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Johnson & Johnson said Wednesday that a batch of its main vaccine ingredient did not meet quality control standards at a facility in Baltimore.
The problem will not affect the timing of the Biden administration to have enough doses of the vaccine for the adult U.S. population by the end of May, two senior administration officials said.
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The manufacturing issue was first reported by The New York Times on Wednesday. Johnson & Johnson said in a statement that a batch of the active ingredient from Emerging BioSolutions in Baltimore “did not meet quality standards.”
“This batch has never been advanced to the filling and finishing stages of our manufacturing process,” the statement said.
The doses available to date were taken at a separate facility licensed by the Food and Drug Administration and were unaffected by the issue at Emergent BioSolutions, the two senior administration officials said.
In an email, an FDA spokeswoman said, “The FDA is aware of the situation, but we are unable to comment further. Questions about a company’s manufacturing facilities should be raised. addressed to this company. “
Contacted for comment Wednesday evening, Emergent BioSolutions referred NBC News to Johnson & Johnson.
The company statement said Johnson & Johnson would provide “additional on-site manufacturing, technical operations and quality experts at Emergent to oversee, direct and support all manufacture” of its vaccine.
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Johnson & Johnson’s vaccine, made by the company’s Janssen subsidiary, was found to be 86% effective in preventing severe forms of Covid-19, and it received emergency use clearance from the FDA at the end of the day. February.
The company immediately deployed around 4 million doses, but shipments have stalled since then.
Late Wednesday, Johnson & Johnson said it had fulfilled its “commitment to provide enough single-injection vaccines by the end of March to allow the full immunization of more than 20 million people in the United States.”
According to the Centers for Disease Control and Prevention, just over 6.7 million doses had been delivered as of Wednesday evening. The difference in delivery numbers may be due to a delay in reporting to CDC.
The company also pledged to deliver 100 million doses by the end of May.
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Kristen Welker and Laura Strickler contributed.
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