$156.8 Million Buys Additional Mpox / Smallpox Vaccine Production

Bavarian Nordic A/S today announced that it had received a new order valued at USD 156.8 million from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to manufacture additional bulk product for JYNNEOS® (MVA-BN®, IMVAMUNE®, IMVANEX®), the company’s smallpox/mpox vaccine.

The new BARDA contract will help replenish the inventory of bulk vaccines required for future manufacturing and supply of freeze-dried vaccines.

The bulk product, representing $139.7 million of the contract value, will be manufactured and invoiced in 2024 and will partly replenish the inventory used to manufacture vaccines in response to the global mpox outbreak that began in May 2022.

Replenishment of the bulk inventory is necessary to fulfill the company’s existing contract to supply a next-generation, freeze-dried version of the vaccine for U.S. smallpox preparedness.

Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing, and supply of a non-replicating smallpox vaccine.

The vaccine was approved by the U.S. FDA in 2019 under the trade name JYNNEOS®, which is indicated for preventing both smallpox and mpox infection.

In real-world studies, JYNNEOS effectiveness against mpox disease adjusted vaccine effectiveness estimates ranged from 35% (95% CI, -2-59) to 89% (95% CI, 76-95) after one dose and from 66% (95% CI, 47-78) to 90% (95% CI, 86-92) after two doses.

Before FDA approval, Bavarian Nordic had supplied nearly 30 million doses of the liquid-frozen version to the U.S., with the vast majority being delivered for emergency use - and now expired.

“Our smallpox/mpox vaccine represents a key component in the U.S. biological preparedness, as demonstrated during the 2022 mpox outbreak," said Paul Chaplin, President & CEO of Bavarian Nordic, in a press release on August 8, 2024.

"JYNNEOS was also the first smallpox vaccine successfully developed under Project BioShield, a program created by the U.S. Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear agents through public-private partnerships."

"We applaud the U.S. government’s steadfast commitment to maintaining a robust preparedness and are proud to continue providing vaccines to protect its citizens against current and future public health threats,” added Chaplin.

The new BARDA contract also includes approximately $17 million for additional services in 2025-2027, including storage of vaccine doses in the U.S.

BARDA has supported the development of a freeze-dried version of the vaccine with a longer shelf life to replace the stockpile and awarded the company a ten-year contract for the supply of freeze-dried vaccines in 2017.

On March 14, 2024, the U.S. CDC's Agam Rao, MD CAPT, U.S. Public Health Service, stated, 'JYNNEOS vaccination is expected to be effective regardless of mpox clade.'

As of August 2024, the JYNNEOS vaccine is commercially available in the United States. Healthcare providers in the U.S. administer JYNNEOS for no charge, regardless of any administration fee. The CDC does not endorse booster doses (3rd).