On September 24, 2019, FDA announced 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.
With this approval, the FDA issued a material threat medical countermeasure (MCM) priority review voucher to Bavarian Nordic A/S.
.png)
No hay comentarios:
Publicar un comentario