Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.
To the extent feasible, report adverse events to Novavax, Inc. using the contact information below or by providing a copy of the VAERS form to Novavax, Inc.
For general questions, visit the website or call the telephone number provided below.
To access the most recent Novavax COVID-19 Vaccine, Adjuvanted Fact Sheets, please scan the QR code or visit the website provided below.
COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. There may be clinical trials or availability under EUA of other COVID-19 vaccines.
This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients). For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.
Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 Pandemic. In response, the FDA has issued an EUA for the unapproved product, Novavax COVID-19 Vaccine, Adjuvanted, for active immunization to prevent COVID-19 in individuals 12 years of age and older.
FDA issued this EUA based on Novavax, Inc.’s request and submitted data.
Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Novavax COVID-19 Vaccine, Adjuvanted may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.
This EUA for the Novavax COVID-19 Vaccine, Adjuvanted will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.
For additional information about EUA, visit FDA at:
The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about CICP, visit http://www.hrsa.gov/cicp, email email@example.com, or call: 1-855-266-2427.
Novavax, Inc., Gaithersburg, MD, 20878
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END SHORT VERSION FACT SHEET Long Version (Full EUA Prescribing Information) Begins On Next Page
FULL EMERGENCY USE AUTHORIZATION (EUA)PRESCRIBING INFORMATION
NOVAVAX COVID-19 VACCINE, ADJUVANTED
FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION: CONTENTS *
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) 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.
For intramuscular injection only.
Inspect the vial
- The Novavax COVID-19 Vaccine, Adjuvanted is a colorless to slightly yellow, clear to mildly opalescent suspension, free from visible particles.
- Gently swirl the multi-dose vial before each dose withdrawal. Do not shake.
- Parenteral drug products should be inspected visually particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer the vaccine if either of these conditions exist.
Prepare for administration
- Record the date and time of the first puncture on the vial label.
- Each multi-dose vial contains 10 doses of 0.5 mL each.
- Do not pool excess vaccine from multiple vials.
- After the first needle puncture, hold the vial between 2° to 25°C (36° to 77°F) for up to 6 hours.
- Discard vial 6 hours after the first puncture.
Administer the Novavax COVID-19 Vaccine, Adjuvanted intramuscularly.
The Novavax COVID-19 Vaccine, Adjuvanted is administered intramuscularly as a primary series of two doses (0.5 mL each) 3 weeks apart in individuals 12 years of age and older.
A first booster dose (0.5 mL) of Novavax COVID-19 Vaccine, Adjuvanted may be administered intramuscularly 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 in 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 Novavax COVID-19 Vaccine, Adjuvanted is a suspension for injection. A single dose is 0.5 mL.
Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted [see Description (13)].
VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.