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August 14 2022 4:21 PM ˚
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COVID vaccine plant to be ‘monitored closely’

VACCINE FACTORY MISSTEPS 4
A vial of the Johnson & Johnson COVID-19 vaccine in Jersey City, N.J., on March 5, 2021. The Emergent BioSolutions plant in Baltimore that recently had to scrap up to 15 million ruined doses of COVID-19 vaccine had flouted rules and downplayed errors, according to internal audits, ex-employees and clients. (Photo: NYTimes)
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WASHINGTON — A top federal pandemic official warned in June that Emergent BioSolutions, the government contractor that last month threw out millions of doses of COVID-19 vaccines because of contamination, lacked enough trained staff and had a record of problems with quality control.اضافة اعلان

A copy of the official’s assessment, obtained by The New York Times, cited “key risks” in relying on Emergent to handle the production of vaccines developed by both Johnson & Johnson and AstraZeneca at Emergent’s Bayview plant in Baltimore.

The assessment, which has not been released publicly, was based in part on a visit to the plant just days after the government awarded Emergent a contract worth up to $628 million, mostly to prepare its factories to make coronavirus vaccines as part of Operation Warp Speed.

Addressing the problems “will require significant effort,” and the company “will have to be monitored closely,” said the report, which was written by Carlo de Notaristefani, a manufacturing expert who has overseen production of COVID-19 vaccines for the federal government since May. Though marked as a draft, federal officials said the report was considered to be final.

Ten months after his report, the plant has become a major headache for the team named by President Joe Biden to oversee the pandemic response. The Times reported on Tuesday on a host of quality control problems, flagged in audits and investigations by AstraZeneca, Johnson & Johnson, two federal agencies and Emergent’s own quality evaluators.

Federal officials ordered major changes to the plant after revelations late last month that Emergent had to jettison between 13 million and 15 million doses of Johnson & Johnson’s vaccine. It is not clear what will happen to another 62 million doses of the vaccine produced at the plant, or whether Johnson & Johnson will be able to deliver the 24 million doses it has promised to the federal government by the end of the month.

So far, the Food and Drug Administration has not certified the factory to distribute any doses for public use, and the agency is not expected to do so until it conducts a thorough review, which can take weeks.

Asked about the June report, a company spokesman said Wednesday night: “Emergent’s top priority continues to be the strengthening of the supply chain for Johnson & Johnson’s vitally needed COVID-19 vaccine.”
 
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