The U.S. manufacturing partner turning out drug substance for Johnson & Johnson's single-dose COVID-19 vaccine is still waiting on an FDA green light, potentially putting a squeeze on J&J's supply pipeline.
The FDA is weighing an emergency nod for Emergent BioSolutions, tapped in July 2020 to provide large-scale drug substance manufacturing for J&J's shot, Politico reported, citing two people familiar with the company's emergency use authorization process.
The regulator could clear Emergent "very soon," one source said.
While Emergent has been shipping millions of doses to J&J's U.S. fill-finish partner Catalent, which itself snared authorization last week, those shots can't be used until Emergent earns its emergency nod. In the meantime, J&J has been flying in drug substance from the Netherlands, one source told Politico.
Emergent couldn't comment on the specifics of its production work, but a spokesperson said via email that the company's "Baltimore Bayview facility continues to support COVID-19 vaccine production on a large scale and is capable of producing drug substance to support more than 1 billion doses annually."
The manufacturer is on track to meet its orders from J&J and AstraZeneca, he added.
The issue stems from the fact that J&J didn't include its manufacturing partners in its original emergency use application, Politico said. In recent weeks, Biden administration officials have raised flags about whether the company can meet its delivery goal.
But J&J says it's on track to provide a promised 20 million doses by the end of the month and 100 million by June, a company spokesperson said via email.
"To meet our global commitments, we have established a global vaccine supply network where multiple manufacturing sites are involved in the production of the vaccine across different facilities, sometimes in different countries and continents, before the vaccine can be distributed globally once authorized for use by health authorities," the spokesperson said.
The company expects to deliver more than 1 billion COVID-19 vaccine doses this year and is in good shape to meet its 2021 supply pledges, he added. As of Monday, around 5 million J&J vaccines had been deployed in the U.S., according to the Centers for Disease Control and Prevention.
The news of Emergent's impending emergency nod follows last week's authorization of Catalent's Bloomington, Indiana, plant, where the CDMO in April agreed to reserve space for fill-finish work. The move could allow Catalent to release millions of vials that have already been packaged and inspected, Bloomberg reported last week, citing anonymous sources.
Catalent will soon play an upsized role in J&J's European manufacturing operation, too, thanks to a second high-speed vial-filling line the CDMO is adding at its fill-finish plant in Anagni, Italy. The upgrade, pegged for completion in the fourth quarter, should double capacity at the facility, Catalent said.
J&J aims to deliver 200 million doses to the EU this year.
As J&J's shot starts rolling out around the world, the company continues to strike supply deals. Monday, the drugmaker said it would provide the African Union with up to 400 million doses through 2022. Deliveries from an initial 220 million-dose tranche are expected to begin in the third quarter, with the remaining shots to roll out through next year.
Editor's note: This story has been updated with comments from Emergent.