Novavax COVID-19 Vaccine

Adult Dosing .

Dosage forms:  INJ

Investigational New Drug (IND)

[FDA emergency use authorization (EUA)]

Info: for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus; not FDA approved

[mandatory reporting]

Info: vaccine administration errors, serious adverse events, Multisystem Inflammatory Syndrome (MIS) cases, pericarditis or myocarditis cases, and COVID-19-related hospitalizations or deaths following vaccination must be reported to Vaccine Adverse Event Reporting System (vaers.hhs.gov/reportevent.html or 1-800-822-7967) and Novavax Inc. (www.NovavaxMedInfo.com or 1-844-668-2829)

COVID-19 prevention

[immunocompetent or mildly immunocompromised pts, <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 incl. links to CDC/ACIP schedules

[immunocompetent or mildly immunocompromised pts, <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 incl. links to CDC/ACIP schedules

[immunocompetent or mildly immunocompromised pts, <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 incl. links to CDC/ACIP schedules

[immunocompetent or mildly immunocompromised pts, <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 incl. links to CDC/ACIP schedules

[immunocompetent or mildly immunocompromised pts, 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 incl. links to CDC/ACIP schedules

[immunocompetent or mildly immunocompromised pts, 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 incl. links to CDC/ACIP schedules

[immunocompetent or mildly immunocompromised pts, 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 incl. links to CDC/ACIP schedules

[immunocompetent or mildly immunocompromised pts, <65 yo, 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 incl. links to CDC/ACIP schedules

[moderately-severely immunocompromised pts, 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 on case-by-case basis; search 'immunization' for epocrates Adult Immunization decision tool incl. links to CDC/ACIP schedules

[moderately-severely immunocompromised pts, 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 on case-by-case basis; search 'immunization' for epocrates Adult Immunization decision tool incl. links to CDC/ACIP schedules

[moderately-severely immunocompromised pts, 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 on case-by-case basis; search 'immunization' for epocrates Adult Immunization decision tool incl. links to CDC/ACIP schedules

[moderately-severely immunocompromised pts, 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 on case-by-case basis; search 'immunization' for epocrates Adult Immunization decision tool incl. links to CDC/ACIP schedules

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[no adjustment]

Peds Dosing .

Dosage forms:  INJ

Investigational New Drug (IND)

[FDA emergency use authorization (EUA)]

Info: for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus; not FDA approved

[mandatory reporting]

Info: vaccine administration errors, serious adverse events, Multisystem Inflammatory Syndrome (MIS) cases, pericarditis or myocarditis cases, and COVID-19-related hospitalizations or deaths following vaccination must be reported to Vaccine Adverse Event Reporting System (vaers.hhs.gov/reportevent.html or 1-800-822-7967) and Novavax Inc. (www.NovavaxMedInfo.com or 1-844-668-2829)

COVID-19 prevention

[12 yo and older, immunocompetent or mildly immunocompromised pts, 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 Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[12 yo and older, immunocompetent or mildly immunocompromised pts, 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 incl. links to CDC/ACIP schedules

[12 yo and older, immunocompetent or mildly immunocompromised pts, 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 Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[12 yo and older, immunocompetent or mildly immunocompromised pts, 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 incl. links to CDC/ACIP schedules

[12 yo and older, moderately-severely immunocompromised pts, 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 on case-by-case basis; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[12 yo and older, moderately-severely immunocompromised pts, 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 on case-by-case basis; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[12 yo and older, moderately-severely immunocompromised pts, 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 on case-by-case basis; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[12 yo and older, moderately-severely immunocompromised pts, 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 on case-by-case basis; search 'immunization' for epocrates Adult Immunization decision tool incl. links to CDC/ACIP schedules

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[no adjustment]