AdultPediatricDosage Forms & Strengths injectable, IM suspension 5mcg/0.5mL of SARS-CoV-2 recombinant spike (rS) protein and 50 mcg Matrix-M adjuvant 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) July 13, 2022: FDA granted emergency use authorization (EUA) for prevention of coronavirus disease 2019 (COVID-19) infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2-dose primary series: 0.5 mL IM x 2 doses administered 3 weeks apart 3-8 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 Bivalent booster dose Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines (ie, Pfizer or Moderna) may be administered Administer at least 2 months after either Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, OR Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine Monovalent first booster dose Novavax COVID-19 vaccine: EUA amended for use as a first booster dose (3rd dose) in adults aged >18 years Booster: 0.5 mL IM Administer at least 6 months after completion of primary vaccination in adults For whom an mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, OR Who elect to receive the Novavax COVID-19 vaccine, adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine Dosing Considerations Limitations of use: May not protect all vaccine recipientsDosage Forms & Strengths injectable, IM suspension 5mcg/0.5mL of SARS-CoV-2 recombinant spike (rS) protein and 50 mcg Matrix-M adjuvant 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) August 19, 2022: FDA granted emergency use authorization (EUA) for prevention of coronavirus disease 2019 (COVID-19) infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged >12 years <12 years: Safety and efficacy not established ≥12 years 2-dose primary series: 0.5 mL IM x 2 doses administered 3 weeks apart 3-8 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 Moderna or Pfizer omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster at least 2 months after completion of primary vaccination Dosing Considerations Limitations of use: 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, 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% 12-17 years Pain/tenderness, any grade (64.3-75%) Fatigue/malaise, any grade (28.9-57.9%) Headache, any grade (30.4-56.9%) Muscle pain, any grade (34-49%) Nausea/vomiting, any grade (7.8-19.9%) Fever, any grade (0.8-16.9%) Joint pain, any grade (7-16.2%) Fatigue/malaise, grade 3 (2.3-16%) 18-64 years Pain/tenderness, any grade (60.5-80.8%) Headache, any grade (26.2-47.1%) Fatigue/malaise, any grade (30.8-58.3%) Muscle pain, any grade (24.1-50.7%) Joint pain, any grade (23.4%) Nausea/vomiting, any grade (12%) Fatigue/malaise, grade 3 (1.6-10.5%) ≥64 years Pain/tenderness, any grade (37.9-61.4%) Fatigue/malaise, any grade (19.7-34.9%) Muscle pain, any grade (12.6-27.4%) Fatigue/malaise, any grade (24.5%) Headache, any grade (15.3%) Joint pain, any grade (13.2%) 1-10% 12-17 years Swelling, any grade (1.4-8%) Pain/tenderness, grade 3 (1.5-7.7%) Muscle pain, grade 3 (1.2-7.5%) Erythema, any grade (1-7.5%) Headache, grade 3 (0.9-6.2%) Joint pain, grade 3 (0.4-2.9%) Fever, grade 3 (0.07-2.2%) Nausea/vomiting, grade 3 (0.1-1%) 18-64 years Pain/tenderness, grade 3 (1.1-6.3%) Erythema (1-6.9%) Swelling, any grade (0.9-6.2%) Fever, any grade (0.4-6.2%) Muscle pain, grade 3 (0.5-5.3%) Headache, grade 3 (0.8-3.2%) Joint pain, grade 3 (0.3-2.6%) Dose 1 ≥64 years Swelling, any grade (0.8-5.4%) Nausea/vomiting, any grade (3.6-5.3%) Erythema, any grade (0.7-4.8%) Fatigue/malaise, grade 3 (1-3.3%) Pain/tenderness, grade 3 (0.6-2.1%) Fever, any grade (0.4-2%) Muscle pain, grade 3 (0.1-1.6%) <1% 12-17 years Erythema, grade 3 (0.7%) Swelling, grade 3 (0.6%) Fever, grade 4 (0.1%) Headache, grade 4 (0.07%) Nausea/vomiting, grade 4 (0.07%) 18-64 years Fatigue/malaise, grade 4 (0.05%) Nausea/vomiting, grade 3 (0.1-0.2%) Swelling, grade 3 (0.04-0.5%) Fever, grade 3 (0.04-0,4%) Fever, grade 4 (0.03%) Headache, grade 4 (0.03%) Nausea/vomiting, grade 4 (0.3-0.5%) Erythema, grade 3 (0.02-0.9%) Muscle pain, grade 4 (0.01-0.3%) Joint pain, grade 4 (<0.01-0.03%) ≥64 years Headache, grade 3 (0.5-0.9%) Joint pain, grade 3 (0.2-0.8%) Erythema, grade 3 (0.4%) Swelling, grade 3 (0.04-0.4%) Nausea/vomiting, grade 3 (0.1%) Fever, grade 3 (0.04-0.1%) Joint pain, grade 4 (0.05%) Headache, grade 4 (0.04-0.05%) Post-authorization Experience Cardiac disorders: Myocarditis, pericarditis Immune system disorders: Anaphylaxis Nervous system disorders: Paresthesia, hypoesthesia Contraindications Known history of severe hypersensitivity (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 Myocarditis and/or pericarditis were reported by 2 participants after the Novavax COVID-19 vaccine, adjuvanted (0.01%) and no participants after placebo 1 serious event reported by a 67-year-old male 28 days after Dose 1, associated with concomitant COVID-19 infection, and 1 non-serious event reported by a 20-year-old male 10 days after Dose 1 Pregnancy Available data on the Novavax COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy Females who receive the vaccination during pregnancy are encouraged to enroll in the vaccine registry Animal studies No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported when administered IM to female rats 27 and 13 days before mating, and on gestational days 7 and 15 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. Mechanism of Action The goal of vaccination is to elicit long-term antigen-specific antibody responses by plasma cells and to develop persistent T-cell and B-cell memory of the antigen (ie, humoral and cellular immune response) Contains purified full-length protein subunit (rS); an immune response to the rS protein is elicited, which protect against COVID-19 Vaccine contains an adjuvant (ie, saponin-based Matrix-MTM) to enhance immune response and stimulate high levels of neutralizing antibodies IM Preparation Suspension should appear colorless to slightly yellow, clear to mildly opalescent, and free from visible particles Gently swirl multi-dose vial before each dose withdrawal; do NOT shake Inspect visually for particulate matter and discoloration before administering; discard vial if either of these conditions exist Record date and time of first puncture on vial label Each multi-dose vial contains ten 0.5-mL doses Do not pool excess vaccine from multiple vials IM Administration For IM administration only Storage Unpunctured vial Refrigerate at 2-8ºC (36-46ºF) Do not freeze Protect from light After first needle puncture of vial Store punctured vial at 2-25ºC (36-77ºF) for up to 6 hr Discard vial 6 hr after first puncture No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print