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Janssen COVID-19 Vaccine - Dosing/Administration & Storage/Handling (Vials - Shipped Refrigerated)

Last Updated: 12/26/2022

SUMMARY  

  • The Janssen COVID-19 Vaccine has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The Janssen COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an 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 only authorized 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 Federal Food, Drug, and Cosmetic Act unless the declaration is terminated or authorization revoked sooner.1, 2
  • Refrigerate vaccine upon receipt. Do not store in the freezer.
  • The Janssen COVID-19 Vaccine (Ad26.COV2.S; JNJ-78436735) is supplied in a carton of 10 multi-dose vials (NDC 59676-580-15). A maximum of 5 doses can be withdrawn from the multi-dose vial.2
    • No dilution is required.3
    • Needle selection/use:
      • To allow accurate dosing, the use of syringes (polycarbonate or polypropylene) with a volume no larger than 1 mL is recommended.4
      • Needles with dimensions of 22G to 26G and 0.375” to 2” can be used.5
      • Changing needles between extracting the vaccine from a vial and injecting it into an individual is not necessary unless the needle has been damaged or contaminated.
    • Vial overfill:
      • A maximum of 5 doses can be withdrawn from the multi-dose vial.2
      • There is a slight overfill in each vial to accommodate for dead volume in the needle/syringe during administration. 
      • Discard any remaining vaccine in the vial after 5 doses have been extracted.
      • Janssen does not recommend drawing up leftover volume from multiple vials to obtain a full additional dose for patient administration.6
  • The storage and handling information in the Janssen COVID-19 Vaccine Fact Sheet supersedes the storage and handling information on the carton and vial labels.2, 7, 8

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PRODUCT LABELING

For complete information, please review the Janssen COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full Prescribing Information2

STORAGE and HANDLING

The storage and handling information in the Janssen COVID-19 Vaccine Fact Sheet supersedes the storage and handling information on the carton and vial labels.

Storage and Handling2

Storage prior to First Puncture of the Vaccine Vial

  • Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2°C to 8°C (36°F to 46°F) and protect from light. Do not store frozen.
  • Unpunctured vials of Janssen COVID-19 Vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours.
  • The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 2°C to 8°C (36°F to 46°F). If vaccine is still frozen upon receipt, thaw at 2°C to 8°C (36°F to 46°F). If needed immediately, thaw at room temperature (maximally 25°C/77°F). At room temperature (maximally 25°C/77°F), a carton of 10 vials will take approximately 4 hours to thaw, and an individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed.

Storage after First Puncture of the Vaccine Vial

Multiple microbiological challenge studies were performed to support the microbial safety of the Janssen COVID-19 Vaccine.8, 9

After the first dose has been withdrawn, hold the vial between 2°C to 8°C (36°F to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard the vial if vaccine is not used within these times.2 Maximum hold times for these 2 temperature ranges are not cumulative (i.e., The vaccine cannot be held at room temperature for 2 hours and then held refrigerated for another 6 hours).7, 8

If stored refrigerated after the first puncture, the vaccine can be moved to room temperature for brief periods of time for dose withdrawal. This does not impact the maximum 6-hour hold period in the refrigerator.7, 8

EXPOSURE TO LIGHT

The Janssen COVID-19 Vaccine should not be exposed to direct sunlight or ultraviolet (UV) light.10

  • The secondary carton packaging protects against impact from exposure to direct sunlight or UV light.

The Janssen COVID-19 vaccine can be exposed to indoor ambient light for 6 hours during preparation and administration.7

DOSING AND SCHEDULE

Primary Vaccination

The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL) administered to individuals 18 years of age and older.2

Booster Dose

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, to individuals 18 years of age and older.2

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 eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.2

DOSE PREPARATION and ADMINISTRATION

Dose Preparation2

  • The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. Visually inspect the Janssen COVID-19 Vaccine vials for particulate matter and discoloration prior to administration. If either of these conditions exists, do not administer the vaccine.
  • Before withdrawing each dose of vaccine, carefully mix the contents of the multi-dose vial by swirling gently in an upright position for 10 seconds. Do not shake.
    • In case a vial is accidentally shaken during preparation of the vaccine dose, allow foam to settle to enable proper/sufficient dose extraction prior to administration.11
  • Each dose is 0.5 mL. Each vial contains five doses. Do not pool excess vaccine from multiple vials.
  • The Janssen COVID-19 Vaccine does not contain a preservative. Record the date and time of first use on the Janssen COVID-19 Vaccine vial label. After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard if vaccine is not used within these times.

Administration2

Visually inspect each dose in the dosing syringe prior to administration. The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. During the visual inspection,

  • verify the final dosing volume of 0.5 mL.
  • confirm there are no particulates and that no discoloration is observed.
  • do not administer if vaccine is discolored or contains particulate matter.

Administer the Janssen COVID-19 Vaccine intramuscularly.

Centers for Disease Control (CDC) Observation Guideline

Observe recipients after vaccination for an immediate adverse reaction:

  • 30 minutes: Persons with a:
    • History of an immediate allergic reaction of any severity to a vaccine or injectable therapy
    • Contraindication to messenger ribonucleic acid (mRNA) COVID-19 vaccines who receive Janssen COVID-19 Vaccine
    • History of anaphylaxis due to any cause
  • 15 minutes: All other persons

OVERVIEW - JANSSEN COVID-19 VACCINE DOSE PREPARATION AND ADMINISTRATION

DOSE PREPARATION2
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The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. Visually inspect the Janssen COVID-19 Vaccine vials for particulate matter and discoloration prior to administration. If either of these conditions exists, do not administer the vaccine.
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Description automatically generated
Before withdrawing each dose of vaccine, carefully mix the contents of the multi-dose vial by swirling gently in an upright position for 10 seconds. Do not shake.
  • In case a vial is accidentally shaken during preparation of the vaccine dose, allow foam to settle to enable proper/sufficient dose extraction prior to administration.11
Diagram

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Each dose is 0.5 mL. Each vial contains five doses.
  • A maximum of 5 doses can be withdrawn from the multi-dose vial. Do not pool excess vaccine from multiple vials.
Diagram

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The Janssen COVID-19 Vaccine does not contain a preservative.
  • Record the date and time of first use on the Janssen COVID-19 Vaccine vial label.
  • After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C /77°F) for up to 2 hours.
  • Discard if vaccine is not used within these times.
ADMINISTRATION2
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Visually inspect each dose in the dosing syringe prior to administration.
The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension.
During the visual inspection,
  • verify the final dosing volume of 0.5 mL.
  • confirm there are no particulates and that no discoloration is observed.
  • do not administer if vaccine is discolored or contains particulate matter.


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Administer the Janssen COVID-19 Vaccine intramuscularly.

References

1 United States Food and Drug Administration. Janssen COVID-19 Vaccine. FDA Emergency Use Authorization Letter. Available from: https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-EUA.pdf.
2 Janssen COVID-19 Vaccine. Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full Prescribing Information. Janssen Biotech, Inc; https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf.
3 Janssen Pharmaceutical Companies of Johnson & Johnson. Emergency use authorization (EUA) application for Ad26.COV2.S. Vaccines and Related Biological Products Advisory Committee. Meeting date: 26 February 2021. Presentation available from: https://www.fda.gov/media/146265/download.
4 Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-185069. Janssen Biotech, Inc.; 2020.
5 Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-177477. Janssen Biotech, Inc.; 2020.
6 Data on File. Janssen COVID-19 Vaccine. Vial Overfill. CMC Regulatory. 25 February 2021.
7 Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-183523. Janssen Biotech, Inc.; 2020.
8 Data on File. Janssen COVID-19 Vaccine  Technical Document: TV-TEC-188332. Janssen Biotech, Inc.; 2020.
9 Data on File. Janssen COVID-19 Vaccine  Technical Document: TV-TEC-183318. Janssen Biotech, Inc.; 2020.
10 Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-190932. Janssen Biotech, Inc.; 2020.
11 Data on File. Janssen COVID-19 Vaccine  Technical Document: TV-TEC-181883. Janssen Biotech, Inc.; 2020.