Bavarian Nordic Receives $63M from U.S. for More Smallpox/Mpox Vaccines

Bavarian Nordic A/S (OMX: BAVA) has secured an additional order worth USD 63 million from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). This contract aims to manufacture more bulk product and final freeze-dried doses of the JYNNEOS® smallpox/mpox vaccine. This effort will bolster the United States' vaccine inventory, especially in light of the mpox outbreak in 2022. The bulk product, which makes up the majority of the contract's value, is crucial for replenishing the inventory used for vaccine production during that outbreak.

Part of the bulk inventory will be used to manufacture 1 million freeze-dried vaccine doses. The bulk production is slated for next year, considering international orders to address the ongoing mpox outbreak. However, the freeze-dried doses are scheduled for delivery in 2026.

Paul Chaplin, President & CEO of Bavarian Nordic, expressed appreciation for the U.S. government’s leadership in securing vaccine availability for public preparedness. He emphasized that this new order reinforces the public preparedness business for 2025 and beyond, highlighting MVA-BN as the leading smallpox/mpox vaccine. Chaplin noted the importance of addressing the current mpox outbreak and ensuring equitable access to vaccines globally.

Since 2003, Bavarian Nordic has collaborated with the U.S. government to develop, manufacture, and supply a non-replicating smallpox vaccine. This partnership aims to protect all populations, including those with weakened immune systems, from smallpox and mpox. The FDA approved the vaccine in 2019 under the trade name JYNNEOS®, for the prevention of both diseases. Before its approval, Bavarian Nordic supplied nearly 30 million doses to the U.S., mostly for emergency use, which have since expired.

BARDA has supported the development of a freeze-dried version of the vaccine, which has a longer shelf-life. In 2017, Bavarian Nordic received a ten-year contract from BARDA to supply these freeze-dried vaccines. Under this agreement, the company has manufactured bulk vaccine equivalent to around 13 million freeze-dried doses, awaiting filling and supply. A USD 299 million option covers freeze-dried dose production, with the first part awarded in 2022 for USD 119 million. However, the need to supply the liquid-frozen version of the vaccine in 2022 to address the mpox outbreak depleted the bulk inventory, necessitating replenishment to fulfill the contract for freeze-dried vaccines. The first contract for bulk replenishment was awarded in 2023, followed by additional contracts in 2024.

The MVA-BN vaccine, marketed as JYNNEOS® in the U.S., Switzerland, Singapore, and Mexico, IMVAMUNE® in Canada, and IMVANEX® in the EU/EAA and United Kingdom, is the only non-replicating mpox vaccine approved in these regions. Originally developed as a smallpox vaccine in collaboration with the U.S. government, MVA-BN is suitable for immunocompromised individuals. It is approved for use in adults at risk for smallpox or mpox infection, and in the EU/EAA, it is also approved for adolescents aged 12-17.

Bavarian Nordic has been a long-term supplier of the vaccine to numerous countries. During the 2022-2023 mpox outbreak, the company expanded vaccine access to over 70 countries worldwide, supporting governments and international organizations.

Bavarian Nordic is a fully integrated vaccine company specializing in innovative vaccines to protect and save lives. As a global leader in smallpox and mpox vaccines, Bavarian Nordic supplies vaccines to enhance public health preparedness and has a robust portfolio of vaccines for travelers and endemic diseases.