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FOR THE PREVENTION OF COVID-19PROTECT PATIENTS—ESPECIALLY THOSE AGED 65 AND OLDER—WITH mNEXSPIKE, A NEW COVID-19 VACCINE 1
Relative Vaccine Efficacy
mNEXSPIKE demonstrated increased rVE vs Spikevax® (COVID-19 Vaccine, mRNA)1
A Comparable Safety Profile
Solicited local and systemic adverse reactions were generally similar to Spikevax1
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Indication and Important Safety Information
INDICATION
mNEXSPIKE (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).
mNEXSPIKE is approved for use in individuals who are:
- 65 years of age and older, or
- 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer mNEXSPIKE to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of mNEXSPIKE or to individuals who had a severe allergic reaction following a previous dose of SPIKEVAX (COVID-19 Vaccine, mRNA) or any Moderna COVID-19 vaccine authorized for emergency use.
Warnings and Precautions
- Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of mNEXSPIKE.
- Myocarditis and Pericarditis: Postmarketing data with authorized or approved mRNA COVID-19 vaccines have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week following vaccination. The observed risk has been highest in males 12 years through 24 years of age.
- Syncope (fainting): May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
- Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to mNEXSPIKE.
- Limitations of Vaccine Effectiveness: mNEXSPIKE may not protect all vaccine recipients.
Adverse Reactions
The most commonly reported (≥10%) adverse reactions were pain at the injection site, fatigue, headache, myalgia, chills, arthralgia, axillary swelling or tenderness, and nausea/vomiting.
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 or by calling 1-800-822-7967.
Please click for mNEXSPIKE Full Prescribing Information.
References
- mNEXSPIKE Prescribing Information. ModernaTX, Inc.
- Allen JC, Toapanta FR, Chen W, Tennant SM. Understanding immunosenescence and its impact on vaccination of older adults. Vaccine. 2020;38(52):8264-8272. doi:10.1016/j.vaccine.2020.11.002
- Andrew MK, Schmader KE, Rockwood K, Clarke B, McElhaney JE. Considering frailty in SARS-CoV-2 vaccine development: how geriatricians can assist. Clin Interv Aging. 2021;16:731-738. doi:10.2147/CIA.S295522
- Centers for Disease Control and Prevention. Staying up to date with COVID-19 vaccines. Updated June 6, 2025. Accessed August 26, 2025. https://www.cdc.gov/covid/vaccines/stay-up-to-date.html
- Centers for Disease Control and Prevention. People with certain medical conditions and COVID-19 risk factors. Updated June 11, 2025. Accessed August 26, 2025. https://www.cdc.gov/covid/risk-factors/index.html
- Chaudhary N, Weissman D, Whitehead KA. mRNA vaccines for infectious diseases: principles, delivery and clinical translation. Nat Rev Drug Discov. 2021;20(11):817-838. doi:10.1038/s41573-021-00283-5
- Montgomerie I, Bird TW, Palmer OR, et al; VAANZ Group. Incorporation of SARS-CoV-2 spike NTD to RBD protein vaccine improves immunity against viral variants. iScience. 2023;26(4):106256. doi:10.1016/j.isci.2023.106256
- Spikevax Prescribing Information. ModernaTX, Inc.
Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure