Flu and COVID combination vaccine (mCOMBRIAX, mRNA-1083)
Authorized in the EU in April 2026 for adults 50 and older; US filing is waiting on FDA guidance.
What it is
mCOMBRIAX combines Moderna's mNEXSPIKE COVID-19 vaccine with its mRNA flu vaccine in one shot. The European Commission authorized it in April 2026, based on a Phase 3 study of about 8,000 adults. In the US, Moderna is waiting for FDA guidance before resubmitting.↗ source
Why it matters to the stock. It would be the first combined flu and COVID vaccine on the market. The EU approval is a first revenue step, and a US approval would open a much larger market.
News
European Commission authorizes mCOMBRIAX, the first flu plus COVID combination vaccine
The European Commission granted marketing authorization for mCOMBRIAX, Moderna's mRNA vaccine combining flu and COVID-19 antigens, for adults 50 and older.
Regulation