FDA approves smallpox, monkeypox vaccine

The U.S. Food and Drug Administration (FDA) approved the vaccine Jynneos to treat smallpox and monkeypox in adults.

It is the only currently FDA-approved vaccine for this disease.

“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 U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “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 U.S. government’s commitment to preparedness through support for the development of safe and effective vaccines, therapeutics, and other medical countermeasures.”

Jynneos will also be part of the Strategic National Stockpile, the nation’s supply of pharmaceuticals and medical supplies for use in a public health emergency.

Smallpox is caused by the variola virus and is highly contagious and often fatal. A person with smallpox typically develops a rash. It is spread through saliva and droplets from the respiratory tract, by direct or indirect contact with the virus, or through other body fluids and contaminated clothing or bed linen.

Monkeypox is a rare disease caused by infection with monkeypox virus, which causes fever, headache, muscle aches, and exhaustion. It is typically milder than smallpox. It is transmitted to people from various wild animals, such as rodents and primates. The United States experienced an outbreak of monkeypox in 2003, the first time it was reported outside of Africa.

The effectiveness of Jynneos for the prevention of smallpox was determined in a clinical study. Its safety was assessed in more than 7,800 individuals who received at least one dose of the vaccine. The FDA granted the approval of Jynneos to Bavarian Nordic A/S.