ME
ME THEY'LL HAVE A BIG OLD PRESS CONFERENCE SOMETIME EARLY NEXT
WEEK. HOPEFULLY WITH A LOT MORE
ANSWERS. JAN , BACK TO YOU.
>> THANK YOU, CHRIS . WELL , AS
HE SAID, APPROVAL OF THE VACCINE
IS NOW IN THE HANDS OF THE FDA
EMERGENCY APPROVAL ANYWAY. THIS
AFTERNOON WE LEARNED THAT PANEL
WILL FORMALLY MEET TO REVIEW
THE APPLICATION ON DECEMBER
10TH. SO TONIGHT KENT EXPLAINS
WHAT THE FDA WILL BE LOOKING AT.
IN THE MEANTIME AND WHY
THE PROCESS IN THIS REALLY
MATTERS
MATTERS
MATTERS >> IF YOU'VE BEEN SKEPTICAL
ABOUT OPERATION WARP SPEED AND
THE RUSH TO FIND THE VACCINE,
YOU'RE NOT ALONE. THERE IS A LOT
OF SKEPTICISM, I HAVE TO SAY,
AND CONCERN IN THE MEDICAL
COMMUNITY WHEN IT WAS FIRST
ANNOUNCED THAT WE'RE GOING
TO TRY AND GET A VACCINE WITHIN
A YEAR JUST BECAUSE MOST DRUGS
TAKE IT. IT'S A MULTI-YEAR
PROCESS, NOT A MULTI MONTH
PROCESS.
PROCESS.
PROCESS. >> DR. WILLIAM MORRIS, PRESIDENT
OF MAYO CLINIC LABS, SAYS HIS
CONFIDENCE IN THE PROCESS HAS
GROWN AS THE PFIZER BIONTECH
VACCINE BECOMES THE FIRST
TO SEEK FDA EMERGENCY USE
AUTHORIZATION OR E.U..
>> IT'S REALLY IMPORTANT
FOR PEOPLE TO KNOW THAT THERE
ARE SAFETY DATA SAFETY
MONITORING BOARDS FOR THESE
VACCINES THAT ARE LOOKING AT ALL
THE DATA REAL TIME. SO IT'S VERY
LIKELY THAT THE SAFETY DATA
WILL BE STRONG AND PROVEN TO BE
SAFE BECAUSE IT'S NOT LIKE
IT'S GOING TO BE THE FIRST TIME
PEOPLE ARE LOOKING AT
THE INFORMATION SO FAR. HE SAYS
THERE HAVE BEEN NO MAJOR
INCIDENTS LIKE THE ONE THAT LED
ASTRAZENECA TO SUSPEND ITS
VACCINE STUDY EARLIER THIS YEAR.
BUT HE SAYS THE FDA WILL STILL
LOOK FOR ANY ISSUES NO MATTER
HOW MINOR THEY'RE LOOKING
FOR THINGS
FOR THINGS >> LIKE HEADACHE, RASH REACTION
TO THE VACCINE AND THERE'S BEEN
SOME OF THOSE THINGS. ONE OF
THINGS I'VE HEARD JUST FROM
PEOPLE THAT ARE FAMILIAR WITH IT
IS THAT IT CAN BE PAINFUL,
PARTICULARLY THIS SECOND
INJECTION. SO THOSE SORTS
OF THINGS ARE WHAT THEY'RE
LOOKING FOR .
>> HE SAYS THE VACCINE'S
EFFECTIVENESS WAS A BIGGER
QUESTION THAN SAFETY GOING INTO
THE PROCESS. BUT HE SAYS THAT IS
NOW WHY MANY IN THE MEDICAL
COMMUNITY ARE NOW VERY
OPTIMISTIC. DR.
OPTIMISTIC. DR. >> FALCHI HAD ANNOUNCED I THINK
EARLY ON THAT THEY WANTED THESE
TO BE AT LEAST 75 % EFFECTIVE
TO REALLY AT LEAST BE CONSIDERED
FOR U.A. SO TO HAVE THESE EARLY
RESULTS TO SUGGEST THAT
EFFECTIVENESS IN THAT GREATER
THAN 90 % RANGE IS REALLY QUITE
ENCOURAGING. HERE'S HOW
THAT BREAKS DOWN PFIZER
AND BIONTECH TRIAL INCLUDED
44000 VOLUNTEERS. TWENTY TWO
THOUSAND OF THEM GOT THE VACCINE
AND THE OTHER HALF GOT A PLACEBO
SHOT OF SALT-WATER. OVER TIME,
162 PEOPLE IN THE PLACEBO GROUP
DEVELOPED COVID . COMPARE
THAT TO JUST EIGHT WHO RECEIVED
THE VACCINE. DO THE MATH
AND THAT'S MORE THAN 95 %
EFFECTIVE SO FAR. I THINK
THE TWO BIG QUESTIONS OUT THERE
FOR ALL THE VACCINES, INCLUDING
THESE NUMBER ONE , YOU KNOW
THAT NINE YEAR NINETY FIVE %,
THAT DOES MEAN THAT SOME
PEOPLE THAT GOT VACCINATED STILL
HAVE DEVELOPED COVERED . SO
THE QUESTION IS WILL HAVING
THE VACCINE PREVENT YOU FROM
GETTING SICK? BECAUSE THAT'S HOW
A LOT OF VACCINES WORK,
PARTICULARLY FOR RESPIRATORY
VIRUSES LIKE INFLUENZA. YOU
MIGHT STILL GET THE VIRUS,
BUT YOU TEND TO GET MUCH LESS
SICK IF YOU DO . AND THE OTHER,
OF COURSE, IS HOW LONG WILL IT
LAST? YOU KNOW, HOW LONG
WILL THE IMMUNITY LAST? SO WHERE
YOU ARE NOW VERSUS WHERE YOU
WERE WHEN THIS OPERATION WARP
SPEED WAS ANNOUNCED FOR US
>>, FOR THE MEDICAL COMMUNITY,
WHAT THIS MEANS IS WITH THIS
THERE'S DATA I JUST WAS ON
A CALL WITH THE STUDY GROUP
NATIONALLY LOOKING AT
CONVALESCENT PLASMA. THERE'S
NOW CONTROLLED TRIALS COMING OUT
THAT'S SHOWING THAT IS
EFFECTIVE. WE KNOW
THE MONOCLONAL ANTIBODY
THERAPIES ARE EFFECTIVE. SO
WE ARE NOW AT A POINT WHERE
WE CAN START TO SEE, IF YOU
WILL , THE BEGINNING OF THE END
WHERE WE'LL HAVE ACTUAL TOOLS
TO HELP FIGHT
COVERED . UNFORTUNATELY FOR ALL
OF US IS COMING A LITTLE BIT TOO
LATE COMPARED TO THE SURGE
THAT WE'RE IN THE MIDST OF RIGHT
NOW IN OUR REGION. BUT IT GIVES
US GREAT HOPE HERE GOING 2021
THAT WE WILL HAVE THE TOOLS
TO REALLY MANAGE COVID GOING
FORWARD. NOW KEEP
>> IN MIND THE FDA WILL START
GOING THROUGH ALL OF THIS DATA.
IT'S A LOT OF IT LEADING UP TO
THAT MEETING ON DECEMBER 10TH.
SO THEY SHOULD BE ABLE TO HIT
THE GROUND RUNNING , BUT WE
DON'T KNOW EXACTLY WHEN
THAT APPROVAL WILL COME IN .
PART OF THAT IS BECAUSE
IT'S CHRIS MENTIONED THERE IS
ANOTHER VACCINE OUT THERE
THAT WILL ALSO BE STARTING THIS
PROCESS SOON. SO HOW MUCH THOSE
WILL OVERLAP? HOW MUCH DATA HAS
GONE THROUGH THAT WILL
HELP DETERMINE ALL OF IT? JANA
KANTI MENTIONED IN THIS STORY
SEVERAL DOCTORS HAVE MENTIONED
TO ME WHEN I'VE INTERVIEWED
THEM ABOUT THIS THAT THERE IS
STILL CONCERNED BY SOME FOLKS
OUT IN THE PUBLIC ABOUT
THE SPEED OF THIS. WE'RE USED
TO THESE THINGS TAKING FIVE
YEARS. WHAT ARE THEY DOING ABOUT
ANY POTENTIAL LONG TERM SIDE
EFFECTS IN THESE VACCINES? HOW
CAN THEY FIGURE THOSE OUT?
>>, IT'S SOMETHING THAT THEY'RE
CONTINUING TO RESEARCH. HE SAID
AS MANY ARE TRYING TO SAY
RIGHT NOW IS JUST BECAUSE
THERE'S AN EMERGENCY USE USE
AUTHORIZATION DOESN'T MEAN
THAT THE OLDER METRICS DON'T
CONTINUE AND THAT THIS RESEARCH
DOESN'T STOP. SO BY THE TIME
MOST OF US HAVE ACCESS TO THAT
VACCINE, WE WILL HAVE MONTHS
MORE OF DATA AND RESEARCH TO