Dosing & Uses
Dosage Forms & Strengths
injection, suspension
- 100mcg/0.5mL (red cap and label with light blue 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
Moderately or severely immunosuppressed: Administer a third primary dose at least 4 weeks after second dose
4-8 week interval between primary 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
Booster dose
- Administer either Pfizer or Moderna omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster at least 2 months after completion of primary vaccination or most recent booster dose with any authorized/approved monovalent COVID-19 vaccine
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
- EUA updated on December 8th, 2022
- 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
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Booster dose
Administer Moderna bivalent COVID-19 vaccine booster at least 2 months after completing a primary series with the monovalent Moderna COVID-19 vaccine
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
-
Booster 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
-
4-8 week interval between primary 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 and others who need rapid protection owing increased concern about community transmission or risk of severe disease
- CDC COVID-19 vaccine interim immunization schedule
-
Booster dose
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 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)
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
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.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
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
Monitor for immediate adverse reactions according to CDC guidelines
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
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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)
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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
Images
Formulary
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Adding plans allows you to:
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- Compare formulary status to other drugs in the same class.
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