Employees at a Baltimore COVID-19 vaccine manufacturing plant are said to have mixed up ingredients weeks ago during the vaccine manufacturing process, effectively ruining nearly 15 million doses of the Johnson & Johnson vaccine, the New York Times first reported.
Federal officials reportedly called the mix-up at Maryland-based biopharmaceutical firm Emergent BioSolutions "human error." Emergent BioSolutions is a manufacturing partner to both Johnson & Johnson and pharmaceutical giant AstraZeneca.
As the New York Times reported, the conflation of ingredients caused shipments of Johnson & Johnson's single-dose vaccine to be put on hold by the factory manufacturing the vaccine.
"It kind of gives Johnson & Johnson a little bit of a black eye," said Miro Copic, a marketing professor at San Diego State University.
Copic said this mix-up at the Baltimore-based manufacturing plant which Johnson & Johnson has partnered with is now creating some uncomfortable headlines for the pharmaceutical giant.
"This is not a day of production," Copic told News 8. "This is multiple days or weeks of production and should have been caught earlier. But independent of that, the fact that it was caught is important."
Politico reported on March 24 that Emergent BioSolutions had not yet received FDA emergency authorization to manufacture vaccine ingredients for Johnson & Johnson, but was reportedly already doing so in preparation for regulators to approve the factory to move ahead with manufacturing.
In a statement from Johnson & Johnson Wednesday, the company said its "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."
While the statement from Johnson & Johnson didn't mention how many doses of the vaccine were put in jeopardy, the company emphasized that discovering the problem showed how "rigorous" its quality control practices are globally.
Johnson & Johnson said it expects to meet the goal of delivering enough single-dose vaccines by the end of March for the full vaccination of more than 20 million people in the United States and 100 million doses by the end of May.
Consumer confidence in the Johnson & Johnson vaccine may be challenged, at least for a little while, according to Copic.
"There will be some who are skittish," he said, "so if they are given the option for the two-dose vaccine from Moderna or Pfizer, some people might feel more comfortable, saying 'I'm willing to do the two-dose, even though the one-dose is extraordinarily convenient.'"
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