Submit a Biologics License Application to the FDA for full U.S. licensure of the vaccine

No public evidence found either way

AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.

Announced: 21 Dec 2020
Due: 31 Dec 2021
Last checked: 10 Oct 2026

Deadline
Met
Late
Not met
Today

What the company said

“Moderna intends to submit a Biologics License Application for full U.S. licensure in 2021”

SourceModerna Form 8-K press release, 2020-12-21
FilingSEC filing index
Deadline as statedin 2021
Deadline used31 Dec 2021, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2020-MRNA-006156
Cite as https://keptindex.org/c/KI-C-2020-MRNA-006156/ — this address never changes.

What we found

After 4 checks we found no clear public record either way, so this commitment is not counted as met or not met.

If you have a public source showing the outcome, please send it to us.

Commitment lineage

Every time the company restated this commitment. The original is never changed, and the outcome is always measured against version 1.

Deadline drift +546 days
2 versions

Version 1 · original · stated 21 Dec 2020

Deadline 31 Dec 2021 (“in 2021”) · wording aspirational
Version 2 · stated 23 Feb 2023

Deadline 30 Jun 2023 (“in the first half of 2023”) · wording firm

“Company will file for regulatory approval for mRNA-1345, Moderna's investigational RSV vaccine for older adults, in the first half of 2023.”
Source for this version

Commitment DNA

The structured record of this commitment. Fields the company did not state are left blank rather than guessed.

Event type: Regulatory submission
Indicative materiality: High rules
Action: Submit
Deliverable: Biologics License Application for full U.S. licensure
Where: United States
Language: Aspirational (“aims”, “intends”)
In the company’s control: High
Specificity: Medium

How this entry was checked

Commitment recordedThe company's words were matched word for word against the filing.
First checkAn AI model read the company's later filings and recorded the outcome with a quoted passage.

Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. 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Is something here wrong or out of date?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.