AGAIN TODAY, BUT LET’S TALK ABOUT PUBLIC HEALTH OFFICIALS
SCOLDING A COVID VACCINE DEVELOPER TODAY FOR INCLUDING
WHAT THEY CALL MISLEADING INFORMATION ON A PRESS RELEASE
ABOUT ITS CLINICAL TRIAL.
HERE TO ANSWER YOUR QUESTIONS ABOUT THAT IS DR. TODD ELLERIN,
CHIEF OF INFECTIOUS DISEASES AT SOUTH SHORE HEALTH.
THANKS FOR BEING WITH US.
ED: LET’S DRILL DOWN ON THE ASTRAZENECA VACCINE.
IT’S NOT AUTHORIZED FOR USE IN THE UNITED STATES YET, BUT IT IS
AVAILABLE IN OTHER COUNTRIES.
YESTERDAY, THE COMPANY RELEASED DATA FROM A U.S. TRIAL SAYING
THE VACCINE SHOWED 79% EFFICACY AGAINST SYMPTOMATIC DISEASE, AND
100% EFFICACY AGAINST SEVERE DISEASE AND HOSPITALIZATIO
LET ME ASK YOU THIS -- WHAT COULD BE MISLEADING ABOUT THOSE
NUMBERS?
THIS IS REALLY AMAZING.
INITIALLY, THEY RELEASED THE DATA YOU JUST SHOWED.
THAT WAS A GLOBAL SIGH OF RELIEF.
I REMEMBER SAYING, THIS IS IMPRESSIVE.
THEN TONY FOUR HOURS LATER, WE HEAR THE INDEPENDENT SAFETY DATA
MODERN BOARD TOLD THE NIH AND ASTRAZENECA THAT THEY FELT THESE
NUMBERS WERE NOT COMPLETE.
THERE WAS ISSUES WITH DATA INTEGRITY.
BASICALLY, IT IS POSSIBLE THOSE TOPLINE NUMBERS THAT WE ARE
HEARING ABOUT MAY NOT BE ACCURATE, AND THEY MAY HAVE BEEN
REPORTED, BUT NOT IN A COMPLETELY.
SO IT’S POSSIBLE -- NOT A COMPLETE WAY.
SO IT’S POSSIBLE THERE ARE OTHER RESULTS THAT NEED TO BE
INCLUDED.
THERE HAVE BEEN A SERIES OF MISHAPS WITH ASTRAZENECA.
I BELIEVE THIS VACCINE HAS ENORMOUS POTENTIAL, BUT THEY
REALLY HAVE TO PROVE TO US THEY CAN STOP BEING CARELESS WITH THE
WAY THEY ARE HANDLING COMMUNICATIONS, DATA INTEGRITY,
AND THE WAY THE OPERATED SOME OF THESE CONICAL TRIALS.
MARIA: BUT NOW THAT WE HAVE THIS NEWS, IT’S GOING TO BE HARD TO
CONVINCE THE PUBLIC.
THIS IS ALL NEW TO ALL OF US.
IS THIS SAFE TO GET?
IS THIS SOMETHING I WANT TO STAY AWAY FROM?
GIVE ME PFIZER, MAGENTA, JOHNSON & JOHNSON, GIVE ME SOMETHING
ELSE, BASED ON THIS -- HOW DO YOU SHIFT PUBLIC OPINION ON
THIS?
OR IS IT TOO LATE?
>> THERE’S NO ISSUES WITH SAFETY.
I WANT EVERYONE TO KNOW, I DO BELIEVE THIS IS GOING TO BE A
VERY EFFECTIVE VACCINE.
IT’S JUST A LOT OF IT IS ISSUES ABOUT JUST A OF CARELESS
HANDLING OF THINGS.
DESPITE THE FACT THAT IT IS LIKELY EFFECTIVE.
WE ARE GOING TO HEAR WITHIN THE NEXT 48 HOURS OF RESULTS.
BUT I WANT PEOPLE TO REMEMBER, THE FDA STILL NEEDS TO WEIGH IN
ON THIS.
THEY LOOK AT THE RAW DATA.
THEY DON’T LOOK AT PRESS RELEASES.
ASTRAZENECA RELEASES.
THE OTHER THING IS THAT THE CDC HAS AN ADVISORY COMMITTEE THAT
ALSO SCRUTINIZES THE DATA AND MAKES RECOMMENDATIONS.
BETWEEN THAT, I AM CONFIDENT WE ARE GOING TO WHETHER OR NOT THIS
IS A SAFE AND EFFECTIVE VACCINE FOR THE U.S.
ED: AND THAT RAW DATA, -- IN THAT RAW DATA, THERE SHOULD BE
INFORMATION ABOUT THE LINK BETWEEN ASTRAZENECA AND REAR
BLOOD CLOTS.
WILL THAT BE PART OF WHAT THEY REVEAL?
-- RARE BLOOD CLOTS.
WILL THAT BE PART OF WHAT THEY REVEAL?
>> I WANT TO POINT OUT, THERE WERE ABOUT 21,000 PATIENTS IN
THE VACCINE GREW BETWEEN THE U.S., CHILE, AND PERU COME OF
THE THREE COUNTRIES INVOLVED IN THIS PHASE THREE CLINICAL TRIAL.
THERE WERE ZERO CASES OF CLOTS LINKED TO THE MR. ZENECA VACCINE
AND THE EUROPEAN MEDICINE AGENCY , THEY HAVE BASICALLY SAID
THAT IT’S NOT SHOWN THAT THERE IS GREATER THAN EXPECTED CASES
OF CLOTS THEN WHAT WE NORMALLY WOULD EXPECT.
MARIA: REALLY QUICKLY, IF THE FDA APPROVES THE, IF THE FDA
APPROVES THE, WOULD YOU LET YOUR PATIENTS GET THIS
SHOT?
>> VERY IMPORTANT QUESTION.
I DO BELIEVE ASTRAZENECA’S VACCINE IS SAFE AND IS GOING TO
BE SHOWN TO BE EFFECTIVE.
SO THE ANSWER IS YES.
BUT I WANT TO SEE THAT THE FDA HAS SCRUTINIZED, AND I WANT TO
HEAR THE CDC HAS RECOMMENDED IT.
I WANT TO SEE WHAT THE NEXT 48 HOURS BRINGS.
I WANT TO SEE DATA INTEGRITY HEAR FROM ASTRAZENECA.