# EDGAR Filing Document

**Accession Number:** 0001836564
**File Stem:** 0001628280-26-004814
**Filing Date:** 2026-2
**Character Count:** 13590
**Document Hash:** 7619cda998dd81a1fe98b501af4c7094
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628280-26-004814.hdr.sgml**: 20260203

**ACCESSION NUMBER**: 0001628280-26-004814

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 2

**CONFORMED PERIOD OF REPORT**: 20261231

**FILED AS OF DATE**: 20260203

**DATE AS OF CHANGE**: 20260203

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Valneva SE
- **CENTRAL INDEX KEY:** 0001836564
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** I0
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40377
- **FILM NUMBER:** 26590337

**BUSINESS ADDRESS:**
- **STREET 1:** 6, RUE ALAIN BOMBARD
- **CITY:** SAINT-HERBLAIN
- **STATE:** I0
- **ZIP:** 44800
- **BUSINESS PHONE:** 33 2 28 07 37 10

**MAIL ADDRESS:**
- **STREET 1:** 6, RUE ALAIN BOMBARD
- **CITY:** SAINT-HERBLAIN
- **STATE:** I0
- **ZIP:** 44800

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 6-K**

**REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE** 

**SECURITIES EXCHANGE ACT OF 1934**

**Date of Report: February 3, 2026**

Commission File Number: **001-40377**

 **Valneva SE**

(Translation of registrant's name into English)

**Îlot Saint-Joseph, Bureaux Convergence**

**12ter Quai Perrache**

**69002 Lyon, France**

**(Address of principal executive office)**

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

On February 3, 2026, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1. The information contained in this Form 6-K is hereby incorporated by reference into the registrant's registration Statement on Form F-3 (File No. 333-268071).

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| | |
|:---|:---|
| **<u>Exhibit</u>** | |
| &nbsp;&nbsp;Exhibit 99.1 | &nbsp;&nbsp;<u>[Press release dated February 3, 2026](a2026_02x03xvlaxbutantanxp.htm)</u> |

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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, thereunto duly authorized.

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| | |
|:---|:---|
| | **<u>Valneva SE</u>** (Registrant) |
| Date: February 3, 2026 | <u>/s/ Thomas Lingelbach</u>  |
| | Thomas Lingelbach |
| | Chief Executive Officer and President |

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## Exhibit 99.1

**Valneva and Instituto Butantan Announce Initiation of a Pilot Vaccination Campaign in Brazil with Single-Shot Chikungunya Vaccine IXCHIQ**<sup>®</sup>

**Lyon (France), Sao Paulo, (Brazil), February 3, 2026** –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company and Instituto Butantan, one of the world's largest biomedical research centers, today announced the initiation of a Pilot Vaccination Strategy (PVS) in Brazil using Valneva's single-shot chikungunya vaccine, IXCHIQ<sup>®</sup>. The pilot vaccination program will serve as the basis for post-marketing commitment studies evaluating the effectiveness and safety of IXCHIQ<sup>®</sup> in a real-world setting and generating real-world evidence in a large population.

The PVS, agreed between the Brazilian Ministry of Health (MoH) and Instituto Butantan, will be implemented in ten Brazilian municipalities strategically selected based on epidemiological and operational criteria in support of the PVS. In line with the current IXCHIQ<sup>®</sup> label in Brazil, adults aged 18 to 59 years will be invited to participate, with the objective of achieving 20% to 40% vaccine coverage within the target population. Valneva, through its partner Instituto Butantan, will donate up to 500,000 doses of IXCHIQ<sup>®</sup> to the Brazilian MoH, for use in the program. IXCHIQ<sup>®</sup> was granted marketing approval in Brazil in individuals 18 years of age and older by the Brazilian Health Regulatory Agency (ANVISA) in April 2025<sup>1</sup>, marking the world's first approval of a chikungunya vaccine in an endemic country.

**Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva**, said, "Contributing to this large-scale pilot vaccination strategy underscores our continued commitment to supporting global preparedness against the growing threat of chikungunya. With IXCHIQ<sup>®</sup> already available in several markets, generating robust real-world data in regions with active CHIKV transmission remains critical. This program is expected to provide additional evidence of the vaccine's performance and further reinforce its public health value."

**Esper Kallas M.D., Ph.D., Director, Instituto Butantan,** outlined the path towards the PVS, stating: "This program stems from a deeply rigorous scientific collaboration between Valneva, Instituto Butantan, and leading arbovirus experts. Through continuous engagement with the Ministry of Health, regional health secretaries, and ANVISA, I am confident that we have built a program that is both robust and regulatory-compliant. These combined efforts are expected to enable timely access to vaccination and reduce the significant public health burden posed by this arboviral disease."

The World Health Organization has called for urgent action to prevent a potential major chikungunya epidemic from sweeping the globe<sup>2</sup>. So far, Brazil has reported the highest number of chikungunya cases worldwide, with over one million cases between January 2019 and July 2024<sup>3</sup>, including 263,502 cases in 2024 alone, which resulted in 246 deaths<sup>4</sup>.

<sup>1</sup> *2025_04_14_ANVISA_Approval_PR_EN_Final.pdf*

<sup>2</sup> *Outbreak of Chikungunya Virus Poses Global Risk, Warns WHO : ScienceAlert*

<sup>3</sup> https://bluedot.global/vaccines-on-the-table-as-chikungunya-outbreak-intensifies-in-india/

<sup>4</sup> *Source: Brazilian Ministry of Health*

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Valneva and Instituto Butantan signed an agreement in January 2021<sup>5</sup> for the technology transfer of Valneva's chikungunya vaccine to Instituto Butantan, which will develop, manufacture and commercialize the vaccine in Latin America. This collaboration falls within the framework of the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union<sup>6</sup>.

**About Chikungunya**

Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years<sup>7</sup>. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas3. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas<sup>8</sup> and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem<sup>9</sup>.

**About Valneva SE**

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com.

**About Instituto Butantan** 

Instituto Butantan is the main producer of immunobiological products and vaccines in Brazil. Instituto Butantan carries out scientific missions domestically and abroad through the Pan American Health Organization, the World Health Organization, UNICEF and the United Nations. The Institute collaborates with other agencies of the São Paulo State Secretariat of Health and the Brazilian Ministry of Health for the improvement of overall health in Brazil. It acts in partnership with various universities and entities such as the Bill & Melinda Gates Foundation for the achievement of its institutional objectives. For more information please visit

<sup>5</sup> *Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries - Valneva*

<sup>6</sup> *CEPI awards up to US$23.4 million to Valneva for late-stage development of a single-dose chikungunya vaccine*

<sup>7</sup> Reemergence of Chikungunya Virus

<sup>8</sup> Vaccine and Therapeutic Options To Control Chikungunya Virus

<sup>9</sup> Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)

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the Institute website at www.butantan.gov.br or contact the press office at (+55 11) 2627-9606 / 9428 or email to imprensa@butantan.gov.br

**About CEPI**

CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organizations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic disease threats and enable equitable access to them. CEPI has supported the development of more than 70 vaccine candidates or platform technologies against multiple known high-risk pathogens and is advancing the development of rapid response platforms for vaccines against a future Disease X. Central to CEPI's pandemic-beating five-year plan for 2022-2026 is the '100 Days Mission' to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.

**About Horizon Europe**

Horizon Europe — #HorizonEU — is the European Union's flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95.5 billion to spend over a seven-year period (2021-2027). Under Horizon Europe, health research will be supported with the aim of finding new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalized medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones.

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| | |
|:---|:---|
| **Valneva Investor and Media Contacts**<br>Laetitia Bachelot-Fontaine<br>VP Global Communications & European Investor Relations<br>M +33 (0)6 4516 7099<br>laetitia.bachelot-fontaine@valneva.com&nbsp;&nbsp;&nbsp;&nbsp; | <br>Joshua Drumm, Ph.D.<br>VP Global Investor Relations<br>M +001 917 815 4520<br>joshua.drumm@valneva.com |

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**Forward-Looking Statements**

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results or new adverse events, unexpected regulatory actions or

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delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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