NVX-CoV2373 COVID-19 Vaccine (Novavax)

Kathryn Dzintars, Pharm.D., BCPS
NVX-CoV2373 COVID-19 Vaccine (Novavax) is a topic covered in the Johns Hopkins ABX Guide.

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VACCINE TYPE

  • The Novavax COVID-19 vaccine (NVX-CoV2373) is an adjuvanted vaccine containing purified, full-length rS protein. The vaccine elicits an immune response to this protein, leading to protection against COVID-19.
    • Primary Series: two-dose series, given 21 days apart.
    • No booster dose is recommended at this time.
  • The Novavax COVID-19 vaccine is available through an Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine for individuals 12 years of age and older.
    • Mandatory requirements for the administration of the Novavax COVID-19 vaccine under the EUA are as follows:
      • The vaccination provider must give the individual receiving the Novavax COVID-19 vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” before receiving the Novavax COVID-19 vaccine.
      • Vaccine providers must include vaccine information in the state’s or local jurisdiction’s Immunization Information System or other designated systems.
      • Vaccine providers are responsible for reporting certain events to the Vaccine Adverse Events Reporting System (VAERS):
        • Vaccine administration errors, whether or not associated with an adverse event
        • Serious adverse events include death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, congenital anomaly/birth defects.
        • Cases of multisystem inflammatory syndrome (MIS) in children and adults
        • Cases of COVID-19 that result in hospitalization and death
      • Vaccine providers are responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following the administration of Novavax COVID-19 vaccine to recipients.

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VACCINE TYPE

  • The Novavax COVID-19 vaccine (NVX-CoV2373) is an adjuvanted vaccine containing purified, full-length rS protein. The vaccine elicits an immune response to this protein, leading to protection against COVID-19.
    • Primary Series: two-dose series, given 21 days apart.
    • No booster dose is recommended at this time.
  • The Novavax COVID-19 vaccine is available through an Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine for individuals 12 years of age and older.
    • Mandatory requirements for the administration of the Novavax COVID-19 vaccine under the EUA are as follows:
      • The vaccination provider must give the individual receiving the Novavax COVID-19 vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” before receiving the Novavax COVID-19 vaccine.
      • Vaccine providers must include vaccine information in the state’s or local jurisdiction’s Immunization Information System or other designated systems.
      • Vaccine providers are responsible for reporting certain events to the Vaccine Adverse Events Reporting System (VAERS):
        • Vaccine administration errors, whether or not associated with an adverse event
        • Serious adverse events include death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, congenital anomaly/birth defects.
        • Cases of multisystem inflammatory syndrome (MIS) in children and adults
        • Cases of COVID-19 that result in hospitalization and death
      • Vaccine providers are responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following the administration of Novavax COVID-19 vaccine to recipients.

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Last updated: October 17, 2022