Bavarian Nordic A/S announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has voted in favor of recommending the routine use of JYNNEOS®?, the Company's FDA-approved mpox vaccine, in adults at risk of mpox infection. Specifically, the ACIP voted to recommend that individuals 18 years and older with certain risk factors1 should receive the two-dose regimen of JYNNEOS. Previously, ACIP had recommended JYNNEOS for individuals at risk of mpox only during an outbreak.

The recommendations will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services for review and following approval, the recommendations will be published in the Morbidity and Mortality Weekly Report. The CDC estimates that 2 million U.S. individuals are eligible for vaccination against mpox under these recommendations2. To date, approximately 23% of this group has received the recommended two doses of JYNNEOS during the 2022/2023 outbreak, leaving a significant number of people vulnerable to infection with mpox.

Pending approval of the updated recommendations, Bavarian Nordic is targeting a commercial launch of JYNNEOS in the U.S. in the first half of 2024. This represents the second national recommendation for Bavarian Nordic's mpox vaccine in adult risk groups following a similar endorsement by the Standing Committee for Vaccination (STIKO) in Germany during 2022. More recently, the European AIDS Clinical Society (EACS) also recommend the use of the vaccine for adults infected with HIV, or on pre-exposure prophylaxis (PrEP) treatment3, which may support additional national recommendations for the use of the vaccine in the future.

JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) is approved for the prevention of smallpox andmpox disease in adults 18 years of age and older determined to be at high risk for smallpox and mpox infection. The vaccine was developed in collaboration with the U.S. government originally to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in 2019 and in 2021, ACIP voted to recommended JYNNEOSfor pre-exposure vaccination of people at occupational risk for orthopoxvirus exposures.

In 2022, the CDC issued interim guidance, enabling pre- and post-exposure use of JYNNE OS during the mpox outbreak and an Emergency Use Authorization (EUA) was issued allowing the use of JYNNEos in people under 18 years.