COVID-19 vaccine, adjuvanted-Novavax (Investigational)

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-M^TM) 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