Discard 60 million Covid vaccine doses made at Baltimore plant: US FDA to J&J

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The U.S. Food & Drug Administration on Friday said Johnson & Johnson must throw away millions of doses of its COVID-19 vaccine that were manufactured at a problem-plagued Baltimore factory but also cleared millions for use.

A further 10 million J&J doses would be allowed to be distributed with a warning that there was no guarantee contract manufacturer Emergent BioSolutions Inc had followed proper practices, the newspaper said.

Without disclosing or confirming the number of vaccine doses, the FDA said in a news release that it had authorized two batches of the vaccine for use, that multiple other batches were not suitable for use and that others were being evaluated.

The agency said it was not yet ready to authorize Emergent’s plant for manufacturing the J&J vaccine. Production of J&J’s vaccine at the Baltimore site was halted by U.S. authorities in April and J&J was put in charge of manufacturing at the plant.

J&J did not have an immediate comment. The FDA declined to comment beyond its statement.

The FDA said its decision allows the J&J doses to be used in the United States or exported. It said that for J&J and Emergent to export these shots, they must agree that the FDA can share information on the batches with the regulatory authorities of the countries in which the vaccine may be used.

 

Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 million doses of J&J’s one-shot vaccine ready for FDA review and that regulators had begun the review process.

The April halt followed the discovery that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J’s vaccine. AstraZeneca’s shot is no longer being made there.

An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.

Separately, Europe’s drug regulator said on Friday that batches of J&J COVID-19 vaccine made for the region around the time the contamination issues were revealed at the Baltimore plant would, as a precaution, not be used.

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