J&J, with new deal, plans for long-term manufacture of coronavirus vaccine - BioPharma Dive

Dive Brief:

Emergent Biosolutions, a Maryland-based drug manufacturer that's become a key player in the coronavirus vaccine race, will help Johnson & Johnson produce its candidate at scale over the next five years under a long-term agreement announced Monday.
The deal, which expands on a preliminary contract the companies agreed to in April, is worth $480 million to Emergent over the first two years, beginning in 2021. Emergent will produce commercial drug product for J&J's vaccine at its site in Baltimore.
J&J expects to begin testing its vaccine in humans before the end of the month, a timeline accelerated from its original plan to start trials in September. Pending positive safety data, the drugmaker aims to quickly progress its candidate into Phase 3 testing and has set an ambitious goal of producing more than 1 billion doses in 2021.

Dive Insight:

J&J's expanded agreement with Emergent suggests the pharmaceutical company expects a yearslong need for coronavirus vaccine supply, even as the leading developers anticipate producing some 6 billion vaccine doses beginning next year.

Not all of those plans will work out, nor is there any guarantee that J&J's candidate will be among the vaccines that succeed. Still, the Emergent deal points to the long-term commitment large drugmakers like J&J are making, even before testing proves their products safe and effective.

Per the new arrangement with J&J, Emergent will provide contract development and manufacturing services for large-scale drug production. Beginning in 2023, Emergent will make additional batches on a "flexible capacity" basis.

J&J's candidate is what's known as a viral vector vaccine, which relies on a non-replicating virus to shuttle genetic instructions into the body's cells. Those instructions tell the cell to make viral proteins — in this case, the new coronavirus' characteristic 'spike' protein — that in theory train the immune system to fend off real infections in the future.

The technology J&J is using recently won a stamp of approval from European regulators, which last week cleared the company's Ebola vaccine for commercial use. The vaccine employs the same "AdVac" platform J&J is using for its coronavirus candidate.

Other groups, including the team of AstraZeneca and the University of Oxford as well as China's CanSino Biologics, are also developing viral vector vaccine candidates for SARS-CoV-2.

J&J has also tapped Catalent, a major contract manufacturer, to help produce its vaccine.

Emergent and Catalent have become critical partners in the multi-company push to produce enough vaccine supply for the world. In addition to J&J, both companies are working with AstraZeneca, and Emergent has also signed a deal to help Novavax make its candidate.

The U.S. government, which under "Operation Warp Speed" aims to make a coronavirus vaccine available beginning in January 2021, has backed Emergent with more than half a billion dollars in funding.

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