The Food and Drug Administration has told Johnson & Johnson to discard about 60 million doses of its Covid-19 vaccine that were produced at a troubled plant in Baltimore, according to two people familiar with the matter.
The FDA ordered the vaccines to be tossed after determining they were “not suitable for use,” the agency said Friday. But the FDA plans to allow Johnson & Johnson to distribute 10 million doses that were manufactured at the same facility, according to the two people familiar with the decision.
The agency said in a press release that it authorized some batches for use but not others, but it didn’t provide specific numbers.
“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the release.
The FDA’s decision to tell Johnson & Johnson to dump the vaccines was first reported by the New York Times.
“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,” Kathy Wengel, Johnson & Johnson's chief global supply chain officer, said in a statement.
“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.”
The doses in question were produced at the Emergent BioSolutions plant in Baltimore. The facility threw away ingredients for 15 million doses in late April because of contamination with materials from the AstraZeneca vaccine, which was also manufactured at the plant.
The FDA’s subsequent inspection of the Baltimore facility revealed it had serious problems with unsanitary conditions and had failed to properly train workers.
Following the inspection, the agency required Johnson & Johnson to take full control of the facility.
Public health experts in countries where there are no vaccines have told NBC News they prefer the one-shot Johnson & Johnson vaccine citing its ease of administration since second appointments are not necessary.
In approving the 10 million doses for distribution in the United States or abroad, the FDA updated its letter of authorization for J&J to help “facilitate potential export to other countries.” The FDA is still reviewing other batches from the Baltimore plant for potential distribution, according to the agency’s press release.
Friday’s action followed a move earlier in the week by the FDA to extend the shelf life of Johnson & Johnson doses from three months to four and a half months. NBC News reported that hundreds of thousands and potentially millions of J&J doses are sitting on shelves around the country and were set to expire soon.