On Oct. 25, 2023, Bavarian Nordic announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) had 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 factors should receive the two-dose regimen of JYNNEOS. Previously, the ACIP had recommended JYNNEOS for individuals at risk of mpox only during an outbreak.

The CDC estimates that 2 million U.S. individuals are eligible for vaccination against mpox under these recommendations. 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 targeted a commercial launch of JYNNEOS in the U.S. in the first half of 2024.

This represented 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) treatment.