Janssen COVID-19 Vaccine (Johnson & Johnson)

Updates on 12/22/2021

• 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 December 17, 2021.

Updates on 12/22/2021

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 December 17, 2021.

• Janssen (Johnson & Johnson) COVID-19 Vaccine Standing Orders
• Janssen (Johnson & Johnson) Preparation and Administration Summary

Updates on 10/28/2021

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:

• 1 primary dose
• 1 booster dose at least 2 months (8 weeks) after primary dose

Intramuscular (IM) injection in the deltoid muscle

• Contraindications:
  • 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)

• Precautions
  • History of an immediate allergic reaction* to any non-COVID-19 vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies.)

• • • 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 to a previous dose of the 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

*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.

• People with a contraindication to mRNA COVID-19 vaccines (including due to a known PEG allergy) have a precaution to Janssen COVID-19 vaccination. People who have previously received an mRNA COVID-19 vaccine dose should wait at least 28 days to receive Janssen COVID-19 vaccine.
• People with a contraindication to Janssen COVID-19 vaccine (including due to a known polysorbate allergy) have a precaution to mRNA COVID-19 vaccination.

1. Follow aseptic technique. Perform hand hygiene before vaccine preparation, between patients, when changing gloves (if worn), and any time hands become soiled.*
2. 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.

3. 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.
4. 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.
5. Using a new, sterile alcohol prep pad, cleanse the stopper of the multidose vaccine vial.
6. Choose the correct equipment, including the correct needle size. Use a new, sterile needle and syringe for each injection.
7. 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.
8. 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.

1. 1. Assess recipient status:

• 1. • Screen for contraindications and precautions.
     • Review vaccination history.
     • Review medical considerations.
  2. Bring the dose of vaccine from the designated preparation area immediately to the patient treatment area for administration.
  3. Ensure staff has the correct PPE before administering vaccines and implement policies for the use of face coverings for vaccine recipients (if tolerated).
  4. Administer the vaccine immediately by intramuscular (IM) injection in the deltoid muscle.
  5. 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

• 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:
  • 1 primary dose
  • 1 booster dose, at least 2 months after the primary dose
• COVID-19 vaccines may be coadministered with other vaccines, including simultaneous administration.

• 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.

• 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.