WORLD HEALTH ORGANIZATION

EMA approves Bavarian Nordic's mpox vaccine for adolescents aged 12-17 in Europe, based on NIH-sponsored trial data showing non-inferior immune responses and similar safety profile. Bavarian Nordic plans to expand approval to other high-risk countries, including Africa, where mpox has caused over 25,000 cases and 720 deaths.

Strategies for improving Ebola virus disease post-exposure prophylaxis, origin of SARS-CoV-2 linked to Wuhan market, 'scoop and run' best for nerve agent mass casualty events, T cell memory from seasonal flu may offer pre-existing immunity to H5N1.

The Committee for Human Medicinal Products (CHMP) elected Bruno Sepodes as its new chair, effective 21 September. CHMP recommended marketing authorisations for eight new medicines, including Elahere, Hetronifly, Hympavzi, Penbraya, Theralugand, Afqlir, Opuviz, and Pomalidomide Teva. It also recommended extending indications for 12 existing medicines and confirmed the refusal of Syfovre's marketing authorisation. Applications for Durysta, Tecentriq, and Sialanar were withdrawn. CHMP updated Spikevax and Comirnaty vaccines to target new COVID-19 variants.

The EU approves Bavarian Nordic's mpox vaccine for adolescents aged 12-17, based on clinical study data showing comparable immune responses and safety profiles to adults. This follows the approval of Mvabea® for younger populations in 2020. The vaccine, effective against mpox, aims to improve access for vulnerable populations, particularly in Africa, where the outbreak is severe.

Pearsanta, a subsidiary of Aditxt, partners with Evofem Biosciences to develop a blood-based diagnostic test for endometriosis, leveraging a novel mitochondrial DNA biomarker. The test aims to become the first validated and commercialized blood-based test for endometriosis, with a planned U.S. launch in mid-2025.

ECDC raises mpox risk level to moderate following first case in Sweden, emphasizing global health interconnectedness. WHO declares mpox a global public health emergency, focusing on equitable access to diagnostics, therapies, and vaccines. Bavarian Nordic's JYNNEOS vaccine gains attention, while global collaboration and vaccination efforts are crucial, especially in Africa.

Article references focus on healthcare costs, disease management, and patient self-management, particularly in type 2 diabetes and cardiovascular disease in Germany.

Rwanda began vaccinating high-risk individuals against mpox, receiving 1,000 doses. The campaign targets 7 districts bordering the DRC, focusing on truck drivers and sex workers. Africa reported 2,912 new cases last week, with 14 deaths. The Global Fund pledged $9.5 million to the DRC. Japan and the DRC finalized a plan for Japan to donate 3 million mpox vaccine doses, administered by dermal scarification.

Bavarian Nordic's mpox vaccine approved by EU for adolescents; WHO declares mpox a global emergency, emphasizing children's vulnerability. JYNNEOS approved by FDA for adults, with EUA for adolescents in 2022 outbreak. EMA's CHMP approval based on recent data submission. WHO supports off-label use in under-18s but only backs adult use officially. DRC not planning to vaccinate under-18s initially. KM Biologics' vaccine already approved for children in Japan.