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Emergent admits to manufacturing issues with J&J vaccine - POLITICO

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A contractor Johnson & Johnson enlisted to make its coronavirus vaccine acknowledged Thursday that it had contaminated millions of doses, confirming reports of supply problems related to the firm's Maryland facility.

The acknowledgment by Emergent BioSolutions came one day after news reports revealed the mistake at its West Baltimore plant that affected 15 million doses.

The company signed on to produce a J&J vaccine substance last spring and later added AstraZeneca, another drugmaker producing a potential Covid-19 shot, to its roster of clients. Emergent previously promised to deliver 1 billion shots between the two by the end of this year.

Biden administration officials became aware more than a week ago of supply issues related to problems with Emergent. The company reportedly mixed up ingredients from the J&J and AstraZeneca vaccines.

“We isolated this batch and it will be disposed of properly,” Emergent said in a statement. “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.”

White House press secretary Jen Psaki said Thursday that the administration did not expect Emergent's woes to prevent J&J from meeting its goal of delivering 100 million shots by the end of May.

A senior administration official told POLITICO Wednesday that health officials learned of the contaminated batch late last week. But other officials said that problems with Emergent’s production were looming.

The Maryland manufacturer said that it continues to manufacture substance and is “proud of the role the Emergent team is playing in support of the response to COVID-19.”

The administration ordered J&J this week to directly take over on the Emergent manufacturing process, the senior official said.

AstraZeneca, which is also relying on Emergent for millions of shots, told POLITICO that they "are aware of the reports regarding the facility and we understand Emergent is investigating the matter." The British drugmaker has not filed for U.S. authorization yet but has said they have at least 30 million doses on hand for when they are cleared.

J&J delivered on its promise of 20 million doses by March after another contracted manufacturer, Catalent, helped fill and finish vials of the vaccine and sent millions of doses this past week. J&J's bump led to a record number of doses, 33 million, being allotted to states for distribution.

Going forward, J&J has emphasized that it can still hit its 100 million doses by June target despite the Emergent delays.

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Emergent admits to manufacturing issues with J&J vaccine - POLITICO
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