Spikevax

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Spikevax Generic Name & Formulations

    Legal Class

    Rx

    General Description

    COVID-19 vaccine (mRNA); contains 100mcg of nucleoside-modified mRNA encoding the viral spike S glycoprotein of SARS-CoV-2; per 0.5mL; susp for IM inj; preservative-free.

    Pharmacological Class

    COVID-19 vaccine.

    How Supplied

    Multiple-dose vials (5.5mL, 7.5mL)—10

    Storage

    Frozen Storage

    • Store frozen between -50°C to -15°C (-58°F to 5°F).

    Storage after Thawing

    • Storage at 2°C to 8°C (36°F to 46°F): 

      • Vials may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to first use. 

      • Vials should be discarded 12 hours after the first puncture. 

    • Storage at 8°C to 25°C (46°F to 77°F): 

      • Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours. 

      • Vials should be discarded 12 hours after the first puncture. o Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours. 

    Do not refreeze once thawed.

    Manufacturer

    Moderna, Inc.

    Generic Availability

    NO

    Mechanism of Action

    The nucleoside-modified mRNA in Spikevax is formulated in lipid particles, which enable delivery of the mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.

    Spikevax Indications

    Indications

    Active immunization to prevent COVID-19 in individuals ≥18yrs of age.

    Spikevax Dosage and Administration

    Adult

    Give by IM inj only. ≥18yrs: 0.5mL given as a 2-dose series 1 month apart.

    Children

    <18yrs: not established.

    Administration

    Preparation for Administration 

    • Multiple-Dose Vial Containing 5.5 mL

      • Thaw in Refrigerator: Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours and 30 minutes. Let each vial stand at room temperature for 15 minutes before administering.

      • Thaw at Room Temperature: Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 1 hour.

    • Multiple-Dose Vial Containing 7.5 mL

      • Thaw in Refrigerator: Thaw between 2°C to 8°C (36°F to 46°F) for 3 hours. Let each vial stand at room temperature for 15 minutes before administering.

      • Thaw at Room Temperature: Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 1 hour and 30 minutes.

    • After thawing, do not refreeze.

    Spikevax Contraindications

    Not Applicable

    Spikevax Boxed Warnings

    Not Applicable

    Spikevax Warnings/Precautions

    Warnings/Precautions

    Have epinephrine inj available. Increased risks of myocarditis and pericarditis (esp. within 7 days after the second dose); higher risk among males <40yrs of age, and highest among males 18–24yrs of age. Syncope. Immunocompromised. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have appropriate medical treatment available to manage immediate allergic reactions in the event an acute anaphylactic reaction occurs after administration.

    Myocarditis and Pericarditis

    • Increased risks of myocarditis and pericarditis especially within 7 days after the second dose.

    • Higher risk among males <40yrs of age, and highest risk among males 18–24yrs of age. Short-term follow-up showed that most individuals had resolution of symptoms with conservative management, while some cases required intensive care support.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting.

    Altered Immunocompetence

    • May have diminished immune response to Spikevax among immunocompromised persons, including those receiving immunosuppressive therapy.

    Limitations of Vaccine Effectiveness

    • May not protect all vaccine recipients.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Spikevax during pregnancy. Women who are vaccinated with Spikevax during pregnancy are encouraged to enroll in the registry by calling 1-866-MODERNA (1-866-663-3762).

    Risk Summary

    • Available data on Spikevax administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. 

    Nursing Mother Considerations

    Risk Summary

    • It is not known whether Spikevax is excreted in human milk.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Spikevax and any potential adverse effects on the breastfed infant from Spikevax or from the underlying maternal condition.

    Pediatric Considerations

    • Safety and efficacy have not been established in individuals less than 18 years of age.

    Spikevax Pharmacokinetics

    See Literature

    Spikevax Interactions

    Interactions

    Immunosuppressants: may get suboptimal response.

    Spikevax Adverse Reactions

    Adverse Reactions

    Inj site reactions (eg, pain, swelling, tenderness, erythema), fatigue, headache, muscle pain, chills, joint pain, fever, nausea/vomiting.

    Spikevax Clinical Trials

    Clinical Trials

    The approval was based on data from the ongoing randomized, placebo-controlled, observer-blind phase 3 clinical trial which evaluated the efficacy, safety, and immunogenicity of Spikevax in adults 18 years of age and older in the US. The study excluded patients who were immunocompromised and with a known history of SARS-CoV-2 infection. A total of 30,415 patients were randomly assigned equally to receive 2 doses of Spikevax or saline placebo 1 month apart.

    Efficacy Against COVID-19

    • Spikevax was 93.2% (95% CI, 91.0-94.8) effective at preventing COVID-19 in participants 18 years of age and older starting 14 days after the second dose. There were 55 cases of COVID-19 in the Spikevax group and 744 cases in the placebo group. 

    • Spikevax was 98.2% (95% CI, 92.8-99.6) effective at preventing severe disease. There were 2 cases of severe COVID-19 in the Spikevax group and 106 cases in the placebo group.

    Spikevax Note

    Notes

    To enroll in the pregnancy exposure registry, call (866) 663-3762.

    Spikevax Patient Counseling

    See Literature

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