The Pfizer-BioNTechCOVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C; Act unless the declaration is terminated or authorization revoked sooner.
The Pfizer-BioNTech COVID-19 Vaccine must be kept in an ultra-low-temperature (ULT) freezer between ‑80ºC to
‑60ºC (‑112ºF to ‑76ºF).
If an ultra-low-temperature freezer is not available, the thermal shipping container in which the
Pfizer-BioNTechCOVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled
with dry ice. Refer to the re-icing guidelines packed in the original thermal shipping container
for instructions regarding the use of the thermal shipping container for temporary storage. The thermal shipping
container maintains a temperature range of -90ºC to -60ºC (-130ºF to
-76ºF). Storage within this temperature range is not considered an excursion from the recommended
storage condition.
For the thermal shipping container to maintain the ultra-low temperatures required, it is recommended that the thermal shipping container itself be stored at 15°C to 25°C (59°F to 77°F).
Vaccination Storage & Dry Ice Safety Handling
Updated as of 1/15/2021
Checklist for Storage, Handling, and Preparation of the Pfizer-BioNTech
COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine Video (A Guide to Product Handling and Administration at Your
Vaccination Center)
A chapterized video guide detailing the storage and handling, preparation and administration, and thermal shipping container return processes for the Pfizer-BioNTech COVID-19 Vaccine.
Chapter 1: Storage and Handling*
How to store and handle the thermal shipping container, dry ice, and vaccine vial trays.
*CAUTION: During the unpacking process, you might feel resistance when trying to remove the box that holds the vial trays. Do not apply force to remove the box. Use the 2 bands wrapped around each vial tray to remove the trays from the thermal shipping container.
How to properly thaw the multiple dose vials, as well as how to prepare and administer the vaccine to
recipients.
*CAUTION: During the unpacking process, you might feel resistance when trying to remove the box that holds the vial trays. Do not apply force to remove the box. Use the 2 bands wrapped around each vial tray to remove the trays from the thermal shipping container.
*CAUTION: During the unpacking process, you might feel resistance when trying to remove the box that holds the vial trays. Do not apply force to remove the box. Use the 2 bands wrapped around each vial tray to remove the trays from the thermal shipping container.
Safety and Storage
Safe Handling Guidelines for Dry Ice
Facts about dry ice, general safety guidance, and disposal procedures.
Pfizer-BioNTech COVID-19 Vaccine Storage and Handling
Do not open the vial trays or remove vials until you are ready for thawing or use
Upon delivery:
Inspect the thermal shipping container to confirm all vial trays were received
Do not stack or place anything on top of the thermal shipping container
Vial Tray and Vial Handling
Closed-lid vial trays containing 195 vials removed from frozen storage (<-60°C) may be at room temperature (<25°C) for up to 5 minutes for transfer between ultra-low-temperature environments
Open-lid vial trays, or vial trays containing less than 195 vials removed from frozen storage (<-60°C) may be at room temperature (<25°C) for up to 3 minutes
After vial trays are returned to frozen storage following room temperature exposure, they must remain in frozen storage for at least 2 hours before they can be removed again
Once an individual vial is removed from a vial tray at room temperature, it should not be returned to frozen storage and should be thawed for use
If using the Thermal Shipper for Storage; To help maintain the level of dry ice and the temperature of the vaccine product:
24 hours: The thermal shipping container must be replenished with dry ice within 24 hours of receipt
2x/Day: It is recommended that the thermal shipping container not be opened more than 2 times a day
3 Minutes: The thermal shipping container should not be opened more than 3 minutes at a time
5 Days: The thermal shipping container should be re-iced every 5 days
Dry Ice can be hazardous. Take necessary precautions by reviewing the Dry Ice Safety Data Sheet and consult with your Occupational Health Department. Ensure there is proper ventilation and wear safety goggles or safety glasses with side shields and waterproof insulated gloves when handling dry ice
Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and store in an ultra-low-temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). Vials must be kept frozen between -80ºC to -60ºC (-112ºF to -76ºF) and protected from light until ready to use
If an ultra-low-temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90ºC to -60ºC (-130ºF to -76ºF). Storage within this temperature range is not considered an excursion from the recommended storage condition
Thawed Vials Before Dilution
Thawed Under Refrigeration
Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 5 days (120 hours). A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time
Thawed at Room Temperature
For immediate use, thaw undiluted vials at room temperature [up to 25°C (77°F)] for 30 minutes. Thawed vials can be handled in room light conditions. Vials must reach room temperature before dilution
Undiluted vials may be stored at room temperature for no more than 2 hours
Vials must reach room temperature before dilution
Vials After Dilution
After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light
Any vaccine remaining in vials must be discarded after 6 hours
Do not refreeze
Safely Dispose
Discard vaccine vials that:
Have been fully discharged and used to administer vaccinations
Are more than 6 hours from time of dilution
Discard vaccine vials in a sharps container as medical waste to ensure they are permanently destroyed. Discard vial trays as medical waste so they cannot be reused.
Important Safety Information
Do not administer Pfizer-BioNTechCOVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTechCOVID-19 Vaccine
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTechCOVID-19 Vaccine
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/)
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTechCOVID-19 Vaccine
The Pfizer-BioNTechCOVID-19 Vaccine may not protect all vaccine recipients
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
Severe allergic reactions have been reported following the Pfizer-BioNTechCOVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTechCOVID-19 Vaccine
Available data on Pfizer-BioNTechCOVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
Data are not available to assess the effects of Pfizer-BioNTechCOVID-19 Vaccine on the breastfed infant or on milk production/excretion
There are no data available on the interchangeability of the Pfizer-BioNTechCOVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTechCOVID-19 Vaccine should receive a second dose of Pfizer-BioNTechCOVID-19 Vaccine to complete the vaccination series
Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com
