Letter Shelf Life Extension Pfizer Vaccines

NEW YORK CITY DEPARTMENT OF
HEALTH AND MENTAL HYGIENE

Dave A. Chokshi, MD, MSc
Commissioner
December 21, 2021

Dear COVID-19 Vaccination Program Providers,
The FDA has approved a shelf-life extension for the Pfizer pediatric COVID-19 vaccine (orange cap,
ages 5 to 11, diluent required) and the soon to be available adolescent/adult Tris (gray cap, ages 12
and older, no diluent) effective immediately. These approvals are available at Healthcare Providers for
5-11 years of age, orange cap (must dilute) (fda.gov) and Healthcare Providers for 12 years of age and older,
gray cap (no dilution) (fda.gov). This extension applies to vaccine stored at ultracold temperatures
(ULT frozen) only.
As a reminder, the date printed on the Pfizer vaccine for ages 5 to 11 (orange cap) and vaccine for
ages 12 and older (gray cap) vaccine vials indicate the manufacture date and not the expiration date.
Originally, the expiration date was 6 months from the manufacture date. The expiration date for the
Pfizer orange and gray cap vaccines has now been extended to 9 months (while held at ULT frozen).
The orange and gray cap vaccines can both be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for
up to 10 weeks, if within 9 months after the manufacture date. The updated expiration dates for both
the orange and gray cap vials based on 9 months from the date of manufacture are provided below.
Printed Manufacturing Date 9-Month Expiration

Date*
06/2021 Feb. 28, 2022
07/2021 Mar. 31, 2022
08/2021 Apr. 30, 2022
09/2021 May 31, 2022
10/2021 Jun. 30, 2022
11/2021 July 31, 2022
12/2021 Aug. 31, 2022
01/2022 Sept. 30, 2022
02/2022 Oct. 31, 2022
*Date of expiration always falls on the last day of the month
The QR code provided on the Pfizer pediatric vaccine carton provides a link to the Emergency Use
Authorization (EUA) but does not provide information on expiration dates.
Please follow EUA recommendations for storage:
Pfizer 5 to 11 years of age vaccine (orange cap)

• If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature
[up to 25°C (77°F)] for 30 minutes.
NEW YORK CITY DEPARTMENT OF
HEALTH AND MENTAL HYGIENE
Dave A. Chokshi, MD, MSc
Commissioner
• Vaccine may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours
prior to dilution.
• After dilution, the vial should be held at 2°C to 25°C (35°F to 77°F). Vials should be discarded
12 hours after dilution.
Pfizer ages 12 and older vaccine (gray cap)

• Frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -
76°F). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should
not be refrozen.
• Vials may be transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed and stored for
up to 10 weeks. The 10-week refrigerated expiration date should be recorded on the carton at
the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.
Regardless of storage condition, vaccines should not be used after 9 months from the date of
manufacture printed on the vial and cartons.
Please email COVIDVax@health.nyc.gov with questions. Thank you for protecting the health of New
Yorkers.
Sincerely,
Jane R. Zucker, MD, MSc

Assistant Commissioner
Bureau of Immunization
COVID-19 Vaccination Program
Update : New Pfizer Vaccine
Formulation
Vaccine Operations Center
Bureau of Immunization
New York City Department of Health & Mental Hygiene
December 20, 2021
The information in this presentation is current as of the time of
presentation and subject to change.
Pfizer-BioNTech COVID-19 Vaccines
9 9

Pfizer Tris Sucrose Formulation - Gray Cap
(Comirnaty)
• Will replace the current Pfizer purple cap formulation
• Indicated for individuals 12 years of age and older
• Does not require dilution
• Available in smaller 300-dose packages

Vaccine Indications
• The Pfizer gray cap product can be used for:

o Two-dose primary series in individuals 12 years of age and older
o Third dose (additional dose) in individuals 12 years of age and older who have
been determined to be moderately or severely immunocompromised and
who completed a primary series with Pfizer-BioNTech COVID-19 Vaccine (or
Comirnaty)
o Single booster dose for individuals 16 years of age and older who completed a
primary series with Pfizer-BioNTech COVID-19 Vaccine (or Comirnaty)
o Single booster dose for individuals 18 years of age and older who completed
primary vaccination with a different FDA-authorized COVID-19 vaccine
(Moderna or Johnson&Johnson/Janssen)
Vaccine Indications (2)
• Under Emergency Use Instruction,* the Pfizer-gray cap can be used

for:
o Third dose (additional dose) to individuals 12 years of age and older who have
been determined to be moderately to severely immunocompromised and
who completed a primary series with a WHO-listed (non-FDA authorized or
approved) COVID-19 vaccine
o Single booster dose to individuals 16 years of age and older who have
completed primary vaccination with a WHO-listed (non-FDA authorized or
approved) COVID-19 vaccine
*CDC. COVID-19 Vaccine Emergency Use Instructions (EUI) Fact Sheet for Healthcare Providers. Available at: https://www.cdc.gov/vaccines/covid-
19/eui/index.html
Storage and Handling
• May be stored in an ultracold vaccine storage for up to 9 months after
the manufacture date and in a refrigerator at 2-8oC (36-46oF) for up to
10 weeks.
• The 10 weeks is within the 9 months after the manufacture date
• Cannot be stored in a regular freezer
• Pfizer thermal shippers cannot be used for temporary storage of this
product
• Once punctured, the vial must be discarded after 12 hours (the
packaging may indicate 6 hours, but this has been updated in the FDA
fact sheet)
The information in this presentation is current as of the time of presentation and subject to change.
Beyond Use Dates
• Label cartons and vials with beyond use dates
when vaccine is first placed in the ultracold
freezer or refrigerator
o Beyond Use Date labels Pfizer 12+
• If the Pfizer-gray cap vaccine is moved from
the ultracold freezer to the refrigerator, the
label needs to be updated with the date and
time and new beyond use date (up to 10
weeks)
• Vials should be relabeled when first
punctured
Vaccine Preparation and Administration
• Check expiration and beyond use dates before utilizing any vial
• Verify that the vial has a gray plastic cap and a label with a gray border
• Do not reconstitute/do not dilute
• Mix by inverting vaccine vial gently 10 times (do not shake)
• Label vial at time of first puncture – discard any unused vaccine 12 hours
after first puncture
• Administer 0.3 mL via intramuscular injection
o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL,
discard the vial and any excess vaccine – do not pool a dose from 2 separate vials

Vaccine Preparation and Administration (2)
FDA. Pfizer-BioNTech Fact Sheet for Healthcare Providers. Available at: https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
Staff Training
• Require and document staff training

o All clinical staff: screeners, vaccinators, site supervisors, clinical leads, head clinicians
o All vaccine management staff
o Include review of the up-to-date Fact Sheet for Healthcare Providers Administering
Vaccine
 Require review of Fact Sheets each time they are updated
o Include the CDC Training – Pfizer-BioNTech COVID-19 Vaccine: What Healthcare
Professionals Need to Know https://www2.cdc.gov/vaccines/ed/covid19/pfizer/index.asp
 Require training each time vaccine indications change
• Conduct a staff huddle at the start of every clinical shift
o Review key details of each vaccine being used: age, dose, dilution requirements, beyond
use timing
Storage, Handling and Administration Errors
• Report all storage, handling and administration errors to the NYC
Department of Health and Mental Hygiene
o Email: COVIDvax@health.nyc.gov
• For storage and handling errors, submit storage and administration

information to the manufacturer – ask for a written response on
viability of vaccine
• Report all vaccine administration errors (including those due to

improper storage and handling of vaccine) to VAERS
o https://vaers.hhs.gov/reportevent.html
Considerations for Inventory Management
• Providers should deplete their inventory and finish any remaining
Pfizer-purple cap before ordering the new 300 tray Pfizer gray cap
vaccine
• In order to avoid mistakes during this period of transition when both
products may be in circulation, these products should not be offered
or administered at the same time
• Providers with multiple vaccination sites should consider
consolidating all remaining Pfizer purple cap vaccine at a particular
site(s) during the transition or transitioning one site at a time

Pfizer-Gray Cap Ordering
• The CIR Online Registry will be updated on December 21,
2021
o300 minimum dose quantity
oSites will no longer be able to order Pfizer-purple cap
• The US government will retire the current Pfizer-purple cap
and transition to the Pfizer-gray cap on December 23 for
jurisdictions and federal entities

Reporting to the Citywide Immunization
Registry
• Providers should reach out to their electronic health record vendor
for guidance on adding the new gray cap vaccine codes
oCVX Code: 217
oNDC: 59267-1025-04
• Note there is no change to the Pfizer-orange cap (Pfizer vaccine for
ages 5 to 11)
oCVX Code: 218
oNDC: 59267-1055-04

Questions?
COVIDvax@health.nyc.gov


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NEW YORK CITY DEPARTMENT OF

HEALTH AND MENTAL HYGIENE

December 21, 2021

Printed Manufacturing Date 9-Month Expiration

Please follow EUA recommendations for storage:

Pfizer 5 to 11 years of age vaccine (orange cap)

Pfizer ages 12 and older vaccine (gray cap)

Jane R. Zucker, MD, MSc

The information in this presentation is current as of the time of

The information in this presentation is current as of the time of

• The Pfizer gray cap product can be used for:

• Under Emergency Use Instruction,* the Pfizer-gray cap can be used

The information in this presentation is current as of the time of

• Require and document staff training

• For storage and handling errors, submit storage and administration

• Report all vaccine administration errors (including those due to

The information in this presentation is current as of the time of

The information in this presentation is current as of the time of

The information in this presentation is current as of the time of

The information in this presentation is current as of the time of

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