Version July 2025
COVID-19, prevention:
Note: The COVID-19 (subunit) vaccine authorized for use in the United States is based on the SARS-CoV-2 Omicron variant JN.1 strain and labeled "2024-2025 Formula" (Ref).
CDC recommendations (Ref):
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 (Ref). Note: An 8-week interval between the first and second doses might be optimal for some people, as it might reduce the rare risk of myocarditis and pericarditis associated with these vaccines (Ref).
One dose of any previous Novavax COVID-19 vaccine formulation: IM: 0.5 mL as a single dose administered 3 to 8 weeks after last dose (Ref). Note: An 8-week interval between the first and second doses might be optimal for some people, as it might reduce the rare risk of myocarditis and pericarditis associated with these vaccines. If >8 weeks have elapsed since first dose of Novavax COVID-19 vaccine, then may administer any COVID-19 vaccine (Ref).
≥2 doses of any previous Novavax COVID-19 vaccine formulation: IM: 0.5 mL as a single dose administered ≥8 weeks after the last dose of previous formulation (Ref).
≥1 dose of any previous mRNA COVID-19 vaccine formulation or Janssen COVID-19 vaccine: IM: 0.5 mL as a single dose administered ≥8 weeks after the last dose of previous formulation (Ref).
Persons WITH moderate to severe immunocompromising conditions or treatment:
No prior COVID-19 vaccine: IM: 0.5 mL per dose for 3 doses with Dose 2 administered 3 weeks after Dose 1, and then Dose 3 administered 6 months after Dose 2 (minimum interval 2 months) (Ref).
One dose of any previous Novavax COVID-19 vaccine formulation: IM: 0.5 mL per dose for 2 doses with Dose 1 administered ≥3 weeks after last dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months) (Ref).
≥2 doses of any previous Novavax COVID-19 vaccine formulation: IM: 0.5 mL per dose for 2 doses with Dose 1 administered ≥8 weeks after the last dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months) (Ref).
≥3 doses of any previous mRNA COVID-19 vaccine formulation: IM: 0.5 mL per dose for 2 doses with Dose 1 administered ≥8 weeks after the last dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months) (Ref).
≥1 dose of Janssen COVID-19 vaccine: IM: 0.5 mL per dose for 2 doses with Dose 2 administered 6 months after Dose 1 (minimum interval 2 months) (Ref).
Additional doses in persons who are moderately or severely immunocompromised: Per shared decision making, may receive additional age-appropriate doses of a 2024-2025 formulation COVID-19 vaccine ≥2 months following the last 2024-2025 formulation COVID-19 vaccine dose (Ref).
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 (Ref).
Interchangeability: Vaccination series should be from the same manufacturer if possible. A different age-appropriate COVID-19 vaccine may be administered in some circumstances (ie, same vaccine not available at the vaccination site at the time of the clinic visit, previous dose unknown, person would otherwise not receive a recommended vaccine dose, or person starts but is unable to complete a vaccination series with the same COVID-19 vaccine due to a contraindication) (Ref).
If 1 dose of mRNA COVID-19 vaccine (2024-2025 formulation) and 1 dose of Novavax (2024-2025 formulation) administered to previously unvaccinated person as part of an initial vaccination series:
If not moderately or severely immunocompromised, then no further doses needed (Ref).
If moderately or severely immunocompromised, administer 1 dose of any COVID-19 vaccine (2024-2025 formulation) ≥4 weeks after the last dose to complete initial vaccination series. Then, administer another dose 6 months later (minimum interval 2 months) (total of 4 doses); additional doses may be administered ≥2 months following the last dose under shared clinical decision making (Ref).
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 (Ref).
Dosing recommendations for deviations in administration, preparation, or storage:
|
Deviation |
Adjustment |
|---|---|
|
a CDC 2024; 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 who are not moderately or severely immunocompromised as it may reduce the potential for increased reactogenicity and rare risk of myocarditis and pericarditis; 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. |
|
Dosing interval | |
|
Any COVID-19 vaccine 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 |
|
Storage | |
|
Improper storage or handling of vaccine (eg, temperature excursion) |
Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval).c |
|
Dose administered past expiration/beyond-use date |
Repeat dose immediately (no minimum interval).c |
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
CDC recommendations (Ref):
Persons ≥65 years WITHOUT moderate to severe immunocompromising conditions or treatment:
No prior COVID-19 vaccine: IM: 0.5 mL per dose for 3 doses with Dose 2 administered 3 to 8 weeks after Dose 1, and then Dose 3 administered 6 months after Dose 2 (minimum interval 2 months). Note: An 8-week interval between the first and second doses might be optimal for some people, as it might reduce the rare risk of myocarditis and pericarditis associated with these vaccines.
One dose of any previous Novavax COVID-19 vaccine formulation: IM: 0.5 mL per dose for 2 doses with Dose 1 administered 3 to 8 weeks after dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months). Note: An 8-week interval between the first and second doses might be optimal for some people, as it might reduce the rare risk of myocarditis and pericarditis associated with these vaccines. If >8 weeks have elapsed since first dose of Novavax COVID-19 vaccine, then may administer any COVID-19 vaccine.
≥2 doses of any previous Novavax COVID-19 vaccine formulation: IM: 0.5 mL per dose for 2 doses with Dose 1 administered ≥8 weeks after dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months).
≥1 dose of any previous mRNA COVID-19 vaccine: IM: 0.5 mL per dose for 2 doses with Dose 1 administered ≥8 weeks after dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months).
≥1 dose of Janssen COVID-19 vaccine: IM: 0.5 mL per dose for 2 doses with Dose 2 administered 6 months after Dose 1 (minimum interval 2 months).
Persons ≥65 years WITH moderate to severe immunocompromising conditions or treatment:
No prior COVID-19 vaccine: IM: 0.5 mL per dose for 3 doses with Dose 2 administered 3 weeks after Dose 1, and then Dose 3 administered 6 months after Dose 2 (minimum interval 2 months).
One dose of any previous Novavax COVID-19 vaccine formulation: IM: 0.5 mL per dose for 2 doses with Dose 1 administered ≥3 weeks after last dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months).
≥2 doses of any previous Novavax COVID-19 vaccine formulation: IM: 0.5 mL per dose for 2 doses with Dose 1 administered ≥8 weeks after the last dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months).
≥3 doses of any previous mRNA COVID-19 vaccine formulation: IM: 0.5 mL per dose for 2 doses with Dose 1 administered ≥8 weeks after the last dose of previous formulation, and then Dose 2 administered 6 months after Dose 1 (minimum interval 2 months).
≥1 dose of Janssen COVID-19 vaccine: IM: 0.5 mL per dose for 2 doses with Dose 2 administered 6 months after Dose 1 (minimum interval 2 months).
(For additional information see "COVID-19 subunit vaccine (United States and Canada: Authorized for use): Pediatric drug information")
COVID-19, prevention:
CDC recommendations (Ref):
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 history (prior to 2024-2025 formulation) |
Dosage |
Number of 2024-2025 formulation doses indicated (administer IM) |
Interval between doses |
|---|---|---|---|
|
a Previously unvaccinated patients who receive a first dose of Novavax COVID-19 vaccine should complete the 2-dose series with Novavax vaccine. However, if it has been >8 weeks since the first dose, any 2024-2025 formulation COVID-19 vaccine (Novavax, Moderna, or Pfizer-BioNTech) may be administered. | |||
|
b 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 |
0.5 mL |
2 dosesa |
Administer second dose 3 to 8 weeks following the first doseb |
|
1 dose of previous Novavax COVID-19 vaccine formulation (prior to 2024-2025 formulation) |
0.5 mL |
1 dose |
3 to 8 weeks after last dose of previous formulationb |
|
≥1 dose of previous mRNA COVID-19 vaccine formulation, or ≥2 doses of previous Novavax COVID-19 vaccine formulation (prior to 2024-2025 formulations) |
0.5 mL |
1 dose |
≥8 weeks after last dose of previous formulation |
|
COVID-19 vaccine history (prior to 2024-2025 formulation) |
Dosage |
Number of 2024-2025 formulation doses indicated (administer IM) |
Interval between doses |
|---|---|---|---|
|
a Persons ≥12 years of age who are moderately or severely immunocompromised may receive additional doses of 2024-2025 formulation Novavax COVID-19 vaccine ≥2 months following the last recommended 2024-2025 COVID-19 vaccine dose (mRNA or Novavax) per shared clinical decision making. | |||
|
b Previously unvaccinated patients who receive a first dose of Novavax COVID-19 vaccine should complete the 2-dose series with Novavax vaccine. However, if it has been >8 weeks since the first dose, any 2024-2025 formulation COVID-19 vaccine (Novavax, Moderna, or Pfizer-BioNTech) may be administered under routine vaccination. | |||
|
No prior COVID-19 vaccine |
0.5 mL |
3 dosesa,b |
Administer second dose 3 weeks following the first dose. Administer third dose 6 months after second dose (minimum interval: 2 months). |
|
1 dose of previous Novavax COVID-19 vaccine formulation (prior to 2024-2025 formulation) |
0.5 mL |
2 dosesa |
Administer first dose ≥3 weeks after last dose of previous formulation, then administer second dose 6 months after first (minimum interval: 2 months) |
|
≥2 doses of previous Novavax COVID-19 vaccine or ≥3 doses of any previous COVID-19 mRNA vaccine formulation or completed initial series prior to 2024-2025 formulation |
0.5 mL |
2 dosesa |
Administer first dose ≥8 weeks after last dose of previous formulation, then administer second dose 6 months after first (minimum interval: 2 months) |
Canadian and international recommendations: Preparations of COVID-19 vaccines containing different components may be available. The Canadian National Advisory Committee on Immunization (NACI) may provide different recommendations as compared to the CDC, including longer intervals; see NACI recommendations for details (Ref).
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, 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 (Ref).
Dosing recommendations for deviations in administration, preparation, or storage:
|
Deviation |
Adjustment |
|---|---|
|
a CDC 2024; 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, administer full dose. |
|
Interchangeability | |
|
Person ≥12 years of age (previously unvaccinated) received 1 dose of mRNA vaccine and 1 dose of Novavax vaccine |
For routine vaccination, no further doses needed. For patients who are moderately to severely immunocompromised, administer any age-appropriate dose of 2024-2025 vaccine (ie, Novavax, Moderna, or Pfizer-BioNTech) ≥4 weeks after the last dose, followed by another dose of any 2024-2025 vaccine 6 months later (minimum interval: 2 months). |
|
Dosing interval | |
|
Dose administered too early (ie, more than 4 days prior to the minimum 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 <12 years) |
If part of a multidose initial series, count the dose, and continue the series with an age-appropriate 2024-2025 mRNA vaccine, spaced by at least the minimum interval. If dose given in error was the last dose in the series, no further doses are needed. For children 5 to <12 years of age who are not moderately or severely immunocompromised, no further doses are needed if the patient previously received ≥1 dose of any mRNA vaccine. If the patient did not previously receive any mRNA vaccine, administer 1 dose of a 2024-2025 mRNA vaccine ≥4 weeks after the 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 |
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
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, 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 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 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)
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), vomiting (≤20%) (table 2)
|
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" |
|
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), tenderness at injection site (≤81%) (table 4)
|
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" |
|
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), headache (15% to 57%) (table 6), malaise (≤58%)
|
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" |
|
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), myalgia (adolescents: 34% to 49%; adults: 13% to 51%) (table 8)
|
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 |
|
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), swelling at injection site (≤8%) (table 10)
|
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 |
|
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)
|
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
History of severe allergic reaction (eg, anaphylaxis) after a previous dose or to any component of the formulation (FDA 2024).
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. In general, it is recommended to defer vaccine administration in patients with moderate or severe acute febrile illness (with or without fever) and to provide vaccination in patients with mild acute illness (with or without fever) (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 Bleeding Disorders 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 2024).
• Myocarditis/pericarditis (CDC 2024):
- 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.
- 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 2024):
- 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.
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 2024). 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 2024; 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 2024; 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]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Prefilled Syringe, Intramuscular [preservative free]:
Novavax COVID-19 Vaccine: 5 mcg/0.5 mL (0.5 mL) [contains polysorbate 80]
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intramuscular:
Nuvaxovid Omicron JN.1: 5 mcg/0.5 mL (2.5 mL) [contains polysorbate 80]
The Novavax COVID-19 Vaccine is not commercially available; it is available under emergency use authorization (EUA) from the FDA.
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.
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
• 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.
IM: Administer IM into deltoid muscle or anterolateral thigh (Ref). 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 (Ref). 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 (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement edition date and date it was provided, and the administering person's name, title, and address be recorded.
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) (Ref).
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 (Ref).
Parenteral: IM: Prior to use, gently swirl vial before each withdrawal; do not shake. Administer IM into deltoid muscle or anterolateral thigh (Ref). 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 (Ref). 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 (Ref). 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 (Ref).
Inappropriate administration technique: If administered SUBQ or into a muscle other than the deltoid or anterolateral thigh, do not repeat dose (Ref).
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 (Ref).
COVID-19 prevention (Nuvaxovid [Canadian product], Nuvaxovid XBB.1.5 [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."
COVID-19 prevention
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]).
None known.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Abatacept: May decrease therapeutic effects 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 decrease therapeutic effects 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 decrease therapeutic effects 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 decrease therapeutic effects 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
Atidarsagene Autotemcel: May increase adverse/toxic effects of Vaccines. Atidarsagene Autotemcel may decrease therapeutic effects of Vaccines. Risk X: Avoid
AzaTHIOprine: May decrease therapeutic effects 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 decrease therapeutic effects 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 decrease therapeutic effects 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 decrease therapeutic effects 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 increase adverse/toxic effects of CloZAPine. COVID-19 Vaccines may increase serum concentration of CloZAPine. Risk C: Monitor
Corticosteroids (Systemic): May decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CycloPHOSphamide: May decrease therapeutic effects 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 increase adverse/toxic effects of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may decrease therapeutic effects 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
Immunosuppressants (Cytotoxic Chemotherapy): May decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Immunosuppressants (Miscellaneous Oncologic Agents): May decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Immunosuppressants (Therapeutic Immunosuppressant Agents): May decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Leflunomide: May decrease therapeutic effects 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 decrease therapeutic effects 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 decrease therapeutic effects 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
Pemivibart: May decrease therapeutic effects of COVID-19 Vaccines. Management: Do not administer pemivibart for at least 2 weeks after receipt of COVID-19 vaccination. Risk D: Consider Therapy Modification
Propacetamol: May decrease therapeutic effects 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
Sipavibart: May decrease therapeutic effects of COVID-19 Vaccines. Management: Consider waiting at least 2 weeks after receipt of a COVID-19 vaccine to initiate sipavibart. Risk D: Consider Therapy Modification
SulfaSALAzine: May decrease therapeutic effects 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 decrease therapeutic effects 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
Tofacitinib: May decrease therapeutic effects 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 decrease therapeutic effects 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
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 2024). Refer to current CDC guidelines for vaccination of adults.
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).
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 pregnant patients (ACOG 2023; CDC 2024). Refer to current CDC guidelines for vaccination of adults.
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/).
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 2024). 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).
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]; CDC 2024). 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 2024). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
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.
