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Moderna

Moderna

Moderna

Sponsored by Moderna

Moderna: Advancing mRNA Science to Help Protect Patients

Moderna is pioneering the future of medicine through mRNA technology—delivering vaccines designed to help protect against serious infectious diseases. Our vaccine portfolio reflects cutting-edge science, built on a foundation of mRNA expertise. We provide healthcare professionals with the tools and resources they need to make informed decisions for their patients. Our commitment to public health extends beyond vaccines—we're here to support the HCP community with ongoing education and partnership. Moderna’s offerings are easily accessible through trusted distributor platforms like Henry Schein.

mNEXSPIKE® (COVID-19 Vaccine, mRNA)

Moderna

Introducing mNEXSPIKE: A New and Different COVID-19 Vaccine1

mNEXSPIKE is designed to be different from Spikevax® (COVID-19 Vaccine, mRNA)1,2

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.1,3

LOWER DOSE
1/5
that of Spikevax
(10 μg vs 50 μg)1,2		 SMALLER VOLUME
0.2 mL
vs 0.5 mL dose
for Spikevax1,2

mNEXSPIKE demonstrated a numerically higher rVE against COVID-19 vs Spikevax in a phase 3 noninferiority trial1*

  • 11,366 vaccine-experienced participants aged ≥12 years received either mNEXSPIKE (n=5679) or Spikevax (n=5687)
  • Primary efficacy objective: noninferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared with that after Spikevax

Higher antibody response and seroresponse rate led to a greater immune response compared with Spikevax.†

Clinical study of mNEXSPIKE was not designed to evaluate superiority.

Primary Efficacy Analysis Population
9.3%
numerically higher rVE
against Covid-19‡ vs Spikevax§ (99.4% Cl: -6.6, 22.8)

In a subgroup analysis of adults aged ≥65 years, mNEXSPIKE demonstrated a numerically higher rVE vs Spikevax1*

COVID-19 events through January 31, 2024 – per-protocol set for efficacy

mNEXSPIKE
(10 µg)
n=1630

Spikevax
(50 µg)
n=1635

COVID-19 cases

149

172

Incidence rate per 100 person-months

1.3

1.5

rVE analyses by subgroups were descriptive without P-values.
13.5%
numerically higher rVE
against Covid-19‡ vs Spikevax (95% Cl: -7.7, 30.6)

Clinical study of mNEXSPIKE was not designed to evaluate superiority.

*Participants had previously received at least one dose of a COVID-19 vaccine prior to the study. ‡Co-primary immunogenicity endpoints: At Day 29, the mNEXSPIKE to Spikevax GMC ratio (95% CI) was 1.3 (1.2, 1.5), and the seroresponse rate difference (95% CI) was 14.4% (9.3, 19.4). mNEXSPIKE met the pre-specified noninferiority criterion of the lower bound of the 95% CI of GMC ratio >0.667, and the pre-specified noninferiority criterion of the lower bound of the 95% CI of the SRR-difference >-10%. ‡Presence of at least 1 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. §Success criteria were defined as lower bound of 2-sided 99.4% (alpha-adjusted) Cl of rVE >-10% (2-sided alpha spending function: 0.0028).

Click here to learn more about Relative Vaccine Efficacy.

Find out if mNEXSPIKE is appropriate for your patients—especially those aged 65 and older.

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 have been previously vaccinated with any COVID-19 vaccine and 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.

Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure

References

1 mNEXSPIKE Prescribing Information. Moderna; 2025.
2 Spikevax Prescribing Information. Moderna; 2025.
3 Chalkias S, et al. J Infect Dis. 2025;231(4):e754-e763.
4 Chalkias S, et al. Lancet Infect Dis. Published online July 7, 2025. doi:10.1016/S1473-3099(25)00236-1
5 CDC. Accessed August 27, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html

mRESVIA® (Respiratory Syncytial Virus Vaccine)

mRESVIA is the only RSV protection in a ready-to-use, pre-filled syringe.1

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

Indication and Important Safety Information

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

  • Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of mRESVIA.
  • Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including mRESVIA. Procedures should be in place to avoid injury from fainting.
  • Altered Immunocompetence: Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to mRESVIA.

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.

References

1 mRESVIA Prescribing Information. ModernaTX, Inc.

Spikevax® (COVID-19 Vaccine, mRNA)

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.

Indication and Important Safety Information

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:

  • 65 years of age and older, or
  • 6 months 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 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

  • Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of SPIKEVAX.
  • 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 SPIKEVAX.
  • Limitations of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients.

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.

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