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The process of restarting operations began Thursday, but it will take time for the factory to ramp up and reach the production level of before the shutdown, according to Emergent spokesman
Since April, FDA inspectors have combed the factory and reviewed security camera footage to identify lapses in handling material inside the factory and worked with
The agency also has been reviewing data on months’ worth of vaccine substance made in the factory and has allowed several large batches of vaccine doses made from it to be released for distribution.
Shares of Emergent rose
Emergent is one of several J&J contractors that produce its one-shot vaccine in bulk. The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.
The lapses at the Bayview factory have hampered J&J’s efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it’s the only drugmaker with an authorized vaccine that only requires one dose and standard refrigeration. It’s also cheaper than some other vaccines.
The productions problems have forced J&J to import millions of doses from its factory in
Emergent Chief Executive
Emergent’s factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained employees and an inadequate strategy to prevent contamination, yet it was given a huge role in COVID-19 vaccine production by the Trump administration. Emergent was handed a lucrative contract to make many millions of COVID-19 vaccines for both J&J and
The Biden administration has been working to find a different American manufacturing partner for British drugmaker
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