HEAR FROM THOSE HEALTH CARE
WORKERS.
MEAGAN FITZGERALD, THANK YOU FOR
THAT REPORT.
>>> WE WANT TO TURN NOW TO NBC
NEWS MEDICAL CONTRIBUTOR DR.
KAVITA PATEL.
SHE WAS PART OF THE PRESIDENT
OBAMA’S RESPONSE TO THE H1N1 FLU
OUTBREAK.
NOW SHE IS A PRIMARY CARE
PHYSICIAN AND WITH THE BROOKINGS
INSTITUTION.
DR. PATEL, GOOD MORNING.
IT’S NICE TO SEE YOU ON THIS
HOPEFUL DAY.
FINALLY THE ARRIVAL OF A
VACCINE.
NORMALLY THIS CAN TAKE FIVE
YEARS, THIS TIME IT’S TAKING
LESS THAN A YEAR BUT SPEED CAN
ALSO BE A DOUBLE-EDGED SWORD.
HOW DO YOU CONVINCE AMERICANS
THAT NO CORNERS WERE CUT IN THIS
PROCESS AND THAT THIS VACCINE IS
SAFE FOR THEM TO TAKE?
>> YEAH, PETER, GOOD MORNING.
YOU’RE RIGHT, IT IS AN
INCREDIBLE -- IT TRULY IS A
MIRACLE AND WE’RE ALL VERY EAGER
TO SEE HOW WE CAN BENEFIT FROM
THIS.
HERE’S WHY I FEEL IT’S SAFE.
IT’S REALLY BECAUSE OF THE
TRANSPARENCY AROUND THE DATA.
THE SHORTCUTS, SO TO SPEAK, IN
TERMS OF TIME WAS NOT FROM
SAFETY, IT WAS FROM COMBINING
AND RUNNING PHASES ONE AND TWO
ESSENTIALLY IN PARALLEL WHERE
NORMALLY THEY WOULD BE
CONTIGUOUS.
SO ONE AND TWO WERE BASICALLY
DONE AT THE SAME TIME.
PHASE THREE, THE MOST IMPORTANT
BECAUSE IT HAD UP TO 44,000
PEOPLE ENROLLED ACROSS THE WORLD
IN THIS TRIAL WAS NOT SHORTCUT
AND THE FDA WAS REALLY CLEAR
THAT THEY WANTED TO SEE
FOLLOW-ON DATA AND INCREDIBLY
DETAILED STATISTICS WHICH WERE
FULLY PRODUCED IN THE "NEW
ENGLAND JOURNAL OF MEDICINE" AS
WELL AS THE FDA’S ADVISORY
PACKET.
THERE WE SAW EVERYTHING, PETER,
FROM ADVERSE EFFECTS LIKE LOCAL
SITE INJECTION SORENESS AND ALSO
INCLUDED IN THAT PACKET WERE
DETAILS ABOUT THE PEOPLE IN THE
TRIAL, AND THAT’S WHAT LED TO
THE FDA OFFERING AS YOU PUT IT
AN EMERGENCY AUTHORIZATION.
REMEMBER, NOT A FULL APPROVAL.
THINK OF IT AS A TEMPORARY
PERMIT, WHICH WOULD STILL MEAN
THAT THE FDA IS GOING TO CLOSELY
TRACK SAFETY DATA.
>> SO LET ME DRILL DOWN ON THAT.
AS YOU NOTE, EMERGENCY USE
AUTHORIZATION IS DIFFERENT THAN
FULL APPROVAL.
IT MEANS THERE ARE MORE
QUESTIONS OUT THERE, MORE
STUDIES TO BE DONE.
WHAT ARE THOSE OUTSTANDING
QUESTIONS AS THEY RELATE TO
LONG-TERM EFFECTS AND HOW LONG
THIS MIGHT LAST?
>> INCREDIBLY IMPORTANT
QUESTIONS THAT THE FDA AND
SCIENTISTS ACROSS THE WORLD ARE
STILL GOING TO BE LOOKING FOR.
NUMBER ONE ARE CERTAIN
POPULATIONS.
OBVIOUSLY THE AUTHORIZATION WAS
FOR AGES 16 AND OLDER.
THAT LEAVES OPEN QUESTIONS FOR
WHAT TO DO ABOUT PEDIATRIC
POPULATIONS UNDER THE AGE OF 16.
TRIALS WILL EVENTUALLY GO ON
THAT WILL LOOK AT DIFFERENT AGE
GROUPS.
NUMBER TWO, PREGNANT WOMEN.
WE’VE ALREADY SEEN THAT PREGNANT
WOMEN WHO GET COVID CAN BE AT A
HIGHER RISK POTENTIALLY FOR
PRETERM LABOR.
SO WE REALLY WANT TO UNDERSTAND
SHOULD WE OFFER THIS TO PREGNANT
WOMEN.
THERE WERE SOME INCLUDED IN THIS
TRIAL POPULATION, BUT NOT ENOUGH
TO MAKE A STATISTICAL
CALCULATION ON WHETHER WE SHOULD
OFFER THIS.
THE THIRD GROUP THAT IS STILL
OUTSTANDING IS PEOPLE WHO HAVE
HAD COVID, PETER.
WE KNOW THAT SOME OF THE TRIAL
PARTICIPANTS DID, BUT WE ALSO
WANT TO WATCH CLOSELY TO SEE
WHAT HAPPENS FOR PEOPLE WHO HAVE
HAD COVID AND CONTINUE AND
RECOMMEND THAT WE GET THE
VACCINE TO THEM.
>> LET ME ASK YOU QUICKLY, THE
WHITE HOUSE CORONAVIRUS TASK
FORCE THIS WEEKEND REPORTS TO
STATES THAT THE CURRENT VACCINE
IMPLEMENTATION WILL NOT
SUBSTANTIALLY REDUCE VIRAL
SPREAD, HOSPITALIZATIONS OR
FATALITIES UNTIL THE 100 MILLION
AMERICANS WITH CO-MORBIDITYIES
CAN BE IMMUNIZED WHICH WILL TAKE
UNTIL THE LATE SPRING.
SO THERE IS LIGHT AT THE END OF
THE TUNNEL BUT CAN AMERICANS LET
THEIR GUARD TOWNDOWN NOW?
>> NO.
CASE IN POINT IF I WERE TO GET
THE VACCINE TOMORROW, I WOULD
CONTINUE TO WEAR MY PPE AND HAVE
MY ENTIRE FAMILY EVEN AS THEY
GET VACCINATED AT SOME POINT.
YOU SHOULD NOT LET YOUR GUARD
DOWN.
REMEMBER, THE VACCINE CANNOT
PREVENT YOU FROM GETTING
CORONAVIRUS.
YOU CAN STILL GET THE
CORONAVIRUS.
IT JUST HELPS TO REDUCE THE
RELATIVE RISK OF DISEASE FROM
IT.
AND THEN ON TOP OF THAT, PETER,
WE STILL DON’T KNOW IF WE CAN
GIVE IT TO OTHER PEOPLE IF WE
GET VACCINATED SO WE CANNOT LET
OUR GUARD DOWN.