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Bavarian Nordic gets FDA tick for monkeypox vaccine

Jynneos has become the first vaccine to be approved for smallpox in the US and monkeypox in worldwide.

BPI Staff

September 26, 2019

2 Min Read
Bavarian Nordic gets FDA tick for monkeypox vaccine
Image: Sanjay Acharya/wikimedia.org

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.

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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.