EMA approves 12 medicines including combined COVID-19 and influenza vaccine
New combined vaccine could simplify annual vaccine updates
At its February 2026 meeting, EMA’s human medicines committee (CHMP) recommended 12 medicines for approval, covering vaccines, innovative treatments and biosimilars, and issued two negative opinions.
A major highlight was mCombriax, the first combined mRNA vaccine to protect adults aged 50 and over against both COVID-19 and seasonal influenza. With hundreds of millions of COVID-19 cases reported in Europe and tens of millions of flu cases annually in the EEA, the dual vaccine aims to reduce the burden of seasonal respiratory infections.
"The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review."
The committee recommended conditional approval for Ojemda (tovorafenib), a once-weekly oral treatment for paediatric low-grade glioma brain cancer from six months of age, offering a new option beyond surgery and chemotherapy. Positive opinions were also adopted for Onerji for advanced Parkinson’s disease, Palsonify for acromegaly - a rare hormonal disorder, Rhapsido for chronic spontaneous hives, and Xolremdi for the ultra-rare immune disorder WHIM syndrome.
Six biosimilars for diabetes, inflammatory diseases, breast cancer and osteoporosis were also supported, helping expand access and improve sustainability.
In addition, Acoziborole Winthrop received a positive opinion under the EU-M4All programme as a single-dose oral treatment for sleeping sickness.
The CHMP recommended not approving Daybu for Rett syndrome and iloperidone for schizophrenia and bipolar disorder, and supported six extensions of existing medicines’ indications, including new paediatric uses.
