[Photo by Artem Podrez from Pexels]
FDA has signed off on a supplement to the biologics license for Bavarian Nordic’s (OTCMKTS:BVNRY) Jynneos vaccine, which is indicated for both monkeypox and smallpox. The move will make an additional 786,000 doses of vaccine available for use in the U.S.
The extra doses are available following an FDA expedited inspection and approval of Bavarian Nordic’s fill-and-finish capabilities.
HHS is moving to ship the doses to states and jurisdictions as soon as it can, according to the U.S. Department of Health and Human Services Secretary Xavier Becerra.
Becerra indicated that the federal government would continue to ramp up the distribution of further monkeypox vaccine doses in the near future.
The U.S. has been working to procure 5.5 million monkeypox vaccine doses for 2023.
The country had distributed more than 300,000 vaccine doses in July.
“We have procured more vaccines than any other country in the world — probably more than every other country in the world combined,” said Dr. Ashish Jha, White House COVID-19 response coordinator, in a press conference.
The FDA has also authorized Sanofi’s ACAM2000 vaccine and SIGA Technologies’ orthopoxvirus p37 protein inhibitor tecovirimat for monkeypox.