They stop Johnson & Johnson vaccine production in the USA

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Tiffany Karschamroon extracts a dose from a vial of Johnson & Johnson COVID-19, a US FDA-approved vaccine. UU.

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Tiffany Karschamroon extracts a dose from a vial of Johnson & Johnson COVID-19, a US FDA-approved vaccine. UU.

According to Reuters, the US Food and Drug Administration (FDA) stopped production of Johnson & Johnson’s Sar-Cov-2 virus vaccine in a plant of the biopharmaceutical company Emergent Biosolutions, while an error is being investigated that led to the fact that last March, millions of doses of the drug were damaged.

According to Emergent Biosolutions, FDA authorities began a new inspection of its facilities in Bayview, Baltimore, on April 12, and last Friday, upon request. of this body the company “agreed not to commence the manufacture of any new material at its Bayview facilities and to quarantine existing material manufactured at the Bayview facilities until the inspection and sanitation of Bayview is completed. any resulting findings, “according to The Washington Post.

An error in vaccine production

The crisis of a major human error was triggered on March 31, at a plant in Baltimore in a factory of the company Emergent Biosolutions, producer of injectables from AstraZeneca and Johnson & Johnson. The fact that production of this vaccine has now ceased, was that plant workers accidentally combined the ingredients of both drugs so that about 15 million doses of Johnson & Johnson vaccine were present manufacturing defects. It was also established that the severity was that one of the ingredients used to make the vaccine had not passed the quality controls.

The ingredients used in the manufacture of another vaccine, AstraZeneca, have been mixed with those of the Johnson & Johnson vaccine, according to The New York Times, quoted by Las Americas.

This incident called into question the ability of Johnson & Johnson to meet its commitment, as not only were this number of vaccines ruined, but authorities closed the factory as long as investigations into what had happened were given.

It should be noted that quality control, I detect defective doses of Janssen vaccine, so that these doses never left the production plant, and in turn, the production of AstraZeneca biologicals were withdrawn. of the plant.

“Human errors occur,” apologized to Dr. Anthony Fauci, the country’s leading epidemiologist. Its antidote to the concern it unleashes is precisely that it has been detected, “that’s why there are quality controls.” The fact that nothing has come out of this plant is, for him, another guarantee that the system works. In addition, the Federal Food and Drug Administration (FDA) had not yet given the plant approval. Those that have been administered so far come from the Netherlands, where production had been focused, according to the Mail.

After detecting the initial error, Emergent said on April 1 it isolated itself and rejected a single batch of the drug component. “The disposal of a batch of bulk pharmaceutical substance, while disappointing, happens occasionally during the manufacture of the vaccine, which is a complex and multi-step biological process,” the company was quoted as saying by La República.

“Johnson & Johnson takes full responsibility” for the incident, the U.S. company said in a statement Saturday, saying it is “working closely” with the U.S. Food and Drug Administration (FDA) to get emergency approval to produce its vaccine at the Baltimore plant, according to Newspaper Les Américas.

J&J also said that “it is adding leaders dedicated to operations and quality, and is significantly increasing the amount of manufacturing operations staff, quality and techniques to work with the company’s specialists who are already in Emerging, “the statement said.

Blood clots: the Johnson & Johnson vaccine problem

On the other hand, although this vaccine had the great advantage of requiring only one dose, its administration was paused by U.S. regulators while reviewing research reports on the formation of cerebral blood clots in people. who received the injection of this antidote, Reuters reported.

The cases observed are “extremely rare” but “vaccine safety for the VOCID-19 virus is a priority for the federal government,” they said, stressing that the recommendation for a pause in administration was decided as a precaution. “Until the process is complete, we recommend a pause in the use of this vaccine as a precaution,” said in a joint statement Dr. Anne Schuchat, senior deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biological Assessment and Research.

Finally, the pharmaceutical company Johnson & Johnson in reference to the cessation of production of its vaccines, noted that it will work hand in hand with Emergent and the FDA to address any findings at the end of the inspection.

“Right now, it’s premature to speculate on any potential impact this could have at the time of delivery of our vaccines,” said the company, which plans to deliver 100 million doses of its vaccine to the U.S. during the first half of 2021. So far Johnson & Johnson has delivered about 18 million doses.

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