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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 . 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 . 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. View the original press release on ACCESS Newswire

While mRNA may be back in the headlines courtesy of Moderna and Merck & Co.'s phase 3 cancer vaccine success, new research coming out of the University of Toronto has shown that its cousin, transfer RNA (tRNA), may offer a promising therapeutic avenue for treating genetic diseases. In a study published Aug. 27 in Science , researchers who delivered inhalable modified tRNA to mice with nonsense mutation-driven cystic fibrosis noted that the therapy was safe, reached the lungs, remained there for up to 40 days and restored mutated protein function. They also tested the efficiency of the modified tRNA against Vertex Pharmaceuticals' FDA-approved cystic fibrosis drug Trikafta in an organoid model using cells from cystic fibrosis patients. The researchers observed that treating the cells with Trikafta alone was not enough to restore protein function, and only when the cells were treated with both Trikafta and the modified tRNA was this goal achieved. The team is now working to take their inhalable tRNA into the clinic in the “next two or three years,” Bowen Li, Ph.D., associate professor at the University of Toronto’s Leslie Dan Faculty of Pharmacy, told Fierce. “We are testing it in other disease contexts, like [Duchenne muscular dystrophy] and Rett syndrome, which lacks therapeutic options at the moment,” explained Li, who is a corresponding author of the study. In cells, messenger RNA (mRNA) provides the message for a protein to be made. This message is then read, or translated, by tRNA. A type of mutation, called nonsense mutations, can arise during this translation process if a premature stop codon is introduced in the mRNA. As a result, the cell is left with no expression of that protein or a truncated protein, which can lead to disease. For example, nonsense mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene is one of the causes of the inherited genetic disorder. It causes the body to produce thick mucus and liquids that can clog up organs such as the lungs and pancreas. Li and his team sought out a way to leverage the biological reading power of tRNA to overcome the premature stop codon in cystic fibrosis. “We were able to engineer the tRNA to make sure the tRNA can still read through this premature termination codon, even though the nonsense mutation happened inside of the mRNA,” Li told Fierce. “The tRNA can bring in amino acids to fill the hole and make sure that protein translation can still be normal.” The field of tRNA therapies still has a long way to go to catch up with the mRNA space, which experienced global success thanks to COVID-19 vaccines from Pfizer-BioNTech and as well as Moderna. Interest in mRNA was reinvigorated last week when Moderna and its partner Merck announced that their personalized mRNA cancer vaccine had successfully lengthened recurrence-free survival when paired with Keytruda in a phase 3 study of patients with high-risk skin cancer. Yet tRNA does boast some attributes that give it an advantage over mRNA. While mRNA is very transient, Li and his team found evidence of tRNA in key epithelial cells of the lungs, which are affected in cystic fibrosis, for up to 40 days after inhalation. Additionally, mRNA therapies can carry a risk that the modified mRNA given to the cell can cause the protein target to be translated differently, Li explained. In contrast, the modified tRNA used in this study didn't introduce a foreign protein—instead it boosts the endogenous tRNA to work through the stop codon on the endogenous mRNA. In diseases where the protein mutation is quite large, such as Duchenne muscular dystrophy, it is difficult to have high efficiency if leveraging mRNA to deliver the protein because of the size. With tRNA, the size of the protein deficiency is not a problem, because the size of the tRNA will not change, Li pointed out. “We are quickly expanding the application of the tRNA—not only limited to lung disease, but also liver disease, muscle disease and some CNS diseases such as autism,” he added.