Thursday, July 8, 2021

15 million Johnson & Johnson coronavirus vaccines ruined due to human error: NYT

Johnson & Johnson’s COVID-19 vaccine rollout has been slower than expected in the U.S., with just 6.8 million doses delivered to states in the first month. Now, The New York Times has revealed behind-the-scenes details into an unfortunate mix-up in the production process.

Workers at an Emergent BioSolutions plant in Baltimore mixed up vaccine ingredients weeks ago and ruined a large batch of the vaccine containing around 15 million doses, the Times reports. The FDA is investigating the mistake, but the episode has led to a temporary halt of future J&J shot deliveries from the site, according to the newspaper. In a statement, J&J said it’s working with federal authorities to deliver 24 million doses of the vaccine in April.

Federal investigators have ruled that the episode was the result of “human error,” NYT reports.

Moving forward, J&J is moving to implement tighter controls at its manufacturing partner, the company’s statement said. J&J and AstraZeneca, another leading COVID-19 vaccine player, tapped the contract manufacturer in their production ramp-up efforts last year.

J&J has met its goal to ship 20 million doses to the U.S. government by the end of March, the company said in its statement. J&J didn’t immediately offer an explanation as to why CDC data show just 6.8 million doses having been delivered to states. Only 3.3 million doses have been administered, CDC data show.

RELATED: Johnson & Johnson vaccine partner Emergent still lacks FDA’s manufacturing green light

The company said its manufacturing ramp-up “includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards.” That process identified a batch that didn’t meet standards at the Emergent site, which J&J noted has not yet been authorized.

Emergent spotted the issue and notified the FDA, J&J said.

Moving forward, as the company and Emergent seek an FDA manufacturing authorization for the site, J&J is “providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.”

Working with officials at HHS, the company plans to ship 24 million doses of the vaccine in April, the statement said. J&J has leaned on its vaccine plant in the Netherlands to help with production while its U.S. supply chain comes online.

A representative from Emergent didn’t immediately respond to a request for comment.

SPECIAL REPORT: What does it take to supply COVID-19 vaccines across the globe? Here’s how the leading players are working it

When J&J executives spoke with the investment community about the scale-up on the company’s fourth-quarter earnings call in late January, executives didn’t raise any concerns about the manufacturing ramp. CFO Joe Wolk said the company was “very comfortable” meeting its delivery commitments, but that there could be “fluidity” around timing.

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