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  • After the first dose has been withdrawn, hold the OPENED (PUNCTURED) vial between 2°C to 8°C (36°F to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours.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

or

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.

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

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.

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