Johnson & Johnson COVID-19 vaccine batch fails quality check


Johnson & Johnson’s COVID-19 vaccine batch does not meet quality standards and cannot be used, a major pharmaceutical company said late Wednesday.

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

According to J & J, vaccine ingredients manufactured by Emergent BioSolutions, one of the approximately 10 companies Johnson & Johnson uses to speed up the production of recently approved vaccines, did not meet quality standards. ..

J & J said the relevant Emergent BioSolutions plant has not yet been approved by the US Food and Drug Administration to make some of the vaccines. Emergent declined to comment.

J & J has promised to provide the US government with 20 million doses of vaccine by the end of March and another 80 million doses by the end of May. According to a statement on manufacturing issues, 100 million doses are planned to be administered by the end of June, and “we aim to administer these doses by the end of May.”

President Joe Biden has promised that all US adults will be vaccinated adequately by the end of May. The US government ordered Pfizer and Modana to be vaccinated twice, vaccinated 200 million people by late May, and 100 million more from J & J.

Federal officials said Wednesday evening that the administration’s goals could be achieved without additional J & J administration.

A J & J spokesman said earlier Wednesday that the company had achieved its end-March target, but did not answer questions about whether Baltimore’s new plant was approved by the FDA.

As of Wednesday, J & J had about 6.8 million doses, according to the US Centers for Disease Control and Prevention’s online vaccine tracker. Some additional doses may not yet be recorded as delivered, and federal health officials said Wednesday that an additional 11 million doses of vaccine would be available for shipment starting Thursday.

It wasn’t immediately clear where these 11 million doses came from, but J & J is shipping the finished vaccine from its Dutch factory to the United States.

J & J said it has manufacturing and quality experts at its Baltimore plant in Emergent to oversee the production of the COVID-19 vaccine.

J & J vaccines are considered essential to vaccination campaigns around the world because they require a single vaccination and, unlike other vials that require freezing, can be shipped and stored at standard refrigerated temperatures. The company also promised to sell the vaccine without profit only in a pandemic emergency.

J & J said it plans to vaccinate more than a billion times worldwide by the end of the year.

The vaccine batch issue was first reported by the New York Times. The FDA said it was aware of the situation, but declined further comments.

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Associated Press reporters Matt Perone and Zeke Miller of Washington contributed to this report.

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

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



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