Friday, 16 April, 2021

U.S. halts AstraZeneca’s Covid-19 vaccine production at Baltimore plant

AstraZeneca will work with the Biden administration to find an alternative site AstraZeneca will work with the Biden administration to find an alternative site. Premium
Adrian Cunningham | 05 April, 2021, 04:50

But the Emergent BioSolutions plant at the heart of the issue has faced scrutiny for its shortcomings from federal regulators before.

The United States has loan deals to send Mexico and Canada roughly 4 million doses of the AstraZeneca vaccine, made at its U.S. facility.

The vaccine has already been approved for adults in the US.

Some employees at the Bayview plant hadn't been properly trained, the investigator claimed, according to the Post. Records hadn't been secured and testing procedures weren't being followed.

Experts in vaccine manufacturing said that in the past, the F.D.A. had a rule to prevent such mishaps by not allowing a plant to make two live viral vector vaccines, because of the potential for mix-ups and contamination.

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The Biden administration on Saturday put Johnson & Johnson in charge of a troubled Baltimore manufacturing plant that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and moved to stop the plant from making another vaccine by AstraZeneca, senior federal health officials said. "This is a critical part of ensuring quality and safety of vaccine product".

Earlier this week, Emergent BioSolutions said in a statement that it was acknowledging that it botched a batch of vaccines but it remained confident in its ability to meet the United States government safety requirements and standards. Instead, the batch was disposed of.

The episode shows that Emergent's quality control systems are working, he said. "Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process". "It was more simply the fact that one production run, one batch of product, was determined to be inconsistent with our quality specifications".

J&J said it was "assuming full responsibility" of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May. Currently, only the one-dose regimen of the J&J jab is authorised in the US. According to data from the Centers for Disease Control, over 99.5 million Americans have received at least one vaccine dose.