Health

Johnson & Johnson oversee vaccine manufacturing in Baltimore – NPR

Johnson & Johnson will oversee all aspects of vaccine production at the Emergent BioSolutions facility in Baltimore. The Biden administration and the Department of Health and Human Services have made the change in management easier.

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Johnson & Johnson will oversee all aspects of vaccine production at the Emergent BioSolutions facility in Baltimore. The Biden administration and the Department of Health and Human Services have made the change in management easier.

Stephen Zenner / Getty Images

The Biden administration made it easier for Johnson & Johnson to take "full responsibility" for a manufacturing facility after a mishap likely botched millions of doses of COVID-19 vaccine.

The company has pledged to ship 100 million cans by the end of May. However, on March 31, J&J announced that Quality Control had determined that a batch of ingredients for the single-dose vaccine manufactured by Janssen Pharmaceuticals did not meet required standards at the Emergent BioSolutions facility in Baltimore.

The facility had worked on making ingredients for Johnson & Johnson and AstraZeneca vaccines, mixing the ingredients for the two vaccines, according to the New York Times and Washington Post. The newspapers reported that the mix-up ruined a batch equivalent to about 15 million cans.

A senior government health official said the Department of Health and Human Services and the Food and Drug Administration had now determined that it was "best suited" for the facility to produce only one vaccine.

J&J confirmed over the weekend that it will be taking a more hands-on approach at the Baltimore site and "increasing the number of manufacturing, quality and technical operations people who work with the corporate specialists already at Emergent."

The Emergent facility has made a substance that will be included in the Johnson & Johnson vaccine, but the facility has not yet received approval from the FDA. To date, no vaccine he has made has been used in the US vaccination effort.

Had this part of the ingredients been approved, it would have contributed to vaccine production. Instead, the batch was discarded.

Emergent also produced a compound for AstraZeneca's vaccine – a vaccine that has not previously been approved for use in the United States. However, following the incident, the facility will no longer be used to manufacture ingredients for AstraZeneca's vaccine. The government is working with AstraZeneca to relocate this production.

"J&J continues to work on manufacturing issues with the FDA and no product will come out of the Baltimore facility without FDA approval," a senior health official told NPR. "This is a critical factor in ensuring the quality and safety of the vaccine product."

Emergent said the existing quality control systems were working as planned and will continue to work towards FDA approval.

"Rigorous quality reviews are conducted throughout our vaccine manufacturing processes. These reviews identified a single batch of drug substances that did not meet specifications and our strict quality standards," said a statement from Emergent. "Discarding a batch of drug substances, while disappointing, does happen occasionally in the manufacture of vaccines, which is a complex and multi-step biological process."

Since being granted emergency clearance on Feb. 27, Johnson & Johnson has dispensed 8.6 million doses of its vaccine, of which more than 4 million have been given, according to the Centers for Disease Control and Prevention. In contrast to the other vaccines, it is a single vaccine that requires standard refrigeration temperatures instead of hypercold storage.

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