HHS-aided agreement between Bavarian Nordic and Michigan-based GRAM to create first fill and finish line for monkeypox vaccine

Bavarian Nordic reached an agreement last week with pharmaceutical contract manufacturer Grand River Aseptic Manufacturing (GRAM), making arrangements backed by the U.S. Department of Health and Human Services (HHS) to create the first U.S. fill and finish line for the JYNNEOS vaccine.

JYNNEOS is Bavarian Nordic’s smallpox and monkeypox vaccine, and while the U.S. has relied heavily on it amidst the ongoing outbreak, that reliance has been based on overseas packaging and shipment. Currently, the Biomedical Advanced Research and Development Authority (BARDA) has an outstanding order for 5.5 million vials of JYNNEOS marked for filling, finishing, and delivery. While that bulk supply is stored in Denmark, Bavarian Nordic will complete a technology transfer of 2.5 million of those vials to the Michigan-based GRAM under the new arrangement.

“We continue to do everything we can to make more vaccine doses available more quickly to those in need,” said HHS Secretary Xavier Becerra. “Establishing a second line in the U.S. will double the capacity available to fill and finish these vaccines, create high-quality American jobs, and strengthen our domestic supply chain security.”

As a result of the transfer, which Bavarian Nordic intends to complete within three months, manufacturing should start later this year. The U.S. Food and Drug Administration (FDA) already approved the facility operated by GRAM, so there will be no slowdowns on that end.

“We have been working diligently since the beginning of the monkeypox outbreak to expand our manufacturing capacity, and the agreement with GRAM is an important step,” Paul Chaplin, president and CEO of Bavarian Nordic, said. “With this agreement, we will significantly expand our manufacturing capabilities into the United States allowing Bavarian Nordic to meet the growing worldwide demand.”

All 5.5 million doses of the vaccine ordered by the U.S. government should be manufactured and delivered by the end of 2023, drawing from existing bulk vaccine supplies. Another advantage of shifting some of the fill and finish to domestic operations is that Bavarian Nordic will also be able to free up some of its existing capacity for other countries’ orders. Presently, its manufacturing site in Denmark is operating at double the capacity as before the monkeypox outbreak that began in May.

“Rapidly increasing the supply and safe delivery of monkeypox vaccine to those at the highest risk of contracting the virus is a top priority for President Biden,” Bob Fenton, coordinator of the White House National Monkeypox Response, said. “This partnership between Bavarian Nordic and GRAM will significantly increase the capacity to fill and finish government-owned doses – for the first time in the U.S. – and allow us to deliver our current and future supply more quickly to locations nationwide.”