FDA Decision on Moderna's mFLUSIVA (mRNA-1010) Flu Vaccine / Prediction
Will the FDA approve Moderna's mFLUSIVA (mRNA-1010) seasonal influenza vaccine by its PDUFA goal date of Wednesday, August 5, 2026?
Closed · Closed 11m ago · Aug 5, 2026, 1:42 PM
The unanimous advisory-committee vote in June 2026 makes approval the base case, but PDUFA goal dates are not guarantees.
Outcomes
Calls are closed. Values show the Starting Forecast (no Calls were made).
- Yes85%
- No15%
Make your Call
This Prediction is closed. Calls are no longer accepted.
Resolution rule
Resolves Yes if mFLUSIVA (mRNA-1010) appears as an FDA-licensed vaccine, per FDA's list of vaccines licensed for use in the United States or the accessdata.fda.gov approvals database, with an approval action dated on or before Wednesday, August 5, 2026 Eastern time; No if the FDA extends the goal date, issues a Complete Response Letter, or otherwise does not approve by that date.
Starting Forecast source: editorial prior
- https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states
- https://www.accessdata.fda.gov/scripts/cder/daf/