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Johnson & Johnson vaccine in the United States: a manufacturing plant shut down longer than expected


A factory in Maryland no longer produces doses of the Janssen vaccine since a manufacturing error. Johnson & Johnson, who hoped to revive

Will the Janssen vaccine from the American pharmaceutical group Johnson & Johnson suffer the same crisis of confidence as the AstraZeneca?

The US drug agency, the Food and Drug Administration (FDA), last week called for production of the Johnson & Johnson vaccine to be halted at a plant that reportedly produced 15 million deficient doses.


Cases of thrombosis: what to know about the Johnson & Johnson vaccine before the opinion of the EMA

At the end of March, the pharmaceutical giant had identified in a plant in Baltimore (Maryland) managed by the firm Emergent BioSolutions a batch of doses "which did not comply with quality standards".

The lot had been contaminated with ingredients from AstraZeneca vaccine.

Johnson & Johnson had not specified the quantity of doses involved.

The New York Times had subsequently indicated that this batch contained 15 million doses.

All were destroyed last month.

But, as a precaution, the Biden administration withdrew the AstraZeneca manufacture from the factory and requested a complete control before resumption of manufacture.

Six cases of women with blood clots

Emergent BioSolutions said in an administrative filing sent to the Securities and Exchange Commission, the federal financial market regulator on Monday, that the FDA on April 16 requested a pause in vaccine production in Baltimore pending further inspection. “On April 16, 2021, at the request of the FDA, Emergent agreed not to start manufacturing any new material at its Bayview plant and to isolate existing material manufactured at the Bayview plant pending completion of the inspection and the correction (of any problems, Editor's note) noted during the findings ”, declares the file. The FDA inspection began on April 12, according to Emergent.

The requested break in manufacturing is the latest of problems with the vaccine in the United States, where regulators temporarily halted its use after authorities reported six cases of women who developed blood clots in association with low platelet levels, including one fatal case, within two weeks of a Johnson & Johnson vaccine injection. "This is a handful of cases, not an overwhelming number of cases," Dr Rochelle Walensky said at a White House briefing Monday. "We are working on these questions, assessing them and checking whether they actually reflect a real case," added the director of the Centers for Disease Control and Prevention. Over 7 million people in the United States have received their single dose of Janssen,from batches made in the Netherlands.

It is this Tuesday, at 5 p.m., that the European Medicines Agency (EMA) must make its recommendations on the American group's vaccine. France has already decided to reserve it for people over 55, and Belgium not to administer it.

Source: leparis

All life articles on 2021-04-20

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