Today, the Food and Drug Administration (FDA) announced it has approved a supplement to the biologics license for the JYNNEOS Vaccine, which is manufactured by Bavarian Nordic and approved to prevent smallpox and monkeypox.
U.S. Department of Health and Human Services Secretary Xavier Becerra issued the following statement:
“This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox. The expedited inspection and approval by FDA of Bavarian Nordic’s fill-and-finish capabilities means that an additional 786,000 doses of vaccine are now available for use in the U.S. HHS is working to make these doses available to states and jurisdictions as soon as possible to fulfill their needs and will announce allocations tomorrow.
“Aggressively responding to the monkeypox outbreak is a critical priority for HHS. Within days of the first U.S. case, we activated a multi-pronged response, significantly increasing vaccine supply and distribution, expanding access to tests, making treatments available for free, and educating the public on steps to reduce risk of infection. We will continue to accelerate and strengthen our response in the coming days, and will work with partners on the ground, in the community, and internationally to combat this virus and protect those at risk. I applaud the entire FDA team for their tireless work in making this additional vaccine available as quickly as possible while ensuring it meets the highest standards of quality and safety.”