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mNEXSPIKE is now approved and coming this fall1 Introducing mNEXSPIKE: An Innovative New COVID-19 Vaccine for At-Risk Individuals1-8 mNEXSPIKE is a different COVID-19 vaccine that provides a robust immune response at a lower dose.1 mNEXSPIKE is different from the comparator vaccine.1,4–6,9 mNEXSPIKE encodes immunodominant epitopes of the COVID-19 spike protein, thus incorporating a smaller mRNA molecule compared to Spikevax, which encodes for the entire spike protein.1,4
mNEXSPIKE was studied in a noninferiority trial: Relative vaccine efficacy results1 Relative vaccine efficacy against COVID-19¹*
Per-protocol set for efficacy
mNEXSPIKE (10 µg) n=5679
Spikevax (50 µg) n=5687
Number of participants with COVID-19, n (%)
9.9% (560)
10.8% (617)
Incidence rate per 100 person-months
1.4
1.5
Relative vaccine efficacy (99.4% CI)†
9.3% (-6.6, 22.8)
mNEXSPIKE satisfied the primary criterion for noninferiority.1 STUDY WAS NOT DESIGNED TO EVALUATE SUPERIORITY. rVE analyses by subgroups were descriptive without P values. *Presence of at least one symptom from a list of COVID-19 symptoms and a positive NP swab for SARS-CoV-2 by RT-PCR. Listed symptoms were fever (temperature ≥38°C/≥100.4°F) or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.1 †Lower bound of two-sided 99.4% (alpha-adjusted) Cl of rVE >-10% (1-sided alpha spending: 0.0028).1 rVE = relative vaccine efficacy.
Product Details and Ordering Learn More About mNEXSPIKE
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:
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
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. Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure
1 mNEXSPIKE Prescribing Information. Moderna; 2025. 2 Allen JC, et al. Vaccine. 2020;38(52):8264-8272. 3 Andrew MK, et al. Clin Interv Aging. 2021;16:731-738. 4 Chalkias S, et al. J Infect Dis. 2025;231(4):e754-e763. 5 Montgomerie I, et al. iScience. 2023;26(4):106256. 6 Spikevax Prescribing Information. Moderna; 2025. 7 Chalkias S. Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine: results from NextCOVE, a phase 3, randomized, observer-blind, active-controlled trial. 2025. Supplementary appendix. 8 CDC. Accessed May 9, 2025. https://www.cdc.gov/covid/risk-factors/index.html 9 Chaudhary N, et al. Nat Rev Drug Discov. 2021;20(11):817-838.
mRESVIA is the only RSV protection in a ready-to-use, pre-filled syringe.1-3 NOW INDICATED FOR A BROADER AGE RANGE: For adults aged 60 or older, as well as adults aged 18 to 59 who are at increased risk for LRTD caused by RSV.1 mRESVIA Provides Exceptional Convenience1: Pre-filled syringe presentation, no reconstitution required. mRESVIA is ready to use once thawed to room temperature.1 *Increased risk was defined as documented confirmation of at least one of the following conditions: CAD and/or CHF, chronic lung disease (including but not limited to COPD or persistent asthma), and Type 1 or Type 2 DM.1
Product Details and Ordering Learn More About mRESVIA
INDICATION mRESVIA® (Respiratory Syncytial Virus Vaccine) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older and individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. IMPORTANT SAFETY INFORMATION Contraindications Do not administer mRESVIA to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of mRESVIA. Warnings and Precautions
Adverse Reactions In a clinical trial conducted in participants 60 years of age and older, the most commonly reported (≥10%) adverse reactions were injection-site pain (55.9%), fatigue (30.8%), headache (26.7%), myalgia (25.6%), arthralgia (21.7%), axillary (underarm) swelling or tenderness (15.2%) and chills (11.6%). In a clinical trial conducted in participants 18 through 59 years of age at increased risk for LRTD caused by RSV, the most commonly reported (≥10%) adverse reactions were injection site pain (73.9%), fatigue (36.9%), headache (33.3%), myalgia (28.9%), arthralgia (22.7%), chills (19.9%), axillary (underarm) swelling or tenderness (17.1%), and nausea/vomiting (10.8%). To report suspected adverse reactions, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800-822-7967 or https://vaers.hhs.gov. Please click for mRESVIA Full Prescribing Information. *Stored frozen between -40 °C to -15 °C (-40 °F to 5 °F), with the option to thaw at refrigeration or room temperature. A carton of 1 pre-filled syringe can be thawed at refrigeration 2 °C to 8 °C (36 °F to 46 °F) for 100 minutes or at room temperature 15 °C to 25 °C (59 °F to 77 °F) for 40 minutes. A carton of 10 pre-filled syringes can be thawed at refrigeration 2 °C to 8 °C (36 °F to 46 °F) for 160 minutes or at room temperature 15 °C to 25 °C (59 °F to 77 °F) for 80 minutes.1 †Please see mRESVIA Full Prescribing Information for details on how to store mRESVIA. ACIP, Advisory Committee on Immunization Practices; RSV, respiratory syncytial virus. For Colorado and Connecticut price disclosure, please visit https://modernadirect.com/wac-disclosure.
1 mRESVIA Prescribing Information. ModernaTX, Inc. 2 AREXVY Prescribing Information. GlaxoSmithKline Biologics SA. 3 ABRYSVO Product Information. Pfizer Inc.
When protection is needed against new COVID-19 variants, Spikevax updates.* Get your vaccine supply for the season. Reserve the 2025–2026 formula today. Storage and handling information for the 2025–2026 presentation will be shared when available. *Update is consistent with VRBPAC guidance.
Product Details and Ordering Learn More About Spikevax
INDICATION SPIKEVAX (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). SPIKEVAX is approved for use in individuals who are:
IMPORTANT SAFETY INFORMATION Contraindications Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Moderna COVID-19 vaccine. Warnings and Precautions
Adverse Reactions The most commonly reported (>10%) adverse reactions in participants 6 - 36 months of age: irritability/crying, pain at the injection site, sleepiness, loss of appetite, fever, erythema, swelling at the injection site, and axillary (or groin) swelling/tenderness. The most commonly reported (>10%) adverse reactions in participants 37 months - 11 years of age were: pain at the injection site, fatigue, headache, myalgia, chills, nausea/vomiting, axillary (or groin) swelling/tenderness, fever, erythema, swelling at the injection site, and arthralgia. The most commonly reported (≥10%) adverse reactions in participants 12 years and older were: pain at the injection site, headache, fatigue, myalgia, arthralgia, chills, and axillary swelling/tenderness, nausea/vomiting, and swelling at the injection site. Reporting Adverse Events and Vaccine Administration Errors To report suspected adverse reactions, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800-822-7967 or https://vaers.hhs.gov. Please click for SPIKEVAX Full Prescribing Information. For Colorado and Connecticut price disclosure, please visit https://modernadirect.com/wac-disclosure.