FDA Clears Way to Make 786,000 Monkeypox Shots Available Thursday

The US Food and Drug Administration said Wednesday that it approved a supplement to Bavarian Nordic’s biologics license for Jynneos, meaning that doses manufactured at the Denmark-based company’s fill-and-finish facility can be distributed in the US. The 786,000 doses were shipped to the US ahead of final FDA approval so that they could be made immediately available once the quality inspection was completed and manufacturing changes were approved, the FDA said in a statement.