BAVARIAN NORDIC

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WHO approves Bavarian Nordic’s mpox vaccine for adolescents.

NIH clinical trial shows Bavarian Nordic's mpox vaccine induces equivalent antibody response in adolescents and adults, supporting extended use in under-18s. EMA approved MVA-BN for adolescents in Sept, while FDA granted EUA for adolescents during 2022-2023 outbreak. NIH study found no significant adverse events, though dizziness was more common in adolescents. Bavarian Nordic plans Phase II trial for children aged 2-12, aiming to extend vaccine indication to younger populations.

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MVA-BN vaccine showed similar immune response in adolescents and adults with no safety issues in a U.S. phase 2 trial. The vaccine, marketed as Jynneos in the U.S. and Imvanex in Europe, is now approved for adolescents. The WHO has prequalified the vaccine for use in high-risk groups, including infants and pregnant women. Bavarian Nordic plans to trial the vaccine in children aged 2 to 12, and CEPI is funding studies on post-exposure vaccination efficacy.

E. Heath reports advisory/consulting, steering committee, honoraria/paid travel, speaker’s bureau, and research support from various companies. J.R. Ribeiro, K. Poorman, and J. Xiu report personal fees and other support from Caris Life Sciences. H. Mamdani reports other support and grants from Daiichi Sankyo, AstraZeneca, and Genentech. A.F. Shields reports personal fees from Caris Life Sciences. G.L. Lopes reports stock ownership, honoraria, consulting, research funding, travel, and other relationships with multiple companies. S.A. Kareff reports personal fees and travel grants from various organizations. M. Radovich and G.W. Sledge report other support from Caris Life Sciences. G.A. Vidal reports relationships with Guardant360, Gilead, BillionToOne, Genentech/Roche, GSK, and AstraZeneca. J.L. Marshall reports personal fees from Caris. No other disclosures were reported by the other authors.

Bavarian Nordic A/S extends commitment to fight mpox outbreak in Africa with MVA-BN vaccine, approved by US FDA and EMA. Over 9,000 cases and 400 deaths reported in 2024, mostly in DR Congo. DRC grants Emergency Use Authorization for MVA-BN. Bavarian Nordic plans clinical studies for full approval and donates 15,000 doses, collaborating with WHO, UNICEF, and Gavi.

Bavarian Nordic commits to donate 15,000 doses of MVA-BN mpox vaccine to Africa, with Emergency Use Authorization granted in DR Congo. The vaccine, approved by FDA and EMA, aims to combat the rising mpox outbreak in Africa, where over 9,000 cases and 400 deaths have been reported in 2024.

WHO prequalifies MVA-BN vaccine from Bavarian Nordic, accelerating access in Africa to combat mpox. Recommended for adults in two doses, 4 weeks apart, with 82% effectiveness. Urgent scale-up in procurement and distribution needed for equitable access.