EMERGENCY USE AUTHORIZATION (EUA) OF THE JANSSEN COVID-19 VACCINE 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, Janssen COVID-19 Vaccine, 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 Janssen COVID-19 Vaccine. See "MANDATORY REQUIREMENTS FOR THE JANSSEN COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements.

The Janssen COVID-19 Vaccine is a suspension for intramuscular injection administered as a single dose (0.5 mL).

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 www.janssencovid19vaccine.com.

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

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, 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

The storage and handling information in this Fact Sheet supersedes the storage and handling information on the carton and vial labels.

Storage and Handling

Storage Prior to First Puncture of the Vaccine Vial

Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2°C to 8°C (36°F to 46°F) and protect from light. Do not store frozen.

Unpunctured vials of Janssen COVID-19 Vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours.

The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 2°C to 8°C (36°F to 46°F). If vaccine is still frozen upon receipt, thaw at 2°C to 8°C (36°F to 46°F). If needed immediately, thaw at room temperature (maximally 25°C/77°F). At room temperature (maximally 25°C/77°F), a carton of 10 vials will take approximately 4 hours to thaw, and an individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed.

Storage After First Puncture of the Vaccine Vial

After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard the vial if vaccine is not used within these times.

Dosing and Schedule

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose (0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 Vaccine.

Dose Preparation

• The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. Visually inspect the Janssen COVID-19 Vaccine vials for particulate matter and discoloration prior to administration. If either of these conditions exists, do not administer the vaccine.
• Before withdrawing each dose of vaccine, carefully mix the contents of the multi-dose vial by swirling gently in an upright position for 10 seconds. Do not shake.
• Each dose is 0.5 mL. Each vial contains five doses. Do not pool excess vaccine from multiple vials.
• The Janssen COVID-19 Vaccine does not contain a preservative. Record the date and time of first use on the Janssen COVID-19 Vaccine vial label. After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard if vaccine is not used within these times.

Administration

Visually inspect each dose in the dosing syringe prior to administration. The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. During the visual inspection,

• verify the final dosing volume of 0.5 mL.
• confirm there are no particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains particulate matter.

Administer the Janssen COVID-19 Vaccine intramuscularly.

CONTRAINDICATION

Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine (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 Janssen COVID-19 Vaccine.

Monitor Janssen COVID-19 Vaccine 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).

Thrombosis with Thrombocytopenia

Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. The reporting rate of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine has been highest in females ages 18 through 49 years; some cases have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia). (see Full EUA Prescribing Information).

Guillain-Barré Syndrome

Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.

Altered Immunocompetence

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

Syncope

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

Limitations of Vaccine Effectiveness

The Janssen COVID-19 Vaccine may not protect all vaccinated individuals.

ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

Adverse reactions reported in a clinical trial following administration of the Janssen COVID-19 Vaccine include injection site pain, headache, fatigue, myalgia, nausea, fever, injection site erythema and injection site swelling. In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following administration of the Janssen COVID-19 Vaccine (see Full EUA Prescribing Information).

Adverse Reactions Identified during Post Authorization Use

Severe allergic reactions (including anaphylaxis), thrombosis with thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been reported following administration of the Janssen COVID-19 Vaccine during mass vaccination outside of clinical trials.

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

USE WITH OTHER VACCINES

There is no information on the co-administration of the Janssen COVID-19 Vaccine 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 www.janssencovid19vaccine.com to obtain the Fact Sheet) prior to the individual receiving the Janssen COVID-19 Vaccine, including:

• FDA has authorized the emergency use of the Janssen COVID-19 Vaccine, which is not an FDA approved vaccine.
• The recipient or their caregiver has the option to accept or refuse the Janssen COVID-19 Vaccine.
• The significant known and potential risks and benefits of the Janssen COVID-19 Vaccine, 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 testing the use of the Janssen COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver with the name of the vaccine ("Janssen COVID-19 Vaccine") and date of administration to document vaccination.

Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a new 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 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 JANSSEN COVID-19 VACCINE 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 Janssen COVID-19 Vaccine, the following items are required. Use of unapproved Janssen COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):

1. The Janssen COVID-19 Vaccine is authorized for use in individuals 18 years of age and older.
2. The vaccination provider must communicate to the individual receiving the Janssen COVID-19 Vaccine or their caregiver, information consistent with the "Fact Sheet for Recipients and Caregivers" prior to the individual receiving the Janssen COVID-19 Vaccine.
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 "Janssen COVID-19 Vaccine 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 Janssen COVID-19 Vaccine 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 JANSSEN BIOTECH, 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 Janssen Biotech, Inc. using the contact information below or by providing a copy of the VAERS form to Janssen Biotech, Inc:

e-mail	Fax number	Telephone numbers
JNJvaccineAE@its.jnj.com	215-293-9955	US Toll Free: 1-800-565-4008 US Toll: (908) 455-9922

ADDITIONAL INFORMATION

For general questions or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan the QR code using your device, visit www.janssencovid19vaccine.com or call the telephone numbers provided below.

QR Code	Fact Sheets Website	Telephone numbers
	www.janssencovid19vaccine.com.	US Toll Free: 1-800-565-4008 US Toll: 1-908-455-9922

AVAILABLE ALTERNATIVES

Comirnaty (COVID-19 Vaccine, mRNA) is an FDA-approved vaccine 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) declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. In response, FDA has issued an EUA for the unapproved product, Janssen COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 18 years of age and older.

FDA issued this EUA, based on Janssen Biotech, 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 Janssen COVID-19 Vaccine may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

This EUA for the Janssen COVID-19 Vaccine 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 Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

THE 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 www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.

Manufactured by:
Janssen Biotech, Inc.
a Janssen Pharmaceutical Company of Johnson & Johnson
Horsham, PA 19044, USA

© 2021 Janssen Pharmaceutical Companies

END SHORT VERSION FACT SHEET

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

Revised: Aug/27/2021

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
JANSSEN COVID-19 VACCINE
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 Thrombosis with Thrombocytopenia   5.3 Guillain-Barré Syndrome   5.4 Syncope   5.5 Altered Immunocompetence   5.6 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 19 HOW SUPPLIED/STORAGE AND HANDLING 20 PATIENT COUNSELING INFORMATION 21 CONTACT INFORMATION *Sections or subsections omitted from the full prescribing information are not listed.

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Janssen COVID-19 vaccine 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

Janssen COVID-19 Vaccine is a suspension for intramuscular injection. A single dose is 0.5 mL.

4 CONTRAINDICATIONS

Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine [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 Janssen COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to Janssen Biotech, Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS or Janssen Biotech, Inc.

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 Janssen COVID-19 Vaccine administration 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.

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Janssen COVID-19 Vaccine with other vaccines.

11 USE IN SPECIFIC POPULATIONS

13 DESCRIPTION

The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent sterile suspension for intramuscular injection. It contains no visible particulates. The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein in a stabilized conformation.

The Ad26 vector expressing the SARS-CoV-2 S protein is grown in PER.C6 TetR cells, in media containing amino acids and no animal-derived proteins. After propagation, the vaccine is processed through several purification steps, formulated with inactive ingredients and filled into vials.

Each 0.5 mL dose of Janssen COVID-19 Vaccine is formulated to contain 5×1010 virus particles (VP) and the following inactive ingredients: citric acid monohydrate (0.14 mg), trisodium citrate dihydrate (2.02 mg), ethanol (2.04 mg), 2-hydroxypropyl-β-cyclodextrin (HBCD) (25.50 mg), polysorbate-80 (0.16 mg), sodium chloride (2.19 mg). Each dose may also contain residual amounts of host cell proteins (≤0.15 mcg) and/or host cell DNA (≤3 ng).

Janssen COVID-19 Vaccine does not contain a preservative.

The vial stoppers are not made with natural rubber latex.

14 CLINICAL PHARMACOLOGY

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

An ongoing, multicenter, randomized, double-blind, placebo-controlled Phase 3 Study (COV3001) (NCT04505722) is being conducted in the United States, South Africa, Brazil, Chile, Argentina, Colombia, Peru and Mexico to assess the efficacy, safety, and immunogenicity of a single-dose of the Janssen COVID-19 Vaccine for the prevention of COVID-19 in adults aged 18 years and older. Randomization was stratified by age (18–59 years, 60 years and older) and presence or absence of comorbidities associated with an increased risk of progression to severe COVID-19. The study allowed for the inclusion of individuals with stable pre-existing medical conditions, defined as disease not requiring significant change in therapy during the 3 months preceding vaccination, as well as individuals with stable human immunodeficiency virus (HIV) infection.

A total of 44,325 individuals were randomized equally to receive Janssen COVID-19 Vaccine or saline placebo. Individuals are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.

The primary efficacy analysis population of 39,321 individuals (19,630 in the Janssen COVID-19 Vaccine group and 19,691 in the placebo group) included 38,059 SARSCoV-2 seronegative individuals at baseline and 1,262 individuals with an unknown serostatus. Demographic and baseline characteristics were similar among individuals who received the Janssen COVID-19 Vaccine and those who received placebo (see Table 5).

Table 5: Summary of Demographics and Baseline Characteristics - Primary Efficacy Analysis Population

	Janssen COVID-19 Vaccine (N=19,630) n (%)	Placebo (N=19,691) n (%)
* Some individuals could be classified in more than one category. † Including 175 individuals in the United States, which represents 1% of the population recruited in the United States. ‡ Number of individuals who have 1 or more comorbidities at baseline that increase the risk of progression to severe/critical COVID-19: Obesity defined as BMI ≥30 kg/m2 (27.5%), hypertension (10.3%), type 2 diabetes (7.2%), stable/well-controlled HIV infection (2.5%), serious heart conditions (2.4%), asthma (1.3%), and in ≤1% of individuals: cancer, cerebrovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, cystic fibrosis, immunocompromised state (weakened immune system) from blood or organ transplant, liver disease, neurologic conditions, pulmonary fibrosis, sickle cell disease, thalassemia and type 1 diabetes, regardless of age.
Sex
Male	10,924 (55.6)	10,910 (55.4)
Female	8,702 (44.3)	8,777 (44.6)
Age (years)
Mean (SD)	51.1 (15.0)	51.2 (15.0)
Median	52.0	53.0
Min, max	(18; 100)	(18; 94)
Age group
≥18 to 59 years of age	12,830 (65.4)	12,881 (65.4)
≥60 years of age	6,800 (34.6)	6,810 (34.6)
≥65 years of age	3,984 (20.3)	4,018 (20.4)
≥75 years of age	755 (3.8)	693 (3.5)
Race*
White	12,200 (62.1)	12,216 (62.0)
Black or African American	3,374 (17.2)	3,390 (17.2)
Asian	720 (3.7)	663 (3.4)
American Indian/Alaska Native†	1,643 (8.4)	1,628 (8.3)
Native Hawaiian or other Pacific Islander	54 (0.3)	45 (0.2)
Multiple	1,036 (5.3)	1,087 (5.5)
Unknown	262 (1.3)	272 (1.4)
Not reported	341 (1.7)	390 (2.0)
Ethnicity
Hispanic or Latino	8,793 (44.8)	8,936 (45.4)
Not Hispanic or Latino	10,344 (52.7)	10,259 (52.1)
Unknown	173 (0.9)	162 (0.8)
Not reported	319 (1.6)	333 (1.7)
Region
Northern America (United States)	9,185 (46.8)	9,171 (46.6)
Latin America	7,967 (40.6)	8,014 (40.7)
Southern Africa (South Africa)	2,478 (12.6)	2,506 (12.7)
Comorbidities‡
Yes	7,830 (39.9)	7,867 (40.0)
No	11,800 (60.1)	11,824 (60.0)

19 HOW SUPPLIED/STORAGE AND HANDLING

Janssen COVID-19 Vaccine is supplied in a carton of 10 multi-dose vials (NDC 59676-580-15). A maximum of 5 doses can be withdrawn from the multi-dose vial.

The storage and handling information in this Fact Sheet supersedes the storage and handling information on the carton and vial labels.

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 or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan the QR code using your device, visit www.janssencovid19vaccine.com or call the telephone numbers provided below.

QR Code	Fact Sheets Website	Telephone numbers
	www.janssencovid19vaccine.com.	US Toll Free: 1-800-565-4008 US Toll: 1-908-455-9922

This Full EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing Information, please see www.janssencovid19vaccine.com.

Manufactured by:
Janssen Biotech, Inc.
a Janssen Pharmaceutical Company of Johnson & Johnson
Horsham, PA 19044, USA

Revised: Aug/27/2021

© 2021 Janssen Pharmaceutical Companies

FACT SHEET FOR RECIPIENTS AND CAREGIVERS

EMERGENCY USE AUTHORIZATION (EUA) OF
THE JANSSEN COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019
(COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER

You are being offered the Janssen COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you understand the risks and benefits of receiving the Janssen COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.

The Janssen COVID-19 Vaccine may prevent you from getting COVID-19.

Read this Fact Sheet for information about the Janssen COVID-19 Vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Janssen COVID-19 Vaccine.

The Janssen COVID-19 Vaccine is administered as a single dose, into the muscle.

The Janssen COVID-19 Vaccine may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit www.janssencovid19vaccine.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. Common 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 JANSSEN COVID-19 VACCINE?

The Janssen COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19.

The FDA has authorized the emergency use of the Janssen COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization (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 JANSSEN COVID-19 VACCINE?

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

• have any allergies,
• 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 GET THE JANSSEN COVID-19 VACCINE?

FDA has authorized the emergency use of the Janssen COVID-19 Vaccine in individuals 18 years of age and older.

WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?

You should not get the Janssen COVID-19 Vaccine if you:

• had a severe allergic reaction to any ingredient of this vaccine.

WHAT ARE THE INGREDIENTS IN THE JANSSEN COVID-19 VACCINE?

The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.

HOW IS THE JANSSEN COVID -19 VACCINE GIVEN?

The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle.

The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

HAS THE JANSSEN COVID-19 VACCINE BEEN USED BEFORE?

The Janssen COVID-19 Vaccine is an unapproved vaccine. In an ongoing clinical trial, 21,895 individuals 18 years of age and older have received the Janssen COVID-19 Vaccine.

WHAT ARE THE BENEFITS OF THE JANSSEN COVID-19 VACCINE?

In an ongoing clinical trial, the Janssen COVID-19 Vaccine has been shown to prevent COVID-19 following a single dose. The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?

Side effects that have been reported with the Janssen COVID-19 Vaccine include:

• Injection site reactions: pain, redness of the skin and swelling.
• General side effects: headache, feeling very tired, muscle aches, nausea, and fever.
• Swollen lymph nodes.
• Unusual feeling in the skin (such as tingling or a crawling feeling) (paresthesia), decreased feeling or sensitivity, especially in the skin (hypoesthesia).
• Persistent ringing in the ears (tinnitus).
• Diarrhea, vomiting.

Severe Allergic Reactions

There is a remote chance that the Janssen COVID-19 Vaccine 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 Janssen COVID-19 Vaccine. 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.

Blood Clots with Low Levels of Platelets

Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two weeks after vaccination. Reporting of these blood clots and low levels of platelets has been highest in females ages 18 through 49 years. The chance of having this occur is remote. You should seek medical attention right away if you have any of the following symptoms after receiving Janssen COVID-19 Vaccine:

• Shortness of breath,
• Chest pain,
• Leg swelling,
• Persistent abdominal pain,
• Severe or persistent headaches or blurred vision,
• Easy bruising or tiny blood spots under the skin beyond the site of the injection.

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

Guillain Barré Syndrome

Guillain Barré syndrome (a neurological disorder in which the body's immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

• Weakness or tingling sensations, especially in the legs or arms, that's worsening and spreading to other parts of the body.
• Difficulty walking.
• Difficulty with facial movements, including speaking, chewing, or swallowing.
• Double vision or inability to move eyes.
• Difficulty with bladder control or bowel function.

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 FDA/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 "Janssen COVID-19 Vaccine EUA" in the first line of box #18 of the report form.

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

e-mail	Fax number	Telephone numbers
JNJvaccineAE@its.jnj.com	215-293-9955	US Toll Free: 1-800-565-4008 US Toll: (908) 455-9922

You may also be given an option to enroll in v-safe. V-safe is a new 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 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 JANSSEN COVID-19 VACCINE?

It is your choice to receive or not receive the Janssen COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES JANSSEN COVID-19 VACCINE?

Another choice for preventing COVID-19 is Comirnaty, an FDA-approved COVID-19 vaccine. Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.

CAN I RECEIVE THE JANSSEN COVID-19 VACCINE WITH OTHER VACCINES?

There is no information on the use of the Janssen COVID-19 Vaccine with other vaccines.

WHAT IF I AM PREGNANT OR BREASTFEEDING?

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

WILL THE JANSSEN COVID-19 VACCINE GIVE ME COVID-19?

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

KEEP YOUR VACCINATION CARD

When you receive the Janssen COVID-19 Vaccine, you will get a vaccination card to document the name of the vaccine and date of when you received the vaccine.

ADDITIONAL INFORMATION

If you have questions or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan the QR code using your device, visit the website or call the telephone numbers provided below.

QR Code	Fact Sheets Website	Telephone numbers
	www.janssencovid19vaccine.com.	US Toll Free: 1-800-565-4008 US Toll: (908) 455-9922

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 local or state 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. 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 COUNTERMEASURE 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 for 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)?

The United States FDA has made the Janssen COVID-19 Vaccine available under an emergency access mechanism called an EUA. The 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.

The Janssen COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared 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 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.

The EUA for the Janssen COVID-19 Vaccine is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

Manufactured by:
Janssen Biotech, Inc.
a Janssen Pharmaceutical Company of Johnson & Johnson
Horsham, PA 19044, USA

© 2021 Janssen Pharmaceutical Companies

For more information, call US Toll Free: 1-800-565-4008, US Toll: (908) 455-9922 or go to www.janssencovid19vaccine.com

Revised: Aug/27/2021

	Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems.
Barcode Date: 02/2021

PRINCIPAL DISPLAY PANEL - 2.5 mL Vial Label

AW_177786

For use
under
Emergency
Use
Authorization

Janssen COVID-19
Vaccine

5 doses of 0.5 mL

Intramuscular Injection

No Preservative

For EXP: www.vaxcheck.jnj

After first use, hold at
2°C to 8°C (36°F to 46°F).
Discard after 6 hours.

Record date and time
of first use:

LOT

PRINCIPAL DISPLAY PANEL - 10 Vial Carton

NDC 59676-580-15
No Preservative

10 Multi-dose Vials
Each vial contains 5 doses of 0.5 mL

Janssen COVID-19 Vaccine
SUSPENSION FOR INTRAMUSCULAR INJECTION

For use under Emergency Use Authorization

Attention: After first use, hold at 2°C to 8°C (36°F to 46°F)
for up to 6 hours or at room temperature (maximally
25°C/77°F) for up to 2 hours. Discard if not used within
these times. Do not freeze.

janssen