J&J dumps millions vaccines due to poor quality of productionEuropost
One of the producers of Covid-19 vaccines Johnson and Johnson has announced it would dump a large volume of jabs due to registered poor manufacturing quality caused by personnel with no adequate training, AP reported. The company at the center of quality problems that led Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a series of citations from US FDA for quality control problems.
Emergent BioSolutons, 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 US by the end of May. 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 AP through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017. Johnson & Johnson said 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. It wasn't clear exactly how many doses were involved or how the problem would affect future delivers of J&J's vaccine. 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.”
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.”
Emergent’s revenues skyrocketed during the Donald Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone.
Emergent is one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine, the company said. The Bayview factory where the tainted vaccine ingredient was found had not yet been approved by the FDA, so no vaccine in circulation is affected. Emergent declined to comment.
The J&J vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.