HQ Team
April 2, 2025: Denmark’s Bavarian Nordic A/S has got approval from the US Food and Drug Administration for its freeze-dried formulation of smallpox and mpox vaccine, Jynneos.
The vaccine, meant to treat adults 18 years of age and older, will provide “additional flexibility for stockpiling against a smallpox event or mpox outbreak,” according to a company statement.
The approval follows a standard review with the FDA of a supplemental Biologics License Application (sBLA) submitted in May 2024.
The sBLA was primarily based on clinical data that showed comparability in terms of the immune responses and safety between the freeze-dried and liquid-frozen formulations, as well as other non-clinical and manufacturing data.
The liquid-frozen formulation of Jynneos, approved by the FDA in September 2019, has specific cold-chain requirements, while the freeze-dried formulation provides advantages in terms of transportation, storage conditions and shelf life — all of which are important factors for long-term stockpiling.
‘Strengthen public health security’
“Today’s FDA approval represents a significant milestone in our development of this next generation of Jynneos and in our collaborative efforts with the US government to strengthen public health security,” said Paul Chaplin, President and CEO of Bavarian Nordic.
“As a long-term supplier of Jynneos to the US biological preparedness, we are committed to continue supporting the government’s efforts to protect its citizens against current and future public health threats.”
Jynneos was the first smallpox vaccine successfully developed under Project BioShield, a program created by the US Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents through public-private partnerships.
Bavarian Nordic received a contract from the US Biomedical Advanced Research and Development Authority (BARDA) to develop and supply a freeze-dried version of Jynneos for stockpiling.
Manufacturing under the contract was initiated in 2024, and the first vaccines will be delivered later in 2025.
