Frequently Asked Questions

Frequently Asked Questions

The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

General

Who is Janssen?

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

For more information about our company, please visit Janssen.com

What is a viral vector vaccine?

A viral vector vaccine is a type of vaccine that uses a modified, non-replicating version of a virus (the vector) to deliver the genetic code of an antigen into cells. The cells then use that code to produce copies of the antigen, which triggers an immune response.1

For more information from the CDC about viral vector vaccines, please visit www.cdc.gov

What is the Janssen COVID-19 Vaccine?

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).

The Janssen COVID-19 Vaccine does not contain a preservative.

The vial stoppers are not made with natural rubber latex.

Supply & Availability

How do I order the Janssen COVID-19 Vaccine?

Distribution of the Janssen COVID-19 Vaccine will be organized and executed by the US government. Eligibility and availability will likely vary from state to state. Please contact your local health authorities for the most accurate information for your region.

How can I verify the authenticity of my doses of the Janssen COVID-19 Vaccine?

Johnson & Johnson and Janssen Pharmaceuticals are committed to identifying and mitigating the risks of counterfeit healthcare products. Information regarding how we address counterfeiting can be found at healthforhumanityreport.jnj.com

The Janssen COVID-19 Vaccine is to be administered intramuscularly by a healthcare professional.

An authentic Janssen COVID-19 Vaccine includes the Janssen name and logo on the carton. The Janssen COVID-19 Vaccine is supplied in multi-dose vials. The vial stoppers are not made with natural rubber latex.

The Janssen COVID-19 Vaccine is never sold online and is distributed only through government channels. Janssen cannot verify the authenticity of products acquired outside of the legitimate supply chain. If you suspect the Janssen COVID-19 Vaccine you have may be counterfeit, contact us at 1-800-565-40081-800-565-4008 (US Toll Free) or 1-908-455-99221-908-455-9922 (US Toll).

Who should receive the Janssen COVID-19 Vaccine first?

The Advisory Committee on Immunization Practices (ACIP) provides recommendations for approved or authorized vaccines.2 You can learn more about the eligibility of COVID-19 vaccine recipients at CDC.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html

As the availability of the vaccine increases, more people will become eligible to receive it. Eligibility and availability will likely vary from state to state. Please contact your local health authorities for the most accurate information for your region.

Storage & Handling

Is the Janssen COVID-19 Vaccine shipped frozen?

The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 36°F to 46°F (2°C to 8°C). If vaccine is still frozen upon receipt, thaw at 36°F to 46°F (2°C to 8°C). If needed immediately, thaw at room temperature (maximally 77°F/25°C).

Dosage & Administration

What should I do if the incorrect dose volume has been administered?

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.

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-79671-800-822-7967. The reports should include the words "Janssen COVID-19 Vaccine EUA" in the description section of the report.

Who should not receive the Janssen COVID-19 Vaccine?

Do not administer the Janssen COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Janssen COVID-19 Vaccine (see EUA Fact Sheet and full Prescribing Information for Vaccination Providers).

The 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.

Product Expiration & Returns

Coding & Reimbursement

What is the cost of the Janssen COVID-19 Vaccine? Can I get reimbursed for it?

According to the CDC, vaccine doses purchased with US taxpayer dollars will be given to the American people at no cost. However, vaccination providers can charge an administration fee for giving someone the shot. Vaccination providers can be reimbursed for this by the patient’s public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration’s Provider Relief Fund. No one can be denied a vaccine if they are unable to pay the vaccine administration fee.3

CDC=Centers for Disease Control and Prevention; COVID-19=coronavirus disease 2019; CPT®=Current Procedural Terminology; CVX=Code for Vaccine Administered; EUA=Emergency Use Authorization; FD&C Act=Federal Food, Drug, and Cosmetic Act; IIS=Immunization Information Systems; MVX=Manufacturers of Vaccines; NDC=National Drug Code; QR=quick response.

CPT® is a registered trademark of the American Medical Association, 2021.

Janssen COVID-19 Vaccine purchased by the US government is provided to immunizers at no cost.

This CPT® code reports the actual work of administering vaccine, in addition to all necessary counseling provided to patients or caregivers and updating the electronic record.

Important safety information

CONTRAINDICATIONS

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.

WARNINGS AND PRECAUTIONS

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).

ADVERSE REACTIONS

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 the administration of the Janssen COVID-19 Vaccine.

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

Reporting Adverse Events and Vaccine Administration Error

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):

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 below. Reports should include the words “Janssen COVID-19 Vaccine EUA” in the description section of the report as the first line.

Report adverse events to Janssen Biotech, Inc. by calling 1-800-565-40081-800-565-4008 or provide a copy of the VAERS form by faxing 1-215-293-9955.

PREGNANCY AND LACTATION

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.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet.

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Important safety information

CONTRAINDICATIONS

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.

WARNINGS AND PRECAUTIONS

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).

ADVERSE REACTIONS

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 the administration of the Janssen COVID-19 Vaccine.

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

Reporting Adverse Events and Vaccine Administration Error

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):

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 below. Reports should include the words “Janssen COVID-19 Vaccine EUA” in the description section of the report as the first line.

Report adverse events to Janssen Biotech, Inc. by calling 1-800-565-40081-800-565-4008 or provide a copy of the VAERS form by faxing 1-215-293-9955.

PREGNANCY AND LACTATION

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.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet.

cp-213942v1