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.
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