Grand River Aseptic Manufacturing (GRAM) of Grand Rapids, Mich., secured its place as the first face of domestic manufacturing for the JYNNEOS smallpox and monkeypox vaccine this week, thanks to an award of approximately $11 million in support from the United States Department of Health and Human Services (HHS).
The vaccine is produced by Bavarian Nordic, a biotechnology company based in Denmark. While its European facilities were already working to fill supply agreements with the U.S., cooperation between Bavarian Nordic and GRAM will allow it to offload and hasten much of its vaccine production schedule and open up more possibilities for other nations. GRAM will aid the fill and finish manufacturing portion of things through a recently expanded facility. With the funding from HHS, though, it will be able to purchase even more equipment for JYNNEOS production, as well as recruit and train additional staff for operations.
BARDA estimates GRAM’s vaccine production capabilities should be online later this year, shaving months off the usual timeline.
“Rapidly increasing the supply and safe delivery of monkeypox vaccine to at-risk Americans is a top priority,” Dawn O’Connell, Assistant Secretary for Preparedness and Response, said. “BARDA’s support helps ensure success in doubling the capacity available to fill and finish this vaccine, improves preparedness for smallpox bioterrorism, and strengthens the security of the U.S. supply chain. Production of JYNNEOS in the U.S. creates jobs and speeds the availability of the vaccine.”
An agreement between Bavarian Nordic and GRAM was first announced earlier this month, as facilitated by BARDA. As of July, BARDA had tapped agreements for 5 million vials of JYNNEOS, based on government-owned bulk vaccine stored by Bavarian Nordic in Denmark. Under the arrangement with GRAM, 2.5 million vials will be shipped to GRAM for fill and finish.