The European Medicines Agency (EMA) today said it’s recommending marketing authorization for mCombriax, Moderna’s combined mRNA vaccine for protecting older adults against COVID-19 and flu.

The recommendation was made by the EMA’s Committee for Medicinal Products for Human Use, which looked at data from a phase 3 trial involving 8,000 participants aged 50 and older. The results of that trial showed participants who received mCombriax (mRNA-1083) had non-inferior immune responses to those who received Moderna’s licensed COVID-19 vaccine (Spikevax) or authorized high- or standard-dose flu vaccines (Fluzone and Fluarix).

If the European Commission accepts the recommendation, the vaccine will be available throughout the European Union. The EMA said the vaccine will provide people with the option of having a single shot to protect against both illnesses.

“mCombriax will be one more option for national authorities to consider for vaccination campaigns against COVID-19 and influenza,” the EMA said in a news release. “National authorities decide which vaccines to roll out and make recommendations about who should receive them, taking into account the situation in their countries.”

Moderna CEO Stephane Bancel, MBA, MEng, said in a statement that the recommendation “represents an important milestone for respiratory virus vaccination and for Moderna.”

“Combination vaccines have the potential to simplify vaccination and support improved health outcomes,” Bancel said. “We appreciate the EMA's rigorous scientific review.”

Moderna submitted a Biologic License Application to the US Food and Drug Administration (FDA) for mCmobriax in 2024 but pulled the application in May 2025 after the FDA asked for more data.

A new global systematic review and meta-analysis finds that over 40% of health care workers experienced insomnia during and after the acute phase of the COVID pandemic—a rate significantly higher than those reported in the general population. 

For the study, published in Current Psychology, researchers from the Universidad Catolica de Murcia in Spain analyzed 34 studies involving 32,930 health care professionals in 14 countries. The pooled prevalence of insomnia was 43.5%, with substantial variability between studies. 

The findings suggest that sleep disturbances among health care workers have persisted beyond the initial pandemic surge. Meta-analyses conducted in 2020 reported insomnia rates ranging from 34% to 49%, and the updated analysis indicates that rates have remained within that range even after the pandemic peak. 

Frontline status emerged as an important risk factor. Health care workers directly involved in patient care had a significantly higher prevalence of insomnia (54.9%) than second-line staff (33.5%). The authors note that frontline workers faced harsher working conditions and direct contact with infected patients, which may have contributed to sleep disruption. 

Prioritizing the management of sleep disturbances remains essential, not only to improve immediate quality of life but also to mitigate future psychological risks.

But the insomnia rate among workers not on the front lines “was also considerably high,” they write. “Our findings suggest that the type of healthcare professional included in the studies did not significantly moderate the prevalence of insomnia symptoms.”

Geographic location was also a significant predictor of prevalence. Studies conducted in Europe reported higher pooled prevalence than those conducted in Asia, and studies from China reported significantly lower rates than those from other countries. 

The authors conclude that a subset of health care workers continue to experience the effects of the pandemic and, given the known links between insomnia and mental illness, “prioritizing the management of sleep disturbances remains essential, not only to improve immediate quality of life but also to mitigate future psychological risks.”