FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox

The US Food and Drug Administration yesterday announced the approval of Jynneos smallpox and monkeypox vaccine, live, on-replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

Developed by Denmark’s Bavarian Nordic (OMX: BAVA), Jynneos is the only currently FDA-approved vaccine for the prevention of monkeypox disease, but, despite this positive news, the company’s shares were down 4.56% at 194.50 Danish kroner by midday today, ahead of a planned conference call later this afternoon.

“Following the global Smallpox Eradication Program, the World Health Organization certified the eradication of naturally occurring smallpox disease in 1980. Routine vaccination of the American public was stopped in 1972 after the disease was eradicated in the US and, as a result, a large proportion of the US, as well as the global population has no immunity,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Therefore, although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect. Today’s approval reflects the US government’s commitment to preparedness through support for the development of safe and effective vaccines, therapeutics, and other medical countermeasures.”