Welcome to the Clinical Center Grand Rounds,
a weekly series of educational lectures for physicians and
health care professionals broadcast from the Clinical
Center at the National Institutes of Health in
Bethesda, MD.
The NIH Clinical Center is the world's largest hospital totally
dedicated to investigational research and leads the global
effort in training today's investigators and discovering
tomorrow's cures.
Learn more by visiting us online at http://clinicalcenter.nih.gov
WELCOME TO TODAY'S ETHICS GRAND
ROUNDS.
I'M FROM THE DEPARTMENT OF
BIOETHICS AT THE NIH CLINICAL
CENTER.
WE DO ETHICS GRAND ROUNDS FOUR
TIMES A YEAR FOR ANYBODY
PLANNING AHEAD THE NEXT AND LAST
SESSION FOR THE SPRING WILL BE
THE FIRST WEDNESDAY IN APRIL.
THAT'S THE FIRST WEDNESDAY IN
APRIL.
THAT ALSO WILL BE EXCLUSIVELY ON
VIDEOCAST.
HOPEFULLY IN THE FALL WE'LL GET
BACK TO IN PERSON.
WE'LL SEE ABOUT THAT.
THE GOAL FOR ETHICS GRAND ROUNDS
IS TO PROVIDE AN OPPORTUNITY FOR
THE NIH COMMUNITY AND THE
BROADER COMMUNITY TO DISCUSS
WHAT WE THINK ARE INTERESTING
AND IMPORTANT ETHICAL ISSUES.
AND IN THAT REGARD, IT'S
IMPORTANT TO NOTE THAT WE'RE NOT
SPOKES PEOPLE.
I'M CERTAINLY NOT A SPOKESPERSON
FOR THE NIH.
WE'RE NOT POLICY MAKERS.
THE GOAL IS FOR EVERYBODY WHO
SPEAKS TO GIVE THEIR VIEWS SO
UNLESS THEY TELL YOU OTHERWISE,
NOBODY'S SPEAKING FOR THE
INSTITUTIONS TO WHICH THEY'RE
AFFILIATED.
THEY'RE JUST SPEAKING FOR
THEMSELVES.
WE WELCOME ANYBODY'S QUESTIONS.
WE ALWAYS GET SOME REALLY GOOD
QUESTIONS FROM THE AUDIENCE.
TO DO THAT FIND THE LIVE
FEEDBACK BUTTON ON THE VIDEOCAST
WEBS
WEBSITE, CLICK THAT AND ASK YOUR
QUESTION AND THAT WILL GET SENT
TO ME AND I'LL TRY TO ASK
QUESTIONS AS WE HAVE TIME.
WE TYPICALLY HAVE MORE QUESTIONS
THAN WE'RE ABLE TO GET TO.
IT'S ONE OF THE COST OF HAVING A
WONDERFUL AND ENGAGED AUDIENCE
BUT I'LL TRY TO FORWARD THEM TO
THE APPROPRIATE PERSON FOR THE
ONES WE DON'T GET TO AND
HOPEFULLY GET YOU ANSWERS TO
THOSE.
WE ALSO GET CME CREDIT THROUGH
JOHNS HOPKINS FOR THESE
SESSIONS.
AND IN ORDER TO CLAIM THAT
CREDIT WHAT YOU NEED TO DO IS
YOU NEED TO TEXT THE CODE TO THE
PHONE NUMBER YOU'LL SEE THAT
COMES UP ON THE SLIDES HERE.
AND THE CODE FOR TODAY'S SESSION
IS 44542.
THAT'S 44542 AND AGAIN YOU TEXT
THAT CODE TO THE HOPKINS CME
CREDIT NUMBER YOU'LL SEE.
THERE'S ALSO EVALUATION PDFs ON
THE WEBSITE.
WE'RE VERY INTERESTED IN
FEEDBACK.
ANYBODY WHO HAS INTEREST THIS OR
FUTURE SESSIONS WE WELCOME THEM.
FOR PEOPLE JOINING US FOR A LONG
TIME THEY REALIZE MANY OF OUR
SESSIONS ARE THE RESULT OF CASES
WE GOT THROUGH OUR ETHICS
CONSULTATION SERVICE.
OUR DEPARTMENT HAS A 24/7
BIOETHICS CONSULTATION SERVICE.
THIS CAME THROUGH DIFFERENTLY.
IT WAS A RECOMMENDATION FROM
JANICE LEE THE CLINICAL DIRECTOR
OF NIDCR AND THOUGHT IT WAS A
GREAT IDEA AND DECIDED TO DO THE
SESSION.
AGAIN, WE WELCOME SESSIONS FOR
FURTHER ONES.
JANICE IS A CLINICAL DIRECTOR
AND HER OFFICE IS CO-SPONSORING
THIS EVENT.
SO TODAY'S SESSION STARTS WITH
THE FACT THAT DEVELOPING NEW
MEDICAL INTERVENTIONS IS REALLY,
REALLY EXPENSIVE.
IT COSTS HUNDREDS OF MILLIONS TO
BILLIONS OF DOLLARS TO DEVELOP
JUST ONE NEW MEDICAL
INTERVENTION.
THE WAY THE SYSTEM CURRENTLY
WORKS, MOST OF THAT COST IS BORN
BY PHARMACEUTICAL COMPANIES,
PRIVATE, FOR-PROFIT ENTITIES
THAT PAY FOR THE DEVELOPMENT OF
THOSE DRUGS AND IN RETURN THEY
KEEP THE INFORMATION ON HOW TO
DEVELOP THEM PROPRIETARY AND
THAT ALLOWS THEM TO RECOUP THE
COST OF DEVELOPING THE DRUGS AND
ALSO TO MAKE A PROFIT.
AT THE SAME TIME, WHAT THAT DOES
IS IT MAKES IT DIFFICULT AND
THERE'S A LITTLE INCENTIVE TO
DEVELOP DRUGS AS YOU'LL HEAR FOR
DISEASES THAT PRIMARILY AFFECT
PEOPLE IN LOWER INCOME
COUNTRIES.
IT CAN MAKE IT DIFFICULT EVEN
FOR DISEASES WORLDWIDE TO GET
ACCESS TO PEOPLE IN LOWER INCOME
COUNTRIES.
AND ONE WAY TO EXEMPLIFY THAT
DILEMMA WE THINK OF THE
INCREDIBLE MIRACLE AND TRAGEDY
OF COVID-19 VACCINES.
TO GIVE A QUOTE FROM AN ARTICLE
FROM INFECTIOUS DISEASES, I'LL
READ THIS, COVID-19 VACCINATION
ALTER THE COURSE OF THE PANDEMIC
SAVING TENS OF MILLIONS OF LIVES
GLOBALLY.
HOWEVER, INADEQUATE ACCESS TO
VACCINES IN LOW-IMPACT COUNTRIES
REINFORCED THE IDEA FOR EQUITY
AND COVERING AND LIMITING THE
IMPACT MEANING BECAUSE OF THE
COST PEOPLE IN LOWER INCOME
COUNTRIES WEREN'T ABLE TO ACCESS
THE VACCINES AND SOME PEOPLE
DIED SO THIS IS SERIOUS IMPACT.
THE QUESTION IS WHAT IF ANYTHING
WE CAN DO ABOUT THAT.
WHAT WE'LL DISCUSS TODAY IS AN
AMAZING EFFORT AS YOU'LL HEAR
AND HOW TO MAKE THE INFORMATION
TO MAKE VACCINES GLOBALLY
ACCESSIBLE SO THOSE VACCINES CAN
BE DEVELOPED IN DEVELOPING
COUNTRIES AND HOPEFULLY MADE
MORE ACCESSIBLE TO PEOPLE WHO
NEED THEM IN LOWER INCOME
COUNTRIES.
SO THE QUESTION FOR TODAY IS, IS
THIS OR SHOULD THIS TO SOME
EXTENT OR MORE BE THE WAY WE DO
THIS IN THE FUTURE?
THE WAY WE DEVELOP AND MAKE
DRUGS IN MEDICAL INTERVENTIONS
ACCESSIBLE?
TO EXPLAIN THAT POSSIBILITY TO
US WE HAVE WITH US THE SENIOR
ASSOCIATE DEAN AND DISTINGUISHED
PROFESSOR OF BIOLOGY AT BAYLOR
AND SHE'S THE CO-DIRECTOR OF
CHILDREN'S CENTER VACCINE
DEVELOPMENT AND SHE'LL TALK
ABOUT WHAT THEY'VE DONE IN TERMS
OF DEVELOPING VACCINES AND
MAKING THEM ACCESSIBLE AND AFTER
MARIA GOES THEN FOR THE
DISCUSSANT TO HELP US WORK
THROUGH THE ETHICAL ISSUES
RAISED BY THIS CASE, WE HAVE THE
VICE PROVOST FOR GLOBAL
INITIATIVES IN THE UNIVERSITY
PROFESSOR AT THE UNIVERSITY OF
PENNSYLVANIA.
HE'S REGARDED AS AN EXPERT ON
HEALTH POLICY AND BIOETHICS IN
THE WORLD AND HAPPY TO HAVE HIM
HERE TODAY AND SOME PEOPLE MAY
REMEMBER HE WAS ESSENTIALLY THE
FOUNDER OF THE BIOETHICS
DEPARTMENT AND THE PERSON WHO
SET UP THE ETHICS GRAND ROUND
SESSIONS.
WELCOME BACK, ZEKE, IT'S GREAT
TO HAVE YOU.
TO GET US STARTED, MARIA.
>>THANK YOU, DR. WENDLER.
IT'S A PLEASURE TO BE WITH YOU
AND OF COURSE I ALSO SEND MY
REGARDS TO DR. LEE WHO IS MY
PARTNER IN CRIME A TRAINING
PROGRAM.
SO WE HAVE A FEW YEARS WE KNOW
EACH OTHER.
IT'S JUST A PLEASURE AND
DR. EMANUEL FOR GIVING HIS
INSIGHTFUL REMARKS AFTER A
PRESENTATION.
>>I'LL START MY PRESENTATION
WITH OF COURSE WITH MY
DISCLOSURES WITH THE COVID-19
TECHNOLOGY AND THAT I'M WITH A
TEAM A CO-INVENTOR OF A FEW
PATENTS IN SEVERAL VACCINE
TECHNOLOGIES.
I WANT TO BRING YOU BACK TO THE
TURN OF THE CENTURY.
THE REASON I WANT TO START THERE
IS A FEW THINGS THAT WERE VERY
IMPORTANT ESPECIALLY IN THE AREA
OF GLOBAL HEALTH HAPPENED.
THE LAUNCH OF THE MILLENNIUM
DEVELOPMENT GOALS WERE PUT FORTH
BY THE UNITED NATIONS WITH
AUDACIOUS GOALS.
ALL VERY IMPORTANT, ALL OF THEM
VERY WELL INTERCONNECTED WITH
EACH OTHER.
BUT AS WE AND WE AND MYSELF AND
DR. PETER HOTIS AND OUR TEAM
NOTICED A FEW MDGs THAT WERE
IMPORTANT FOR US AS WE WERE
CRAFTING OUR SCIENTIFIC
PROGRAMS.
ONE OF THEM WAS MDG NUMBER 6
THAT SPECIFICALLY CALLED AT THE
TIME TO COMBAT INFECTIOUS
DISEASES LIKE HIV/AIDS, MALL
MALARIA AND THERE WERE ANOTHER
CATEGORY OF DISEASES WITH THE
YEARS BRANDED AND LAUDED THEY
COULD BE A COMPENDIUM OF MANY
DISEASES.
MANY CONSIDER NEGLECT EDOF DISE
BRANDED AND LAUDED THEY COULD BE
A COMPENDIUM OF MANY DISEASES.
MANY CONSIDER NEGLECT ED AND
AFFLICT MANY RESOURCE POOR
AREAS.
AND WHAT WAS INTERESTING WAS
NUMBER EIGHT WHICH CALLS WITH
TRYING TO DO THIS TYPE OF
DEVELOPMENT USING PARTNERSHIPS.
I HIGHLIGHT THAT AT THE SAME
TIME.
FOUNDATIONS, MANY, NOT ONLY BUT
FOUNDATIONS SUCH AS THE BILL AND
MELINDA GATES FOUNDATION WERE
CREATED WITH THIS ASPIRATION TO
TRY TO USE THE PARTNERSHIP
APPROACH AND THE MODEL OF
BRINGING TOGETHER TO SAVE
EFFICIENCIES AND FOR THE ADVENT
OF TECHNOLOGIES TOWARDS GLOBAL
HEALTH AND WE ALSO STARTED
SEEING THE PUSH FOR THAT CONCEPT
OF TRYING TO MAKE SCIENCE OPEN
BY BEING MORE SHAREABLE, BY
PROVIDING NOT ONLY THE
EDUCATIONAL RESOURCES BUT ALSO
RE-AGENTS AND DATA.
THAT'S WHY IN THE CREATING OF
OUR GUIDING PRINCIPLES OF THE
WORK WE WANTED TO ACHIEVE, OUR
GROUP DECIDED THAT WE WOULD TRY
TO FOCUS ON TRYING TO ATTEMPT TO
ADDRESS SOME OF THESE MDGs.
WE CREATED AN INFRASTRUCTURE
PREDICATED ON THE STRUCTURE OF
PARTNERSHIPS.
THERE'S THE PRODUCT DEVELOPMENT
PARTNERSHIP MODEL SOME EXAMPLE
THE MALARIA VACCINE INITIATIVE
AND ONE FOR AIDS AND THERE'S
ORGANIZATIONS THAT USE THIS TYPE
OF MODEL.
OUR MODEL WAS FOR NEGLECTED S
AND WE WANTED TO FOCUS ON
CONVENTIONAL PLATFORMS IN OUR
CASE RECOMBINANT PROTEIN
TECHNOLOGIES THOUGH WITH THE
YEARS IT MORPHED TECHNOLOGIES.
THE DECISION START WITH US AT
THE GEORGE WASHINGTON UNIVERSITY
FOR 11 YEARS AND FOR 11 MORE
WE'VE BEEN AT TEXAS AT THE
BAYLOR CHILDREN'S HOSPITAL AND
WE HAD TO SELECT WHICH OF THE
GLOBAL MORBIDITY DISEASES WE
WOULD WANT TO FOCUS.
JUST TO GIVE YOU VERY BRIEF
MOSTLY DISEASES THAT AFFLICT
MANY PEOPLE AROUND THE WORLD IN
FACT MANY CALL THEM THE DISEASE
AFFECT PEOPLE THAT MOSTLY LIVE
BELOW THE POVERTY LINE.
THEY CAN BE PARASITES.
THEY CAN BE VIRUSES.
THEY CAN BE FUNGI.
THEY CAN BE BACTERIA THEY HAD
SOCIAL FACTORS THAT AFFECT THEIR
TRANSMISSION AND EVEN CLINICAL
DISEASE CAPABILITIES.
OF COURSE, EXAMPLES NOT ONLY
CLIMATE CHANGE AND POLITICAL
INSTABILITY, ETCETERA.
AND WE NOW USE METRICS WHICH
SOMETIMES YOU HAVE TO QUANTIFY
WHAT MORBIDITY THEY CAUSE AND
YOU KNOW MORBIDITY METRIC IS THE
DISABILITY ADJUSTED AND IN
AGGREGATE THESE GLOBAL MORBIDITY
DISEASES CAN CAUSE MANY MANY
YEARS LOSS BECAUSE PEOPLE LIVE
WITH A LOW CAPABILITY WITH A LOT
OF DISABILITY AND THEREFORE THEY
PROMOTE AND CAUSE POVERTY.
WITH HEALTH ECONOMISTS WE CAN
QUANTIFY HOW THE MORBIDITY CAN
IMPACT THE ECONOMIC POTENTIAL OF
A SOCIETY.
WE KNOW FOR EXAMPLE WITH
DISEASES WE CAN QUANTIFY A LOT
OF ECONOMIC LOSSES NOT ONLY IN
HEALTH CARE LOSSES BUT ALSO
PRODUCTIVITY LOSSES BECAUSE
INDIVIDUALS DON'T CONTRIBUTE TO
SOCIETY.
OF COURSE, AS YOU KNOW, DISEASES
NEVER TRAVEL ALONE.
THERE'S MAJOR COFACTORS AND
MOSTLY THE PARASITIC OR
MORBIDITY DISEASES GO WITH MANY
OTHER DISEASES LIKE MALARIA OR
HIV.
SO RAPIDLY HOW DID WE EMBARK IN
DEVELOPING A STRATEGY TO DEVELOP
THESE TYPES OF VACCINES KNOWING
THEY WERE NEGLECTED AND DIDN'T
HAVE THAT COMMERCIALIZATION
POTENTIAL THAT WE PROBABLY WOULD
NOT GET THE INCENTIVES OF THE
MULTI-NATIONAL COMPANIES.
THE INTENT WAS TO TRY TO NOT
ONLY DEVELOP THEM BUT PRODUCE
THEM AND HAND THEM OFF TO THE
LOW AND MIDDLE-INCOME COUNTRIES
BUT FOR PEOPLE WHO LIVE IN THE
POOR RESOURCE AREAS.
WE USED A SIX-PRONGED STRATEGY
THAT OF COURSE HAS MORE THAN TWO
DECADES OF TRYING TO SHOW IT
WORKS AND FUNCTIONS.
ONE, AS YOU KNOW, LEVERAGING OUR
ACADEMIC POTENTIAL AND
CREATIVITY AND RESOURCES AND
KNOWLEDGE WITHIN THE ACADEMIC
FRAMEWORK WHICH ALSO ENABLES US
TO BUILD CAPACITY AND TRAIN THE
NEXT GENERATION OF SCIENTISTS.
USE ALL THE COMPLIANCES AND
ETHICS AND EVEN THE GRAND
FINANCIAL MANAGEMENT OF THE
ORGANIZATIONS AND OF COURSE THE
LABORATORIES.
WE THEN HAVE TO LEARN HOW TO
SPEAK THE BUSINESS LANGUAGE,
RIGHT, BECAUSE WE HAVE TO COME
FROM THE BENCH INTO THE CLINIC
AND BEYOND AND THEREFORE WE HAVE
TO LEARN HOW TO SPEAK IN VALUE
PROPOSITIONS AND BRANDING AND
VALUE PRODUCT CHAINS.
AS MENTIONED EARLIER, ALSO
UNDERSTANDING THAT CRITICAL PATH
OF WHEN A PRODUCT STARTS TO BE
REGULATORY, ENABLING AND HAVE
QUALITY AND REGULATORY SCIENCE.
I THINK THAT'S A BIG LESSON
LEARNED WE HAVE TO WRAP UP THIS
KNOWLEDGE IN REGULATORY SCIENCE
AND DOCUMENTATION AND QUALITY
MANAGEMENT SYSTEMS ENABLING ALL
THE MATERIALS AND REAGENTS AND
DOCUMENTATION TO BE SUITABLE FOR
THE REGULATORY AGENCIES.
SINCE WE PREDICATE ON
PARTNERSHIPS WE HAVE TO FIND
PARTNERS, FORGE THE
PARTNERSHIPS, TRUST THE
PARTNERSHIPS, UNDERSTAND WHAT
THEY DO, WHAT WOULD DO, HOW WE
WOULD MANAGE THE ACCOUNTABILITY
AND THEREFORE AT THE END OF THE
DAY THEN DISSEMINATE OUR
INFORMATION IF WE WERE
PREDICATING ON OPEN SCIENCE HOW
WE WOULD ENGAGE NOT ONLY THE
FUNDERS, THE SOCIETY, OUR PEERS
AND FOR THAT OF COURSE IT'S
REQUIRED TO BE A LITTLE BIT OUT
OF THE FUNDING STRATEGY.
WE OF COURSE LEVERAGED A LOT OF
THE FEDERAL FUNDING CONVENTIONAL
STRATEGIES OF GRANTS BUT WE ALSO
SEEK PHILANTHROPIC FUNDING OR
SHARED GOVERNMENT FUNDING
CONTRIBUTIONS OR EVEN PRIVATE
INDIVIDUALS.
SO WE WERE ACTUALLY PRETTY
EFFICIENT IN 15, 20 YEARS WE
HAVE ADVANCED SOME IMPORTANT AND
UNIQUE VACCINES.
OUR HUMAN VACCINE IS NOW IN
PHASE 2 CLINICAL TRIALS AFTER 20
YEARS BUT IT'S MOVING AND WE'RE
SLOWLY ADVANCING IT.
WE HAVE A VACCINE ALSO ENTERING
PHASE 2 CLINICAL TRIALS.
WE ARE NOW ADVANCING A CHILDHOOD
VACCINE WE JUST MANUFACTURED IN
MEXICO AND WILL START A CLINICAL
TRIAL THIS YEAR IN MEXICO.
AS YOU KNOW, THE MDGs CAME AND
WENT, 2015 GAME.
THE WORLD CONTINUED CHANGING.
NOW WE KNOW WE HAVE A
SUSTAINABLE DEVELOPMENT GOAL AND
GLOBAL GOAL AND THERE WAS
SOMETHING WE STARTED PAYING
ATTENTION ON THE FACT THAT IN
THE MIDST OF THESE 20 YEARS, A
FEW CORONAVIRUS OUTBREAKS POPPED
UP.
THE SARS, THE MERS, BUT WE
NOTICED WITH A CRISIS AND IT
BECAME CLEAR THE CORONAVIRUSES
WERE ENTERING INTO THE
DEFINITION OF NEGLECTED.
WE KNEW A BUNCH OF OUR
COLLABORATORS THAT WERE NOT ONLY
WORKING WITH US IN SOME OF OUR
VACCINES BUT ALSO EXPERTS IN
CORONAVIRUS VIROLOGY AND WE
FORMED A PRODUCT DEVELOPMENT
PARTNERSHIP.
WE WERE VERY LUCKY WE GOT AN NIH
GRANT TO INDEED MOVE A
TECHNOLOGY FROM BENCH TO CLINIC
SPECIFICALLY FOR SARS.
WE FOCUSSED ON LOW-COST
TECHNOLOGY.
WE KNEW THE SPIKE PROTEIN OF
CORONAVIRUS WAS A CANDIDATE AND
LOOKED AT SARS AND MERS AND
LOOKED AT THE PROFESSION
DEVELOPMENT AND SCALABILITY OF
THE TECHNOLOGIES.
WE TRANSFERRED THE TECHNOLOGY TO
THE ARMY.
WALTER REED HAS A BIO
MANUFACTURING FACILITY THAT MADE
A PILOT PRODUCT FOR US BUT THEN
OF COURSE AS IT BECAME NEGLECTED
IT BECAME MORE NEGLECTED AND THE
SURPRISE CAME WE HAVE A THIRD
OUTBREAK THAT LED TO THE GLOBAL
PANDEMIC WHICH WAS THE SARS
COV2.
SO WE WERE READY.
WE WERE READY IN 2010 WE START
THE PROGRAM AND BY 2020 WE KNEW
HOW TO ENGINEER WHAT WE CALLED
STARTER KITS.
WE HAD TO READAPT THEM TO MAKE
SPECIFICALLY THE RBD FOR THE
SARS COV2.
WE ALSO KNEW HOW TO CREATE THE
PRAX IS FOR THE PRODUCTION AND
FORMULATION AND WE HAD
PRE-CLINICAL EVIDENCE WE
REPRODUCED FOR SARS COV2 AND
THOSE WERE THE RECIPES AND
DEVELOPED A TOOLBOX OF THE
REGULATORY ENABLING ASSAYS TO
TEST THEIR QUALITY AND
STABILITY.
AND THEN WE EMBARKED INTO WHAT
WILL WE DO WITH THE TECHNOLOGY.
OUR HOPE WAS A MULTI-NATIONAL
LIKE MERCK THAT KNOWS HOW TO
MAKE RECOMBINANT PROTEIN
VACCINES WOULD COLLABORATE WITH
US BUT WITH NO AVAIL WE STARTED
LOOKING FOR THE NTDs INTO
ANOTHER GROUP OF PRODUCERS THE
DEVELOPING COUNTRIES VACCINE
MANUFACTURERS.
WHEN WE LOOKED AT HOW THE
COVID-19s WERE BEING CONTRIBUTED
AROUND THE WORLD, MOST THE
MULTI-NATIONALS WERE FOCUSSING
ON WHAT WE NICELY CALL THE SHINY
NEW TOYS, THE RNA TECHNOLOGIES
WHICH ARE AMAZING BUT RELATIVELY
NEW, MAYBE NOT SCIENTIFICALLY
NEW BUT NEEDED TO SHOW THEY WERE
IN LARGE WORLD EXERCISES AND
EVEN TODAY WE SEE THE DIFFERENT
COUNTRIES AND WHERE YOU SEE RED
AND ORANGE ARE ALL THE COUNTRIES
PRIMARILY LOW-INCOME COUNTRIES
AND LOW-MIDDLE INCOME COUNTRIES
AND SOME IN UPPER MIDDLE INCOME
COUNTRIES THEY'VE HAD NO ACCESS
TO THE COVID-19 VACCINE.
I THINK THE REASON THE
TRADITIONAL METHODOLOGY AND
MODEL FOR VACCINE DEVELOPMENT
REALIZE ON AN R&D LAB LIKE OURS
TO GIVE THE TECHNOLOGY TO A BIG
MULTI-NATIONAL WHERE THEY ABSORB
THE I.T.
WE DON'T KNOW HOW THEY DEVELOP
IT OR HOW THEY MATURE IT, MAYBE
THEY UTILIZE SOME OF THE
DEVELOPING COUNTRY PRODUCERS AS
FOL
FOLLOW-ONES SAYING THIS WHAT WE
WANT YOU TO MAKE AND RATHER THAN
A DIRECT TRANSFER LIKE WE DO AND
HAVE THEM DEVELOP AS A
FIRST-RATE INNOVATION AND
EMPOWER THEM BY REMOVING IP
BARRIERS TO OWN THE TECHNOLOGY
AND CALL IT AND USE IT AS THEIR
OWN AND WE DID THAT WITH OTHER
COUNTRIES AND INDONESIA WAS VERY
ADVANCED AND TWO COMPANIES KNEW
HOW TO MAKE YEAST RECOMBINANT
PROTEINS AND KNEW HOW TO MATURE
THE PROCESS AND SCALE IT AND A
SMALLER COMPANY WORKED ON SCALE
AND IN BOTSWANA WE BUILT AND
CREATED NEW INFRASTRUCTURE.
THE RESULT FROM THE PROCESS TO
GETTING AUTHORIZATION AND THE
COMMUNITIES WHERE WE HAVE
VACCINATED NOW MORE THAN 100
MILLION VACCINATIONS IS BIO-E
WHO DEVELOPED A VACCINE THEY
CALL CORBEVAX AND ANOTHER CALLED
INDOVAC AND THEY WENT ONE STEP
AHEAD BECAUSE THEY WERE ABLE TO
SUBMIT A REQUEST TO THEIR
REGULATORY AUTHORITIES TO
RECEIVE CERTIFICATION.
ALSO VERY CULTURALLY IMPORTANT
TO KNOW WHEN YOU DEVELOP A
TECHNOLOGY WHO WILL BE YOUR
HANDOFF TO AND IN OUR CASE IT
WAS A YEAST VEGAN TECHNOLOGY WE
KNEW HAD NO CONCERNS ABOUT
ANIMAL-DERIVED PRODUCTS OR HUMAN
CELL LINES SO WE WERE ABLE TO
GIVE THEM ALL THAT DOCUMENT IN
SUPPORT TO THEIR REGULATORY
REQUIREMENTS.
IN SUMMARY, I JUST WANT TO
HIGHLIGHT AGAIN THAT FROM THE
BEGINNING BECAUSE WE KNEW WE
WERE WORKING ON NEGLECTED
DISEASES, WE EMBRACED THE
CONCEPT OF OPEN SCIENCE WHERE WE
SHARED KNOWLEDGE DATA AND
PUBLISHED WIDELY AND ALSO WANTED
TO MAKE SURE WHEN WE CREATED OUR
PARTNERSHIPS THAT OUR TEAM-BASED
APPROACHES WERE VERY HOLISTIC.
AS I MENTIONED WE NOT ONLY
WORKED SCIENTIFICALLY WITH
HARD-CORE SCIENCE, ALSO WITH
ENGINEERS AND LAWYERS AND
ECONOMISTS.
ANYTHING WE NEEDED TO ENSURE WE
FOLLOW THE PROCESSES LOOKING AT
WHOLISTIC WAY WHERE OUR PRODUCT
WILL EVENTUALLY END UP.
APPROPRIATE BASED ON WHAT IS
NEEDED.
WE KNEW TECHNOLOGIES LIKE
RECOMBINANT PROTEINS WOULD BE
VERY -- A LITTLE EASIER TO ADOPT
AND ADAPT.
THEY'RE CHEAPER AND ALREADY HAVE
AN INFRASTRUCTURE AND FOR
COVID-19 WE WENT EVEN ONE MORE
STEP.
WE REMOVED COMPLETELY THE
BARRIER OF INTELLECTUAL PROPERTY
AND DECIDED NOT TO PATENT OUR
GENETIC ENGINEERING.
THIS CONCEPT ENABLED US TO DO
REVERSE INNOVATION WHERE WE HAND
OVER TECHNOLOGY WHICH WAS CRUDE
AND HAD A STARTING POINT OF A
BASE OF INFORMATION BUT THEN
DLMIC PRODUCER INNOVATED AND
CREATED THEIR OWN PRODUCT AS WE
VALUE THE ENGAGEMENT TO ENSURE
WE SHARE OUR INFORMATION TO
EDUCATE WITH POLICY MAKERS TO
MAKE GOOD DECISIONS FOR THE
GOVERNMENT AND TO ENABLE TRUST
WITHIN SOCIETY.
AND WE WERE SUPPORTED MOSTLY
AGAIN BY COMBINING TRADITIONAL
AND ALTERNATIVE TYPE OF FUNDING.
AND THIS IS OUR TEAM JUST TO
GIVE YOU A FEW FACES BEHIND THE
SCENES.
AND AS YOU CAN SEE EVEN FROM THE
LIST OF OUR SPONSORS, WE DID GET
SOME NIH TRADITIONAL FEDERAL
FUNDING BUT AS YOU CAN SEE MOST
THE FUNDING CAME FROM VERY
INTERESTING ORGANIZATIONS
INCLUDING ORGANIZATIONS SUCH AS
FIFTH GENERATION WHICH IS THE
COMPANY THAT OWNS TITO'S
HANDMADE VODKA IN TEXAS AND
INDIVIDUALS.
I'LL STOP SHARING AND GIVE THE
MICROPHONE TO DR. EMMANUEL.
>>THANK YOU FOR ALL MY FRIENDS
AT THE NIH FOR INVITING ME TO
PRESENT AND ADDRESS THIS VERY
IMPORTANT ISSUE.
SO LET ME MAKE TWO PRELIMINARY
OBSERVATIONS.
THE FIRST IS ABOUT MY CONFLICT
OF INTEREST.
YOU HAVE THEM.
LET ME SUMMARIZE THEM IN THE
FOLLOWING WAY, I DO NO WORK -- I
HAVE NO PHARMA STOCK, NO
INVESTMENT IN ANY PHARMA
COMPANY.
I DO WORK WITH J&J TRYING TO
IMPROVE INFORMED CONSENT
DOCUMENTS FOR CLINICAL RESEARCH
TRIALS AND THEY PAY FOR THE
AMOUNT OF TIME I WORK ON IT BUT
NOTHING ABOVE THAT.
I'M ON THE ADVISORY BOARD OF
SOLARUS IT'S A COMPANY TRYING TO
AUTOMATE CELL PRODUCTION FOR CAR
T THERAPY AND DO THOSE KINDS OF
THINGS.
I DON'T THINK THAT'S
PARTICULARLY RELEVANT TO TODAY'S
DISCUSSION BUT YOU CAN TAKE IT
AS YOU WILL.
THE SECOND OBSERVATION I WANT TO
MAKE IS ABOUT MY COMMITMENT TO
NTDs.
BETWEEN 2009 AND 2011 AT THE
OFFICE OF MANAGEMENT AND BUDGET,
I HAD SOME OVERSIGHT AND
DEVELOPMENT WITH OUR GLOBAL
HEALTH ASSISTANCE BUDGET.
ONE OF THE THINGS I NOTED WAS
THE ABSOLUTE TOTAL PITIFUL
CONTRIBUTIONS WE WERE MAKING TO
TROPICAL DISEASES I BELIEVE IN
THE $30 MILLION RANGE AT THAT
TIME.
I THINK OUR CONTRIBUTION AT THAT
TIME TO MALARIA WAS SOMETHING IN
THE HALF A BILLION DOLLAR RANGE.
IN BOTH THOSE CASES, I
DRAMATICALLY IMPROVED AND
SUBSTANTIALLY INCREASED THE
U.S. GOVERNMENT CONTRIBUTIONS TO
THOSE PROGRAMS.
I NEGLECTED TROPICAL DISEASES,
EXACTLY WHAT MARIA SAID SEVERELY
UNDER FINANCED AND VERY
SIGNIFICANTLY UNATTENDED TO.
THAT'S WHY WE CALL THEM
NEGLECTED.
BUT THEY ARE SUBSTANTIALLY
IMPORTANT.
NOW, I WANT TO MAKE JUST SIX
SIMPLE POINTS TO START OUR
DISCUSSION AND START OUR
ANALYSIS.
THE FIRST ONE IS I'M HERE
BECAUSE I'M A BIOETHICISTS.
THE ONE THING WE OUGHT TO BE
DOING IS DELINEATE THE ETHICAL
PRINCIPLES RELEVANT TO THE
CONSIDERATION HERE TODAY.
I'M GOING TO FOCUS NOT ON THE
PROCEDURAL PRINCIPLES LIKE
ACCOUNTABILITY OR TRANSPARENCY
OR THAT BUT THREE SUBSTANTIVE
PRINCIPLES WHICH WE PUBLISHED IN
THE LANCET, I THINK SEPTEMBER
2021, WHEN WE WERE DISCUSSING
THE PHARMACEUTICAL COMPANY
OBLIGATIONS DURING A HEALTH CARE
EMERGENCY BUT I THINK THEY'RE
QUITE IMPORTANT GENERAL AND
MARIA, STAY TUNED BECAUSE I'LL
ASK YOU TO BRING UP THE SLIDE
WHEN I DISCUSS THE SECOND
PRINCIPLE, YOUR CIRCLE SLIDE
WITH HOW MANY UNVACCINATED
PEOPLE IN THE POPULATION ARE.
SO THE FIRST PRINCIPLE IS WE
WANT TO OPTIMIZE VACCINE
PRODUCTION FOR THE DISEASES
WE'RE CONSIDERING WHATEVER
DISEASES THEY ARE.
THIS IS EXTREMELY IMPORTANT AS
MARIA'S MADE CLEAR.
IF YOU HAVE A TECHNOLOGY BUT
YOU'RE NOT ACTUALLY ABLE TO
PRODUCE IT, THAT IS A SERIOUS
PROBLEM.
IT MEANS PEOPLE WILL DIE OR AT
THE WORSE WILL NOT BE PROTECTED.
SO RESOURCES HAVE TO BE
MOBILIZED AS QUICKLY AS POSSIBLE
TO REDUCE THE HEALTH AND
ECONOMIC BURDENS OF ANY HEALTH
CARE CONDITION AND ESPECIALLY IN
AN EMERGENCY.
AND THE RESEARCH AND DEVELOPMENT
PROCESS ESPECIALLY IN AN
EMERGENCY WITH A SEVERE ILLNESS
CAN PUSH THE BOUNDS OF RISK
TOLERANCE.
THE SEVERITY OF DISEASE AFFECTS
OUR PERCEPTION OF A RISK BENEFIT
RATIO.
HOW MUCH RISK WITH A PRODUCT
WE'RE WILLING TO TOLERATE.
THAT'S THE FIRST PRINCIPLE.
SO OPTIMIZE VACCINE PRODUCTION
AND AVAILABILITY.
THE SECOND PRINCIPLE IS FAIR
DISTRIBUTION.
ONCE YOU HAVE A VACCINE,
FAIRNESS IS GOING TO REQUIRE
THAT THE VACCINE ALLOCATION
SHOULD BE APPROPRIATELY
PRIORITIZED COUNTRIES IN THE
GREATEST NEED NOT THOSE WITH THE
GREATEST WEALTH OR THE GREATEST
POPULATION.
FAIRNESS REQUIRES NOT LEAVING
PEOPLE WHO ARE IN NEED AT THE
BACK OF THE QUEUE BUT INSTEAD
ENSURING THAT THE VACCINE
ARRIVED TO THEM IN A TIMELY
MANNER.
SO THIS PRINCIPLE OF
DISTRIBUTING IT ON THE BASIS OF
THE GREATEST NEED IS VERY
IMPORTANT.
I'M GOING TO COME BACK TO THIS
WHEN WE TALK ABOUT COVID BUT
MAYBE MARIA, YOU CAN BRING UP
THE FAN SLIDE I WAS SUGGESTING.
THIS FAN SLIDE IS TOTALLY WRONG,
NOT ETHICAL.
WHAT THIS SHOWS IS THE SHARE OF
UNVACCINATED IN A POPULATION.
WE DON'T KNOW WHETHER THOSE
PEOPLE ARE IN NEED.
THIS IS NOT A VACCINE -- A
VACCINE SHOULD NOT BE
DISTRIBUTED BY THE POPULATION
ESPECIALLY FOR A
LIFE-THREATENING SITUATION LIKE
COVID BUT DISTRIBUTED ON THE
BASIS OF HEALTH NEED.
SO HOW MUCH IS THAT CONDITION
AFFLICTING PEOPLE?
NOT EVERYONE IN THE WORLD WAS IN
THE SAME CONDITION TO BE EXPOSED
TO COVID FOR EXAMPLE.
SO LOOKING AT COUNTRIES IN TERMS
OF POPULATION.
YOU SEE THIS ALL THE TIME,
VACCINE BY POPULATION AND WHEN
YOU HAVE A LARGE POPULATION
WITHOUT A VACCINE, PEOPLE SAY
OH, IT'S UNETHICAL.
WRONG QUESTION.
THE DISTRIBUTION YOU NEED TO
LOOK AT IS VACCINE BY COVID
DEATHS OR EXCESS DEATHS.
THANK YOU, MARIA FOR
DISTRIBUTING THAT.
THAT'S NOT THE RIGHT SLIDE FROM
AN ETHICAL STANDPOINT.
THE THIRD IS AN ETHICAL
PRINCIPLE WHICH I THINK RECEIVES
TOO LITTLE ATTENTION IN THE
PHARMACEUTICAL SPACE THAT IS
EXTREMELY IMPORTANT THIS IS THE
PRINCIPLE OF SUSTAINABILITY.
WE NEED GROUPS LIKE MARIA'S.
WE NEED COMPANIES LIKE THE
PHARMACEUTICAL COMPANIES TO BE
IN THE GAME FOR A LONG TIME.
NOT JUST THE CRISIS NOW OR JUST
THE PRODUCT NOW BUT OVER TIME.
WE NEED A LONG-TERM PERSPECTIVE
FOR NOT JUST ADDRESSING THE
CURRENT SITUATION BUT ENSURE WE
HAVE THE INCENTIVES THAT ARE
GOING TO KEEP GROUPS AND PEOPLE
INVOLVED FOR THE NEXT CRISIS.
IF YOU THINK THAT OVER THE NEXT
20 YEARS THERE'S A 50/50 CHANCE
WE'LL HAVE ANOTHER HEALTH
EMERGENCY WITH THE SAME KIND OF
GLOBAL IMPACT AS COVID, WHICH
RECENT STUDIES SUGGEST, WE
DEFINITELY NEED PHARMACEUTICAL
COMPANIES, ACADEMICS, ALL SORTS
OF PEOPLE TO BE ENGAGED IN THE
NEXT CRISIS WITH THE CAPACITY TO
ADDRESS THE PROBLEMS.
SO WHEN WE THINK ABOUT -- WE
SHOULD GET RID OF IP WE HAVE TO
ASK THE QUESTION NOT ONLY IS
THAT GOOD FOR THE MOMENT BUT FOR
THE LONG-TERM HEALTH OF
PRODUCTION?
SO THAT'S THE FIRST THING.
THREE ETHICAL PRINCIPLES.
OPTIMIZE VACCINE PRODUCTION, A
FAIR DISTRIBUTION OF VACCINE
THAT TAKES INTO ACCOUNT
DISTRIBUTING IT BY HEALTH NEED
NOT BY POPULATION, NOT BY
WEALTH, NOT BY EXTRANEOUS
FACTORS BUT BY THE NEED OF THE
POPULATION FOR THE INTERVENTION.
AND THIRD, IS THE ARRANGEMENT
WE'RE CREATING IN TERMS OF
OPTIMIZING PRODUCTION, FAIR
DISTRIBUTION, GOT THE RIGHT
INCENTIVES FOR SUSTAINABLE
ABILITY TO ADDRESS HEALTH
PROBLEMS.
FIRST POINT, THREE ETHICAL
PRINCIPLES.
SECOND POINT, I WOULD POSIT THAT
SPEED AND SCALABILITY IN
PRODUCTION REQUIRES COMPANIES
THAT WE ARE NOT LIKELY SPEED AND
SCALE MUCH LESS SCALABILITY
WITHOUT THE PHARMACEUTICAL
COMPANIES.
WHAT WE SEE IS ADVANCED PHASE 2
AND PHASE 3 RESEARCH SURMOUNTING
THE REGULATORY CHALLENGES FOR
GETTING A VACCINE OR DRUG
PRODUCED, MAKING SURE WE HAVE
CAPACITY TO PRODUCE THEM IN
LARGE ACCOUNTS QUICKLY
ESPECIALLY IN AN EMERGENCY AND
THE ABILITY FOR WORLDWIDE
DISTRIBUTION ALL OF THOSE THINGS
WHICH ARE NECESSARY TO ACTUALLY
RESPOND REQUIRE PHARMACEUTICAL
COMPANIES.
WE ARE NOT GOING TO DO THOSE
WITHOUT PHARMACEUTICAL
COMPANIES.
INTERESTINGLY WE HAVE A LOT OF
COMPANIES, NOW THEY'RE NOT FOR
PROFIT COMPANIES IN THE AMERICAN
DRUG MARKET TRYING TO PRODUCE
BASICALLY GENERIC DRUGS.
THAT MIGHT BE TRUE.
GENERIC DRUGS HAVE FEWER OF
THESE ISSUES.
THEY DON'T HAVE PHASE II, III
RESEARCH AND AS MANY REGULATORY
HURDLES AS OTHERS.
THEY HAVE A PRODUCTION AND THE
REGULATION AROUND GOOD
MANUFACTURING PROCESSES.
AND THE DISTRIBUTION BUT LESS OF
THE OTHERS.
LET ME JUST SAY YOU WOULD BE
HARD PRESSED IN MOST THINGS TO
FIND SCALE WHERE WE DON'T HAVE
FOR PROFIT COMPANIES.
I THINK THAT'S IMPORTANT AND WE
SHOULD THINK THAT ALSO IN A CASE
OF PUBLIC HEALTH EMERGENCY OR IN
THE CASE OF CONDITIONS THAT
MARIA'S OUTLINED LIKE NEGLECTED
TROPICAL DISEASES, THE ALL THIS
BECOMES MORE COMPLICATED BECAUSE
WE HAVE A WORLDWIDE MARKET
THEREFORE MULTIPLE HURDLES TO
PASS AND PRODUCTION AND
DISTRIBUTION THAT HAS OCCURRED
ON A GLOBAL SCALE.
THE ABILITY TO DO THAT REQUIRES
LARGE COMPANIES.
IF YOU THINK ABOUT ALL THE
THINGS THAT NEED TO BE DONE YOU
SEE SMALLER COMPANIES GETTING
EATEN UP BY THE LARGER
COMPANIES.
AND SPEED AND SCALABILITY
REQUIRING PHARMACEUTICAL
COMPANIES THE BEST PROCESS IS
NOT NECESSARILY AN OLD
PRODUCTION PROCESS OR TRIED AND
TRUE PROCESS.
WE LEARNED THAT A LOT IN COVID.
THE CHINESE TRIED AN OLD PROTEIN
PROCESS.
THE RUSSIANS TRIED A PROCESS
THAT HAD BEEN ESTABLISHED.
THE BIGGEST IMPACT ON DISEASE
SUSTAINABILITY WITH NOVEL
TECHNOLOGY, mRNA.
I DON'T THINK WE HAVEN'T SEEN
THAT AND THINKING OF NEW
PROCESSES THOUGH THEY'RE MORE
EXPENSIVE THAN TRIED AND TRUE
PROCESSES, MAYBE THE BEST EVEN
IN NEGLECTED TROPICAL DISEASES
MARIA OUTLINED, GOING TO THE
BOTTOM OF THE BARREL AND THE
REASON IS GIVEN THE ECONOMIC
DISEAS
DISEASES AND AFFECTING PEOPLE
WITH THESE DISEASES SHOULD BE
INVOLVED WITH THE DISTRIBUTION
OF THE NOVEL VACCINES.
FOURTH POINT, IG AND
INTELLECTUAL PROPERTY.
THEY WERE TALKING ABOUT GETTING
RID OF THE PATENTS AND IP
PROTECTIONS SO COUNTRIES CAN
PRODUCE THIS.
AS WE ALL KNOW, IT WAS NOT IP
THE REAL BARRIER WAS KNOW-HOW.
THERE WERE OVER 200 DIFFERENT
INPUTS NEEDED FOR THE RNA
VACCINES AND MAKE THEM
SUCCESSFUL.
THAT KNOW-HOW WAS MORE VALUABLE
THAN ANY IP IN THE PROCESS.
IT WAS THE KNOW-HOW THAT WAS
MAINLY THE BARRIER AND THE MAIN
BARRIER IN THE CASE OF THE
KNOW-HOW IS THE FACT THERE
WEREN'T THAT MANY PEOPLE
AVAILABLE TO BOTH KEEP
PRODUCTION UP AND DISTRIBUTE AND
LAUNCH PRODUCTION IN MULTIPLE
SITES AT ONCE.
WE NEED TO KEEP THINKING IP IS
NOT THE ONLY LIMIT IN THE
PRODUCTION OF NOVEL TECHNOLOGIES
IT'S ALSO KNOW-HOW.
FIFTH POINT, LET ME HIGHLIGHT
SOMETHING -- TWO THINGS WHICH I
DON'T THINK GET ENOUGH
ATTENTION.
WE HAD AVAILABILITY OF VACCINE
IN DECEMBER 2020.
THEN WE TOOK 2021 TO DISTRIBUTE
IT.
WE DIDN'T HAVE A FAIR
DISTRIBUTION.
I CAN SAY THAT PRETTY
CONFIDENTLY IN THE FIRST SIX
MONTHS CERTAINLY.
HIGH-INCOME COUNTRIES MANY OF
WHOM LIKE THE UNITED STATES WERE
SUFFERING A SUBSTANTIAL COVID
BURDEN RECEIVED A
DISPROPORTIONATE AMOUNT OF
VACCINE.
LATTER 2021 THAT EQUALIZED BUT
IT'S NOT TRUE THE LOW-INCOME
COUNTRIES HAD A HIGH BURDEN.
THEY HAD A TINY BURDEN OF COVID
AND THE BIG BURDEN AND BIG
UNFAIRNESS AND DISTRIBUTION WAS
THE LOW MIDDLE-INCOME COUNTRIES
THAT DID NOT RECEIVE THEIR FAIR
SHARE GIVEN THEIR BURDEN.
COUNTRIES LIKE PERU HAD DEATHS
AND NOT SUFFICIENT SUPPLY.
BY THE SECOND HALF OF 2021 THE
PROBLEM WAS NOT SUPPLY, THE
PROBLEM WAS DEMAND.
AND GOVERNMENT OFFICIALS AND THE
EDUCATED AND BUSINESS LEADERS
TOOK UP A VACCINE THE REST OF
THE POPULATION DIDN'T SEE A NEED
FOR A VACCINE.
DIDN'T WANT TO TAKE A VACCINE
THOUGH IT WAS NO-COST AND THERE
WAS PLENTY OF VACCINE TO GO
AROUND.
I BIG PROBLEM WAS DEMAND AND
THERE'S NO SUGAR COATING THE
FACT BY Q3 OF 2021 AND Q4 OF
2021 THE BIG PROBLEM AND
CERTAINLY ALL THROUGH 2022 THE
BIG PROBLEM WAS DEMAND NOT
SUPPLY.
WE HAVE SEEN THIS IN 2022 BUT
SAW THIS IN MANY PARTS OF THE
WORLD.
SECOND PART IS WE SHOULD BE
CLEAR ABOUT VACCINE NATIONALISM.
ALL CREDIT TO MARIA AND HER
GROUP FOR PUTTING PRODUCTION IN
INDIA.
BUT LET'S BE CLEAR, INDIA
EXERCISED VACCINE NATIONALISM
VERY MUCH.
WHEN THEY HAD THE CRISIS WITH
DELTA WHAT DID THEY DO, NO MORE
EXPORTS TO VACCINES IN THE WORLD
IT'S STAYING IN INDIA.
AND MANY ARE GOING TO
NATIONALIZE VACCINES AND THAT
REQUIRES OUTLINE FROM PROBABLY
OTHER PLACES AROUND THE WORLD.
AND I THINK PEOPLE TALK ABOUT
VACCINE NATIONALISM IN AMERICA
AND JUST REMEMBER PEOPLE IN
INDIA AND IN THE ABSENCE OF
WORLD GOVERNMENT THE BEST WAY
FOR CITIZENS TO GET THEIR MEANS
MET IS GOING TO BE NATIONAL
GOVERNMENT AND THEREFORE THE
NATIONAL GOVERNMENT IS
ACCOUNTABLE TO THEIR CITIZENS
AND SO ALMOST INEVITABLY ANY
NATIONAL GOVERNMENT IS GOING TO
NATIONALIZE THEIR VACCINE
PRODUCTION AND THEREFORE WE NEED
MULTIPLE VACCINES.
BUT WE SHOULD BE -- AND THIS IS
MY FINAL POINT, VERY VERY AWARE
THAT PRODUCTION IN LOW AND
MIDDLE INCOME COUNTRY IS NOT A
GUARANTEE OF DISTRIBUTION.
AS I MENTIONED, VACCINE
NATIONALISM IS ONE PROBLEM WE
SAW WITH INDIA.
I WOULD ALSO MENTION WAY BACK
WHEN DURING INFLUENZA WE SAW
SOME NATIONALISM ON THE PART OF
INDONESIA BY HOLDING ON TO
SAMPLES OF THE FLU THAT WAS
CIRCULATING BECAUSE THEY WANT
CONSIDERATION FOR THEIR OWN
POPULATION.
THIS KIND OF NATIONAL INSTINCT
IS GOING TO BE INEVITABLE.
THE FINAL POINT I'D MAKE IN
THINKING ABOUT SUSTAINABILITY
AND GOING FORWARD IT STRIKES ME
WITH YOU SHOULD NOT DRIVE FIRST
TO THE MOST HIGH TECH PRODUCTION
IN ALL OF THESE COUNTRIES.
HERE I DO WANT TO COMMEND MARIA
AND HER COLLEAGUES THAT THINKING
ABOUT TRIED AND TRUE PRODUCING
VACCINE AND EMBARKING ON mRNA
VACCINES AND THE KNOW-HOW AND
EXPERTISE AND CHALLENGES AS THE
FIRST APPROACH IS NOT A GOOD
IDEA IN MY HUMBLE OPINION.
IT'S NOT.
UNTIL THAT'S MORE TREME LINED
AND HAVE MORE EXPERTISE THAT CAN
ADDRESS THIS IT'S NOT THE PLACE
I WOULD GO.
LET ME CONCLUDE WITH
REEMPHASIZING THE THREE
PRINCIPLES IN CASES LIKE THE ONE
MARIA RAISES ABOUT THE NEGLECTED
TROPICAL DISEASE AND FOR
DISEASES WHERE THE COST AND THE
BENEFITS MAY NOT BE AS HIGH.
WE WANT TO OMENT MISVACCINE
PRODUCTION.
WE WANT TO HAVE A FAIR
DISTRIBUTION WHERE IT'S NOT A
DISTRIBUTION BASED ON POLICY OR
POPULATION BUT A DISTRIBUTION
BASED ON HEALTH NEED AND WE WANT
A SUSTAINABLE PRODUCTION
ARRANGEMENT WITH THE RIGHT
INCENTIVES SO THE PEOPLE WITH
THE SKILLS WILL NOT JUST FOR THE
MOMENT OR FOR THE NEXT YEAR BUT
FOR THE NEXT 20, 30 YEARS WILL
BE ENGAGED IN DEVELOPING
PRODUCTS AND MAKING PRODUCTS AND
DISTRIBUTING PRODUCTS THAT ARE
GOING TO BRING UP THE HEALTH OF
THE WORLD.
THANK YOU VERY MUCH.
I LOOK FORWARD TO YOUR
QUESTIONS.
>>A QUICK REMINDER THERE'S CME
CREDIT.
TO GET IT TEXT THE LINE AND IT'S
44542 AND TO ASK QUESTIONS, LOOK
FOR THE LIVE FEEDBACK BUTTON ON
THE VIDEOCAST WEBSITE.
YOU'RE SAYING IF WE GET THE
FACILITIES IN FOUR OR FIVE
COUNTRIES TO THE EXTENT THERE'S
NATIONALISM GOING ON WE HAVE TO
HAVE THE FACTORIES I ASSUME IN
SOME COUNTRIES AND HAVE NO IDEA
WHERE THE NEXT PANDEMIC WILL BE
AND NOT BE.
>>YES.
THIS IS FOR THE PARTICULAR
DISEASE NOT BASED ON THE
POPULATION.
CONTINUING TO CIRCULATE GRAPHICS
LIKE MARIA SHOWED PUBLISHED IN
THE NEW ENGLAND JOURNAL I THINK
SEPTEMBER SHOWING POPULATION AND
VACCINE DISTRIBUTION DISTORTS
THE POINT IN THE END WE SHOWED
IT WAS NOT JUSTIFIABLE.
YOU HAVE TO HAVE A DISEASE
BURDEN BASED DISTRIBUTION
METHOD.
RECOGNIZING THAT PRINCIPLE IS
FIRST AND FOREMOST.
SO HE WE DON'T SEND VACCINES TO
COUNTRIES THAT DON'T HAVE A HIGH
DISEASE BURDEN LIKE GHANA DURING
THE PANDEMIC INSTEAD OF SENDING
ENOUGH VACCINE TO PERU.
THE SECOND THING WE HAVE TO DO
IS BEFORE THE NEXT PANDEMIC GET
A BETTER ORGANIZATION THAN WE
HAD IN COVAX WHICH HAD MULTIPLE
MISTAKES AND ESTABLISH SO WE
HAVE A DISTRIBUTION OF VACCINE
AROUND THE WORLD IN A FAIR
PROCESS AND MAKE IT FAIR.
THE THIRD POINT I WOULD SAY IS,
LOOK, IN THE NEXT FEW YEARS WE
HAVE TO ESTABLISH A PRODUCTION
FACILITY AROUND THE WORLD.
WE DON'T KNOW WHAT THE BEST
VACCINE IS GOING TO BE, RIGHT?
IF WE HAD BEEN PRESENT SAY 2017
PLANNING FOR A PANDEMIC AND
SAYING ALL RIGHT WE'RE GOING TO
PLAN FOR A PANDEMIC.
WE WOULD NOT HAVE PLANNED FOR
mRNA PRODUCTION FACILITIES
ANYWHERE.
IT JUST WASN'T ON THE MAP.
WE DON'T KNOW.
WE CAN DO OUR BEST JOB AND WE
SHOULD DO THAT VERY EFFICIENTLY
AND EFFECTIVELY.
IT MAY NOT BE THAT WE DISTRIBUTE
mRNA VACCINATION IN 30
COUNTRIES.
WE PROBABLY HAVE TO DO IT SO
EVERY FACTORY OPERATES AT ITS
PEAK EFFICIENCY AND WE NEED TO
ENSURE THAT THOSE FACILITIES
WILL CONTRIBUTE NOT JUST TO THE
COUNTRY THEY'RE IN BUT TO A
GLOBAL POOL.
I THINK GETTING THAT AGREEMENT,
YES, WE UNDERSTAND THE DRIVE FOR
NATIONALIZATION OF VACCINE BUT
THERE'S A LIMIT TO THAT AND SOME
OF MY WRITINGS WE'VE EXPRESSED
AND CLEARLY DEFINED THE LIMIT TO
THAT.
THEREFORE WE NEED TO MAKE SURE
ABOVE THAT LIMIT COUNTRIES
CONTRIBUTE TO THE COMMON POOL
THAT GETS REDISTRIBUTED AROUND
THE WORLD.
I THINK THAT'S THE KEY APPROACH
AND THAT BEGINS WITH HAVING THE
RIGHT ETHICAL PRINCIPLES BECAUSE
WE SAW IN COVID WE HAD THE WRONG
ETHICAL PRINCIPLES AND TO KEEP
EVALUATING THE COVID
DISTRIBUTION ON THE BASIS OF THE
WRONG ETHICAL PRINCIPLES
DISTORTS THE EVALUATION AND
DISTORTS OUR JUDGMENT ABOUT WHAT
WE NEED.
I HOPE I ANSWERED THE QUESTION.
>>CAN YOU SAY MORE ABOUT THE
GLOBAL POOL SOUNDS INTERESTING.
HOW'S THAT WORK.
DO SOMEONE OVERSEE IT OR DO
COUNTRIES OVERSEE IT?
>>OF COURSE SOMEONE HAS TO
OVERSEE IT.
ONE OF OR PROBLEMS IS I THINK
THE W.H.O. AND OTHERS IN
ESTABLISHING COVAX DID NOT DO A
GOOD PROCESS.
THE GOVERNANCE WAS NOT GOOD,
I'VE WRITTEN ABOUT AND THAT THE
ETHICAL PRINCIPLES UNDER THE
DISTRIBUTION WERE NOT FAIR.
I THINK WE HAVE TO BEGIN BY
ESTABLISHING NOW A FRAMEWORK --
MAYBE IT HAS TO BE OUTSIDE OF
THE W.H.O. FRAMEWORK KIND OF
LIKE U.N. AIDS A NEW FRAMEWORK
TO DISTRIBUTE ACCORDING TO
ETHICS NOT POPULATION AND PUT IN
THAT FRAMEWORK CAN WE GUARANTEE
COUNTRIES WILL PARTICIPATE?
NO.
CAN WE BEGIN DOING IT NOW BEFORE
ANY COUNTRY IS AT THE BOTTOM END
LIKE UNDER A VEIL OF IGNORANCE,
BRING IN THE PHARMACEUTICAL
COMPANIES THAT ARE LIKELY TO
DRIVE PRODUCTION?
THAT I THINK WE HAVE TO START
NOW BEFORE WE'RE FACED WITH THE
NEXT CRISIS AND PUT IT IN PLACE
AND OVERCOME SOME OF THE MAJOR
GOVERNANCE AND ETHICAL BARRIERS
THAT CONFRONTED COVID.
>>GREAT.
>>CAN I MAKE A QUICK COMMENT?
>>ABSOLUTELY.
>>I REALLY AGREE WITH YOUR
ETHICAL PRINCIPLES AND MAY I
COMMENT ON THE FIRST ETHICAL
PRINCIPLE WHICH IS THE
PRODUCTION CONCEPT.
I THINK THAT MAYBE WE CAN USE
THE WORD DIVERSIFICATION.
I THINK WHAT MAYBE WOULD HELP IS
THAT THE CAPACITY, KNOW
KNOWLEDGE, THE WORKFORCE THE
INFRASTRUCTURE HAS TO HAVE A
GOOD DIVERSIFICATION OF
TECHNOLOGIES BECAUSE AS YOU
SAID, RIGHT, SOME FACTORIES WERE
GOOD FOR ENA VACCINES BUT DON'TW
HOW TO DO PROTEINS SO
DIVERSIFICATION OF TECHNOLOGIES
WILL BE IMPORTANT BECAUSE WE
DON'T KNOW WHICH ONE WILL WORK.
THAT ALSO THEN FEEDS INTO THE
SELECTION OF YOUR ETHICAL
PRINCIPLE 2 OF WHO ARE THE
PEOPLE IN NEED.
MAYBE SOME WORDS FROM YOU,
DRDR
DRDR.
POPULATION THAT IS IN NEED OF
VACCINE BUT CAN'T SAY WHO THE
POPULATION IN NEED IS AND ONLY
THING THEY CAN RELY ON IS PEOPLE
WHO ARE OLD AND SHOULD GET THE
PRIORITY.
I FEEL THAT MAY BE SOMETHING
THAT I WOULD LIKE TO LEARN MORE
BECAUSE I AGREE WITH YOU BUT I
DON'T KNOW THE COUNTRIES WOULD
BE ABLE TO COME UP WITH
INFORMATION AND THEN COME WITH
THE INFORMATION WOULD BE ABLE TO
THEN MEET THAT REQUIREMENT AND
RECEIVE THE BENEFIT OF IT AND WE
WOULD ALWAYS LEAVE PEOPLE
BEHIND.
IF YOU COMBINE BOTH OF THEM, I
TOTALLY AGREE.
THEN YOU CAN --
>>THANK YOU FOR THAT
CLARIFICATION, MARIA.
WE NEED TO DISTINGUISH
DISTRIBUTION INSIDE A COUNTRY
FROM DISTRIBUTION AROUND THE
WORLD.
DISTRIBUTION AMONG COUNTRIES.
THE BEST ASSESSMENT IS WHAT IS
THEIR DISEASE BURDEN.
IN THE CASE OF COVID THE
ASSESSMENT IS WHAT IS THEIR
EXCESS STEPS.
THE W.H.O. COLLECTS DATA ON
EXCESS DEATHS IN THE COUNTRY
PRETTY REGULARLY.
WE CAN DEBATE HOW RELIABLE IT
IS.
IT'S A METRIC WE DO USE
GLOBALLY.
THAT WAS IN COVID OUR BEST
ASSESSMENT OF DISEASE BURDEN.
LOOKING AT COUNTRIES THAT DIDN'T
HAVE A HIGH EXCESS DEATHS VERSUS
COUNTRIES THAT HAVE -- THERE'S
SOME COUNTRIES THAT HAVE
NEGATIVE EXCESS DEATHS DURING
COVID THEY DID A LOCKDOWN AND
OTHER THINGS AND THEY'RE DEATH
RATE DECLINED.
YOU HAVE A NUMBER OF
COUNTRIES -- I CAN'T TELL YOU
THE EXACT NUMBER SOMETHING LIKE
3035 THAT ACTUALLY WERE NEGATIVE
EXCESS DEATHS.
SO THAT'S A METRIC YOU CAN USE.
IT'S A METRIC WE HAVE IN PLACE.
IT'S A METRIC I THINK WHILE NOT
PERFECT AND THERE'S GOING TO BE
SOME DELAY IN TIME IS USEFUL.
ONE OF THE THINGS YOU FIND OUT
IS EXCESS DEATHS IN A LOT OF
LOW-INCOME COUNTRIES WAS LOW OR
EVEN NEGATIVE.
THAT TELLS YOU THEY PROBABLY
AREN'T AT THE TOP OF YOUR LIST
WHEREAS COUNTRIES THAT ARE
HAVING AN ENORMOUS OUTBREAK AND
I USE PERU AS AN EXAMPLE, I
THINK PERU HAD THE SECOND
HIGHEST EXCESS DEATH RATE DURING
THE COVID PANDEMIC, I COULD BE
WRONG ABOUT THAT, IT CERTAINLY
WAS VERY HIGH UP IN TERMS OF
COVID BURDEN AND SHOULD HAVE
GOTTEN MORE VACCINE.
I CAN SEE NO JUSTIFICATION FOR
USING POPULATION.
>>AND SEEMS LIKE WITH PANDEMIC
THERE'S TWO GENERAL APPROACHES
AND THIS IS SIMPLISTIC BUT WE
HAVE TO GET AHEAD AND GET
MANUFACTURING FACILITIES SET.
WE HAVE TO BE READY.
THE SECOND ONE IS THE PANDEMICS
ARE UNPREDICTABLE DISASTERS.
AND WE HAVE TO RECOGNIZE THAT
AND REALIZE THE LIMITATIONS TO
WHICH WE CAN ANTICIPATE THEM.
SO WE SHOULDN'T EXPECT THE SAME
RULES WHICH APPLY IN GENERAL ARE
GOING TO APPLY IN TERMS OF
PANDEMICS.
AS YOU KNOW PHILOSOPHERS LIKE TO
TALK ABOUT DISASTER SCENARIOS.
WE HAVE PRINCIPLES THAT APPLY
AND IN A DISASTER THEY MAY NO
LONGER APPLY.
SOME PEOPLE ARE WONDERING
WHETHER PANDEMICS ARE LIKE THAT
WITH RESPECT TO THINGS LIKE
INTELLECTUAL PROPERTY AND HOW WE
DEVELOP AND DISTRIBUTE
INTERVENTIONS WHERE, YEAH,
DURING REGULAR TIMES IT'S A GOOD
WAY TO GO BUT IN A DISASTER, WE
SHOULDN'T FOLLOW THEM NECESSARY.
IS THAT A GOOD IDEA OR BAD?
>>I DON'T THINK SO.
PART OF WHAT WE DID IN THINKING
THROUGH WAS THINKING THROUGH
DURING A PANDEMIC WHICH IS WHY
YOU WANT TO OPTIMIZE PRODUCTION.
YOU WANT SPEED, YOU WANT SCALE
AND YOU WANT SUSTAINABILITY.
I THINK ALL OF THOSE ARE FOR AN
EMERGENCY ABSOLUTELY ESSENTIAL
AND YOU WANT TO PUSH THERE.
WE SHOULD NOT LET THE WORLD OFF
FROM PREPARING FOR A PANDEMIC.
THEY ARE NOT -- WE CANNOT
PREDICT THEM.
WE DO HAVE SOME WAY.
WE CAN'T PREDICT EXACTLY WHEN
THEY'LL HAPPEN OR THE SHAPE
THEY'LL HAPPEN BUT WE CAN
PREDICT THEY'RE GOING TO HAPPEN
AND THEREFORE DO NEED TO PREPARE
AND WE DO NEED TO PUT IN PLACE
INFRASTRUCTURE, THINK THROUGH
THE ETHICAL PRINCIPLES.
BY THE WAY, NOT EVERY PANDEMIC
IS GOING TO BE THE ELDERLY OR
PEOPLE WITH IMMUNOCOMPROMISED
DISEASES ARE LIKELY TO BE WORSE
HIT.
IN A FLU PANDEMIC IT VERY WELL
COULD BE LIKE IN 1918 YOUNG
PEOPLE WILL BE HIT HARDEST AND
THEY ARE THE ONES THAT SHOULD
RECEIVE PRIORITY.
SO WE NEED TO HAVE THE RIGHT
PRINCIPLES TO IDENTIFY THE RIGHT
GROUPS TO GO TO THE TOP OF THE
PRIORITY LIST.
BUT THE IDEA THAT WE CAN'T PLAN
IS A TERRIBLE IDEA AND LETS OUR
POLICY MAKERS OFF TOO EASILY.
NOW, THERE'S MANY THINGS WE
CAN'T PREDICT EXACTLY HOW BAD IT
WILL BE AND WHETHER IT WILL
FIZZLE OUT, ALL OF THINGS BUT
DOESN'T MEAN WE SHOULDN'T
ANTICIPATE THE PROBLEMS.
THANK YOU.
>>THANK YOU.
I WANT TO APOLOGIZE TO ALL THE
GOOD QUESTIONS.
I'LL TRY TO RESPOND TO SOME I
DIDN'T HAVE TIME TO GET TO.
AND I LOOK FORWARD TO SEEING
PEOPLE AGAIN THE FIRST WEDNESDAY
IN APRIL.
IN THE MEANTIME, THANKS VERY
MUCH TO MARIA AND ZEKE FOR A
FABULOUS SESSION.
WE REALLY APPRECIATE YOUR
PARTICIPATION.
THANKS, EVERYBODY.