J&J contracts with Catalent to boost coronavirus vaccine production
Catalent has agreed to manufacture Johnson & Johnson's lead candidate for a COVID-19 vaccine, committing to a joint investment and technology transfer.
The contract manufacturer said it will hire about 300 more workers to start preparations in July 2020 at its site in Bloomington, Indiana. As of last summer, Catalent had about 12,000 employees in 39 facilities around the world.
By January 2021, Catalent expects to be able to produce the vaccine 24 hours a day, seven days a week, according to an April 29 statement.
The agreement illustrates the extraordinary steps the pharmaceutical industry is taking to meet the challenge of COVID-19. There's currently no preventive medicine for the novel coronavirus, which has infected more than 3.2 million people across the globe.
Usually, vaccines take many years to develop, with enormous clinical trials and complicated manufacturing hurdles to overcome. Johnson & Johnson is trying to get its vaccine hopeful ready in less than a year, aiming for clinical testing in September and availability for emergency use in early 2021.
The pharmaceutical giant says it's preparing for production at its own facility in the Netherlands as it signs deals with other manufacturers. Johnson & Johnson is investing in the vaccine "at risk" — meaning it's producing doses without any surety that clinical testing will prove it works — and says it won't take a profit from the vaccine for emergency pandemic use.
The company last week inked a deal with Emergent BioSolutions Inc. for drug substance manufacturing services and reserved capacity for commercial manufacturing of the vaccine. Johnson & Johnson intends to be able to eventually supply more than 1 billion doses around the world.
Pfizer Inc. is also racing to get a vaccine to market, on an even faster timeline. The drugmaker and partner BioNTech are already running a clinical trial in Germany, and Pfizer expects U.S. clearance to begin human testing soon.
If the studies are a success and regulatory approvals come through, doses might be available as early as the fourth quarter of this year, Pfizer CEO Albert Bourla told investors on a conference call. The company is also planning to start manufacturing its vaccine at risk.
Meanwhile, competitors Sanofi and GlaxoSmithKline have come together in an unusual alliance to work on a vaccine and expect to begin clinical testing in the second half of this year. When the companies made the announcement earlier this month, their target for availability was the second half of 2021.
Smaller companies are also part of the rush to address the pandemic. Moderna won a U.S. government award of as much as $483 million for its vaccine candidate. The company plans to hire as many as many as 150 extra workers, representing an increase of almost 20% to its workforce.
The National Institutes of Health is leading a Phase 1 study Moderna's candidate, dubbed mRNA-1273. Moderna says a Phase 3 study may be possible this fall.
AUTHOR :Kristin Jensen PUBLISHED:April 30, 2020 https://www.biopharmadive.com/news/johnson-johnson-catalent-manufacture-coronavirus-vaccine/577129/