Johnson & Johnson COVID-19 vaccine batch fails high quality verify

According to Johnson & Johnson, a batch of the COVID-19 vaccine did not meet quality standards and cannot be used

March 31, 2021, 11:42 p.m.

3 min read

A batch of Johnson & Johnson’s COVID-19 vaccine has not met quality standards and cannot be used, the drug giant said late Wednesday.

The drug maker didn’t say how many doses were lost, and it wasn’t clear how the problem would affect future shipments.

A vaccine ingredient from Emergent BioSolutions – one of about 10 companies Johnson & Johnson is working with to accelerate the manufacturing of its recently approved vaccine – was not up to quality standards, according to J&J.

J&J said the affected Emergent BioSolutions factory has not yet been approved by the U.S. Food and Drug Administration to become part of the vaccine. Emergent declined to comment.

J&J had pledged to provide the US government with 20 million doses of its vaccine by the end of March and an additional 80 million doses by the end of May. His statement on the manufacturing problem states that it is still planning to sell 100 million cans by the end of June and “intends to sell those cans by the end of May”.

President Joe Biden has pledged to have enough vaccines for all adults in the United States by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by the end of May, as well as the 100 million shots from J&J.

A federal official said Wednesday evening the government’s goal could be achieved without additional J&J doses.

A J&J spokesman said earlier Wednesday that the company had met its late March target but did not respond to questions about whether the Emergent Baltimore plant had been approved by the FDA.

J&J had provided approximately 6.8 million doses as of Wednesday, according to the U.S. Centers for Disease Control and Prevention’s online vaccine tracker. Some additional doses may not have been registered as dispensed, and federal health officials said Wednesday that an additional 11 million doses of the vaccine would be available for shipments as of Thursday.

It wasn’t immediately clear where those 11 million doses came from, but J&J shipped finished vaccines to the US from its factory in the Netherlands

J&J announced that more of its manufacturing and quality experts will be deployed to Emergent’s Baltimore facility to oversee production of the COVID-19 vaccine. This move should allow an additional 24 million doses of vaccine to be delivered by April.

The J&J vaccine has been seen as critical to vaccination campaigns around the world because it only requires one shot and, unlike some other vials that must be kept frozen, it can be shipped and stored at standard refrigeration temperatures. The company has also pledged to sell the vaccine for no profit, but only during the pandemic emergency.

J&J expects more than 1 billion vaccine doses to be sold worldwide by the end of the year.

The problem with the vaccine lot was first reported by the New York Times. The FDA said it was aware of the situation but declined to comment.

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Washington associate press reporters Matt Perrone and Zeke Miller contributed to this report.

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Follow Linda A. Johnson at https://twitter.com/LindaJ—onPharma

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

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