J&J waiting on new plant approval to ship high volumes of vaccine: executive

(Reuters) - Johnson & Johnson is waiting on regulatory approval of a new, larger plant operated by contract manufacturer Catalent Inc to begin large-scale U.S. deliveries of its just-authorized COVID-19 vaccine following initial shipments this week, a top J&J executive said on Monday.

J&J will ship nearly 4 million doses of the one-shot vaccine around the United States this week and expects to deliver another 16 million doses later this month. But none is expected to go out next week.

“The first doses come from a smaller plant, which we could start up earlier,” J&J Chief Scientific Officer Paul Stoffels said in an interview. “The big plant is on board, the FDA is looking at all the quality data and hopefully very quickly, we’ll be able to get approval to ship from that plant and then we get going.”

Stoffels said he expects the Catalent plant to receive approval in the next few days and the company would be able to meet its promise to supply 20 million doses of the vaccine by the end of March.

“Catalent is on track to deliver on our commitments for Johnson & Johnson COVID-19 vaccine deliveries as soon as we are approved to begin shipments by the FDA, which we anticipate in the coming weeks,” Mike Riley, president for Catalent North America said in a statement.

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J&J is also working to expand its manufacturing capacity globally and is in talks with potential new partners, Stoffels said, adding that he expects to be able to announce more manufacturing deals soon.

While the company is shooting for 1 billion doses using the existing capacity that J&J has built and is bringing online before the end of the year, Stoffels said, “there will be need for more, and that’s where collaboration with our partners will be needed, to scale up even further.”

“Those discussions are ongoing,” he said.

Those plans include an expansion in India, where the company is working to bring on board a plant this year with a very high capacity that will “serve a very large part of the world,” Stoffels said.

The managing director of Indian pharmaceutical company Biological E Ltd told Reuters last month that her company was looking to contract-manufacture roughly 600 million doses of J&J’s COVID-19 vaccine a year.

Reporting by Michael Erman and Julie Steenhuysen; Editing by Bill Berkrot