Moderna, Inc. (NASDAQ: MRNA) announced that the United States Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283). It is a new COVID-19 vaccine intended for use in adults aged 65 and older and individuals aged 12 to 64 years with one or more underlying risk factors specified by the Centers for Disease Control and Prevention (CDC).
Moderna CEO Stéphane Bancel stated that the FDA approval of mNEXSPIKE provides significant protection to individuals at an elevated risk of severe COVID-19. COVID-19 is still a major threat to the public, with more than 47,000 Americans losing their lives from this virus in the past year. We are grateful for the timely review by the FDA and acknowledge the hard work and dedication of the Moderna team to public health.
The FDA approval of mNEXSPIKE is based on the results of a randomized, active-controlled Phase 3 clinical trial. It enrolled approximately 11,400 candidates aged 12 years and older. The primary efficacy objective was to demonstrate that mNEXSPIKE is not inferior to the mRNA-1273 (Spikevax®) vaccine, beginning 14 days after vaccination. mRNA-1273 (Spikevax®) is the original COVID-19 vaccine of Moderna. Either a 50 μg dosage of mRNA-1273 or a 10 μg dosage of mRNA-1283 was administered to participants. mRNA-1283 has a 9.3% increased relative vaccination efficacy (rVE) compared to mRNA-1273 in participants 12 years or older, and a 13.5% increased rVE in participants 65 years or older.
In Moderna’s Phase 3 study, mRNA-1283 has a comparable safety profile to mRNA-1273 with fewer systemic and local responses. Common adverse effects involve myalgia, headache, fatigue, and injection site pain. Moderna aims to make mNEXSPIKE accessible in the U.S. for the 2025 to 2026 respiratory virus season (RSV) with mRESVIA® and Spikevax.
Moderna is a leader in mRNA medicine in transforming drug development and preventing disease. With more than a decade of experience in research, health, and technology, Moderna has created medications with unparalleled effectiveness and speed, and has produced one of the first and most effective COVID-19 vaccinations. Their mRNA technology has facilitated the creation of medicines and vaccines for immuno-oncology, infectious illnesses, uncommon diseases, and autoimmune disorders. Moderna’s distinct culture and global workforce drive a dedication to sustainably transforming the future of human health, with the goal of delivering the greatest potential impact through mRNA therapies.
mRESVIA®, Spikevax®, and mNEXSPIKE® are registered products of Moderna. mNEXSPIKE is a vaccination used to prevent COVID-19. It is used in individuals who are 65 years or older and those aged 12 to 64 with elevated risk. It may not protect all individuals who get the vaccination.
Individuals should not receive the mNEXSPIKE vaccine if they had a severe allergic reaction to the earlier dosage of SPIKEVAX or mNEXSPIKE or any other Moderna COVID-19 vaccination or any component in the vaccines.
While the mNEXSPIKE vaccine is generally well tolerated, there is a small risk of a severe allergic reaction. This occurs within a few minutes to an hour after getting the vaccination. A healthcare provider can ask patients to remain at the place where they get the vaccine. Symptoms of severe allergic reactions include swelling of the throat and face, difficulty breathing, a rapid heartbeat, weakness, dizziness, and a rash.
Pericarditis and myocarditis are observed in some patients who have received mRNA COVID-19 vaccines. It occurs in men aged 12 to 24 years. The symptoms include shortness of breath, chest pain, a sensation of fluttering, pounding, or a rapid heartbeat. Seek medical attention immediately.
Clinical trials of mNEXSPIKE involved side effects, including injection site reactions such as tenderness, swelling of lymph nodes in the same arm of injection, hardness, redness, and pain. General side effects included joint pain, muscle pain, headache, fatigue, fever, vomiting, nausea, and chills.
To ensure a safe vaccination, inform your healthcare provider of any medical conditions you have, like allergies, severe allergic reactions after earlier COVID-19 vaccination, breastfeeding or pregnancy, pericarditis or myocarditis, bleeding disorders, fever, immunocompromised condition, or having received any COVID-19 vaccine earlier or any past fainting reaction linked with injection.
Reference: Moderna. Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE. Cambridge, MA; May 31, 2025. Accessed June 9, 2025. Moderna Receives U.S. FDA Approval for COVID‑19 Vaccine mNEXSPIKE
