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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
The AAFP and CDC recommend a 2nd COVID-19 vaccine dose at 6 months for adults aged 65 and older.8,9
Your patients aged 65 and older are particularly vulnerable to serious COVID-19 outcomes. These organizations recommend your patients aged 65 and older receive a second vaccine dose with a minimum spacing of 3 months between doses.6,8,9*
*The CDC recommends COVID-19 vaccines based on individual decision-making.
See AAFP recommendation.
See CDC recommendation.
AAFP = American Academy of Family Physicians; CDC = Centers for Disease Control and Prevention.

mNEXSPIKE: A Different COVID-19 Vaccine1-7,10,11

mNEXSPIKE is designed to be different from Spikevax® (COVID-19 Vaccine, mRNA)1,4

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.1,12

High protection in a lower dose for those at higher risk of severe COVID-191,5

LOWER DOSE
1/5
that of Spikevax
(10 μg vs 50 μg)1,4		 SMALLER VOLUME
0.2 mL
vs 0.5 mL dose
for Spikevax1,4

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 for 18 to 64 year age group: 9.7% (-3.8%, 21.3%); mNEXSPIKE (10 μg) n=3558, Spikevax (50 μg) n=3562
  • rVE for 12 to 17 year age group: -29.2% (-123.3%, 25.3%); mNEXSPIKE (10 μg) n=491, Spikevax (50 μg) n=490
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. ModernaTX, Inc.
2 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
3 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
4 Spikevax Prescribing Information. ModernaTX, Inc.
5 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
6 Centers for Disease Control and Prevention. People with certain medical conditions and COVID-19 risk factors. Updated June 11, 2025. Accessed January 22, 2026. https://www.cdc.gov/covid/risk-factors/index.html
7 Centers for Disease Control and Prevention. Staying up to date with COVID-19 vaccines. Updated November 19, 2025. Accessed January 22, 2026. https://www.cdc.gov/covid/vaccines/stay-up-to-date.html
8 American Academy of Family Physicians. Adults 19 and older immunization schedule. Published December 5, 2025. Accessed January 22, 2026. https://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/immunization-schedules/adult-immunization-schedule.html
9 Centers for Disease Control and Prevention. 2025–2026 COVID-19 vaccination guidance. Published November 4, 2025. Accessed January 22, 2026. https://www.cdc.gov/covid/hcp/vaccine-considerations/routine-guidance.html
10 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
11 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
12 Chalkias S, et al. J Infect Dis. 2025;231(4):e754-e763

 



mRESVIA® (Respiratory Syncytial Virus Vaccine)

INDICATED FOR:
Adults aged 60 or older, as well as adults aged 18 to 59 who are at increased risk for LRTD caused by RSV.

Tired of Reconstituting? mRESVIA is the only RSV protection in a ready-to-use, pre-filled syringe (PFS). No reconstitution required.1

mRESVIA is a single-dose 0.5 mL pre-filled syringe, ready for you to use for protection against RSV.1

Pre-filled syringes offer a convenient way to administer protection.1-3

mRESVIA is ready to use once thawed.1

Talk to your adult patients about RSV

Patients aged 60 or older and patients aged 18 to 59 who are at increased risk for LRTD caused by RSV may not realize the risks associated with RSV. You can help them understand what's at stake.

  • There is no treatment for an RSV infection beyond supportive care3,4
  • Studies have shown that adults with underlying chronic medical conditions, regardless of age, should be considered at risk of severe RSV-associated outcomes.5,6

CDC Recommendations for RSV Vaccines7-9

To protect against RSV, the CDC recommends vaccinating all adult patients who are:

  • 50-74 years of age who are at increased risk of severe RSV disease7-9
  • Aged 75 years or older8

Talk to your eligible adult patients to determine if mRESVIA is right for them.

LRTD = lower respiratory tract disease; RSV = respiratory syncytial virus.

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.

For Colorado and Connecticut price disclosure, please visit https://modernadirect.com/wac-disclosure.

References

1 mRESVIA Prescribing Information. ModernaTX, Inc.
2 Icardi G, Orsi A, Vitali Rosati G, Tognetto A, Checcucci Lisi G, Parisi S. Preferences of healthcare professionals regarding hexavalent pediatric vaccines in Italy: a survey of attitudes and expectations. J Prev Med Hyg. 2020;61(3):E424-E444. doi:10.15167/2421-4248/jpmh2020.61.3.1535
3 Malik S, Ahmad T, Muhammad K, Waheed Y. Respiratory syncytial virus infection: treatments and clinical management. Vaccines (Basel). 2023;11(2):491. doi:10.3390/vaccines11020491
4 Gatt D, Martin I, AlFouzan R, Moraes TJ. Prevention and treatment strategies for respiratory syncytial virus (RSV). Pathogens. 2023;12(2):154. doi:10.3390/pathogens12020154
5 Prasad N, Walker TA, Waite B, et al. Respiratory syncytial virus-associated hospitalizations among adults with chronic medical conditions. Clin Infect Dis. 2021;73(1):e158-e163. doi:10.1093/cid/ciaa730
6 Njue A, Nuabor W, Lyall M, et al. Systematic literature review of risk factors for poor outcomes among adults with respiratory syncytial virus infection in high-income countries. Open Forum Infect Dis. 2023;10(11):ofad513. doi:10.1093/ofid/ofad513
7 Britton A. Evidence to recommendations framework (EtR) RSV vaccination in adults aged 20–59 years. Published April 16, 2025.
8 Centers for Disease Control and Prevention. CDC updates RSV vaccination recommendation for adults. Updated August 30, 2024. Accessed June 6, 2025. https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html
9 Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP). ACIP recommendations. Updated May 15, 2025. Accessed July 3, 2025. https://www.cdc.gov/acip/vaccine-recommendations/index.html#cdc_toolkit_main_toolkit_cat_1-recent-meeting-recommendations

Spikevax® (COVID-19 Vaccine, mRNA)

When protection is needed against new COVID-19 variants, Spikevax updates1,2*

Spikevax. Made to evolve.
The virus that causes COVID-19 is constantly changing.1 So we've updated our vaccine.2

Available in a pre-filled syringe.
Spikevax comes frozen in a single dose of 0.25 mL and 0.5 mL.2

Flexible storage on your terms.
Keep frozen up to the expiration date or thawed in the refrigerator for up to 60 days.2

Get your vaccine supply for the season.

*Update is consistent with VRBPAC guidance.3

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.

References

1 Centers for Disease Control. About COVID-19. Updated June 13, 2024. Accessed July 25, 2025. https://www.cdc.gov/covid/about/index.html
2 Spikevax. Prescribing Information. ModernaTX, Inc.
3 Food and Drug Administration. COVID-19 vaccines (2025-2026 Formula) for use in the United States beginning in fall 2025. Updated May 22, 2025. Accessed August 7, 2025. https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025

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