Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

A Baltimore plant run by Emergent BioSolutions that produces coronavirus vaccines ruined a batch of Johnson & Johnson’s vaccine, according to a statement released by Johnson & Johnson Wednesday.

Why it matters: The plant, which was projected to produce and ship tens of millions of Johnson & Johnson doses next month, must now cease producing the one-dose vaccine while the Food and Drug Administration investigates the error, the New York Times first reported. Axios confirmed the report is accurate.

Context: Workers at the plant, which had been producing Johnson & Johnson and AstraZeneca vaccines, conflated the ingredients between the two different types of vaccines, destroying 15 million doses of Johnson & Johnson vaccine, according to the Times.

• The error should not affect Johnson & Johnson doses currently being delivered and administered nationwide, as they were produced in the Netherlands.
• The Emergent BioSolutions plant had not yet been authorized by the FDA to manufacture drug substance for Johnson & Johnson's vaccine, but an authorization application had been pending, according to Politico.

What they're saying: Johnson & Johnson said Wednesday that 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," the company added.
• Johnson & Johnson said it is sending manufacturing and quality control experts to the plant to oversee future production.

Thought bubble, via Axios' Caitlin Owens: The Times says the accident won't stop the U.S. from reaching President Biden's goal of having enough vaccine by the end of May for every adult, but in the global race against the virus, every dose counts.

from Hacker News https://ift.tt/31yrDXj