Updated: 12:35 PM EDT Apr 5, 2021
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>> IT HAS JUST BEEN ONE DAY SINCE OFFICIALS AT THIS COMPANY CONFIRMED ON THE RECORD FOR THE FIRST TIME THAT THEY HAVE YET TO GET FDA APPROVAL TO MAKE THE VACCINE. THEY CHALKED IT UP TO PROCESS YESTERDAY, BUT TODAY THERE IS A PAIR OF REPORTS THAT POINT TO SOME OTHER REASONS WHY. ACCORDING TO THE AP EMERGENT HAS , BEEN REPEATEDLY CITED FOR QUALITY CONTROL ISSUES. THE NEW YORK TIMES REPORTING, A A MIXUP HERE LED TO 15 MILLION DOSES GOING IN THE TRASH. >> I JUST BECAME AWARE OF IT YESTERDAY AS IT BECAME PUBLI AND MOST OF THE WORLD BECAME AWARE. IT WAS NOT MENTIONED BY THE WHITE HOUSE DURING OUR TUESDAY CALL. >> MARYLAND GOVERNOR LARRY HOGAN DIDN’T HEAR ABOUT THE PROBLEM WITH EMERGENT BIOSOLUTIONS’ JOHNSON AND JOHNSON VACCINE PRODUCTION FROM THE FEDS. HE TOLD REPORTERS TODAY HE FOUND OUT LIKE NEARLY EVERYONE ELSE, THE NEW YORK TIMES REPORTING THAT A MASSIVE MISTAKE AT EMERGENT’S BAYVIEW MANUFACTURING PLANT RUINED 15 MILLION DOSES VACCINE, DELAYING DISTRIBUTION OF THE ONE DOSE J AND J JAB. AND DELAYING FDA EMERGENCY APPROVAL OF THE BAYVIEW FACILITY. >> OBVIOUSLY THIS 15 MILLION SETBACK IS NOT HELPFUL BUT I DOESN’T DETER US. >> MARYLAND HEALTH OFFICIALS SAY WHILE OTHER VACCINE MAKERS ARE CHURNING OUT MORE TO MAKE UP THE DIFFERENCE, THE DELAYED INFLUX OF THE GAME-CHANGING JOHNSON AND JOHNSON SHOT WILL HAVE AN IMPACT. >> WE’RE DIALING BACK FROM WHAT WE HAD HOPED TO GET. BUT WE’RE ACTUALLY GETTING MORE THAN WE HAD LAST WEEK. SO IT’S NOT, IT’S NOT HURTING OUR EFFORTS. IN STATEMENTS JOHNSON AND , JOHNSON AND EMERGENT BOTH ADMITTING THE MISTAKE WAS MADE, WHILE STRESSING THE SYSTEMS WORKED AS DESIGNED TO DETECT AND ISOLATE THIS SINGLE BATCH. AND THIS IS AN EXAMPLE OF THE RIGOROUS QUALITY CONTROL APPLIED TO EACH BATCH OF DRUG SUBSTANCE. HOWEVER, ACCORDING TO ASSOCIATED PRESS REPORT TODAY EMERGENT HAS HAD A SERIES OF , QUALITY CONTROL ISSUES RAISED BY FDA. THE COMPANY REPEATEDLY CITED FOR PROBLEMS INCLUDING MOLD, POORLY TRAINED EMPLOYEES, AND CRACKED VIALS. >> THE GOOD NEWS IS THE ROBUST PROGRAM WE HAVE AT THE FDA IS THAT THEY MAKE SURE NONE O THESE THINGS HAVE BEEN UTILIZED AND THAT THEY CAUGHT THE PROBLEM BEFORE IT BECAME A BIGGER PROBLEM. >> VERY IMPORTANT POINT WE MUST MAKE. THE CONTAMINATION PROBLEM HERE HAS NO CONNECTION TO ANY OTHER JOHNSON AND JOHNSON VACCINE THAT HAS BEEN BEEN DELIVERED AND ADMINISTERED ALREADY THERE IS NO CONNECTION TO ANY JOHNSON & JOHNSON SHOT YOU MAY HAVE GOTTEN OR A LOVED ONE MAY HAVE GOTTEN. THE DRUG IN THOSE DOSES WAS MADE IN THE NETHERLANDS. AT A PLANTS THAT ALREADY HAD FDA APPROVAL.