Company at heart of J&J vaccine woes has series of citations

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The company at the center of quality problems that led Johnson & Johnson to discard a batch of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.

FILE - In this March 25, 2021 file photo, a box of the Johnson & Johnson COVID-19 vaccine is shown in a refrigerator at a clinic in Washington state. A batch of Johnson & Johnson’s COVID-19 vaccine failed quality standards and can’t be used, the drug giant said late Wednesday, March 31, 2021. The drugmaker didn’t say how many doses were lost, and it wasn’t clear how the problem would impact future deliveries.

Emergent BioSolutons, a little-known company at the center of the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the U.S. by the end of May. But the company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act.

On the same day, Johnson & Johnson, in a separate news release, heralded its partnership with Emergent as a step toward the pharmaceutical giant’s goal of supplying more than 1 billion doses of the vaccine globally by the end of 2021.Other problems cited by the FDA during the April 2020 inspection included failures by the Bayview plant “to ensure that electronically held data generated during analytical testing” of material “was protected from deletion or manipulation.

Emergent is one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine, the company said. The Bayview factory where the tainted vaccine ingredient was found had not yet been approved by the FDA, so no vaccine in circulation is affected. Emergent declined to comment.

A J&J spokesman said earlier Wednesday that the company met the end-of-March goal, and the Centers for Disease Control and Prevention’s online vaccine tracker showed J&J had provided about 6.8 million doses to the U.S. vaccine effort. J&J has been shipping finished vaccines from its factory in the Netherlands to the U.S.

 

ขอบคุณสำหรับความคิดเห็นของคุณ ความคิดเห็นของคุณจะถูกเผยแพร่หลังจากได้รับการตรวจสอบแล้ว

Am I the first to say this? johnsonandjohnson better cancel their contract with Emergent or nobody in their right mind will take their vaccine! Company is a disgrace and confidence in their vaccine will tank!

😳

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J&J knew about their history & contracted anyway. jjbabypowder

thanks for reporting this story. True, nobody wants to read news like this right now, but without your investigation people wouldn't know about J&J's due diligence failure. Thanks for fighting the good fight!

Hey I mean at least they caught it.

If it weren't a whole fucking century AFTER the Industrial Revolution this type of skullduggery could be overlooked.

one time i found a whole fingernail in a mcdonald’s cheeseburger

Is this another covert hit from the mRNA vaccine makers? Like AZ, J&J also vowed to sell vaccines at cost price during the pandemic.

Wow. Way to fuck it up!

More good news please(((

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