The US Food and Drug Administration (FDA) approved Jynneos in 2019 for the prevention of smallpox and mpox. Credit: Viacheslav Lopatin via Shutterstock.

Bavarian Nordic has commercially launched its mpox (monkeypox) vaccine Jynneos (Imvanex/Imvamune) in the US, creating more avenues for its procurement, distribution, and reimbursement, and catering to both public and private healthcare providers. 

Healthcare providers now have the option to request Jynneos via chosen wholesalers and distribution channels, thereby increasing access for vulnerable individuals at nearby pharmacies, doctor’s offices, and public health centres.  

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Mpox is a rare viral disease most commonly found in Central and West Africa. It is similar to smallpox, but less severe and causes fever, rash, and muscle aches and spreads through contact with infected animals or materials.  

The US Food and Drug Administration (FDA) originally approved Jynneos in 2019 for the prevention of smallpox and mpox. In May 2022, a case of mpox was confirmed in the UK, originating from a British resident who had travelled to Nigeria. Cases then emerged in countries where the disease is not endemic, and continue to be reported in several endemic countries, according to the WHO. In the 10 major pharmaceutical markets (UK, US, Italy, Spain, France, Germany, Japan, Mexico, Brazil, and Canada), GlobalData epidemiologists estimated there were more than 66,674 incident cases of mpox in 2022. 

GlobalData is the parent company of Pharmaceutical Technology. 

The same year, following the declaration of public health emergencies from the FDA and WHO, the FDA recommended an emergency use authorisation of the vaccine for the prevention of mpox and smallpox disease in individuals aged 18 years and older who are at high risk of infection. 

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Jynneos is derived from the parental strain of modified vaccinia virus Ankara, which is a highly attenuated pox virus that has lost the capacity to replicate in human cells. The vaccine is currently the only available approved live, non-replicating mpox vaccine, according to Bavarian Nordic. 

The vaccine has been a huge driver of revenue for Bavarian Nordic, with the company reporting Jynneos sales of DKr5bn ($725m) in 2023, and an overall revenue of DKr7.06bn ($1bn) compared to DKr3.15bn ($456m) in 2022. In August 2023, the US Biomedical Advanced Research and Development Authority (BARDA) placed a $120m order for bulk manufacturing of the vaccine. 

In the announcement accompanying the launch, Bavarian’s CEO Paul Chaplin said: “Building on the trust and reliability as a supplier of vaccines to the US government for more than a decade, we are proud to extend our commitment to improving the nation’s public health by making our mpox vaccine widely available to at-risk individuals through the regular channels.”