Moderna, Inc.

CAMBRIDGE, MA, USA I May 23, 2025 I Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1. The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 lineage, with a preference for the LP.8.1 variant. 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. AUTHORIZED USE IN THE U.S. INDICATION (U.S.) SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. IMPORTANT SAFETY INFORMATION Contraindications Warnings and Precautions Adverse Reactions The most commonly reported (≥10%) adverse reactions following any dose in any indicated patient population were pain at the injection site, headache, fatigue, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, swelling at the injection site, erythema at the injection site, and fever. Reporting Adverse Events and Vaccine Administration Errors The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. Please see the SPIKEVAX Full Prescribing Information . Please see the Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine for more information . SOURCE: Moderna Therapeutics

Phase 1/2 H5 avian flu vaccine study shows positive interim results Company has been notified that HHS will terminate Moderna’s award for late-stage development of pre-pandemic influenza vaccines CAMBRIDGE, MA, USA I May 28, 2025 I Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study ( NCT05972174 ) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype. The Company had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services (HHS); however, today Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines. “While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program,” said Stéphane Bancel, Chief Executive Officer of Moderna. “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.” The Phase 1/2 study evaluated a two-dose regimen of Moderna’s investigational avian influenza vaccine. mRNA-1018 demonstrated a rapid, potent and durable immune response. At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition (HAI) antibody titers ≥1:40, an HAI titer considered to correlate with protection. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers ≥1:40 with a 44.5-fold increase of titers from baseline. The investigational vaccine was generally well-tolerated, with no dose-limiting tolerability concerns observed. Most solicited adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses. Further data is expected to be submitted for presentation at an upcoming scientific meeting. Moderna will explore alternatives for late-stage development and manufacturing of the H5 program consistent with the Company’s strategic commitment to pandemic preparedness. 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. SOURCE: Moderna Therapeutics

Moderna is facing another setback from the vaccine-sceptical Trump administration, with the company disclosing Wednesday that the Department of Health and Human Services (HHS) has canceled over $760 million in funding to develop vaccines for pre-pandemic influenzas — including the bird flu. The announcement came in conjunction with an interim data readout from Moderna's 300-person Phase I/II trial of its H5 avian influenza vaccine, mRNA-1018. More than 97% of participants who received two doses of the experimental vaccine had hemagglutination inhibition (HAI) antibody titers ≥1:40 — the level considered to be protective — at three weeks after the second vaccination. About 2% of individuals had protective levels of HAI antibodies at baseline. In addition, mRNA-1018 was generally well-tolerated, with most adverse reactions being either Grade 1 or 2, and no dose-limiting tolerability concerns. Moderna plans to present additional data at an upcoming scientific meeting.  "While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed," CEO Stéphane Bancel said in a company release. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats."Moderna had been counting on a $590-million contract — awarded in the final days of the Biden administration — to fund late-stage development of mRNA-1018. The biotech had also received a $176-million award from HHS's Biomedical Advanced Research and Development Authority (BARDA) last year to develop mRNA-based vaccines to head off future viral outbreaks.Without the funding, Moderna said it will "explore alternatives for late-stage development and manufacturing of the H5 programme."There had been hints earlier this year that Moderna's influenza award was in danger of being pulled. In February, an HHS spokesperson said that "four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production."The canceled contract is the latest fallout from the US's overhaul of how it regulates and develops vaccines, overseen by HHS Secretary Robert F. Kennedy Jr. For more, see Vital Signs: Moderna starts sweating vaccine climate at the 'new FDA'.Last week, Moderna voluntarily withdrew an application seeking approval of its combination influenza/COVID-19 vaccine mRNA-1083 for adults aged 50 years and older after the FDA said that Phase III flu efficacy data would be required.HHS agencies have released a flurry of vaccine policy changes this month. The FDA will now require placebo-controlled trials for "new vaccines," including COVID-19 boosters for healthy individuals under the age of 65.Earlier this week, Kennedy announced that the Centers for Disease Control and Prevention (CDC) would no longer recommend healthy children and pregnant women receive COVID-19 vaccines.However, Kennedy's influence on US health policy has drawn criticism, with virology and immunology expert Paul Offit warning in a recent FirstWord interview that the secretary's health agenda may be based more on ideology than evidence (see – ViewPoints: A vaccine expert's grim verdict on Kennedy's health agenda).