The U.S. Food & Drug Administration has asked Johnson & Johnson to discard 60 million doses of its COVID-19 vaccine manufactured at a problem-plagued Baltimore factory, the New York Times reported on Friday, citing people familiar with the matter.
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.
The European Medicines Agency did not say how many shots were affected, but Reuters has reported it involves millions of doses, making it harder for J&J to meet a target of delivering 55 million to Europe by end of June.
