Global pharma giant Moderna has cleared a major regulatory hurdle in Europe for what it calls the world’s first combined flu and COVID-19 shot.

 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of mCOMBRIAX (mRNA-1083), a single vaccine designed to protect adults 50 and older against both seasonal influenza and COVID-19 caused by SARS-CoV-2.

 

The decision marks a pivotal moment for the Massachusetts-based biotech giant, which has been racing to expand its respiratory vaccine portfolio beyond its blockbuster COVID shot.

 

"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. If approved, this would be Moderna's fourth marketed product in Europe," 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."

 

mCOMBRIAX builds on the company’s existing COVID-19 vaccine, mNEXSPIKE, and its investigational flu shot, mRNA-1010, which is under regulatory review in the United States, European Union, Canada and Australia.

 

The CHMP’s recommendation is backed by results from a large Phase 3 trial involving roughly 8,000 adults split into two age groups: those 65 and older, and those between 50 and 64.

 

In the older cohort, the combination shot was measured against co-administered Fluzone HD — marketed in the EU as Efluelda — and Spikevax, Moderna’s approved COVID-19 vaccine. In the younger group, it was compared to Fluarix and Spikevax given separately.

 

All primary endpoints were met, demonstrating non-inferior immune responses. After a single dose, mRNA-1083 generated statistically significantly higher immune responses against three influenza strains — A/H1N1, A/H3N2 and B/Victoria — as well as against SARS-CoV-2 in both age groups.

 

The only exception was the B/Yamagata strain — no longer recommended for seasonal flu vaccines — where a statistically significant advantage was not observed in adults 65 and older compared with the licensed comparator vaccines.

 

Safety data also held up. The vaccine showed an acceptable tolerability profile, with most reported side effects classified as mild to moderate and consistent with those seen in existing licensed flu and COVID-19 vaccines.

 

The final decision now rests with the European Commission, which typically follows the CHMP’s recommendation. If approved, the authorization would apply across all EU member states and the European Economic Area, including Iceland, Liechtenstein and Norway.

 

For Moderna, the ruling could open the door to a new era of streamlined respiratory vaccination — and cement its foothold in Europe’s post-pandemic vaccine market.