J&J’s COVID-19 vaccine batch fails to meet U.S. FDA quality standards

Thu, Apr 1, 2021
By editor

Coronavirus Pandemic

A batch of Johnson and Johnson’s COVID-19 vaccine failed quality standards and can’t be used, the drug giant has said.

It said the site was not yet authorized to manufacture a drug substance for its single-shot COVID-19 vaccine.

The batch was never advanced to the filling and finishing stages of its manufacturing process.

Johnson & Johnson’s comments follow a report earlier today by The New York Times saying that about 15 million doses of the company’s vaccine had been accidentally ruined by humans.

It said the error occurred after workers in the facility mixed ingredients incorrectly, with shipments of the vaccine delayed as a result.

The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca, whose vaccine has yet to be authorized for use in the U.S…

Johnson & Johnson stated that it continues to work with the Food & Drug Administration and Emergent toward the Emergency Use Authorisation of the Emergent Bayview Facility.

The company was providing additional experts in manufacturing, technical operations, and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the COVID-19 vaccine.

Meanwhile, Johnson & Johnson said it was still on track to deliver more than 20 million vaccine doses it promised the U.S. by Wednesday, as well as another 24 million doses by the end of April.

It is part of the company’s plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May.

The company continued to expect to deliver its COVID-19 vaccine at a rate of more than one billion doses by the end of 2021. (dpa/NAN)

– Apr. 01, 2021 @ 10:44 GMT