The FDA Just Made J&J Throw Out 60 Million Doses Over This, Reports Say
After a vaccine plant was shuttered, Johnson & Johnson has to scrap millions of doses.
The Johnson & Johnson COVID vaccine, notable for its one-dose regimen, has experienced a handful of trials and tribulations over the past few months. The vaccine was briefly paused by the U.S. Food and Drug Administration (FDA) due to its link to blood clots, then brought back into circulation. Now, The New York Times reports that the FDA is forcing Johnson & Johnson to throw out 60 million doses of its COVID vaccine. The millions of doses will be trashed due to possible contamination at the plant they were produced at in Baltimore, run by Emergent BioSolutions.
Issues with the plant began back in April—it was shut down after an inspection identified a handful of violations, and has yet to reopen. One of the most problematic violations was the possible contamination of the Johnson & Johnson vaccines with an ingredient from AstraZeneca's COVID vaccine, The New York Times reported. While about 170 million doses of both vaccines were in question following the inspection, Johnson & Johnson only has to scrap a fraction of them. The FDA told CNBC that several batches weren't "suitable for use."
On June 11, the FDA released a statement saying that before making the decision, it "conducted a thorough review of facility records and the results of quality testing performed by the manufacturer." Taking into consideration the ongoing global health crisis and the results of the review, the FDA decided that some batches of the Johnson & Johnson were salvageable. The agency said it was continuing to "work through issues" at the Emergent BioSolutions plant.
According to The New York Times, the FDA plans to let about 10 million doses be distributed in the U.S. or sent abroad with the stipulation that the agency cannot guarantee that Emergent BioSolutions followed good manufacturing practices while producing the vaccine. The doses of Johnson & Johnson that are already in arms in the U.S. were produced at a plant in the Netherlands, so they weren't affected by this possible contamination.
Following the inspection, officials said Emergent BioSolutions can no longer produce AstaZeneca's vaccine and instructed Johnson & Johnson to take direct control over manufacturing its vaccines at the plant, per The New York Times. Peter Marks, PhD, the FDA's top vaccine regulator, said in the statement that the "review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA's current good manufacturing practice requirements."
While the U.S. has ample Pfizer and Moderna vaccines to distribute, losing 60 million doses of Johnson & Johnson poses an issue for President Joe Biden's plan to send vaccines abroad. The New York Times reports that the administration planned on sharing doses of the Johnson & Johnson and AstraZeneca COVID vaccines, but this plan has been delayed amid the FDA's review of the Emergent BioSolutions facilities.