The footage also showed employees moving between manufacturing areas for the two vaccines without documenting whether they changed protective gowns and showered in between, as well as removing protective clothing in the warehouse near prepared vaccine ingredients, dropping the clothing on the floor and then tossing it in open trash cans. The inspectors also reviewed security camera footage, which showed employees carrying unsealed bags of medical waste around in the factory, with the bags touching materials ready to be used to make vaccine batches. The company has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press.Īfter the J&J vaccine batch was contaminated, FDA inspectors started checking the Emergent factory on April 12 and finished their investigation on Tuesday. On Tuesday, the European Medicines Agency’s safety committee concluded the blood clots are a very rare side effect but that the vaccine's benefits outweigh that risk.Įmergent, a little-known drug manufacturing contractor, was granted a major role in the Trump administration's response to the coronavirus. Their decision on whether to allow its use to resume could come Friday. as government health officials investigate its possible connection to very rare blood clots. “We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness,” the FDA said.Īt the moment, use of the J&J vaccine is on hold in the U.S. The agency hasn’t given emergency approval to the factory, which is needed before any vaccine material made there can be distributed.Īll the bulk vaccine substance inside Emergent's factory, plus early batches made there and then put in vials and packaged by other J&J contractors, are being stored and will undergo additional testing by the FDA, the agency said. The Baltimore factory halted all production late last week at the FDA's request. AstraZeneca has yet to seek emergency authorization for use of its vaccine in the U.S. The Biden administration now is working to move AstraZeneca vaccine manufacturing to another factory. came from Europe.īoth Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible.Īfter quality problems surfaced late last month, J&J took control of the factory. The nearly 8 million doses of J&J vaccine given in the U.S. Nothing made at the factory for J&J has been distributed, the FDA noted.
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