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Johnson & Johnson COVID-19 vaccine batch fails quality check

Johnson & Johnson COVID-19 vaccine batch fails quality check
CONFIRMED NOT ONE OF THEM HAS BEEN ADMINISTERED TO A PERSON IN THE US. >> THE NUMBER OF DOSES THAT ARE IN THE MILLIONS THAT ARE BEING PRODUCED HERE REGULARLY IS QUITE EXTRAORDINARY. REPORTER: THEY ARE MAKING MILLIONS OF DOSES OF THE JOHNSON AND JOHNSON VACCINE AT EMERGENT BIOSOLUTIONS IN BALTIMORE, AND THAT'S WHY MARYLAND DEMOCRATIC CONGRESSMAN ANTHONY >> A LOT OF THIS IS MADE POSSIBLE, OF COURSE, BECAUSE OF THE APPROPRIATIONS AND AUTHORIZATIONS FROM CONGRESS. REPORTER: AT ITS BAYVIEW THE COMPANY SAYS, SOME 400 EMPLOYEES, ARE WORKING AROUND THE CLOCK TO BULK-PRODUCE THE "DRUG SUBSTANCE" FOR THE J AND J, ONE-DOSE, COVID-19 JAB >> WE MANUFACTURE THE BULK DRUG SUBSTANCE HERE AND THE FINISHED, THE FILL AND FINISH GOODS ARE MADE ELSEWHERE, ARE MANUFACTURED ELSEWHERE. AFTER THAT THE VIALS OF VACCINE ARE SUPPOSED TO BE SHIPPED TO PROVIDERS. BUT AS OF WEDNESDAY MORNING, THE COMPANY CONFIRMS NOTHING HAS MOVED OUT OF STORAGE AND NONE OF THEIR DOSES HAVE GONE INTO ARMS >> NOT AT THIS, NOT YET. NOT YET. NOT AT THIS MOMENT. EMERGENT'S VACCINE OUTPUT PILING-UP BEHIND A REGULATORY ROAD-BLOCK. THE DRUG-MANUFACTURER TELLING 11-NEWS THEY'RE STILL AWAITING EMERGENCY USE AUTHORIZATION FROM THE FDA. THIS COMES AMID MOUNTING CRITICISM FROM THE WHITE HOUSE OVER J AND J'S MANUFACTURING DELAYS BUT EMERGENT SAYS NO FDA GREEN LIGHT MEANS NO DOSES CAN BE SHIPPED TO PROVIDERS OR PUT INTO ARMS.. >> THAT IS CORRECT. UNTIL EUA APPROVAL IS GRANTED. WE'RE CONTINUING TO PRODUCE PRODUCTS EVERY DAY. SO NOTHING HAS CHANGED. WE'RE IN FULL PRODUCTION 24-7. REPORTER: EMERGENT'S BAYVIEW FACILITY ACCORDING TO THE COMPANY
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Johnson & Johnson COVID-19 vaccine batch fails quality check
A batch of Johnson & Johnson바카라 게임 웹사이트s COVID-19 vaccine failed quality standards and can바카라 게임 웹사이트t be used, the drug giant said Wednesday.The drugmaker didn바카라 게임 웹사이트t say how many doses were lost, and it wasn바카라 게임 웹사이트t clear how the problem would impact future deliveries.A vaccine ingredient made by Emergent BioSolutions 바카라 게임 웹사이트 one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine 바카라 게임 웹사이트 did not meet quality standards, J&J said.J&J said the Emergent BioSolutions factory involved had not yet been approved by the U.S. Food and Drug Administration to make part of the vaccine. Emergent declined to comment.J&J had pledged to provide 20 million doses of its vaccine to the U.S. government by the end of March, and 80 million more doses by the end of May. Its statement on the manufacturing problem said it was still planning to deliver 100 million doses by the end of June and was 바카라 게임 웹사이트aiming to deliver those doses by the end of May.바카라 게임 웹사이트President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million shots from J&J.A federal official said Wednesday evening the administration바카라 게임 웹사이트s goal can be met without additional J&J doses.A J&J spokesman said earlier Wednesday that the company met the end-of-March goal, but did not respond to questions about whether the Emergent plant in Baltimore, known as Bayview, had been cleared by FDA.As of Wednesday, J&J had provided about 6.8 million doses to the U.S. vaccine effort, according to the Centers for Disease Control and Prevention바카라 게임 웹사이트s online vaccine tracker. Some additional doses may not yet have been recorded as delivered, and federal health officials said Wednesday that another 11 million doses of the vaccine would be available for shipments starting on Thursday.It was not immediately clear where those 11 million doses originated, but J&J has been shipping finished vaccines from its factory in the Netherlands to the U.S.Emergent, a little known pharmaceutical company granted a major role in the federal government바카라 게임 웹사이트s response to coronavirus pandemic, has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act.The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn바카라 게임 웹사이트t corrected 바카라 게임 웹사이트continued low-level mold and yeast isolates바카라 게임 웹사이트 found in the facility. Nearly a year later, agency investigators questioned why Emergent had 바카라 게임 웹사이트an unwritten policy of not conducting routine compliance audits바카라 게임 웹사이트 at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.Emergent바카라 게임 웹사이트s revenues skyrocketed during the Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone.J&J said it was putting more of its manufacturing and quality experts inside Emergent바카라 게임 웹사이트s factory to supervise production of the COVID-19 vaccine, a move meant to enable delivery of an additional 24 million vaccine doses through April.J&J said it still expects to deliver more than 1 billion vaccine doses globally by the end of the year.The J&J vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.The problem with the vaccine batch was first reported by The New York Times. The FDA said it was aware of the situation but declined further comment.___Johnson reported from Fairless Hills, Pennsylvania, and Lardner from Washington. AP reporters Matt Perrone and Zeke Miller in Washington contributed.

A batch of Johnson & Johnson바카라 게임 웹사이트s COVID-19 vaccine failed quality standards and can바카라 게임 웹사이트t be used, the drug giant said Wednesday.

The drugmaker didn바카라 게임 웹사이트t say how many doses were lost, and it wasn바카라 게임 웹사이트t clear how the problem would impact future deliveries.

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A vaccine ingredient made by Emergent BioSolutions 바카라 게임 웹사이트 one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine 바카라 게임 웹사이트 did not meet quality standards, J&J said.

J&J said the Emergent BioSolutions factory involved had not yet been approved by the U.S. Food and Drug Administration to make part of the vaccine. Emergent declined to comment.

J&J had pledged to provide 20 million doses of its vaccine to the U.S. government by the end of March, and 80 million more doses by the end of May. Its statement on the manufacturing problem said it was still planning to deliver 100 million doses by the end of June and was 바카라 게임 웹사이트aiming to deliver those doses by the end of May.바카라 게임 웹사이트

President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million shots from J&J.

A federal official said Wednesday evening the administration바카라 게임 웹사이트s goal can be met without additional J&J doses.

A J&J spokesman said earlier Wednesday that the company met the end-of-March goal, but did not respond to questions about whether the Emergent plant in Baltimore, known as Bayview, had been cleared by FDA.

As of Wednesday, J&J had provided about 6.8 million doses to the U.S. vaccine effort, according to the Centers for Disease Control and Prevention바카라 게임 웹사이트s online vaccine tracker. Some additional doses may not yet have been recorded as delivered, and federal health officials said Wednesday that another 11 million doses of the vaccine would be available for shipments starting on Thursday.

It was not immediately clear where those 11 million doses originated, but J&J has been shipping finished vaccines from its factory in the Netherlands to the U.S.

Emergent, a little known pharmaceutical company granted a major role in the federal government바카라 게임 웹사이트s response to coronavirus pandemic, has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act.

The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn바카라 게임 웹사이트t corrected 바카라 게임 웹사이트continued low-level mold and yeast isolates바카라 게임 웹사이트 found in the facility. Nearly a year later, agency investigators questioned why Emergent had 바카라 게임 웹사이트an unwritten policy of not conducting routine compliance audits바카라 게임 웹사이트 at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.

Emergent바카라 게임 웹사이트s revenues skyrocketed during the Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone.

J&J said it was putting more of its manufacturing and quality experts inside Emergent바카라 게임 웹사이트s factory to supervise production of the COVID-19 vaccine, a move meant to enable delivery of an additional 24 million vaccine doses through April.

J&J said it still expects to deliver more than 1 billion vaccine doses globally by the end of the year.

The J&J vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.

The problem with the vaccine batch was first reported by The New York Times. The FDA said it was aware of the situation but declined further comment.

___

Johnson reported from Fairless Hills, Pennsylvania, and Lardner from Washington. AP reporters Matt Perrone and Zeke Miller in Washington contributed.