BAVARIAN NORDIC

WHO approves MVA-BN mpox vaccine for first time, aiming to facilitate timely access for millions at risk in Africa. The vaccine, already approved in Europe and the US, is 82% effective in two doses and can be used in single doses when supply is limited.

The MVA-BN vaccine from Bavarian Nordic, prequalified by WHO, is approved for adults in Europe and the U.S. WHO's approval aims to accelerate access to reduce mpox transmission. The vaccine, 82% effective with two doses, can be used in special cases like infants and immunocompromised individuals. WHO's prequalification aids procurement and regulatory approval globally.

WHO adds MVA-BN vaccine to prequalification list for Mpox, aiming to increase access and contain outbreaks. The vaccine, administered in 2 doses, can be kept at 2–8°C for up to 8 weeks and is recommended for high-risk individuals. WHO emphasizes the need for equitable access and data collection on vaccine safety and effectiveness.

Bavarian Nordic's IMVANEX® (MVA-BN®) becomes the first mpox vaccine to receive WHO prequalification, facilitating broader access across African countries. The vaccine, indicated for adults, may be used 'off-label' in vulnerable groups during outbreaks. MVA-BN has also received provisional consent from New Zealand and full approval from Mexico.

Various drugs and their statuses are listed, including IN-001 for anaphylaxis (Fast Track), Finereonone for heart failure (Phase 3), Tirzepatide for heart failure and obesity (Phase 3), TMB-001 for congenital ichthyosis (Phase 3), Bentracimab for ticagrelor reversal (Priority Review), Fabhalta for immunoglobulin A nephropathy (accelerated approval), RLS-0071 for acute graft-vs-host disease (Fast Track and Orphan Drug), CHIKV VLP for chikungunya (Priority Review), Diazoxide choline for Prader-Willi syndrome (Priority Review), Mirdametinib for neurofibromatosis type 1 (Priority Review), Setmelanotide for genetic obesity (Priority Review), AR882 for gout (Fast Track), SPN-830 for Parkinson disease (NDA review), BGB-16673 for chronic lymphocytic leukemia (Fast Track), Cabozantinib for neuroendocrine tumors (NDA review), Linvoseltamab for multiple myeloma (Complete Response Letter), Nivolumab plus ipilimumab for hepatocellular carcinoma (BLA review), Midomafetamine for PTSD (Complete Response Letter), and Tezepelumab-ekko for COPD (Breakthrough Therapy).

TNX-801, a synthetic horsepox vaccine, shows efficacy against mpox and improved tolerability in immunocompromised animals, with no spread to blood or tissues. Selected by NIH’s Project NextGen for clinical testing, it aims to provide single-dose protection and long-term immunity, addressing the need for simpler vaccine distribution.

The WHO's mpox declaration led to significant stock market increases for pharmaceutical, medical tech, and biopharmaceutical companies, while airline stocks declined, reflecting investor concerns about mpox's global spread.

Africa CDC and WHO launched a $600M, 6-month mpox response plan focusing on surveillance, testing, and community engagement. 55% of funds target 14 affected nations, 45% for operational support. 5,549 cases and 643 deaths reported in 2024, with Congo accounting for 91% of cases. 200,000 mpox vaccines donated by EU arrived in Congo, with 3M needed to curb outbreaks. Vaccination prioritizes close contacts and sex workers, with potential future expansion to children aged 12-17.