Janssen COVID-19 Vaccine (Johnson & Johnson)
Webpage content and individual PDFs are updated when there’s new guidance concerning the Janssen (Johnson & Johnson) COVID-19 Vaccine. Expand each section below to see a summary of new and updated items.
Updates on 2/22/2022
- Janssen (Johnson & Johnson) COVID-19 vaccine materials have been updated to include the Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States from February 22, 2022.
Updates on 2/22/2022
The following have been updated to reference the Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States from February 22, 2022.
- Janssen (Johnson & Johnson) COVID-19 Vaccine Standing Orders
- Janssen (Johnson & Johnson) Preparation and Administration Summary
Updates on 2/2/2022
Updates to Storage and Handling Labels
Multidose vial: 5 doses per vial
Dosage: 0.5 mL
18 years and older
mRNA COVID-19 vaccines are preferred over Janssen COVID-19 Vaccine for primary and booster vaccination. If a person elects to receive Janssen COVID-19 Vaccine, the schedule is:
Primary Series: 1 dose
Additional Primary Dose for moderately or severely immunocompromised people: Administer a second (additional) dose using an mRNA COVID-19 vaccine at least 4 weeks later.
Booster Dose: Administer a booster dose at least 2 months after the primary series dose (1st dose) or additional primary dose (2nd dose) for those who are moderately or severely immunocompromised. Some people may be able to receive a second booster dose. Learn more about considerations for COVID-19 vaccine booster doses.
For detailed information see Interim COVID-19 Immunization Schedule for Ages 5+pdf icon
Intramuscular (IM) injection in the deltoid muscle
Before administering vaccine, screen recipients for contraindications and precautions, even if the recipient is scheduled to receive the second or booster dose. The recipient’s health condition or recommendations regarding contraindications and precautions for vaccination may change from one visit to the next.
To assess patients correctly and consistently, vaccination providers should use a standardized, comprehensive screening tool.
- History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine
- Known diagnosed allergy to a component of the vaccine
- History of thrombosis with thrombocytopenia syndrome (TTS) following receipt of a previous Janssen COVID-19 Vaccine (or other COVID-19 vaccines not currently authorized in the United States that are based on adenovirus vectors)
- Additionally, people with a history of an episode of immune-mediated syndrome characterized by thrombosis and thrombocytopenia, such as spontaneous or classic HIT, should not receive Janssen COVID-19 Vaccine. These people should receive an mRNA COVID-19 vaccine.
- History of an immediate allergic reaction* to any non-COVID-19 vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies [excluding subcutaneous immunotherapy for allergies, i.e., “allergy shots”].)
- This includes non-COVID-19 vaccines or therapies with multiple components, and the component(s) that elicited the reaction is unknown.
- History of an immediate (within 4 hours after vaccination) non-severe, allergic reaction after a dose of one type of COVID-19 vaccine (i.e. mRNA or Janssen) have a precaution to the same type of COVID-19 vaccine
- Contradiction to one type of COVID-19 vaccines (mRNA) is a precaution to other types of COVID-19 vaccines (Janssen)†
- Moderate or severe acute illness, with or without fever
- For mRNA COVID-19 vaccines, history of myocarditis or pericarditis after a dose of an mRNA COVID-19 vaccine
- For Janssen COVID-19 vaccine, a history of GBS
- People who develop GBS within 6 weeks after receipt of Janssen COVID-19 Vaccine should not receive another dose of Janssen COVID-19 vaccine. These people should receive an mRNA COVID-19 vaccine.
*For the purpose of this guidance, an immediate allergic reaction is defined as any hypersensitivity-related signs or symptoms, such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within 4 hours following exposure to a vaccine or medication.
†Consider consultation with an allergist-immunologist to help determine if the patient can safely receive vaccination. Healthcare providers and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVIDvax Project https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html. Vaccination of these individuals should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.
- Follow aseptic technique. Perform hand hygiene before vaccine preparation, between patients, when changing gloves (if worn), and any time hands become soiled.*
- Unpunctured vials: Check the expiration date by:
- Scan the QR code on the outer carton, or
- Call the manufacturer (1-800-565-4008,) or
- Go to vaxcheck.jnjexternal iconexternal icon.
Use CDC’s expiration date tracker to document expiration date changes.
Do not discard vaccine until ensuring the expiration date has passed.
- As the expiration date approaches, check the expiration date again using the same process.
- Never use expired vaccine.
- Punctured vials: Check the beyond-use time. Never use vaccine after the beyond-use time.
- With the vial upright, gently swirl the vaccine for 10 seconds. Do NOT shake. If the vial is shaken, contact the manufacturer. Note: Gently swirl the vaccine before withdrawing subsequent doses.
- Examine the vaccine. It should be colorless to slightly yellow, clear to very opalescent suspension. Do not use if liquid contains particulate matter or is discolored.
- Using a new, sterile alcohol prep pad, cleanse the stopper of the multidose vaccine vial.
- Choose the correct equipment, including the correct needle size. Use a new, sterile needle and syringe for each injection.
- Ensure the needle and syringe are secured tightly together. Withdraw 0.5 mL of vaccine into the syringe.†
- Regardless of the type of syringe used, ensure the amount of vaccine in the syringe equals 0.5 mL.
- If the amount of vaccine remaining in the vial cannot provide a full 0.5 mL dose, discard the vial and contents.
- Do not combine vaccine from multiple vials to obtain a dose.
- Note the date and time the vial was first punctured. Keep the vaccine between 2°C and 8°C (36°F and 46°F) for up to 6 hours or at room temperature (up to 25°C or 77°F) for 2 hours. Discard any unused vaccine if not used within these timeframes.
- Assess recipient status:
- Screen for contraindications and precautions.
- Review vaccination history.
- Review medical considerations.
- Bring the dose of vaccine from the designated preparation area immediately to the patient treatment area for administration.
- Ensure staff has the correct PPE before administering vaccines and implement policies for the use of face coverings for vaccine recipients (if tolerated).
- Administer the vaccine immediately by intramuscular (IM) injection in the deltoid muscle.
- Observe recipients after vaccination for an immediate adverse reaction:
- 30 minutes: Persons with a history of
- A contraindication to another type of COVID-19 vaccine product
- Immediate (within 4 hours of exposure) non-severe allergic reaction to a non-COVID-19 vaccine or injectable therapies
- Immediate allergic reaction of any severity to a non-COVID-19 vaccine or injectable therapies
- Anaphylaxis due to any cause.
- 15 minutes: All other persons
- 30 minutes: Persons with a history of
- mRNA COVID-19 vaccines are preferred over Janssen COVID-19 Vaccine for primary and booster vaccination. If a person elects to receive Janssen COVID-19 Vaccine, the schedule is:
- Primary Series: 1 dose
- Additional Primary Dose for moderately or severely immunocompromised people: Administer a second (additional) dose using an mRNA COVID-19 vaccine at least 4 weeks later.
- Booster Dose: Administer a booster dose at least 2 months after the initial primary series dose (1st dose) or additional primary dose (2nd dose) for those who are moderately or severely immunocompromised. Some people may be able to receive a second booster dose. Learn more about considerations for COVID-19 vaccine booster doses.
- COVID-19 vaccines may be coadministered with other vaccines, including simultaneous administration.
- Janssen COVID-19 Vaccine Standing Orderspdf icon (updated 4/27/22)
- Preparation and Administration Summarypdf icon (updated 4/12/22)
- Vaccine administration training and clinical materials
Download a prevaccination checklist in multiple languages.
Arabicpdf icon, Daripdf icon, Englishpdf icon, French (Canada)pdf icon, Haitian Creolepdf icon, Koreanpdf icon, Pashtopdf icon, Portuguese (Portugal)pdf icon, Simplified Chinesepdf icon, Spanishpdf icon, Ukrainianpdf icon, Vietnamesepdf icon
COVID-19 vaccination providers must document vaccine administration in their medical record systems within 24 hours of administration and use their best efforts to report administration data to the relevant system for the jurisdiction (i.e., immunization information system) as soon as practicable and no later than 72 hours after administration.
Store vaccine in a refrigerator. Do not freeze.
The vaccine will arrive at a refrigerated temperature of 2°C to 8°C (36°F and 46°F).
- Unpack the vaccine shipment following the manufacturer’s directions.
- As a backup to the qualified shipping container, temperature monitors are placed in each shipment. Only warm monitors will be included in Janssen shipments.
- Remove the instruction card for the temperature monitor immediately. Follow the guide on the back of the card to read the monitor.
- An ancillary supply kit will arrive separately from the vaccine.
- Vaccine vials may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) until the expiration date before vials are punctured.
- As the expiration date approaches, check the expiration date again.
- Scan the QR code located on the outer carton, or
- Call 1-800-565-4008, or
- Go to www.vaxcheck.jnjexternal iconexternal icon
- Use CDC’s expiration date tracking tool to document expiration date changes.
- As the expiration date approaches, check the expiration date again.
- After puncturing the multidose vial seal, store vaccine in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 6 hours or at room temperature (up to 25°C/77°F) for 2 hours.
Storage unit temperatures must be monitored regularly and checked and recorded at the beginning of each workday to determine if any excursions have occurred since the last temperature check. For accurate temperature monitoring, use a digital data logger (DDL) with a detachable probe that best reflects vaccine temperatures (e.g., probe buffered with glycol, glass beads, sand, or Teflon®). Check and record the temperature daily using a temperature log and one of the options below:
- Option 1 (preferred): Minimum/Maximum Temperatures Most DDLs display minimum and maximum (min/max) temperatures. Check and record the min/max temperatures at the start of each workday.
- Option 2: Current Temperature If the DDL does not display min/max temperatures, check and record the current temperature at the start and end of the workday. Review the continuous DDL temperature data daily.
For CDC temperatures logs, see Storage and Handling Resources below.
Temperature excursions or inappropriate storage conditions for any vaccine require immediate action. Any temperature reading outside the recommended ranges is considered a temperature excursion. Responses to temperature excursion reports are dependent on information given by the provider to the manufacturer. Completing the Vaccine Troubleshooting Record for temperature excursions can help provide needed information for manufacturers to determine the viability of the vaccine.
- Storage and Handling Summarypdf icon
- Storage and Handling Labelspdf icon
- Transporting Vaccine for Vaccination Clinics Held at Satellite, Temporary or Off-Site Locationspdf icon
- Transport Temperature Logpdf icon
- Refrigerator Storage Temperature Log (Celsius)pdf icon
- Refrigerator Storage Temperature Log (Fahrenheit)pdf icon
- Vaccine Storage Troubleshooting Record for temperature excursionspdf iconexternal icon
- Vaccine Expiration Date Tracking Toolpdf icon
Adverse events that occur in a recipient after COVID-19 vaccination are required to be reported to the Vaccine Adverse Event Reporting System (VAERS). FDA requires vaccination providers to report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. Complete and submit reports to VAERS onlineexternal icon.
For further assistance with reporting to VAERS, call 1-800-822-7967.
To receive email updates about this page, enter your email address: