Future shipments of Johnson & Johnson’s COVID-19 vaccine will be delayed after one of its subcontractors ruined 15 million doses.
Johnson & Johnson hired the company, Emergent BioSolutions, to manufacture the active ingredient of the vaccine at its plant in West Baltimore, but over the last several weeks, Politico reports that workers at the facility mistakenly mixed ingredients for the J&J vaccine with those of another manufacturer’s coronavirus shot.
The article states the mixup prompted the Food and Drug Administration to delay approving Emergent to help Johnson & Johnson produce the vaccine.
Politico reports the company had sought permission through an amendment to the emergency use authorization for its shot.
Johnson & Johnson said in a statement that its quality control processes identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions.
“This batch was never advanced to the filling and finishing stages of our manufacturing process,” the company said. “This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).”
Johnson & Johnson has also partnered with Catalent, a “fill-finish” facility that bottles vaccines.
Politico reports Emergent is already sending millions of doses to Catalent, but those shots cannot be used until Emergent receives its own FDA authorization.