Smallpox and monkeypox vaccines under domestic production

Aug. 31, 2022

The U.S. Department of Health and Human Services (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.

"We continue to build on our efforts to secure and make safe and effective vaccines readily available," said HHS Secretary Xavier Becerra. "This new agreement solidifies a domestic manufacturing capability that will bring us more vaccine sooner to end this outbreak."

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.

"Rapidly increasing the supply and safe delivery of monkeypox vaccine to at-risk Americans is a top priority," said Assistant Secretary for Preparedness and Response Dawn O'Connell. "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."

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.

HHS release