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Not just the accident, a human error, according to federal FDA officials who have opened an investigation. Huge shame for pharmaceutical giant J&J: Workers at a Baltimore plant that produces two outsourced coronavirus vaccines accidentally confused the ingredients of the two anti-Covid drugs and contaminated up to 15 million doses of Johnson & Johnson vaccine, forcing regulators to delay authorization of the coronavirus vaccine. plant production lines. The New York Times reports it. Johnson & Johnson said Wednesday that a batch of the vaccine produced by Emergent at its Baltimore facility, known as Bayview, cannot be used because it does not meet quality standards. Those doses didn’t end up on the market, they weren’t even packaged. The error is not about the doses of Johnson & Johnson vaccine that have already been distributed, and manufactured in the Netherlands, but there will inevitably be an impact on future shipments of the vaccine.
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The facility is operated by Emergent BioSolutions, a Johnson & Johnson manufacturing partner and AstraZeneca, the British-Swedish company whose vaccine has not yet been licensed for use in the United States. Johnson & Johnson has promised to strengthen the control of Emergent BioSolutions work to avoid further quality control problems.
And then Johnson & Johnson had to discard a still inaccurate amount of its Covid vaccine. But beyond the Baltimore incident (the combination of different substances in the vaccine), health officials from the Food and Drug Administration reportedly found other problems with the quality control process of the company that makes the drug on behalf of Johnson. The Associated Press reports.
Emergent BioSolutions, this little-known company at the center of the vaccine supply chain, is key to Johnson & Johnson’s plan to deliver 100 million doses in the United States as of the end of May. But the company has been repeatedly cited by the Food and Drug Administration. For what reasons Poorly trained employees, cracked vials, and mold around some structures, according to documents obtained by The Associated Press through the Foia.
With $ 628 million from the US government, Emergent BioSolutions in Baltimore is expanding the Johnson & Johnson and AstraZeneca COVID-19 vaccines separately, which are still pending FDA approval.
See what it takes to make bulk vaccines: https://t.co/JPeHd3RsRW pic.twitter.com/mHS2AWysFT
– 60 minutes (to 60 minutes) November 12, 2020
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The Baltimore Labs
The agreement with Emergent to produce the vaccine developed with federal funds was closed a year ago. On the same days, the FDA wanted to inspect the plants. At the time, Emergent’s Bayview facility may not be able to produce millions of doses of a potential Covid-19 vaccine, according to Food and Drug Administration (FDA) documents describing the facility as a contracted testing laboratory that «did not produce products for distribution».
At the end of the inspection, the federal agency raised several criticisms – from an electronic data integrity issue to the aforementioned employee loopholes. However, on the same day, Johnson & Johnson, in a statement, announced its partnership with Emergent as a step toward the pharmaceutical giant’s goal of providing more than 1 billion doses of the vaccine globally by the end of 2021.
An interesting detail: A company called Emergent has received more than $ 1 billion to produce an undisclosed number of vaccine doses for Johnson & Johnson at its Baltimore facility. It has yet to receive FDA approval, which is expected in a few weeks. https://t.co/GiikFBbZsm
– John Reeves (@reevesjw) March 3, 2021
Emergent is one of ten companies Johnson & Johnson is using to accelerate production of its recently approved vaccine, the company said. 24 million doses of the vaccine are expected through April. J&J said it still expects to deliver more than 1 billion doses of the vaccine worldwide by the end of the year.
The J&J vaccine is crucial because it is a single dose and can be shipped and stored at standard refrigeration temperatures, unlike other vials that must be kept frozen. The company has also pledged to sell the vaccine for non-profit purposes, but only during the pandemic emergency.
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