AdultPediatricDosage Forms & Strengths injection, frozen suspension concentrate Aged ≥12 years (grey cap, no dilution): 30mcg/0.3mL; contains 15 mcg of original (wild-type spike protein) plus 15 mcg of omicron BA.4/BA.5 subvariants spike protein; available as single-dose and multiple dose vials COVID-19 Disease Prevention June 2023: FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the 2023-2024 composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant (ie, XBB.1.5) Emergency use authorization granted August 31, 2022 Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is indicated for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 Primary immunization Not previously vaccinated with a COVID-19 vaccine: 0.3 mL IM as a single dose Age ≥65 years: One additional dose, 0.3 mL, may be administered at least 4 months after first dose of an authorized bivalent COVID-19 vaccine Previously vaccinated with ≥1 doses of monovalent COVID-19 vaccine 0.3 mL IM as a single dose Age ≥65 years: One additional dose, 0.3 mL, may be administered at least 4 months after first dose of an authorized bivalent COVID-19 vaccine Immunosuppressed individuals For individuals with certain kinds of immunocompromise, a single additional dose may be administered at least 2 months following initial dose of a bivalent COVID-19 vaccine Additional doses of bivalent vaccine may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances Dosing Considerations Limitations of effectiveness: May not protect all vaccine recipients Dosage Forms & Strengths injection, frozen suspension concentrate Aged 6 months through 4 years (maroon cap, must dilute): 3mcg/0.2mL (after dilution); contains 1.5 mcg of original (wild-type spike protein) plus 1.5 mcg of omicron BA.4/BA.5 subvariants spike protein; available as multiple dose vials Aged 5-11 years (orange cap, must dilute): 10mcg/0.2mL (after dilution); contains 5 mcg of original (wild-type spike protein) plus 5 mcg of omicron BA.4/BA.5 subvariants spike protein; available as multiple dose vials Aged ≥12 years (grey cap, no dilution): 30mcg/0.3mL; contains 15 mcg of original (wild-type spike protein) plus 15 mcg of omicron BA.4/BA.5 subvariants spike protein; available as single-dose and multiple dose vials COVID-19 Disease Prevention June 2023: FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the 2023-2024 composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant (ie, XBB.1.5) Emergency use authorization granted August 31, 2022 for aged 12-17 years, October 12, 2022 for 5-11 years, and December 8, 2022 for 6 months through 4 years Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is indicated for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in children aged ≥6 months <6 months: Safety and efficacy not established Not previously vaccinated with a COVID-19 vaccine 6 months through 4 years Use maroon cap vial, must dilute 3 dose series: 0.2 mL (3 mcg) IM at 0, 3 weeks, and >8 weeks after 2nd dose 5-11 years Use orange cap vial, must dilute 1 dose: 0.2 mL (10 mcg) IM 12-17 years Use gray cap vial, no dilution required 1 dose: 0.3 mL (30 mcg) IM Aged 6 months through 4 years previously vaccinated with ≥1 doses of Pfizer monovalent COVID-19 mRNA vaccine Use maroon cap vial, must dilute 1 previous dose received 2 doses, 0.2 mL each Dose 1: 3 weeks after receipt of Pfizer monovalent COVID-19 mRNA vaccine Dose 2: ≥8 weeks after Dose 1 2 previous doses received Single dose, 0.2 mL ≥8 weeks after receipt of second dose of Pfizer monovalent COVID-19 mRNA vaccine 3 previous doses received Single dose, 0.2 mL ≥2 months after receipt of third dose of Pfizer monovalent COVID-19 mRNA vaccine Previously vaccinated with ≥1 doses of a monovalent COVID-19 vaccine 5-11 years Use orange cap vial, must dilute Single dose, 0.2 mL ≥2 months after monovalent COVID-19 vaccine 12-17 years Use gray cap vial, no dilution required Single dose, 0.3 mL ≥2 months after monovalent COVID-19 vaccine Immunosuppressed individuals For individuals with certain kinds of immunocompromise aged >5 years, a single additional age-appropriate dose may be administered at least 2 months following initial dose of a bivalent COVID-19 vaccine Additional age-appropriate doses of bivalent vaccine may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances ​ Dosing Considerations Limitations of effectiveness: May not protect all vaccine recipients 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 in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination >10% Injection site pain, mild (52.8%) Fatigue, mild (29.2%) Use of antipyretic/pain medication (29.2%) Headache, mild (23.6%) Fatigue, moderate (18.3%) New/worsened muscle pain, mild (13.3%) 1-10% Headache, moderate (9.6%) New/worsened muscle pain, moderate (9%) Chills, mild (8.3%) New/worsened joint pain, mild (7.6%) Diarrhea, mild (6%) Injection site pain, moderate (5%) Fever ≥38ºC (5%) Swelling, mild (4.7%) Chills, moderate (4.7%) Redness, mild (4.3%) Fever 38-38.4ºC (3.7%) New/worsened joint pain, moderate (3.7%) Redness, moderate (2.7%) Swelling, moderate (2%) Fatigue, mild (1.7%) Vomiting, mild (1.7%) Diarrhea, moderate (1.7%) Diarrhea, severe (1.3%) Fever >38.9-40ºC (1.3%) <1% H3 Injection site pain, severe (0.3%) Headache, severe (0.3%) 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 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 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 vaccinePregnancy 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. 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 IM Preparation Gray top vial (30mcg/0.3mL, no dilution) For aged ≥12 years Thaw in refrigerator for 2 hr (carton of single dose vials), 6 hr (carton of multiple dose vials), and then sit at room temperature for 30 minutes Suspension should appear white to off-white; do not administer if discolored or contains particulate matter Before use, mix by inverting vaccine vial gently 10 times Do not shake Before gently mixing, the thawed vaccine may contain white to off-white opaque amorphous particles; after mixing, it should appear as a white to off-white suspension with no visible particles Orange top vial (must dilute) For aged 5-11 years Thaw vials in refrigerator for 2 hr (carton of single dose vials), 4 hr (carton of multiple dose vials), and then sit at room temperature for 30 minutes Suspension should appear white to off-white; do not administer if discolored or contains particulate matter Before dilution, mix by inverting vaccine vial gently 10 times Do not shake Before gently mixing, the thawed vaccine may contain white to off-white opaque amorphous particles; after mixing, it should appear as a white to off-white suspension with no visible particles Dilute vial contents with 1.3 mL of sterile nonbacteriostatic 0.9% NaCl (not provided); again, mix by gently inverting vial 10 times (do not shake) After dilution, 1 vial contains 10 doses of 0.2 mL Maroon top vial (must dilute) For aged 6 months to 4 years Allow vials to thaw in refrigerator for 2 hr (carton of single dose vials) and then sit at room temperature for 30 minutes Before dilution, gently invert vaccine vial 10 times to mix Do not shake Before gently mixing, the thawed vaccine may contain white to off-white opaque amorphous particles; after mixing, it should appear as a white to off-white suspension with no visible particles Dilute vial contents with 2.2 mL of sterile 0.9% NaCl (not provided); again, mix by gently inverting vial 10 times (do not shake) Suspension should appear white to off-white; do not administer if discolored or contains particulate matter After dilution, 1 vial contains 10 doses of 0.2 mL IM Administration For IM injection only Monitor for immediate adverse reactions according to CDC guidelines Storage Once received, frozen vials may be immediately transferred to refrigerator or frozen in ultra-low temperature freezer Vial storage before use Refrigerate at 2-8ºC (3-46ºF), thaw and store for up to 10 weeks; record expiry date on carton Ultra-low temperature freezer at -90 to -60ºC (-130 to -76ºF) for up to 12 months from the date of manufacture Do NOT store vials in conventional freezer at -25 to -15ºC (-13 to 5ºF) Once vials are thawed, do not refreeze Vial storage during use Before first puncture: May store at room temperature (8-25ºC [46-77ºF]) up to 12 hr After first puncture (multiple dose vial): Store at 2-25ºC (35-77ºF); discard 12 hr after first puncture Transportation of vials If local redistribution needed, vials may be transported at -90 to -60ºC (-130 to -76ºF) or at 2-8ºC (35-46ºF) No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print