Moderna Files FDA Application for the LP.8.1 Targeting COVID-19 Vaccine

Rhea-AI Summary

Moderna (NASDAQ:MRNA) has submitted an FDA application for its updated Spikevax 2025-2026 formula, specifically designed to target the SARS-CoV-2 LP.8.1 variant. The submission aligns with FDA guidance recommending COVID-19 vaccines be updated to a monovalent JN.1 lineage, with preference for the LP.8.1 variant.

Positive

• FDA application submitted for updated COVID-19 vaccine formula
• Alignment with FDA's recommended guidance for vaccine updates

Negative

• None.

CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1. The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 lineage, with a preference for the LP.8.1 variant.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.


Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives 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 (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

AUTHORIZED USE IN THE U.S.

INDICATION (U.S.)

SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications

• Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX.

Warnings and Precautions

• Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of SPIKEVAX.

• Myocarditis and Pericarditis: Post marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 years through 24 years of age.

• Syncope (fainting): May occur in association with administration of injectable vaccines, including SPIKEVAX. Procedures should be in place to avoid injury from fainting.

• Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to SPIKEVAX.

• Limitations of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients.

Adverse Reactions

The most commonly reported (≥10%) adverse reactions following any dose in any indicated patient population were pain at the injection site, headache, fatigue, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, swelling at the injection site, erythema at the injection site, and fever.

Reporting Adverse Events and Vaccine Administration Errors

The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.

Please see the SPIKEVAX Full Prescribing Information.

Please see the Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine for more 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 regulatory submission to the U.S. FDA for its Spikevax 2025-2026 formula, including the potential for approval in the U.S. 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, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, 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
Global Head of Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

What is Moderna's new COVID-19 vaccine application for?

Moderna has applied for FDA review of its Spikevax 2025-2026 formula, specifically targeting the SARS-CoV-2 LP.8.1 variant.

When did Moderna (MRNA) submit its FDA application for the LP.8.1 vaccine?

Moderna submitted the FDA application on May 23, 2025.

Which COVID-19 variant does Moderna's new vaccine target?

The new vaccine targets the LP.8.1 variant, which is part of the JN.1 lineage as recommended by the FDA.

Why is Moderna updating its COVID-19 vaccine to target LP.8.1?

The update follows FDA guidance recommending COVID-19 vaccines be updated to a monovalent JN.1 lineage, with preference for the LP.8.1 variant.