mNEXSPIKE DEMONSTRATED A SAFETY PROFILE COMPARABLE TO SPIKEVAX1
- Rates of solicited systemic adverse reactions were generally similar between the 2 vaccines
- Fatigue, headache, and myalgia were the most frequently observed solicited systemic adverse reactions for both groups
- Solicited systemic adverse reactions reported following vaccine administration had a median duration of 2 days for mNEXSPIKE and 2 to 3 days for Spikevax
- Serious adverse reactions were reported by 2.7% of participants (n=156) who received mNEXSPIKE and 2.6% of participants (n=151) who received Spikevax
- There were no serious adverse reactions considered causally related to mNEXSPIKE
- There were no notable patterns or imbalances between treatment groups for specific categories of adverse reactions that would suggest a causal relationship to mNEXSPIKE
In a subgroup analysis, mNEXSPIKE showed generally fewer local adverse reactions for patients aged 65+
or tenderness
or tenderness
Solicited systemic adverse reactions within 7 days* after mNEXSPIKE compared to Spikevax for 65+ (solicited safety set)†
Systemic adverse reactions | mNEXSPIKE (10 µg)
n=1632n (%) | Spikevax (50 µg)n=1637n (%) |
|---|---|---|
Fatigue | 43.0 | 41.0 |
Fatigue, Grade 3 | 3.6 | 2.5 |
Headache | 33.1 | 29.3 |
Headache, Grade 3 | 1.3 | 1.3 |
Myalgia | 30.5 | 28.5 |
Myalgia, Grade 3 | 2.0 | 1.6 |
Arthralgia | 25.6 | 22.4 |
Arthralgia, Grade 3 | 1.5 | 1.3 |
Chills | 16.5 | 12.8 |
Chills, Grade 3 | 0.6 | 0.5 |
Nausea/vomiting | 7.3 | 7.0 |
Nausea/vomiting, Grade 3 | 0.1 | 0.3 |
Fever | 4.6 | 4.3 |
Fever, Grade 3 | 0.1 | 0.6 |
Fever, Grade 4 | 0 | <0.1 |
Use of antipyretic or pain medication | 26.3 | 24.0 |
*7 days included the day of vaccination and the subsequent 6 days. Events were collected in the electronic diary (e-diary).
†No Grade 4 adverse reactions were reported.
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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 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