The US Food and Drug Administration said Friday it had told Johnson & Johnson that millions of doses of its COVID-19 vaccine produced at a troubled plant can’t be used because of possible contamination issues, AFP reported.
In a statement, the FDA said “several” batches of vaccine manufactured at the Emergent BioSolutions facility in Baltimore are not suitable for use. Each batch is known to correspond to several million doses.
Neither the agency nor J&J revealed the precise number doses, but the New York Times placed the number at 60 million, quoting people familiar with the matter.
The Emergent plant was ordered to pause production in April, several weeks after it was determined that batches of substance used to produce the J&J vaccine were cross-contaminated with ingredients from the AstraZeneca vaccine, ruining a reported 15 million J&J doses.
The FDA is still deciding whether to allow the factory to reopen. 60 million AstraZeneca doses produced there and earmarked to be donated abroad are currently being inspected for quality before they can be shipped, according to AFP.
All of the J&J vaccines distributed and used in the United States so far were made in the Netherlands, not in Baltimore.
“Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere,” said J&J executive vice president Kathy Wengel.
The FDA cleared the Johnson & Johnson COVID-19 vaccine, that works with just one dose instead of two, in late February.
Source: Arutz Sheva