August 30, 2022 – The HHS will provide approximately $11 million to support the first U.S.-based fill and finish manufacturing of JYNNEOS – a vaccine approved to prevent smallpox and monkeypox – at Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, Michigan.
The agreement between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), and GRAM aids the company in accelerating the fill and finish manufacturing qualification and production in its recently expanded facility. The funding will allow GRAM to purchase additional equipment necessary for JYNNEOS production and recruit and train additional staff to operate the line. With BARDA’s support, vaccine production at the facility is expected to be underway later this year, months ahead of the 9-month schedule typical for this type of work.
On August 18, Bavarian Nordic, maker of JYNNEOS, and GRAM announced an agreement to establish this first U.S.-based fill and finish capability for the JYNNEOS vaccine, an agreement facilitated by BARDA. Even prior to that agreement, Bavarian Nordic and GRAM had begun working together on the technology transfer to enable the opening of a U.S.-based line.
In July, to support the current monkeypox outbreak and future smallpox preparedness, BARDA placed orders for fill, finish, and delivery of 5 million vials of JYNNEOS from U.S. government-owned bulk vaccine stored in Denmark. In that contract, Bavarian Nordic agreed to complete a technology transfer that would allow a U.S.-based contract manufacturer to fill and finish 2.5 million vials of JYNNEOS.
The new manufacturing support at GRAM is the latest in ASPR’s efforts to expand the capacity and capability in the U.S. to manufacture medical supplies, equipment, and the materials used to make medical supplies. These efforts enhance the U.S response to public health emergencies; the COVID-19 pandemic demonstrated the need to expand the U.S. industrial base for vaccine production. To date, ASPR has invested nearly $6.9 billion in manufacturing expansion to produce vaccines, glass vials, nitrile gloves, surgical gowns, test swabs, the raw materials needed for diagnostic tests, therapeutics and vaccines.