What the FDA's full approval for Pfizer's COVID-19 vaccine means for U.S. adults and children

[vc_row][vc_column][vc_video link="https://www.youtube.com/watch?v=BdKHAnT2KgA"][/vc_column][/vc_row][vc_row][vc_column][vc_column_text][/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]&gt;&gt; THANK YOU SO MUCH. &gt;&gt;&gt; PFIZER'S COVID-19 VACCINE IS THE FIRST IN THE U.S. TO RECEIVE FULL APPROVAL FROM THE FDA. UNTIL YESTERDAY, THE SHOT WAS UNDER EMERGENCY USE AUTHORIZATION. IT STILL HAS NOT BEEN FULLY APPROVED FOR CHILDREN 12 TO 15 YEARS OLD. NEVERTHELESS, HEALTH OFFICIALS ARE HOPING THESE TWO BUSINESSMEN WILL CONVINCE MORE AMERICANS TO GET VACCINATED. HERE TO TALK ABOUT ALL OF THIS IS DR. JESSICA SHEPPARD, THE CHIEF MEDICAL OFFICER AT BERRY WILL HELP. THANK YOU FOR JOINING US THIS MORNING, JESSICA, GOOD TO SEE YOU. WHAT MORE CAN YOU TELL US ABOUT THE FDA GRANTING FULL APPROVAL FOR THE PFIZER VACCINE? HOW DOES THE AGENCY MAKE THAT DETERMINATION? &gt;&gt; GOOD MORNING, ANNE-MARIE. SUCH A MILESTONE WHEN YOU THINK OF THE VACCINATION PROCESS. WHEN YOU THINK THAT THIS WAS UNDER EMERGENCY AUTHORIZATION FOR SO LONG, BUT YET WE STILL HAVE THE SCIENCE BEHIND THE VACCINE THAT REALLY ALLOWS US UNDERSTAND THAT IT DOES WORK. AND WHAT WE ARE SEEING NOW IS A MORE THAN 1000 PEOPLE HAVE DIED JUST THIS WEEK, OVER 95% OF THOSE OF BEEN UNVACCINATED. THIS IS A MILESTONE AS WE CONTINUE TO BATTLE THE COVID-19 VIRUS , AND THE PANDEMIC. WE KNOW THAT ANOTHER WE HAVE APPROVAL, THIS SHOULD HELP WITH ANY VACCINE HESITANCY. &gt;&gt; THE PFIZER VACCINE IS UNDER EMERGENCY USE AUTHORIZATION FOR CHILDREN 12 TO 15 YEARS OLD, IS THERE ANY INDICATION THAT IT MAY SOON BE GRANTED FULL APPROVAL FOR THAT AGE BRACKET? &gt;&gt; THERE WAS A LETTER THAT WAS WRITTEN LAST WEEK BY THE AMERICAN ASSOCIATION OF PEDIATRICS, URGING TO GET THAT AUTHORIZATION FOR THE VACCINE FOR 12 TO 15, HOWEVER, THE FDA HAS BEEN STRONGEST FOR SKIPPING SAFETY AND EFFECTIVENESS AS FAR AS PASSING VACCINE FOR CHILDREN BETWEEN THE AGES OF 12 TO 15. THIS AND THAT HOPEFULLY BY THE END OF THE YEAR, PROBABLY BY NOVEMBER, WE WILL SEE THAT THERE IS AUTHORIZATION FOR THAT AGE GROUP. &gt;&gt; THE FDA IS ALSO PUTTING OUT A BIT OF A WARNING ABOUT USING THE VACCINE OFF LABEL IN CHILDREN YOUNGER THAN 12 YEARS OLD. CAN YOU EXPLAIN TO VIEWERS WHAT OFF LABEL MEANS? &gt;&gt; WHEN WE THINK OF ON LABEL AND OFF LABEL, ON LABELS EXACTLY AS YOU SAID. SOMETHING THE FDA HAS APPROVED. THIS IS GOING WITH STUDIES AND RESEARCH THAT GOES BEHIND AUTHORIZATION. EVEN EMERGENCY USE AS WELL. OFF LABEL IS WHEN YOU MIGHT HAVE SOMEONE WHO UTILIZES A DRUG OR SURGERY OR DEVICE, KNOWING WHAT IT IS FOR, BUT USING IT IN A POPULATION FOR WHAT IT IS NOT AUTHORIZED TO BE USED. AGAIN, THIS IS WHAT WE SEE WITH MANY MEDICATIONS TO THE PANDEMIC THE PEOPLE USING ON OFF LABEL USE. THAT IS WHAT THEY ARE URGING, THIS IS NOT GOING TO HAPPEN WITH THE VACCINE BEING USED IN UNDER THE AGE OF 12. &gt;&gt; I GOTTA TELL YOU, I'VE HAD PEOPLE SAY TO ME, ASKED ME BUT MY DAUGHTER, WHO IS UNDER THE AGE OF 12, AND WHETHER OR NOT I WOULD GET HER VACCINATED. THEY WILL NOT ASK YOU THE AGE OF THE CHILD. SUGGESTING THAT I COULD DO THAT, I THINK THAT IS WHY THE FDA HAS TO MAKE IT VERY VERY CLEAR. DON'T DO THIS, THERE IS AN AGE LIMIT FOR REASON. THE TIME COMES, IT WILL BE APPROVED. WHAT ABOUT SKEPTICS WHO THINK THE FDA RUSHED APPROVAL? WHAT WOULD YOU SAY TO THEM? &gt;&gt; I THINK IT'S A GREAT QUESTION, THERE ARE THOSE ON THE OTHER SIDE WHO FELT THE FDA TOOK RATHER LONG. I THINK WE HAVE SEEN BOTH -- SKEPTICS AGAINST THE GOVERNMENT AND AGENCIES AND HOW THEY DO THEIR WORK. THE FDA WAS VERY CAREFUL, SPECIFICALLY WITH THIS VACCINE BECAUSE IT WAS UNDER EMERGENCY USE 3 1/2 MONTHS AFTER THE PAPERWORK WAS TURNED IN BY PFIZER WHEN THE PANDEMIC FIRST STARTED. NOW THAT THEY HAVE TAKEN THEIR TIME TO ACTUALLY HAVE FULL APPROVAL OF THE VACCINE, THEY ARE VERY FIRM AND READY TO SAY THAT THEY DID IT WITH THE AMOUNT OF TIME THAT WAS NEEDED IN ORDER TO GO THROUGH THE STUDIES AND THE DATA THAT WAS DONE IN PRECLINICAL AND CLINICAL STUDIES. &gt;&gt; SO, YOU KNOW, THIS APPROVAL IS ONE WAY THAT WE ARE PROGRESSING. BUT, THE DELTA VARIANT CONTINUES TO MAKE ITS WAY ACROSS THE COUNTRY. WAS IN THE UNVACCINATED POPULATION, WE'RE TALKING ABOUT KIDS. YOU ARE DR., CASES OF BEEN ON THE RISE IN YOUR STATE. THEIR REPORTS OF PEDIATRIC ICUs ARE COMPLETELY FULL. WHAT MORE CAN YOU TELL US ABOUT THE SITUATION? ARE YOU HOPEFUL THINGS WILL BE GETTING BETTER NOW THAT ONE OF THE VACCINE SAYS FULL APPROVAL? &gt;&gt; YOU KNOW, THIS IS SOMETHING THAT HITS HOME. AS WE STARTED TO SEE FROM CHILDREN FILLING ICUs, WE KNOW THAT THIS IS VERY IMPACTFUL. WHEN WE THINK OF ACTUAL REPORTED CASES, SINCE 2000 -- SORRY, JUNE OF 2021, THERE BEEN 181 MILLION REPORTED CASES GLOBALLY. 2 TO 4 MILLION DEATHS. WHAT WE KNOW FROM THIS IS THAT IT IS MOSTLY UNVACCINATED PERSONS. WHAT DOES THAT REALLY MEAN? IT MEANS THAT THE VIRUS CAN STILL BESPREAD TO CHILDREN, BECAUSE THEY ARE NOT VACCINATED. AGAIN, NOW WE SEE THE DELTA VARIANT, MUCH MORE AGGRESSIVE. MUCH MORE TRANSMISSIBLE. NOW THAT IS WHY WE ARE SEEING IT IMPACTED IN THIS POPULATION, AND REPORTED THAT MORE ADMISSIONS, AND POSSIBLY DEATHS WITH CHILDREN. THIS IS CHANGE THE GAME SO MUCH MORE THAN WHAT WE SAW LAST YEAR. NOW WE'RE DEALING WITH VARIANCE. WITH THE VACCINE BEING PASSED, WE NEED MORE OF THE COMMUNITY BEING VACCINATED IN ORDER TO PROTECT THE GREATER GOOD. INCLUDING CHILDREN. &gt;&gt; SO JESSICA, YOU'RE NOT JUST THE CHIEF MEDICAL OFFICER, YOU'RE ALSO A TRAINED OB/GYN. WE HAVE TALKED A LOT ABOUT THE VACCINE IN TELLING WOMEN WHO ARE PREGNANT THAT THE VACCINE IS SAFE FOR THEM TO USE. WE HAVE NOT SPENT A LOT OF TIME TALKING ABOUT HOW DANGEROUS COVID-19 IS SACKED BURGERS REPORTING THAT AS OF AUGUST, 76% OF WHAT PREGNANT WOMEN WERE UNVACCINATED. I COULDN'T BELIEVE THAT STATISTICS. IS AN OB/GYN, WHAT CONCERNS YOU THE MOST ABOUT THIS? THE REPORT ALSO HAD SOME REALLY CONCERNING STATISTICS ABOUT HOW VULNERABLE PREGNANT WOMEN ARE TO THE VIRUS. &gt;&gt; I THINK YOU USED THE PERFECT WORD, VULNERABLE. A VULNERABLE POPULATION, AND WE THINK A PREGNANCY OR THOSE WHO ARE POSTPARTUM OR LACTATING, THERE SEEMS TO BE A CHANGE IN PERCEPTION AND WHO THEY'RE TRYING TO PROTECT. NOT ONLY THEMSELVES, BUT AN UNBORN CHILD OR NEWBORN. IT CHANGES THE GAME. WHAT WE HAVE SEEN IS THAT THERE IS A LOT OF DIFFERING OPINIONS, EVEN AMONG HEALTHCARE PROVIDERS , WHO MAY NOT STRONGLY ADVISE PREGNANT PATIENTS TO GET THE VACCINE. THIS IS WHERE WE STILL NEED TO KEEP THAT MESSAGING OF THE IMPORTANCE OF THE VACCINE IN THOSE WHO ARE PREGNANT, LACTATING, AND THOSE WHO ARE DECIDING TO GET PREGNANT. IT IS SO IMPORTANT, BECAUSE WHAT WE DO KNOW IN PREGNANCY, IS THAT IF YOU DO HAVE COVID- 19, YOUR LIKELIHOOD OF BEING INTUBATED, ADMITTED TO THE ICU, AND DEATH, WE ARE STILL SEEING DEATHS IN OUR LOCAL HOSPITAL BUT A WORKOUT IN DALLAS, PEOPLE DYING WHO ARE PREGNANT. THROUGHOUT THIS SEGMENT, WE REALLY WANT TO SPEAK TO THOSE PREGNANT WOMEN TO GET VACCINATED<br><!-- wp:image {"id":1776,"sizeSlug":"large","linkDestination":"none"} -->rn<figure class="wp-block-image size-large"><img class="wp-image-1776" src="https://en.videoencontexto.com/wp-content/uploads/2021/10/What_the_FDAs_full_approval_for_Pfizers_COVID19_vaccine_means_for_US_adults_and__BdKHAnT2KgA.jpg" alt="What the FDA\'s full approval for Pfizer\'s COVID-19 vaccine means for U.S. adults and children" /></figure>rn<!-- /wp:image -->[/vc_column_text][/vc_column][/vc_row]

What the FDA's full approval for Pfizer's COVID-19 vaccine means for U.S. adults and children

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