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.

Novavax is unable to provide medical advice regarding your health condition. Please consult your doctor, nurse or healthcare provider, who is in the best position to advise you about the suitability of a particular treatment as they have access to the details of your medical history, as well as information on all medicinal products.

To ask Novavax Medical Information a question about a Novavax product please call
844-NOVAVAX between 8:00AM-8:00PM ET Monday - Friday.

Report vaccine side effects to the FDA and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‑800‑822‑7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Novavax COVID-19 Vaccine, Adjuvanted EUA” in the first line of box #18 of the report form.

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.