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Feds Were Warned That Vaccine Plant Should Be 'Monitored Closely'

Troubles were highlighted days after Maryland plant was awarded contract
By Rob Quinn,  Newser Staff
Posted Apr 8, 2021 7:44 AM CDT

(Newser) – The Trump and Biden administrations were warned about a Maryland plant that has had to destroy enough vaccine doses to inoculate a small country. In an assessment seen by the New York Times, the expert who has overseen COVID vaccine production for the government since last May warned in June that it would be risky to rely on the Emergent BioSolutions plant unless major improvements were made. Carlo de Notaristefani—who visited the plant days after it was awarded a $628 million contract under Operation Warp Speed—warned that it didn't have enough trained staff and would have to strengthen quality controls before it could make large amounts of vaccine. The plant already had a history of FDA violations.

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The report, which said the company "will have to be monitored closely," was shared with senior Trump administration officials and was handed over to the Biden administration in the transition, sources tell Politico. The sources say Trump administration officials suggested J&J send employees to improve operations at Emergent, but the company sent far fewer than the administration wanted. Former plant supervisors tell the Times that with heavy workloads, unrealistic timetables, and a shortage of trained staff, shortcuts were often taken. The plant, which made Johnson & Johnson and AstraZeneca vaccines, had to destroy 15 million doses of the J&J vaccine after it was contaminated with AstraZeneca ingredients. None of the 150 million doses of both vaccines it had produced have been distributed yet. (Read more coronavirus vaccine stories.)

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