The USFDA has approved a request from Pfizer, Inc. to extend the shelf-life of the Pfizer COVID-19 vaccine for an additional three months – from six months to nine months — when the vaccine is stored at a temperature of -90 to -60 degrees Celsius.
On August 22, 2021 USFDA issued a concurrence letter approving Pfizer Inc’s request, and on August 23, 2021, the agency revised the Fact Sheet for Healthcare Providers Administering Vaccine to provide updates on expiration dates for the authorized Pfizer-BioNTech COVID-19 Vaccine.
According to the fact sheet, cartons and vials of Pfizer COVID-19 Vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as approved storage conditions between -90 degrees Celsius to -60 degrees Celsius have been maintained.
The Pfizer vaccine is a USFDA-approved COVID-19 vaccine indicated for immunization against COVID-19 in individuals 16 years of age and older. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 16 years of age and older. It is also authorized for emergency use to provide:
A two-dose primary series in individuals 12 through 15 years;
A third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise; and A single booster dose in individuals:
o 65 years of age and older
o 18 through 64 years of age at high risk of severe COVID-19
o 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.