Moderna Receives U.S. FDA Approval for Updated 2026-2027 COVID-19 Vaccines
Rhea-AI Summary
Moderna (NASDAQ:MRNA) announced U.S. FDA approval of supplemental Biologics License Applications for its 2026-2027 formulas of Spikevax and mNEXSPIKE COVID-19 vaccines, updated to a monovalent JN.1-lineage XFG subvariant composition. According to Moderna, the updated Spikevax is approved for adults 65+ and for individuals 6 months through 64 years at high risk for severe COVID-19. mNEXSPIKE is approved for adults 65+ and for those 12 through 64 years at high risk.
Moderna said the updated vaccines are expected to be available in the U.S. in the coming days and that Spikevax’s 2026-2027 formula has already received approvals in Europe, South Korea, Singapore, Switzerland, the UK and other countries, while mNEXSPIKE has been approved in Japan, with additional regulatory reviews ongoing globally.
Positive
- U.S. FDA approval for 2026-2027 Spikevax and mNEXSPIKE formulas targeting JN.1-lineage XFG
- Broad U.S. label covering adults 65+ and high-risk groups from 6 months or 12 years
- International regulatory approvals for 2026-2027 Spikevax in Europe and multiple Asian markets
- mNEXSPIKE 2026-2027 approval already granted by regulators in Japan
- Near-term U.S. availability with updated vaccines expected in the coming days
Negative
- mNEXSPIKE and Spikevax carry a risk of severe allergic reactions, including anaphylaxis
- Myocarditis and pericarditis have occurred after mRNA COVID-19 vaccines, especially in males 12–24
- Reported systemic side effects such as fatigue, headache, muscle and joint pain, chills, nausea, vomiting and fever may affect tolerability and uptake
Key Figures
Previous Fda approval,covid-19 Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 27 | COVID vaccine approval | Positive | +1.5% | FDA approved updated Spikevax and mNEXSPIKE formulas targeting the LP.8.1 variant. |
| May 31 | COVID vaccine approval | Positive | +1.8% | FDA approved mNEXSPIKE for older and high-risk individuals. |
| May 23 | COVID vaccine filing | Positive | +1.9% | Moderna filed an FDA application for the LP.8.1-targeting COVID-19 vaccine. |
| Sep 02 | COVID vaccine approval | Positive | -5.8% | Taiwan approved an updated Spikevax formulation targeting the JN.1 variant. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
The tag-specific record showed three positive reactions and one negative reaction to comparable COVID-19 regulatory news.
Key Terms
monovalent medical
sars-cov-2 medical
myocarditis medical
pericarditis medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
CAMBRIDGE, MA / ACCESS Newswire / August 27, 2026 / 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 2026-2027 formulas for Spikevax® (COVID-19 Vaccine, mRNA) and mNEXSPIKE® (COVID-19 Vaccine, mRNA), containing the JN.1-lineage XFG subvariant 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 placing them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. mNEXSPIKE, Moderna's latest 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.
"COVID-19 remains a serious public health threat, responsible for up to 2.3 million outpatient visits and 250,000 hospitalizations in the U.S. last year alone," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our updated COVID-19 vaccines help protect those at high risk of severe disease, and we are proud to help ensure Americans have access to the latest protection against currently circulating SARS-CoV-2 strains this respiratory virus season."
The updated vaccine composition is based on guidance from the U.S. FDA, which states that COVID-19 vaccines should be developed with a monovalent JN.1 lineage XFG subvariant composition. Following the U.S. FDA's decision, Moderna's updated vaccines are expected to be available in the coming days.
The 2026-2027 formula for Spikevax has already been granted approval by regulators in Europe, South Korea, Singapore, Switzerland, the United Kingdom and other countries. The 2026-2027 formula for mNEXSPIKE has also been granted approval by regulators in Japan. Additional regulatory applications are under review around the world in preparation for the coming season.
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.
mNEXSPIKE® and Spikevax® are registered trademarks of Moderna.
INDICATION
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; and Moderna's pending regulatory applications. 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
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.
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