COVID-19 vaccine, mRNA-Moderna (Rx)

Brand and Other Names:Spikevax

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension

  • Aged ≥12 years
  • 0.5mL single-dose vial or prefilled syringe
  • 2.5 mL multiple-dose vial (contains 5 doses)

COVID-19 Disease Prevention

Indicated for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals aged ≥12 years

0.5 mL IM as a single dose

If previously vaccinated with any COVID-19 vaccine, administer at least 2 months after last vaccine dose

Immunosuppressed individuals

  • For individuals with certain kinds of immunocompromise (ie, solid organ transplantation or conditions that are considered to have equivalent level of immunocompromise), an additional dose may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 formula)
  • Additional doses of may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances
  • The timing of additional doses are based on the individual’s clinical circumstances

2023-2024 vaccine components

  • Monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant (ie, XBB.1.5)

Dosing Considerations

Limitation of effectiveness: May not protect all vaccine recipients

Dosage Forms & Strengths

injectable, suspension

  • Aged 6 months through 11 years (vial with dark blue cap): 0.25mL single-dose vial

COVID-19 Disease Prevention

September 2023: EUA issued for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 6 months through 11 years

<6 months Safety and efficacy not established

2023-2024 vaccine components

  • Monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant (ie, XBB.1.5)

6 months through 4 years

  • Not previously vaccinated with a COVID-19 vaccine
    • 2 doses primary series: 0.25 mL IM x 2 doses 1 month apart
    • Individuals turning from 4 years to 5 years of age during the vaccination series should receive both doses with Moderna COVID-19 vaccine (2023-2024 formula)
  • Previously vaccinated with 1 dose of Moderna COVID-19 mRNA vaccine
    • Single dose: 0.25 mL IM 1 month after previous dose of Moderna COVID-19 vaccine
  • Previously vaccinated with ≥2 dose of Moderna COVID-19 mRNA vaccine
    • Single dose: 0.25 mL IM 2 months after previous dose of Moderna COVID-19 vaccine

5-11 years

  • Single dose: 0.25 mL IM
  • Administer ≥2 months after receipt of last previous COVID-19 vaccine

12-17 years

  • See Adult Dosing

Immunosuppressed individuals

  • Individuals with certain kinds of immunocompromise aged 6 months through 11 years should complete at least a 3-dose series with a COVID-19 vaccine, each dose one month apart (at least 1 dose should be with a COVID-19 vaccine (2023-2024 formula)
  • If previously not vaccinated, complete the 3-dose series with COVID-19 vaccine (2023-2024 formula)
  • If previously vaccinated with 1-2 dose(s): Complete the remaining dose(s) in the 3-dose series with 2023-2024 formula
  • If previously vaccinated with ≥3 doses, administer a single dose of 2023-2024 formula ≥2 months following last previous dose

Dosing Considerations

Limitation of effectiveness: May not protect all vaccine recipients

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Adverse Effects

VAERS Reporting

Mandatory for vaccination providers to report to the vaccine adverse events reporting system (VAERS) all vaccine administration errors, serious adverse events, cases of myocarditis, cases of pericarditis, multisystem inflammatory syndrome in adults and children, and cases of COVID-19 that result in hospitalization or death

>10%

Aged 18-64 years

  • Injection site pain (93.3%)
  • Fatigue (71.9%)
  • Headache (68.7%)
  • Myalgia (64.8%)
  • Arthralgia (48.6%)
  • Nausea/vomiting (25.7%)
  • Axillary swelling/tenderness (22.2%)
  • Fever (17.3%)
  • Injection site swelling (15.4%)
  • Injection site erythema (10.5%)

Aged ≥65 years

  • Injection site pain (88.3%)
  • Fatigue (64.8%)
  • Headache (53.3%)
  • Myalgia (51.8%)
  • Arthralgia (40.2%)
  • Chills (32.7%)
  • Nausea/vomiting (15%)
  • Injection site swelling (13%)
  • Axillary Swelling/tenderness (12.7%)

Post Authorization Experience

Cardiac disorders: Myocarditis, pericarditis

Immune system disorders: Anaphylaxis

Nervous system disorders: Syncope

Unsolicited Adverse Events During Clinical Trial

Lymphadenopathy related events: 1.7% vaccine; 0.8% placebo

Hypersensitivity: 6 participants with vaccine; none with placebo

Delayed injection site reactions >7 days postinjection: 1.4% vaccine; 0.7% placebo

Facial paralysis (including Bell palsy): 8 cases vaccine; 3 case placebo (data insufficient to determine causal relationship with vaccine)

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Warnings

Contraindications

Known history of severe allergic reaction (eg, anaphylaxis) to any component in vaccine

CDC listed contraindications

  • CDC has listed the following contraindications
  • Severe allergic reaction after previously receiving mRNA COVID-19 vaccine or its components
  • Allergic reaction (of any severity) immediately after receiving mRNA COVID-19 vaccine or its components, including polyethylene glycol (PEG)
  • Immediate allergic reaction (of any severity) to polysorbate (due to potential cross-reactive hypersensitivity with vaccine ingredient PEG)

Cautions

Appropriate treatment used to manage immediate allergic reactions must be immediately available if an acute anaphylactic reaction occurs following administration

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to vaccine

Syncope (fainting) may occur; procedures should be in place to avoid injury from fainting

Vaccine may not protect all vaccine recipients

Vaccination providers enrolled in the federal COVID-19

Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of multisystem inflammatory syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine

Myocarditis and pericarditis

  • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose
  • Risk is higher among adolescent and adult males aged <40 yr than among females and older males; risk is highest in males aged 18-24 yr
  • Some cases required intensive care support, although available data from short-term follow-up suggest most individuals had symptom resolution with conservative management
  • The CDC has published clinical considerations relevant to myocarditis and pericarditis with mRNA COVID-19 vaccines

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Pregnancy & Lactation

Pregnancy

A growing body of evidence on the safety and effectiveness of COVID-19 vaccination indicates that the benefits of vaccination outweigh any known or potential risks of COVID-19 vaccination during pregnancy

Recent studies have also shown that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, and COVID-19 vaccination of people who are pregnant reduces the risk of COVID-19 hospitalization in infants younger than 6 months

CDC guidelines for vaccination of pregnant or lactating females

Animal data

  • Vaccine administered IM to female rats 28 and 14 days prior to mating, and on gestation days 1 and 13
  • No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported

Clinical considerations

  • Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with nonpregnant individuals

Pregnancy registry

  • Monitors pregnancy outcomes in women exposed to vaccine during pregnancy
  • Encourage females who are vaccinated during pregnancy to enroll in the registry

Lactation

Unknown whether vaccine is excreted in human milk

Data are unavailable to assess the effects on breastfed infants or milk production/excretion

For preventive vaccines, underlying maternal condition is susceptibility to disease prevented by the vaccine

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; formulated in lipid particles, which enable delivery of RNA into host cells to allow expression of the SARS-CoV-2 S antigen

Elicits an immune response to the S antigen, which protects against COVID-19

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Administration

IM Preparation

Thaw

  • Refrigerator: Thaw for 45 hr; let each vial stand at room temperature for 15 minutes before administering
  • Room temperature: Thaw for 15 minutes
  • After thawing, do not refreeze

Inspect contents

  • Suspension should appear white to off-white
  • It may contain white or translucent product-related particulates
  • Do not administer if vaccine is discolored or contains other particulate matter

Prepare dose

  • Swirl vial gently after thawing and between each withdrawal
  • Do not shake
  • Do not dilute

Prefilled syringe

  • Do not shake
  • Do not dilute
  • Use appropriate size sterile needle for IM injection
  • With tip cap upright, remove tip cap by twisting counterclockwise until tip cap releases
  • Remove tip cap in a slow, steady motion; avoid pulling tip cap while twisting
  • Attach needle by twisting in clockwise direction until needle fits securely on syringe

IM Administration

For IM injection only

Monitor for immediate adverse reactions according to CDC guidelines

Storage

Minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light

Frozen storage

  • Freeze between -50 to -15ºC (-58 to 5ºF)

Storage after thawing

  • Do not refreeze once thawed
  • Multiple dose vial: Record date and time of first use on vial label; discard after 12 hr
  • Thawed vials can be handled in room light conditions
  • Storage at 2-8ºC (36-46ºF): Refrigerate for up to 30 days before first use
  • Storage at 8-25ºC (46-77ºF): Vials may be stored for up to 24 hr (total storage time at this temperature range)
  • Vial storage during use: Store at 2-25ºC (36-77ºF); record date and time of first use on vial label

Transport

  • If transport at -50 to -15ºC (-58 to 5ºF) is not feasible, may transport thawed vials for up to 12 hr at 2-8ºC (36-46ºF)
  • Do not refreeze, continue storage at 2-8ºC (36-46ºF) until use
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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.