Research & Development
J&J waiting regulatory approval for new plant to deliver high volumes of COVID-19 vaccines to US
2 March 2021 -

The chief scientific officer of US pharmaceutical company Johnson & Johnson Inc (J&J), Paul Stoffels, said on 1 March 2021 that the company is waiting on regulatory approval of a new, larger plant operated by contract manufacturer Catalent Inc to begin large-scale US deliveries of its just-authorised COVID-19 vaccine following initial shipments this week, Reuters news agency reported on Tuesday.

Reportedly, J&J will ship nearly four million doses of its one-shot COVID-19 vaccine around the US this week and expects to deliver another 16 million doses later this month. However, no doses are expected to go out next week.

Stoffels was quoted as saying in an interview: "The first doses come from a smaller plant, which we could start up earlier. 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 added 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 2021.

President for Catalent North America, Mike Riley, stated: "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."

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.