![]() ![]() Other problems cited by the FDA during the April 2020 inspection included failures by the Bayview plant “to ensure that electronically held data generated during analytical testing” of material “was protected from deletion or manipulation.” The FDA’s lead investigator, Marcellinus Dordunoo, wrote that Emergent hadn’t investigated what he described as “data integrity concerns.” On the same day, Johnson & Johnson, in a separate news release, heralded its partnership with Emergent as a step toward the pharmaceutical giant’s goal of supplying more than 1 billion doses of the vaccine globally by the end of 2021. The FDA’s lead investigator cited the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices.” The federal agency criticized the company for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced. At the time, Emergent’s Bayview facility wasn’t scaled for making millions of doses of a potential COVID-19 vaccine, according to the FDA records that describe the plant as a contract testing laboratory that “did not manufacture products for distribution.” Upgrades in technology and personnel were required before Bayview could begin making what’s known as “drug substance” material for the vaccine, a two-month process during which the required biological cells are grown. J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal funding. The company said in a statement it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.” It was unclear how many doses were involved or how the problem would affect future deliveries of J&J’s vaccine. Johnson & Johnson said Wednesday that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, can’t be used because it didn’t meet quality standards. The records cover inspections at Emergent facilities since 2017. But the company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. health officials for quality control problems.Įmergent BioSolutions, a little-known company at the center of the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the U.S. The spokesperson said Johnson & Johnson has "millions of doses" of its COVID-19 vaccine in its inventory.The company at the center of quality problems that led Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a string of citations from U.S. They added: "We manage our production planning accordingly and are currently supplying from our extensive global network based on the demand for our vaccine and the needs of our patients and customers." "Our manufacturing sites produce multiple products as we have an obligation to supply life changing medicines to patients around the world and bring forward our innovative pipeline of new medicines and vaccines," the spokesperson said. The halt is temporary and production is expected to start back up after a few months, according to the Times report.Ī spokesperson for Johnson & Johnson did not confirm or deny the Times report in a statement shared with Insider. ![]() Johnson & Johnson has reportedly been using the facility to develop an experimental vaccine that's unrelated to the COVID-19 pandemic. The Times reported that the company shut down the only plant making usable vaccine batches in the Netherlands late last year. Johnson & Johnson shut down production of its COVID-19 vaccines in late 2021, the New York Times reported on Tuesday. Johnson & Johnson has reportedly been using the facility to develop an experimental vaccine.Ī spokesperson for the company did not confirm or deny the Times report in a statement to Insider. Johnson & Johnson shut down production of its COVID-19 vaccines recently, the New York Times said.
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