PROTECT YOUR PATIENTS WITH COMORBIDITIES FROM COVID-19
PROTECT YOUR PATIENTS WITH COMORBIDITIES FROM COVID-19
Your patients with comorbidities like heart conditions and COPD are vulnerable to severe COVID-19—mNEXSPIKE is for them1,2
Severe COVID-19 and certain underlying conditions can exacerbate one another2‑5
The risk for both severe COVID-19 infection and worsening of the underlying conditions after infection can increase. For example, not only does having cardiovascular disease (CVD) or COPD affect the risk of severe illness, but severe COVID-19 infection increases the risk of worsening of CVD or exacerbating COPD.
Higher cardiovascular risk persisted 1 year after infection3*
Increased mortality risk in COPD patients lingered months after severe infection6†
A post hoc analysis was conducted in individuals with underlying conditions to assess rVE across several age groups,
based on the CDC definition of COVID-19 risk.‡
Post hoc analysis—based on the CDC definition of COVID-19 risk7‡
Post hoc analysis—based on the CDC definition of COVID-19 risk7‡
mNEXSPIKE (10 µg) | Spikevax (50 µg) | ||
|---|---|---|---|
rVE based on HR (95% CI) | Participants with COVID-19 [N/n (%)] | ||
≥1 comorbidities in 65 years of age and older | 28.1% (4.4, 45.9) | 81/947 (8.6%) | 114/971 (11.7%) |
≥1 comorbidities in 50 years of age and older | 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 comorbidities in 65 years of age and older | 81/947 (8.6%) | 114/971 (11.7%) |
≥1 comorbidities in 50 years of age and older | 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 comorbidities in 65 years of age and older | 28.1% (4.4, 45.9) |
≥1 comorbidities in 50 years of age and older | 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.
*From a retrospective cohort study using US
Department of Veterans Affairs national healthcare databases, including 153,760
individuals with COVID-19 from March 1, 2020
to January 15, 2021. Cardiovascular outcomes were assessed up to 12 months after infection versus contemporary and historical controls.3
†From a retrospective cohort study using the Korea National Health Insurance Service database. The study included 2,499 individuals with COPD who were diagnosed with COVID-19 between October 8, 2020 and December 31, 2021, and 1:1 propensity score matched controls, and compared the risk of long-term mortality.6
‡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 (eg, heart failure, coronary artery disease, cardiomyopathy), hemoglobin blood disorders, HIV infection, immunocompromised conditions/weakened immune system, mental health conditions, overweight/obesity, physical inactivity, pregnancy, smoking, solid organ or blood stem cell transplantation, substance use disorders, primary immunodeficiencies, use of corticosteroids or other immunosuppressive medications, and tuberculosis.2,7
CDC = Centers for Disease Control and Prevention; COPD = chronic obstructive pulmonary disease; HR = hazard ratio; 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
- mNEXSPIKE Prescribing Information. ModernaTX, Inc.
- Centers for Disease Control and Prevention. People with certain medical conditions and COVID-19 risk factors. Updated June 11, 2025. Accessed July 10, 2026. https://www.cdc.gov/covid/risk-factors/index.html
- Xie Y, Xu E, Bowe B, Al-Aly Z. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022;28(3):583-590. doi:10.1038/s41591-022-01689-3
- Kim SH, Lee H, Kim MJ, et al. Risk of acute exacerbation of chronic obstructive pulmonary disease after COVID-19 recovery: a nationwide population-based cohort study. Respir Res. 2025;26(1):116. doi:10.1186/s12931-025-03123-x
- Huang TS, Chao JY, Chang HH, Lin WR, Lin WH. COVID-19 and diabetes: persistent cardiovascular and renal risks in the post-pandemic landscape. Life (Basel). 2025;15(5):726. doi:10.3390/life15050726
- Lee H, Kim SH, Jeong CY, et al. COVID-19 and risk of long-term mortality in COPD: a nationwide population-based cohort study. BMJ Open Respir Res. 2025;12(1):e002694. doi:10.1136/bmjresp-2024-002694
- 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;25(11):1230-1242. doi:10.1016/S1473-3099(25)00236-1
Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure