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Mcombriax

All articles tagged with #mcombriax

health1 month ago

EU poised to approve first single-shot COVID-19 and flu vaccine for 50+

The European Medicines Agency recommended EU-wide marketing authorisation for mCombriax, the first combined mRNA vaccine protecting people aged 50 and older against both COVID-19 and seasonal influenza in a single shot. In trials, antibodies against both viruses were non-inferior to existing vaccines, and the vaccine showed common short-term side effects (injection-site pain, fatigue, muscle/joint pain, fever, etc.). The European Commission will decide on authorization, after which price and reimbursement are set by individual member states.

CHMP February 2026: 12 medicines move toward EU approval, including a first combined flu-COVID vaccine
health1 month ago

CHMP February 2026: 12 medicines move toward EU approval, including a first combined flu-COVID vaccine

CHMP’s February 2026 meeting recommended 12 medicines for EU approval (including mCombriax, the first combined influenza and COVID-19 mRNA vaccine) and granted a conditional authorisation for Ojemda to treat paediatric low-grade glioma. Positive opinions were issued for Onerji (Parkinson’s), Palsonify (acromegaly), and Rhapsido (chronic spontaneous urticaria), plus six biosimilars. Acoziborole Winthrop received a positive outside-EU opinion. Negative opinions were given for Daybu and Iloperidone. Extensions of indication were recommended for Dupixent, Jorveza, Keytruda, Olumiant, Scemblix, and Stelara, with Zumrad withdrawn. Minutes will follow, and many decisions await EC approval.