Dosing & Uses
Dosage Forms & Strengths
injection, suspension
- 0.3mL per single-dose vial or prefilled syringe
COVID-19 Disease Prevention
Indicated for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals aged ≥12 years
0.3 mL IM as a single dose
If previously vaccinated with any COVID-19 vaccine, administer at least 2 months after last vaccine dose
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
injection, frozen suspension concentrate
- Requires dilution before administration
- Aged 6 months through 4 years: Yellow cap and label border; after dilution yields three (0.3-mL) doses/vial
injection, suspension (single-dose vial)
- Do not dilute
- Aged 5-11 years: Blue cap and label border; withdraw a single 0.3- mL dose
- Discard vial and any excess volume
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
- Use vial with yellow cap and label (must dilute)
-
Not previously vaccinated with a COVID-19 vaccine
- 3 dose primary series: 0.3 mL IM each
- Dose1: Week 0
- Dose 2: Week 3
- Dose 3: ≥8 weeks after dose 2
-
Previously vaccinated with 1 dose of Pfizer COVID-19 mRNA vaccine
- 2 doses: 0.3 mL IM each
- Dose 1: 3 weeks after previous dose of Pfizer COVID-19 vaccine
- Dose 2: ≥8 weeks after dose 1
-
Previously vaccinated with 2-4 doses of Pfizer COVID-19 mRNA vaccine
- Single dose: 0.3 mL IM ≥8 weeks after last previous COVID-19 vaccine dose
5-11 years
- Use vial with blue cap and label (do not dilute)
- Single dose: 0.3 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 5-11 years
-
Dose 1
- Pain at the injection site, mild-severe (0.3-58.9%)
- Fatigue, mild-severe (0.3-22%)
- Headache, mild-severe (0.1-16.5%)
-
Dose 2
- Pain at the injection site, mild-severe (0.3-52.8%)
- Fatigue, mild-severe (0.7-21.4%)
- Headache, mild-severe (0.2-18.7%)
Aged 12-15 years
-
Dose 1
- Pain at the injection site, mild-severe (1-43.7%)
- Fatigue, mild-severe (1.3-34.1%)
- Headache, mild-severe (1-32%)
- Chills, mild-severe (0.4-17.3%)
- New or worsened muscle pain, mild-severe (0.2-12.9%)
-
Dose 2
- Pain at the injection site, mild-severe (0.6-42.5%)
- Fatigue, mild-severe (2.4-42.7%)
- Headache, mild-severe (2-35%)
- Chills, mild-severe (1.8-20.1%)
- New or worsened muscle pain, mild-severe (0.5-18%)
Aged 16-55 years
-
Dose 1
- Pain at the injection site, mild-severe (1.3-50.5%)
- Headache, mild-severe (1.1-27.1%)
- Fatigue, mild-severe (1.4-26.2%)
- New or worsened muscle pain, mild-severe (0.5-12.2%)
- Chills, mild-severe (0.5-11.7%)
-
Dose 2
- Pain at the injection site, mild-severe (1.5-47.5%)
- Fatigue, mild-severe (2.4-35.4%)
- Headache, mild-severe (3.4-26.1%)
- New or worsened muscle pain, mild-severe (2.3-20.6%)
- Chills, mild-severe (2.6-17.8 %)
- New or worsened joint pain, mild-severe (1-11.9%)
Aged ≥56 years
-
Dose 1
- Pain at the injection site, mild-severe (0.2-55.2%)
- Fatigue, mild-severe (0.1-20.7%)
- Headache, mild-severe (0.1-19%)
- New or worsened muscle pain, mild-severe (1.1-15.5%)
-
Dose 2
- Pain at the injection site, mild-severe (0.5-46.9%)
- Fatigue, mild-severe (0.1-26.7%)
- Headache, mild-severe (0.7-24.9%)
- Chills, mild-severe (1.1-12.3 %)
1-10%
Aged 5-11 years
-
Dose 1
- Injection site redness, mild-severe (5.2-9.5%)
- New or worsened muscle pain, mild-severe (0.1-6.4%)
- Injection site swelling, mild-severe (0.1-5.6%)
- Diarrhea, mild-severe (0.7-5.2%)
- Chills, mild-severe (1.1-3.6%)
- New or worsened joint pain, mild-severe (1.1-2.3%)
- Vomiting, mild-severe (0.5-1.7%)
- Fever (≥38°C) (0.2-1.5%)
-
Dose 2
- Injection site redness, mild-severe (0.2-9.5%)
- Injection site swelling, mild-severe (7.5-7.8%)
- New or worsened muscle pain, mild-severe (0.1-7.7%)
- Chills, mild-severe (0.1-7%)
- Diarrhea, mild-severe (0.5-4.8%)
- New or worsened joint pain, mild-severe (1.4-3.8%)
- Fever (≥38°C) (0.1-3.4%)
- Vomiting, mild-severe (0.1-1.8%)
Aged 12-15 years
-
Dose 1
- Diarrhea, mild-severe (1.2-6.8%)
- Fever (≥38°C) (0.1-6.6%)
- New or worsened joint pain, mild-severe (0.1-5.9%)
- Diarrhea, mild-severe (0.5-5.4%)
- Injection site redness, mild-severe (0.1-3.9%)
- Injection site swelling, mild-severe (2-4.9%)
- Vomiting, mild-severe (0.1-2.7%)
-
Dose 2
- Fever (≥38°C) (2.3-9.8%)
- New or worsened joint pain, mild-severe (0.4-8.3%)
- Injection site swelling, mild-severe (1.6-3.3%)
- Injection site redness, mild-severe (2.4-2.6%)
- Vomiting, mild-severe (0.4-2.3%)
Aged 18-55 years
-
Dose 1
- Diarrhea, mild-severe (0.1-8.7%)
- New or worsened joint pain, mild-severe (0.2-6.9%)
- Injection site swelling, mild-severe (0.2-4.3%)
- Injection site redness, mild-severe (0.2-3.9%)
- Fever (≥38°C) (0.3-3%)
- Vomiting, mild-severe (0.2-1%)
-
Dose 2
- Fever (≥38°C) (1.5-9.5%)
- Diarrhea, mild-severe (0.2-8.2%)
- Injection site swelling, mild-severe (0.3-4.1%)
- Injection site redness, mild-severe (0.4-3.4%)
- Vomiting, mild-severe (0.1-1.6%)
Aged >56 years
-
Dose 1
- New or worsened muscle pain, mild-severe (4.5-9.1%)
- Diarrhea, mild-severe (0.2-6.8%)
- New or worsened joint pain, mild-severe (0.1-5.9%)
- Chills, mild-severe (1.4-5.1 %)
- Injection site swelling, mild-severe (0.1-4.3%)
- Injection site redness, mild-severe (0.2-3.5%)
- Fever (≥38°C) (0.1-1.1%)
- Vomiting, mild-severe (0.4%)
-
Dose 2
- New or worsened joint pain, mild-severe (0.5-9.8%)
- Fever (≥38°C) (0.4-8.5%)
- Diarrhea, mild-severe (0.1-6.7%)
- Injection site swelling, mild-severe (0.2-4.3%)
- Injection site redness, mild-severe (0.5-3.5%)
<1%
Malaise (0.5%)
Lymphadenopathy (0.3%)
>56 years
-
Dose 1
- Vomiting, mild-severe (0.4%)
-
Dose 2
- Vomiting, mild-severe (0.1-0.5%)
Postmarketing Experience
Cardiac disorders: Myocarditis, pericarditis
Gastrointestinal disorders: Diarrhea, vomiting
Immune system disorders: Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema)
Musculoskeletal and connective tissue disorders: Pain in extremity (arm)
Warnings
Contraindications
Known history of severe allergic reaction (eg, anaphylaxis) to any component in vaccine
Cautions
Appropriate treatment used to manage immediate allergic reactions must be immediately available if an acute anaphylactic reaction occurs following administration
Syncope (fainting) may occur; procedures should be in place to avoid injury from fainting
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response
May not protect all vaccine recipients
Myocarditis and pericarditis
- May increase risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
- Risk is higher among adolescent and adult males aged <40 years than among females and older males, and the observed risk is highest in males aged 12-17 years
- Available data suggest that majority of symptoms resolved 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
Pregnancy registry
- Monitors pregnancy outcomes in women exposed to vaccine during pregnancy
- Encourage females who are vaccinated during pregnancy to enroll in the registry
Clinical considerations
- Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with nonpregnant individuals
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
IM Preparation
Multiple-dose vials
- Yellow caps and labels
- Add 1.1 mL of sterile 0.9% NaCl into vial
- Before removing needle from vial, equalize vial pressure by withdrawing air into the empty diluent syringe
- Record date and time of dilution on vial label
- Store at 2-25ºC (35-77ºF) and discard after 12 hr
- After dilution, multiple-dose vials contain 3 doses of 0.3 mL each
- If the amount of vaccine in vial cannot provide a full dose of 0.3 mL, discard vial and any excess volume; do not pool excess vaccine from multiple vials
Single-dose vials
- Do not dilute
- Thaw vial in refrigerator at 2-8ºC (35-46ºF) or at room temperature (up to 25ºC [77ºF])
- Before use, mix by inverting vial gently 10 times; do not shake
- Discard vial and any excess volume
Single-dose prefilled syringes
- Thaw syringe in carton in refrigerator at 2-8ºC (35-46ºF) or at room temperature (up to 25ºC [77ºF])
- Do not remove syringe from carton to thaw
- Do not shake
- Remove tip cap and attach a sterile needle
Inspect vial/syringe
- Inspect visually for particulate matter and discoloration before administration
- Vaccine will be a white to off-white suspension
- Discard if discolored or contains particulate matter
IM Administration
Administer by IM injection
Storage
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light
Do not refreeze thawed vials or prefilled syringes
Frozen vials or syringes before use
- Vials may arrive frozen at ultra-cold conditions in thermal containers with dry ice
- Once received, remove vial cartons immediately from the thermal container and transfer to refrigerator at 2-8C (35-46F), thawed and stored for up to 10 weeks
- Alternatively, may store in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF)
- Do not store vials and syringes at vials may be stored at -25ºC to -15ºC (-13ºF to 5ºF)
Refrigerated vials or syringes before use
- If vials and prefilled syringes are received refrigerated at 2-8ºC (35-46ºF), they should be stored refrigerated
- Check that the carton has been previously updated to reflect the 10-week refrigerated expiry date
Images
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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