Bavarian Nordic has secured a new order worth $156.8m from the US government for additional production of Jynneos, the company’s vaccine for smallpox and mpox.
The Denmark-based firm has received the order from the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response.
Jynneos, developed originally in collaboration with the US government, is approved by the US Food and Drug Administration (FDA), European Commission (EC), Health Canada, and other global regulatory bodies.
It was launched commercially in the US in April 2024.
The bulk product, accounting for $139.7m of the total contract value, will be produced and billed in 2024.
The move is expected to help replenish inventory that was used to manufacture vaccines during the mpox outbreak in 2022.
Replenishing this bulk inventory is crucial for meeting the company’s existing contract to provide a next-generation, freeze-dried version of the vaccine for US smallpox preparedness.
Additionally, the contract includes around $17m allocated for extra services from 2025 to 2027, which will cover the storage of vaccine doses in the US.
Bavarian Nordic president and CEO Paul Chaplin said: “Our smallpox/mpox vaccine represents a key component in the US biological preparedness, as demonstrated during the 2022 mpox outbreak.
“Jynneos was also the first smallpox vaccine successfully developed under Project BioShield, a programme 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.”
Since 2003, Bavarian Nordic has partnered with the US government to develop, manufacture, and supply a non-replicating smallpox vaccine.
In 2017, BARDA supported the development of a freeze-dried version of the vaccine, which offers a longer shelf life and serves as a replacement for the stockpile.
BARDA awarded Bavarian Nordic a ten-year contract to supply this freeze-dried vaccine.
In 2022, the authority requested the liquid-frozen vaccine to address the mpox outbreak.
The first replenishment contract was granted in 2023, allowing for the start of manufacturing and supply of the first freeze-dried doses in 2024.