FDA Approves First Vaccine to Prevent Monkeypox

The FDA approved Bavarian Nordic’s Jynneos vaccine for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for infection.

Jynneos is administered in two doses given four weeks apart. The vaccine’s effectiveness was determined in a clinical study including approximately 400 healthy adults. The safety of Jynneos was assessed in more than 7,800 individuals.

Naturally occurring smallpox disease is no longer a global threat, but that “the intentional release of this highly contagious virus could have a devastating effect,” said CBER Director Peter Marks.