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Stability Information

Janssen COVID-19 Vaccine - Stability - Temperature Excursions (Vials)

The company cannot recommend any practices, procedures, usage, or storage conditions that deviate from the product labeling or which are not approved by regulatory agencies.

For product that is within expiry date (www.vaxcheck.jnj), stability studies were conducted to define acceptable conditions to support situations of (accidental) exposure of the Janssen COVID-19 Vaccine outside of the recommended ranges. These data were collected in strictly controlled environments. It is not possible to predict and design studies that reflect every combination or duration of temperatures that the product may encounter. Therefore, caution is recommended in assessing the effects of specific excursions on the product.1 If you have 10 or more vials affected by accidental exposure to temperatures beyond the acceptable limits noted on this website, store in the refrigerator and before disposing, please contact Janssen at 1-800-565-4008.

REMINDER – Recommended Storage Conditions2:

  • Store UNOPENED (UNPUNCTURED) multi-dose vials at 2°C to 8°C (36°F to 46°F) and protect from light. Do not store frozen.
  • After the first dose has been withdrawn, hold the OPENED (PUNCTURED) vial between 2°C to 8°C (36°F to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours.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.

SELECT if the stability inquiry involves either an opened (punctured) OR unopened (unpunctured) vial

Enter the temperature (°C or °F) at which the Janssen COVID-19 Vaccine was stored

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References

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1. Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-169822. Janssen Biotech, Inc.; 2020.

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.

Real-Time Expiry at Labeled Storage Conditions

  • For expiry date, scan the QR code using your device, visit (www.vaxcheck.jnj), or call US Toll Free: 1-800-565-4008
  • As the expiration approaches, check again to determine if the expiry date has been extended.

QR code

For complete information, please view the EUA Fact Sheet & Full Prescribing Information for Vaccination Providers1

References

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1. Janssen COVID-19 Vaccine. Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering vaccine (Vaccination Providers) and Full Prescribing Information. Janssen Biotech, Inc.

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.

  • Store UNOPENED (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.1
  • UNOPENED (UNPUNCTURED) vials of the Janssen COVID-19 Vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours.1
  • The Janssen COVID-19 Vaccine can be exposed to indoor ambient light for 6 hours during preparation and administration.2 The Janssen COVID-19 Vaccine should not be exposed to direct sunlight or ultraviolet (UV) light.3 The secondary carton packaging protects against impact from exposure to direct sunlight or UV light.
  • 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 OPENED (PUNCTURED) 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.1
    • 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).2,4,5
      • If you do not reach the 2-hour time limit at room temperature, you may transfer the punctured vial to a refrigerated storage unit between 2°C and 8°C for the remaining time, up to 2 hours. For example, a vial held at room temperature for 1 hour after first puncture can be stored in the refrigerator (between 2°C and 8°C) for no more than 1 hour before using or discarding. If the 2-hour time limit at room temperature has been met, it must be discarded and cannot be transferred to the refrigerator.5
    • 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.2,4
  • 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 2 hours to thaw, and an individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed.1

For complete information, please view the EUA Fact Sheet & Full Prescribing Information for Vaccination Providers1

References

Show Hide

1. Janssen COVID-19 Vaccine. Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full Prescribing Information. Janssen Biotech, Inc.

2. Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-183523. Janssen Biotech, Inc.; 2020.

3. Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-190932. Janssen Biotech, Inc.; 2020.

4. Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-188332. Janssen Biotech, Inc.; 2020.

5. Centers for Disease Control and Prevention. Janssen Covid-19 Vaccine (Johnson & Johnson) Questions. Centers for Disease Control and Prevention; March 2, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/janssen-faqs.html. Accessed March 3, 2021.

Janssen COVID-19 Vaccine - Stability - Temperature Excursion
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