Emergent BioSolutions: Quality Control Systems Worked to Detect Single Covid-19 Vaccine Batch After Quality Lapse

   By Maria Armental 
 

Johnson & Johnson Covid-19 vaccine contract manufacturer Emergent BioSolutions Inc. said its quality checks had worked, detecting a batch of vaccines that didn't meet standards.

"Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process," the company said in a statement Thursday.

Emergent BioSolutions didn't specify the number of doses affected or what had happened, but The Wall Street Journal, citing anonymous sources, reported that the batch was contaminated.

One of those people, The Journal reported, estimated the error at the Baltimore plant affected approximately 15 million doses of the vaccine's main ingredient.

J&J, which also didn't discuss what had happened, said it would be able to make enough doses to meet production targets for the U.S. in the coming months. J&J's plant in the Netherlands has been making the main ingredient for the initial U.S. supply of its vaccine, including the nearly four million doses that were distributed immediately after it was authorized in late February.

Emergent also makes at the same plant the main ingredient for AstraZeneca PLC's Covid-19 vaccine, which hasn't been authorized for use in the U.S.

--Peter Loftus and Thomas M. Burton contributed to this story.

Write to Maria Armental at [e-mail]

(END) Dow Jones Newswires

April 01, 2021 18:35 ET (22:35 GMT)

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