Bavarian Nordic is capable of supplying around three million doses of its mpox vaccine Jynneos this year, the WHO said following its global health emergency declaration.
WHO Director-General Tedros Adhanom Ghebreyesus said Wednesday the increase in mpox cases in the Democratic Republic of the Congo and several other African countries is “very worrying” and that a “coordinated international response” is needed to save lives and control the outbreak.
The same day, the European Commission’s Health Emergency Preparedness and Response Authority (HERA) said it will purchase 175,420 doses of Jynneos from Bavarian Nordic and donate them to Africa’s Centres for Disease Control.
This adds to Bavarian Nordic’s own donation of 40,000 shots to HERA and the US giving away 50,000 doses to the DRC. Jynneos is priced at around $100 per dose, according to Africa’s CDC.
Overall, the company has half a million doses in stock that can be purchased by governments, said Tim Nguyen, the WHO’s head of the unit for high impact events preparedness, at a press conference Wednesday.
“Another 2.4 million could be produced by the end of this year if buyers are there to make a firm procurement request,” Nguyen said, adding that a further 10 million could be made in 2025.
If ordered next year, the 10 million doses could bring potential revenues of $600 million to $1 billion depending on “price, discounts and donation,” Jefferies analysts said Thursday. Bavarian’s shares $BAVA were up as much as 17% Thursday morning on the Copenhagen stock exchange.
Jynneos protects against both mpox and smallpox, and is given as two shots administered 28 days apart. It is the only vaccine with an FDA approval for mpox. Moderna is investigating its mRNA candidate in a Phase 1/2 trial, while BioNTech is also testing its RNA-based multivalent vaccine asset in an early-phase study.
The mpox outbreak in Africa features a “new, more deadly strain” driven by the Clade I virus, the Jefferies analysts said, adding that Jynneos is believed to be effective against this strain. Since Clade I transmission can occur from “rodents being handled by younger children,” it could be important for Bavarian to seek approval in children and adolescents, they added.
Earlier this month, BARDA ordered $156.8 million worth of Jynneos shots. Even before that, the vaccine received major interest during the mpox outbreak of 2022, which featured a strain driven by the Clade II virus. Bavarian made 5.5 million doses of the vaccine for the US starting that year through to 2023. Demand for the vaccine was so high in 2022 that US regulators were considering using some expired doses from its stockpile.
In August 2023, BARDA ordered a further $120 million worth of the shot, prompting the Danish company to raise its guidance from DKK 6 billion ($889 million) to DKK 6.9 billion ($1 billion). Earlier this year, Bavarian also launched Jynneos in US private markets, a venture that it described as “a whole new commercial opportunity.”
Between January 2022 and June 2024, there were more than 99,000 lab-confirmed cases of mpox across 116 countries which resulted in 208 deaths, according to WHO data.
On Thursday, SIGA Technologies’ antiviral tecovirimat failed to significantly reduce the duration of mpox lesions in a Phase 2 trial in children and adults in the DRC.