Moderna's New COVID Shot Is mNEXSPIKE the Vaccine Upgrade You Need?

Moderna's mNEXSPIKE COVID-19 Vaccine Receives FDA Approval: A New Chapter in Public Health

In a significant stride towards bolstering public health, Moderna, Inc. (NASDAQ:MRNA) has announced that its next-generation COVID-19 vaccine, mNEXSPIKE® (mRNA-1283), has received approval from the U.S. Food and Drug Administration (FDA). This marks Moderna's third FDA-approved product, further solidifying its role as a key player in mRNA medicine.

This newly approved vaccine is authorized for use in:

• Adults aged 65 and older
• Individuals aged 12-64 years with at least one or more underlying risk factors as defined by the Centers for Disease Control and Prevention (CDC).

Stéphane Bancel, Chief Executive Officer of Moderna, emphasized the importance of this milestone: "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19. COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health."

Clinical Trial Highlights

The FDA's decision was based on the encouraging results of a Phase 3 clinical trial (NCT05815498), involving approximately 11,400 participants aged 12 years and older. The trial aimed to demonstrate the non-inferior vaccine efficacy of mNEXSPIKE compared to Moderna's original COVID-19 vaccine, Spikevax® (mRNA-1273).

Key findings from the trial include:

• mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older.
• A descriptive sub-group analysis revealed a 13.5% higher rVE in adults aged 65 and older.

Furthermore, mNEXSPIKE exhibited a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. Common side effects reported were injection site pain, fatigue, headache, and myalgia.

Availability and Future Outlook

Moderna anticipates making mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA®, the Company's approved respiratory syncytial virus (RSV) vaccine. Additionally, mRNA-1283 is currently under review with regulators in multiple markets worldwide.

Important Safety Information: Key Considerations Before Vaccination

Before receiving the mNEXSPIKE vaccine, individuals should be aware of the following:

• Contraindications: mNEXSPIKE should not be administered to individuals with a history of severe allergic reactions to any Moderna COVID-19 vaccine or its ingredients.
• Potential Risks: There is a slight chance of severe allergic reactions, typically occurring within minutes to an hour post-vaccination. Monitoring is recommended post-vaccination.
• Myocarditis and Pericarditis: Although rare, cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have been reported, particularly in males aged 12-24. Seek immediate medical attention for symptoms like chest pain, shortness of breath, or palpitations.
• Common Side Effects: Expect injection site reactions like pain, tenderness, and swelling. General side effects may include fatigue, headache, muscle pain, and fever.
• Inform Your Provider: Disclose any allergies, previous allergic reactions to vaccines, a history of myocarditis or pericarditis, bleeding disorders, immunocompromised status, pregnancy, breastfeeding, and any other relevant medical conditions.

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.

Moderna: Pioneering mRNA Medicine

Moderna stands at the forefront of mRNA medicine, leveraging its innovative technology to transform the treatment and prevention of diseases. With a focus on infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases, Moderna continues to push the boundaries of medical science. Their commitment to innovation and public health is evident in their rapid development of effective vaccines and therapeutics.

Conclusion: A Promising Step Forward

The FDA approval of mNEXSPIKE represents a significant milestone in the ongoing fight against COVID-19. This next-generation vaccine offers enhanced protection, particularly for older adults and those with underlying risk factors. As Moderna continues to innovate and expand its portfolio of mRNA medicines, the future of public health looks increasingly promising, offering hope and improved outcomes for individuals worldwide.

Source: https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx