FDA Orders Some 60 Million Johnson & Johnson Vaccines Made by Emergent to be Destroyed
Johnson and Johnson single-dose vaccine

The US Food and Drug Administration (FDA) has authorised the release of two batches of the Janssen/ Johnson & Johnson COVID-19 vaccine – about 10 million doses – manufactured at the Emergent BioSolutions facility in Baltimore, according to a statement on Friday.

However, it also “determined several other batches are not suitable for use” while “additional batches are still under review,” it added.

The rejected doses amount to around 60 million doses, according to the New York Times.

For weeks, the future of the Johnson & Johnson vaccines have been up in the air as the FDA conducted “a thorough review of facility records and the results of quality testing performed by the manufacturer”.

This follows the discovery of serious breaches at Emergent, including the cross-contamination of Johnson & Johnson and AstraZeneca vaccines and mould in the Baltimore plant.

The Emergent problems have hampered severely South Africa’s vaccine rollout, as a local company, Aspen, is contracted to fill and finish for Johnson & Johnson, and was due to supply over two million vaccines to the national vaccination programme.

It is unclear how many of the South African vaccines are affected by the FDA decision.

“The FDA’s decision to include these two batches of vaccine drug substance in the Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries,” said the FDA.

“A condition on any export of these batches, or of vaccine manufactured from these batches, is that Janssen and Emergent agree that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.”

The FDA has also extended the expiration date for refrigerated Janssen COVID-19 vaccines from 3 months to 4.5 months.

“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product. This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. 

“Additionally, the action to extend the shelf life for the refrigerated Janssen vaccine means that jurisdictions that have doses on hand now have additional time to administer vaccine.”


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