The FDA cleared the way for Bavarian Nordic, the world's only vaccine-maker with an authorized monkeypox vaccine, to manufacture more supply after authorizing its Denmark facility July 27.
The federal agency, along with the European Medicines Agency, expedited the process to assess the manufacturing plant in June after the global monkeypox outbreak began.
"With the approvals of the final drug production — the process by which the vaccine is formulated and filled into vials — the company is now allowed to deliver drug product manufactured at its own site to the U.S. and EU market," Bavarian Nordic said in a statement. The company didn't specify the recently approved facility's production limits.
As of July 27, the U.S. has nearly 7 million monkeypox doses ordered, but multiple states and cities are running out of supply within hours.