WORLD HEALTH ORGANIZATION

COVID vaccines have saved over 1.4 million lives in WHO's European region. SARS-CoV-2 continues to evolve, affecting immunity. Australia has updated vaccines four times, now considering a fifth targeting JN.1. JN.1 vaccines should protect against newer subvariants like FLiRT and FLuQE. Regulatory bodies like the FDA and TGA are evaluating JN.1 vaccines, with Moderna and Pfizer's Spikevax and Comirnaty under review in Australia. Safety and efficacy data show improved immune responses against newer variants. Novavax, a protein-based vaccine, offers an alternative for those unable to receive mRNA vaccines. Challenges include vaccine uptake and quicker approval processes.

FDA approves Roche's Ocrevus Zunovo for MS and Eli Lilly's Ebglyss for eczema. Walgreens to pay $106.8 million for fraudulent billing. WHO supports Bavarian Nordic's mpox vaccine distribution in low-income countries.

FDA approves Roche's subcutaneous MS treatment; Walgreens to pay $106.8M for prescription fraud; WHO approves mpox vaccine for global access; China to promote marriage and childbirth; Eli Lilly's eczema drug gets FDA approval; studies on mammography and heart disease, video visits for end-of-life care; Uganda's mpox cases rise; Nebraska allows abortion ballot measures; Pfizer targets rare lung cancer mutation.

DOH warns against unauthorized mpox vaccines; WHO prequalifies MVA-BN vaccine for mpox, emphasizing urgent scale-up for equitable access.

Cascadia's U.S. Senators voted on major issues during the legislative week ending September 13th, 2024, including bills to counter Chinese government influence, bar contracts with Chinese biotechnology firms, respond to Hong Kong's erosion of autonomy, and exclude vehicles with Chinese-made components from federal tax credits. The Senate also confirmed several district court judge nominations.

WHO prequalified MVA-BN as the first mpox vaccine, aiming to boost access and contain outbreaks. Bavarian Nordic plans to supply 10 million doses by 2025. The vaccine is 99.2% effective after two doses, according to CDC data.

CSL and Arcturus Therapeutics' KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, was approved for adults in Japan, targeting the JN.1 Omicron subvariants, with distribution starting in October.

NICHE-3 study, approved by NedMec, enrolled adults with dMMR resectable colon adenocarcinoma. Patients received nivolumab and relatlimab, followed by surgery. Primary endpoint was pathologic response (≤50% RVT), with secondary endpoints including safety and survival. Study used a Simon’s two-stage design, aiming for a response rate of 85%. Pathologic response was assessed by central histopathologic review. Safety and efficacy populations were defined, with binary endpoints reported as proportions. MMR status was assessed via immunohistochemistry.

WHO approves MVA-BN mpox vaccine, facilitating access for millions at risk in Africa. The vaccine, already approved in Europe and the U.S., is recommended for adults in two doses, with an 82% effectiveness. In limited supply situations, single doses are 76% effective. WHO aims for urgent scale-up in procurement and distribution to prevent infections and save lives.

Updated MARIPOSA-2 study results show RYBREVANT® plus chemotherapy significantly improves post-progression outcomes in previously treated NSCLC patients with EGFR exon 19 deletions or L858R mutations, with a favorable trend toward improved overall survival compared to chemotherapy alone. Data presented at ESMO 2024 Congress.