COVID-19 subunit vaccine (United States and Canada: Authorized for use): Drug information

(For additional information see "COVID-19 subunit vaccine (United States and Canada: Authorized for use): Patient drug information" and see "COVID-19 subunit vaccine (United States and Canada: Authorized for use): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Novavax COVID-19 Vaccine

Brand Names: Canada

Nuvaxovid

Pharmacologic Category

Vaccine;
Vaccine, COVID-19;
Vaccine, Subunit

Dosing: Adult

COVID-19 prevention

COVID-19 prevention:

Note: The only COVID-19 vaccines approved for use in the United States are based on the SARS-CoV-2 Omicron variant XBB.1.5 and labeled "2023-2024 Formula." Emergency use authorization is no longer available for older monovalent and bivalent products (FDA 2023).

CDC recommendations (CDC 2023):

Persons WITHOUT moderate to severe immunocompromising conditions or treatment:

No prior COVID-19 vaccine: IM: 0.5 mL per dose for 2 doses administered 3 to 8 weeks apart (CDC 2023; FDA 2023). Note: An 8-week interval between the first and second doses might be optimal for some people, as it might reduce the small risk of myocarditis and pericarditis associated with these vaccines (CDC 2023).

≥1 doses of any COVID-19 vaccine formulation (prior to 2023-2024 formulation): IM: 0.5 mL as a single dose administered ≥8 weeks after the last dose (CDC 2023; FDA 2023).

Persons WITH moderate to severe immunocompromising conditions or treatment:

No prior COVID-19 vaccine: IM: 0.5 mL per dose for 2 doses administered 3 weeks apart (CDC 2023; FDA 2023).

≥3 doses of any mRNA COVID-19 vaccine formulation (prior to 2023-2024 formulation): IM: 0.5 mL as a single dose administered ≥8 weeks after the last dose (CDC 2023).

≥1 doses of Novavax or Janssen, including in combination with any previous COVID-19 vaccine formulation (prior to 2023-2024 formulation): IM: 0.5 mL as a single dose administered ≥8 weeks after the last dose (CDC 2023).

Additional doses: Persons ≥18 years of age who are moderately or severely immunocompromised may receive an additional age-appropriate dose of a 2023-2024 formulation COVID-19 vaccine ≥2 months following the last recommended 2023-2024 formulation COVID-19 dose. Further additional doses may be administered, informed by the clinical judgment of a health care provider and personal preference and circumstances, ≥2 months after the last COVID-19 vaccine dose (CDC 2023).

Canadian recommendations : Preparations of COVID-19 vaccines containing different components (eg, SARS-CoV-2 Original strain, Omicron BA.1, BA.4/BA.5, XBB.1.5 variants) are approved in Canada. The Canadian National Advisory Committee on Immunization (NACI) provides different recommendations as compared to the CDC, including longer intervals; see NACI recommendations for details (NACI 2023).

Revaccination: Note: For patients who received ≥1 doses of COVID-19 vaccine prior to or while receiving a hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)–T-cell therapy, revaccination is recommended; revaccinate when ≥3 months post HCT or CAR–T-cell therapy. In patients who received ≥1 doses of COVID-19 vaccine during treatment with B-cell–depleting therapies (eg, rituximab, ocrelizumab) that were administered over a limited period (eg, as part of a treatment regimen for certain malignancies), revaccination may be considered ~6 months after completion of B-cell–depleting therapy (CDC 2023).

Dosing recommendations for deviations in administration, preparation, or storage:

**Recommendations for Deviations in COVID-19 Vaccine Usage^a**
Deviation	Adjustment
^a CDC 2023; refer to CDC guidance documents for additional information.
^b Unless patient experiences significant or prolonged adverse reactions (assess on a case-by-case basis).
^c A longer interval (8 weeks) after the invalid dose may be optimal for some patients because of the potential for increased reactogenicity and small risk of myocarditis and pericarditis (eg, especially males 12 to 39 years of age); consider patient benefit versus risk.
Product and dosage
Dose too high (due to incorrect product or dosage administered, including dose volume too high)	Do not repeat dose; administer subsequent dose(s) at appropriate interval(s).^b
Dose too low (due to incorrect product or dosage administered, including dose volume too low)	Repeat dose immediately (no minimum interval) with age-appropriate product and dosage.^c
Half-dose volume or formulation administered inadvertently	If same clinic day, administer another half dose (2 doses counted as full dose). If different day, repeat dose.
Original monovalent Novavax COVID-19 vaccine formulation administered instead of 2023-2024 formulation	Repeat dose using age-appropriate updated 2023-2024 formulation Novavax COVID-19 vaccine. If dose given in error was the first dose, then administer repeat dose ≥3 weeks later. If second dose, then administer repeat dose ≥8 weeks later.^c
2023-2024 formulation COVID-19 vaccines from different manufacturers inadvertently administered as part of a 2- or 3-dose initial vaccination series	No further doses needed for persons not moderately or severely immunocompromised. If moderately or severely immunocompromised, administer 1 dose of any COVID-19 vaccine (2023-2024 formulation) ≥4 weeks after the last dose (total of 3 doses).
Dosing interval
Any COVID-19 dose administered prior to the minimum interval	Repeat dose at the minimum recommended interval from dose given in error.^c
Storage
Improper storage or handling of vaccine (eg, temperature excursion, dose administered past expiration date)	Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval).^c

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "COVID-19 subunit vaccine (United States and Canada: Authorized for use): Pediatric drug information")

COVID-19 prevention

COVID-19 prevention:

CDC recommendations (CDC 2023):

Children ≥12 years and Adolescents: IM: Dosing based on COVID-19 vaccination history; tables for patients with and without moderate to severe immunocompromising conditions are separate; use caution.

**COVID-19 Vaccine (Subunit) 2023-2024 Formulation Dose Recommendations for Patients ≥12 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)**
COVID-19 vaccine history (prior to 2023-2024 formulation)	Vial description	Dosage	Number of 2023-2024 formulation doses indicated (administer IM)	Interval between doses
^a An 8-week interval between the first and second doses might be optimal for some people, as it might reduce the small risk of myocarditis and pericarditis associated with these vaccines.
No prior COVID-19 vaccine	Blue label and blue cap	5 mcg rS protein and 50 mcg Matrix-M adjuvant per 0.5 mL	2 doses	3 to 8 weeks^a
≥1 dose of any previous COVID-19 vaccine formulation (prior to 2023-2024 formulation)	Blue label and blue cap	5 mcg rS protein and 50 mcg Matrix-M adjuvant per 0.5 mL	1 dose	≥8 weeks after last dose of previous formulation

**COVID-19 Vaccine (Subunit) 2023-2024 Formulation Dose Recommendations for Patients ≥12 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)**
COVID-19 vaccine history (prior to 2023-2024 formulation)	Vial description	Dosage	Number of 2023-2024 formulation doses indicated (administer IM)	Interval between doses
^a Persons ≥12 years of age who are moderately or severely immunocompromised may receive an additional age-appropriate dose of a COVID-19 vaccine 2023-2024 formulation ≥2 months following the last recommended 2023-2024 COVID-19 dose. Further additional 2023-2024 formulation doses may be administered, informed by the clinical judgment of a health care provider and personal preference and circumstances.
No prior COVID-19 vaccine	Blue label and blue cap	5 mcg rS protein and 50 mcg Matrix-M adjuvant per 0.5 mL	2 doses^a	3 weeks
≥3 doses of any previous COVID-19 mRNA vaccine formulation (prior to 2023-2024 formulation)	Blue label and blue cap	5 mcg rS protein and 50 mcg Matrix-M adjuvant per 0.5 mL	1 dose^a	≥8 weeks after last dose of previous formulation
≥1 dose of any Novavax including in combination with any previous COVID-19 vaccine formulation (prior to 2023-2024 formulation)	Blue label and blue cap	5 mcg rS protein and 50 mcg Matrix-M adjuvant per 0.5 mL	1 dose^a	≥8 weeks after last dose of previous formulation

Canadian recommendations:Preparations of COVID-19 vaccines containing different components (eg, SARS-CoV-2 original strain, Omicron BA.1, BA.4/BA.5, and XBB.1.5 variants) are approved in Canada. The Canadian National Advisory Committee on Immunization (NACI) provides different recommendations as compared to the CDC, including longer intervals; see NACI recommendations for details (NACI 2023).

Revaccination: Note: In patients who received ≥1 doses of COVID-19 vaccine prior to or while receiving a hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)–T-cell therapy, revaccination is recommended when ≥3 months post HCT or CAR–T-cell therapy and should follow the schedule for unvaccinated persons with moderate to severe immunosuppressing condition or treatment. In patients who received ≥1 doses of COVID-19 vaccine during treatment with B-cell–depleting therapies (eg, rituximab, ocrelizumab) that were administered over a limited period (eg, as part of a treatment regimen for certain malignancies), revaccination may be considered ~6 months after completion of B-cell–depleting therapy (CDC 2023).

Dosing recommendations for deviations in administration, preparation, or storage:

**Recommendations for Deviations in COVID-19 Vaccine Usage^a**
Deviation	Adjustment
^a CDC 2023; refer to CDC guidance documents for additional information.
^b Unless patient experiences significant or prolonged adverse reactions (assess on a case-by-case basis).
^c A longer interval (8 weeks) after the invalid dose may be optimal for some patients because of the potential for increased reactogenicity and rare risk of myocarditis and pericarditis (eg, especially males 12 to 39 years of age); consider patient benefit versus risk.
Product and dosage
Dose too high (due to incorrect product or dosage administered, including dose volume too high)	Do not repeat dose; administer subsequent dose at appropriate interval.^b
Dose too low (due to incorrect product or dosage administered, including volume too low)	Repeat dose immediately (no minimum interval) with age-appropriate product and dosage.^c
Half-dose volume or formulation administered inadvertently	If same clinic day, administer another half dose (2 doses counted as full dose). If different day, repeat dose.
Original monovalent Novavax COVID-19 vaccine formulation administered instead of 2023-2024 Formula	Repeat dose using age-appropriate updated 2023-2024 formulation Novavax COVID-19 vaccine. If dose given in error was the first dose, then administer repeat dose ≥3 weeks later. If second dose, then administer repeat dose ≥8 weeks later.^c
2023-2024 Formulation COVID-19 vaccines from different manufacturers inadvertently administered as part of a 2- or 3-dose initial vaccination series	No further doses needed for persons not moderately or severely immunocompromised. If moderately to severely immunocompromised, administer 1 dose of any COVID-19 vaccine (2023-2024 formulation) ≥4 weeks after last dose to complete 3-dose series.
Dosing interval
Dose administered too early (ie, more than 4 days prior to the recommended interval)	Repeat dose at the minimum recommended interval from dose given in error.^c
*Age*
Novavax vaccine administered to an unauthorized age group (recipients ages 6 months to 11 years)	Do not repeat the dose with mRNA vaccine. If part of a multidose initial series, continue the series with an age-appropriate updated 2023-2024 Formula mRNA vaccine. If dose given in error was the first dose, space second dose by at least 4 weeks; for other doses, space repeat dose after the dose given in error by at least the minimum interval.
Storage
Improper storage or handling of vaccine (eg, temperature excursion, dose administered past expiration date)	Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval).^c

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions (Significant): Considerations

Guillain-Barre syndrome

Guillain-Barre syndrome (GBS) has rarely been reported with the COVID-19 (subunit) vaccine (Ref).

Onset: Onset in one reported case was 9 days following first vaccination (Ref); onset in another reported case was <1 day following first vaccination (Ref).

Hypersensitivity reactions

Severe hypersensitivity reactions, including anaphylaxis have been reported with the COVID-19 (subunit) vaccine (Ref). Other hypersensitivity reactions that were reported include urticaria and angioedema (Ref). Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (Ref).

Onset: Anaphylaxis: Unknown; however, drug-induced anaphylaxis, in general, is IgE mediated with rapid onset (ie, within 1 hour of administration, but may occur up to 6 hours after exposure) (Ref). Angioedema: Rapid; in 2 reported cases, symptoms occurred at 2 and 5 days following first vaccination (Ref).

Risk factors:

Precautions (but not contraindications) include:

• History of any non-severe, immediate (onset <4 hours) allergic reaction to a previous dose of the same COVID-19 vaccine (Ref)

• History of any immediate allergic reaction (eg, anaphylaxis) to any other vaccine or injectable therapy (eg, IM, IV, or SUBQ vaccines or therapies [excluding SUBQ immunotherapy for allergies]) (Ref)

• Patients with an allergy-related contraindication to another type of COVID-19 vaccine (eg, mRNA, adenovirus vector) (certain measures must be taken before a different type of COVID-19 vaccine is administered to these patients) (Ref)

Local reactions

Local reactions, including erythema at injection site, pain at injection site, injection-site pruritus, and swelling at injection site have been reported with the COVID-19 (subunit) vaccine (Ref). Local reactions were reported more frequently in younger patients (18 to 64 years of age) compared with patients ≥65 years of age, and reactions were more likely to occur following the booster dose of the COVID-19 (subunit) vaccine compared to the second dose of the primary series and more likely to occur following the second dose of the primary series compared to the first dose (Ref). In general, local reactions were mild to moderate in severity and resolved within 1 to 3 days (Ref).

Onset: Varied; within 7 days after vaccination (Ref).

Myocarditis and pericarditis

Myocarditis and pericarditis have been reported rarely with the COVID-19 (subunit) vaccine (Ref). Symptoms may include acute chest pain, shortness of breath, or tachycardia (Ref). Most cases resolved with hospitalization, treatment, and rest within 1 month (Ref).

Onset: Varied; most cases occurred within 2 to 10 days of vaccination (Ref)

Risk factors:

• Males <40 years of age (potential risk factor) (Ref)

Systemic reactions (excluding hypersensitivity)

Systemic reactions include arthralgia, fatigue, fever, headache, myalgia, nausea, or vomiting. Systemic reactions were reported more frequently in younger patients (18 to 64 years of age) compared to patients ≥65 years of age and were more likely to occur following the booster dose of the COVID-19 (subunit) vaccine compared to the second dose of the primary series and more likely to occur following the second dose of the primary series compared to the first dose (Ref). Most symptoms were mild to moderate in severity (Ref).

Onset: Varied; within 7 days after vaccination (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from the FDA-issued emergency use authorization (EUA) for the Novavax COVID-19 Vaccine primary series. Reported adverse reactions are for adolescents and adults, unless otherwise noted. Refer to EUA for information regarding reporting adverse reactions (FDA 2023).

>10%:

Gastrointestinal: Nausea (≤20%) (table 1)Nausea, vomiting (≤20%) (table 2)Vomiting

**COVID-19 Vaccine (Subunit): Adverse Reaction: Nausea**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)	Comments
8%	8%	12 to 17 years of age	Dose 1	1,448	726	Described as "nausea or vomiting"
20%	5%	12 to 17 years of age	Dose 2	1,394	686	Described as "nausea or vomiting"
7%	6%	18 to 64 years of age	Dose 1	15,884	7,868	Described as "nausea or vomiting"
12%	6%	18 to 64 years of age	Dose 2	15,148	7,361	Described as "nausea or vomiting"
4%	3%	≥65 years of age	Dose 1	2,251	1,114	Described as "nausea/vomiting"
5%	4%	≥65 years of age	Dose 2	2,048	978	Described as "nausea/vomiting"

**COVID-19 Vaccine (Subunit): Adverse Reaction: Vomiting**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)	Comments
8%	8%	12 to 17 years of age	Dose 1	1,448	726	Described as "nausea or vomiting"
20%	5%	12 to 17 years of age	Dose 2	1,394	686	Described as "nausea or vomiting"
7%	6%	18 to 64 years of age	Dose 1	15,884	7,868	Described as "nausea or vomiting"
12%	6%	18 to 64 years of age	Dose 2	15,148	7,361	Described as "nausea or vomiting"
4%	3%	≥65 years of age	Dose 1	2,251	1,114	Described as "nausea/vomiting"
5%	4%	≥65 years of age	Dose 2	2,048	978	Described as "nausea/vomiting"

Local: Pain at injection site (≤81%) (table 3)Pain at Injection Site, tenderness at injection site (≤81%) (table 4)Tenderness at Injection Site

**COVID-19 Vaccine (Subunit): Adverse Reaction: Pain at Injection Site**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)	Comments
65%	28%	12 to 17 years of age	Dose 1	1,448	726	Described as local "pain/tenderness"
75%	21%	12 to 17 years of age	Dose 2	1,394	686	Described as local "pain/tenderness"
61%	22%	18 to 64 years of age	Dose 1	15,884	7,868	Described as local "pain/tenderness"
81%	22%	18 to 64 years of age	Dose 2	15,148	7,361	Described as local "pain/tenderness"
38%	16%	≥65 years of age	Dose 1	2,251	1,114	Described as local "pain/tenderness"
61%	17%	≥65 years of age	Dose 2	2,048	978	Described as local "pain/tenderness"

**COVID-19 Vaccine (Subunit): Adverse Reaction: Tenderness at Injection Site**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)	Comments
65%	28%	12 to 17 years of age	Dose 1	1,448	726	Described as local "pain/tenderness"
75%	21%	12 to 17 years of age	Dose 2	1,394	686	Described as local "pain/tenderness"
61%	22%	18 to 64 years of age	Dose 1	15,884	7,868	Described as local "pain/tenderness"
81%	22%	18 to 64 years of age	Dose 2	15,148	7,361	Described as local "pain/tenderness"
38%	16%	≥65 years of age	Dose 1	2,251	1,114	Described as local "pain/tenderness"
61%	17%	≥65 years of age	Dose 2	2,048	978	Described as local "pain/tenderness"

Nervous system: Fatigue (≤58%) (table 5)Fatigue, headache (15% to 57%) (table 6)Headache, malaise (≤58%)

**COVID-19 Vaccine (Subunit): Adverse Reaction: Fatigue**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)	Comments
29%	20%	12 to 17 years of age	Dose 1	1,448	726	Described as "fatigue/malaise"
58%	17%	12 to 17 years of age	Dose 2	1,394	686	Described as "fatigue/malaise"
31%	27%	18 to 64 years of age	Dose 1	15,884	7,868	Described as "fatigue/malaise"
58%	26%	18 to 64 years of age	Dose 2	15,148	7,361	Described as "fatigue/malaise"
20%	18%	≥65 years of age	Dose 1	2,251	1,114	Described as "fatigue/malaise"
35%	19%	≥65 years of age	Dose 2	2,048	978	Described as "fatigue/malaise"

**COVID-19 Vaccine (Subunit): Adverse Reaction: Headache**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)
30%	25%	12 to 17 years of age	Dose 1	1,448	726
57%	17%	12 to 17 years of age	Dose 2	1,394	686
26%	24%	18 to 64 years of age	Dose 1	15,884	7,868
47%	20%	18 to 64 years of age	Dose 2	15,148	7,361
15%	17%	≥65 years of age	Dose 1	2,251	1,114
25%	15%	≥65 years of age	Dose 2	2,048	978

Neuromuscular & skeletal: Arthralgia (adolescents: 7% to 16%; adults: 6% to 23%) (table 7)Arthralgia, myalgia (adolescents: 34% to 49%; adults: 13% to 51%) (table 8)Myalgia

**COVID-19 Vaccine (Subunit): Adverse Reaction: Arthralgia**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)
7%	5%	12 to 17 years of age	Dose 1	1,448	726
16%	3%	12 to 17 years of age	Dose 2	1,394	686
8%	7%	18 to 64 years of age	Dose 1	15,884	7,868
23%	7%	18 to 64 years of age	Dose 2	15,148	7,361
6%	6%	≥65 years of age	Dose 1	2,251	1,114
13%	6%	≥65 years of age	Dose 2	2,048	978

**COVID-19 Vaccine (Subunit): Adverse Reaction: Myalgia**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)
34%	16%	12 to 17 years of age	Dose 1	1,448	726
49%	12%	12 to 17 years of age	Dose 2	1,394	686
24%	14%	18 to 64 years of age	Dose 1	15,884	7,868
51%	12%	18 to 64 years of age	Dose 2	15,148	7,361
13%	11%	≥65 years of age	Dose 1	2,251	1,114
27%	10%	≥65 years of age	Dose 2	2,048	978

1% to 10%:

Local: Erythema at injection site (≤8%) (table 9)Erythema at Injection Site, swelling at injection site (≤8%) (table 10)Swelling at Injection Site

**COVID-19 Vaccine (Subunit): Adverse Reaction: Erythema at Injection Site**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)
1%	0.7%	12 to 17 years of age	Dose 1	1,448	726
8%	0%	12 to 17 years of age	Dose 2	1,394	686
1%	0.3%	18 to 64 years of age	Dose 1	15,884	7,868
7%	0.4%	18 to 64 years of age	Dose 2	15,148	7,361
0.7%	0.4%	≥65 years of age	Dose 1	2,251	1,114
5%	0.4%	≥65 years of age	Dose 2	2,048	978

**COVID-19 Vaccine (Subunit): Adverse Reaction: Swelling at Injection Site**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)
1%	0.4%	12 to 17 years of age	Dose 1	1,448	726
8%	0.1%	12 to 17 years of age	Dose 2	1,394	686
0.9%	0.3%	18 to 64 years of age	Dose 1	15,884	7,868
6%	0.3%	18 to 64 years of age	Dose 2	15,148	7,361
0.8%	0.1%	≥65 years of age	Dose 1	2,251	1,114
5%	0.4%	≥65 years of age	Dose 2	2,048	978

Miscellaneous: Fever (adolescents: ≤17%; adults: ≤6%) (table 11)Fever

**COVID-19 Vaccine (Subunit): Adverse Reaction: Fever**
Drug (COVID-19 Vaccine (Subunit])	Placebo	Population	Dose	Number of Patients (COVID-19 Vaccine [Subunit])	Number of Patients (Placebo)
0.8%	0.7%	12 to 17 years of age	Dose 1	1,448	726
17%	0.1%	12 to 17 years of age	Dose 2	1,394	686
0.4%	0.4%	18 to 64 years of age	Dose 1	15,884	7,868
6%	0.2%	18 to 64 years of age	Dose 2	15,148	7,361
0.4%	0.3%	≥65 years of age	Dose 1	2,251	1,114
2%	0.7%	≥65 years of age	Dose 2	2,048	978

<1%:

Cardiovascular: Cardiomyopathy (adults: unsolicited; data insufficient to determine causal relationship), heart failure (adults: unsolicited; data insufficient to determine causal relationship), myocarditis, pericarditis (adults), thromboembolism (adults: including deep vein thrombosis, pulmonary embolism, portal vein thrombosis, arterial mesenteric thrombosis, and peripheral arterial disease; unsolicited; data insufficient to determine causal relationship)

Gastrointestinal: Cholecystitis (adults: unsolicited; data insufficient to determine causal relationship), decreased appetite

Hematologic & oncologic: Lymphadenopathy (including axillary pain, lymphadenitis, and lymph node pain)

Hypersensitivity: Hypersensitivity reaction (adults: including severe hypersensitivity reaction, angioedema, urticaria)

Local: Injection-site pruritus

Nervous system: Chills, Guillain-Barre syndrome

Ophthalmic: Uveitis (adults: including iritis and iridocyclitis; unsolicited; data insufficient to determine causal relationship)

Post-authorization (any population):

Endocrine & metabolic: Type 1 diabetes mellitus (fulminant) (Huang 2023)

Hypersensitivity: Anaphylaxis

Infection: Herpes zoster infection (Lin 2023)

Nervous system: Hypoesthesia, paresthesia

Contraindications

History of severe allergic reaction (eg, anaphylaxis) to COVID-19 vaccine (subunit) or any component of the formulation (FDA 2023).

Warnings/Precautions

Concerns related to adverse effects:

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone vaccination in individuals with moderate or severe acute illness (with or without fever). The presence of a mild acute illness (with or without fever) should not delay vaccination (ACIP [Kroger 2023]).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration. If the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]). For more information on administering the COVID-19 vaccine in patients with bleeding disorders, see society recommendations (eg, US National Hemophilia Foundation, World Federation of Hemophilia).

• Multisystem inflammatory syndrome: In patients with a history of multisystem inflammatory syndrome (MIS), the benefits of vaccination are thought to outweigh the risks in patients who meet two recovery criteria: 1) clinical recovery from MIS (including return to baseline cardiac function) and 2) ≥90 days have passed since diagnosis. Vaccination can be considered in patients who do not meet both criteria on a case-by-case basis. In patients who developed MIS within 60 days following a dose of COVID-19 vaccine, decisions about subsequent doses should be made on a case-by-case basis. In patients who developed MIS >60 days after a previous dose of COVID-19 vaccine, subsequent doses should be considered ≥90 days after MIS diagnosis for patients who have clinically recovered (including return to baseline cardiac function) (CDC 2023).

• Myocarditis/pericarditis (CDC 2023):

- Persons who experience myocarditis/pericarditis after a dose of the vaccine: For persons who developed myocarditis or pericarditis within 3 weeks after a COVID-19 vaccine dose, subsequent doses of any COVID-19 vaccine are generally not recommended. If after risk assessment, a decision is made to administer subsequent dose(s), wait until complete resolution of signs/symptoms of myocarditis or pericarditis with no evidence of ongoing heart inflammation or sequelae as determined by clinical team and cardiac testing.

- Persons with history of myocarditis or pericarditis that occurred prior to vaccination or >3 weeks after a COVID-19 vaccine dose: Persons with history of myocarditis or pericarditis that occurred prior to COVID-19 vaccination or >3 weeks after a COVID-19 vaccine dose may receive any FDA-approved or FDA-authorized COVID-19 vaccine after complete resolution of signs/symptoms of myocarditis or pericarditis with no evidence of ongoing heart inflammation or sequelae as determined by clinical team. This also applies to persons who had myocarditis or pericarditis due to SARS-CoV-2 or other viruses.

• SARS-CoV-2 infection or exposure (CDC 2023):

- Persons with history of COVID-19 or asymptomatic SARS-CoV-2 infection: Vaccination is recommended for everyone ≥6 months of age (with an age-appropriate COVID-19 vaccine), regardless of history of symptomatic or asymptomatic SARS-CoV-2 infection. Persons who recently had SARS-CoV-2 infection may consider delaying vaccine doses by 3 months from symptom onset or positive test (if asymptomatic); increased time between infection and vaccination may improve vaccination immune response.

- Persons with current SARS-CoV-2 infection (including asymptomatic): In persons with known current SARS-CoV-2 infection, defer vaccination until the person has recovered from acute illness (if symptomatic) and no longer requires isolation.

- Persons with known SARS-CoV-2 exposure: Persons with recent known exposure may be vaccinated if they do not have symptoms consistent with SARS-CoV-2 infection; follow CDC's postexposure guidance. Vaccination for postexposure prophylaxis is not recommended.

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).

• Vaccines: The CDC and American Academy of Pediatrics recommend simultaneous administration of the COVID-19 vaccine with other vaccines or administration in the days before and after receipt of other vaccines (AAP 2022; CDC 2023). There is no minimum interval between administering a COVID-19 vaccine and an orthopoxvirus vaccine (Jynneos or ACAM2000). Because of the risk for myocarditis and pericarditis related to the COVID-19 vaccine and smallpox vaccine (ACAM2000) and the hypothetical risk of myocarditis and pericarditis related to smallpox and monkeypox vaccine (Jynneos or Imvamune), consider waiting 4 weeks between administering orthopoxvirus vaccine (ACAM2000; Jynneos or Imvamune) and COVID-19 vaccine (especially for adolescent/young adult males). However, vaccination with either agent should not be delayed if the patient is at increased risk for mpox or severe COVID-19. The CDC recommends prioritizing the use of Jynneos over ACAM2000 when coadministering with a COVID-19 vaccine (CDC 2023; CDC/ACIP [Rao 2022]).

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Special populations:

• Altered immunocompetence: Age-appropriate COVID-19 vaccines can be safely administered to immunocompromised persons (including those with HIV or receiving immunosuppressant therapy) if no contraindications exist. Immunocompromised persons may have a diminished immune response to the vaccine, but the potential benefit of the vaccine outweighs the uncertainties. If possible, complete COVID-19 vaccination ≥2 weeks prior to initiation or resumption of immunosuppressive therapy. For patients who receive ongoing B-cell-depleting therapies, administer COVID-19 vaccines ~4 weeks before the next scheduled therapy (CDC 2023; NACI 2023). For more information on administering the COVID-19 vaccine in specific disease states, see society recommendations (eg, American Cancer Society, National Multiple Sclerosis Society).

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) (ACIP [Kroger 2023]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Intramuscular [preservative free]:

Novavax COVID-19 Vaccine: 5 mcg/0.5 mL (0.5 mL [DSC], 2.5 mL, 5 mL [DSC]) [contains polysorbate 80]

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intramuscular:

Nuvaxovid: 5 mcg/0.5 mL (2.5 mL, 5 mL) [contains polysorbate 80]

Prescribing and Access Restrictions

The Novavax COVID-19 Vaccine is not commercially available; it is available under emergency use authorization (EUA) from the FDA. The US federal government, in conjunction with state health departments, allocates supply to individual sites of care across the United States.

As part of the EUA, information consistent with fact sheets pertaining to emergency use of the COVID-19 vaccines must be provided to health care providers and recipients/caregivers, and certain mandatory requirements for administration under the EUA must be met as outlined in the FDA EUA letter.

Novavax COVID-19 Vaccine: The health care provider fact sheet is located at: https://www.fda.gov/media/159897/download. The recipient/caregiver fact sheet is located at: https://www.fda.gov/media/159898/download.

The vaccine provider should include vaccination information in the state/local jurisdiction Immunization Information System or other designated system and provide a paper record card as a backup.

Additionally, the vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS) (https://vaers.hhs.gov/reportevent.html or 1-800-822-7967):

• Vaccine administration errors whether or not associated with an adverse event

• Serious adverse events (irrespective of attribution to vaccination)

• Cases of multisystem inflammatory syndrome in adults and children

• Cases of myocarditis or pericarditis

• Cases of COVID-19 that result in hospitalization or death

The vaccination provider is also responsible for responding to FDA requests for more information. Additional adverse events may be reported to VAERS and the manufacturer. Adverse events related to the Novavax vaccine may be reported to Novavax, Inc via phone: 1-844-668-2829; or fax: 1-888-988-8809.

Administration: Adult

IM: Prior to use, gently swirl vial before each withdrawal; do not shake. Administer IM into deltoid muscle or anterolateral thigh (CDC 2023). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013). Do not administer intravenously, intradermally, or subcutaneously. Inspect for particulate matter and discoloration prior to administration. Do not mix with other vaccines or injections. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2023]). US recipients or caregivers should be given a vaccination card that includes the name of the vaccine, lot number, the vaccination date, and name of the health care site or person where the vaccine was administered (FDA 2023).

Inappropriate administration technique: If administered SUBQ or into a muscle other than the deltoid or anterolateral thigh (alternate administration site), do not repeat dose. If additional doses are needed, administer at the recommended interval(s) (CDC 2023).

Patients at risk for hemorrhage: For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting disorders (ACIP [Kroger 2023]).

Administration: Pediatric

Parenteral: IM: Prior to use, gently swirl multi-dose vial before each withdrawal; do not shake. Administer IM into deltoid muscle or anterolateral thigh (CDC 2023). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013). Do not administer IV, intradermally, or SUBQ. Inspect for particulate matter and discoloration prior to administration. Do not mix with other vaccines or injections. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2023]). US recipients or caregivers should be given a vaccination card that includes the name of the vaccine, lot number, the vaccination date, and name of the health care site or person where the vaccine was administered (FDA 2023).

Inappropriate administration technique: If administered SUBQ or into a muscle other than the deltoid or anterolateral thigh, do not repeat dose (CDC 2023).

Patients at risk for hemorrhage: For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting disorders (ACIP [Kroger 2023]).

Medication Guide and/or Vaccine Information Statement (VIS)

In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at https://www.cdc.gov/vaccines/hcp/vis/vis-statements/covid-19.html.

Use: Labeled Indications

COVID-19 prevention (Nuvaxovid [Canadian product]): Active immunization to prevent COVID-19 in adults and pediatric patients ≥12 years of age.

The National Advisory Committee on Immunization has made recommendations on the use of COVID-19 vaccines; see recommendations for details (NACI 2023).

For US product, see "Use: Off-Label: Adult."

Use: Off-Label: Adult

COVID-19 prevention

Medication Safety Issues

Sound-alike/look-alike issues:

Similarity of COVID-19 vaccine names may lead to confusion among products with subtle differences (eg, dosage volumes, dosing schedules, storage requirements, preparation for administration).

COVID-19 vaccine may be confused with influenza virus vaccine. Medication errors have occurred when COVID-19 vaccine was inadvertently administered instead of influenza virus vaccine (and vice versa). These products may be stored in close proximity to each other. Confirm the correct vaccine has been selected prior to administration (ISMP/NAN 2021).

COVID-19 vaccine may be confused with epinephrine injection. Medication errors have occurred when epinephrine injection was inadvertently administered instead of COVID-19 vaccine. Most mix-ups were due to look-alike, predrawn syringes of epinephrine and the vaccine, which were stored in close proximity (ISMP [Smetzer 2022]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abatacept: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding SQ abatacept for 1 to 2 weeks after each vaccine dose and timing vaccine dose so that it is given 1 week prior to the next IV abatacept dose. Risk D: Consider therapy modification

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider therapy modification

Apremilast: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding apremilast for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. These guidelines consider apremilast to be an immunomodulatory or immunosuppressive medication. Risk D: Consider therapy modification

AzaTHIOprine: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding azathioprine for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This recommendation is specific to patients using azathioprine for rheumatic and musculoskeletal disease. Risk D: Consider therapy modification

Baricitinib: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Belimumab: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding subcutaneous belimumab doses for 1 to 2 weeks after each COVID-19 vaccine dose as disease activity permits. The recommendation specifies subcutaneous belimumab and does not mention intravenous belimumab. Risk D: Consider therapy modification

Calcineurin Inhibitors (Systemic): May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding calcineurin inhibitors for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This is specific to the use of calcineurin inhibitors for rheumatologic or musculoskeletal disease. Risk D: Consider therapy modification

CloZAPine: COVID-19 Vaccines may enhance the adverse/toxic effect of CloZAPine. COVID-19 Vaccines may increase the serum concentration of CloZAPine. Risk C: Monitor therapy

Corticosteroids (Systemic): May diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

CycloPHOSphamide: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Adjust timing of intravenous cyclophosphamide so that administration occurs 1 week after each vaccine dose, if feasible; hold oral cyclophosphamide for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

Leflunomide: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding leflunomide for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding methotrexate for 1 to 2 weeks after vaccine administration as permitted by underlying disease. This is specific to patients using methotrexate for rheumatic and musculoskeletal disease. Risk D: Consider therapy modification

Mycophenolate: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding mycophenolate for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This recommendation is specific to patients using mycophenolate for rheumatic and musculoskeletal diseases. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

SulfaSALAzine: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding sulfasalazine for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. These guidelines consider sulfasalazine to be an immunomodulatory or immunosuppressive medication. Risk D: Consider therapy modification

Teplizumab: May diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Management: Inactivated vaccines are not recommended during the 2 weeks prior to teplizumab, during therapy, or for 6 weeks afterward. Reduced efficacy of the vaccine may occur if administered to patients on immunosuppressant therapy. Risk D: Consider therapy modification

Tixagevimab and Cilgavimab: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Wait at least 2 weeks after receipt of a COVID-19 vaccine before administering tixagevimab and cilgavimab for pre-exposure prophylaxis. Risk D: Consider therapy modification

Tofacitinib: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Upadacitinib: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Reproductive Considerations

The Novavax COVID-19 Vaccine is an investigational vaccine permitted for use under FDA emergency use authorization (EUA). Pregnancy testing is not required prior to vaccination. Pregnancy does not need to be delayed following vaccination. COVID-19 vaccines are not a cause of infertility (ACOG 2023).

There have been anecdotal reports of temporary menstrual changes following vaccination. Vaccines have not previously been associated with menstrual disturbances; however, environmental stresses can temporarily impact menses. Based on available data, any changes in the length of menstrual cycle following COVID-19 vaccination are <1 day and changes in duration or quantity of bleeding resolve within 1 to 2 menstrual cycles. COVID-19 vaccines may be given to patients who are menstruating, and vaccination does not need to be scheduled based on menstrual cycle. Potential changes in menstrual bleeding are not a reason to avoid vaccination (ACOG 2023).

Due to the risk of severe illness, pregnancy complications, and death from COVID-19 infection during pregnancy, staying current with COVID-19 vaccination is strongly recommended for all patients planning a pregnancy, patients trying to become pregnant now, and patients who might become pregnant in the future, including those patients previously diagnosed with COVID-19 infection (ACOG 2023, CDC 2023). Refer to current CDC guidelines for vaccination of adults.

Pregnancy Considerations

The Novavax COVID-19 Vaccine is an investigational vaccine permitted for use under FDA emergency use authorization (EUA). Outcome data following inadvertent exposure during pregnancy are limited (ACOG 2023; Graña 2022).

The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections compared to pregnant patients without COVID-19. Pregnant patients with symptoms may require ICU admission, mechanical ventilation, or ventilatory support (extracorporeal membrane oxygenation) compared to symptomatic nonpregnant patients. Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG FAQ 2023; NIH 2023).

Vaccination of pregnant patients may be done in any setting authorized to administer the vaccine. COVID-19 vaccines may be administered simultaneously with other vaccines routinely administered during pregnancy. The COVID-19 vaccine may be administered in any trimester and should be given as soon as possible to maximize maternal and fetal health. Vaccination status should be documented for all pregnant patients; for patients who do not receive the COVID-19 vaccine, the discussion should be documented in the medical record and vaccination offered again at subsequent visits (ACOG 2023).

Rho(D) immune globulin is not expected to interfere with an immune response to the COVID-19 vaccine. Treatment should not be withheld in patients planning to be vaccinated or who recently received the COVID-19 vaccine (ACOG 2023).

Information related to COVID-19 vaccines continues to emerge; refer to current guidelines for vaccinating pregnant patients.

Data collection to monitor pregnancy and infant outcomes following exposure to COVID-19 vaccines is ongoing.

Pregnant patients who are vaccinated with Novavax COVID-19 vaccine are encouraged to enroll in the pregnancy registry (https://c-viper.pregistry.com/).

Breastfeeding Considerations

It is not known if components of this vaccine are present in breast milk.

The Novavax COVID-19 Vaccine is an investigational vaccine permitted for use under FDA emergency use authorization (EUA).

The risk of severe illness from COVID-19 infection is increased in recently pregnant patients compared to nonpregnant patients (ACOG FAQ 2023). Staying current with COVID-19 vaccination is recommended for all lactating patients who do not otherwise have contraindications to the vaccine (CDC 2023). Refer to current CDC guidelines for vaccination of adults.

The initiation of breastfeeding does not need to be avoided, and breastfeeding does not need to be discontinued in patients who are vaccinated (ACOG 2023).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]; CDC 2023). Observe for 30 minutes after vaccination in those patients with the following: History of anaphylaxis (due to any cause); history of non-severe, immediate (within 4 hours) allergic reaction after receipt of a COVID-19 vaccine; history of an allergic reaction of any severity within 4 hours of receipt of a non–COVID-19 vaccine or injectable therapy; a contraindication to a different type of COVID-19 vaccine (CDC 2023). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Mechanism of Action

Promotes active immunization against COVID-19 caused by SARS-CoV-2 virus. The vaccine contains a purified recombinant spike (S) antigen of the SARS-Co-V-2 virus. The vaccine then elicits an immune response to the S antigen, which contributes to protection against COVID-19 disease.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AT) Austria: Nuvaxovid;
(AU) Australia: Nuvaxovid;
(BE) Belgium: Nuvaxovid;
(BG) Bulgaria: Nuvaxovid;
(CN) China: Recombinant novel coronavirus vaccine (CHO cell) | Zhi ke wei de;
(CO) Colombia: Zifivax;
(CY) Cyprus: Nuvaxovid;
(CZ) Czech Republic: Nuvaxovid;
(DE) Germany: Nuvaxovid;
(DK) Denmark: Nuvaxovid;
(EE) Estonia: Nuvaxovid;
(ES) Spain: Nuvaxovid;
(FI) Finland: Nuvaxovid;
(FR) France: Nuvaxovid;
(GR) Greece: Nuvaxovid;
(HR) Croatia: Nuvaxovid;
(HU) Hungary: Nuvaxovid;
(ID) Indonesia: Covovax | Zifivax;
(IE) Ireland: Nuvaxovid;
(IN) India: Covovax;
(IS) Iceland: Nuvaxovid;
(IT) Italy: Nuvaxovid;
(KR) Korea, Republic of: Nuvaxovid;
(LT) Lithuania: Nuvaxovid;
(LV) Latvia: Nuvaxovid;
(MT) Malta: Nuvaxovid;
(NL) Netherlands: Nuvaxovid;
(NO) Norway: Nuvaxovid;
(NZ) New Zealand: Nuvaxovid;
(PH) Philippines: Covovax;
(PL) Poland: Nuvaxovid;
(PT) Portugal: Nuvaxovid;
(RO) Romania: Nuvaxovid;
(RU) Russian Federation: EpiVacCorona;
(SE) Sweden: Nuvaxovid;
(SI) Slovenia: Nuvaxovid;
(SK) Slovakia: Nuvaxovid;
(TW) Taiwan: Mvc covid-19 vaccine | Nuvaxovid;
(ZA) South Africa: Covovax

Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
American College of Obstetricians and Gynecologists (ACOG). COVID-19 FAQs for obstetricians-gynecologists, obstetrics. https://www.acog.org/clinical-information/physician-faqs/covid-19-faqs-for-ob-gyns-obstetrics. Accessed September 21, 2023.
American College of Obstetricians and Gynecologists (ACOG). COVID-19 vaccination considerations for obstetric-gynecologic care. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19. Updated September 25, 2023. Accessed September 26, 2023.
Blumenthal KG, Peter JG, Trubiano JA, Phillips EJ. Antibiotic allergy. Lancet. 2019;393(10167):183-198. doi:10.1016/S0140-6736(18)32218-9 [PubMed 30558872]
Centers for Disease Control and Prevention (CDC). Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html. Updated October 6, 2023. Accessed October 8, 2023.
Centers for Disease Control and Prevention (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. [PubMed 6423951]
Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don't aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303-306. [PubMed 27166466]
Foster SL, Davis MV. Vaccine administration: preventing serious shoulder injuries. J Am Pharm Assoc (2003). 2013;53(1):102-103. doi:10.1331/JAPhA.2013.13503 [PubMed 23636163]
Graña C, Ghosn L, Evrenoglou T, et al. Efficacy and safety of COVID-19 vaccines. Cochrane Database Syst Rev. 2022;12(12):CD015477. doi:10.1002/14651858.CD015477 [PubMed 36473651]
Huang L, Liang M, He Y. New-onset fulminant type 1 diabetes following SARS-CoV-2 protein subunit vaccine: a case report and literature review. J Korean Med Sci. 2023;38(24):e209. doi:10.3346/jkms.2023.38.e209 [PubMed 37337812]
Institute for Safe Medication Practices (ISMP); The National Alert Network (NAN). Mix-ups between the influenza (flu) vaccine and COVID-19 vaccine. https://www.ismp.org/alerts/mix-ups-between-influenza-flu-vaccine-and-covid-19-vaccines. Published October 15, 2021.
Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. doi:10.1034/j.1600-0536.2002.4705104.x [PubMed 12534540]
Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed May 17, 2023.
Lin CS, Chang CH. Disseminated herpes zoster following protein subunit and mRNA COVID-19 vaccination in immunocompetent patients: report of two cases and literature review. Medicina (Kaunas). 2023;59(9):1542. doi:10.3390/medicina59091542 [PubMed 37763662]
Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
Montroy J, Wong E, Krishnan R, et al. An advisory committee statement (ACS) National Advisory Committee on Immunization (NACI). Updated guidance on COVID-19 vaccine booster doses in Canada. https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/guidance-covid-19-vaccine-booster-doses.pdf. Published October 7, 2022. Accessed October 12, 2022.
National Advisory Committee on Immunization (NACI). COVID-19 vaccine: Canadian immunization guide for health professionals. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html. Updated March 23, 2023. Accessed May 19, 2023.
National Institute for Health and Care Excellence (NICE). Drug allergy: diagnosis and management. Clinical guideline 183. https://www.nice.org.uk/guidance/cg183. Published September 3, 2014. Accessed August 3, 2022.
National Institutes of Health (NIH). COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Updated April 20, 2023. Accessed May 15, 2023.
Nuvaxovid (COVID-19 vaccine [subunit]) [product monograph]. Oakville, Ontario, Canada: Innomar Strategies Inc; November 2023.
Rao AK, Petersen BW, Whitehill F, et al. Use of JYNNEOS (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: recommendations of the Advisory Committee on Immunization Practices - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(22):734-742. doi:10.15585/mmwr.mm7122e1 [PubMed 35653347]
Rohilla R, Kakkar AK, Divyashree K, Mohindra R, Suri V. Recombinant protein subunit COVID-19 vaccine-induced Guillain-Barré Syndrome in an adolescent: A case report. Br J Clin Pharmacol. 2022;10.1111/bcp.15466. doi:10.1111/bcp.15466 [PubMed 35856283]
Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8960):1312-1313. doi:10.1016/s0140-6736(95)90963-x [PubMed 7746084]
Smetzer J, Cohen M, Shastay A, Jenkins R, Shultz K; Institute for Safe Medication Practices (ISMP). Acute care: ISMP medication safety alert. 2022;27(2):1-5. Published January 27, 2021. Accessed July 14, 2022. [PubMed Smetzer.1]
US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine: Emergency Use Authorization (EUA) of the Novavax COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). https://www.fda.gov/media/159897/download. Updated October 3, 2023. Accessed October 4, 2023.
US Food and Drug Administration (FDA). Vaccines and related biological products advisory committee meeting briefing document: Novavax COVID-19 vaccine. https://www.fda.gov/media/158912/download. Updated June 7, 2022b. Accessed August 3, 2022.

Topic 135147 Version 67.0

خرید پکیج

COVID-19 subunit vaccine (United States and Canada: Authorized for use): Drug information