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Nuvaxovid
COVID-19 vaccine, protein subunit, adjuvanted (1vCOV-aPS)
Adult Dosing .
Dosage forms: INJ
COVID-19 prevention
- [immunocompetent or mildly immunocompromised patients, <65 yo, not previously vaccinated]
- Dose: 0.5 mL IM x2 doses 3wk apart; Info: may consider giving 2nd dose 8wk after 1st dose; search 'immunization' for epocrates Adult Immunization decision tool
- [immunocompetent or mildly immunocompromised patients, <65 yo, previously received 1 or more mRNA vaccine doses]
- Dose: 0.5 mL IM x1 dose; Start: at least 8wk after last dose; search 'immunization' for epocrates Adult Immunization decision tool
- [immunocompetent or mildly immunocompromised patients, <65 yo, previously received 1 Novavax vaccine dose]
- Dose: 0.5 mL IM x1 dose; Start: at least 3-8wk after last dose; search 'immunization' for epocrates Adult Immunization decision tool including links to CDC/ACIP schedules
- [immunocompetent or mildly immunocompromised patients, <65 yo, previously received 2 or more Novavax vaccine doses]
- Dose: 0.5 mL IM x1 dose; Start: at least 8wk after last dose; search 'immunization' for epocrates Adult Immunization decision tool
- [immunocompetent or mildly immunocompromised patients, 65 yo and older, not previously vaccinated]
- Dose: 0.5 mL IM x2 doses 3wk apart, then 0.5 mL IM x1 dose at least 6mo later; Info: may consider giving 2nd dose 8wk after 1st dose; search 'immunization' for epocrates Adult Immunization decision tool
- [immunocompetent or mildly immunocompromised patients, 65 yo and older, previously received 1 or more mRNA vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; search 'immunization' for epocrates Adult Immunization decision tool
- [immunocompetent or mildly immunocompromised patients, 65 yo and older, previously received 1 Novavax vaccine dose]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 3-8wk after last dose; search 'immunization' for epocrates Adult Immunization decision tool
- [immunocompetent or mildly immunocompromised patients, 65 yo and older, previously received 2 or more Novavax vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, not previously vaccinated]
- Dose: 0.5 mL IM x2 doses 3wk apart, then 0.5 mL IM x1 dose at least 6mo later; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, previously received 3 or more mRNA vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, previously received 1 Novavax vaccine dose]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 3-8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, previously received 2 or more Novavax vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ
COVID-19 prevention
- [12 yo and older, immunocompetent or mildly immunocompromised patients, not previously vaccinated]
- Dose: 0.5 mL IM x2 doses 3-8wk apart; Start: at least 2mo after last COVID-19 vaccine dose if previously vaccinated; Info: give based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, immunocompetent or mildly immunocompromised patients, previously received 1 or more mRNA vaccine doses]
- Dose: 0.5 mL IM x1 dose; Start: at least 8wk after last dose; Info: give based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [12 yo and older, immunocompetent or mildly immunocompromised patients, previously received 1 Novavax vaccine dose]
- Dose: 0.5 mL IM x1 dose; Start: at least 3-8wk after last dose; Info: give based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, immunocompetent or mildly immunocompromised patients, previously received 2 or more Novavax vaccine doses]
- Dose: 0.5 mL IM x1 dose; Start: at least 8wk after last dose; Info: give based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, not previously vaccinated]
- Dose: 0.5 mL IM x2 doses 3wk apart, then 0.5 mL IM x1 dose at least 6mo later; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, previously received 3 or more mRNA vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, previously received 1 Novavax vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 3-8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, previously received 2 or more Novavax vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: non-severe hypersensitivity to prior protein subunit COVID-19 vaccine dose
- caution: non-severe hypersensitivity to protein subunit COVID-19 vaccine component
- caution: hypersensitivity to mRNA COVID-19 vaccine
- caution: hypersensitivity to vector COVID-19 vaccine
- caution: immunocompromised patients
- caution: male patients <40 yo
- caution: multisystem inflammatory syndrome history
- caution: myocarditis within 3wk of prior COVID-19 vaccine
- caution: pericarditis within 3wk of prior COVID-19 vaccine
- caution: illness, acute moderate-severe
Drug Interactions .
Overview
COVID-19 vaccine
vaccine
- non-live vaccine
Avoid/Use Alternative
Monitor/Modify Tx
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- myocarditis
- pericarditis
Common Reactions
- injection site reaction
- fatigue
- myalgia
- headache
- malaise
- arthralgia
- nausea
- vomiting
- fever
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; inadequate human data available, though risk of fetal harm not expected based on other protein subunit vaccines; no known risk of fetal harm based on animal data
Pregnancy Registry
encourage patients to enroll in COVID-19 Vaccines International Pregnancy Exposure Registry at https://cviper.pregistry.com; encourage patients to enroll in v-safe COVID-19 Vaccine Pregnancy Registry at https://vsafe.cdc.gov; encourage patients to enroll in COVID-19 Vaccines Pregnancy Registry at https://mothertobaby.org/ongoing-study/covid19-vaccines/
Lactation
Clinical Summary
may use while breastfeeding; no human data available, though risk of infant harm not expected based on vaccine properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for COVID-19 vaccine: other; CYP450: unknown
Excretion: for COVID-19 vaccine: other; Half-life: unknown
Subclass: Coronavirus Vaccines ; Routine Adult Vaccines ; Routine Pediatric Vaccines
Mechanism of Action
for COVID-19 vaccine: elicits humoral and cellular immune response to the SARS-CoV-2 virus
Formulary .
No Formulary Selected
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