Johnson & Johnson vaccine production has stopped in the United States

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

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

According to Reuters, the US Food and Drug Administration (FDA) has stopped production of the Johnson & Johnson Sars-Cov-2 virus vaccine at a factory of biopharmaceutical company Emergent BioSolutions while an investigation is underway. error that led to the loss of millions of doses of the drug in March last year.

According to Emergent BioSolutions, FDA authorities began a new inspection of its facilities in Bayview, Baltimore, on April 12, and last Friday, at the agency’s request, the company “agreed not to begin manufacturing any new materials at the Bayview facility, and quarantine existing material manufactured at the Bayview facility until the completion of the inspection and cleaning of any resulting discoveries, ”as quoted by the Washington Post.

An error in vaccine production

The crisis of a great human error was triggered on March 31, in a factory in Baltimore, in a factory of the company Emergent BioSolutions, manufacturer of injectable products AstraZeneca and Johnson & Johnson. The fact that the production of this vaccine has now stopped was the fact that factory workers accidentally combined the ingredients of both drugs, resulting in around 15 million doses of Johnson & Johnson vaccine with manufacturing defects. It was also established that the seriousness is that one of the ingredients used to make the vaccine did not pass the quality controls.

The ingredients used to make another vaccine, that of AstraZeneca, were mixed with those of the Johnson & Johnson vaccine, according to The New York Times, quoted by Diario Las Americas.

This incident called into question Johnson & Johnson’s ability to fulfill its commitment, as this amount of vaccines was not only destroyed, but the authorities closed the factory as long as investigations into what happened were given.

It should be noted that quality control detected defective doses of the Janssen vaccine, so that these doses never left the production plant and, in turn, the AstraZeneca organic production was withdrawn from the plant.

“Human errors are happening,” Dr. Anthony Fauci, the country’s chief epidemiologist, apologized. Its antidote to the concern that it is unleashed is the fact that it was detected, “that’s why there are quality controls.” The fact that nothing has left this plant is, for him, an additional guarantee that the system works. In addition, the Federal Food and Drug Administration (FDA) had not yet approved the plant. Those who have been administered so far come from the Netherlands, where production had been concentrated, according to the publication.

After detecting the initial error, Emergent said that only one batch of the drug was isolated and discarded on April 1. “The removal of a batch of bulk pharmaceuticals, although disappointing, occasionally takes place during the manufacture of the vaccine, which is a complex biological process, in several stages,” the company was quoted as saying by La Republica.

“Johnson & Johnson assumes full responsibility” for the incident, the US company said in a statement on Saturday, saying it is “working closely” with the US Food and Drug Administration (FDA) to obtain emergency approval to produce its vaccine. the Baltimore plant, according to Diario Las Américas.

In addition, J&J said it “adds leaders dedicated to quality and operations and significantly increases the number of technical, quality and manufacturing operations staff to work with the company’s specialists already at Emergent,” the statement said.

Blood clots: the Johnson & Johnson vaccine problem

On the other hand, although this vaccine had the great advantage of requiring a single dose, its administration was discontinued by US regulators, while research reports on the formation of cerebral blood clots in people who received the injection with this vaccine have been reviewed. Reuters reported.

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

Finally, the pharmaceutical company Johnson & Johnson, referring to the cessation of vaccine production, indicated 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 it could have on the delivery of our vaccines,” said the company, which plans to deliver 100 million doses of its vaccine to the United States in the first half. of the year. so far Johnson & Johnson has administered approximately 18 million doses.

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