Bavarian Nordic scores FDA nod for smallpox and monkeypox vaccine Jynneos

Bavarian Nordic
Bavarian Nordic scored an approval for Jynneos, the first non-replicating smallpox vaccine in the U.S. and the first monkeypox vaccine worldwide. (Bavarian Nordic)

Bavarian Nordic and the U.S. government have been working for years to advance a next-gen smallpox vaccine, and now the company has scored its much-anticipated approval. The vaccine, Jynneos, represents the first non-replicating smallpox vaccine in the U.S. and the first monkeypox vaccine worldwide. 

Importantly, Jynneos is also the first smallpox vaccine for people with compromised immune systems, such as people with eczema, and addresses a long-running U.S. goal to be able to provide the full population with protection. Bavarian Nordic CEO Paul Chaplin said on a Wednesday conference call the vaccine is the “result of a fifteen-year partnership” between the U.S. government and the company.

So far in that partnership, the U.S. government has awarded Bavarian Nordic $1.8 billion for development and procurement, a Bavarian Nordic investor presentation shows. The company delivered 28 million doses to the national stockpile before approval. The vaccine is approved in Europe as Imvanex and in Canada as Imvamune. 

RELATED: Bavarian Nordic, touting phase 3 smallpox win, says it plans FDA filing for Imvamune

Emergent BioSolutions makes smallpox vaccine ACAM2000, but certain immunocompromised individuals can’t receive it. As Bavarian Nordic notes, the life-threatening virus was eradicated 40 years ago but has emerged more recently as a potential bioterrorism threat.

The approval “enhances domestic biodefense and global health security,” Department of Health and Human Services Deputy Assistant Secretary for Preparedness Rick Bright said in a statement. It also “demonstrates what can be accomplished for the American people through public-private partnerships,” he added.

As for monkeypox, Bavarian Nordic says cases have been recorded recently in the U.K., Israel and Singapore; all the cases originated in Nigeria. About 5 million people annually travel to areas affected by monkeypox, so Bavarian Nordic sees a market for the new vaccine as a traveler’s shot. The company predicts about $65 million in peak sales for that indication, but Chaplin said sales won't start to come in until late next year. In the meantime, Bavarian Nordic will be working to build awareness of the disease.

To add to the approval, Bavarian Nordic picked up a priority review voucher that it plans to sell to another drugmaker. AstraZeneca purchased a priority review voucher last month for $95 million.

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