Refile the mRNA-1083 flu/COVID combination vaccine with Health Canada
Delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 6 Nov 2025
- Due
- 31 Dec 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The Company expects to refile with Health Canada in 2025 and is awaiting further guidance from U.S. FDA on refiling.”
What we found
Evidence strength A What the grades mean
A January 2026 8-K states Moderna submitted mRNA-1083 to Health Canada in 2025, within the stated period. The exact submission date is not given.
-
A Moderna 8-K filed 2026-01-12
“Moderna submitted for approval to Health Canada in 2025.” ✓ confirmed on the page
-
A Moderna 10-K filed 2026-02-20
“mRNA-1083 is under regulatory review in Europe and Canada” ✓ confirmed on the page
Market reaction: the shares moved +18.8% against the S&P 500 over the three sessions around the disclosure (9 Jan 2026 to 14 Jan 2026). What this measures
Checked 11 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Refile
- Deliverable
- Refiling of mRNA-1083 flu/COVID combination vaccine with Health Canada
- Where
- Canada
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Gemini (Google), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
Are you Moderna? You can publish an official statement next to this entry, free. Add a statement.
Is something here wrong or out of date? Companies and readers can ask us to check it. Please bring a link to a public source.
Report an error in this entry Reference: KI-C-2025-MRNA-006244 · Corrections policy