Novavax HCP Fact Sheet 10192022

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA) OF

THE NOVAVAX COVID-19 VACCINE, ADJUVANTED TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
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 12 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 myocarditis, cases of pericarditis, cases of
Multisystem Inflammatory Syndrome (MIS) in adults and children, 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.
Primary Series
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for emergency use to provide a two-dose
primary series to individuals 12 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.
Booster Dose
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for emergency use to provide a first booster
dose to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent 1 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.
For these individuals, a booster dose (0.5 mL) of Novavax COVID-19 Vaccine, Adjuvanted may be
administered at least 6 months after completion of primary vaccination with an authorized or approved
COVID-19 vaccine.
1
Authorized bivalent COVID-19 vaccines encode the spike protein of the Original SARS-CoV-2 and the Omicron
BA.4/BA.5 SARS-CoV-2
Revised: October/19/2022 1
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
Storage and Handling
Storage of Unpunctured Vial
Store the unpunctured multi-dose vial in a refrigerator between 2° to 8°C (36° to 46°F).
Do not freeze.
Protect from light.
Storage After First Puncture of the Vaccine Vial
After the first needle 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.
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 in 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.
Dose Preparation
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 for 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.
Administration
Administer the Novavax COVID-19 Vaccine, Adjuvanted intramuscularly.
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).
The CDC has published considerations related to myocarditis and pericarditis after vaccination,
including for vaccination of individuals with a history of myocarditis or pericarditis
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-
us.html#myocarditis-pericarditis).
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, anaphylaxis, paresthesia, and hypoesthesia 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
 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 THENOVAVAX 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 12 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 myocarditis,
 cases of pericarditis,
 cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, 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 myocarditis, cases of pericarditis, cases of
MIS in adults and children 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

1-844-NOVAVAX
www.NovavaxMedInfo.com 1-888-988-8809
(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 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.
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 ........................................................10 11.2 Lactation ............................................................... 28

2 DOSAGE AND ADMINISTRATION .............................10 11.3 Pediatric Use ......................................................... 29
2.1 Preparation for Administration...............................10 11.4 Geriatric Use ........................................................ 29
2.2 Administration.......................................................10 13 DESCRIPTION................................................................ 29
2.3 Dosing and Schedule.............................................10 14 CLINICAL PHARMACOLOGY..................................... 30
3 DOSAGE FORMS AND STRENGTHS ..........................11 14.1 Mechanism of Action............................................ 30
4 CONTRAINDICATIONS ................................................11 18 CLINICAL TRIAL RESULTS AND SUPPORTING
5 WARNINGS AND PRECAUTIONS ...............................11 DATA FOR EUA............................................................. 30
5.1 Management of Acute Allergic Reactions..............11 18.1 Efficacy of Two-Dose Primary Series in Participants
18 Years of Age and Older................................... 30
5.2 Myocarditis and Pericarditis..................................11
18.2 Effectiveness of a Two-Dose Primary Series in
5.3 Syncope.................................................................12 Adolescents 12 Through 17 Years of Age............ 32
5.4 Altered Immunocompetence .................................12 18.3 Immunogenicity of a Booster Dose Following a
5.5 Limitations of Vaccine Effectiveness ....................12 Novavax COVID-19 Vaccine, Adjuvanted Primary
6 OVERALL SAFETY SUMMARY ..................................12 Series in Participants 18 Years and Older ............ 34
6.1 Clinical Trials Experience .....................................13 18.4 Immunogenicity of a Booster Dose Following
Primary Vaccination with Another Authorized or
6.2 Post-Authorization Experience..............................25
Approved COVID-19 Vaccine ............................. 36
8 REQUIREMENTS AND INSTRUCTIONS FOR
19 HOW SUPPLIED/STORAGE AND HANDLING .......... 36
REPORTING ADVERSE EVENTS AND VACCINE
ADMINISTRATION ERRORS .......................................26 20 PATIENT COUNSELING INFORMATION .................. 37
10 DRUG INTERACTIONS .................................................28 21 CONTACT INFORMATION .......................................... 37
11 USE IN SPECIFIC POPULATIONS ...............................28 * Sections or subsections omitted from the full emergency use
authorization prescribing information are not listed.
11.1 Pregnancy..............................................................28
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)].
5 WARNINGS AND PRECAUTIONS
5.1 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 and Prevention
guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-
anaphylaxis.html).
5.2 Myocarditis and Pericarditis
Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following
administration of Novavax COVID-19 Vaccine, Adjuvanted [see Clinical Trials Experience
(6.1)].
The CDC has published considerations related to myocarditis and pericarditis after vaccination,
including for vaccination of individuals with a history of myocarditis or pericarditis
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-
us.html#myocarditis-pericarditis).
5.3 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines.

Procedures should be in place to avoid injury from fainting.
5.4 Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may

have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
5.5 Limitations of Vaccine Effectiveness
The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
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 myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome
(MIS) in adults and children, 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
Primary Series
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%).
In a clinical trial, among participants 12 through 17 years of age, solicited ARs following
administration of any dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection site
pain/tenderness (79.8%), headache (63.3%), fatigue/malaise (61.6%), muscle pain (56.9%),
nausea/vomiting (23.1%), joint pain (19.5%), fever (16.7%), injection site swelling (8.5%), and
injection site redness (7.7%).
Myocarditis, pericarditis, chills, injection site pruritus, hypersensitivity reactions,
lymphadenopathy-related reactions, and decreased appetite have been reported following
administration of the Novavax COVID-19 Vaccine, Adjuvanted.
Booster Dose
In a clinical trial, among participants 18 years of age and older, solicited ARs following
administration of a booster dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection
site pain/tenderness (81.1%), fatigue/malaise (63.4%), muscle pain (63.0%), headache (52.9%),
joint pain (30.3%), nausea/vomiting (14.7%), injection site swelling (8.4%), injection site
redness (6.3%), and fever (6.3%).
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical
trials of another vaccine and may not reflect the rates observed in practice.
Two-Dose Primary Series
Participants 18 years of age and older
Safety of the Novavax COVID-19 Vaccine, Adjuvanted was assessed in a clinical study
conducted in the United States (US) and Mexico (NCT04611802; Study 1). In this study, 26,106
participants 18 years of age and older have received at least one dose of the Novavax COVID-19
Vaccine, Adjuvanted. Additional safety data are available from three other clinical trials in the
United Kingdom (NCT04583995; Study 2), South Africa (NCT04533399; Study 3), and
Australia (NCT04368988, Parts 1 and 2 in Australia and the US; Study 4) which evaluated a
COVID-19 vaccine containing the SARS-CoV-2 recombinant spike (rS) protein and Matrix-M
adjuvant but manufactured by a different process.
Adolescents 12 Through 17 Years of Age
Safety of the Novavax COVID-19 Vaccine, Adjuvanted in adolescents was assessed in the
adolescent primary series expansion of Study 1 conducted in the US. In this study, 2,232
participants 12 through 17 years of age have received at least one dose of Novavax COVID-19
Vaccine, Adjuvanted (n=1,487) or placebo (n=745).
Safety Data from Study 1
In Study 1, an ongoing Phase 3, multicenter, randomized, observer-blinded, placebo-controlled

study, participants 18 years of age and older have received the Novavax COVID-19 Vaccine,
Adjuvanted (n=19,735) or placebo (n= 9,847). Overall, 52.0% were male, 48.0% were female;
75.0% were White, 11.8% were Black or African American, 4.1% were Asian, 6.7% were
American Indian (including Native Americans) or Alaskan Native, and 1.6% were multiple races;
21.9% were Hispanic/Latino. Demographic characteristics of participants were well balanced
between the Novavax COVID-19 Vaccine, Adjuvanted and placebo groups. During the study,
COVID-19 vaccines authorized for emergency use became available, and participants, when
eligible for vaccination, were offered the opportunity to cross over from the originally assigned
study treatment to the other study treatment (vaccine or placebo) in a blinded fashion (“blinded
crossover”). In the post-crossover period, 6,416 participants received the Novavax COVID-19
Vaccine, Adjuvanted, and 15,298 participants received placebo. The demographic characteristics
of participants in the pre- and post-crossover groups were comparable. Due to data quality issues
at two study sites, a total of 289 additional participants were excluded from the safety analysis
set.
Study 1 also included an adolescent primary series expansion. In the pre-crossover period, among
adolescent participants who received at least one dose of vaccine (n=1487) or placebo (n=745),
52.5% were male, 47.5% were female; 74.4% were White, 13.9% were Black or African
American, 3.4% were Asian, 2.1% were American Indian (including Native Americans) or
Alaskan Native, and 5.3% were multiple races; 18.5% were Hispanic/Latino. Demographic
characteristics were well balanced between the Novavax COVID-19 Vaccine, Adjuvanted and
placebo groups. During the study, COVID-19 vaccines authorized for emergency use became
available, and participants, when eligible for vaccination, were offered the opportunity to cross
over from the originally assigned study treatment to the other study treatment (vaccine or
placebo) in a blinded fashion (“blinded crossover”). In the post-crossover period, 665 participants
received the Novavax COVID-19 Vaccine, Adjuvanted, and 1,353 participants received placebo.
The demographic characteristics of participants in the pre- and post-crossover groups were
comparable.
Study 1 was amended to include a booster dose in which 12,738 individuals 18 to 96 years of age
received a booster dose of the Novavax COVID-19 Vaccine, Adjuvanted starting approximately
6 months after the two-dose primary series.
Participants 18 years of age and older
Solicited Adverse Reactions
During the pre-crossover period, local and systemic adverse reactions were solicited within
7 days following each dose of the Novavax COVID-19 Vaccine, Adjuvanted or placebo in
participants using an electronic diary.
The reported frequency and severity of solicited local and systemic adverse reactions series are
presented for participants 18 through 64 years of age in Error! Reference source not found..
Table 1 Number and Percentage of Participants with Solicited Local and Systemic
Adverse Reactions Starting within 7 Daysa After Each Dose in Participants 18-
64 Years (Solicited Safety Set,b Dose 1 and Dose 2)c
Novavax COVID-19 Vaccine,
Placebod
Adjuvanted
Primary Series Primary Series
Event
Dose 1 Dose 2 Dose 1 Dose 2
N = 15884 N = 15148 N = 7868 N = 7361
n (%) n (%) n (%) n (%)
Local Adverse Reactions
Pain/tenderness
Any Grade 9604 (60.5) 12234 (80.8) 1706 (21.7) 1623 (22.0)
Grade 3e,f 174 (1.1) 951 (6.3) 17 (0.2) 20 (0.3)
Grade 4g 0 5 (0.03) 0 1 (0.01)
Redness (erythema)
Any Grade 151 (1.0) 1040 (6.9) 21 (0.3) 26 (0.4)
Grade 3h 3 (0.02) 134 (0.9) 0 2 (0.03)
Swelling
Any Grade 137 (0.9) 943 (6.2) 24 (0.3) 22 (0.3)
Grade 3i 7 (0.04) 82 (0.5) 3 (0.04) 1 (0.01)
Systemic Adverse Reactions
Fever
Any Grade 56 (0.4) 941 (6.2) 31 (0.4) 16 (0.2)
Grade 3j 7 (0.04) 60 (0.4) 7 (0.09) 2 (0.03)
Grade 4k 4 (0.03) 2 (0.01) 1 (0.01) 0
Headache
Any Grade 4158 (26.2) 7128 (47.1) 1866 (23.7) 1492 (20.3)
Grade 3l 132 (0.8) 492 (3.2) 58 (0.7) 36 (0.5)
Grade 4m 4 (0.03) 5 (0.03) 1 (0.01) 2 (0.03)
Fatigue/malaise
Any Grade 4892 (30.8) 8825 (58.3) 2095 (26.6) 1889 (25.7)
Grade 3n 249 (1.6) 1591 (10.5) 113 (1.4) 114 (1.5)
Grade 4m 8 (0.05) 7 (0.05) 1 (0.01) 3 (0.04)
Muscle pain (myalgia)
Any Grade 3827 (24.1) 7682 (50.7) 1073 (13.6) 900 (12.2)
Grade 3n 79 (0.5) 805 (5.3) 31 (0.4) 28 (0.4)
Grade 4m 2 (0.01) 5 (0.03) 1 (0.01) 4 (0.05)
Joint pain (arthralgia)
Any Grade 1260 (7.9) 3542 (23.4) 522 (6.6) 504 (6.8)
Grade 3n 49 (0.3) 393 (2.6) 25 (0.3) 22 (0.3)
Grade 4m 1 (< 0.01) 5 (0.03) 0 2 (0.03)
Placebod
Adjuvanted
Event
N = 15884 N = 15148 N = 7868 N = 7361
n (%) n (%) n (%) n (%)
Nausea or vomiting
Any Grade 1069 (6.7) 1822 (12.0) 466 (5.9) 417 (5.7)
Grade 3o 18 (0.1) 26 (0.2) 7 (0.09) 7 (0.1)
Grade 4p 4 (0.03) 7 (0.05) 2 (0.03) 2 (0.03)
a
7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were
collected in the electronic diary (eDiary).
b
Solicited safety set includes participants who received at least one dose of study vaccine and completed their eDiary.
c
Absence of rows for Grade 4 adverse reactions indicates no events were reported.
d
Placebo was a saline solution.
e
Grade 3 pain: Defined as any use of narcotic pain reliever or prevents daily activity.
f
Grade 3 tenderness: Defined as significant discomfort at rest.
g
Grade 4 pain/ tenderness: Defined as Emergency Room (ER) visit or hospitalization.
h
Grade 3 redness (erythema): Defined as > 10 cm.
i
Grade 3 swelling: Defined as > 10 cm or prevents daily activity.
j
Grade 3 fever: Defined as 39.0 to 40°C (102.1 to 104°F).
k
Grade 4 fever: Defined as > 40°C (> 104°F).
l
Grade 3 headache: Defined as significant; any use of narcotic pain reliever or prevents daily activity.
m
Grade 4 headache, fatigue/malaise, muscle pain (myalgia), joint pain (arthralgia): Defined as ER visit or hospitalization.
n
Grade 3 fatigue/malaise, muscle pain (myalgia), joint pain (arthralgia): Defined as significant; prevents daily activity.
o
Grade 3 nausea or vomiting: Defined as prevents daily activity, requires outpatient IV hydration.
p
Grade 4 nausea or vomiting: Defined as ER visit or hospitalization for hypotensive shock.
The reported frequency and severity of solicited local and systemic adverse reactions are
presented for participants 65 years of age and older in Table 2.
Adverse Reactions Starting within 7 Daysa After Each Dose in Participants
65 Years and Older (Solicited Safety Set,b Dose 1 and Dose 2)c

Placebod
Adjuvanted
Event
N = 2251 N = 2048 N = 1114 N = 978
n (%) n (%) n (%) n (%)
Pain/tenderness
Any Grade 854 (37.9) 1258 (61.4) 175 (15.7) 161 (16.5)
Grade 3e,f 13 (0.6) 43 (2.1) 3 (0.3) 1 (0.1)
Adverse Reactions Starting within 7 Daysa After Each Dose in Participants
65 Years and Older (Solicited Safety Set,b Dose 1 and Dose 2)c

Placebod
Adjuvanted
Event
N = 2251 N = 2048 N = 1114 N = 978
n (%) n (%) n (%) n (%)
Redness (erythema)
Any Grade 16 (0.7) 99 (4.8) 5 (0.4) 4 (0.4)
Grade 3g 0 7 (0.3) 0 0
Swelling
Any Grade 18 (0.8) 111 (5.4) 1 (0.09) 4 (0.4)
Grade 3h 1 (0.04) 8 (0.4) 0 1 (0.1)
Fever
Any Grade 8 (0.4) 40 (2.0) 3 (0.3) 7 (0.7)
Grade 3i 1 (0.04) 2 (0.1) 0 1 (0.1)
Headache
Any Grade 344 (15.3) 502 (24.5) 184 (16.5) 144 (14.7)
Grade 3j 12 (0.5) 18 (0.9) 4 (0.4) 2 (0.2)
Grade 4k 1 (0.04) 1 (0.05) 0 0
Fatigue/malaise
Any Grade 444 (19.7) 714 (34.9) 202 (18.1) 182 (18.6)
Grade 3l 23 (1.0) 68 (3.3) 5 (0.4) 13 (1.3)
Any Grade 284 (12.6) 561 (27.4) 125 (11.2) 102 (10.4)
Grade 3l 3 (0.1) 32 (1.6) 4 (0.4) 2 (0.2)
Any Grade 139 (6.2) 271 (13.2) 71 (6.4) 63 (6.4)
l
Grade 3 4 (0.2) 16 (0.8) 4 (0.4) 2 (0.2)
Grade 4k 0 1 (0.05) 0 0
Nausea/vomiting
Any Grade 81 (3.6) 108 (5.3) 32 (2.9) 35 (3.6)
Grade 3m 0 3 (0.1) 0 0
a
7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected
in the electronic diary (eDiary).
b
c
d
e
f
g
h
i
j
k
Grade 4 headache, joint pain (arthralgia): Defined as ER visit or hospitalization.
l
m
Unsolicited Adverse Events (non-serious and serious)
In Study 1, participants were monitored for non-serious unsolicited adverse events from the first
dose through 28 days after the second dose in both the pre- and post-crossover periods and for
serious adverse events for the duration of study participation. Participants who only received the
first dose in the pre- and post-crossover periods were monitored for non-serious unsolicited
adverse events through 49 days after administration of vaccine or placebo and for serious adverse
events for the duration of study participation. In the pre-crossover period 19,735 participants
received the Novavax COVID-19 Vaccine, Adjuvanted and 9,847 participants received placebo.
In the post-crossover period, 6,416 participants received the Novavax COVID-19 Vaccine,
Adjuvanted and 15,298 received placebo. Of participants who received two doses of the Novavax
COVID-19 Vaccine, Adjuvanted in the pre-crossover period (n=19,111), 78% had a follow-up
duration of at least 2 months (median = 2.5 months) after Dose 2. Of participants who received
two doses of the Novavax COVID-19 Vaccine, Adjuvanted in the post-crossover period
(n=6,346), 99% had a follow-up duration of at least 2 months (median = 4.4 months) after the last
dose.
From Dose 1 through 28 days following Dose 2 in the pre-crossover period, the overall frequency
of non-serious unsolicited adverse events was similar in the Novavax COVID-19 Vaccine,
Adjuvanted group (11.6%) and the placebo group (11.2%). The most frequently reported
unsolicited adverse reactions were chills (0.4% vaccine recipients vs. 0.1% placebo recipients),
lymphadenopathy-related reactions (0.3% vaccine recipients vs. 0.1% placebo recipients), and
injection site pruritis (0.1% vaccine recipients vs. 0.0% placebo recipients). Lymphadenopathy-
related reactions included lymphadenopathy, lymphadenitis, lymph node pain, and axillary pain.
All lymphadenopathy-related reactions occurred in participants 18 through 64 years of age.
In the pre-crossover period, serious adverse events were reported by 199 (1.0%) participants in
the Novavax COVID-19 Vaccine, Adjuvanted group and by 108 (1.1%) participants in the
placebo group. In the post-crossover period, serious adverse events were reported by 88 (1.4%)
participants who received the Novavax COVID-19 Vaccine, Adjuvanted and by 178 (1.2%)
participants who received placebo.
Within 7 days of any dose (including 26,151 Novavax COVID-19 Vaccine, Adjuvanted
recipients and 25,145 placebo recipients in both the pre- and post-crossover periods),
hypersensitivity reactions (including urticaria, hypersensitivity, angioedema, and swelling of the
face, lips, ear, and/or eyelids) were reported by 26 participants after the Novavax COVID-19
Vaccine, Adjuvanted (0.1%) and 8 participants after placebo (0.03%). Of these events, 1 reaction
(generalized urticaria and facial angioedema with a duration of 2 days) was serious and occurred
2 days after Dose 1 of the Novavax COVID-19 Vaccine, Adjuvanted.
Within 28 days of any dose, the following numerical imbalances with more events in vaccine
than placebo recipients (including 26,151 Novavax COVID-19 Vaccine, Adjuvanted recipients
and 25,145 placebo recipients in both the pre- and post-crossover periods) were observed for the
following serious and other adverse events of interest.
 Myocarditis and/or pericarditis were reported by two participants after the Novavax
COVID-19 Vaccine, Adjuvanted (0.01%) and no participants after placebo. One serious
event was reported by a 67-year-old male 28 days after Dose 1, associated with
concomitant COVID-19, and one non-serious event was reported by a 20-year-old male
10 days after Dose 1. Among the two reported events, one was reported as resolved and
one did not have follow-up available. Reports of myocarditis and/or pericarditis from
Study 1 and Study 2 (see Safety Data from Study 2) provide evidence for increased risks
of myocarditis and pericarditis following administration of the Novavax COVID-19
 Events of cardiomyopathy or cardiac failure were reported by eight participants after the
Novavax COVID-19 Vaccine, Adjuvanted (0.03%) and one participant after placebo
(<0.01%). All events were serious. Additionally, an event of congestive cardiac failure
was reported after the Novavax COVID-19 Vaccine, Adjuvanted by a participant who
was excluded from the safety analysis set. Currently available information on
cardiomyopathy or cardiac failure is insufficient to determine a causal relationship with
the vaccine.
 Events of acute cholecystitis were reported by six participants after the Novavax COVID-
19 Vaccine, Adjuvanted (0.02%) and two participants after placebo (0.01%). All events
were serious. Currently available information on cholecystitis is insufficient to determine
a causal relationship with the vaccine.
 A total of 12 non-cardiac, non-neurovascular thrombotic and embolic events were
reported by 11 participants after the Novavax COVID-19 Vaccine, Adjuvanted (0.04%)
and a total of seven events were reported by six participants after placebo (0.02%). Events
following the Novavax COVID-19 Vaccine, Adjuvanted included pulmonary embolism
(n=5), deep vein thrombosis (n=2), thrombosis (n=2), and portal vein thrombosis,
mesenteric artery thrombosis, and peripheral arterial occlusive disease (n=1 each); six of
the events were serious, including pulmonary embolism (n=5) and deep vein thrombosis
(n=1). Events following placebo included pulmonary embolism (n=3), and deep vein
thrombosis and peripheral arterial occlusive disease (n=2 each), all of which were serious
except deep vein thrombosis and peripheral arterial occlusive disease (n=1 each).
Currently available information on non-cardiac, non-neurovascular thrombotic and
embolic events is insufficient to determine a causal relationship with the vaccine.
Events of uveitis (iritis, uveitis, iridocyclitis) were reported by 3 participants after Novavax
COVID-19 Vaccine, Adjuvanted (0.01%) and 2 participants after placebo (0.01%). All events
were non-serious. One participant had onset of uveitis after Dose 1 of Novavax COVID-19
Vaccine, Adjuvanted which resolved and then recurred following Dose 2. The two placebo
recipients with events appeared to have had a previous history of uveitis and one of the Novavax
COVID-19 Vaccine, Adjuvanted recipients had a history of iritis. Currently available
information on uveitis is insufficient to determine a causal relationship with the vaccine.
Adolescents 12 Through 17 Years of Age
During the pre-crossover period, local and systemic adverse reactions were solicited within
7 days following each dose of the Novavax COVID-19 Vaccine, Adjuvanted or placebo in
participants using an electronic diary.
The reported frequency and severity of solicited local and systemic adverse reactions are
presented for participants 12 through 17 years of age in Table 3.
Placebod
Adjuvanted
Event Dose 1 Dose 2 Dose 1 Dose 2
N = 1448 N = 1394 N = 726 N = 686
n (%) n (%) n (%) n (%)
Pain/tenderness
Any Grade 945 (65.3) 1045 (75.0) 204 (28.1) 141 (20.6)
Grade 3e,f 22 (1.5) 108 (7.7) 4 (0.6) 4 (0.6)
Redness (erythema)
Any Grade 15 (1.0) 104 (7.5) 5 (0.7) 0
g
Grade 3 0 10 (0.7) 0 0
Swelling
Any Grade 20 (1.4) 111 (8.0) 3 (0.4) 1 (0.1)
Grade 3h 0 8 (0.6) 1 (0.1) 0
Fever
Any Grade 11 (0.8) 235 (16.9) 5 (0.7) 1 (0.1)
Grade 3i 1 (0.07) 31 (2.2) 0 0
Grade 4j 2 (0.1) 0 0 0
Headache
Any Grade 440 (30.4) 793 (56.9) 181 (24.9) 119 (17.3)
Grade 3k 13 (0.9) 87 (6.2) 12 (1.7) 14 (2.0)
l
Grade 4 0 1 (0.07) 0 0
Fatigue/malaise
Any Grade 418 (28.9) 807 (57.9) 142 (19.6) 113 (16.5)
Grade 3m 33 (2.3) 223 (16.0) 13 (1.8) 13 (1.9)
Any Grade 492 (34.0) 683 (49.0) 114 (15.7) 82 (12.0)
m
Grade 3 17 (1.2) 104 (7.5) 4 (0.6) 6 (0.9)
Placebod
Adjuvanted
Event Dose 1 Dose 2 Dose 1 Dose 2
N = 1448 N = 1394 N = 726 N = 686
n (%) n (%) n (%) n (%)
Any Grade 102 (7.0) 226 (16.2) 35 (4.8) 21 (3.1)
Grade 3m 6 (0.4) 40 (2.9) 1 (0.1) 2 (0.3)
Nausea or vomiting
Any Grade 113 (7.8) 277 (19.9) 56 (7.7) 33 (4.8)
Grade 3n 2 (0.1) 14 (1.0) 3 (0.4) 3 (0.4)
Grade 4o 0 1 (0.07) 0 0
a
b
c
d
e
f
g
h
i
j
Grade 4 fever: Defined as > 40°C (> 104°F).
k
l
Grade 4 headache, fatigue/malaise, muscle pain (myalgia), joint pain (arthralgia): Defined as ER visit or hospitalization.
m
n
o
In Study 1, participants were monitored for non-serious unsolicited adverse events from the first
dose through 28 days after the second dose in both the pre- and post-crossover periods and for
serious adverse events for the duration of study participation. Participants who only received the
first dose in the pre- and post-crossover periods were monitored for non-serious unsolicited
adverse events through 49 days after administration of vaccine or placebo and for serious adverse
events for the duration of study participation. In the pre-crossover period 1,487 participants
received the Novavax COVID-19 Vaccine, Adjuvanted and 745 participants received placebo. In
the post-crossover period, 665 participants received the Novavax COVID-19 Vaccine,
Adjuvanted and 1,353 received placebo. Of participants who received two doses of the Novavax
COVID-19 Vaccine, Adjuvanted in the pre-crossover period (n=1,468), 86% had a follow-up
duration of at least 2 months (median = 71 days) after Dose 2. Of participants who received two
doses of the Novavax COVID-19 Vaccine, Adjuvanted in the post-crossover period (n=638),
43% had a follow-up duration of at least 1 month (median = 30 days) after the last dose.
From Dose 1 through 28 days following Dose 2 in the pre-crossover period, the overall frequency
of non-serious unsolicited adverse events was similar in the Novavax COVID-19 Vaccine,
Adjuvanted group (15.5%) and the placebo group (15.3%). The most frequently reported
unsolicited adverse reactions were lymphadenopathy-related reactions (0.9% vaccine recipients
vs. 0.0% placebo recipients), fatigue (0.5% vaccine recipients vs. 0.0% placebo recipients),
decreased appetite (0.3% vaccine recipients vs. 0.0% placebo recipients), arthralgia (0.2%
vaccine recipients vs. 0.0% placebo recipients), injection site pruritus (0.2% vaccine recipients
vs. 0.0% placebo recipients), and myalgia (0.1% vaccine recipients vs. 0.0% placebo recipients).
Lymphadenopathy-related reactions included lymphadenopathy, lymph node pain, and axillary
pain.
In the pre-crossover period, serious adverse events were reported by 7 (0.5%) participants in the
Novavax COVID-19 Vaccine, Adjuvanted group and by 2 (0.3%) participants in the placebo
group. In the post-crossover period, serious adverse events were reported by 3 (0.5%)
participants who received the Novavax COVID-19 Vaccine, Adjuvanted and by 2 (0.1%)
participants who received placebo.
Within 28 days of any dose, one serious adverse event of interest of myocarditis was observed.
The event was reported by a 16-year-old adolescent participant 2 days after Dose 2 of the
Novavax COVID-19 Vaccine, Adjuvanted.
Safety Data from Other Studies with Primary Series
Study 2 was a randomized, placebo-controlled study that included a crossover design.

Approximately 10,800 participants received at least one dose of a COVID-19 vaccine containing
SARS-CoV-2 recombinant spike (rS) protein and Matrix-M adjuvant, manufactured by a
different process than the Novavax COVID-19 Vaccine, Adjuvanted evaluated in Study 1, and
approximately 10,900 participants received at least one dose of placebo.
Serious events of myocarditis in a 19-year-old male and pericarditis in a 60-year-old female were
reported within 10 days following administration of Dose 2 and Dose 1, respectively, of the
vaccine. Both events were reported as resolved. No events of myocarditis or pericarditis were
reported following administration of placebo.
A serious event of Guillain Barré syndrome was reported 9 days following administration of
Dose 1 of the vaccine. No events of Guillain Barré syndrome were reported following
administration of placebo.
In Studies 3 and 4, approximately 5,500 participants received at least one dose of a COVID-19
vaccine containing SARS-CoV-2 recombinant spike (rS) protein and Matrix-M adjuvant,
manufactured by a different process than the Novavax COVID-19 Vaccine, Adjuvanted
evaluated in Study 1. No serious adverse events considered related to vaccination were reported
in these studies. No events of myocarditis/pericarditis or Guillain Barré syndrome were reported
in vaccine recipients in these studies.
Booster Dose Following a Primary Series of Novavax COVID-19 Vaccine, Adjuvanted in

Participants 18 Years or Older
In an open label portion of Study 1, 12,738 participants 18 years of age and older (based on
enrollment until March 26, 2022) received a single booster dose of Novavax COVID-19
Vaccine, Adjuvanted (0.5 mL) at least 6 months after the two-dose primary series (median of
11.0 months between completion of primary series and booster dose). Safety analyses included
evaluation of solicited local and systemic adverse reactions within 7 days after a booster dose
(n=238) and nonserious unsolicited adverse events within 28 days after a booster dose (n=298).
Safety analysis also included evaluation of serious adverse events and adverse events of interest
after a booster dose (n=12,738) with a median follow-up of 121 days post booster dose through
data extraction of August 18, 2022. The safety follow-up is ongoing.
Among the 12,738 boosted participants, 84.3% were between 18 and 64 years of age and 15.7%
were 65 years of age and older, 50.6% were male, 49.4% were female; 72.6% were White,
14.4% were Black or African American, 3.8% were Asian, 6.5% were American Indian
(including Native Americans) or Alaskan Native, 0.2% were Native Hawaiian or Other Pacific
Islander, and 1.7% were multiple races; 21.4% were Hispanic or Latino.
Local and systemic adverse reactions were solicited within 7 days following the third (booster)
dose of the Novavax COVID-19 Vaccine, Adjuvanted using an electronic diary.
The reported frequency and severity of solicited local and systemic adverse reactions in
participants 18 years of age and older are presented in Table 4.
Adverse Reactions Starting within 7a Days After Booster Dose in Participants 18
Years and Older (Booster Safety Analysis Set b), c
Adjuvanted Booster
Event
N = 238
n (%)
Pain/tenderness
Any Grade 193 (81.1)
Grade 3d,e 18 (7.6)
Redness (erythema)
Any Grade 15 (6.3)
Grade 3f 1 (0.4)
Swelling
Any Grade 20 (8.4)
Grade 3g 2 (0.8)
Fever
Any Grade 15 (6.3)
Grade 3h 2 (0.8)
Headache
Grade 3i 14 (5.9)
Fatigue/malaise
Adjuvanted Booster
Event
N = 238
n (%)
Grade 3j 41 (17.2)
Grade 4k 2 (0.8)
Grade 3j 20 (8.4)
Grade 4k 2 (0.8)
Any Grade 72 (30.3)
Grade 3j 9 (3.8)
Nausea or vomiting
Any Grade 35 (14.7)
Grade 3l 2 (0.8)
Grade 4m 1 (0.4)
a
b
The analysis included a total of 238 participants who received the booster dose who completed their eDiary
c
d
e
f
g
h
i
j
k
Grade 4 fatigue/malaise, muscle pain (myalgia): Defined as ER visit or hospitalization.
l
m
Participants were monitored through 28 days after the booster dose for unsolicited adverse
events. Out of 12,738 total booster participants, data are available for 298 participants for non-
serious unsolicited adverse events until May 19, 2022 (median follow-up post booster of 122
days). There were no unsolicited adverse events that occurred in more than one participant.
Additionally, data for serious adverse events and adverse events of interest, including but not
limited to allergic, neurologic, inflammatory, vascular, and autoimmune disorders, are available
for 12,738 participants until August 18, 2022 (median follow-up post booster of 121 days).
An event of myocarditis was reported by a 28-year-old male participant 3 days after a booster
dose of Novavax COVID-19 Vaccine, Adjuvanted in Study 1. The event following the booster
dose was adjudicated as a non-ST elevation myocardial infarction; however, clinical features
were also consistent with myocarditis (chest pain and elevated troponin), and no cardiac
catheterization or cardiac MRI was performed during the acute presentation.
A serious adverse event of autoimmune hepatitis was reported in a 57-year-old male participant
approximately 12 days after a booster dose of Novavax COVID-19 Vaccine, Adjuvanted. A year
prior to vaccination, the participant had transient increases in alanine transferase (ALT), up to 3
times the upper limit of normal (ULN). From a normal baseline ALT prior to receipt of the first
dose of Novavax COVID-19 Vaccine, Adjuvanted, ALT increased to 4 times ULN following the
second dose of the primary series. After the booster dose, a recurrent and higher ALT increase
was observed (7 times ULN). Viral hepatitis tests were negative, and no alternative etiologies
have been identified. The event has been ongoing for 8 months and is not resolved with
azathioprine treatment. Currently available information for this event is insufficient to determine
a causal relationship with the vaccine.
Two serious adverse events in the injected arm were reported, including muscle edema in a 51-
year-old female with onset 7 days after booster vaccination and cellulitis of the injection site in a
58-year-old male with onset 3 days after booster vaccination. The cellulitis resolved following
antibiotic and steroid treatment. The muscle edema was not responsive to non-steroidal anti-
inflammatory agents and has been ongoing for 6 months and is not resolved. Available
information for these events is insufficient to determine a causal relationship with the vaccine.
A serious adverse event of extensive left leg and pelvic deep vein thrombosis and pulmonary
embolism was reported 7 and 10 days, respectively, post booster in a 35-year-old female
participant receiving oral contraceptive therapy. She required surgical intervention, thrombolytic
therapy, and needs prolonged anti-coagulation. Available information for these events is
insufficient to determine a causal relationship with the vaccine.
Booster Dose Following Primary Vaccination with Another Authorized or Approved

COVID-19 Vaccine
The safety of a Novavax COVID-19 Vaccine, Adjuvanted booster dose in individuals who
completed a primary vaccination with another authorized or approved COVID-19 vaccine
(heterologous booster dose) is inferred from the report of an independent, multicenter,
randomized, controlled, Phase 2, trial conducted in the United Kingdom (ISRCTN 73765130).
This study was conducted in adults aged 30 years and older with no history of laboratory-
confirmed SARS-CoV-2 infection. One study group (n=114 participants; median age 63 years)
received Novavax COVID-19 Vaccine, Adjuvanted administered at least 84 days (median 105
days) after completion of the Pfizer-BioNTech COVID-19 Vaccine primary series. Reported
adverse reactions through 28 days following a Novavax COVID-19 Vaccine, Adjuvanted booster
dose did not identify any new safety concerns, as compared with adverse reactions reported
following two doses of Novavax COVID-19 Vaccine, Adjuvanted given as a primary series.
6.2 Post-Authorization Experience
The following adverse reactions have been identified during post-authorization use of the
Novavax COVID-19 Vaccine, Adjuvanted. Because these reactions are reported voluntarily, it is
not always possible to reliably estimate their frequency or establish a causal relationship to
vaccine exposure.
Cardiac Disorders: myocarditis, pericarditis
Immune System Disorders: anaphylaxis
Nervous System Disorders: paresthesia, hypoesthesia
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 myocarditis,
 Cases of pericarditis,
 Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
 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:
a. Write “Novavax COVID-19 Vaccine, Adjuvanted EUA” as the first line.
b. 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:
a. In Box 13, provide the name and contact information of the prescribing healthcare
provider or institutional designee who is responsible for the report.
b. In Box 14, provide the name and contact information of the best doctor/healthcare
professional to contact about the adverse event.
c. 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

1-844-NOVAVAX
www.NovavaxMedInfo.com 1-888-988-8809
(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
11.1 Pregnancy
Pregnancy Exposure Registry
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/.
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general
population, the estimated background risk of major birth defects and miscarriage in clinically
recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on the Novavax
COVID-19 Vaccine, Adjuvanted administered to pregnant women are insufficient to inform
vaccine-associated risks in pregnancy.
In a developmental toxicity study, 0.1 mL of a vaccine formulation containing the same quantity
of SARS-CoV-2 rS protein (5 mcg), one-fifth the quantity of adjuvant (10 mcg) and inactive
ingredients which comprise the formulation buffer (25mM sodium phosphate, 300mM sodium
chloride, and 0.01% (w/v) polysorbate 80) contained in a single dose of the Novavax COVID-19
Vaccine, Adjuvanted was administered to female rats by the intramuscular route on four
occasions: 27 and 13 days prior to mating, and on gestational days 7 and 15. No vaccine-related
adverse effects on female fertility, fetal development or postnatal development were reported in
the study.
11.2 Lactation
Risk Summary
Data are not available to assess the effects of the Novavax COVID-19 Vaccine, Adjuvanted on
the breastfed infant or on milk production/excretion.
11.3 Pediatric Use
Emergency Use Authorization of Novavax COVID-19 Vaccine, Adjuvanted in adolescents 12

through 17 years of age is based on safety and effectiveness data in this age group and in adults.
The Novavax COVID-19 Vaccine, Adjuvanted is not authorized for use in individuals younger than
12 years of age.
11.4 Geriatric Use
Clinical studies that evaluated primary vaccination with the Novavax COVID-19 Vaccine,
Adjuvanted included participants 65 years of age and older receiving vaccine or placebo, and
their data contribute to the overall assessment of safety and efficacy. In an ongoing Phase 3
clinical study (Study 1), 12.6% (n=2,480 Novavax COVID-19 Vaccine, Adjuvanted, n=1,235
placebo) of participants were 65 years of age and older and 1.8% (n=361 Novavax COVID-19
Vaccine, Adjuvanted, n=179 placebo) of participants were 75 years of age and older. Vaccine
efficacy in participants 65 years of age and older was 78.6% (95% CI: -16.6%, 96.1%) relative to
90.7% (95% CI: 72.9%, 96.8%) in participants 50 through 64 years of age. [see Clinical Trial
Results and Supporting Data for EUA (18)]. Overall, there were no notable differences in the
safety profiles observed between participants 65 years of age and older and younger participants. [see
Overall Safety Summary (6)]
In the clinical study that evaluated a booster dose of Novavax COVID-19 Vaccine,
Adjuvanted, 15.7% (n=2006) of participants were 65 years of age and older and 2.6% (n=326)
of participants were 75 years of age and older. Overall, there were no notable differences in the
safety profiles observed between participants 65 years of age and older and younger participants. [see
Overall Safety Summary (6)]
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
14.1 Mechanism of Action
The Novavax COVID-19 Vaccine, Adjuvanted contains purified, full-length rS protein. The
vaccine elicits an immune response to the rS protein, which protects against COVID-19.
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
Study 1 is an ongoing Phase 3, multicenter, randomized, observer-blinded, placebo-controlled

study in participants 18 years of age and older in United States and Mexico.
Upon enrollment, participants were stratified by age (18 through 64 years or 65 years of age
and older). The study excluded participants who were significantly immunocompromised due
to immunodeficiency disease; had active cancer on chemotherapy; received chronic
immunosuppressive therapy or received immunoglobulin or blood-derived products within
90 days; were pregnant or breastfeeding; or had a history of laboratory-confirmed diagnosed
COVID-19. Participants with clinically stable underlying comorbidities were included as were
participants with well-controlled human immunodeficiency virus (HIV) infection.
A total of 29,945 participants were randomized in a 2:1 ratio to receive two doses of the
Novavax COVID-19 Vaccine, Adjuvanted or placebo 3 weeks apart. Assessments of safety and
efficacy against COVID-19 are planned for up to 24 months after the second dose.
The primary efficacy analysis population (Per Protocol Efficacy [PP-EFF] Analysis Set)
included 25,657 participants who received either the Novavax COVID-19 Vaccine,
Adjuvanted (n=17,272) or placebo (n=8,385), received two doses (Dose 1 on day 0; Dose 2 on
day 21 median 21 days, range 14-60), did not experience an exclusionary protocol deviation,
and did not have evidence of SARS-CoV-2 infection through 6 days after the second dose. In
the PP-EFF Analysis Set, 48.5% were female; 21.5% were Hispanic or Latino; 75.9% were
White, 11.0% were Black or African American, 6.2% were American Indian or Alaska Native,
4.4% were Asian, and 1.7% were multiracial. The median age of participants was 47 years (range
18-95 years) and 11.7% were 65 years of age and older. Of the study participants in the PP-EFF
Analysis Set, 95.2% were at high risk for COVID-19 due to living or working conditions
involving known frequent exposure to SARS-CoV-2, comorbidities (chronic lung disease,
cardiovascular disease, chronic liver disease, severe obesity, and diabetes), or age ≥ 65 years.
Between participants who received the Novavax COVID-19 Vaccine, Adjuvanted and those who
received placebo, there were no notable differences in demographics or pre-existing medical
conditions. Participants in the PP-EFF Analysis Set were included in the primary efficacy
analysis up until the time that they received their crossover vaccination. As of the September 27,
2021, data cutoff date, the PP-EFF Analysis Set had a median follow-up of 2.5 months post-Dose
2 during the pre-crossover period.
Efficacy of a Primary Series in Participants 18 Years of Age and Older
Vaccine efficacy in participants without evidence of SARS-CoV-2 infection through 6 days after
the second dose is presented in Table 5. Based on data accrued through September 27, 2021, the
efficacy of the Novavax COVID-19 Vaccine, Adjuvanted to prevent polymerase chain reaction
(PCR)-confirmed symptomatic mild, moderate or severe COVID-19 from 7 days after Dose 2
was 90.4% (95% CI: 83.8%, 94.3%). In the PP-EFF Analysis Set, no cases of moderate or
severe COVID-19 were reported in participants who had received the Novavax COVID-19
Vaccine, Adjuvanted, compared with nine cases of moderate COVID-19 and four cases of
severe COVID-19 reported in participants who had received placebo.
Table 5 Vaccine Efficacy Against PCR-confirmed COVID-19 with Onset from 7 Days
After Second Vaccination 1 (PP-EFF Analysis Set)
Placebo
Adjuvanted
Mean Mean
Incidence Incidence
Partici- COVID-19 Partici- COVID-19 Vaccine
Rate Per Rate Per
Subgroup pants Cases pants Cases Efficacy
1,000 1,000
N n (%) N n (%) (95% CI) (%)
Person- Person-
Years2 Years2
Primary efficacy endpoint
All 90.4
17,272 17 (0.1) 5.59 8,385 79 (0.9) 58.30
participants (83.8, 94.3) 3,4
Mild - 17 (0.1) - - 66 (0.8) - -
Moderate - 0 - - 9 (0.1) - -
Severe - 0 - - 4 (< 0.1) - -
1
Vaccine efficacy (VE) evaluated in participants without major protocol deviations who are seronegative (for SARS-CoV-2) at
baseline and do not have a laboratory confirmed current SARS-CoV-2 infection with symptom onset through 6 days after the
second dose, and who have received two doses of vaccine or placebo as randomized.
2
Mean incidence rate per 1,000 person-years was estimated with weighting for age strata reflective of the distribution seen in the
study population.
3
Based on log-linear model of PCR-confirmed COVID-19 infection incidence rate using Poisson regression with treatment group
and age strata as fixed effects and robust error variance, where VE = 100 × (1 – ratio of incidence rate) (Zou 2004).
4
Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) >30% at the planned
primary confirmatory analysis.
Descriptive analyses of efficacy showed efficacy point estimates similar to the estimate for the
overall study population across genders and racial groups, and across participants with or without
medical comorbidities associated with high risk of severe COVID-19. Vaccine efficacy in
participants of Hispanic/Latino ethnicity was 77.0% (95% CI: 48.7%, 89.7%) relative to 94.2%
(95% CI: 87.9%, 97.2%) in participants who were not Hispanic/Latino. Vaccine efficacy in
participants 65 years of age and older was 78.6% (95% CI: -16.6%, 96.1%) relative to 90.7%
(95% CI: 72.9%, 96.8%) in participants 50 through 64 years of age.
18.2 Effectiveness of a Two-Dose Primary Series in Adolescents 12 Through 17 Years of Age
Effectiveness in adolescents 12 years through 17 years of age is based on a comparison of

immune responses in this age group to adults 18 years through 25 years of age.
Study 1 is an ongoing Phase 3 multicenter, randomized, observer-blinded, placebo-controlled

study that included 2,247 participants 12 through 17 years of age in the United States.
Participants were randomized in a 2:1 ratio to receive two doses of the Novavax COVID-19
Vaccine, Adjuvanted or placebo 3 weeks apart. The study excluded participants who were
significantly immunocompromised due to immunodeficiency disease; had active cancer on
chemotherapy; had received chronic immunosuppressive therapy or had received
immunoglobulin or blood-derived products within 90 days; were pregnant or breastfeeding; or
had a history of laboratory-confirmed diagnosed COVID-19. Participants with clinically stable
underlying comorbidities and participants with well-controlled HIV infection were included.
In Study 1, an analysis was conducted of SARS-CoV-2 neutralizing antibody titers 14 days after
Dose 2 in a subset of adolescents 12 through 17 years of age and participants 18 through 25 years
of age from the adult main study. Noninferior immune responses as assessed by geometric mean
titers and seroconversion rates were demonstrated in a comparison of adolescents 12 through 17
years of age to participants 18 through 25 years of age (Table 6).
Table 6 SARS-CoV-2 Neutralizing Antibody Geometric Mean Titer Ratio and

Seroconversion Rate – Comparison of Adolescents 12 Years Through 17 Years
of Age to Participants 18 Years Through 25 Years of Age – Per-Protocol
Immunogenicity Analysis Set
12 Years Through 18 Years Through 12 Years Through 17 Years/
17 Years 25 Years 18 Years Through 25 Years
Time
Assay GMTa GMTa Met
Point GMRb
(95% CI) (95% CI) Noninferiority
(95% CI)
n=390 n=415 Criteriac
3859.6  2611.8 1.47
(3422.8, 4352.1)  (2367.4, 2881.5) (1.26, 1.72)3
SARS-CoV-2 wild-type 14 days SCR%e SCR%e Difference in
microneutralization after (95% CI) (95% CI) SCR%f Yes
assay (1/dilution) d
Dose 2 n=385 n=414 (95% CI)
98.7 99.8 -1.04
(97.0, 99.6) (98.7, 100.0) (-2.75, 0.20)
CI = Confidence interval; GMR = Geometric mean ratio; GMT = Geometric mean titer; SCR = Seroconversion rate
a
The 95% CI for GMT is calculated based on the t-distribution of the log-transformed values, then back transformed to the
original scale for presentation.
b
GMR is defined as the ratio of two geometric mean titers for comparison of two age cohorts. An analysis of covariance
(ANCOVA) with age cohort as main effect and baseline microneutralization assay neutralizing antibodies as covariate was
performed to estimate the GMR.
c
Noninferiority was achieved if the following 3 pre-specified criteria were met simultaneously: 1) Lower bound of two-sided
95% CI for the ratio of GMTs (GMT12-17yo/GMT18-25yo) > 0.67; 2) Point estimate of the ratio of GMTs ≥ 0.82; and 3) Lower
bound of the two-sided 95% CI for difference of SCRs (SCR12-17yo - SCR18-25yo) was > -10%.
d
Validated virus neutralizing assay (VNA) with wild-type virus (SARS-CoV-2 hCoV-19/Australia/VIC01/2020 [GenBank
MT007544.1]; 360biolabs, Melbourne, Australia). The lower limit for quantification for this assay was a titer of 20, with
titers below this level documented as 10.
e
SCR is defined as percentage of participants with a ≥ 4-fold difference in titers between Day 35 and Day 0. The 95% CI for
SCR was calculated using the Clopper-Pearson exact method.
f
Difference in SCR in the adolescent primary series expansion (Study 1) for 12 years through 17 years of Study 1 minus SCR in
Adult Main Study (Study 1) for 18 years through 25 years. The 95% CI for the difference of SCR between groups was
calculated with the method of Miettinen and Nurminen.
A descriptive efficacy analysis evaluating PCR-confirmed symptomatic mild, moderate or severe

COVID-19 cases was performed in 1,799 participants who were included in the per-protocol
efficacy (PP-EFF) Analysis Set, which required receipt of two doses (Dose 1 on day 0; Dose 2
on day 21), no exclusionary protocol deviation(s), and no evidence of SARS-CoV-2 infection
through 6 days after the second dose. In the PP-EFF Analysis Set, 47.2% were female; 15.8%
were Hispanic or Latino; 76.1% were White, 12.9% were Black or African American, 1.1% were
American Indian or Alaska Native, 3.6% were Asian, and 5.6% were multiracial. The median
age of participants was 14 years (range 12-17 years). Of the study participants in the PP-EFF
Analysis Set, 25.3% were obese. Between participants who received the Novavax COVID-19
Vaccine, Adjuvanted and those who received placebo, there were no notable differences in
demographics. The median interval between doses of study vaccine was 22 days (range 14-43).
As of the August 9, 2021, data cutoff date, the PP-EFF Analysis Set had a median follow-up of
67 days post-Dose 2 during the pre-crossover period.
Vaccine efficacy in participants without evidence of SARS-CoV-2 infection through 6 days after
the second dose is presented in Table 7 Based on data accrued through August 9, 2021, the
efficacy of the Novavax COVID-19 Vaccine, Adjuvanted to prevent PCR-confirmed
symptomatic mild, moderate or severe COVID-19 from 7 days after Dose 2 was 78.29%
(95% CI: 37.55%, 92.45%). No cases of moderate or severe COVID-19 were reported in
participants who had received the Novavax COVID-19 Vaccine, Adjuvanted or placebo.
Table 7 Vaccine Efficacy Against PCR-confirmed COVID-19 with Onset from 7 Days
After Second Vaccination1 (PP-EFF Analysis Set)
Placebo
Adjuvanted
Mean Mean
Incidence Incidence
Partici- COVID-19 Partici- COVID-19 Vaccine
Rate Per Rate Per
Subgroup pants Cases3 pants Cases3 Efficacy
100 100
N n (%) N n (%) (95% CI) (%)
Person- Person-
Years Years
Primary efficacy endpoint
All 78.29
1205 5 (0.4) 2.69 594 11 (1.9) 12.38
participants (37.55, 92.45) 2
Mild - 5 (0.4) - - 11 (1.9) - -
Moderate - 0 - - 0 - -
Severe - 0 - - 0 - -
1
Vaccine efficacy (VE) evaluated in participants without major protocol deviations who were seronegative (for SARS-CoV-2) at
baseline and did not have a laboratory confirmed current SARS-CoV-2 infection with symptom onset through 6 days after the
second dose, and who had received two doses of vaccine or placebo as randomized.
2
Based on Modified Poisson regression with logarithmic link function and treatment group as fixed effect and robust error
variance (Zou 2004).
3
All cases for which sequence data are available (vaccine n=2; placebo n=7) were due to the Delta variant.
18.3 Immunogenicity of a Booster Dose Following a Novavax COVID-19 Vaccine,

Adjuvanted Primary Series in Participants 18 Years and Older
Effectiveness of a booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was based on
assessment of neutralizing antibody titers (MN50) against the original SARS-CoV-2 strain
(SARS-CoV-2 hCoV-19/Australia/VIC01/2020). Immunogenicity analyses compared the MN 50
titers following the booster dose to the MN50 titers following the primary series.
In the open-label booster phase of Study 1, participants 18 years of age and older received a
single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted at least 6 months after
completion of the primary series. A subset of 243 participants were included in the per-protocol
immunogenicity (PP-IMM) analysis set, did not have serologic or virologic evidence (if
available) of SARS-CoV-2 infection up to 28 days post booster dose. Among participants
assessed for immunogenicity, 87.2% were 18-64 years of age, 12.8 % were 65 years of age and
older, 51.0% were males, 49.0% were female; 15.6% were Hispanic or Latino; 81.5% were
White, 11.1% were Black or African American, 0.4% were American Indian or Alaska Native,
4.9% were Asian, and 1.6% were multiracial. The median age of participants was 52 years
(range 19-79 years).
Prespecified immunogenicity non-inferiority analyses included an assessment of MN 50 geometric

mean titer (GMT) ratio and difference in seroconversion rates. Seroconversion for a participant
was defined as achieving a 4-fold rise in MN50 from baseline (before the booster dose and before
the first dose of the primary series).
The analysis of the GMT ratio of MN50 following the booster dose compared to the primary
series met the non-inferiority criteria for a booster response (lower limit of the 95% CI > 0.67)
and point estimate > 0.83.
The lower limit of the two-sided 95% CI for the difference in seroconversion rates was -14.4%,
which did not meet the non-inferiority criteria for a booster response (lower limit of 95% CI for
the percentage difference of ≥ -10%). These analyses are summarized in Table 8 and Table 9.
Table 8 Neutralizing Antibody Geometric Titers (MN50) Against the Original SARS-
CoV-2 Virus Strain (SARS CoV-2 hCoV-19/Australia/VIC01/2020) at 28 Days
after a Booster Dose Versus 14 Days After Completion of the Primary Series,
Participants ≥ 18 Years of Age, PP-IMM Analysis Set1
Booster Dose Primary Series
GMT Ratio
(N = 239)2 (N = 239)
(Booster/Primary Series) Met Success Criteria
GMT GMT
(95% CI)1
(95% CI)3 (95% CI) 3
5075.6 1505.7 3.4 Lower limit of 95% CI > 0.67 and
(4448.3, 5791.4) (1244.1, 1822.3) (2.8, 4.0) point estimate > 0.83 criteria: Yes
Abbreviations: CI = confidence interval; GMT = geometric mean titer; MN 50 = microneutralization assay with an inhibitory
concentration of 50%; PP-IMM = Per-Protocol Immunogenicity.
1
PP-IMM Analysis Set included participants who received two doses (0.5 mL 3 weeks apart) of the Novavax COVID-19
Vaccine, Adjuvanted in the initial vaccination period or in the blinded crossover vaccination period, had an immunogenicity
blood sample collected at Day 35, did not have serologic or virologic evidence (if available) of SARS-CoV-2 infection up to
28 days post booster dose, did not receive an emergency use authorized COVID-19 vaccine, received the booster dose, and
remained blinded on study and without major protocol deviations until 7 days post-crossover Dose.
2
The analysis included a total of 239 participants of the PP-IMM analysis set who had immunogenicity data available for both
the booster and primary series.
3
The 95% CI for GMT and GMT ratio were calculated based on the t-distribution of the log-transformed values, then back
transformed to the original scale for presentation.
Note: The median duration between the time of the second dose of the Novavax COVID-19 Vaccine, Adjuvanted and the time of
the booster dose was 10 months.
Table 9 Seroconversion Rates Against the Original SARS-CoV-2 Strain (SARS-CoV-2

hCoV-19/Australia/VIC01/2020) at 28 Days after a Booster Dose Versus
14 Days After Completion of the Primary Series, Participants ≥ 18 Years of
Age, PP-IMM Analysis Set1
(N = 239)2 (N = 239) Difference in SCR4
SCR SCR (Booster-Primary Series) Met Success Criteria6
n (%) n (%) (95% CI)5
(95% CI)3 (95% CI)3
-9.2%
204 (85.4) 226 (94.6) Lower limit of 95% CI > -10%
(-14.4%, -4.5
(80.2, 89.6) (90.9, 97.1) criterion: No
%)
Abbreviations: CI = confidence interval; PP-IMM = Per-Protocol Immunogenicity; SCR = seroconversion rate.
1
PP-IMM Analysis Set included participants who received two doses (0.5 mL 3 weeks apart) of the Novavax COVID-19
remained blinded on study and without major protocol deviations until 7 days post-crossover Dose 2.
2.
The analysis included a total of 239 participants of the PP-IMM analysis set who had immunogenicity data
(microneutralization) available for both the booster and primary series
3.
95% CI is based on the Clopper-Pearson method.
4
Based on the Tango method.
5
Comparison between SCR of 28 days post-booster relative to time of booster and SCR of 14 days after second dose of the
primary series relative to time of first dose.
6
Non-inferiority of the single booster dose was achieved if the lower limit of the 95% CI for the difference of the proportion of
participants with SCR at 28 days after a single booster dose relative to the time of booster vaccination versus at 14 days after
the second dose of the Novavax COVID-19 Vaccine, Adjuvanted relative to the time of first vaccination was > -10%.
Note: SCR was defined as the proportion of participants with post-vaccination levels ≥ 4-fold higher than the baseline levels.
An additional descriptive analysis evaluated seroconversion rates using baseline neutralizing

antibody titers prior to Dose 1 of the primary series. As shown in Table 10, the booster dose
seroconversion rate, with seroconversion defined as at least a 4-fold rise relative to the time of
first dose, was 98.3%. The difference in seroconversion rates in this post-hoc analysis was 3.8%
(95% CI: 2.0%, 7.0%).
Table 10 Analysis of Seroconversion Rates Against the Original SARS-CoV-2 Strain
(SARS CoV-2 hCoV-19/Australia/VIC01/2020) at 28 Days after a Booster Dose
Versus 14 Days After Completion of the Primary Series, Participants ≥ 18 Years
of Age, PP-IMM Analysis Set1
(N = 239)2 (N = 239) Difference in SCR4
SCR SCR (Booster-Primary Series)
n (%) n (%) (95% CI)5
(95% CI)3 (95% CI)3
235 (98.3) 226 (94.6) 3.8%
(95.8, 99.5) (90.9, 97.1) (2.0%, 7.0%)
Abbreviations: CI = confidence interval; PP-IMM = Per-Protocol Immunogenicity; SCR = seroconversion rate.
1
PP-IMM Analysis Set included all participants who received two doses (0.5 mL 3 weeks apart) of the Novavax COVID-19
remained blinded on study and without major protocol deviations until 7 days post-crossover Dose 2.
2.
The analysis included a total of 239 participants of the PP-IMM analysis set who had immunogenicity data
(microneutralization) available for both the booster and primary series
3
95% CI is based on the Clopper-Pearson method.
4
Based on the Tango method.
5
Comparison between SCR of 28 days post-booster relative to time of first dose and SCR of 14 days after second dose of the
primary series relative to time of first dose.
Note: SCR was defined as the proportion of participants with post-vaccination levels ≥ 4-fold higher than at the time of the first
dose.
18.4 Immunogenicity of a Booster Dose Following Primary Vaccination with Another

Authorized or Approved COVID-19 Vaccine
Effectiveness of a Novavax COVID-19 Vaccine, Adjuvanted booster dose in individuals who

completed primary vaccination with another authorized or approved COVID-19 vaccine is
inferred from immunogenicity data reported from an independent study conducted in the United
Kingdom (ISRCTN 73765130). This multicenter, randomized, controlled Phase 2 trial
investigated the immunogenicity of a single booster dose of Novavax COVID-19 Vaccine,
Adjuvanted in participants who had received two doses of the Pfizer-BioNTech COVID-19
Vaccine as a primary vaccination series. Participants included adults aged 30 years and older
with no history of laboratory-confirmed SARS-CoV-2 infection. The Novavax COVID-19
Vaccine, Adjuvanted was administered at least 84 days after completion of a Pfizer-BioNTech
COVID-19 Vaccine primary series in 114 participants. Neutralizing antibody titers measured by
a microneutralization assay were assessed prior to the booster dose and 28 days post-booster
dose. A booster response to the Novavax COVID-19 Vaccine, Adjuvanted was demonstrated.
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-004
Revised: October/19/2022
©2022 Novavax, Inc. All rights reserved.

Novavax HCP Fact Sheet 10192022

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FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE

EMERGENCY USE AUTHORIZATION (EUA) OF

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

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

DOSAGE AND ADMINISTRATION

Storage and Handling

Storage of Unpunctured Vial

Protect from light.

Storage After First Puncture of the Vaccine Vial

Dosing and Schedule

The Novavax COVID-19 Vaccine, Adjuvanted is administered intramuscularly as a primary series of

Inspect the vial

Prepare for administration

Administer the Novavax COVID-19 Vaccine, Adjuvanted intramuscularly.

Management of Acute Allergic Reactions

Myocarditis and Pericarditis

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a

Limitations of Vaccine Effectiveness

Adverse Reactions in Clinical Trials

Adverse Reactions Identified during Post-Authorization Use

USE WITH OTHER VACCINES

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

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

MANDATORY REQUIREMENTS FOR THENOVAVAX COVID-19 VACCINE, ADJUVANTED

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For

OTHER ADVERSE EVENT REPORTING TO VAERS AND NOVAVAX, INC.

Website Fax number Telephone number

FEDERAL COVID-19 VACCINATION PROGRAM

AUTHORITY FOR ISSUANCE OF THE EUA

For additional information about EUA, visit FDA at:

COUNTERMEASURES INJURY COMPENSATION PROGRAM

©2022 Novavax, Inc. All rights reserved.

END SHORT VERSION FACT SHEET

Long Version (Full EUA Prescribing Information) Begins On Next Page

NOVAVAX COVID-19 VACCINE, ADJUVANTED

FULL EMERGENCY USE

1 AUTHORIZED USE ........................................................10 11.2 Lactation ............................................................... 28

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

Inspect the vial

Prepare for administration

Administer the Novavax COVID-19 Vaccine, Adjuvanted intramuscularly.

2.3 Dosing and Schedule

The Novavax COVID-19 Vaccine, Adjuvanted is administered intramuscularly as a primary series

3 DOSAGE FORMS AND STRENGTHS

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately

5.2 Myocarditis and Pericarditis

Syncope (fainting) may occur in association with administration of injectable vaccines.

5.4 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may

5.5 Limitations of Vaccine Effectiveness

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event

Adverse Reactions in Clinical Trials

6.1 Clinical Trials Experience

Two-Dose Primary Series

Participants 18 years of age and older