BARDA orders extra 500,000 doses of Bavarian Nordic’s JYNNEOS smallpox, monkeypox vaccine

Responding to an increase in global cases of monkeypox, the U.S. Biomedical Advanced Research and Development Authority (BARDA) purchased an additional 500,000 doses of the liquid-frozen JYNNEOS vaccine, a Bavarian Nordic A/S product.

JYNNEOS holds the unique position of being the only U.S. Food and Drug Administration-approved vaccine for use against monkeypox. It is also a non-replicating smallpox vaccine. In 2020, BARDA ordered 1.4 million doses. This year’s additions will bring the national vaccine inventory to nearly 2 million doses.

“The long-term commitment from the U.S. government to the development and procurement of JYNNEOS has provided the opportunity to act swiftly, ensuring a rapid deployment of vaccines to mitigate the current monkeypox outbreak,” Paul Chaplin, president and CEO of Bavarian Nordic, said. “We are pleased to support BARDA in their continued efforts to build and strengthen the national preparedness against smallpox and monkeypox.”

Deliveries are expected later this year, and the update brought significant financial gains for Bavarian Nordic. Still, the company maintains that its most significant investments remain in research and development of a vaccine against respiratory syncytial virus (RSV) and a booster vaccine for COVID-19, which has entered Phase 3 clinical trials.

Since 2003, Bavarian Nordic has manufactured and supplied nearly 30 million doses of the liquid-frozen version of JYNNEOS to the U.S. Department of Health and Human Services. Most expired before the FDA fully approved the vaccine in 2019. For the rebuild of U.S. supply, the company noted that new doses would be produced from bulk vaccines already manufactured and invoiced from previous BARDA contracts and currently stored at Bavarian Nordic.

This inventory will be converted to approximately 13 million freeze-dried doses between 2023 and 2025.