Emergent BioSolutions announced Thursday that the US Food and Drug Administration will allow it to resume the manufacturing of the drug substance that goes into Johnson & Johnson's Covid-19 vaccine.
According to an administration official, the Baltimore plant has not been fully authorized yet, and while production can resume, the FDA will still need to inspect the individual lots of vaccine before they go out for shipment and can be administered.
The plant had been contracted by Johnson & Johnson and AstraZeneca, but production was stopped after a mix-up earlier this year that involved ingredients for Johnson & Johnson's vaccine and AstraZeneca's vaccine resulted in 15 million vaccine doses being spoiled by contamination.The government then asked J&J to take over production at the plant. The plant also stopped making the AstraZeneca vaccine substance.
After the plant's production was stopped, the FDA returned to conduct several additional inspections at the facility, Emergent said. The company said it also has worked closely with the FDA and J&J to address quality concerns, and has developed an action plan.
"The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves," Emergent CEO Robert Kramer said in a statment.
"We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end. We'd like to thank our government partners as well as Johnson & Johnson for their support."
In an email to CNN, J&J confirmed the restart of production.
"We will continue to work toward securing Emergency Use Authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible," a spokesperson from Johnson & Johnson said in the email.
The FDA has been giving extra scrutiny to batches produced at the facility, which are shipped to other facilities to be put into vials and finished.
On July 13, the FDA authorized the fifth batch of J&J vaccine to be shipped but did not note how many doses that equaled.
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