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Urgent: FDA Allows Reopening of Problematic COVID Vaccine Factory | Work

The U.S. Food and Drug Administration has allowed the troubled factory of its contract manufacturer, Emergent BioSolutions, to resume production of the COVID-19 vaccine, the company said Thursday.

NS Baltimore factory closed By the FDA in mid-April due to pollution problems that forced the company to dispose of the equivalent of tens of millions of vaccines it had manufactured under a contract with Johnson & Johnson. The bulk vaccine was contaminated with ingredients from AstraZeneca’s COVID-19 vaccine, which was manufactured at the same plant.

The process of resuming operations began on Thursday, but according to Emergent spokesman Matt Hartwig, it will take some time for the plant to start up and reach production levels before the shutdown.

Since April, FDA inspectors have examined the factory, checked security camera footage, identified mishandling of materials in the factory, and worked with Emergent, Gaithersburg, Maryland, to work with Emergent. It has solved many problems, including unsanitary conditions and poorly trained workers.

Authorities are also reviewing data on months of factory-produced vaccine material and have allowed several large batches of vaccine doses produced from it to be released for distribution.

On Thursday afternoon trading, Emergent’s share price rose $ 1.31 (2%) to $ 66.47.

Emergent is one of the J & J contractors that mass-produces one-shot vaccines. The concentrated vaccine is then diluted to the appropriate strength and shipped to other plants for final steps such as vialing and packaging.

Bayview plant revocation is people, especially in remote areas and poor countries, given that J & J is the only pharmaceutical company to have a licensed vaccine that requires only a single dose and standard refrigeration. Is hindering efforts to become a major player in vaccination. It is also cheaper than other vaccines.

Production problems forced J & J to import millions of doses from its Dutch factory into the United States and miss its supply promise.

Emergent CEO Robert Kramer said the company was below public expectations.

The Emergent factory has a history of being quoted by the FDA on issues such as mold, dirty walls and floors, poorly trained employees, and poor strategies to prevent pollution, but the Trump administration has COVID. -19 Given a major role in the production of vaccines. Emergent has signed a favorable contract to produce millions of COVID-19 vaccines for both J & J and AstraZeneca at the Bayview plant.

The Biden administration has been working to find another US manufacturing partner for the British pharmaceutical company AstraZeneca, which is not licensed to distribute the COVID-19 vaccine in the United States.


Follow Linda A. Johnson—onPharma


The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.

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Urgent: FDA Allows Reopening of Problematic COVID Vaccine Factory | Work

Source link Urgent: FDA Allows Reopening of Problematic COVID Vaccine Factory | Work

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