Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.
The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.
In a news release announcing the extension of the shelf life of J&J’s COVID-19 vaccine, the FDA confirmed the allowance of two batches from the Emergent facility (The New York Times reported that those batches total about 10 million doses). However, the FDA mentioned that it “determined several other batches are not suitable for use, but additional batches are still under review,” likely referring to the 60 million or so doses as reported by The New York Times.
This comes as the latest blow to Emergent and J&J after news broke in April that a factory error at the same Baltimore facility resulted in 15 million discarded COVID-19 vaccines. The FDA weeks later released a scathing report citing multiple failures in the Emergent BioSolutions plant.
According to The New York Times report, the FDA has not yet determined whether Emergent can reopen the factory that has been closed for two months following the initial failures in April.
When reached for comment, the FDA did not offer a statement, instead directing questions to Johnson & Johnson, which, when reached, directed questions to a news release put out today. The release acknowledgesd the two authorized batches of drug substance, although the company did not mention the batches that were not authorized.
“Since establishing our COVID-19 vaccine program, Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere,” J&J EVP & chief global supply chain officer Kathy Wengel said in the release. “Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities.”
Emergent BioSolutions did not immediately respond to requests for comment. This story may be updated.