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Contract to expedite delivery of additional smallpox and monkeypox vaccines using new US production line facilitated by HHS

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News Tech: In order to establish the first fill and finish line for the JYNNEOS vaccine in the United States, Bavarian Nordic and Grand River Aseptic Manufacturing (GRAM), a pharmaceutical contract manufacturer with headquarters in Michigan, reached an agreement with the assistance of the U.S. Department of Health and Human Services (HHS).

The Biomedical Advance Research and Development Authority (BARDA), within the HHS Administration for Strategic Preparedness and Response (ASPR), has ordered 5.5 million vials of JYNNEOS from Bavarian Nordic to be filled, finished, and delivered from U.S. government-owned bulk vaccine stored in Denmark. This is to support the current monkeypox outbreak and future smallpox preparedness. As part of the contract, Bavarian Nordic consented to finish a technology transfer that would enable a U.S.-based contract manufacturer to fill and finish 2.5 million of those vials.

“This announcement, which is the result of extensive coordination between BARDA, Bavarian Nordic, and GRAM, will help bolster our current monkeypox response and enhance our smallpox preparedness,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “We look forward to continuing to work with our partners to ensure successful production ramp up and ultimately delivery of additional vaccine doses to those in need sooner.”

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