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Johnson & Johnson Halts Shipment of COVID Vaccine After Factory Mistake Ruins 15 Million Doses | National Review

Johnson & Johnson has paused shipment of its COVID-19 vaccine in the United States while the Food and Drug Administration investigates a factory mixup that ruined roughly 15 million doses of the vaccine.

Workers at a Baltimore plant run by Emergent BioSolutions, a manufacturing partner to Johnson & Johnson and AstraZeneca, reportedly mixed up the vaccines’ ingredients several weeks ago
 
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Marc

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#2
"Johnson & Johnson had hired the company, Emergent BioSolutions, to manufacture the active ingredient, or drug substance, of the vaccine at its plant in West Baltimore," reported Erin Blanco, Sarah Owermohle, and Rachel Roubein. "Workers at the facility mistakenly mixed ingredients for the J&J vaccine with those of another manufacturer's coronavirus shot, according to the two officials."

"The Biden administration has asked Johnson & Johnson to directly supervise Emergent's vaccine production going forward, said a senior administration official. Getting the facility back on track — and up to regulatory standards — could take a matter of days or weeks, the official added," said the report. "The incident at the plant prompted the Food and Drug Administration to delay approving Emergent to help Johnson & Johnson produce vaccine; the company had sought permission via an amendment to the emergency use authorization for its shot."

So - Puts some doubt on the other vaccine unnamed company's vaccines well.
 

Mike S.

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#4
It's unfortunate, but I can see this happening. The pressure to ship is huge, with shipments being watched at the highest levels of corporate and the federal government. New employees, rushed training, optimistic or maybe even unreasonable production quotas - any of this sound familiar to anyone?

Even when they meet their quota, it is cast in a negative light: "The company barely met its pledge to provide 20 million doses by the end of March, Politico notes." It's not, they met their quota, it's they "barely" met it.
 

Watchcat

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#8
I'm sure many lawyers will be paid much money to answer this question. IMO, we already paid for them, if you amortize development costs across each dose. So the question is, will we pay yet more? Almost certain to depend on the fine print in the Warped Speed agreement.
 

Watchcat

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#9
I can see this happening. The pressure to ship is huge
If only it was unique to the manufacture of COVID-19 vaccines, but it's not. FDA didn't put it in the QSR and ISO didn't put it in 13485 in anticipation of this pandemic. Nor because they just came up with it as a bright idea, instead of having seen it happen more than a couple of times, and not just with vaccines.

It's also being speculated that this may have been less of a "mix-up" than a case of cross-contamination. Gottlieb spoke of mRNA vaccine's being "sticky." Remember the original COVID-19 test developed by CDC, which apparently was contaminated with bacteria? They probably didn't mix up their bacteria with their reagent; the bacteria got in somehow.

None of this stuff is easy.
 
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