HHS Funds U.S. Monkeypox Vaccine Manufacturing

The Department of Health and Human Services will provide about $11 million to support the first U.S.-based fill and finish manufacturing of smallpox and monkeypox vaccine Jynneos. The manufacturing will be conducted at Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, MI.

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

In early August, Becerra declared the ongoing spread of monkeypox virus in the United States a public health and expandedvaccine distribution.

Related: HHS Declares Monkeypox Emergency, Expands Vaccine Distribution

The new agreement between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), and Grand River Aseptic Manufacturing aids the company in accelerating the fill and finish manufacturing qualification and production in its recently expanded facility, HHS said.

With BARDA’s support, vaccine production at the facility is expected to be underway later this year, months ahead of the nine-month schedule typical for this type of work.

In early August, Jynneos manufacturer Bavarian Nordic and Grand River Aseptic Manufacturing announced an agreement to establish the first U.S.-based fill and finish capability for the vaccine, an agreement facilitated by BARDA. Prior to that agreement, Bavarian Nordic and Grand River Aseptic Manufacturing 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.”