Submit flu/COVID combination vaccine mRNA-1083 for approval
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
- 12 Sep 2024
- Due
- 31 Dec 2024
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The Company expects to file for approval in 2024 and intends to use a Priority Review Voucher.”
What we found
Evidence strength A What the grades mean
Multiple later 10-K and 8-K filings state Moderna submitted mRNA-1083 for regulatory approval in older adults during 2024, within the deadline. Approval timing was later extended to 2026.
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A Moderna 10-K filed 2025-02-21
“In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older.” ✓ confirmed on the page
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A Moderna 8-K filed 2025-05-01
“The Company submitted mRNA-1083 for regulatory approval in older adults in 2024.” ✓ confirmed on the page
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A Moderna 8-K filed 2025-05-01
“Based on FDA feedback confirming the need for Phase 3 flu efficacy data, Moderna expects an extended review timeline and is now targeting approval in 2026.” ✓ confirmed on the page
Market reaction: the shares moved +1.3% against the S&P 500 over the three sessions around the disclosure (20 Feb 2025 to 25 Feb 2025). What this measures
Checked 10 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
- Submit
- Deliverable
- Flu/COVID combination vaccine mRNA-1083 regulatory filing
- Language
- Aspirational (“aims”, “intends”)
- 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
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Report an error in this entry Reference: KI-C-2024-MRNA-006226 · Corrections policy