mNEXSPIKE was studied in a noninferiority trial:
Safety results1
Solicited local adverse reactions within 7 days* after mNEXSPIKE compared to Spikevax (solicited safety set)1†
or tenderness
Participants aged 12-17 years
or tenderness
Participants aged 18-64 years
or tenderness
Participants aged 65 years and older
or tenderness
- Pain at the injection site was the most frequently observed solicited local adverse reaction for all groups1
- Solicited local adverse reactions reported following vaccine administration had a median duration of 2 days for mNEXSPIKE and 2 to 3 days for Spikevax1
Solicited systemic adverse reactions within 7 days* after mNEXSPIKE compared to Spikevax (solicited safety set)1
12-17 years | 18-64 years | ≥65 years | ||||
|---|---|---|---|---|---|---|
Systemic adverse reactions | mNEXSPIKE(10 µg)
n=497n (%) | Spikevax(50 µg)n=495n (%) | mNEXSPIKE(10 µg)
n=3573n (%) | Spikevax(50 µg)n=3574n (%) | mNEXSPIKE(10 µg)
n=1632n (%) | Spikevax(50 µg)n=1637n (%) |
Fatigue | 47.3 | 50.7 | 54.3 | 52.5 | 43.0 | 41.0 |
Fatigue, Grade 3 | 6.8 | 4.4 | 4.8 | 4.4 | 3.6 | 2.5 |
Headache | 54.5 | 58.0 | 47.8 | 44.3 | 33.1 | 29.3 |
Headache, Grade 3 | 7.0 | 4.0 | 2.5 | 2.1 | 1.3 | 1.3 |
Myalgia | 39.2 | 36.0 | 41.6 | 41.1 | 30.5 | 28.5 |
Myalgia, Grade 3 | 5.6 | 3.4 | 4.0 | 2.9 | 2.0 | 1.6 |
Arthralgia | 23.9 | 23.6 | 32.4 | 30.6 | 25.6 | 22.4 |
Arthralgia, Grade 3 | 2.0 | 1.2 | 2.4 | 1.7 | 1.5 | 1.3 |
Chills | 31.6 | 31.9 | 24.3 | 21.3 | 16.5 | 12.8 |
Chills, Grade 3 | 1.2 | 0.2 | 0.7 | 0.6 | 0.6 | 0.5 |
Nausea/vomiting | 16.1 | 17.6 | 13.8 | 11.9 | 7.3 | 7.0 |
Nausea/vomiting, Grade 3 | 0 | 0.4 | 0.1 | <0.1 | 0.1 | 0.3 |
Fever | 9.9 | 9.3 | 5.4 | 3.9 | 4.6 | 4.3 |
Fever, Grade 3 | 0.8 | 0.4 | 0.8 | 0.5 | 0.1 | 0.6 |
Fever, Grade 4 | 0 | 0 | 0 | 0 | 0 | <0.1 |
Use of antipyretic or pain medication | 37.4 | 42.6 | 34.8 | 34.3 | 26.3 | 24.0 |
- Fatigue, headache, and myalgia were the most frequently observed solicited systemic adverse reactions for all groups1
- Solicited systemic adverse reactions reported following vaccine administration had a median duration of 2 days for mNEXSPIKE and 2 to 3 days for Spikevax1
- Serious adverse events were reported by 2.7% of participants (n=156) who received mNEXSPIKE and 2.6% of participants (n=151) who received Spikevax1
- There were no serious adverse events considered causally related to mNEXSPIKE1
- There were no notable patterns or imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to mNEXSPIKE1
*7 days included the day of vaccination and the subsequent 6 days. Events were collected in the electronic diary (e-diary).1
†No Grade 4 adverse reactions were reported.1
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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 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.
Reference
- mNEXSPIKE Prescribing Information. ModernaTX, Inc.
Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure