Moderna, Inc.: Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2

CAMBRIDGE, MA / ACCESS Newswire / August 27, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19.

The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. mNEXSPIKE, Moderna's new COVID-19 vaccine, is approved for individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. With the U.S. FDA's decision, Moderna's updated vaccines are expected to be available in the coming days.

"Protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health as COVID-19 was responsible for up to 4 million outpatient visits and nearly half of a million hospitalizations last year," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are proud to help ensure Americans will have the latest protection against currently circulating strains this respiratory virus season."

The updated vaccine composition is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be developed with a monovalent JN.1 lineage, with a preference for the LP.8.1 variant.

Moderna's updated COVID-19 vaccines targeting LP.8.1 have already been granted approval by regulators in Canada, Europe, Japan, Switzerland and other countries. Additional regulatory applications are under review around the world in preparation for the coming season.

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.

Spikevax® and mNEXSPIKE®are registered trademarks of Moderna.

What is mNEXSPIKE® (COVID-19 Vaccine, mRNA) AND SPIKEVAX® (COVID-19 Vaccine, mRNA)?

mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who are:

• 65 years of age and older, or

• 12 years through 64 years of age at high risk for severe COVID-19.

SPIKEVAX is a vaccine to protect against COVID-19. SPIKEVAX is for people who are:

• 65 years of age and older, or

• 6 months through 64 years of age at high risk for severe COVID-19.

Vaccination with mNEXSPIKE or SPIKEVAX may not protect all people who receive the vaccine.

IMPORTANT SAFETY INFORMATION

You or your child should not get mNEXSPIKE® or SPIKEVAX® if you had a severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX, any Moderna COVID-19 vaccine, or to any ingredient in these vaccines.

What are the risks of mNEXSPIKE and SPIKEVAX?

There is a very small chance that mNEXSPIKE or SPIKEVAX could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of mNEXSPIKE or SPIKEVAX. 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 can include:

• Trouble breathing

• Swelling of your face and throat

• A fast heartbeat

• A rash all over your body

• Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving mNEXSPIKE or SPIKEVAX, particularly during the 2 weeks after receiving a dose of the vaccine: chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart. Additional symptoms in children may include fainting, irritability, poor feeding, lack of energy, vomiting, pain in the abdomen, or cool, pale skin.

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

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness.

• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever

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

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

• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash, irritability/crying, sleepiness, and loss of appetite.

• Fainting and febrile seizures (convulsions during a fever) have also been reported

Tell your vaccination provider about all of your or your child's medical conditions, including if you or your child:

• have any allergies

• had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine

• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

• 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

• are pregnant or plan to become pregnant

• are breastfeeding

• have received any other COVID-19 vaccine

• have ever fainted in association with an injection

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

Please click for mNEXSPIKE Full Prescribing Information and Information for Recipients and Caregivers.

Please click for SPIKEVAX Full Prescribing Information and Information for Recipients and Caregivers.

Moderna 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: the availability of Moderna's updated COVID vaccines; the efficacy, safety and tolerability of Moderna's COVID vaccines; and Moderna's regulatory applications under review around the world. 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
Head of Global Media Relations
[phone]
[e-mail]

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
[phone]
[e-mail]

SOURCE: Moderna, Inc.

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