Vaccine maker Bavarian Nordic readies production for mpox risk

The World Health Organization (WHO) declared mpox (previously known as monkeypox) a global public health emergency last week following an outbreak in Democratic Republic of Congo that spread to neighboring countries.

While it usually causes mild flu-like symptoms, a more dangerous form of the virus – Clade 1b – can kill and has been detected in Europe.

One of two vaccines approved to treat mpox is Jynneos (MVA – modified Vaccinia Ankara). The vaccine won US Food and Drug Administration (FDA) approval in 2023 and was launched earlier this year by vaccine maker Bavarian Nordic. The vaccine, originally developed for the prevention of smallpox, received approval in the European Union in 2022 under the brand name Imvanex.

In response to the growing mpox risk, Bavarian Nordic has struck a supply agreement with HERA (the European Health Emergency Preparedness and Response Authority). The agency is set to procure 175,420 doses for donation to the Africa CDC (Centres for Disease Control and Prevention). Under terms of the deal, Bavarian Nordic will donate a further 40,000 doses.

“Mpox is spreading at an alarming rate in Africa, calling for further action from the international community. We are proud to support HERA’s contribution of vaccines to the region and are pleased to announce an additional donation from Bavarian Nordic,” said CEO Paul Chaplin.

Bavarian Nordic claims to have already produced more than 15 million doses of the mpox vaccine across 76 countries since an earlier outbreak in 2022, but in response to this latest threat it has pledged to “ramp-up vaccine manufacturing to ensure the continued equitable access to the mpox vaccine.”

According to the firm, this will complement a vaccine inventory strategy set up in 2022 to provide a surge capacity for potential outbreaks and will give Bavarian Nordic capacity to make 10 million doses by the end of 2025.

"We have 500,000 doses on stock and can produce another 2 million doses by end of year," a spokesperson from the firm told BioProcess Insider. "Next Year we can ramp up and produce an additional 8 million doses."

Jynneos is a live, attenuated virus grown in cell lines derived from chicken eggs, made at Bavarian Nordic’s large-scale facility in Kvistgaard, Denmark. The site, located 40km north of Copenhagen, has benefitted from recent expansions, including the addition of a $75 million fill/finish facility and clean room suite.

In 2023, the firm bulked out its production network with a 16,000 square meter plant in Bern, Switzerland, acquired from Emergent Biosolutions as part of a $270 million deal. The site has capabilities for mammalian, microbial, viral drug substance, and drug product production, and currently makes the respective oral typhoid and cholera vaccines, Vivotif and Vaxchora.