DATA.
ON THE RIGHT SAY PUBLICATION
FROM MARCH OF THIS YEAR
REPORTING RESULT 0 THE
OMICRON-SPECIFIC BOOSTING IN
MONKEYS.
WHILE NOT HUMAN DATA I THINK THE
FINDINGS PRESENTED IN THESE TWO
PUBLICATIONS WERE AMONG THE
CRITICAL DATA THAT SHAPED POLICY
FOR VACCINE BOOSTING IN THE U.S.
DATA IN HUMANS MIRRORED AT LEAST
IN TERMS OF IMMUNE RESPONSES,
WHAT Dr. SEDER SAW IN HIS
MONKEY EXPERIMENTS, THIS IS DATA
FROM THE NEW ENGLAND JOURNAL OF
MEDICINE THIS YEAR SHOWING THAT
NEUTRALIZING ANTIBODY RESPONSES
AGAINST THE WASHINGTON D614J AND
OMICRON STRAINS AFTER TWO DOSES
OF MODERNA'S 1273MRNA VACCINE ON
THE LEFT AND A BOOST WITH THAT
SAME VACCINE ON THE RIGHT.
WHILE THIS PUBLICATION
HIGHLIGHTED THE FULL DIFFERENCE
IN NEUTRALIZATION AGAINST THE
STRAINS, AFTER PRIMARY AND
BOOSTING VACCINATIONS SHOWN IN
THE BLUE NUMBERS ACROSS THE
FIGURES, I THINK THE IMPORTANT
DATA ARE THE ACTUAL AT TITER WD
VACCINATIONS SHOWN IN RED.
CIRCLED YOU CAN SEE THAT THE
NEUTRALIZING ANTIBODY RESPONSE
AGAINST OMICRON WAS QUITE LOW
AFTER THE PRIMARY VACCINE SERIES
BUT WAS STRONGLY BOOSTED WITH
THE THIRD DOSE OF THE MRNA1273
VACCINE.
THEY WERE LOWER AGAINST THE BETA
STRAIN, THAT DIFFERENCE WAS MUCH
LESS AFTER BOOSTING.
LET ME NOW SPEND A LITTLE TIME
TELLING YOU ABOUT ON GOING
RESEARCH EFFORTS IN UNIVERSAL
INFLUENZA VACCINES AND PANDEMIC
PREPAREDNESS.
THE ENTIRE FLU VACCINE
DEVELOPMENT TEAM AT THE VRC HAVE
MULTIPLE PRODUCTS AND
DEVELOPMENT AND HUMAN CLINICAL
TESTING ALL BASED UPON THE
NANOPARTICLE PLATFORMS SHOWN
HERE.
THE THREE ON THE LEFT ARE BASED
UPON FERRITIN NANO PARTS AND
HAVE HA PRIMERS PER PARTICLE.
THE FIRST EXPRESSES FULL LENGTH
HA AND THE NEXT TWO EXPRESS
STABILIZED-STEMS FROM THE HA
FROM GROUP ONE OR GROUP TWO
INFLUENZA.
THOSE LETTERS STEM ONLY
PARTICLES ARE DESIGNED WITH THE
SOLE PURPOSE OF BEING ABLE TO
STIMULATE BROAD CROSS REACTIVE
STEM-SPECIFIC ANTIBODY
RESPONSES.
SPECIFICALLY, BECAUSE THE MORE
VARIABLE HEAD REGION IS NOT
PRESENT.
AND THE IMMUNE SYSTEM WILL NOT
BE DISTRACTED TO PRODUCE MORE
TYPE-SPECIFIC ANTIBODIES TO HEAD
SPECIFIC VARIABLE EPITOPES.
IN COLLABORATION WITH NEIL KING
IN SEATTLE, SHE HAS ALSO
DEVELOPED AWE A MOSAIC HIV
NANOPARTICLE VACCINE THAT
EXPRESSES 20HA PRIMERS FROM FOUR
DIFFERENT STRAINS IN AN ORDER
ARRAY.
THAT VACCINE ENTERED CLINICAL
TRIALS LAST YEAR.
THE POTENTIAL ADVANTAGES OF THE
NANOPARTICLE PLATFORMS ARE THE
THESE PARTICLES MIMIC THE SIZE
AND SHAPE OF THE VIRUS, AND ARE
ENGINEERED SUCH THAT WE CAN
CONTROL THE EXPRESSION OF THE
ANTIGEN ON THE SURFACE OF THE
PARTICLE AND CAN MAKE THEM MULTI
VEIL ANT WITH STRAINS OF
INFLUENZA AND DATA ARE COMING IN
RAPIDLY ON THESE VACCINE
CONSTRUCT, LET ME GIVE YOU THE
RESULT FULL LENGTH NANOPARTICLE
SHOWN IN THE FAR-LEFT.
THE VACCINE WAS SAFE AND IMMUNE
AGAIN I CAN IN HUMANS WHETHER
THE VACCINE WAS GIVEN AS TWO
DOSES OF THE PARTICLE, SHOWN ON
THE LEFT, OR AS A PARTICLEN
CODED BY DNA FOLLOWED BY THE
PROTEIN PARTICLE ON THE RIGHT,
THE VACCINE WAS ABLE TO
STIMULATE NEUTRALIZING
ANTIBODIES AGAINST A H2N2 STRAIN
ON THE TOP, OR THE STRAIN SHOWN
ON THE BOTTOM.
AND THE NEUTRALIZING RESPONSES
INDUCED BY THE H2 NANOPARTICLE
VACCINE WERE MORE CROSS REACTIVE
THAN ANTIBODIES GENERATED BY THE
H5MIV VACCINE USED AS A
COMPARATIVE GROUP IN THIS TRIAL.
AS SHOWN IN THE BOTTOM GRAPH,
THE NANOPARTICLE VACCINE INDUCED
A BALANCED H2H5 RESPONSE WHERE
THE H5 VACCINE HAD A DOMINANT H5
RESPONSE TO THE DETRIMENT OF THE
H2 RESPONSE.
Dr. SARAH ANDREWS WORKING IN
Dr. ADRIAN McDERMOTT'S LAB
SHOWED IT WAS A SINGLE CHANGE AT
POSITION 45 WITHIN THE STEM.
IN THE ABSENCE OF THIS CHANGE, A
DOMINANT RESPONSE WAS ELICITED
TO THE H5 WHICH COULD NOT
RECOGNIZE THE STEM OF H2 AS
SHOWN ON THE RIGHT.
LASTLY, THE DOCTOR HAS BEEN
WORKING WITH Dr. NEIL KING TO
STABILIZE THE TETRA FORM OF THE
INFLUENZA FOR FUTURE VACCINES
EFFORTS.
AS YOU ARE AWARE, NEURAMINIDAES
IS MUCH LESS VARIABLE THAN HA.
MAKING IT AN EXCELLENT IMMUNEGEN
CHOICE FOR INFLUENZA VACCINE
EFFORTS.
THE DOCTORS WORKING TOGETHER
HAVE FIGURED OUT HOW TO
STABILIZE THE PROTEIN AS A TIGHT
FORM AS SHOWN IN BLUE.
THIS STABILIZED PROTEIN CALLED
SNAP, CAN NOW BE USED FOR
STRUCTURAL STUDIES OF THE
NEURAMINIDASE AND IT CAN BE USED
AS A ASSAY OR A PROBE TO PULL
OUT NEURAMINIDASE-SPECIFIC
MONOCLONAL ANTIBODIES.
NOW ON TO OUR PANDEMIC
PREPAREDNESS EFFORTS.
THE VRC HAS BEEN DEVELOPING A
STRATEGY TO PREPARE FOR
POTENTIAL FUTURE VIRAL PANDEMIC.
THE PRIORITY PROTOCOL PATHOGEN
APPROACH WAS DESCRIBED BY VRC
SCIENTISTS Dr. BARNEY GRAHAM
AND Dr. NANCY SULLIVAN IN
NATURE MEDICINE IN 2018.
AND CAN BE SUMMARIZED AS FOLLOW0
DIFFERENT VIRUS FAMILIES THAT
COULD FORM THE BASIS OF FUTURE
PANDEMIC.
FOR EACH VIRAL FAMILY, ONE NEEDS
TO UNDERSTAND THE VIRAL
CHARACTERISTICS.
FOR INSTANCE, THE TYPE OF
SURFACE PROTEIN USED FOR ENTRY,
AND HOW TO STABILIZE IT IN A PRE
FUSION FORM.
INFORMATION THAT WAS CRITICAL TO
THE DEVELOPMENT OF RSV AND COVID
VACCINES.
BASED UPON THAT KNOWLEDGE,
IMMUNE AGAINS CAN BE DESIGNED
AND USED BOTH AS POTENTIAL
VACCINES AND PROBES TO PULL OUT
MONOCLONAL ANTIBODIES.
BOTH AND MONOCLONAL ANTIBODIES
CANNING MANUFACTURED AND TESTED
IN HUMANS FOR SAFETY OR
THERAPEUTIC EFFECT RESPECTIVELY.
TO ICE A BASEBALL ANALOGY, THIS
WOULD PUT US ON THIRD BASE AT
START OF A PANDEMIC NOT SITTING
IN THE DUGOUT.
Dr. CAREEN BOK HAS REVIEWED
THE CURRENT STATUS OF VACCINES
AGAINST THE 30 VIRUS FAMILY AND
HAS RANKED THEM ACCORDING TO
PREPAREDNESS LEVELS FROM 0 IN
RED LACKING ANY PROTOTYPE WITH A
CANDIDATE VACCINE TO 3 IN GREEN,
WHERE AT LEAST ONE EXISTING
PROTOTYPE VACCINE IS IN LATE
CLINICAL DEVELOPMENT OR ALREADY
APPROVED.
THE DARKER BOXES HERE INDICATE
THE VIRUS FAMILIES FOR WHICH THE
VRC HAS AN ACTIVE VACCINE OR
MONOCLONAL ANTIBODY PROGRAM.
WE HAVE A FAIRLY EXTENSIVE
EFFORT.
WHILE I CAN'T DESCRIBE ALL OF
THEM, LET ME UPDATE YOU ON OUR
PARA MIX OF VIRUS VACCINES
EFFORTS, THE SECOND DARK ORANGE
BOX.
THE TAX OWE MIX OWE OF PANDEMIC
POTENTIAL.
Dr. NANCY SULLIVAN IS RUNNING
THIS PROGRAM AND IT WAS
INITIALLY BEGUN IN Dr. BARNEY
GRAHAM'S LAB.
THIS WAS BEGUN AS A
COLLABORATION BETWEEN MODERNA
AND THE VRC AS A DEMONSTRATION
PROJECT FOR HOW RAPIDLY WE COULD
RESPOND TO A PANDEMIC USING MRNA
TECHNOLOGY.
IT WAS SIDELINED TEMPORARILY
DURING THE COVID PANDEMIC BUT
THE COLLABORATION BETWEEN THE
VRC AND MODERNA TO BRING A COVID
VACCINE TO AUTHORIZATION IN LESS
THAN A YEAR, WAS A REAL WORLD
TEST OF HOW SUCCESSFUL THIS
APPROACH CAN BE.
BUT IN TERMS OF THE NIPAH
PROJECT AND MUCH LIAR FORECAST
RSV AND SARS-CoV-2,
STRUCTURE-BASED DESIGN AND THE
USE OF A DOMAIN WERE USED TOUSNF
NIPAH VIRUS IN THE PRE FUSION
FORM AND SHOWN IN THE CRYO EM IN
THE LOWER LEFT PANEL.
BECAUSE ADDITIONAL SURFACE
PROTEINS OF NIPAH VIRUS CAN BE
INVOLVED IN ENTRY, THE
ATTACHMENT OR G PROTEIN, IT TOO
WAS STABILIZED WITH THE TONE
MAIN AS SHOWN IN THE LER RIGHT.
AND INTERESTINGLY, A KAI MERIK
OF THE SINGLE PRE F AND 3G
PROTEINS LIKED TO A TRIMERIZATON
WAS SHOWN AND DEVELOPED IN THE
MIDDLE PANEL.
THESE THREE INU IMMUNO AGAINS AN
WITHAL UM ON THE RIGHT, WERE
USED TO IMMUNIZE MICE.
THE POST FUSION FORM OF THE F
PROTEIN WAS USED AS A CONTROL
IMMUNOGEN.
THROW WEEKS AFTER IMMUNIZATION,
SERUM WERE TESTED FOR ABILITY TO
NEUTRALIZE NIPAH VIRUS IN VITRO
AND THE COM BENATION OF PRE F
AND G OR G ALONE ADMINISTERED AS
MRNA OR ROW TEEN STIMULATED
STRONG NEUTRALIZING ANTIBODY
RESPONSE THAT'S WERE
SIGNIFICANTLY BETTER THAN THE
PRE F ALONE.
IT'S APPARENT THE ATTACHMENT OR
G PROTEIN IS AN IMPORTANT TARGET
OF THE NEUTRALIZING ANTIBODY
SPENCE TO NIPAH VIRUS AND NEEDS
TO BE INCLUDE INSIDE A VACCINE.
BASED UPON THESE AND OTHER
RESULTS, A FIRST IN HUMAN
CLINICAL TRIAL OF A MRNA VACCINE
WITH THE IMMUNE AGAIN, IS SET TO
START AT THE VRC LATER THIS
MONTH.
IS THIS SURVEILLANCE INITIATIVE
IS CALLED PREMISE.
AND IT IS A PROACTIVE PANDEMIC
PREPAREDNESS PROGRAM TO HELP
ACCESS RATE THE RESPONSE TO
PANDEMIC THREATS GLOBALLY BY
DEVELOPING DATA RESOURCES,
DIAGNOSTIC REAGENTS, MONOCLONAL
ANTIBODIES AND IMMUNOGENS FOR
SCENES.
IN PARTNERSHIP WITH ACADEMIC
CENTERS, U.S. GOVERNMENT
AGENCIES, NGOs AND OTHER
INTERNATIONAL AGENCIES,
SCIENTISTS WILL ESTABLISH HIGH
THROUGH PUT IMMUNE LOGIC
SCREENING METHODS WITH TARGETED
COHORTS TO DETECT SERUM AND
B-CELL REACTIVITY AGAINST
VIRUSES OF PANDEMIC POTENTIAL.
WHILE PRIMARILY DESIGNED AS A
PATHOGEN AGNOSTIC APPROACH,
WHERE AVAILABLE, THIS EFFORT
WILL ALSO SEQUENCE SAMPLES FROM
RESERVOIRS AND SYMPTOMATIC
HUMANS FOR VIRUS IDENTIFICATION.
THIS EFFORT IS JUST BEGINNING
AND ALREADY INVOLVES MULTIPLE
NATIONAL AND INTERNATIONAL
COLLABORATORS.
IN ORDER TO SHOW ITS POTENTIAL,
PREMISE HAS A DEMONSTRATION
PROJECT ON ACUTE FLACCID HIGH
PLAS MYLEITISAND THERE HAVE BEED
TO EV-D68 BUT NOT EVERY CHILD
GETS AFM.
PROBABLY DUE TO INFECTION
CONTROL MEASURES DURING THE
COVID PANDEMIC, THERE HAVE NOT
BEEN OUTBREAKS OF █AFM IN 2020 R
2021.
AS A RESULT, EPIDEMIOLOGIC
MODELING SUGGESTS THAT THERE MAY
BE A MUCH LARGER SUSCEPTIBLE
POPULATION OF CHILDREN IN 2022
THAN IN PRIOR YEARS.
AS PART OF PREMISE, AN EV-D68
PEDIATRIC OBSERVATIONAL PILOT
STUDY HAS BEEN SET UP AND
UNDERWAY AT FOUR U.S. SITES.
120 CHILDREN HAVE BEEN RECRUITED
WITH BLOOD AND RESPIRATORY
SAMPLING.
THE GOAL IS TO SHOW WITH
PROACTIVE SURVEILLANCE, AND
EARLY DETECTION, WE'LL BE ABLE
TO RAPIDLY DEVELOP BIOLOGICAL
COUNTERMEASURES INCLUDING
VACCINES AND MONOCLONAL
ANTIBODIES.
WITH THAT, I WOULD LIKE TO THANK
YOU ALL FOR THE OPPORTUNITY TO
PRESENT ON BEHALF OF THE
DEDICATED GROUP OF DRC
SCIENTISTS SHOWN ON THIS SLIDE,
MANY OF WHOM'S CONTRIBUTION I'VE
BEEN ABLE TO HIGHLIGHT DURING MY
PRESENTATION.
I WILL BE HAPPY TO TAKE ANY
QUESTIONS THAT YOU MAY HAVE.
>> Dr. Anthony Fauci: THANK YOU,
VERY MUCH, RICK.
TERRIFIC PRESENTATION.
LET'S LEAVE IT OPEN FOR
QUESTIONS NOW AND JUST INDICATE
WITH THE HAND UP IF YOU HAVE ANY
QUESTIONS OF RICK.
I'M NOT SEEING ANY.
>> Dr. Anthony Fauci: MONICA, I
SEE YOUR HAND UP.
>> I MEAN, I THINK THANK YOU SO
MUCH FOR THAT TALK.
I THINK IT WAS INCREDIBLE WHAT
HAS BEEN DONE WITH COVID-19 AND
HOPEFULLY THIS, LIKE YOU BOTH
SPOKE ABOUT, EVERYTHING CAN BE
EXTENDED TO OTHER RNA VIRUSES
WHIZ WE NEEDED IN A WAY BETTER
VACCINES AND THERAPEUTICS FOR SO
MY QUESTION IS, IS THAT FUNDING
FOR PANDEMIC PREPAREDNESS THAT
YOU SHOWED Dr. FAUCI, IN YOUR
FIRST TALK, INTACT?
IS THAT DEFINITELY BEEN ALLOCATE
BID CONGRESS SO ALL FOUR STEPS
OF PATHOGENS THAT YOU JUST
INDICATED THAT ALL ARE IN
VARIOUS PHASES OF DEVELOPMENT OF
VACCINE PREPAREDNESS WE CAN MOVE
FORWARD WITH THOSE?
IS THAT NONE COMMITTED.
>> Dr. Anthony Fauci: IT'S A
VERY COMPLICATED SITUATION AND
I'LL TRY AND SIMPLIFY IT BUT YOU
WON'T LIKE WHAT I'M GOING TO
SAY.
IT'S AS FOLLOWS, THE MONEY THAT
WE HAVE FOR THAT HAS BEEN
SUPPLEMENTAL MONEY THAT
ESSENTIALLY GOES TO THE
DEPARTMENT WHICH THEN GETS
TRANSFERRED TO US.
IT DOESN'T GO INTO OUR BASE.
AND SO, RIGHT NOW, A SHORT OF AN
APPROPRIATION, WHICH WOULD GIVE
US A CERTAIN AMOUNT TO CONTINUE
THE PANDEMIC PREPAREDNESS, WE DO
NOT HAVE THE MONEY WITH A GREAT
DEAL OF CONFIDENCE TO DO THE
THINGS OVER THE LONG-TERM THAT
RICK IS TALKING ABOUT AND THAT I
SPOKE ABOUT.
HE CAN CONTINUE TO DO THE THINGS
THAT WE'RE DOING APPOINT, BUT WE
WILL RUN OUT OF MONEY WHEN THE
SUPPLEMENT RUNS OUT.
SO USUALLY, WHEN WE GET MONEY TO
DO THINGS, THEY PUT IT IN OUR
BASE AND WHETHER YOU GET A
CONTINUE RESOLUTION, OR A BRAND
NEW BUDGET WITH AN INCREASE,
IT'S THERE.
UNFORTUNATELY, THE MONEY THAT'S
BEEN ALTO INDICATE A LOT ALLOCAD
HAS BEEN THROUGH SUPPLEMENTALS
THAT GO TO THE DEPARTMENT, NOT
DIRECTLY TO THE NIH.
THEN THEY GET ALLOCATED FROM THE
DEPARTMENT SO THAT IS THE REASON
WHY YOU MAY HAVE HEARD ME IN THE
MEDIA ALWAYS ENDING MY
PRESENTATIONS BUT WE NEED THE
CONGRESS TO ACT AND TO GIVE US A
SUPPLEMENTAL APPROPRIATIONS AND
B, TO BUILD INTO OUR 2023 FISCAL
YEAR BUDGET, THE MONEY OTHER
WE'RE NOT WE'RE ABLE TO DO IT.
THAT FOR A TERRIBLE TRAGEDY IN
THE MIDDLE OF A PANDEMIC AND IN
PREPARATION FOR FUTURE PANDEMIC,
IF SOMEHOW OR OTHER FOR ONE
REASON OR ANOTHER, THE CONGRESS
DOESN'T APPROPRIATE MONEY TO US.
>> OK, THANK YOU.
>> Dr. Anthony Fauci: KEITH --
>> YEAH, GREAT TALK, REALLY
ENJOYED THAT.
IF YOU CAN PUT A LITTLE BIT OF
PERSPECTIVE AROUND THE SO MUCH
INTEREST IN MRNA VACCINES AND
HOW YOU SEE THAT FIT NORTH IN
THE SEASONAL INFLUENZA VACCINE
EFFORTS?
>> THANK YOU, KEITH.
SO, OBVIOUSLY I THINK THE POWER
OF THE MRNA VACCINES IS THE
REPITY WITH NEW STRAIN CHANGES
CAN BE TRANSLATED INTO VACCINES
IN ARMS.
AS YOU KNOW, THERE ARE A LOT OF
GROUPS THAT ARE START TO GO A
PLOY THAT TO SEASONAL VACCINES
ON AN EXPERIMENTAL BASIS.
CERTAINLY, I MEAN, IT'S NOT JUST
THE BIG COMPANIES NOW LIKE
PFIZER, BION TECH AND MODERNA
THAT ARE INVOLVED, BUT THE VRC,
DUKE UNIVERSITY, OTHER MAJOR
ACADEMIC CENTERS AND PLACES LIKE
OURS, ARE STARTING TO INVEST IN
THE MRNA TECHNOLOGY HOPING THAT
WE CAN TRANSLATE BASIC SIGNS
DISCOVERIES RAPIDLY INTO
PRODUCTS FOR TESTING.
>> Dr. Anthony Fauci: OK.
AMITA.
>> THANK YOU, THAT WAS AN
EXCELLENT PRESENTATION.
THIS IS A QUESTION TO BOTH YOU
AND TO TONY AND OTHERS.
SO, IT WAS INTRIGUED THAT YOU
HAD VISITED THE -- THE SERVICE
OF INDIA MET WITH YOU AND WE
HOSTED THEM AT HOPKINS A COUPLE
DAYS BEFORE YOU DID.
IN ANY CASE, I'M INTRIGUED
BECAUSE EVERYTHING THAT HAPPENED
WITH COVID AND GETTING ACCESS TO
VACCINE CANDIDATES AND IN LOW
AND MIDDLE INCOME COUNTRIES AND
THE NEED FOR SCIENCE IN
PRODUCTION.
WHAT ARE YOUR THOUGHTS WHERE
TESTING DEVELOPMENT WILL SORT OF
GO IN LOW AND MIDDLE INCOME
COUNTRIES?
Mr. PLACES LIKE SERUM AND
OTHER SUCH GROUPS BECOME MORE IN
THE FOLD WITH THE SCIENCE AND
THE SORT OF TESTING IT OF THESE
CANDIDATES?
WHAT ARE YOUR THOUGHTS ON THAT
FRONT AND HOW WILL VRC PLAY A
ROLE IN THAT EFFORT GLOBALLY?
>
>> Dr. Anthony Fauci: WELL I'LL
ANSWER BREDLY AND HAND IT TO
RICK FOR THE VRC COMB PHONE ANT
OF THE QUESTION.
YES WE MET WITH CYRUS AND HIS
SON HERE IN THE ACTUAL ROOM
WHERE I'M SITTING RIGHT NOW.
AND THEY WANT TO BE ABLE TO
EXPAND TO PROVIDE VACCINES DOSES
FOR LOW AND MIDDLE INCOME
COUNTRIES WITH THE SPECIAL
CAPABILITIES THAT THEY HAVE.
AS YOU WELL KNOW, THERE WAS A
BIT OF A FEW MISSTEPS WITH
COVID-19 WHEN VACCINES THAT WERE
SUPPOSED TO BE AVAILABLE FOR THE
DEVELOPING WORLD AND ELSEWHERE
WERE NOT ALLOWED TO LEAVE INDIA
BECAUSE OF THE DIFFICULTIES THAT
THEY HAD ABOUT GETTING TO THE
INDIAN POPULATION.
I THINK THAT'S ALL BEEN SETTLED
AND TAKEN CARE OF.
TWO IN THINGS, WE WANT TO GET
VACCINE DOSES THROUGH THE MOST
EXPO DISH US MATTER POSSIBLE TO
LOWER AND MIDDLE INCOME
COUNTRIES AND THE INSTITUTE OF
INDIA IS ONE OF THE MAIN PLAYERS
IN THAT BUT WE ALSO LIKELY
THROUGH OUR U.S.A. I.D. WANT TO
HELP Y DEVELOP THE INSTRUCT IN
THE DEVELOPING WORLD TO BE ABLE
TO GET VACCINES INTO THE ARMS OF
INDIVIDUALS.
YOU KNOW, ONE OF THE MOST
FRUSTRATING THINGS THAT WE WERE
CONFRONTED WITH THIS TIME AROUND
IS THAT EVEN WHEN WE GOT THE
VACCINES THAT WE GIVEN OVER A
HALF A BILLION, 500 MILLION
DOSES TO ABOUT 130 COUNTRIES,
THEY TOLD US TO STOP GIVING THE
VACCINES BECAUSE THEY COULDN'T
GET IT INTO THE ARMS OF
INDIVIDUALS BECAUSE THEY DIDN'T
HAVE THE INFRASTRUCTURE.
SO TO ME, I MEAN, THAT'S AS BIG
A PROBLEM GETTING DOSES IN.
IN SPECIFIC ANSWER TO YOUR
QUESTION, THE SERUM INSTITUTE IN
INDIA WILL BE A PLAYER IN THAT
FOR SURE.
RICK, ANY FURTHER COMMENTS
REGARDING THE VRC ON THAT?
>> SURE, OBVIOUSLY WE HAVE BEEN
WORKING WITH AND TALKING TO THE
CRM INSTITUTE FOR A COUPLE OF
YEARS NOW.
INITIALLY, THEY WERE PARTNERING
WITH THEM AND THE SCRIPPS
INSTITUTE WITH THE SERUM
INSTITUTE BEING THE MAJOR
MANUFACTURER OF HIV-SPECIFIC
MONOCLONAL ANTIBODIES, HOPEFULLY
TO ALLOW TO US DO A MUCH LARGER
TRIAL OF COMBINATION OF
MONOCLONAL PREVENTION OF HIV.
THEY'RE AN EXCELLENT PARTNER
THERE.
IN ADDITION AT THIS LATEST
MEETING WE TALKED TO THEM ABOUT
MALARIA, MONOCLONAL AN BEE TODAY
HE'S AND THE NIPHA VACCINE
PROJECT I JUST TOLD YOU ABOUT
AND I THINK THEY'RE INTERESTED
IN ALL OF THOSE.
SO, YES, I SEE THEM AS A MAJOR
COLLABORATIVE HELP IN OUR
EFFORTS.
>> Dr. Anthony Fauci: THANK YOU.
ARE THERE ANY OTHER QUESTIONS?
>> THIS IS KEN.
I HAVE A QUESTION IF YOU CAN
HEAR ME.
SO, FANTASTIC TALK, RICK.
I'M WONDERING YOU KNOW, I NOTICE
A COUPLE PATHOGENS WERE MORE
COMPLEX LIKE TB AND MALARIA AND
WE'RE ALL WONDERING ABOUT COVID
AND I WONDER IF YOU THINK
THERE'S A NEED FOR AN EXPANSION
OF THE CONCEPTUAL APPROACHES TO
VACCINE DEVELOPMENT AND THE DEAL
WITH SOME OF THESE, I GUESS,
MAYBE MORE EXPANSIVE ISSUES?
>> YEAH, VERY GOOD QUESTION,
KEN.
THANK YOU FOR BRINGING THAT UP.
OBVIOUSLY, MOST OF WHAT THE
VACCINE RESEARCH CENTER HAS BEEN
INVOLVED IN HAS BEEN VIRUSES AND
WE HAVE CLEARLY A VERY GOOD
TRACK RECORD WITH ENVELOPED
VIRUSES AND ENTRY MECHANISMS
WHERE WE CAN SIMPLY USE
STRUCTURAL BASED VAXSINNOLOGY TO
DEGREE SIGN IMMUNOGENS IN A PRE
FUSION FORM.
IT DOESN'T COVER EVERYTHING AND
Y. I THINK THAT NOT EVERY
VACCINE IS GOING TO BE AS EASY
AS IT WAS FOR COVID.
RSV FOR YEARS WAS DIFFICULT.
COULDN'T FIGURE OUT HOW TO DO
IT.
WHEN WE FIGURED OUT THE PRE
FUSION F PROTEIN, IT BECAME VERY
EASY.
SO, YEAH, WE NEED TO EXPAND AND
INTO THESE MORE COMPLEX TYPES OF
PATHOGENS AND HOPEFULLY WE CAN
FIND A WAY OF MAKING THEM EASIER
JUST LIKE SARS-CoV-2 AND RSV
ENDED UP BEING.
>> Dr. Anthony Fauci: THANK YOU.
ANY OTHER QUESTIONS BEFORE WE
MOVE ON?
IF NOT, YOU KNOW, USUALLY WE
TAKE A BREAK TO GET PEOPLE OUT
OF THE ROOM AND SO WE CAN RESET
UP FOR THE CLOSED SESSION.
THE CLOSED SESSION, AS YOU ALL
KNOW FOR THOSE OF YOU WHO HAVE
THROUGH THIS TAKES 50 MINUTES SO
RATHER THAN TAKING A BREAK WE
CAN JUST ASK THOSE WHO WERE NOT
GOING TO BE PART OF THE CLOSED
SESSION, NAMELY THE NON
GOVERNMENT EMPLOYEES, TO LEAVE
THIS ZOOM SESSION AND THEN WE'LL
PROCEED ONTO THE CLOSED SESSION.