The Fort Worth Press - Moderna to Present Revaccination Data for Its Investigational Seasonal Influenza Vaccine and for mRESVIA at ESCMID 2026

Moderna's presentation, "Sequential administration of an mRNA-based seasonal influenza vaccine in older adults," details an exploratory, post-hoc analysis assessing the safety and immunogenicity of mRNA-1010 in adults 50 years and older following prior seasonal influenza vaccination with mRNA-1010 or a licensed egg-based influenza vaccine. The analysis was conducted among participants in the pivotal Phase 3 mRNA-1010 study (P304) who previously participated in another Phase 3 mRNA-1010 study (P302 or P303), in which participants received a single dose of mRNA-1010 or a licensed egg-based comparator. With a median time between vaccination of 23 months, day 29 hemagglutination inhibition geometric mean fold rises for all three WHO-recommended influenza strains (A/H1N1, A/H3N2, B/Victoria) were similar in participants who received mRNA-1010 in P304, regardless of prior study vaccination assignment, and numerically higher compared to participants who received a licensed egg-based comparator in P304. Additionally, there were no increases in solicited adverse reactions or new safety concerns observed with sequential mRNA-1010 vaccination.

mRNA-1010 has been accepted for review in the United States, Europe, Canada and Australia, with further submissions planned in 2026. Moderna expects the first potential approvals for mRNA-1010 in 2026, subject to ongoing regulatory reviews.

Additionally, Moderna's presentation, "Safety and immunogenicity of RSV revaccination with mRNA-1345 after primary vaccination with protein-based vaccine," shares interim results from an ongoing, open-label Phase 3 study that evaluated mRESVIA in adults 60 years and older when given as a heterologous revaccination dose >12 months after primary vaccination with a licensed RSV protein-based vaccine. The mRESVIA revaccination dose was well-tolerated, with no new safety concerns observed. The study builds on similar findings from studies that assessed homologous revaccination with mRESVIA after a primary dose of mRESVIA. Together, these results suggest that revaccination with mRESVIA may restore protection comparable to primary dose levels, regardless of whether mRESVIA or a protein-based vaccine was used for a primary dose.

The details of the presentations are as follows:

• Presentation Title: Safety and immunogenicity of RSV revaccination with mRNA-1345 after primary vaccination with protein-based vaccine
  Session: Late-Breaking Vaccine Trials
  Presenter: Mihir Desai, Director, Clinical Development, Infectious Diseases, RSV Vaccines, Moderna
  Date/Time: Saturday, April 18, 8:30 AM CET
  Location: Hall A3-1

Moderna will present 13 additional scientific presentations at ESCMID 2026, including two other oral presentations, one ePoster/Flash Oral and 10 poster presentations, highlighting the breadth of its research in COVID-19, RSV, seasonal influenza and norovirus. Learn more about Moderna's presence at ESCMID here.

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

About mRESVIA^® (RSV Vaccine, mRNA)

mRESVIA^® is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines.

INDICATION

mRESVIA is a vaccine to protect you against lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV).

mRESVIA is for people 60 years of age and older and also for people 18 through 59 years of age who are at increased risk for RSV (people with medical conditions such as diabetes or with diseases affecting the lungs and heart). Vaccination with mRESVIA may not protect all people who receive the vaccine.

mRESVIA does not contain RSV. mRESVIA cannot give you lower respiratory tract disease caused by RSV.

IMPORTANT SAFETY INFORMATION

Who should not get mRESVIA?

You should not get mRESVIA if you had a severe allergic reaction to any ingredient in mRESVIA.

What should you tell your healthcare provider?

Tell your healthcare provider about all of your medical conditions, including if you:

• Have any allergies

• Had a severe allergic reaction after receiving a previous dose of any other vaccine

• Have a fever

• Have a bleeding disorder or are on a blood thinner

• Are immunocompromised or are on a medicine that affects your immune system

• Have received any other RSV vaccine

• Have ever fainted in association with an injection

How is mRESVIA given?

mRESVIA is given as an injection into the muscle.

What are the risks of mRESVIA?

There is a very small chance that mRESVIA could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of mRESVIA. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction may include:

• Trouble breathing

• Swelling of your face and throat

• A fast heartbeat

• A rash all over your body

• Dizziness and weakness

Side effects that have been reported in clinical trials with mRESVIA include:

• Injection-site reactions: pain, underarm swelling or tenderness in the same arm of the injection, swelling (hardness), and redness

• Fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, fever and hives

These may not be all of the possible side effects of mRESVIA. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov.

Please click for mRESVIA Full Prescribing Information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's pending regulatory submissions for mRNA-1010 in various jurisdictions; Moderna's regulatory submissions in additional countries planned for 2026; timing for the first potential approvals for mRNA-1010 in 2026, subject to regulatory reviews; the safety and immunogenicity of mRNA-1010; and the potential for revaccination with mRESVIA to restore protection comparable to primary dose levels. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:

Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
[email protected]

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

B.Martinez--TFWP