Pfizer seeks FDA approval for COVID-19 vaccine booster dose
Updated: 11:23 AM CDT Aug 26, 2021
PFIZER COVID EVACUATION FULL APPROVAL. I'M JOINED NOW BY DOCT JOREFF POTHOF FROM U.W. HEALTH. HOWS DOE THE F.D.A. MOVE FROM EMERGENCY USE TO FULLY APPROVING USE? JEFF: YOU KNOW WT'HAS REALLY THE AMOUNT OF DATA THAT THEY LOOK THROUGH. SO FOR EMERGENCY USE, A LOT OF THAT DATA IS SAFETY, EFFICACY WHEN YOU GET TO FULL APPROVAL, WOW IS IT MANUFACTURED? HOW IS IT TRANSPORTED? HOUNDS OF THOUSANDS OF PESAG OF DOCUMENTS WERE REVIEWED TO GET THIS FLUL F.D.A. APPROVAL. THE MOST RIGOROUS APPROVAL THAT YOU CAN GET ANYWHERE IN THE WORLD ON A MEDICATION OR DRUG. DIANA: SO WE'RE TALKING PFIZER FOR NOW, RIGHT? HOW CLOSE IS MODERNA IN GETTING THAT FULL APPROVAL AS WELL? JEFF: I THINK MODERNA IS FARTHER BEHIND. PFIZER HAD SUBMITTED FIR.ST PFIZER IS A LITETL BIT BIGGER COMPANY. SO THEIR ABILITY TO PRODUCE THAT DATA IS EASIER. BUT ALL OF US IN HEALTH CARE DO THINK MODERNA WILL ALSO AT SEOM POINTN I THE FUTURE GET FULL F.D.A. APPROVAL. DIANA: BASED ON YOUR EXPERIENCE, WILL THIS CHANGE PEOPLE'S MIND IN GETTING THE EVACUATION? HAVE -- VACCINE HAVE YOU HAD THOSE CONVERSATIONS WITH PATIENTS? JEFF: FOR SOME PATITSEN, IT WILL. SOME PATIENTS WEER MISLED THINKING TTHA EMERGENCY USE MEANT THAT THE VACCINE WAS EXPERIMENTATIONAORL WE CAN'T TRUST THE SETAFY PROFI.LE FULL F.D.A. APPROVAL MAKES THIS VACCINE JUST AS SAFE AND FOR SOME PEOE,PL THAT WILL MAKE A DIFFERENCE. AT THE SAME TIME, I DON'T THINK F.D.A. AROPPVAL WILL HAVE EVERYONE WHO'S UNVACCINATED SIGNING UP FOR APPOINTMENT JUST YET. DIANA: AND I KNOW WE'VE BEEN TALKING ABOUT BOOSTER SHOTS AS WELL. ARE YOU RECOMMENDING THE IMMUNOCOMPROMISED GET THAT BOOSTER SHOT OR START THAT COERNVSATION WITH THEIR DOCTOR? JEFF: YEAH, FOR SURE IF YOU'RE IMMUNOCOMPROMISED AND YOU CAN FIGURE OUT THAT DEFINITION. ITS I MODERATELY OR SEVERELY. WHAT WE'VE LEARNED IS FOR THOSE SPECIFIC PEOPLE, A THREE-SHOT SERIES IS BETTER THAN A TWO-STHO SERIES. SO FOR THOSE FOLKS GETNGTI THAT THIRD DOSE IS A GOOD IA.DE DIANA: THERE MUST BE PEOPLE AT HOME THAT HAVE GOTTEN THE JOHNSON & JOHNSON CASINO WE HAVEN'T BEEN HEARING IN TERMS OF FULL APPROVAL FOR THAT ONE. HAVE YOU HRDEA ANYTHING ABOUT THAT VACCI?NE JEFF, NO NOT YET. WHY J&J IS LAGGING IITS WAS THE LAST THAT WAS PROVED FOR EMERGENCY USE. SO THERE'S NOT AS MUCH DATA. BUT I DO KNOW THAT J&J IS LOOKGIN AT THE EFFECTS OF TWO DOSES. AND AS THOSE DATA COME IN, I'M SURE THOSE FOLKSHO W HAVE GOTTEN A&J J VACCINE WILL GET UPDATEDDED A AS FAR AS BOOSTERS, DO YOU NEED SWITCH TO ANOTHER SHOT? THAT'SLL A FORTHCOMING. DIANA: IT'S ALL NORMAL. FOR DATA, FOR SCIENCE, TO CHANGE. I KNOW THIS HAS BEEN A BIG CONVERSATION. THINGS MIGHT CHANGE IN THE COMING MONTHS. JEFF: ABSOLUTELY. I THINK OFTENTIMES WHEN TEEM EXPERIENCE SCIENCE, IT'S AFTER WE'VE HAD DECADES OF EXPIENCEER WHETHER IT'S HEART DISEASE, DIABETES, BUT COVID-19S I A NEW DISEASE SO WHAT YOU'RE WITNESSING IS HOW SCIENCE IS CREATED IS TESTING AND LEARNING MORE AS WE GO. PEOPLE SHOULD BE MORE IF THE DATA WASN'T CHANGING THAN THE FACT THAT IT IS. THE FACT THAT IT IS THAT'S MEANS THAT WE'RE REISRAELING THE DATA AND CHANGING GUIDANCE B
Pfizer seeks FDA approval for COVID-19 vaccine booster dose
Updated: 11:23 AM CDT Aug 26, 2021
Pfizer is seeking U.S. approval of a booster dose of its two-shot COVID-19 vaccine.The drugmaker said Wednesday that it has started the application process for a third dose of its vaccine for people ages 16 and older. The company said it will complete the application with the Food and Drug Administration by the end of this week.The company's move follows an announcement by U.S. health officials last week of plans to give COVID-19 booster shots to all Americans to shore up their protection amid the surging delta variant of the virus. Officials said it is "very clear" that the vaccines' protection against COVID-19 infections wanes over time.Pfizer's vaccine received full FDA approval earlier this week; it had been used since last December under an emergency use authorization. The three vaccines used in the U.S. made by Pfizer, Moderna and Johnson & Johnson are still preventing hospitalizations and deaths from COVID-19. But the vaccines don't appear quite as strong against the highly contagious delta variant as they were against earlier versions of the virus.Earlier this month, U.S. regulators said transplant recipients or others with weakened immune systems can get an extra dose of Pfizer or Moderna vaccines. ___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.
Pfizer is seeking U.S. approval of a booster dose of its two-shot COVID-19 vaccine.
The drugmaker said Wednesday that it has started the application process for a third dose of its vaccine for people ages 16 and older. The company said it will complete the application with the Food and Drug Administration by the end of this week.
The company's move follows an announcement by U.S. health officials last week of plans to give COVID-19 booster shots to all Americans to shore up their protection amid the surging delta variant of the virus. Officials said it is "very clear" that the vaccines' protection against COVID-19 infections wanes over time.
Pfizer's vaccine received full FDA approval earlier this week; it had been used since last December under an emergency use authorization.
The three vaccines used in the U.S. made by Pfizer, Moderna and Johnson & Johnson are still preventing hospitalizations and deaths from COVID-19. But the vaccines don't appear quite as strong against the highly contagious delta variant as they were against earlier versions of the virus.
Earlier this month, U.S. regulators said transplant recipients or others with weakened immune systems can get an extra dose of Pfizer or Moderna vaccines.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.