US FDA says J&J should discard millions of defected doses
J&J Covid-19 vaccine
TheUS Food & Drug Administration on Friday, June 11,said Johnson & Johnson must throw awaymillionsofdosesof itsCOVID-19vaccinethat were manufactured at a problem-plagued Baltimore factory but also clearedmillionsfor use.
Two sources familiar with the situation told Reuters that the agency had cleared about 10 milliondoses. The New York Times said that the batches beingdiscarded amount to around 60 milliondoses, citing people familiar with the matter.
Without disclosing or confirming the number ofvaccinedoses, theFDAsaid in a news release that it had authorized two batches of thevaccinefor use, that several other batches were not suitable for use, and that others were being evaluated.
The agency said it was not yet ready to authorize Emergent BioSolutions Inc's plant for manufacturing the J&Jvaccine. Production of J&J'svaccineat the Baltimore site was halted byUS authorities in April and J&J was put in charge of manufacturing at the plant.
One source familiar with the matter told Reuters that the J&Jdosesare expected to be exported to other countries. Thedosesare already in vials and ready for use, the other source said.
Safety concerns about the J&Jvaccinepaired with flaggingUS demand for vaccinations, in general, have slowed the rollout of the one-shotvaccineto a crawl. Close to half of the 21 milliondosesproduced for the United States sit unused.
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TheFDAsaid its decision allows for the J&Jdosesto be used in the United States or exported. The agency said the drugmaker and Emergent must agree that theFDAcan share relevant information about the manufacturing of thedoseswith regulators where thevaccineis shipped.
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J&J, in a statement, confirmed that theFDAauthorized the two batches, but did not acknowledge thedosesregulators decided should be tossed.
TheFDAdeclined to comment beyond its statement.
Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 milliondosesof J&J'svaccineready forFDAreview and that regulators had begun the review process.
The April halt followed the discovery that ingredients from AstraZeneca'sCOVID-19vaccine, also being produced at the plant at the time, contaminated a batch of J&J'svaccine. AstraZeneca's shot is no longer being made there.
AnFDAinspection 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&JCOVID-19vaccinemade for the region around the time the contamination issueswere 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 involvesmillionsofdoses, making it harder for J&J to meet a target of delivering 55 million to Europe by end of June.