The US Biomedical Advanced Research and Development Authority (BARDA) has requested Bavarian Nordic manufacture more of the product used in its smallpox/mpox vaccine Jynneos, as the company aims to replenish stocks that were used in the 2022 measles outbreak.
In the form of a $156.8m contract to the Danish vaccine specialist, the new order is necessary to fulfil the existing contract to supply a next-generation, freeze-dried version of the vaccine for US smallpox preparedness.
In 2017, BARDA awarded Bavarian Nordic a contract to develop a freeze-dried version of the vaccine with a longer shelf-life to replace the stockpile.
The US had around 20 million Jynneos doses in its stockpile at the time of the 2022 mpox outbreak, the majority of which had expired, according to a report in The New York Times.
BARDA duly requested a liquid-frozen version supply of the vaccine, which reduced Bavarian Nordic’s inventory of bulk products. To fulfil its contract for the freeze-dried version, the drug manufacturer was first awarded a contract to replenish stock last year.
While $139.7m of the most recent US contract value will go towards partly replenishing the inventory used to manufacture Jynneos vaccines, the remaining $17m will be used to store vaccine doses between 2025 and 2027.
Part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, BARDA uses Jynneos as part of its smallpox and mpox medical countermeasure framework, which also includes the antivirals Tpoxx (tecovirimat) and Tembexa (brincidofovir).
Jynneos is a US Food and Drug Administration (FDA)-approved vaccine for both smallpox and mpox, as both belong to the same virus family and exhibit similar preventive features. Although the World Health Organization (WHO) declared that smallpox was eradicated in 1980, mpox continues to pose a threat to global health.
Jynneos, the only FDA-approved vaccine for mpox, was instrumental in fighting the infectious disease during the 2022 outbreak. During the peak of the flare-up, there were 447 cases over a seven-day average in the US. There has been a total of just over 32,000 cases in the country, and though there is only low-level transmission at the moment, the disease is still being reported in other parts of the world, such as the Democratic Republic of the Congo (DRC).
Bavarian Nordic, which previously relied on the US Government to stockpile and distribute Jynneos, rolled out the vaccine itself into the market earlier this year.
Financial outlook for Bavarian Nordic
Bavarian Nordic said the contract would not impact its overall financial guidance for the year, but it did say that its “public preparedness business value” would increase by DKr900m ($131.8m). The company added that a “few additional government contracts” anticipated later this year would bring the business revenue to a range of $730m-$780m.
Bavarian Nordic reported record financial results in 2023, earning a preliminary revenue of $1bn compared to $456m in 2022. The company’s revenue growth was propelled by surges in sales of smallpox and mpox vaccine brands, as countries continued to purchase orders to mitigate the risks of new outbreaks. Jynneos, also known under the brands Imvamune and Imvanex outside the US, generated sales of $725m last year.
