FDA, J&J Reach Agreement to Produce COVID-19 Vaccines at Baltimore Plant –

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FDA, J&J Reach Agreement to Produce COVID-19 Vaccines at Baltimore Plant – fr


WASHINGTON – The Food and Drug Administration and vaccine maker Johnson & Johnson plan to announce as early as Friday that contamination concerns at a COVID-19 vaccine plant in Baltimore have been resolved, paving the way for millions of additional doses.

Vaccine production at the plant operated by contract manufacturer Emergent BioSolutions Inc. was halted after unsanitary conditions led to contamination of J&J vaccines. The facility manufactured the vaccine material and finished vaccine doses for J&J and AstraZeneca PLC.

Emerging CEO Robert Kramer told a House committee last week that the company had produced enough of a key ingredient to produce more than 100 million doses of the J&J vaccine.

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The company has taken corrective action and is in discussions with the FDA and J&J on the steps necessary to reopen the facility.

Johnson & Johnson said it was working with Emergent to obtain “as quickly as possible an emergency use authorization in the United States for the drug substance Covid-19 manufactured at Emergent Bayview”.

Emergent declined to comment for this article.

Authorization for emergency use of the plant to produce the COVID-19 vaccine could be made as early as Friday, US officials said. It could help fulfill President Biden’s promises to share 20 million doses of J&J, Pfizer Inc. and Moderna Inc. with the rest of the world by the end of June.

The Baltimore plant produced millions of doses that were in inventory awaiting clearance, but most are unfinished and are being placed in vials, officials said, adding that it could be months before all these doses are not ready for use.

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An official said that as part of the deal to bring the plant online, the United States and J&J have tentatively agreed that around 60 million doses of the J&J vaccine manufactured at the Baltimore plant will now be allowed to be released. be used in the United States or abroad.

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AstraZeneca is still testing around 60 million doses, also made at the Emergent Baltimore plant, which could be the subject of another deal with the FDA in the coming weeks or perhaps still be part of it. -Here, said another official. AstraZeneca declined to comment for this article.

Doses of J&J, when completed, would be sufficient to immunize approximately 60 million people with the company’s single injection regimen. AstraZeneca doses, if they become available, are a two-dose schedule and could inoculate about half of that number of people.

An accident at the Baltimore plant led to material contamination which could have produced up to 15 million doses in January and February.

An FDA inspection of the Emergent plant in April concluded that the facility had failed to maintain clean and hygienic conditions and had failed to take appropriate action to avoid cross-contamination between the two. vaccine lines.

As part of a deal with the U.S. government, the U.S. had paid Emergent $ 271 million in monthly reservation fees to prepare to manufacture vaccines, but the government partially halted payment after learning about it. contamination, according to a note from Democratic House Select staff. Coronavirus Crisis Subcommittee.

At a subcommittee meeting last week, leaders of Emerg blamed some of the problems at its Baltimore vaccine plant on the need to produce the two different vaccines simultaneously in large quantities.

Mr Kramer said that “the acceleration of production of two new vaccines on a very large scale at the same facility is unprecedented”.

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In an April 30 response to the FDA inspection report, Emergent said it decommissioned the AstraZeneca portion of its plant in the Bayview section of Baltimore and took several steps to prevent contamination of the vaccine ingredient. NOT A WORD.

He said he plans to take several corrective actions, such as repairing, cleaning and disinfecting the manufacturing plant and improving staff training at the site.

The company has committed to taking several corrective actions in May and June, all of which must be completed before fully recommencing manufacturing at the site.

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