rVE ACROSS INDIVIDUALS WITH COMORBIDITIES1
rVE ACROSS INDIVIDUALS WITH COMORBIDITIES1
Post hoc analysis—based on the CDC definition of COVID-19 risk1,2*
Post hoc analysis—based on the CDC definition of COVID-19 risk1,2*
mNEXSPIKE (10 µg) | Spikevax (50 µg) | ||
|---|---|---|---|
rVE based on HR (95% CI) | Participants with COVID-19 [N/n (%)] | ||
≥1 comorbidites in 65 years of age | 28.1% (4.4, 45.9) | 81/947 (8.6%) | 114/971 (11.7%) |
≥1 comorbidites in 50 years of age | 21.3% (4.3, 35.3) | 176/1811 (9.7%) | 233/1895 (12.3%) |
≥1 comorbidities in all participants 12 years and older | 16.3% (1.8, 28.7) | 274/2674 (10.2%) | 334/2725 (12.3%) |
mNEXSPIKE (10 µg) | Spikevax (50 µg) | |
|---|---|---|
Participants with COVID-19 [N/n (%)] | ||
≥1 comorbidites in 65 years of age | 81/947 (8.6%) | 114/971 (11.7%) |
≥1 comorbidites in 50 years of age | 176/1811 (9.7%) | 233/1895 (12.3%) |
≥1 comorbidities in all participants 12 years and older | 274/2674 (10.2%) | 334/2725 (12.3%) |
rVE based on HR (95% CI) | |
≥1 comorbidites in 65 years of age | 28.1% (4.4, 45.9) |
≥1 comorbidites in 50 years of age | 21.3% (4.3, 35.3) |
≥1 comorbidities in all participants 12 years and older | 16.3% (1.8, 28.7) |
Analysis Limitation: This endpoint was not powered for statistical analysis and should be considered descriptive only. Therefore, results require cautious interpretation and could represent chance findings. These data are not included in the mNEXSPIKE prescribing information.
Based on COVID-19 events through January 31, 2024.
*The CDC defined medical condition list includes cancer, cerebrovascular disease, chronic kidney disease, chronic liver disease, chronic lung disease, asthma, cystic fibrosis, dementia or other neurological conditions (limited to dementia and Parkinson’s Disease), diabetes (T1 or T2), disabilities, heart conditions (e.g., heart failure, coronary artery disease, cardiomyopathy), hemoglobin blood disorders, HIV infection, immunocompromised condition/weakened immune system, mental health conditions, overweight/obesity, physical inactivity, pregnancy, smoking, solid organ or blood stem cell transplant, substance use disorders, primary immunodeficiencies, use of corticosteroids or other immunosuppressive medications, and tuberculosis.2
rVE = relative vaccine efficacy.
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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
- Centers for Disease Control and Prevention. Underlying conditions and the higher risk for severe COVID-19. Updated February 6, 2025. Accessed June 10, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html
- Chalkias S, Dennis P, Petersen D, et al. Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine (NextCOVE): results from a phase 3, randomised, observer-blind, active-controlled trial. Lancet Infect Dis. 2025;S1473-3099(25)00236-1. doi: 10.1016/S1473-3099(25)00236-1
Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure