COVID-19 vaccine, mRNA-Moderna (Rx)

Brand and Other Names:Spikevax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension

  • Primary series: 100mcg/0.5mL (red cap and label with light blue border)
  • Booster: 50mcg/0.25mL (dark blue cap and label with purple border)

COVID-19 Disease Prevention

Indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged ≥18 years

2-dose primary series: 0.5 mL (100 mcg) IM x2 doses administered 4 weeks apart

Booster 1: At least 5 months after dose 2

Booster 2: At least 4 months after booster dose 1 for persons aged ≥50 yr

4-8 week interval between doses

  • 8-week interval may be optimal for some people aged ≥12 years, especially for males aged 12-39 years owing to the small risk of myocarditis associated with mRNA COVID-19 vaccines
  • Shorter interval (3 weeks) between dose 1 and 2 remains the recommended interval for people who are moderately or severely immunocompromised, adults aged ≥65 years, and others who need rapid protection owing increased concern about community transmission or risk of severe disease
  • CDC COVID-19 vaccine interim immunization schedule June 1, 2022

Moderately or severely immunocompromised patients (EUA)

  • Administer a third primary dose at least 4 weeks after second dose
  • Booster dose 1: At least 3 months after third primary dose
  • Booster dose 2: At least 4 months after booster dose 1

Dosing Considerations

Limitations of effectiveness: May not protect all vaccine recipients

Dosage Forms & Strengths

injectable, suspension

  • Aged 6 months through 5 years: 25mcg/0.25mL (dark blue cap and label with magenta border); multidose vials (contains 10 doses)
  • Aged 6-11 years: 50mcg/0.5mL (dark blue cap and label with purple or teal border) (contains 5 doses)
  • Aged ≥12 years: 100mcg/0.5mL (red cap and label with light blue border)

COVID-19 Disease Prevention

June 17, 2022: Emergency Use Authorization (EUA) 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

<6 months: Safety and efficacy not established

6 months through 5 years

  • June 17, 2022: EUA
  • 2-dose primary series: 0.25 mL (25 mcg) IM x2 doses administered 1 month apart
  • Severely immunocompromised patients: Administer a third primary dose (0.25 mL [25 mcg]) at least 1 month following the second dose

6-11 years

  • June 17, 2022: EUA
  • 2-dose primary series: 0.5 mL (50 mcg) IM x2 doses administered 1 month apart
  • Severely immunocompromised patients: Administer a third primary dose (0.5 mL [50 mcg]) at least 1 month following the second dose

≥12 years

  • June 17, 2022: EUA
  • 2-dose primary series: 0.5 mL (100 mcg) IM x2 doses administered 1 month apart
  • Severely immunocompromised patients: Administer a third primary dose (0.5 mL [100 mcg]) at least 1 month following the second dose
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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, multisystem inflammatory syndrome, and hospitalized or fatal cases of COVID-19 following vaccination

>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 participatns 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

Myocarditis and pericarditis

  • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose
  • Observed risk is higher among 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

Data are insufficient to inform of vaccine-associated risks in pregnancy

Pregnancy registry: Women who are vaccinated with Moderna COVID-19 vaccine during pregnancy are encouraged to enroll in the registry by calling 1-866-MODERNA (1-866-663-3762)

A smartphone app, v-safe, is also available to report adverse effects to the CDC following vaccination with a COVID-19 vaccine

CDC guidelines for vaccination of pregnant or lactating women

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

Lactation

Data are not available to assess effects on breastfed infants or on milk production/excretion

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 frozen suspension before administering

Thaw in refrigerator: 2-8ºC (36-46ºF) for 2.5 hr (5.5-mL vial) or 3 hr (7.5-mL vial); after thawing, let vial stand at room temperature for 15 minutes before administering

Alternatively, thaw at room temperature of 15-25ºC (59-77ºF) for 1 hr (5.5-mL vial) or 1.5 hr (7.5-mL vial)

After thawing, do not refreeze

Do not shake; swirl vial gently after thawing and between each withdrawal

Do not dilute

Suspension is white to off-white and may contain white or translucent product-related particulates

Visually inspect for other particulate matter and/or discoloration administration; discard if either of these conditions exists

Syringes and needles

  • Each primary series dose must contain 0.5 mL
  • Each booster dose must contain 0.25 mL
  • Primary series doses of 0.5 mL and booster doses of 0.25 mL may be extracted from either vial presentation, preferentially using low dead-volume syringes and/or needles
  • Primary series doses/vial
    • Depending on syringes and needles used for each dose, there may be insufficient volume to extract >10 doses from the maximum of 11 doses vial and >13 doses from the maximum of 15 doses vial
    • Do not exceed 20 doses when extracting only booster doses or a combination of primary series and booster doses; do NOT puncture vial stopper >20 times
  • Irrespective of syringe and needle type
    • Discard vial 12 hr after first puncture
    • If vial has been punctured 20 times, discard vial and contents
    • If amount remaining in vial cannot provide a full dose of 0.5 mL or 0.25 mL, discard vial and contents; do not pool excess vaccine from multiple vials
    • Pierce vial at different site each time drawing dose

IM Administration

For IM injection only

Storage

Does not contain preservatives

Vial stoppers are not made with natural rubber latex

Unopened vials

Store in original carton to minimize exposure to room light

  • Frozen
    • Store frozen at -50ºC to -15ºC (-58ºF to 5ºF)
    • Do not store on dry ice or below -50ºC (-58ºF); dry ice may subject vials to temperatures colder than -50ºC (-58ºF)
  • Refrigerated
    • Can be refrigerated at 2-8ºC (36-46ºF) for up to 30 days before first use
    • Do not refreeze
  • Controlled room temperature
    • May be stored at 8-25ºC (46-77ºF) for up to 24 hr
    • Do not refreeze

After first dose withdrawn from vial

  • Refrigerate or store at room temperature at 2-25ºC (36-77ºF)
  • Discard vial after 12 hr
  • Thawed vials can be handled in room light conditions
  • Do not refreeze

Transportation of thawed vials

  • If unable to transport at -50ºC to -15ºC (-58ºF to 5ºF), available data support transportation for up to 12 hr at 2-8ºC (35-46ºF) when shipped using shipping containers qualified to maintain this temperature under routine road and air transport conditions with shaking and vibration minimized
  • After shipping, do not refreeze vials; refrigerate at 2-8ºC (35-46ºF) 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.