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article imageFeds warned Emergent vaccine plant should be 'monitored closely'

By Karen Graham     Apr 8, 2021 in Politics
Baltimore - An Operation Warp Speed report last June flagged staffing and quality control concerns at Emergent BioSolutions’ factory in Baltimore. The troubled plant recently had to throw out up to 15 million doses.
Officials with the Trump administration’s vaccine program, Operation Warp Speed, and the Department of Health and Human Services were sent a report in June 2020 on Emergent’s inner workings, suggesting that it would be risky to rely on the Baltimore company unless major improvements were made, according to Politico.
Carlo de Notaristefani—who visited the plant days after it was awarded a $628 million contract under Operation Warp Speed, made the assessment, and a copy was obtained by the New York Times.
Addressing the problems “will require significant effort,” and the company “will have to be monitored closely,” said the report, and concluded that the company's plan for manufacturing the COVID-19 vaccines was "inadequate," and Emergent’s problems "hiring and retaining skilled workers" meant that it could not guarantee success in producing the shots.
On Tuesday, the New York Times reported on a host of quality control problems that had been flagged by AstraZeneca, Johnson&Johnson, two federal agencies, and Emergent’s own quality evaluators.
Subsequently, the report was shared by Trump administration officials, including Gen. Gustave Perna, Operation Warp Speed’s chief operating officer, who still serves in that role for the Biden administration Later, the Biden team was given the report along with other key Operation Warp Speed documents when the transition took place.
The mess with Emergent underscores the fact that the United States is ill-prepared to produce critical life-saving drugs and vaccines during a worldwide pandemic. Back in 2012, Emergent was awarded a $163 million government contract to ready the Baltimore plant for mass production of vaccines in the event of a crisis.
Apparently, that was never done. Mr. de Notaristefani wrote in his 2020 report that Emergent had used the site primarily for smaller development projects. Despite the host of problems that have emerged over Emergent's quality control problems, it still leaves the U.S, with very few options if we are to attempt to mass-produce any kind of vaccine needed on a global scale.
More about Emergent BioSolutions, operation warp speed, Quality control, Skilled workers, COVID19 vaccines
 
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