The US Food & Drug Administration has asked Johnson & Johnson to discard 60 million doses of its COVID-19 vaccine that were manufactured at the troubled Baltimore factory, the New York Times reported on Friday.
It cited people familiar with the matter.
This, as Europe’s drug regulator had said on Friday batches of Johnson & Johnson’s COVID-19 vaccine made for the region around the time when contamination issues were revealed at a U.S. manufacturing site would, as a precaution, not be used.
This makes it harder for J&J to meet a target of delivering 55 million to Europe by end of June.
J&J did not immediately respond to queries.
The EMA said it was aware a batch of the active substance for J&J’s COVID-19 vaccine had been contaminated in April with materials for another vaccine made at the site in Maryland owned by Emergent Biosolutions.
The production of J&J’s vaccine at the site was halted by U.S. authorities and J&J was put in charge of manufacturing at the plant.
The April error involved ingredients from AstraZeneca’s COVID-19 vaccine, also being produced at the plant, contaminating a batch of J&J’s vaccine, developed by its Janssen unit.
The EMA said that batch was not intended for the European Union and that batches of the vaccine released in the region had not been affected by the cross contamination, based on the information it has.