Johnson & Johnson's manufacturing partner Emergent BioSolutions said on Thursday that it had disposed of a single batch of COVID-19 drug substance that did not meet specifications, a day after J&J said it had found a problem with a batch being produced at Emergent's site in Baltimore, Maryland.
Colette Luke has more.
Johnson & Johnson's manufacturing partner Emergent BioSolutions said on Thursday that it had disposed of the single batch of COVID-19 drug substance that did not meet specifications.
This comes after J&J said on Wednesday that it had found a problem with a batch of the drug substance for its COVID-19 vaccine being produced at Emergent's site in Baltimore, Maryland, adding that the batch did not advance to the final fill-and-finish stage.
White House Press Secretary Jen Psaki on Thursday said the White House was already aware of the issue: “The issue was identified as part of rigorous quality control system checks and HHS made us aware late last week... The issue doesn't impact - one - the J&J doses that are available of course already on the market.
Johnson & Johnson has made clear that they expect to deliver 24 million issues in April and that they expect to meet their commitment of 100 million doses by the end of May." The New York Times reported that about 15 million doses were ruined, without citing a source.
According to the Times article, workers had conflated ingredients for the J&J vaccine and a coronavirus vaccine developed by AstraZeneca, which is produced at the same plant, several weeks ago.
On Thursday, Emergent said: "Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process," J&J said the problem at the Emergent Biosolutions plant was identified and addressed with Emergent and shared with the U.S. Food and Drug Administration - adding that it was sending more people to supervise manufacturing at the plant.
News of the setback comes at a time when the Biden administration has been trying to accelerate shipments of COVID-19 vaccines to U.S. states.
Last month, the administration said it was exploring ways to increase manufacturing of J&J's vaccine, as the expected levels of early doses were less than it hoped at the time.
J&J said it has met its commitment to deliver more than 20 million doses of its single-shot vaccine by the end of March in the United States.
