Bavarian Nordic gets FDA tick for monkeypox vaccine

Jynneos has become the first vaccine to be approved for non-replicating smallpox in the US and monkeypox in the world.

The US Food and Drug Administration (FDA) has given Danish drugmaker the go ahead to manufacture and supply the liquid-frozen suspension of its vaccine Jynneos for smallpox and monkeypox in adults aged 18 years and over.

The approval is “the culmination of a fifteen-year partnership that started with a call from the NIH [National Institutes of Health] for a safer smallpox vaccine, successfully transitioned to BARDA [Biomedical Advanced Research and Development Authority] and was delivered to the Strategic National Stockpile for use in an emergency,” Paul Chaplin, CEO of Bavarian Nordic said in a statement.

Image: Sanjay Acharya/wikimedia.org

The vaccine is approved for smallpox in Europe and Canada under the names Imvanex and Imvamune, respectively, though the FDA endorsement marks the first time a vaccine has been approved for the rare viral zoonotic disease monkeypox.

A concession was made by Public Health England (PHE) last year for the vaccine to be used to treat UK patients who contracted monkeypox in Nigeria, where there had been a monkeypox outbreak

The vaccine itself is a live, attenuated virus grown in cell lines derived from chicken eggs, made at Bavarian Nordic’s large-scale facility in Kvistgaard, Denmark.

Speaking to this publication in September 2018, spokesperson Thomas Duschek said: “The facility is scalable and already capable of producing at large-scale.”

The FDA also granted Bavarian Nordic with a priority review voucher (PRV), entitling Bavarian Nordic an expedited review process for a designated drug application.

“This priority review voucher may be transferred, including by sale, by you to another sponsor of a human drug or biologic application,” the FDA states. Bavarian Nordic has announced its intentions to sell the voucher to an undisclosed third party.