The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Novavax COVID-19 Vaccine, Adjuvanted, for active immunization to prevent COVID-19 in individuals 18 years of age and older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and cases of COVID-19 that result in hospitalization or death following administration of the Novavax COVID-19 Vaccine, Adjuvanted. See “MANDATORY REQUIREMENTS FOR THE NOVAVAX COVID-19 VACCINE, ADJUVANTED ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Novavax COVID-19 Vaccine, Adjuvanted is a suspension for intramuscular injection.

The Novavax COVID-19 Vaccine, Adjuvanted is authorized for emergency use to provide a two-dose primary series to individuals 18 years of age and older. The primary series of the Novavax COVID-19 Vaccine, Adjuvanted is two doses (0.5 mL each) given 3 weeks apart.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see http://www.NovavaxCovidVaccine.com.

For information on clinical trials that are testing the use of the Novavax COVID-19 Vaccine, Adjuvanted for active immunization against COVID-19, please see http://www.clinicaltrials.gov.

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

DOSAGE AND ADMINISTRATION

CONTRAINDICATIONS

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information).

WARNINGS

Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Novavax COVID-19 Vaccine, Adjuvanted.

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis

Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information).

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.

Limitations of Vaccine Effectiveness

The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.

ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

Adverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis. (see Full EUA Prescribing Information).

Adverse Reactions Identified during Post-Authorization Use

Myocarditis, pericarditis, and anaphylaxis have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.

USE WITH OTHER VACCINES

There is no information on co-administration of the Novavax COVID-19 Vaccine, Adjuvanted with other vaccines.

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website http://www.NovavaxCovidVaccine.com to obtain the Fact Sheet) prior to the individual receiving each dose of the Novavax COVID-19 Vaccine, Adjuvanted, including:

• FDA has authorized the emergency use of the Novavax COVID-19 Vaccine, Adjuvanted, which is not an FDA-approved vaccine.
• The recipient or their caregiver has the option to accept or refuse the Novavax COVID-19 Vaccine, Adjuvanted.
• The significant known and potential risks and benefits of the Novavax COVID-19 Vaccine, Adjuvanted, and the extent to which such risks and benefits are unknown.
• Information about available alternative vaccines and the risks and benefits of those alternatives.

For information on clinical trials that are evaluating the use of the Novavax COVID-19 Vaccine, Adjuvanted to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of the Novavax COVID-19 Vaccine, Adjuvanted.

Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe.

MANDATORY REQUIREMENTS FOR THE NOVAVAX COVID-19 VACCINE, ADJUVANTED ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of the Novavax COVID-19 Vaccine, Adjuvanted, the following items are required. Use of the unapproved Novavax COVID-19 Vaccine, Adjuvanted for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):

1. The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use in individuals 18 years of age and older.
2. The vaccination provider must communicate to the individual receiving the Novavax COVID-19 Vaccine, Adjuvanted or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving the Novavax COVID-19 Vaccine, Adjuvanted.
3. The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system.
4. The vaccination provider is 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) in adults, and
   • cases of COVID-19 that result in hospitalization or death.
     
     Complete and submit reports to VAERS online at 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.
5. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults, and cases of COVID-19 that result in hospitalization or death following administration of the Novavax COVID-19 Vaccine, Adjuvanted to recipients.
   
   *Serious adverse events are defined as:
   • Death;
   • A life-threatening adverse event;
   • Inpatient hospitalization or prolongation of existing hospitalization;
   • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
   • A congenital anomaly/birth defect;
   • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

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	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 18 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.

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

C20001US-001

Revised: July/13/2022
©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 in Participants 18 Years of Age and Older 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 18 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

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)].

5 WARNINGS AND PRECAUTIONS

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and hospitalized or fatal cases of COVID-19 following vaccination with the Novavax COVID-19 Vaccine, Adjuvanted. To the extent feasible, provide a copy of the VAERS form to Novavax, Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Novavax, Inc.

Adverse Reactions in Clinical Trials

In a clinical trial, among participants 18 through 64 years of age, solicited adverse reactions (ARs) following administration of any dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection site pain/tenderness (82.2%), fatigue/malaise (62.0%), muscle pain (54.1%), headache (52.9%), joint pain (25.4%), nausea/vomiting (15.6%), injection site redness (7.0%), injection site swelling (6.3%), and fever (6.0%). In participants ≥65 years of age, solicited ARs following administration of any dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection site pain/tenderness (63.4%), fatigue/malaise (39.2%), muscle pain (30.2%), headache (29.2%), joint pain (15.4%), nausea/vomiting (7.3%), injection site swelling (5.3%), injection site redness (4.8%), and fever (2.0%).

Myocarditis, pericarditis, chills, injection site pruritus, hypersensitivity reactions, and lymphadenopathy-related reactions have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted.

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

See Overall Safety Summary (Section 6) for additional information.

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following the Novavax COVID-19 Vaccine, Adjuvanted 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) in adults
• Cases of COVID-19 that result in hospitalization or death

*Serious adverse events are defined as:

• Death;
• A life-threatening adverse event;
• Inpatient hospitalization or prolongation of existing hospitalization;
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
• A congenital anomaly/birth defect;
• An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods:

• Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
• If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report, you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to info@vaers.org.

IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to the FDA be as detailed and as complete as possible. Information to include:

• Patient demographics (e.g., patient name, date of birth)
• Pertinent medical history
• Pertinent details regarding admission and course of illness
• Concomitant medications
• Timing of adverse event(s) in relationship to administration of the Novavax COVID-19 Vaccine, Adjuvanted
• Pertinent laboratory and virology information
• Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:

1. In Box 17, provide information on the Novavax COVID-19 Vaccine, Adjuvanted and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within one month prior.
2. In Box 18, description of the event:
   1. Write “Novavax COVID-19 Vaccine, Adjuvanted EUA” as the first line.
   2. Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above.
3. Contact information:
   1. In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.
   2. In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.
   3. In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address).

Other Reporting Instructions

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)

10 DRUG INTERACTIONS

There is no information on co-administration of the Novavax COVID-19 Vaccine, Adjuvanted with other vaccines.

11 USE IN SPECIFIC POPULATIONS

13 DESCRIPTION

The Novavax COVID-19 Vaccine, Adjuvanted is a colorless-to-slightly yellow, clear-to-mildly opalescent suspension for intramuscular injection that is free from visible particles. Each 0.5 mL dose of the Novavax COVID-19 Vaccine, Adjuvanted contains 5 mcg of SARS-CoV-2 recombinant spike (rS) protein and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina.

The rS protein is produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species.

Each dose of the Novavax COVID-19 Vaccine, Adjuvanted also contains the following ingredients: cholesterol, phosphatidylcholine, potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg) and polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid.

Each 0.5 mL dose of the Novavax COVID-19 Vaccine, Adjuvanted may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (< 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (<0.92 mcg), pluronic F-68 (< 2.19 mcg), Triton X-100 (< 0.025 mcg), and Tergitol (NP9) (< 0.05 mcg).

The Novavax COVID-19 Vaccine, Adjuvanted does not contain preservative.

The vial stoppers are not made with natural rubber latex.

14 CLINICAL PHARMACOLOGY

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

19 HOW SUPPLIED/STORAGE AND HANDLING

The Novavax COVID-19 Vaccine, Adjuvanted is supplied in a carton (NDC 80631-100-10) containing 10 multi-dose vials (NDC 80631-100-01). Each multi-dose vial contains 10 doses of 0.5 mL each.

Storage of Unpunctured Vial

Store the unpunctured multi-dose vaccine vial in a refrigerator between 2° to 8°C (36° to 46°F).

Do not freeze.

Protect from light.

Storage After First Needle Puncture of the Vial

After first puncture, hold the vial between 2°to 25°C (36°to 77°F) for up to 6 hours. Discard the vial 6 hours after the first puncture.

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.

The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.

21 CONTACT INFORMATION

For general questions, visit the website or call the telephone number provided below.

Website	Telephone number
www.NovavaxCovidVaccine.com	1-844-NOVAVAX (1-844-668-2829)

This Full EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing Information, please see www.NovavaxCovidVaccine.com.

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

C20001US-001

Revised: July/13/2022
©2022 Novavax, Inc. All rights reserved.

FACT SHEET FOR RECIPIENTS AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF THE NOVAVAX COVID-19 VACCINE, ADJUVANTED TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

You are being offered the Novavax COVID-19 Vaccine, Adjuvanted to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The Novavax COVID-19 Vaccine, Adjuvanted has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series to individuals 18 years of age and older.

This Fact Sheet contains information to help you understand the risks and benefits of the Novavax COVID-19 Vaccine, Adjuvanted, which you may receive because there is currently a pandemic of COVID-19. Talk to your vaccination provider if you have questions.

The Novavax COVID-19 Vaccine, Adjuvanted may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit http://www.NovavaxCovidVaccine.com.

WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE

WHAT IS COVID-19?

COVID-19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE NOVAVAX COVID-19 VACCINE, ADJUVANTED?

The Novavax COVID-19 Vaccine, Adjuvanted is an unapproved vaccine that may prevent COVID-19.

The FDA has authorized the emergency use of the Novavax COVID-19 Vaccine, Adjuvanted to prevent COVID-19 in individuals 18 years of age and older under an EUA.

For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE NOVAVAX COVID-19 VACCINE, ADJUVANTED?

Tell your vaccination provider about all of your medical conditions, including if you:

•

have any allergies

•

have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

•

have a fever

•

have a bleeding disorder or are on a blood thinner

•

are immunocompromised or are on a medicine that affects your immune system

•

are pregnant or plan to become pregnant

•

are breastfeeding

•

have received another COVID-19 vaccine

•

have ever fainted in association with an injection

WHO SHOULD NOT GET THE NOVAVAX COVID-19 VACCINE, ADJUVANTED?

You should not get the Novavax COVID-19 Vaccine, Adjuvanted if you:

• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine

WHAT ARE THE INGREDIENTS IN THE NOVAVAX COVID-19 VACCINE, ADJUVANTED?

The Novavax COVID-19 Vaccine, Adjuvanted contains a recombinant form of the SARS-CoV-2 spike protein produced from baculovirus infected Sf9 (fall armyworm) insect cells and Matrix-MTM adjuvant containing saponins derived from the soapbark tree (Quillaja saponaria Molina). Other ingredients include cholesterol, phosphatidylcholine, potassium dihydrogen phosphate, potassium chloride, disodium hydrogen phosphate dihydrate, sodium chloride, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, polysorbate 80, and water for injection. The vaccine may also contain small amounts of baculovirus and insect cell proteins and DNA.

HOW IS THE NOVAVAX COVID-19 VACCINE, ADJUVANTED GIVEN?

The Novavax COVID-19 Vaccine, Adjuvanted will be given to you as an injection in the muscle.

The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose series, 3 weeks apart.

HAS THE NOVAVAX COVID-19 VACCINE, ADJUVANTED BEEN USED BEFORE?

The Novavax COVID-19 Vaccine, Adjuvanted is an unapproved vaccine. In clinical trials, approximately 25,000 individuals 18 years of age and older have received two doses of the Novavax COVID-19 Vaccine, Adjuvanted.

WHAT ARE THE BENEFITS OF THE NOVAVAX COVID-19 VACCINE, ADJUVANTED?

The Novavax COVID-19 Vaccine, Adjuvanted has been shown to prevent COVID-19. The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THE NOVAVAX COVID-19 VACCINE, ADJUVANTED?

There is a remote chance that the Novavax COVID-19 Vaccine, Adjuvanted could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Novavax COVID-19 Vaccine, Adjuvanted. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

•

Difficulty breathing

•

Swelling of your face and throat

•

A fast heartbeat

•

A bad rash all over your body

•

Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within 10 days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine:

•

Chest pain

•

Shortness of breath

•

Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported in clinical trials with the Novavax COVID-19 Vaccine include:

•

Myocarditis (inflammation of the heart muscle)

•

Pericarditis (inflammation of the lining outside the heart)

•

Injection site reactions: pain/tenderness, swelling, redness and itching

•

General side effects: fatigue or generally feeling unwell, muscle pain, headache, joint pain, nausea, vomiting, fever, chills

•

Allergic reactions such as hives and swelling of the face

•

Swollen lymph nodes

Side effects that have been reported in post-authorization use in countries outside of the United States with the Novavax COVID-19 Vaccine include:

•

Severe allergic reactions

•

Myocarditis (inflammation of the heart muscle)

•

Pericarditis (inflammation of the lining outside the heart)

These may not be all the possible side effects of the Novavax COVID-19 Vaccine, Adjuvanted. Serious and unexpected side effects may occur. The Novavax COVID-19 Vaccine, Adjuvanted is still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

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.

In addition, you can report side effects to Novavax, Inc., at the contact information provided below.

Website	Fax number	Telephone number
www.NovavaxMedInfo.com	1-888-988-8809	1-844-NOVAVAX (1-844-668-2829)

You may also be given an option to enroll in v-safe. V-safe is a voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

WHAT IF I DECIDE NOT TO GET THE NOVAVAX COVID-19 VACCINE, ADJUVANTED?

Under the EUA, it is your choice to receive or not receive the Novavax COVID-19 Vaccine, Adjuvanted. Should you decide not to receive it, it will not change your standard medical care.

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES THE NOVAVAX COVID-19 VACCINE, ADJUVANTED?

Other choices for preventing COVID-19 are COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA), FDA-approved COVID-19 vaccines. Other vaccines to prevent COVID-19 may be available under EUA.

CAN I RECEIVE THE NOVAVAX COVID-19 VACCINE, ADJUVANTED AT THE SAME TIME AS OTHER VACCINES?

Data have not yet been submitted to FDA on administration of the Novavax COVID-19 Vaccine, Adjuvanted at the same time as other vaccines. If you are considering receiving the Novavax COVID-19 Vaccine, Adjuvanted with other vaccines, discuss your options with your healthcare provider.

WHAT IF I AM PREGNANT OR BREASTFEEDING?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com/.

WILL THE NOVAVAX COVID-19 VACCINE, ADJUVANTED GIVE ME COVID-19?

No. The Novavax COVID-19 Vaccine, Adjuvanted does not contain SARS-CoV-2 and cannot give you COVID-19.

KEEP YOUR VACCINATION CARD

When you receive your first dose, you will get a vaccination card to show you when to return for your second dose of the Novavax COVID-19 Vaccine, Adjuvanted. Remember to bring your card when you return.

ADDITIONAL INFORMATION

If you have questions, visit the website or call the telephone number provided below.

To access the most recent Fact Sheets, please scan the QR code provided below.

Novavax COVID-19 Vaccine website	Telephone number
www.NovavaxCovidVaccine.com	1-844-NOVAVAX (1-844-668-2829)

HOW CAN I LEARN MORE?

•

Ask the vaccination provider

•

Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html

•

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

•

Contact your state or local public health department

WHERE WILL MY VACCINATION INFORMATION BE RECORDED?

The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for the second dose. For more information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THE COVID-19 VACCINE?

No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. 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).

WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?

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.

WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product.

FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic.

An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used).

Manufactured for:

Novavax, Inc., Gaithersburg, MD, 20878

C20101US-001

Revised: July/13/2022

©2022 Novavax, Inc. All rights reserved.

Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems.

GDTI: 0886983000370

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80631-100-10                                   novavax

Novavax COVID-19 Vaccine,
Adjuvanted

Suspension for Intramuscular Injection

10 Multi-Dose Vials
Each vial contains 10 doses of 0.5 mL

For use under Emergency Use Authorization

NDC 80631-100-01

Novavax COVID-19 Vaccine,
Adjuvanted

Suspension for Intramuscular Injection
Multi-dose vial (10 doses of 0.5mL)

For use under Emergency Use
Authorization. Store at 2 to 8ºC
(36 to 46ºF). DO NOT FREEZE.
After first puncture, hold at 2 to 25°C
(36 to 77°F). Discard after 6 hours.
No Preservative. Protect from light.

20018470/0

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