Novavax Medical Information

• The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) as a primary series in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. 

Authorized Use: The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

Do you have a medical or scientific question about a Novavax medicinal product? Get in touch with Novavax Medical Information experts who will provide tailored, evidence-based, balanced, and up-to-date medical information. 

Healthcare Professionals may request medical information via ONE of the following ways:

Option 1: Complete and submit a Medical Information Request Form by clicking on the button below.

Request Medical Information

Option 2: Call 844-NOVAVAX between 8:00AM-8:00PM ET Monday - Friday.

Vaccination provider enrolled in the federal COVID-19 Vaccination Program are responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):

• vaccine administration errors whether or not associated with an adverse event,
• serious adverse events (irrespective of attribution to vaccination),
• cases of Multisystem Inflammatory Syndrome (MIS), and
• cases of COVID-19 that results in hospitalization or death.

Complete and submit reports to VAERS online: https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Novavax COVID-19 Vaccine, Adjuvanted EUA” in the description section of the report.

Alternatively, adverse events in association with a Novavax product can be reported to Novavax Pharmacovigilance at 844-NOVAVAX between 8:00AM-8:00PM ET Monday - Friday or via the Novavax Adverse Event Reporting Form.

Report an Adverse Event

If you have a product quality complaint related to a physical issue with a Novavax product or its packaging, please report the complaint via ONE of the following ways:

Option 1: Complete and submit a Product Quality Complaint Form by clicking on the button below.

Report a Product Quality Complaint

Option 2: Call 844-NOVAVAX between 8:00AM-8:00PM ET Monday - Friday.