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FDA allows J&J COVID vaccine factory to reopen


US health authorities have authorized the Emergent BioSolutions factory, affected by contamination problems, to resume production of the COVID-19 vaccine, the company said Thursday.

The US Food and Drug Administration (FDA) closed the Baltimore factory in mid-April due to contamination problems that forced it to discard tens of millions of doses of the vaccine it manufactured under contract with Johnson. & Johnson. The bulk vaccine was contaminated by an ingredient in AstraZeneca’s COVID-19 vaccine that is manufactured in the same facility.

Emergent did not say when production will resume.

Since April, FDA inspectors have been reviewing the plant and security camera videos to identify material handling flaws. They also collaborate with the company to solve a series of problems such as deficiencies in sanitary conditions and the lack of training of workers.

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The agency has also reviewed data on vaccine production in recent months and authorized the distribution of several large batches of vaccines.

Emergent is one of several J&J contractors that produce their vaccine in bulk. The concentrated vaccine is sent to other plants for the last steps, such as dilution to the correct ratio and packaging. The J&J vaccine requires a single dose.

Failures at the Bayview factory have affected J & J’s efforts to become a leader in vaccinating people, especially in remote areas and poor countries, as it is the only pharmaceutical company with a licensed vaccine that requires a single dose. and standard refrigeration. Also, it is cheaper than other vaccines.

Production problems have forced J&J to transport millions of doses from its factory in the Netherlands to the United States and to renege on commitments.

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Emergent CEO Robert Kramer said the company has fallen short of people’s expectations.

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