FDA Greenlights Jynneos Monkeypox Vaccine for Additional Manufacturing
The FDA has given the green light for additional manufacturing of Bavarian Nordic’s Jynneos vaccine at the company’s fill and finish facility in Denmark. The fill and finish steps were previously completed by a contract manufacturer.
The U.S. had already ordered close to 800,000 doses of the Jynneos vaccine pending the FDA’s pre-approval inspection of the facility.
Distribution of the doses in the U.S. is expected to begin shortly.
As of July 27, confirmed monkeypox cases in the U.S. totaled 4,639, according to the Centers for Disease Control and Prevention. Confirmed cases worldwide have exceeded 18,000.
JYNNEOS vaccine
The JYNNEOS vaccine has been approved in the U.S. for the prevention of monkeypox and smallpox. The vaccine contains a vaccinia virus, which is a virus related to the monkeypox and smallpox viruses, that has been weakened, cannot copy itself in human cells, and cannot spread to other parts of the body or people.
Bavarian Nordic
Bavarian Nordic A/S is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of vaccines for infectious diseases and cancer immunotherapies. The company is headquartered in Hellerup, Denmark, with a manufacturing facility in Kvistgård, and an additional site in Hørsholm.[3] The company has a research and development facility in Martinsried, Germany, and offices in Zug, Switzerland, and Morrisville, North Carolina. The company uses viral vectors in its research and development.
July 29, 2022
