Dosing & Uses
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
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)
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
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.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
- 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
Images
Formulary
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