The Food and Drug Administration (FDA) has authorized an extended shelf-life for the Janssen COVID-19 vaccine and the 2 presentations of the Tris/Sucrose formulation of the Pfizer-BioNTech COVID-19 vaccine.

The shelf-life for the Janssen COVID-19 vaccine has been extended from 9 to 11 months stored at 2 to 8°C (36°F to 46°F). The extension applies to all batches of the refrigerated vials that have been held according to the manufacturer’s storage conditions.

The Janssen COVID-19 vaccine is available under Emergency Use Authorization as a single primary vaccination dose for individuals 18 years of age and older and as a single booster dose for individuals 18 years of age and older at least 2 months after completing primary vaccination with the vaccine.

The frozen vials of the Tris/Sucrose formulation of the Pfizer-BioNTech COVID-19 vaccine may now be stored at -90 to -60°C (-130°F to -76°F) for up to 12 months from the date of manufacture. The 2 presentations of the Tris/Sucrose formulation are supplied in multiple dose vials with orange caps and labels with an orange border, and in multiple dose vials with gray caps and labels with a gray border.

The Pfizer-BioNTech COVID-19 vaccine is approved under the brand name Comirnaty for active immunization to prevent COVID-19 as a 2-dose primary series for individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine is also authorized for emergency use as:

  • A 2-dose primary series for individuals 5 years of age and older.
  • A third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise.
  • A first booster dose for individuals 12 years of age and older who have completed a primary series with the Pfizer-BioNTech COVID-19 vaccine or Comirnaty.
  • A first booster dose for individuals 18 years of age and older who have completed a primary series with another authorized or approved COVID-19 vaccine.
  • A second booster dose for individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine.
  • A second booster dose for individuals 12 years of age and older with certain kinds of immunocompromise who have received a first booster dose of any authorized or approved COVID-19 vaccine.

References

  1. FDA roundup: April 8, 2022. News release. US Food and Drug Administration. April 8, 2022. Accessed April 18, 2022. https://www.fda.gov/news-events/press-announcements/fda-roundup-april-8-2022
  2. FDA roundup: April 15, 2022. News release. US Food and Drug Administration. April 15, 2022. Accessed April 18, 2022. https://www.fda.gov/news-events/press-announcements/fda-roundup-april-15-2022