Author: Moderna, Inc.

  • Moderna Announces Phase 3 Study of Investigational Cytomegalovirus (CMV) Vaccine Did Not Meet Primary Efficacy Endpoint

    Company to discontinue development of mRNA-1647 in congenital CMV

    Company will continue to evaluate mRNA-1647 in ongoing Phase 2 trial in bone marrow transplant patients

    Company does not anticipate any impact to its 2025 financial guidance or its expectation of achieving breakeven in 2028

    CAMBRIDGE, MA / ACCESS Newswire / October 22, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced topline results from a Phase 3 pivotal trial evaluating the efficacy of mRNA-1647, the Company’s investigational cytomegalovirus (CMV) vaccine. The study did not meet its primary efficacy endpoint of preventing CMV infection in seronegative female participants of childbearing age (16-40 years of age). Moderna will discontinue its congenital CMV clinical development program.

    “Today’s announcement is disappointing for families and healthcare professionals who have been eagerly awaiting a CMV vaccine to prevent congenital CMV, a leading infectious cause of birth defects,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The majority of the data from this trial is still forthcoming, and we will share our full results with the scientific community in hopes that our learnings can contribute to the continued pursuit of a CMV vaccine. I am grateful for our dedicated team, our partners at clinical trial sites, and all the trial participants who made this research possible.”

    The Phase 3 trial (NCT05085366) was a randomized, observer-blind, placebo-controlled study. The study included approximately 7,500 women 16-40 years of age from approximately 300 sites across 13 countries, representing the largest trial assessing the efficacy of a CMV vaccine to-date. Vaccine efficacy against primary CMV infection in healthy women was well below the Company’s target, ranging from 6% to 23% depending on the case definition used.

    “We are clearly disappointed by the failure to prevent primary infection because it means there is still no vaccine for the prevention of congenital CMV despite the many decades of work by the field,” said Stephen Hoge, MD, President of Moderna. “CMV does cause significant disease in other contexts, including reactivation of the latent virus in those undergoing bone marrow transplantation, and we will continue to explore the potential of mRNA-1647 to suppress disease associated with reactivation in those high-risk patients through our ongoing Phase 2 study.”

    mRNA-1647 was found to be generally well-tolerated regardless of CMV serostatus, with a safety profile consistent with earlier studies. No safety concerns have been raised by the Data and Safety Monitoring Board. The Company plans to continue its study of mRNA-1647 in bone marrow transplant patients, which is currently in a Phase 2 trial (NCT05683457).

    Moderna does not anticipate any impact to its 2025 financial guidance or its expectation of achieving breakeven in 2028. Moderna anticipated minimal initial revenue contribution from mRNA-1647 given necessary investments in market building and launch, and expected the product to be cash-flow negative in 2028.

    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 pioneering work on 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.

    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 2025 financial guidance and its expectation of achieving breakeven in 2028; and the potential of mRNA-1647 for bone marrow transplant patients and Moderna’s ongoing Phase 2 trial. 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
    +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

  • Moderna to Report Third Quarter 2025 Financial Results on Thursday, November 6, 2025

    CAMBRIDGE, MA / ACCESS Newswire / October 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, November 6, 2025 to report its third quarter 2025 financial results, and provide a corporate update.

    A live webcast of the call will be available under “Events and Presentations” in the Investors section of the Moderna website.

    The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

    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.

    Media Contacts

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

    SOURCE: Moderna, Inc.

    View the original press release on ACCESS Newswire

  • Moderna Presents Promising Early Data for Its Investigational Cancer Antigen Therapy at the 2025 European Society for Medical Oncology Congress

    mRNA-4359 has advanced into the Phase 2 portion of the ongoing Phase 1/2 trial

    CAMBRIDGE, MA / ACCESS Newswire / October 12, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that clinical, safety and translational data from its Phase 1/2 study evaluating mRNA-4359 in combination with pembrolizumab in checkpoint inhibitor-resistant/refractory(CPI-R/R) melanoma patients will be presented at the 2025 European Society for Medical Oncology (ESMO) Congress, October 17-21, 2025, in Berlin, Germany. mRNA-4359 is an investigational immune-evasion targeted cancer antigen therapy (CAT) that encodes epitopes of two common immune escape pathways, PD-L1 and IDO1, to elicit antigen-specific T cell responses that may directly kill tumor cells and deplete tumor suppressor cells.

    The presentation includes data from 29 participants with CPI-R/R melanoma who have had ≥1 prior checkpoint inhibitor (CPI) therapy. Participants received the combination therapy at 400 µg (n=14) or 1,000 µg (n=15), given intramuscularly every three weeks for up to nine doses. Across all evaluable patients, the objective response rate (ORR) was 24% and disease control rate (DCR), or the combination of patients achieving tumor response and stable disease, was 60%. Among those with response-evaluable disease and PD-L1+ (TPS≥1%) tumors, the ORR was 67% (6 of 9 participants), with treatment successfully inducing peripheral antigen-specific T cell responses and novel T cell receptor clones. The median duration of response (DOR) was not reached. The improved efficacy in PD-L1+ patients supports PD-L1 as a potential predictive biomarker in this high unmet need population.

    “While early, today’s mRNA-4359 melanoma data in highly CPI-refractory metastatic patients are unique in the field and incredibly promising for future development options. We are encouraged by its potential to address such a high unmet need for many patients,” said Dr. Kyle Holen, Head of Development, Therapeutics and Oncology, Moderna. “Where other checkpoint inhibitors restore non-specific T cell activity, mRNA-4359 encodes two critical immune escape pathways to help generate new, target-directed T cells. This could enable broader and more durable immune responses for patients who have not had success with prior lines of therapy. We are proud to present these data and to demonstrate the role our mRNA-based therapies could play in transforming the lives of those affected by cancer.”

    mRNA-4359 in combination with pembrolizumab demonstrated a consistently manageable safety profile, with no new immune-related adverse events (AEs). mRNA-4359 continues to be evaluated in an ongoing phase 1/2 study (NCT05533697) as a monotherapy and in combination with pembrolizumab in patients with advanced melanoma and non-small cell lung cancer (NSCLC).

    “After failing to respond to first-line immunotherapy, existing options for PD-L1+ patients are limited, underscoring a clear need for effective, tolerable therapies,” said Prof. David J. Pinato, Clinical Professor of Experimental Cancer Therapeutics at Imperial College London and Consultant Medical Oncologist at Imperial College Healthcare NHS Trust and lead author and presenter of the abstract. “mRNA-4359 has the potential to rebalance the tumor microenvironment to overcome this immunotherapy resistance. These data are encouraging as we continue to investigate the potential of mRNA-4359.”

    The details of the presentation are as follows:

    • Mini Oral Presentation #1515MO: Clinical Outcomes and PD-L1 Expression Analyses from a Trial of mRNA-4359 Plus Pembrolizumab in Checkpoint Inhibitor-Resistant/Refractory (CPI-R/R) Melanoma

    • Time: Friday, October 17, 2025, 2:00 – 3:30 PM CET

    • Location: Nuremberg Auditorium – Hall 5.2

    • Presenter: David J. Pinato

    Moderna’s Oncology Investor & Analyst Event

    Moderna will host a live webcast for investors and analysts on Friday, October 17, 2025, at 6:00 PM CET (12:00 PM ET), which will be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

    About mRNA-4359

    mRNA-4359 is an immune-evasion targeted cancer antigen therapy that encodes broad epitopes of PD-L1 and IDO1. With its dual mechanism of action, it elicits antigen-specific T-cell responses to simultaneously: (1) kill tumor cells expressing PD-L1 and IDO1, and (2) deplete immunosuppressive cells that shield the tumor from attack. This is hypothesized to rebalance the tumor microenvironment into an immune-permissive state, supporting sustained and durable anti-tumor activity with a manageable safety profile.

    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.

    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 potential of Moderna’s mRNA-based therapies for cancer patients; the potential of PD-L1 as a predictive biomarker; the response rate and safety profile of mRNA-4359; and the potential for mRNA-4359 to enable broader and more durable immune responses for patients who have not had success with prior lines of therapy. 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, 2024, 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
    Head of Global 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

  • Moderna Announces mNEXSPIKE Generates Strong Immune Response Against LP.8.1 Variant in Humans

    Preliminary analysis showed the 2025-2026 formula of mNEXSPIKE generated greater than a 16-fold increase in LP.8.1-neutralizing antibodies across age groups

    Both of Moderna’s COVID-19 vaccines for the 2025-2026 season have demonstrated strong immune responses against today’s top circulating COVID-19 strains

    CAMBRIDGE, MA / ACCESS Newswire / September 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of mNEXSPIKE® (COVID-19 Vaccine, mRNA),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 mNEXSPIKE showed, on average, greater than a 16-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. These findings follow additional preliminary data that showed the 2025-2026 formula of Spikevax® generated greater than an 8-fold increase in LP.8.1-neutralizing antibodies across the same age groups.

    The safety profile of the vaccine was consistent with previous studies. These clinical findings underscore the predictability of preclinical data that supported the recent U.S. Food and Drug Administration approval of the 2025-2026 formula of mNEXSPIKE, which 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.

    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.

    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 ability of Moderna’s COVID vaccines to generate an immune response and to protect against circulating COVID strains; and the safety profile of mNEXSPIKE. 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
    +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

  • Moderna Announces First Made-in-Canada mRNA Vaccines Delivered to Canadian Provinces and Territories

    CAMBRIDGE, MA / ACCESS Newswire / September 19, 2025 / Moderna announced today that the first mRNA vaccines fully manufactured in Canada are being shipped to provinces and territories. This milestone advances Canada’s domestic vaccine production capacity and strengthens national health security.

    “The delivery of the first made-in-Canada mRNA vaccines to provinces and territories across the country marks a major milestone in our partnership with Canada,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This is not just about local manufacturing, it’s about scientific leadership, national health security and ensuring Canadians have timely access to the latest mRNA medicines. We’re proud to stand alongside Canada in advancing innovation, driving economic growth and investing in a resilient future for public health.”

    All drug substance of Moderna’s authorized Spikevax® (COVID-19 mRNA vaccine) product targeting the SARS-CoV-2 LP.8.1 variant is manufactured at the facility in Laval, Quebec. Fill-and-finish of the new single-use pre-filled syringes is completed by Novocol Pharma in Cambridge, Ontario.

    Moderna’s updated COVID-19 vaccine targeting the LP.8.1 variant was approved by Health Canada on August 21, 2025 [1], and has also received authorization from regulators in the United States, Europe, Japan, Switzerland and several other countries. Additional regulatory submissions are under review globally in preparation for the 2025-2026 respiratory virus season.

    Canadian Access and Eligibility

    Timing and eligibility for the COVID-19 public vaccination program in Canada is set by each province and territory. Those who meet provincial criteria will receive COVID-19 vaccines free of charge. For individuals not covered under the public programs, efforts are ongoing with private insurers and payers to streamline access and reimbursement within the private sector. Canadians are encouraged to consult their provincial or territorial health authorities for the latest information on eligibility and availability.

    Additional Quotes:

    Stefan Raos, General Manager, Moderna Canada, said:

    “As a Canadian, it’s incredibly meaningful to see our first made-in-Canada COVID-19 vaccines in pre-filled syringes now reaching across the country to help protect Canadians starting this fall. This marks a critical shift, demonstrating that Canada’s domestic manufacturing capability is real, operational and serving Canadians today. It reflects what’s possible when science, industry and government work together with purpose.”

    The Honourable Mélanie Joly, Minister of Industry and Minister responsible for Canada Economic Development for Quebec Regions, said:

    “Today’s milestone of the production of the first made-in-Canada doses of Moderna’s COVID-19 vaccine represents a major achievement for Canada’s biomanufacturing and life sciences sector. Our government is building a resilient, forward-looking economy that positions Canada as a global leader in scientific research and innovation. Moderna’s investments in Canada strengthen our national life sciences industry, create good-paying new jobs for Canadians and bolster our national security.”

    The Honourable Marjorie Michel, Minister of Health, said:

    “Manufacturing the first-ever doses of a fully made-in-Canada COVID-19 vaccine demonstrates the power of collaboration between government, industry and science to help protect the health of Canadians. By producing vaccines here at home, we are supporting our economy while strengthening Canada’s ability to respond quickly and effectively to future public health emergencies.”

    Images and b-roll can be found here.

    [1] Moderna Canada. SPIKEVAX® Product Monograph. August 21, 2025.

    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® is a registered trademark of Moderna.

    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 in Canadian provinces and territories of Moderna’s updated COVID vaccine for the 2025-2026 vaccination season; Moderna’s Canadian manufacturing; and Moderna’s pending regulatory applications for approval of its COVID vaccine globally. 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:
    Sacha Kennedy
    Director, Communications and Media
    +1 647-385-6846
    Sacha.Kennedy@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

  • Moderna Announces Updated COVID-19 Vaccine Against LP.8.1 Variant Generates Strong Immune Response in Humans

    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 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® 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 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 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 Contacts
    Media:
    Chris Ridley
    Head of Global 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

    View the original press release on ACCESS Newswire