15 million doses of COVID-19 vaccines ruined

Oringinally published by Poynter

 The first big question the public will ask is whether any of the 15 million doses of Johnson & Johnson’s vaccine that workers ruined in a manufacturing mistake made it to vaccination lines. The New York Times, which broke this story late Wednesday, says that the mistake does not involve any of the vaccines in the supply chain right now. In other words, the mistake was contained at the factory. 

That should be a loud and clear message today; that the safety of vaccines that people are lined up to get is not in question.

All of the doses in the pipeline right now came from Johnson & Johnson’s plant in The Netherlands. The mistake happened at the plant of a subcontractor, Emergent BioSolutions, which is in Baltimore. 

Johnson & Johnson hired Emergent BioSolutions to manufacture the active ingredient. Workers at the facility mistakenly mixed ingredients for the Johnson & Johnson vaccine with those of another manufacturer’s shot. Emergent does contract work for both Johnson & Johnson and Moderna.

The Baltimore Sun says the mixup happened a couple of weeks ago, but until now, word did not leak. Johnson & Johnson issued a statement Wednesday night that doesn’t mention the mistake until the third paragraph. When it does get to the issue, it says:

As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.

This quality control process 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. 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).

Politico explains the backstory:

Emergent was supposed to send its drug substance to Catalent, a New Jersey drug manufacturer, to bottle the vaccine. The FDA approved Catalent’s production role last week, and Emergent had already begun shipping millions of doses to the other firm, people familiar with J&J’s authorization told POLITICO last week. But Catalent cannot release the Emergent doses without the Maryland company’s emergency clearance.

The Johnson & Johnson vaccine is the only one-dose shot approved for use in the United States. Even though this supply interruption is not insignificant, Pfizer and Moderna’s two-shot vaccines are in full production (and Pfizer is even ahead of its production schedule), so it is uncertain right now if any Americans will have their vaccinations delayed. Johnson & Johnson says it expects to meet its goal of producing a billion doses by the end of 2021.

The larger unanswerable question is how will this bad news sit with the already skeptical unvaccinated public? 

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