THANK YOU VERY MUCH.
KRISTEN, I HOPE YOU’LL STICK
AROUND.
WE’LL TALK POLITICS IN A FEW
MOMENTS.
FIRST WE HAVE THE GLOBAL HEAD OF
RESEARCH AND DEVELOPMENT FOR THE
JANSSEN PHARMACEUTICAL COMPANIES
OF JOHNSON & JOHNSON.
A BIG DAY FOR YOUR COMPANY.
CRITICAL NEW VACCINE DATA.
TELL US ABOUT THE COMPETITIVE
POSTURE, THE NUMBERS OF JOHNSON
& JOHNSON.
WE’VE BEEN TALKING ABOUT THIS AS
YOU WERE COMING ON ABOUT THE 85%
EFFICACY AND PROTECTING AGAINST
SEVERE DISEASE VERSUS THE
OVERALL 72% FIGURE.
>> IT’S A REALLY EXCITING DAY
FOR US.
THANK YOU FOR HAVING ME ON AND
ADDING COLOR TO WHAT YOU’RE
SAYING.
WE ARE 85% PROTECTIVE AGAINST
SEVERE DISEASE.
WHAT WE MEAN BY SEVERE DISEASE
ARE THOSE THAT EITHER REMAIN AT
HOME AND DON’T SEEK MEDICAL
INTERVENTION BUT FEEL PRETTY
SICK, LIKE THEY’RE IN BED AND
FEELING PRETTY SICK, OR MORE
SEVERE THAN THAT, WHERE THEY GO
IN AND SEEK MEDICAL ATTENTION.
IT’S PROTECTED 100% AGAINST
THOSE THAT NEED TO GO TO THE
HOSPITAL OR THOSE THAT
UNFORTUNATELY GO TO ICU OR EVEN
DIE.
EVERY SINGLE PERSON THAT’S
NEEDED TO GO TO THE HOSPITAL
AFTER VACCINATION OR DIED HAVE
BEEN ON PLACEBO AND ZERO HAVE
BEEN ON OUR VACCINE.
SO WE THINK OF THAT AS A
PARTICULARLY GOOD RESULT.
ESPECIALLY A LARGE NUMBER OF
CASES BEING IN SOUTH AFRICA
WHERE THIS NOTABLE STRAIN IS
CAUSING MORE THAN 8990% OF THE
CASES WE’VE SEEN.
>> SO WE THINK IT’S EFFECTIVE
AGAINST THE SOUTH AFRICAN
VARIANT, WHICH IS JUST BEGINNING
OVERNIGHT TO POP UP HERE IN THE
U.S.
>> WE DO.
WE DO.
SO IF I COULD HIGHLIGHT THE
SINGLE MOST IMPORTANT RESULT FOR
ME IS THAT, THAT WE’RE 85%-PLUS
ACTIVE AGAINST THE SOUTH AFRICAN
VARIANT, PROTECTING AGAINST
SEVERE DISEASE.
THE SOUTH AFRICANS THAT TOOK
OUR, STLD DI HAD AN 85%
REDUCTION IN THE NUMBER OF THOSE
CASES, AND NONE OF THEM NEEDED
TO GO TO THE HOSPITAL THAT TOOK
VACCINE, AND NO SOUTH AFRICAN
DIED THAT TOOK VACCINE.
SO THAT’S A VERY IMPORTANT
RESULT IN LIGHT OF THE LARGE
NUMBER OF VARIANTS THAT ARE
ACTIVE IN THE WORLD TODAY
RELATIVE TO EVEN A COUPLE MONTHS
AGO.
>> THE NEXT CRITICAL STEP IS
APPLYING FOR EMERGENCY USE
AUTHORIZATION.
HOW QUICKLY DO YOU THINK YOU CAN
APPLY AND GO THROUGH THAT FDA
PROCESS AND GET IT TO MARKET?
>> YEAH.
SO MY TEAM HAS BEEN EXTREMELY
HARD AT WORK GETTING THESE DATA
ANALYZED AND IN SHAPE, READY FOR
REGULATORY SUBMISSION.
WE’RE OBVIOUSLY TALKING ABOUT IT
TODAY, AND I’M HOPING INSIDE OF
A WEEK WE’LL BE ABLE TO SUBMIT
THIS LARGE AND COMPLEX DATA SET
TO THE U.S. REGULATOR, FDA, AND
SOON THEREAFTER TO THE REST OF
THE WORLD, TO EUROPE AND OTHER
GLOBAL REGULATORY AGENCIES.
SO WE’RE MOVING AS QUICK AS
HUMANLY POSSIBLE, MOVING HEAVEN
AND EARTH I WOULD SAY TO GET
EVERYTHING TOGETHER IN A
SCIENTIFICALLY RIGOROUS BUT
COMPLETE WAY.
>> JUST VERY BRIEFLY, BY
MID-FEBRUARY DO YOU THINK YOU
COULD ACTUALLY HAVE HOW MANY
DOSES INTO THE PIPELINE HERE IN
THE U.S.?
>> MY EXPECTATION IS WHAT
HAPPENS AFTER, SAY, A WEEK FROM
NOW WE GET OUR EMERGENCY USE
AUTHORIZATION APPLICATION IN, IN
THE DAYS OR THE FOLLOWING DAYS
WE GET A BRIEFING DOCUMENT TO A
SET OF ADVISERS THAT PLAN AN
ADVISORY COMMITTEE MEETING.
WE DON’T KNOW WHAT THE DATE OF
THAT IS YET, BUT IT WILL BE A
COUPLE WEEKS AFTER THAT
PRESUMABLY.
AND THEN FDA HAS BEEN VERY, VERY
HARDWORKING RIGHT NOW AND
INCREDIBLY GOOD IN PROPERLY BUT
QUICKLY ANALYZING OUR DATA.
SO I’M THINKING TOWARDS THE END
OF FEBRUARY IS WHEN WE MIGHT
HAVE AN EMERGENCY USE
AUTHORIZATION, AND WE PLAN ON
DELIVERING DOSES TO THE WORLD
IMMEDIATELY AFTER THAT.
OUR COMMITMENT, OUR PRE-AGREED
COMMITMENT TO THE UNITED STATES
IS 100 MILLION DOSES BY JUNE,
AND WE’VE BEEN ON TRACK AND
REMAIN ON TRACK TO DO EXACTLY
THAT.
AND THERE’S A SCHEDULE RIGHT NOW
THAT I DON’T KNOW THE DETAILS
OF, BUT THERE’S A RAMP-UP TO