Friday , May 14 2021

US government removes AstraZeneca from infected Covid vaccine factory



Emergent BioSolutions Baltimore plant contracted Koranavirus vaccines under contract with both Johnson & Johnson and AstraZeneca. Last month, a batch of Johnson & Johnson “medicines” failed quality control and was withdrawn from production, both J&J and Emergent reported.

The federal government has asked Johnson & Johnson to take full control of its vaccine production at the plant, a management official told CNN on Saturday. The company confirmed that it has taken tighter control of the production process.

The Emergent BioSolutions plant, which had dosed both the Johnson & Johnson vaccine and an AstraZeneca vaccine, will now only produce J&J vaccines, the official said. The Department of Health and Human Services has ordered that the AstraZeneca vaccine will now be produced at another plant, although the official did not specify where.

“Johnson & Johnson assumes full responsibility for the preparation of a COVID-19 vaccine at BioSolutions Inc.’s Bayview facility,” the company said in an email to CNN.

“Specifically, the Company adds dedicated leaders for operations and quality and significantly increases the number of construction, quality and technical staff to work with the Company’s specialists already in Emergent.”

And AstraZeneca has confirmed that it will stop making the vaccine, called AZD1222, at its emerging Baltimore plant.

“AstraZeneca is working with the Biomedical Advanced Research and Development Authority (BARDA) to help maximize and accelerate US COVID-19 vaccine production. As part of this effort and in full cooperation with the US Government, AstraZeneca “AZD1222 vaccine production from the Emergent plant in Baltimore, Maryland,” the company said in a statement posted on the Internet.

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BARDA is a part of HHS that helps develop medical countermeasures for pandemics and biological attacks.

“The company will work with the US government to find an alternative site for domestic production of the AZD1222 drug,” he added.

“AstraZeneca and the US government continue to work closely together to support agreed plans for the development, production and complete delivery of the vaccine.”

AstraZeneca has not yet applied for an emergency permit from the FDA to use its vaccine, but like other coronavirus vaccine manufacturers, it has done so earlier in anticipation of the EUA victory.

None of the infected Johnson & Johnson vaccines had been packaged or shipped and the operation of the factory that did so had not been approved. All J&J vaccine used in the USA was manufactured in a factory in the Netherlands.

Government officials said the discovery of the contamination showed that the meticulous inspection and quality control systems in place at vaccine factories were operating as designed. They characterize the moves to strengthen surveillance at the emerging plant as standard for such an incident, and noted that the infection, although unusual and undesirable, is not an exceptional event.

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A source familiar with the situation told CNN that “it is not so unusual” for the pharmaceutical industry to have to reject batches of vaccines.

While Emergent makes the vaccine material itself, it sends the product to other plants to be placed in vials for use – a process known as filling and finishing. Every step of this process is subject to FDA inspection and authorization.

The J&J vaccine is made using a common cold virus called an adenovirus that has been genetically engineered to produce a small portion of the coronavirus spike protein – the button-like part that infects cells. This genetically modified virus grows in large bins called bioreactors. The AstraZeneca vaccine also uses the so-called viral vector – an adenovirus that infects chimpanzees. It is also grown in bioreactors.
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A source familiar with the Johnson & Johnson vaccine preparation process said the loss of 15 million possible doses of the Johnson & Johnson vaccine was not a major upset.

“Once the plant is up and running, the way this particular vaccine is made in these large batches, compensating for this lot should not be a big hassle. It should be a downside of just a few weeks.” , the source told CNN. .

Another source told CNN that Johnson & Johnson had successfully produced 115 million more doses of its vaccine at the Emergent plant.

J&J has achieved its goal of delivering 20 million doses of its vaccine to the US by the end of March and says it is aiming to deliver 100 million doses by the end of May.


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