Sunday, May 15, 2022

Johnson & Johnson vaccine manufacturing partner Catalent scores approval for Indiana plant: reports

Johnson & Johnson’s COVID-19 vaccine rollout has been more of a trickle than a stream so far in the U.S., with the company still on the hook to deliver some 15 million doses by next week. But J&J has said it can meet that goal, and, thanks to the approval of a U.S. manufacturing site, millions more doses could soon be on the way.

The FDA blessed Catalent’s Bloomington, Indiana, facility with an emergency nod to help produce Johnson & Johnson’s COVID-19 vaccine and ship out finished doses, Bloomberg first reported Tuesday. The CDMO could subsequently release millions of vials that have already been packaged and inspected, a source close to the matter said.

The approval could be announced as soon as Tuesday, Bloomberg added, though Catalent didn’t immediately respond to Fierce Pharma’s request for comment. Reuters also reported on the plant approval.

J&J has pledged to deliver 20 million shots to the U.S. by the end of March. The deadline is fast approaching, and the company has so far only deployed around 4.5 million doses, according to the Centers for Disease Control and Prevention. Catalent’s Bloomington plant, with an authorization in hand, is expected to account for most of the month’s remaining supply, Bloomberg reported. 

RELATED: CDMO Catalent trumpets biologics windfall courtesy of COVID-19

The company has held firm to its 20-million-dose goal for March. Andy Slavitt, the White House’s COVID-19 adviser, said Monday that the company would boost shipments this week and approach its target by the month’s end. 

Catalent last April pledged to reserve fill-finish capacity for J&J’s single-dose COVID-19 shot at its Bloomington plant. The CDMO said it planned to bring on 300 new staffers at the facility starting in July, with the goal to hit 24/7 production schedules by January. The companies expanded their pact in July to include fill-finish work at Catalent’s Anagni, Italy, plant.

Just last week, the CDMO laid plans to double capacity at its Anagni site, thanks to the addition of a second high-speed vial-filling line that should come online in the fourth quarter. 

After Johnson & Johnson’s vaccine won FDA authorization in late February, the company in March agreed to supply the U.S. with another 100 million doses, raising expected U.S. supply of COVID-19 vaccines to 800 million at the time. 

RELATED: J&J single shot sees 66% efficacy in moderate COVID-19, 85% in severe cases; shares fall

News of the expanded supply deal came just one week after J&J enlisted vaccine bigwig Merck to support its manufacturing push. J&J will use a sprawling Merck & Co. plant in Durham, North Carolina, to manufacture the bulk drug substance used to make the vaccines, the Raleigh News & Observer reported last week.

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