BAVARIAN NORDIC

Bavarian Nordic has launched two groundbreaking clinical trials to evaluate the safety and immunogenicity of MVA-BN mpox vaccine in 344 infants aged 4-24 months and 359 pregnant or breastfeeding women.

Bavarian Nordic announced the sale of its Priority Review Voucher for $160 million, awarded following FDA approval of its chikungunya vaccine VIMKUNYA in February 2025.

The CDC's Advisory Committee on Immunization Practices voted to recommend RSV vaccination for high-risk adults aged 50-59, potentially benefiting approximately 30% of Americans in this age group with conditions like COPD, heart failure, and chronic kidney disease.

• A recent study published in The Lancet Infectious Diseases found Bavarian Nordic's Jynneos vaccine was 84% effective in preventing mpox in individuals without HIV, but only 35% effective in those with HIV. • The research, conducted at Charité Universitätsmedizin Berlin with over 6,000 participants, highlights a significant unmet need for effective mpox prevention strategies in immunocompromised populations. • While the vaccine showed an overall 58% effectiveness after one dose, researchers emphasize the importance of completing the two-dose regimen, particularly for HIV-positive individuals who demonstrated reduced T-cell responses.

• The US FDA has approved Bavarian Nordic's freeze-dried formulation of Jynneos vaccine for mpox and smallpox prevention in adults, offering significant advantages in storage, transportation, and shelf life over the liquid-frozen version. • Clinical trials demonstrated comparable immune responses between the freeze-dried and liquid-frozen formulations, with no serious adverse events reported, supporting the supplemental Biologics License Application submitted in May 2024. • The approval represents a milestone in public health preparedness, with Bavarian Nordic manufacturing the freeze-dried vaccine under a contract with BARDA, with first deliveries expected later in 2025.

The U.S. FDA has approved Bavarian Nordic's freeze-dried formulation of JYNNEOS for prevention of smallpox and mpox in adults 18 years and older, offering improved storage stability and transportation advantages.

Moderna's mRESVIA vaccine received MHRA approval in February 2025 for adults aged 60 and older, joining GSK's Arexvy and Pfizer's Abrysvo in the expanding RSV vaccine market.

The European Commission has granted marketing authorization for Bavarian Nordic's CHIKV VLP vaccine, marking the first approved vaccine against chikungunya virus in Europe.

Phase I trial demonstrates Replicate Bioscience's RBI-4000, a self-replicating RNA vaccine, achieves WHO-established immune threshold for rabies protection with a single dose.

• The FDA is set to decide on Bavarian Nordic's CHIKV VLP vaccine for chikungunya, potentially the first VLP-based option in the U.S. • GSK's ABCWY vaccine, targeting multiple strains of Neisseria meningitidis, awaits FDA decision for primary care and pediatric use. • Innoviva Specialty Therapeutics' zoliflodacin, a novel antibiotic for gonorrhea, is under FDA review amid rising antimicrobial resistance. • Merck's clesrovimab, a monoclonal antibody for COVID-19, is being reviewed by the FDA for pediatric patients.