May 18, 2022- 8:10 p.m.
Denmark-based Bavarian Nordic A/S announced today that the U.S. Biomedical Advanced Research and Development Authority (BARDA) exercised the first options under an existing contract to supply a freeze-dried version of the JYNNEOS® smallpox vaccine.
The first doses of this vaccine version will be manufactured and invoiced in 2023 and 2024.
If exercised, additional options on the BARDA contract support the conversion of up to a total of approximately 13 million freeze-dried doses of JYNNEOS smallpox vaccine that are expected to be manufactured in 2024 and 2025.
The majority of the bulk vaccine for these doses has already been manufactured.
A supplement to the existing liquid frozen JYNNEOS U.S. FDA BLA will be made comprising Phase 3 clinical study data, which has already been completed and reported, together with the manufacturing data to support the approval of the freeze-dried version of JYNNEOS in 2024.
Paul Chaplin, President and CEO of Bavarian Nordic, commented in today’s press release, “We are pleased to announce the exercise of the first options under our contract with the U.S. government to deliver a freeze-dried version of the smallpox vaccine with an improved shelf-life, which will be manufactured at our new fill and finish facility.”
“This marks a significant milestone in our long-standing partnership with the U.S. government to ensure availability of life-saving vaccines for the entire population.”
Jynneos is based on a live, attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN), incapable of replicating in the human body yet able to elicit a potent immune response.
To protect people from monkeypox, the Jynneos vaccine was approved by the U.S. FDA in 2019.
Jynneos (Imvamune or Imvanex) was also approved by the European Medicines Agency in 2013 and is indicated for preventing smallpox and monkeypox disease in adults.
Note: The monkeypox virus is related to the variola virus, which caused smallpox, a once dreaded disease that was declared eradicated in 1980. The symptoms of monkeypox are similar to but milder than smallpox. Infected people develop flu-like symptoms — fever, body aches, chills — but also swollen lymph nodes.
