Preliminary analysis showed the 2025-2026 formula of Spikevax generated greater than an 8-fold increase in LP.8.1-neutralizing antibodies across age groups

Clinical findings reinforce preclinical data supporting recent FDA approval of 2025-2026 formula of Spikevax

CAMBRIDGE, MA / ACCESS Newswire / September 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax®, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The data from an ongoing Phase 4 clinical trial evaluating the safety, tolerability and immunogenicity of the 2025-2026 formula of Spikevax showed, on average, greater than an 8-fold increase in neutralizing antibodies against the LP.8.1 variant in 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. The safety profile of the vaccine was consistent with previous studies, with no new safety concerns identified.

Recent surveillance data from the U.S. Centers for Disease Control and Prevention (CDC) shows the U.S. wastewater viral activity for COVID-19 is high, and LP.8.1 and its familial strains, XFG and NB.1.8.1, continue to dominate. [1],[2] This preliminary analysis confirms Moderna's updated COVID-19 vaccine is a strong match to today's top circulating strains in the U.S.

These clinical findings also reinforce preclinical data that supported the recent U.S. Food and Drug Administration (FDA) approval of the 2025-2026 formula of Spikevax, which is approved by the FDA 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. Spikevax has also been granted approval by regulators in Canada, Europe, Japan, Mexico, Switzerland and more.

About ModernaModerna 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® is a registered trademark of Moderna.

What is SPIKEVAX® (COVID-19 Vaccine, mRNA)?SPIKEVAX is a vaccine to protect you 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 SPIKEVAX may not protect all people who receive the vaccine.

IMPORTANT SAFETY INFORMATION

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

What are the risks of SPIKEVAX?There is a very small chance that 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 SPIKEVAX. For this reason, the healthcare provider may ask you or your child to stay for a short time at the place where you or your child 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 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.

Other side effects that have been reported 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) were also reported

Tell the healthcare 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 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 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 SPIKEVAX Full Prescribing Information and Information for Recipients and Caregivers.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the ability of Moderna's COVID vaccines to trigger an immune response and to protect against circulating SARS-CoV-2 variants; and the safety of Moderna's COVID vaccines. 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 ContactsMedia:Chris RidleyHead of Global Media Relations+1 617-800-3651Chris.Ridley@modernatx.com

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

[1] https://www.cdc.gov/nwss/index.html

[2] https://www.cdc.gov/covid/php/variants/variants-and-genomic-surveillance.html

SOURCE: Moderna, Inc.

COMTEX_468810210/2457/2025-09-16T06:12:04