UPDATED: Bavarian Nordic begins commercial launch of mpox vaccine Jynneos in US

After years relying on the U.S. government to stockpile and distribute Jynneos, Bavarian Nordic is launching the mpox vaccine into the commercial market.

Jynneos, the only FDA-approved mpox vaccine, is now commercially available in the U.S., Bavarian Nordic announced Tuesday. The commercial rollout means that interested individuals can access the shot at local pharmacies and physician offices, in addition to the limited number of clinics designated by health authorities.

The launch builds on Jynneos’ availability through public health channels since an mpox—then known as monkeypox—outbreak in 2022. It also follows a unanimous decision in October from the U.S. CDC’s Advisory Committee on Immunization Practices to recommend Jynneos as a routine vaccination in adults at risk of mpox infection, backing the shot’s use beyond an outbreak.

People at risk of mpox include men who have sex with men and others who engage in risky sex practices, according to the CDC.

About 2 million individuals in the U.S. are eligible for Jynneos under the CDC’s new recommendation, Bavarian Nordic said, citing CDC estimates. About 60% of those people remain completely unvaccinated, and 15% have received only one of the two vaccine doses.

A real-world case-match study conducted in 12 U.S. jurisdictions previously showed that Jynneos, when given in two doses, was estimated to be 85.9% effective against mpox. At one dose, the vaccine was found to be 75.2% effective.

Back in 2022, when initial supplies were constrained, the FDA issued an emergency use authorization (EUA) allowing intradermal administration of Jynneos at a lower dose so that a single vial could be used on up to five people. The EUA prioritized sparing doses, while the regular FDA-approved dosing of Jynneos calls for an entire 0.5mL vial given subcutaneously, Peter Costa, the North America medical director at Bavarian Nordic, explained in an interview.

Although mpox is no longer considered an emergency, infections still occur at an average monthly rate of about 200 cases in the U.S., with reports across most of the states so far this year. More than 32,000 mpox cases have been reported in the U.S. since the last outbreak in 2022.

Jynneos was developed with support from the Biomedical Advanced Research and Development Authority as part of the U.S.’s preparedness efforts. The vaccine got its FDA approval for the prevention of smallpox and mpox in 2019 and has been supplied to the government for national stockpiling.

Jynneos was Bavarian Nordic’s first revenue-generating product until the Danish company in 2020 decided to add more commercial products under a deal with GSK. Last year, Jynneos, which is also known as Imvamune or Imvanex outside the U.S., nearly tripled its prior-year sales to reach more than DKK 5 billion ($720 million). The revenues came from contracts with various governments, including the U.S.

The mpox shot also received immunization recommendations from authorities outside the U.S., including Germany, which could potentially also enable a commercial launch in those countries, according to Bavarian Nordic.

Despite setting a company revenue record in 2023, Bavarian Nordic realized that Jynneos’ sales wouldn’t be sustainable as the number of mpox cases declines in part thanks to the protection provided by the vaccine, CEO Paul Chaplin said on the company’s fourth-quarter earnings call in March.

Still, Bavarian Nordic expects its total 2024 revenue to come in a range between DKK 5 billion to DKK 5.3 billion. This guidance includes contribution from travel vaccines, which contributed nearly DKK 1.9 billion in sales last year. The Danish company last year beefed up its offerings with the acquisition of Emergent BioSolutions’ travel health business, which includes the typhoid vaccine Vivotif and the cholera vaccine Vaxchora.

For Jynneos, Chaplin touted additional customers in the public preparedness sector that the company signed on during the mpox outbreak, as well as “concrete discussions” with other governments for more contracts. The U.S. private market will give the Jynneos franchise another boost, he said.

Jynneos is the first vaccine that Bavarian Nordic is taking through the entire U.S. commercial process, including signing reimbursement deals with payers, Lee Ann Kimak, the company’s U.S commercial lead, noted during the interview. 

After the free government-run Jynneos program winds down, Bavarian Nordic will work to make sure that uninsured people also have access to Jynneos, including by working with the CDC’s Vaccines for Adults program, which offers recommended vaccinations to people at no cost, Kimak said.

Jynneos isn't expected to be a seasonal vaccine like flu shots, but Kimak said the company expects some spikes in demand prior to pride events. Bavarian Nordic has partnered with organizations such as the National Coalition of STD Directors and the National Coalition for LGBTQ Health to raise awareness and promote access to Jynneos.

Editor's Note: The story was updated with additional information from an interview with Bavarian Nordic's Peter Costa and Lee Ann Kimak.