Emergent BioSolutions said on Wednesday it will resume production of Johnson & Johnson's COVID-19 vaccine at its troubled Baltimore facility, where operations were stopped in April after millions of doses were found to be contaminated.
The resumption comes after J&J last week slashed its 2021 production target of its single-dose vaccine to between 500 million and 600 million doses from its original goal to produce a billion shots.
The resumption follows additional reviews and collaboration with the FDA and manufacturing partners, Emergent Chief Executive Officer Robert Kramer said.
The FDA has so far approved five batches from the Emergent facility since production there was paused, and J&J is working to clear additional doses for use, the drugmaker said last week.
U.S. health regulators in April halted operations at the Baltimore plant following a discovery that ingredients from AstraZeneca's COVID-19 vaccine, also being produced there at that time, contaminated a batch of J&J's vaccines.
An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices.
J&J's vaccine, considered more convenient for use, storage and shipping to remote areas, has seen a relatively slow uptake in Europe and the United States due to safety concerns and the production issues.
Johnson & Johnson and the FDA did not immediately respond to Reuters requests for comment.
The Wall Street Journal, which first reported the news, cited a letter from the FDA saying the agency had no objections with the plant resuming manufacturing. (https://on.wsj.com/3iXSAfg)
The facility could make as many as 120 million doses a month at full capacity, but the finished doses might not be available until this fall, the Journal reported, citing a source.
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