GOT TO LOVE IT.
WE ARE ZEROING ON A VACCINE THIS
MORNING.
MODERNA’S RACE FOR A VACCINE IS
RAISING QUESTIONS, SCIENTISTS
ARE SAYING MODERNA DID NOT
DISCLOSE SUFFICIENT CRITICAL
DATA TO ASSESSING ITS COVID-19
VACCINE.
THE BIOTECH COMPANY REPORTING
VERY POSITIVE RESULTS EARLIER
THIS WEEK FROM AN EARLY HUMAN
TRIAL WHICH SHOWED THAT PEOPLE
GIVEN ITS POTENTIAL VACCINE
GENERATED ANTIBODIES TO THE
VIRUS AND JOINING ME RIGHT NOW
TO TALK ABOUT ALL OF THIS IS THE
CEO OF MODERNA, STEPHANE BANCEL.
IT’S GREAT TO HAVE YOU THIS
MORNING.
THANK YOU VERY MUCH FOR BEING
HERE.
>> GOOD MORNING, THANK YOU FOR
HAVING ME.
MARIA: AND I KNOW THAT YOU’VE
INVESTED SO MUCH IN THIS OVER
THE LAST 10 YEARS SO I’M GOING
TO GET TO THAT BUT LET’S TALK
ABOUT FIRST THE MOST RECENT
CONCERNS AND TWO VACCINE EXPERTS
INTERVIEWED BY STAT NEWS REPORT
THAT THE COMPANY HAS YET TO
PUBLISH YOUR STUDIES IN
SCIENTIFIC JOURNALS, THEY ALSO
POINTED OUT THAT THE COMPANY
DISCLOSED RESULTS FROM ONLY
EIGHT OF THE 45 PARTICIPANTS
MEANING THAT THE MAJORITY OF
OUTCOMES REMAIN UNKNOWN.
WHAT CAN YOU TELL US?
>> YES, SO WE ON MONDAY MORNING
SHARED INTERIM POSITIVE PHASE
ONE DATA, SO AS THE PRESS
RELEASE, IT WAS INTERIM DATA.
ITI WANT TO REMIND THAT THE STUD
IS BEING RUN BY NYAD, THE
DIVISION OF THE NIH LED BY
DR. FAUCI AND THEY’RE UNDER
STUDY AND THEY ANALYZED ALL OF
THE SAMPLES.
WHAT WE SHOWED IS THAT THE LOW
DOSE AND MIDDLE DOSE WE HAVE ALL
THE POSITIVE UP TO THAT DATA CUT
THAT SHOWED ANTIBODY AT OR ABOVE
THE LEVEL OF CONVALESCENT AND WE
SHARED THAT OF EIGHT OF THOSE,
WE HAD NEUTRALIZING ANTIBODIES,
ANSWEREDS THAT WILL BIND AND
NEUTRALIZE THE VIRUS.
WE HAVE ONLY EIGHT OF THOSE
BECAUSE IT TAKES A LONGER TIME
TO ANALYZE THE NEUTRALIZATION
ASSAY.
THAT’S THE DATA WE HAD AS OF THE
FIRST DAY.
MARIA: WILL YOU BE PUBLISHING
IN SCIENTIFIC JOURNAL THIS
INFORMATION ON THE FIRST HUMAN
TRIAL?
>> YES, OBVIOUSLY.
ONE OF THE REASONS THAT WE ONLY
SHARED TOP-LINE DATA AND NOT THE
FULL DATA SET IS TO PRESERVE THE
ABILITY VERY SOON FOR NYAD TO BE
ABLE TO PUBLISH THE DATA IN A
PEER-REVIEWED MEDICAL JOURNAL
AND THAT’S WHAT THEY INTEND TO
DO AND THAT IS WHAT WE HAVE ALSO
DONE AS A COMPANY IN THE PAST.
SO WE’RE NOT CHANGING OUR
POLICY.
MARIA: I THINK THIS IS AN
IMPORTANT POINT THAT YOU MAKE.
BECAUSE ANOTHER CONCERN THAT WAS
TALKED ABOUT YESTERDAY WAS THAT
THE NATIONAL INSTITUTE FOR
ALLERGY AND INFECTIOUS DISEASES
HAS NOT SAID ANYTHING ABOUT THIS
INFORMATION EVEN THOUGH IT WAS
PARTNERING WITH MODERNA BUT
YESTERDAY THE VICE PRESIDENT
TWEETED THIS OUT.
VICE PRESIDENT MIKE PENCE
TWEETED THIS OUT ON MONDAY
SAYING IN OUR CALL WITH
GOVERNORS TODAY, DR. FAUCI
SHARED EXCITING NEWS FROM
BIOTECH COMPANY MODERNA, THE
FIRST POTENTIAL CORONAVIRUS
VACCINE HAS SHOWN PROMISING
RESULTS IN A CLINICAL TRIAL.
45 PARTICIPANTS RECEIVED TWO
DOSES OF THE VACCINE AND ALL 45
PRODUCED ANTIBODIES.
SO YOU DID GET THE WEIGH-IN FROM
DR. FAUCI ALTHOUGH THAT WAS ONE
OF THE CONCERNS THAT WE HADN’T
HEARD FROM HIM YESTERDAY.
>> YES INDEED WE WERE HAPPY TO
SEE THAT TWEET ON THE INTERNET.
AGAIN, I GO BACK TO WHAT I SAID
BEFORE, WHICH IS THOSE ARE
INTERIM DATA.
THEY ARE EARLY, OBVIOUSLY.
IT’S A SMALL DATA SET.
ALL THE THINGS WE SAID ON MONDAY
THAT IS IN THE PRESS RELEASE.
BUT THEY ARE ENCOURAGING DATA.
THIS IS WHAT DR. FAUCI SEEMS TO
HAVE SAID AT THE MEETING.
OBVIOUSLY, I WAS NOT THERE.
AND THAT’S WHY WE ARE ENCOURAGED
AND WE ARE MOVING AS FAST AS WE
CAN.
THERE IS A LOT OF SUFFERING,
PEOPLE ARE DYING.
FOR THE LAST FOUR MONTHS OUR
TEAM IS PARTNERING WITH THE NIH,
WORKING HAND IN HAND WITH THE
FDA.
THEY’VE BEEN REMARK AND REMARKAB
OF THEIR QUICK RESPONSE.
WE’VE GONE FROM A SEQUENCE OF A
VIRUS TO INTERIM PHASE ONE DATA.
THEY’VE GIVEN US THE GREEN LIGHT
TO GO INTO PHASE TWO AND WE ARE
IN FINAL PLANNING TO START A
PHASE THREE WITH THOUSANDS OF
SUBJECTS AS EARLY AS JULY.
MARIA: AND I THINK THIS IS WHY
YOU HAD THE BUY-IN FROM FAUCI
AND FROM THE GOVERNMENT EARLY
BECAUSE THE SCALE THAT MODERNA
HAS BUILT UP IN THE LAST 10
YEARS, GETTING THE IP IN PLACE,
USING SOFTWARE, USING HARDWARE,
I WANT TO TALK ABOUT YOUR
TECHNOLOGY, THAT THE GOVERNMENT
CAN COME TO YOU AND SAY, WELL,
WE NEED A BILLION DOSES AND WE
NEED YOU TO MANUFACTURE THIS
BECAUSE YOU WORKED WITH THEM FOR
THE LAST 10 YEARS.
CAN YOU TALK TO US A LITTLE
ABOUT THE INVESTMENT THAT YOU’VE
PUT INTO THIS BEFORE THESE
HEADLINES OF THE LAST WEEK?
>> OF COURSE.
MARIA: OVER A 10-YEAR PERIOD.
>> IT’S NINE YEARS OLD, WE HAVE
INVESTED LITERALLY BILLIONS OF
DOLLARS FROM INVESTORS TO BUILD
THE SCIENCE CORRECTLY.
WE PUBLISHED EXTENSIVELY OVER
THE YEARS.
WE’VE PARTNERED WITH MERCK FOUR
TIMES.
WE PARTNERED WITH ASTRAZENECA
THREE TIMES.
WE PARTNERED WITH THE DEPARTMENT
OF DEFENSE, THE GATES FOUNDATION
AND -- THE ZIKA VACCINE THAT’S
IN THE CLINIC, WE SHARED THE
POSITIVE INTERIM PHASE ONE DATA
THAT IS ALSO VERY ENCOURAGING ON
THE ZIKA PRODUCT AND WITH
DR. FAUCI’S TEAM WE’VE BEEN
WORKING FOR ALMOST TWO YEARS NOW
ON A DIFFERENT KIND OF VIRUSES
AND VACCINES AND THE REASON WE
ARE ABLE TO MOVE SO FAST WITH
THEM IS THAT ONE WHATEVER VACCIN
WORKED TOGETHER ON IS THE MIDDLE
EAST RESPIRATORY SYNDROME THAT
HAPPENED IN THE MEAT A FEW YEARS
AGO -- IN THE MIDDLE EAST A FEW
YEARS AND IT WAS ALSO A
CORONAVIRUS.
ALL THE WORK THAT WE’VE BEEN
DOING WITH THE DIVISION OF
DR. FAUCI WAS VERY HELPFUL
BECAUSE WE COULD JUST ON THE
SEQUENCE OF THE VIRUS,
ESTABLISHED BY THE CHINESE
AUTHORITIES, WE COULD USE THAT
INFORMATION TO DESIGN VERY
QUICKLY A VACCINE AND WE NOT
ONLY REPORTED INTERIM POSITIVE
PHASE ONE DATA, WE ALSO REPORTED
ON MONDAY THAT WE SHOWED IN AN
ANIMAL MODEL FULL PROTECTION
WHERE BASICALLY YOU VACCINATE
THE ANIMAL AND THEN YOU GIVE
THEM HIGH DOSE OF A VIRUS AND WE
COULD DEMONSTRATE WE HAD VERY,
VERY REDUCED LEVEL OF VIRUS IN
THEIR LUNGS.
MARIA: I SEE.
SO THEN WHAT DO YOU THINK OF
THIS LATEST STAT REPORT THEN?
>> I JUST THINK THAT, AGAIN,
THEY SAID THINGS THAT WE THINK
THE SAME THING WHICH IS WHY IT
IS QUITE SURPRISING.
WE SAY ON MONDAY THIS IS AN
INTERIM PHASE ONE STUDY AND IT
WAS A SMALL NUMBER OF SUBJECTS.
NEUTRALIZING ANTIBODY, EIGHT
SUBJECTS, IT’S IN THE SUBTITLE
OF THE PRESS RELEASE.
THEY SAY THE DATA WAS NOT
PUBLISHED.
THIS IS TOP-LINE DATA.
IT WILL BE PUBLISHED VERY SOON.
WE’RE TALKING WEEKS, NOT MONTHS
AND THEY SAY THAT THEY REACHED
OUT TO NYAD AND NO COMMENT.
I DON’T KNOW WHO THEY TRIED TO
TALK TO.
THE ONLY THING I KNOW IS WHAT
THE VICE PRESIDENT SAID ABOUT
THE COMMENTS THAT DR. TOUCH EYE
MADE TO -- FAUCI MADE TO THE
GOVERNORS.
MARIA: THAT’S A VERY GOOD
POINT.
YOU DON’T KNOW WHO THEY SPOKE
TO.
WE HEARD FROM THE VICE
PRESIDENT.
TELL ME YOUR LEVEL OF CONFIDENCE
ON PHASE TWO AND PHASE THREE.
>> WE HAVE A PLATFORM, THIS IS
NOT THE FIRST VAC SEEN.
THIS -- VACCINE.
THIS IS THE TENTH VACCINE IN
CLINICAL STUDIES.
WE HAVE PARTNERED WITH BARTA ON
ZIKA.
WE PARTNERED ON MERCK WITH A
RESPIRATORY VIRUS CALLED RSV.
WE HAVE THOSE VERY CLOSE NOW TO
2,000 HEALTHY PEOPLE WITH
DIFFERENT VACCINES AROUND THE
WORLD.
THE FDA HAS SEEN THE DATA OVER
THE YEARS AND WE BELIEVE THAT
OUR PLATFORM HAS THIS VERY
INTERESTING FEATURE, WHICH IS
BASICALLY GENETIC MOLECULE THAT
WE INJECT IN A HUMAN’S ARM LIKE
A TYPICAL VACCINE AND YOUR BODY
IS GOING TO READ THE
INSTRUCTIONS WE GIVE YOU TO MAKE
ONE PROTEIN OF A VIRUS TO
INFILTRATE THE IMMUNE SYSTEM.
WHAT’S INTERESTING ABOUT THE
TECHNOLOGY WHICH MAKES US
CAUTIOUSLY OPTIMISTIC ABOUT THE
PHASE TWO AND THE PHASE THREE, I
AM CAUTIOUSLY OPTIMISTIC BECAUSE
OF THE DATA I HAVE SEEN OVER THE
FOUR YEARS IN ALL OF THE
VACCINES AND YOU SEE A VERY
SMALL VARIATION BETWEEN
DIFFERENT HUMANS THAT GET THE
VACCINE AND THAT’S VERY
ENCOURAGING AS WE GO FROM
THOUSANDS OF PEOPLE, THE PHASE
TWO IS GOING TO BE 600 SUBJECTS
AND THE PHASE THREE WHERE WE
HAVE NOTIFY NOT FINALIZED THE
SIZE WITH THE FDA IS GOING TO BE
MANY THOUSANDS OF PEOPLE.
MARIA: SOUNDS LIKE YOU’RE
OPTIMISTIC ABOUT PHASE TWO.
YOU DID A BIG MONEY RAISE THIS
WEEK, MORE THAN $1 BILLION,
$1.5 BILLION OR SO.
HOW WILL THAT MONEY BE USED AND
TELL US ABOUT YOUR R&D.
YOU’VE GOT OTHER THINGS IN THE
PIPELINE THAT YOU’VE BEEN
WORKING ON.
HOW DO YOU ALLOCATE THE CAPITAL
FROM THE MONEY RAISED THIS WEEK
AND HOW DOES THAT IMPACT THE
OTHER DRUGS IN THE PIPELINE
RIGHT NOW?
>> YES.
SO THE MONEY WE RAISED THIS WEEK
AS WE SAID IN OUR S-4 THAT WE
FILED WITH THE SEC IS TO BE USED
TO BUILD THE MANUFACTURING
CAPACITY, TO BE READY IF THE
VACCINE GETS APPROVED.
WHICH OF COURSE WE ARE HOPING
FOR.
BECAUSE OF ALL THE SUFFERING
THAT’S HAPPENING AROUND THE
WORLD.
WHAT WE’RE TRYING TO SOLVE FOR
IS THE FOLLOWING.
IF WE WAIT TO INVEST IN
MANUFACTURING CAPACITY WHEN WE
HAVE POTENTIALLY AND HOPEFULLY
FDA APPROVAL FOR A VACCINE, WE
WILL NOT BE READY TO SUPPLY THE
UNITED STATES OR OTHER COUNTRIES
WITH A VACCINE THAT WOULD HAVE
BEEN APPROVED AND THAT WOULD BE
OF COURSE AWFUL FROM A PUBLIC
HEALTH STANDPOINT AND SO WHAT WE
ARE DOING WITH THIS CAPITAL THAT
WAS RAISED MONDAY NIGHT IS WE’RE
GOING TO BUY NEW EQUIPMENT,
WE’RE GOING TO BUY RAW
MATERIALS, WE’RE GOING TO HIRE
MORE EMPLOYEES THAT WE HAVE TO
TRAIN BECAUSE IT’S A VERY
REGULATED INDUSTRY.
WE HAVE TO BE VERY CAREFUL AND
FOLLOW PROTOCOLS SO WE MAKE THE
PRODUCTS CORRECTLY TO ENSURE
SAFETY OF PEOPLE THAT WILL
EVENTUALLY POTENTIALLY GET THIS
VACCINE.
MARIA: LET ME ASK YOU ABOUT
YOUR MANUFACTURING CAPABILITY
BECAUSE YOU’VE GOT THE NORWOOD
FACILITY IN BOSTON WHICH IS A
BEAUTIFUL FACILITY, A LOT OF
TECHNOLOGY THERE.
I WANT TO ASK YOU ABOUT ROBOTICS
AND WHAT YOU’VE DONE IN TERMS OF
SOFTWARE AND TECHNOLOGY TO MOVE
THIS FORWARD BUT ALSO I WANT TO
GET YOUR TAKE ON OUTSIDE OF THE
UNITED STATES.
WE KNOW THAT YOU’VE GOT THE
MANUFACTURING CAPABILITY IN THE
UNITED STATES.
WHAT ABOUT EX-U.S.
ARE YOU GOING TO BUILD THAT ON
YOURSELF.
ARE YOU GOING TO TAKE ON A
PARTNER FOR E TAXER EX-U.S.
>> WE HAVE A STATE OF THE ART
FACILITY THAT IS FULLY
INTEGRATED.
WE MAKE THE MATERIALS, WE PUT
LIPID, THE FATS TO DELIVER IT
ONCE YOU GET INJECTED AND WE PUT
IT IN VIALS.
IT’S A FULLY INTEGRATED PLANT,
FULLY DIGITAL.
EVERYTHING IS HIGHLY DOCUMENTED
TO ENSURE QUALITY AND SAFETY OF
A PRODUCT.
AND THIS IS DONE USING
COMPUTERS.
TO REMOVE HUMAN MISTAKES.
THAT’S FOR THE U.S.
THIS FACILITY AS WE SAID IN THE
PAST IS ABLE TO ROUGHLY PRODUCE
AT FULL CAPACITY WITH PROCESS
SCALE-UP AND GOING 24/7 AROUND
100 MILLION DOSE, IF YOU ASSUME
5 # OF MICRO GRAM -- 50 MICRO
GRAM DOSE FOR THIS VACCINE.
IN THE CASE OF A GLOBAL
PANDEMIC, IT IS OBVIOUSLY NOT
ENOUGH.
WHAT WE ANNOUNCED TWO WEEKS AGO
IS A VERY STRATEGIC LONG-TERM
PARTNERSHIP WITH LONZA, ONE OF
THE BIGGEST AND LARGEST SWISS
COMPANIES AND THEY’RE ALLOWING
US THROUGH THEIR INFRASTRUCTURE
AND THEIR FACTORIES TO
POTENTIALLY BUILD MANUFACTURING
CAPACITY TO DELIVER UP TO
1 BILLION DOSES, AGAIN, AT THE
50 MICRO GRAM DOSE.
MARIA: THAT IS AMAZING.
A BILLION DOSES.
DO YOU THINK YOU’LL HAVE A
VACCINE BY YEAR-END?
I KNOW YOU’VE GOT THE PHASE TWO
TRIAL IN JULY.
YEAR-END VACCINE OR NEXT YEAR?
>> SO PHASE TWO IS GOING TO
START ANY DAY.
WE GOT THE GREEN LIGHT FROM THE
FDA.
PHASE THREE WILL START IN JULY.
IT IS POSSIBLE, ASSUMING A BEST
CASE SCENARIO, AND THERE ARE
MANY RISKS THAT COULD DERAIL US
SHALL OBVIOUSLY, BUT WE COULD
POTENTIALLY BE IN A POSITION TO
FILE FOR THE FDA TOWARD THE END
OF THE YEAR OR EARLY NEXT YEAR.
AGAIN, IT’S BEST CASE SCENARIO.
MARIA: AND THAT IS THE MUSIC TO
OUR EARS.
STEPHANE BANCEL, THANK YOU VERY