Johnson & Johnson COVID-19 vaccine batch fails quality control

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

The drugmaker did not say how many doses were lost, and it was not clear how the issue would impact future shipments.

A vaccine ingredient made by Emergent BioSolutions – one of 10 companies Johnson & Johnson is using to speed up manufacture of its recently approved vaccine – did not meet quality standards, J&J said.

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

J&J had pledged to deliver 20 million doses of its vaccine to the US government by the end of March, and an additional 80 million doses by the end of May. Its statement on the manufacturing issue said it still planned to deliver 100 million doses by the end of June and that it “aimed to deliver those doses by the end of May.”

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President Joe Biden has pledged to have enough vaccines for all American adults by the end of May. The U.S. government has ordered enough two-dose vaccines from Pfizer and Moderna to immunize 200 million people to be delivered by the end of May, plus J & J’s 100 million vaccines.

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

A spokesperson for J&J said earlier Wednesday that the company had met the end of March target, but did not answer questions about whether the Emergent Baltimore plant, known as Bayview , had been cleared by the FDA.

As of Wednesday, J&J had provided about 6.8 million doses to the U.S. vaccination effort, according to the Centers for Disease Control and Prevention’s online vaccine tracking system. Some additional doses may not yet have been recorded as delivered, and federal health officials said Wednesday that 11 million additional doses of the vaccine would be available for shipments starting Thursday.

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It was not immediately clear where those 11 million doses came from, but J&J shipped finished vaccines from its factory in the Netherlands to the United States.

Emergent, a little-known pharmaceutical company that has given a major role in the federal government’s response to the coronavirus pandemic, has been repeatedly cited by the FDA for issues ranging from poorly trained employees to cracked vials and mold. around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act.

The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company had failed to correct “the Low level persistent mold and yeast isolates ”found at the facility. . Nearly a year later, agency investigators asked why Emergent had an “unwritten policy not to conduct routine compliance audits” at a separate plant in Baltimore known as Camden, where an anthrax vaccine is introduced into vials.

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Emerg’s revenue skyrocketed during the Trump administration, from around $ 523 million in 2015 to over $ 1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure documents, which show the company spent $ 3.6 million on lobbying in 2020 alone.

J&J said it was putting more of its manufacturing and quality experts into the Emergent factory to oversee production of the COVID-19 vaccine, a move intended to allow delivery of an additional 24 million doses of vaccine through April. .

J&J said it still plans to deliver more than a billion doses of the vaccine globally by the end of the year.

The J&J vaccine has been seen as crucial for vaccination campaigns across the world, as only one injection is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials which must be kept frozen. The company also pledged to sell the vaccine for no profit, but only during the pandemic emergency.

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

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Johnson reported from Fairless Hills, Pa., And Lardner from Washington. AP reporters Matt Perrone and Zeke Miller in Washington contributed.

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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.