AdultPediatricDosage Forms & Strengths injection, suspension 50mcg/0.5mL (multiple dose 2.5mL vial) Each 0.5mL contains 25 mcg of original (wild-type spike protein) plus 25 mcg of omicron BA.4/BA.5 subvariants spike protein 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: 0.5 mL IM as a single dose Age ≥65 years: One additional dose, 0.5 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 0.5 mL IM as a single dose Age ≥65 years: One additional dose, 0.5 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 Limitation of effectiveness: May not protect all vaccine recipientsDosage Forms & Strengths injection, suspension Aged ≥12 years: Dark blue cap and gray label border multiple-dose vial (after thawed yields 5 doses/vial); 50mcg/0.5mL contains 25 mcg of original (wild-type spike protein) plus 25 mcg of omicron BA.4/BA.5 subvariants spike protein Aged 6-11 years: Dark blue cap and gray label border multiple-dose vial (after thawed yields 10 doses/vial); 25mcg/0.25mL contains 12.5 mcg of original (wild-type spike protein) plus 12.5 mcg of omicron BA.4/BA.5 subvariants spike protein Aged 6 months through 5 years: Dark pink cap and yellow label border (after thawed yields 2 doses/vial); 10mcg/0.2mL contains 5 mcg of original (wild-type spike protein) plus 5 mcg of omicron BA.4/BA.5 subvariants spike protein 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 October 12, 2022 for aged ≥6 years and on December 8, 2022 for 6 months through 5 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 5 years Use dark blue cap vial with gray-bordered label 2 dose series: 0.25 mL (25 mcg) IM each at 0 and 1 month 6-11 years Use dark blue cap vial with gray-bordered label 1 dose: 0.25 mL (25 mcg) IM 12-17 years Use dark blue cap vial with gray-bordered label 1 dose: 0.5 mL (50 mcg) IM Aged 6 months through 5 years previously vaccinated with ≥1 doses of Moderna monovalent COVID-19 mRNA vaccine 1 previous dose received Use dark blue cap vial with gray-bordered label 1 dose, 0.25 mL IM 1 month after receipt of Moderna monovalent COVID-19 mRNA vaccine 2 previous doses received Use dark pink cap vial with yellow box label Single dose, 0.2 mL IM >2 months after receipt of Moderna monovalent COVID-19 mRNA vaccine Previously vaccinated with ≥1 doses of a monovalent COVID-19 vaccine 6-11 years Use dark blue cap vial with gray-bordered label Single dose, 0.25 mL ≥2 months after monovalent COVID-19 vaccine 12-17 years Use dark blue cap vial with gray-bordered label Single dose, 0.5 mL ≥2 months after monovalent COVID-19 vaccine Immunosuppressed individuals For individuals with certain kinds of immunocompromise aged 6 months through 5 years who have received two 0.25 mL doses (Moderna COVID-19 Vaccine or Moderna COVID-19 Vaccine, Bivalent), an additional 0.25 mL dose of Moderna bivalent COVID-19 vaccine (vial with dark blue cap and label with a gray border) may be administered at least 1 month following the most recent dose; additional doses may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances For individuals with certain kinds of immunocompromise aged >6 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 Limitation 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, and hospitalized or fatal cases of COVID-19 following vaccination >10% 18-64 years Pain (87.8%) Fatigue (58.6%) Headache (49%) Myalgia (43%) Use of antipyretic/pain medication (39.5%) Arthralgia (33.1%) Chills (24.3%) Axillary swelling/tenderness (21.3%) Nausea/vomiting (13.3%) ≥65 years Pain (61.5%) Fatigue (49.4%) Headache (36.2%) Myalgia (34.5%) Arthralgia (28.2%) Use of antipyretic/pain medication (26.4%) Chills (23%) Axillary swelling/tenderness (11.5%) 1-10% 18-64 years Swelling ≥25 mm (8.4%) Erythema ≥25 mm (7.6%) Fatigue, grade 3 (3.8%) Fever (3.8%) Myalgias, grade 3 (3.4%) Erythema, grade 3 (2.7%) Swelling, grade 3 (1.5%) Headache, grade 3 (1.5%) Arthralgia, grade 3 (1.1%) ≥65 years Erythema ≥25 mm (5.7%) Nausea/vomiting (4.7%) Swelling ≥25 mm (4.6%) Fever (4.2%) Fatigue, grade 3 (2.9%) Pain, grade 3 (1.1%) Erythema, grade 3 (1.1%) <1% 18-64 years Pain, grade 3 (0.8%) Chills, grade 3 (0.4%) Fever, grade 3 (0.4%) ≥65 years Axillary swelling/tenderness, grade 3 (0.6%) Swelling, Grade 3 (0.6%) Myalgia, grade 3 (0.6%) Headache, grade 3 (0.6%) Nausea/vomiting, grade 3 (0.6%) 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 18-24 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 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. 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 Thaw vials Refrigerator: Thaw for 2 hr; let each vial stand at room temperature for 15 minutes before administering Room temperature: Thaw for 45 minutes After thawing, do not refreeze Inspect vial 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 Dark pink cap and yellow label border: Each multidose vial contains 2 booster doses of 0.2 mL Blue cap and grey label border 6-11 years: Each multidose vial contains 10 booster doses of 0.25 mL ≥12 years: Each multidose vial contains 5 booster doses of 0.5 mL IM Administration For IM injection only Monitor for immediate adverse reactions according to CDC guidelines Storage During 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 Discard vial 12 hr after first puncture Record date and time of first use on vial label 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 No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print