Dosing & Uses
Dosage Forms & Strengths
injectable, IM suspension
- 5mcg/0.5mL of SARS-CoV-2 recombinant spike (rS) protein and 50 mcg Matrix-M adjuvant
- Multidose vial contains 5 doses of 0.5 mL each
COVID-19 Disease Prevention
October 3, 2023: Emergency use authorization (EUA) amended with information on updated formulation for 2023-2024
EUA for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals aged ≥12 years
Previously vaccinated with any COVID-19 vaccine
- 0.5 mL IM as a single dose
- Administer at least 2 months after last COVID-19 vaccine dose
Not previously vaccinated
- 2-dose primary series
- 0.5 mL IM x 2 doses administered 3 weeks apart
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, IM suspension
- 5mcg/0.5mL of SARS-CoV-2 recombinant spike (rS) protein and 50 mcg Matrix-M adjuvant
- Multidose vial contains 5 doses of 0.5 mL each
COVID-19 Disease Prevention
October 3, 2023: Emergency use authorization (EUA) amended with information on updated formulation for 2023-2024
EUA for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals aged ≥12 years
Previously vaccinated with any COVID-19 vaccine
- 0.5 mL IM as a single dose
- Administer at least 2 months after last COVID-19 vaccine dose
Not previously vaccinated
- 2-dose primary series
- 0.5 mL IM x 2 doses administered 3 weeks apart
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
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%
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%)
≥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
Warnings
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 & 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
See the 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
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.Pharmacology
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
Administration
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 5 doses of 0.5-mL each
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)
- Discard vial 12 hr after first puncture