FDA Approves First Live, Non-Replicating Vaccine to Prevent Smallpox and Monkeypox

Washington, DC–The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-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. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease.

Jynneos will be available for those determined to be at high risk of either smallpox or monkeypox infection. This vaccine is also part of the Strategic National Stockpile (SNS), the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency that is severe enough to cause local supplies to be depleted. The availability of this vaccine in the SNS will help ensure that the vaccine is accessible in the U.S. if needed.

Smallpox, which is caused by the variola virus, emerged in human populations thousands of years ago and is a highly contagious and often fatal infectious disease. A person infected with smallpox typically develops a rash characterized by raised pocks on the face and body. The smallpox virus is spread through saliva and droplets from the respiratory tract or by direct or indirect contact with the virus as it is shed from skin lesions. The virus can also be spread through other body fluids and contaminated clothing or bed linen. If a person is infected with smallpox and they are in close contact with others, the virus can spread quickly.

Monkeypox, which does not occur naturally in the U.S., is a rare disease caused by infection with monkeypox virus, which causes symptoms similar to, but milder than, smallpox. Monkeypox begins with fever, headache, muscle aches and exhaustion and can be fatal, even though it is typically milder than smallpox. It is transmitted to people from various wild animals, such as rodents and primates. In 2003, the U.S. experienced an outbreak of monkeypox, which was the first time human monkeypox was reported outside of Africa.

The safety of Jynneos was assessed in more than 7,800 individuals who received at least one dose of the vaccine. The most commonly reported side effects were pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache and fatigue. No safety concerns that would require a Medication Guide have been identified for Jynneos. Jynneos is administered in two doses given four weeks apart.

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