UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 3, 2026

MODERNA, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38753

81-3467528

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)


325 Binney Street
Cambridge, MA						02142
(Address of principal executive offices)						(Zip code)

Registrant’s telephone number, including area code: (617) 714-6500

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common stock, par value $0.0001 per share

MRNA

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On February 10, 2026, Moderna, Inc. (the “Company”) issued a press release regarding the receipt of a Refusal-to-File letter from the U.S. Food and Drug Administration (the “FDA”) for its investigational seasonal influenza vaccine, mRNA-1010. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Item 7.01, as well as Exhibit 99.1, to this Current Report on Form 8-K is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On February 3, 2026, the FDA's Center for Biologics Evaluation and Research (“CBER”) notified the Company that it will not initiate a review of the biologics license application (“BLA”) for the Company's investigational influenza vaccine, mRNA-1010, and has issued a Refusal-to-File letter.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.


Exhibit
No.						Description
99.1						Press release issued by Moderna, Inc. dated February 10 , 2026
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Date: February 10, 2026		MODERNA, INC.

	By:	/s/ Shannon Thyme Klinger
		Shannon Thyme Klinger
		Chief Legal Officer

Moderna, Inc. 8-K