Bavarian Nordic’s Jynneos is a smallpox and monkeypox vaccine (live, non-replicating), which has been approved by the US Food and Drug Administration (FDA) for the prevention of smallpox and monkeypox disease in adults 18 years of age and older.
The vaccine becomes the only approved monkeypox vaccine in the world and can be administered to those deemed at high risk of either a smallpox or monkeypox vaccine. The approval arrives just over a year after the FDA approved the first treatment for smallpox.
Bavarian Nordic’s CEO, Paul Chaplin, explained in a statement that the vaccine had been 15 years in development, through a partnership with the US National Institutes of Health and Biomedical Advanced Research and Development Authority (BARDA).
The vaccine will be delivered to the strategic national stockpile for use in an emergency.
Rick Bright, director of BARDA, said, “The years of dedication working with Bavarian Nordic on this vaccine ultimately mean that the US is better prepared to save lives if an emergency occurs involving one of the deadliest diseases the world has ever known.”
This time last year, the UK experienced a first case of the monkeypox virus and ordered smallpox vaccines as a result.
Monkeypox is a rare virus that occurs primarily in central and west Africa, near tropical rainforests. The virus is similar to human smallpox and therefore smallpox vaccination is effective in preventing monkeypox.
As well as providing approval for the vaccine, the FDA also granted Bavarian Nordic a priority review voucher through the material threat medical countermeasure PRV program.
The program encourages applications from companies to develop treatments against infectious diseases or chemical, biological, radiological, and nuclear threats.
Bavarian Nordic stated that it intends to sell the voucher to a third party. Previously, such vouchers have sold for $95m (€86m).