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WHEN PROTECTION IS NEEDED AGAINST NEW COVID-19 VARIANTS, SPIKEVAX UPDATES.*

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* Update is consistent with VRBPAC guidance.

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Spikevax (Original) was proven effective in adults starting 14 days after dose 2 of primary series1*

COVE study results*: proven protection confirmed by RT-PCR1.

Severe cases of COVID-19 were defined based on confirmed COVID-19 as per the primary efficacy endpoint case definition plus any of the following1‡:

Clinical signs indicative of severe systemic illness, respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room air at sea level or PaO2/FIO2 <300 mm Hg; or respiratory failure or ARDS (defined as needing high-flow oxygen, non-invasive or mechanical ventilation, or ECMO), evidence of shock (systolic BP <90 mm Hg, diastolic BP <60 mm Hg or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; or admission to an intensive care unit or death.

Primary endpoint subgroup analyses2

93.4%

effective against COVID-19 at 4 months in adults aged 18-64 years studied1

(n=10,661)

Primary endpoint subgroup analyses2

91.5%

effective against COVID-19 at 4 months in adults aged ≥65 years studied1

(n=3626)

Secondary endpoint2

98.2%

effective in preventing severe cases of COVID-19 in adults aged ≥18 years studied1

(n=14,287)


Spikevax safety from clinical studies1

Most commonly reported adverse reactions following administration of Spikevax (Original) or Moderna COVID-19 Vaccine, Bivalent containing the same amount of mRNA as the Spikevax 2023-2024 Formula (≥10%):

Adverse reactions18-64 years of age65 years and older
Pain at the injection siteup to 86.3%up to 76.3%
Fatigueup to 62.0%up to 58.1%
Headacheup to 58.9%up to 42.1%
Myalgiaup to 49.6%up to 47.4%
Arthralgiaup to 41.9%up to 39.5%
Chillsup to 40.3up to 18.4%
Axillary swelling/tendernessup to 24.8%up to 14.3%
Nausea/vomiting up to 16.7%<10%

Spikevax clinical study design

StudyCOVE1-3Bivalent1-4

Objective

1:1 randomized, stratified, observer-blind, placebo-controlled study, comparing Spikevax (Original) primary series (mRNA 100 mcg per dose) vs placebo

Open-label, phase 2/3 study, comparing Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster (mRNA 50 mcg per dose) vs Spikevax (Original) booster (mRNA 50 mcg per dose)

Subjects

30,346 adults aged ≥18 years

819 adults aged ≥18 years

Primary endpoints

Safety and efficacy of Spikevax in preventing COVID-19 (confirmed by a RT-PCR test)

Reactogenicity of 2 injections of Spikevax given 1 month apart

Safety and reactogenicity of Moderna COVID-19 Vaccine, Bivalent and Spikevax (Original)

Secondary endpoints

Prevention of severe COVID-19*

Noninferiority (on the basis of the difference in the percentage of participants with a seroresponse) against ancestral SARS-CoV-2 28 days after the second booster


Efficacy footnotes

*Median length of follow-up was 4 months. Data analysis prior to the emergence of the Delta and Omicron variants.

†Effectiveness is defined as preventing COVID-19, which was defined according to the following criteria: The participant must have experienced ≥2 of the following systemic symptoms: fever (≥38 °C/≥100.4 °F), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s); or the participant must have experienced ≥1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographic evidence of pneumonia; and the participant must have ≥1 NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR.

‡Severe cases of COVID-19 were defined based on confirmed COVID-19 as per the primary efficacy endpoint case definition plus any 1 other item.

ARDS = acute respiratory distress syndrome

BP = blood pressure

COVID-19 = coronavirus disease 2019

ECMO = extracorporeal membrane oxygenation

FIO2 = fraction of inspired oxygen

NP = nasopharyngeal

PaO2 = partial pressure of oxygen; RT-PCR, reverse transcription polymerase chain reaction

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

SpO2 = oxygen saturation

Study design footnotes

*Severe cases of COVID-19 were defined based on confirmed COVID-19 as per the primary efficacy endpoint case definition, plus any of the following: Clinical signs indicative of severe systemic illness, respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room air at sea level or PaO2/FIO2 <300 mm Hg; or respiratory failure or ARDS (defined as needing high-flow oxygen, non-invasive or mechanical ventilation, or ECMO), evidence of shock (systolic BP <90 mm Hg, diastolic BP <60 mm Hg or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; or admission to an intensive care unit or death. 

†Subjects had previously received two 100-mcg doses of the Spikevax (Original) primary series and one 50-mcg dose Spikevax (Original) primary series booster ≥3 months before enrollment.

See above for abbreviations
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) in individuals 12 years of age and older.

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 demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 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 following any dose in any indicated patient population were pain at the injection site, fatigue, headache, myalgia, chills, arthralgia, 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 www.vaers.hhs.gov.

Please click for SPIKEVAX Full Prescribing Information.


References

  1. Spikevax Prescribing Information. Moderna; 2024.
  2. Baden, L. et al., "Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine," New England Journal of Medicine, Vol. 384(5), 2020. https://www.nejm.org/doi/full/10.1056/NEJMoa2035389
  3. Moderna TX. Data on file.
  4. Chalkias, S. et al., "A Bivalent Omicron-Containing Booster Vaccine against Covid-19," New England Journal of Medicine, Vol. 387(14), 2022. https://www.nejm.org/doi/full/10.1056/NEJMoa2208343

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