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.