There’s been a pause in the shipment of Covid vaccines to distributors after Johnson & Johnson discovered a huge error made by workers in a manufacturing plant in Baltimore. Emergent BioSolutions, a manufacturing partner to Johnson & Johnson and AstraZeneca, apparently mixed up ingredients of the vaccines several weeks ago.
Emergent was still seeking FDA approval to help J&J manufacture the vaccine when the mix-up occurred.
All previous doses of the J&J vaccine were manufactured in the Netherlands so their safety is not an issue. But the factory accident calls into question J&J’s promise to deliver 100 million doses by the end of May. And with further scrutiny of Emergent and other J&J partners by the government, it’s likely that there will be further manufacturing delays.
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, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine.”
The company added: “This batch was never advanced to the filling and finishing stages of our manufacturing process. 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).”
The White House apparently knew of the situation at least a week ago.
But two senior officials working on the federal government’s Covid-19 response told POLITICO that it became clear earlier this month that there were significant problems at Emergent’s West Baltimore plant, where the company was producing the active ingredient — or drug substance — for J&J’s vaccine. The officials said they had not known the exact details of the situation.
A third senior official said the Department of Health and Human Services found out last week that Emergent had botched the 15 million doses, and how. “It was no secret that Emergent did not have a deep bench of pharmaceutical manufacturing experts,” that official said.
No doubt Biden’s political people figured it was better for the bad news to come from the company and not the White House. Still, it would have been nice if someone mentioned to state governors and local public health officials that shipments were going to be delayed. Now they’re scrambling to come up with alternative plans to meet the needs of citizens.
For Johnson & Johnson, this is a blow. They have only a small window of opportunity to cash in on the vaccine bonanza and this setback will cost them. Their saving grace is that their vaccine is a single-dose treatment. Also, the fact that they need no specialized refrigeration of their vaccine means they may be the preferred vaccine for most of the rest of the world.
The J&J vaccine will still figure into the drive to immunize the United States. And it’s not likely that Biden’s vaccine goals will be radically affected. But losing 15 million doses is still a setback and the U.S. certainly can’t afford many more errors like this.