Vaccine Information: NOVAVAX COVID-19 Vaccine, Adjuvanted (Page 2 of 8)

OTHER ADVERSE EVENT REPORTING TO VAERS AND NOVAVAX, INC.

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.

Website

Fax number

Telephone number

www.NovavaxMedInfo.com

1-888-988-8809

1-844-NOVAVAX(1-844-668-2829)

ADDITIONAL INFORMATION

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.

Website

Telephone number

www.NovavaxCovidVaccine.com

NOVAVAX QR code

1-844-NOVAVAX(1-844-668-2829)

AVAILABLE ALTERNATIVES

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.

FEDERAL COVID-19 VACCINATION PROGRAM

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.

AUTHORITY FOR ISSUANCE OF THE EUA

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:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

COUNTERMEASURES INJURY COMPENSATION PROGRAM

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 cicp@hrsa.gov, or call: 1-855-266-2427.

NOVAVAX

Manufactured for:
Novavax, Inc., Gaithersburg, MD, 20878

C20001US-004

Revised: October/19/2022
©2022 Novavax, Inc. All rights reserved.

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 *

1 AUTHORIZED USE

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

2.2 Administration

2.3 Dosing and Schedule

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

5.2 Myocarditis and Pericarditis

5.3 Syncope

5.4 Altered Immunocompetence

5.5 Limitations of Vaccine Effectiveness

6 OVERALL SAFETY SUMMARY

6.1 Clinical Trials Experience

6.2 Post-Authorization Experience

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS

10 DRUG INTERACTIONS

11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

11.2 Lactation

11.3 Pediatric Use

11.4 Geriatric Use

13 DESCRIPTION

14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

18.1 Efficacy of Two-Dose Primary Series in Participants 18 Years of Age and Older

18.2 Effectiveness of a Two-Dose Primary Series in Adolescents 12 Through 17 Years of Age

18.3 Immunogenicity of a Booster Dose Following a Novavax COVID-19 Vaccine, Adjuvanted Primary Series in Participants 18 Years and older

18.4 Immunogenicity of a Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine

19 HOW SUPPLIED/STORAGE AND HANDLING

20 PATIENT COUNSELING INFORMATION

21 CONTACT INFORMATION

*Sections or subsections omitted from the full emergency use authorization prescribing information are not listed.

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

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.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

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.

2.2 Administration

Administer the Novavax COVID-19 Vaccine, Adjuvanted intramuscularly.

2.3 Dosing and Schedule

Primary Series

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.

Booster Dose

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.

3 DOSAGE FORMS AND STRENGTHS

The Novavax COVID-19 Vaccine, Adjuvanted is a suspension for injection. A single dose is 0.5 mL.

4 CONTRAINDICATIONS

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)].

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