HHS Funds US Production of Smallpox and Monkeypox Vaccines

The U.S. Department of Health and Human Services (HHS) will provide approximately $11 million to support the first U.S. fill-and-finish manufacturing of JYNNEOS — a vaccine approved to prevent smallpox and monkeypox — in 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 helps the company accelerate the qualification and manufacturing production of filling and finishing in its recently expanded plant. The funding will allow GRAM to purchase additional equipment needed to produce JYNNEOS and recruit and train additional staff to operate the line. With support from BARDA, vaccine production at the facility is expected to be underway later this year, months ahead of the typical 9-month schedule for this type of work.

“We continue to strengthen our efforts to secure and make readily available safe and effective vaccines,” HHS Secretary Xavier Becerra said. “This new agreement strengthens a domestic manufacturing capacity that will bring us more vaccines sooner to end this outbreak.”

On August 18, Bavarian Nordic, maker of JYNNEOS, and GRAM announced an agreement to establish this first US-based fill and finish capability for the JYNNEOS vaccine, a deal facilitated by BARDA. Even before this deal, Bavarian Nordic and GRAM had started working together on technology transfer to enable the opening of a US-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 the success of doubling the capacity available to fill and complete this vaccine, improves smallpox bioterrorism preparedness, and strengthens US supply chain security.” The production of JYNNEOS in the United States creates jobs and accelerates the availability of the vaccine. “

In July, to support the current monkeypox outbreak and future smallpox preparedness, BARDA placed orders to fill, finish, and ship 5 million vials of JYNNEOS from U.S. Government-owned bulk vaccines stored in Denmark. In this contract, Bavarian Nordic agreed to carry out a technology transfer that would allow a US-based contractor to fill and finish 2.5 million vials of JYNNEOS.

GRAM’s new manufacturing support is the latest in ASPR’s efforts to expand capacity and capacity in the United States to manufacture medical supplies, equipment and materials used to manufacture medical supplies. These efforts strengthen the United States’ response to public health emergencies; the COVID-19 pandemic has demonstrated the need to expand the US 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, materials raw materials needed for diagnostic tests, therapies and vaccines.

About HHS, ASPR, and BARDA

HHS strives to improve and protect the health and well-being of all Americans by providing effective health and human services and promoting advances in medicine, public health, and human services. ASPR leads HHS in preparing the country to respond to and recover from the adverse health effects of emergencies, supporting the ability of communities to withstand adversity, strengthening health systems and response and improving national health security. Within ASPR, BARDA invests in innovation, advanced research and development, acquisition and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools and non-pharmaceuticals – needed to combat against health security threats.

Leave a Reply