Frequently Asked Questions About
Johnson & Johnson's Janssen COVID-19 Vaccine
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 for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. 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.
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
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
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.
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.
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).
FDA has authorized the emergency use of the Janssen COVID-19 Vaccine in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
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).
The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL).
A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered at least 2 months after primary vaccination with the Janssen COVID-19 Vaccine.
A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
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.
There is no information on the co-administration of the Janssen COVID-19 Vaccine with other vaccines.
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).
Do not administer the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine.
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. Blood clots with low levels of platelets following the Janssen COVID-19 Vaccine have been reported in males and females, across a wide age range of individuals 18 years and older; reporting has been highest in females ages 30 through 49 years (about 8 cases for every 1,000,000 vaccine doses administered), and about 1 out of every 7 cases has been fatal. You should seek medical attention right away if you have any of the following symptoms after receiving the Janssen COVID-19 Vaccine:
The Janssen COVID-19 Vaccine is currently undergoing stability assessment studies. Expiry dates may be updated as these studies are completed. See the Check Expiration page for more information and instructions on how to look up the current expiration date.
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 noninsured 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-TIPS1-800-447-8477 or tips.hhs.gov
Vaccine CPT® code*: 91303
Primary Vaccination Administration CPT® code†: 0031A
Booster Dose Administration CPT® code†: 0034A
Carton NDC: 59676-580-15
Vial NDC: 59676-580-05
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; HRSA=Health Resources
and Services Administration; 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.