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HHS Facilitates Agreement to Accelerate Delivery of Additional Smallpox and Monkeypox Vaccines Using New U.S. Production Line
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U.S. Health and Human Services (HHS) Secretary Xavier Becerra today took action that will allow the U.S. Food and Drug Administration (FDA) Commissioner to grant emergency use authorizations (EUA) for monkeypox vaccines, following the Aug. 4 declaration of a public health emergency for monkeypox. Specifically, the Secretary issued a determination under Section 564 of the Federal Food, Drug and Cosmetic Act (FD&C) that circumstances justify emergency use authorization of vaccines.
Aug 15 - The Biden-Harris Administration, through the U.S. Department of Health and Human Services (HHS), announced today that it is making up to 442,000 doses of the JYNNEOS vaccine available for states and jurisdictions to order under an accelerated Phase 3 of the National Vaccine Strategy (NVS) to combat the current monkeypox outbreak.
FOR IMMEDIATE RELEASE
August 18, 2022
Contact: HHS Press Office
202-690-6343
media"@"hhs.gov
The U.S. Department of Health and Human Services (HHS) has facilitated an agreement between Bavarian Nordic and Grand River Aseptic Manufacturing (GRAM), a Michigan-based pharmaceutical contract manufacturer, to establish the first fill and finish line for the JYNNEOS vaccine in the U.S.
To support the current monkeypox outbreak and future smallpox preparedness, 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. Under the procurement, Bavarian Nordic agreed to complete a technology transfer that would allow for 2.5 million of those vials to be filled and finished by a U.S.-based contract manufacturer.
"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."
"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."
"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," said Bob Fenton, Coordinator of the White House National Monkeypox Response. "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."
Even prior to the contract being signed, Bavarian Nordic initiated the technology transfer necessary for this production at GRAM and that transfer is on track to start manufacturing later this year.
Biden-Harris Administration Makes Hundreds of Thousands More Vaccine Doses Available to Support Monkeypox Response
HHS Secretary Becerra issues 564 determination, paving way for emergency use authorization of monkeypox vaccines
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