Company at heart of J&J COVID-19 vaccine woes has series of quotes

The company at the center of the quality issues that led Johnson & Johnson to throw away an unknown amount of its coronavirus vaccine has a string of citations from US health officials for quality control concerns.

Emergent BioSolutions, a little-known company at the center of the vaccine supply chain, played a key role in Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the United States by the end of the month of May. But the company has been cited repeatedly by the Food and Drug Administration for issues including poorly trained employees, cracked vials and mold around one of its facilities, according to documents obtained by the Associated Press. through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017.

Johnson & Johnson said on Wednesday that a batch of vaccine manufactured by Emergent at its Baltimore plant, known as Bayview, could not be used because it did not meet quality standards. It was not clear how many doses were involved or how the issue would affect future shipments of J&J’s vaccine. The company said in a statement that it still plans to deliver 100 million doses by the end of June and that it “intends to deliver those doses by the end of May.” .

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J&J locked arms with Emergent in April 2020, calling on the lesser-known company to make the vaccine that J&J was developing with federal funding. At the time, Emerg’s facility in Bayview was not sized to manufacture millions of doses of a potential COVID-19 vaccine, according to FDA records which describe the plant as a testing lab under contract which “did not manufacture products for distribution”. Technology and personnel upgrades were needed before Bayview could begin manufacturing so-called “drug substance” material for the vaccine, a two-month process in which the required biological cells are grown. .

The FDA inspected Emerging’s plant in Bayview in April 2020, just as the deal with J&J was announced. The federal agency criticized the company for problems with its testing of a potential treatment for anthrax, according to records obtained by the AP. The lead FDA investigator cited the company for failing to train employees “in the particular operations they perform as part of their job and current good manufacturing practices.”

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On the same day, Johnson & Johnson, in a separate press release, announced its partnership with Emergent as a step towards the pharmaceutical giant’s goal of delivering more than one billion doses of the vaccine to the world by the end. from 2021.

Other issues cited by the FDA during the April 2020 inspection included failures at the Bayview plant “to ensure that data stored electronically generated during analytical testing” of the material “was protected from deletion. or manipulation ”. Lead FDA investigator Marcellinus Dordunoo wrote that Emerg had failed to investigate what he described as “data integrity issues.”

The inspection was the most recent in a series of critical FDA reports on Emergent, including one following a December 2017 inspection at a factory in Canton, Massachusetts, in which the FDA said the company no ‘had not corrected 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.

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.

Emergent is one of 10 companies Johnson & Johnson is using to speed up manufacture of its recently approved vaccine, the company said. The Bayview plant where the contaminated vaccine ingredient was found had not yet been approved by the FDA, so no circulating vaccines are affected. Emergent declined to comment.

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 single-dose doses.

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, and the Centers for Disease Control and Prevention’s online vaccine tracker showed J&J provided around 6.8 million doses. to the American vaccination effort. J&J shipped finished vaccines from its factory in the Netherlands to the United States

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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.