Emergent BioSolutions Inc. has signed a five-year agreement with Johnson & Johnson to manufacture its Covid-19 vaccine candidate.
J&J and Maryland-based CDMO Emergent BioSolutions inked a five-year work order worth at least $480 million to help produce the New Jersey-based drugmaker’s COVID-19 vaccine candidate, Emergent said in a release.
Emergent will provide “large-scale” drug substance manufacturing for J&J’s recombinant DNA shot beginning in 2021, starting with a $480 million order for the first two years of the deal. For the final three years, the partners will use a “flexible capacity deployment model” to provide annual batches as needed, Emergent said.
“Over the next five years, we are committing our leading CDMO services to advance this important vaccine candidate,” Syed Husain, senior vice president and CDMO business unit head at Emergent, said in a statement. “We have the expertise and capabilities to meet the long-term needs of our customers and provide ongoing commercial manufacturing to benefit patients.”
J&J would need to succeed in clinical trials and earn regulatory approval to take a Covid-19 vaccine to market. But those steps aren’t necessary for Emergent to perform large-scale production, which can happen at-risk, or before a Food and Drug Administration approval, Syed said in an email to the WBJ. But for J&J to distribute products to patients, the company would need either that commercial approval or emergency use authorization from the FDA.
The contract comes as J&J gears up to start human testing of its candidate, Ad26.COV2-S, later this month in a phase 1/2a trial. And it follows Emergent and J&J’s earlier pact to reserve manufacturing space for J&J’s shot while initiating the tech transfer to begin a rapid scale-up.
As part of the deal, J&J pledged to expand its own capacity for producing the vaccine with Emergent sharing its “molecule-to-market” manufacturing know-how. Emergent also reserved capacity at its Bayview Baltimore facility to support a potential commercial rollout of J&J’s shot beginning as early as 2021, should it nab an approval.