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

The FDA has announced the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, NonReplicating, 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. Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect.

This 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 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.

See: https://www.fda.gov/news-events/press-announcements/fda-approves-first-live-non-replicating-vaccine-prevent-smallpox-and-monkeypox

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)