# EDGAR Filing Document

**Accession Number:** 0001000694
**File Stem:** 0001104659-25-084049
**Filing Date:** 2025-8
**Character Count:** 20450
**Document Hash:** 7c37af1d53c2bd626b53e109e99c824f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-084049.hdr.sgml**: 20250827

**ACCESSION NUMBER**: 0001104659-25-084049

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250827

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250827

**DATE AS OF CHANGE**: 20250827

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** NOVAVAX INC
- **CENTRAL INDEX KEY:** 0001000694
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 222816046
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-26770
- **FILM NUMBER:** 251265852

**BUSINESS ADDRESS:**
- **STREET 1:** 700 QUINCE ORCHARD ROAD
- **CITY:** GAITHERSBURG
- **STATE:** MD
- **ZIP:** 20878
- **BUSINESS PHONE:** 240-268-2000

**MAIL ADDRESS:**
- **STREET 1:** 700 QUINCE ORCHARD ROAD
- **CITY:** GAITHERSBURG
- **STATE:** MD
- **ZIP:** 20878

?xml version='1.0' encoding='ASCII'?

**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549**

**FORM 8-K**

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**CURRENT REPORT** 

**PURSUANT TO SECTION 13 OR 15(d)**

**OF THE SECURITIES EXCHANGE ACT OF 1934** 

**Date of Report (Date of earliest event reported): August 27, 2025**

**NOVAVAX, INC.**

**(Exact name of registrant as specified in charter)** 

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| | | |
|:---|:---|:---|
| **Delaware** | **0-26770** | **22-2816046** |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

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**700 Quince Orchard Road**

**Gaithersburg, Maryland 20878**

**(Address of Principal Executive Offices, including Zip Code)** 

**(240) 268-2000**

**(Registrant's telephone number, including area code)** 

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

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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 (see General Instruction A.2. below):

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| |
|:---|
| 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)) |

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

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**Title of each class** | &nbsp;&nbsp;**Trading <br> Symbol(s)** | &nbsp;&nbsp;**Name of each exchange on which <br> registered** |
| &nbsp;&nbsp;Common Stock, Par Value $0.01 per share | &nbsp;&nbsp;NVAX | &nbsp;&nbsp;The Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 Information.**

On August 27, 2025, Novavax, Inc. ("Novavax" or the "Company") issued a press release announcing the information discussed under Item 8.01 hereof. 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 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

**Item 8.01. Other Events.**

On August 27, 2025 the Company announced that the U.S. Food and Drug Administration ("FDA") approved the supplemental Biologics License Application ("BLA") for the Nuvaxovid<sup>™</sup> 2025-2026 formula for the prevention of COVID-19 in adults 65 years and older or individuals 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The FDA also approved the extension of the shelf life of the Nuvaxovid<sup>™</sup> 2025-2026 formula from three months to six months.

In connection with the approval of the supplemental BLA, the FDA is requiring two studies as postmarketing commitments ("PMCs"): (i) to conduct a Phase 3 open-label, single-arm study to evaluate safety and immunogenicity, and (ii) to conduct a Phase 4 observer-blind, placebo-controlled, randomized clinical trial to evaluate post-COVID vaccination syndrome.

**Cautionary Note Regarding Forward-Looking Statements.**

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Any statements in the discussion below and elsewhere in this Current Report about expectations, beliefs, plans, objectives, assumptions, or future events or performance of the Company are not historical facts and are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the efficacy, safety and intended utilization of the Company's COVID-19 vaccine for the 2025-2025 vaccination season . Generally, forward-looking statements can be identified through the use of words or phrases such as "believe," "may," "could," "will," "would," "possible," "can," "estimate," "continue," "ongoing," "consider," "anticipate," "intend," "seek," "plan," "project," "expect," "should," "would," "aim," or "assume," the negative of these terms, or other comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Novavax's current beliefs and expectations about the future of our business, events and trends, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, challenges or delays related to the requested PMC or in obtaining further regulatory authorization for its COVID-19 vaccine; antigenic drift or shift in the SARS-CoV-2 spike protein, challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for a JN.1 protein-based COVID-19 vaccine or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and other risks and uncertainties identified in Part I, Item 1A "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission ("SEC") on February 27, 2025, as updated by the information in Part II, Item 1A "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, which may be further detailed and modified or updated in other documents we file with the SEC from time to time, and are available at www.sec.gov and at www.novavax.com. You are encouraged to read these filings as they are made.

Novavax cannot guarantee future results, events, level of activity, performance, or achievement. Any or all of Novavax's forward-looking statements in this Current Report on Form 8-K may turn out to be inaccurate or materially different from actual results. Further, any forward-looking statement speaks only as of the date when it is made, and Novavax undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. New factors emerge from time to time, and it is not possible for Novavax to predict which factors will arise. In addition, Novavax cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

**Item 9.01. Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm2524511d2_ex99-1.htm) | [Press release, Dated August 27, 2025](tm2524511d2_ex99-1.htm) |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL). |

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**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.

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| | | |
|:---|:---|:---|
|  | Novavax, Inc. | Novavax, Inc. |
| Date: August 27, 2025 | By: | /s/ Mark J. Casey |
|  | Name: | Mark J. Casey |
|  | Title: | Executive Vice President, Chief Legal Officer and Corporate Secretary |

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## Exhibit 99.1

**Exhibit 99.1**

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| | |
|:---|:---|
| **Press Release** | ![](tm2524511d2_ex99-1img001.jpg) |

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**Novavax's Nuvaxovid™ 2025-2026 Formula COVID-19 Vaccine Approved in the U.S.**

&nbsp;&nbsp;&nbsp;&nbsp;· *Nuvaxovid™ is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season* 

**GAITHERSBURG, Md., August 27, 2025 –** Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration has approved the Nuvaxovid<sup>™</sup> 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

"With today's approval, we will work with our partner Sanofi to provide access to a protein-based, non-mRNA COVID-19 vaccine for eligible individuals this fall," said John C. Jacobs, President and Chief Executive Officer, Novavax.

Clinical and preclinical data have previously shown that Nuvaxovid is safe and effective for the prevention of COVID-19.<sup>1,2</sup> Both clinical and preclinical data from Nuvaxovid confirm that the JN.1 strain vaccination induces immunity across currently circulating JN.1 lineage strains, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7 and XEC. As of July 2025, the vast majority of COVID-19 infections globally are caused by variants within the JN.1 strain.<sup>3</sup>

Sanofi is leading commercialization efforts for Nuvaxovid and Novavax is eligible to receive ongoing tiered royalties from sales of the vaccine.

**VACCINE AUTHORIZATION (U.S.)**

Nuvaxovid is a vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

**IMPORTANT SAFETY INFORMATION**

**Contraindications**

&nbsp;&nbsp;&nbsp;&nbsp;· Do not administer Nuvaxovid to individuals with
a known history of severe allergic reaction (e.g., anaphylaxis) to any component of Nuvaxovid or to individuals who had a severe allergic
reaction (e.g., anaphylaxis) following a previous dose of Novavax COVID-19 Vaccine, Adjuvanted *.* 

**Warnings and Precautions**

&nbsp;&nbsp;&nbsp;&nbsp;· **Management of Acute Allergic Reactions:** Appropriate
medical treatment must be immediately available to manage potential anaphylactic reactions following administration of Nuvaxovid.

&nbsp;&nbsp;&nbsp;&nbsp;· **Myocarditis and Pericarditis**: Clinical
trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Nuvaxovid. There have been
post-marketing reports of myocarditis and pericarditis following administration of Nuvaxovid. The Centers for Disease Control and Prevention
has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with
a history of myocarditis or pericarditis(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

&nbsp;&nbsp;&nbsp;&nbsp;· **Syncope (fainting):** Syncope (fainting)
may occur in association with administration of injectable vaccines, including Nuvaxovid. Procedures should be in place to avoid injury
from fainting.

&nbsp;&nbsp;&nbsp;&nbsp;· **Altered Immunocompetence:** Immunocompromised
persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to Nuvaxovid.

&nbsp;&nbsp;&nbsp;&nbsp;· **Limitations of Vaccine Effectiveness:** Nuvaxovid
may not protect all vaccine recipients.

**Adverse Reactions**

The most commonly reported (>10%) solicited adverse reactions were injection site tenderness, injection site pain, injection site redness, headache, muscle pain, fatigue, malaise, joint pain, fever and nausea/vomiting.

*To report suspected adverse reactions, contact Novavax, Inc. at 1-844-668-2829 or the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or <u>https://vaers.hhs.gov</u>.*

**About Nuvaxovid**<sup>™</sup>

Nuvaxovid is formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M<sup>®</sup> adjuvant enhances and broadens the immune response. The vaccine is packaged in pre-filled syringes and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.

**About Matrix-M<sup>®</sup> Adjuvant**

Matrix-M is Novavax's proprietary adjuvant that can be added to a vaccine or medicine to stimulate a stronger immune response and is currently used in globally approved vaccines. It is clinically proven to induce potent, durable and broad immune responses with an acceptable safety and tolerability profile and allows use of a lower dose of antigen that is still effective.<sup>4</sup> Matrix-M is sustainably harvested and manufactured and has the potential to enhance existing and new vaccines. When combined with the Company's recombinant, protein-based nanoparticles, this technology platform is the basis of Novavax's expanding pipeline.

**About Novavax**

Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit <u>novavax.com</u> and <u>LinkedIn</u> for more information.

**Forward-Looking Statements**

Statements herein relating to the future of Novavax, its operating plans and prospects, the efficacy, safety and intended utilization of Novavax's COVID-19 vaccine, the possible receipt of tiered royalties from vaccine sales the immunogenic response of its vaccine technology against variant strains and the scope, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges or delays related to the requested postmarketing commitment; antigenic drift or shift in the SARS-CoV-2 spike protein, challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for a JN.1 protein-based COVID-19 vaccine or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by the information identified in the "Risk Factors" section in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at <u>www.sec.gov</u> and <u>www.novavax.com</u>, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors and others should give careful consideration to these risks and uncertainties.

**Contacts:**

<u>Investors</u>

Luis Sanay, CFA

240-268-2022

<u>ir@novavax.com</u>

<u>Media</u>

Giovanna Chandler

(844) 264-8571

<u>media@novavax.com</u>

**References**

&nbsp;&nbsp;&nbsp;&nbsp;1. Dunkle LM. et al; 2019nCoV-301 Study Group. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. *New England Journal of Medicine.* 2022;386(6):531-543. doi:10.1056/NEJMoa2116185.

&nbsp;&nbsp;&nbsp;&nbsp;**2.** Áñez G. et al. Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents: A Randomized
Clinical Trial. *JAMA Netw Open*. 2023;6(4):e239135. doi:10.1001/jamanetworkopen.2023.9135.

&nbsp;&nbsp;&nbsp;&nbsp;3. World Health Organization. COVID-19
 – Global Situation: <u>https://www.who.int/emergencies/disease-outbreak-news/item/2025-DON572</u> Accessed online July 15, 2025.

&nbsp;&nbsp;&nbsp;&nbsp;4. Stertman L. et al.; The Matrix-M™ adjuvant: A critical component of vaccines for the 21st century. *Hum Vaccin Immunother.* 2023 Dec 31;19(1):2189885. doi: 10.1080/21645515.2023.2189885.