The U.S. now has an additional 786,000 doses of the Jynneos vaccine to distribute in an effort to slow the spread of monkeypox.
The additional vaccines were held up while the Food and Drug Administration completed an inspection and received proper documentation about the Denmark plant where the vials are filled.
The FDA said on Wednesday it approved the company's biologics license.
"This inspection and evaluation were necessary work to help ensure the quality and safety of the vaccine," the FDA said in a statement.
Health and Human Services Secretary Xavier Becerra said he will announce where the vaccines will be allocated on Thursday.
“This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox," he said.
There are more than 3,500 confirmed cases of monkeypox in the U.S., according to the Centers for Disease Control.
However, the rollout of the vaccine has not kept up with demand. Cities and states have been forced to prioritize the vaccines for people most at risk of contracting the disease.
The CDC says monkeypox is spread from person-to-person through direct contact with an infectious rash, scabs, or body fluids.