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Johnson & Johnson, with the aid of President Joe Biden’s administration, has been put in charge of a Baltimore vaccine production plant that ruined 15 million doses of its COVID-19 vaccine and has moved to stop British drugmaker AstraZeneca Plc from utilizing the facility to avoid any future mistakes, senior federal health officials said on Saturday.
The extraordinary decision, which was first reported by The New York Times, was put into action by the US Department of Health and Human Services and will allow the Emergent BioSolutions plant to focus on making the single-dose Johnson & Johnson COVID-19 vaccine.
Johnson & Johnson confirmed the move on Saturday, stating that it was “assuming full responsibility regarding the manufacturing of drug substance” at Emergent.
“Specifically, the company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent,” Johnson & Johnson said in a statement.
The change comes after the disclosure that Emergent, which is a manufacturing partner to both AstraZeneca and Johnson & Johnson, mixed up ingredients from the two coronavirus vaccines in a case of human error, causing regulators to delay authorization of the facility’s vaccine production.
The mixup ruined nearly 15 million Johnson & Johnson doses.
The error did not impact any vaccines that are currently being delivered or used, according to the Times report.
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The Biden administration has made note of the delay and has not shifted its stated goal of having enough vaccines for all adult Americans by the end of May.
According to the Times report, federal officials are concerned that the mixup could dampen confidence in the vaccines just as Biden is aggressively pushing for mask mandates to remain in place as new COVID-19 variants spread throughout the US.
Meanwhile, there are concerns about the two-dose AstraZeneca vaccine, which has had a troubled rollout in Europe due to a risk of rare blood clots possibly linked to the vaccine. However, the United Kingdom’s drug regulator deemed the vaccine as safe.
AstraZeneca said that it would work with the Biden administration to find an alternative site for its vaccine production, which has not yet been authorized in the US.
“AstraZeneca and the US government continue to work closely together …read more
Source:: Business Insider