Janssen COVID-19 Vaccine (Johnson & Johnson)

Updates on 5/15/2021

• 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 May 14, 2021.

Updates on 8/10/2021

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 August 6, 2021.

• The Janssen (Johnson & Johnson) COVID-19 Vaccine Standing Orders

Updates on 5/17/2021

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 May 14, 2021.

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

Updates on 5/5/2021

• Updates to the Storage and Handling Summary PDF
• Made the following updates to the Janssen FAQ’s
  • “Do NOT store vaccine in the freezer”
  • Information on How do I dispose of COVID-19 vaccine vials and packaging

Multidose vial: 5 doses per vial
Dosage: 0.5mL

18 years and older

Single dose

Intramuscular (IM) injection in the deltoid muscle

• Contraindications:

• • Severe allergic reaction (e.g., anaphylaxis) to a previous dose or component of Janssen COVID-19 Vaccine.
  • Immediate allergic reaction* of any severity to a previous dose or known (diagnosed) allergy to a component of the vaccine.

Note: Persons who have a contraindication to Janssen COVID-19 may be able to receive an mRNA COVID-19 vaccine (see footnote).†

• Precautions
  • History of an immediate allergic reaction* to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies.)
    • This includes people with a reaction to a vaccine or injectable therapy that contains multiple components, one of which is a vaccine component, but in whom it is unknown which component elicited the immediate allergic reaction.
  • People with a contraindication to Janssen COVID-19 vaccine have a precaution to both mRNA vaccines (see footnote). †
  • 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.

†Consultation with an allergist-immunologist should be considered 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 COVID vax project. Vaccination of these individuals should only be undertaken in an appropriate setting under the supervision of a health care 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 www.vaxcheck.jnjexternal 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.

*Gloves are not required unless the person administering the vaccine is likely to come in contact with potentially infectious body fluids or has open lesions on the hands. If worn, perform hand hygiene and change gloves between patients.

†Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.

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:
6. • 30 minutes: Persons with a history of an immediate allergic reaction of any severity to a vaccine or injectable therapy, contraindication to mRNA COVID-19 vaccines who receive Janssen vaccine, history of anaphylaxis due to any cause
   • 15 minutes: All other persons

• The Janssen COVID-19 vaccine is administered as a single dose.
• 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.
• COVID-19 vaccines and other vaccines may be administered on the same day, as well as within 14 days of each other. When deciding if to administer COVID-19 vaccines and other vaccines, providers should consider whether the patient is behind or at risk of becoming behind on recommended vaccines, their risk of vaccine-preventable diseases (e.g., during an outbreak), and the reactogenicity profile of the vaccines.

• 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.