Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S.

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Bavarian Nordic A/S (OMX: BAVA) announced today that JYNNEOS®, the only FDA-approved mpox vaccine, is now commercially available in the U.S., marking a significant expansion for access to JYNNEOS® by establishing additional pathways for vaccine procurement, distribution, and reimbursement by both public and private payers.

Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection. This was made possible through Bavarian Nordic’s long-standing partnership with the U.S. government to supply the vaccine for the national stockpile and enabled by interim guidance from the Centers for Disease Control and Prevention (CDC), recommending pre- and post-exposure use of the vaccine for individuals at risk during the outbreak. These recommendations were updated in October 2023 by unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), and JYNNEOS is now recommended for routine use in individuals 18 years and older with certain risk factors1.

While mpox no longer constitutes a public health emergency, infections are still occurring throughout the U.S., with around 200 cases every month on average and transmission of the virus having been reported across most of the states in 2024 to-date2. Since the beginning of the outbreak in 2022, more than 32,000 cases have been reported in the U.S., representing a third of all cases reported globally3.

According to estimates from the CDC, two (2) million U.S. individuals are eligible for vaccination against mpox4. Recent data shows 60% of this population remains completely unvaccinated, and 15% have received only one dose of the vaccine5. Real-world data show that protection against mpox disease is superior in vaccinees who received the full schedule of two vaccinations as recommended by the CDC, compared to those who are unvaccinated or have only received one dose of the vaccine6.

Through its existing nationwide vaccine distribution structure, Bavarian Nordic is now making the mpox vaccine commercially available across the nation. As of April 1, health care providers can order JYNNEOS through their preferred wholesaler and distribution partners to make it available for at-risk individuals at local pharmacies and physician offices in addition to public health clinics.

Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, commented: “From the beginning of the mpox outbreak, almost two years ago, the prompt availability of an approved vaccine combined with a strong public health response have helped to significantly reduce the impact of this debilitating disease, but unfortunately, mpox has not gone away completely. Building on the trust and reliability as a supplier of vaccines to the U.S. 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. We look forward to working with healthcare providers across the nation to increase awareness and availability of the mpox vaccine.”

Brian Hujdich, Executive Director, National Coalition for LGBTQ Health, commented: “The expanded availability of JYNNEOS is a vital step toward ensuring equitable access to healthcare for the LGBTQ+ community and marks a significant stride in preventing the spread of mpox. We must continue to advocate for equitable policies that protect and support the health and well-being of all individuals and encourage those at risk to consult with their healthcare providers regarding vaccination.”

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