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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
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- After the first dose has been withdrawn, hold the OPENED (PUNCTURED) vial between 2°C to 8°C (36°F to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours.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
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.
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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.
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.
