Catalent, the fill and finish plant in Bloomington, Indiana, that is helping to produce Johnson & Johnson’s Covid-19 vaccine, said Tuesday it received an OK from the US Food and Drug Administration to ship the vaccine.
Catalent has been producing doses for the past couple months as Johnson & Johnson promised to deliver 20 million of its single-dose vaccine to the US government by the end of the March.
Catalent had dedicated a line specifically to fill vials of the Johnson & Johnson vaccine and hired 300 additional staff to work 24/7 to produce it — but it needed FDA authorization to ship the product.
“Today, Catalent is proud to announce the FDA has provided Emergency Use Authorization for our biologics site in Bloomington, Indiana, to produce and ship millions of doses of Johnson & Johnson’s COVID-19 vaccine,” a statement emailed to CNN said. “The site recently completed a major expansion and scale-up activities on a dedicated, high-speed vial-filling line to support the production of this important vaccine, and Catalent remains on track to meet the supply commitments of our agreement with Johnson & Johnson.”
Catalent would not say how many millions of Johnson & Johnson vaccines it would be able to ship immediately. A spokesperson for the company told CNN it would be up to J&J to disclose that number. Asked by CNN how many doses would be available, Johnson & Johnson did not provide specifics.
Biden administration officials, meanwhile, told CNN this week they were not confident that Johnson & Johnson would be able to meet its self-imposed deadline to deliver 20 million coronavirus vaccines by the end of March. Johnson & Johnson has said it is on target to meet that goal.
Johnson & Johnson only had 4 million doses ready to ship when it was authorized by the FDA at the end of February. An additional 1.2 million doses have gone out since, meaning the company must have another 14.8 million ready in the next week to meet its goal.
White House officials said Tuesday 4 million more J&J doses would be allocated this week.