The U.S. Food and Administration on Tuesday approved Danish drugmaker Bavarian Nordic's Jynneos, making it the first approved vaccine for preventing monkeypox disease.
Monkeypox is a rare viral infection that does not spread easily from person to person. Infections have until recently been limited to central and western regions of Africa, but cases have been reported in Britain last year and in Singapore earlier this year.
The approval triggers the award of a "priority review voucher" from the FDA to Bavarian Nordic, which can be used to speed up review of a future drug application. The company said it planned to sell the voucher to a third party.
The U.S. in 2003 experienced an outbreak of monkeypox, which was the first time the disease was reported outside of Africa, the FDA said.
Monkeypox infections are similar to smallpox, but typically milder. The disease begins with fever, headache, muscle aches and exhaustion, and in some rare cases, can be fatal.
The vaccine Jynneos was also approved to prevent smallpox in adults who are determined to be at a high risk from such an infection, Bavarian Nordic said.
The drug is made from a type of virus that does not cause disease in humans and cannot reproduce inside human cells.
Smallpox was eradicated worldwide in 1980, but there is a risk that it could be used as a weapon of biological warfare.
"Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect," said Peter Marks, director of the FDA's center for biologics evaluation and research.
Jynneos would also be a part of the United States' largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency, the FDA said.
The FDA, in a first, last year approved Siga Technologies Inc's treatment for smallpox.