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Federal officials roll out plan for monkeypox vaccine production


Domestic production to begin at Michigan-based pharmaceutical maker.

Federal officials roll out plan for monkeypox vaccine production

The U.S. Food and Drug Administration published this image of a colorized scanning electron micrograph of monkeypox virus (orange) on the surface of infected VERO E6 cells (green). The image is credited to the National Institute of Allergy and Infectious Diseases.

Federal health leaders are ramping up the monkeypox vaccine production pipeline as the disease spreads around the United States.

The U.S. Department of Health and Human Services announced an agreement between Bavarian Nordic and Grand River Aseptic Manufacturing (GRAM), a Michigan-based pharmaceutical maker, to make the Jynneos vaccine domestically.

“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,” the HHS announcement said. “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.”

“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.”

Fenton was the lead speaker Aug. 18 in a press briefing by the White House Monkeypox Response Team.

Starting Aug. 22, an additional 1.8 million doses of vaccine will be available to jurisdictions for ordering.

As of Aug. 18, the United States had 14,115 cases of monkeypox reported in 49 states; Wyoming was the last state without a recorded case. New York hat 2,744 cases; California had 2,663 cases; Florida had 1,372; Texas had 1,079; and Georgia had 1,066, among states with 1,000 or more cases, according to the latest figures from the U.S. Centers for Disease Control and Prevention (CDC).

The agency also published updated guidance on obtaining and using Tpoxx (Tecovirimat) for treating monkeypox. Clinicians and care facility pharmacists requesting the drug should contact state or territorial health departments to obtain it through the jurisdictions where it has been pre-positioned by the Strategic National Stockpile.