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

Last Updated: 01/11/2023

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
  • Please see mandatory requirements for Janssen COVID-19 Vaccine administration, including how to report adverse events in the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section of the EUA Prescribing Information.2
  • 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.
    • 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 Information available via the following LINK.2

Temperature excursions for UNOPENED (unpunctured) vials outside of recommenDed vaccine storage

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 expiry date at the labeled storage condition of 2°C to 8°C (36°F to 46°F), check product expiry using the instructions on the packaging (also included below).2

For product that is within its expiry date (www.vaxcheck.jnj), stability studies were conducted to define acceptable conditions to support situations of (accidental) storage 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.

Stability studies were conducted with the Janssen COVID-19 Vaccine to provide the acceptable limits for temperature excursions outside of the recommended storage condition of 2°C to 8°C.3 (see Table: Acceptable Limits for Temperature Excursions for the Janssen COVID-19 Vaccine UNOPENED (UNPUNCTURED) Vials during Storage). Based on the stability data, the Janssen COVID-19 Vaccine was not adversely affected when exposed to conditions within the acceptable limits.4


Acceptable Limits for Temperature Excursions for the Janssen COVID-19 Vaccine UNOPENED (UNPUNCTURED) Vials during Storage4
Storage of Unpunctured Vials Excursion Temperature Range
Acceptable Limit
Equal to/below -86°C (-122°F)
No information available (no supporting data)
-85°C to -1°C (-121°F to +31°F)
No restriction in duration if the product is not expired.
Product can be frozen and thawed back one (1) time ONLY
0°C to 1°C (32°F to 35°F)
No restriction in duration if the product is not expired
2°C to 8°C (36°F to 46°F)
See product labeling for recommended storage conditions
9°C to 10°C (47°F to 50°F)
No restriction in duration if the product is not expired
11°C to 25°C (51°F to 77°F)
Up to 12 hours (cumulative) if the product is not expired
26°C to 40°C (78°F to 104°F)
Up to 30 minutes (cumulative) if the product is not expired
Equal to/above 41°C (105°F)
No information available (no supporting data)

Real-Time Expiry at Labeled Storage Conditions

  • For expiry date, scan the QR code below using your device, visit www.vaxcheck.jnj or call the telephone number provided below:
    • US Toll Free: 1-800-565-4008
    • QR Code

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 Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-169822. Janssen Biotech, Inc.; 2022.
4 Data on File. Janssen COVID-19 Vaccine Technical Document: TV-TEC-102593. Janssen Biotech, Inc.; 2020.