01/24/2024 CS321570-AN 1

Updated (2023–2024 Formula) 

Pfizer-BioNTech COVID-19 Vaccine 

At-A-Glance

Guidance below summarizes basic storage, preparation, scheduling, administration, and dosage for all 2023–24 PfizerBioNTech COVID-19 Vaccine products.

Distributed in:

Ages: 6 months through 

4 years 

Multiple-dose vial: 

yellow cap and yellow label

Ages: 5 through 

11 years 

Single dose vial: 

blue cap and blue label

Ages: 12 years and older 

Single-dose vial: gray cap and gray label

Plastic Manufacturer-filled syringe 

Glass Manufacturer-filled syringe 

Storage and Handling

Find additional guidance on storing vaccine properly at:

 CDC Vaccine Storage and Handling Toolkit 

 Pfizer-BioNTech COVID-19 Vaccine | FDA

 Comirnaty | FDA

 Pfizer-BioNTech COVID-19 Vaccine | cvdvaccine.com

Ages 6 months through 

4 years

5 through 

11 years 12 years and older

Supplied in: 3-dose multiple-dose 

vial (MDV) Single-dose vial (SDV) Single-dose vial (SDV)

Plastic Manufacturerfilled syringe (MFS)Glass Manufacturerfilled syringe (MFS)

Cap and/or 

label color:

Yellow cap and 

yellow label

Blue cap and 

blue label

Gray cap and 

gray label N/A Carton with a pink stripe

Storage 

temperature 

before 

puncture 

or use after 

puncture

Between:

 -90°C and -60°C (-130°F and -76°F) until the expiration date

 2°C and 8°C (36°F and 46°F) for up to 10 weeks

 8°C and 25°C (46°F and 77°F) for up to 12 hours prior to the first puncture or use.

Do not store in a standard freezer

NOTE: The beyond-use date (10 weeks) replaces the manufacturer’s expiration date but 

NEVER extends it. Always use the earliest date. Do NOT use vaccine after the expiration date 

or beyond-use date.

Between 2°C and 8°C 

(36°F and 46°F) until 

the expiration date

Do not store in 

an ultra-cold or 

standard freezer

Total time out 

of refrigeration 

temperatures can 

not exceed 12 hours

Thawing 

frozen 

vaccine

Between:

 2°C and 8°C (36°F and 46°F) for up to 2 hours

OR 

 Up to 25°C (77°F) for 30 minutes

Between:

 2°C and 8°C (36°F 

and 46°F) for 2 

hours (preferred 

method)

OR 

 Up to 25°C (77°F) 

for 60 minutes 

Note: Individual 

syringes thawed at 

room temperature 

that are not used 

immediately must be 

used within 4 hours 

or discarded.

N/A
01/24/2024 CS321570-AN 2

Updated (2023–2024 Formula) 

Pfizer-BioNTech COVID-19 Vaccine 

At-A-Glance

Preparation and Administration Basics 

Find additional guidance on preparing and administering vaccine properly at: 

* A 5/8 inch needle may be used if administering the vaccine in the deltoid muscle AND the skin is stretched tightly and the subcutaneous tissue is not bunched for children and adolescents 

ages 1–18 years and adults ages 19 years and older who weigh less than 130 pounds.

† The deltoid muscle in the upper arm may be used if the muscle mass is adequate for children ages 1–2 years.

‡ The vastus lateralis muscle in the anterolateral thigh may be used as an alternate site.

§ See Vaccine Administration: Needle Gauge and Length chart for more details.

 Interim Clinical Considerations for Use of COVID-19 

Vaccines | CDC

 Vaccine Administration Resource Library | CDC

 Pfizer-BioNTech COVID-19 Vaccines | FDA

 Pfizer-BioNTech COVID-19 Vaccine | cvdvaccine.com

Preparation

 If the vaccine is frozen, thaw before use.

 Check the vial or syringe label to ensure the expiration 

date or BUD (if applicable) has not passed.

○ Use Pfizer-BioNTech expiration date tool at lotexpiry.

cvdvaccine.com 

 Product for ages 6 months through 4 years: mix with diluent.

○ Mix vial with 1.1 mL diluent. If using the MDV for the first 

time, record the date and time the vial was punctured. 

NOTE: The beyond-use time of 12 hours replaces the 

manufacturer’s expiration date but NEVER extends it. 

Always use the earliest date. Do NOT use vaccine after 

the expiration date or beyond-use time.

 Products for 5 and older : Do NOT dilute.

 Do NOT shake. If using an SDV, gently invert prior to 

withdrawing vaccine.

 Refer to package insert or EUA Fact Sheet for detailed 

instructions.

Administration

 COVID-19 vaccines may be administered at the same 

clinical visit as other routinely recommended vaccines.

Recipient’s Age Dosage Route Needle gauge 

and length Site 

6 months through 

4 years of age 0.3 mL/3 μg IM injection 22–25 gauge, 1”*

6 months–2 years of age: Vastus lateralis 

muscle in the anterolateral thigh†

2 through 4 years: Deltoid muscle in the 

upper arm‡

5 through 11 years 

of age 0.3 mL/10 μgL IM injection 22–25 gauge, 1"* Deltoid muscle in the upper arm‡

12 years of age 

and older 0.3 mL/30 μg IM injection 22–25 gauge, 1–1.5"*§ Deltoid muscle in the upper arm‡
01/24/2024 CS321570-AN 3

Updated (2023–2024 Formula) 

Pfizer-BioNTech COVID-19 Vaccine 

At-A-Glance

Scheduling Doses

The number of recommended 2023–24 COVID-19 vaccine 

doses varies by age, vaccine, vaccination history, and the 

presence of moderate or severe immune compromise. 

Review CDC's Interim Clinical Considerations for Use of 

COVID-19 Vaccines in the United States for detailed clinical 

guidance when scheduling doses, and the Interim COVID-19 

Immunization Schedule for summary information.

Contraindications, Precautions, and 

Post-Vaccination Observation

Screen for contraindications and precautions before 

administering EACH dose — even if the vaccine was 

previously administered. 

Contraindications

History of a severe allergic reaction (e.g., anaphylaxis) after a 

previous dose or to a component of the COVID-19 vaccine

Precautions

History of:

 A diagnosed non-severe allergy to a component of the 

COVID-19 vaccine

 Non-severe, immediate (onset less than 4 hours) allergic 

reaction after administration of a previous dose of one 

COVID-19 vaccine type, if receiving the same vaccine type 

 Moderate to severe acute illness, with or without fever

 Multisystem inflammatory syndrome in children (MIS-C) 

or adults (MIS-A)

 Myocarditis or pericarditis within 3 weeks after a dose of 

any COVID-19 vaccine

Consider observing persons after vaccination to monitor 

for allergic reactions and syncope:

 30 minutes for persons with:

○ A history of a non-severe, immediate (onset within 4 

hours) allergic reaction after a previous dose of one 

COVID-19 vaccine type, if receiving the same vaccine type

○ A history of a diagnosed non-severe allergy to a 

component of the COVID-19 vaccine, if receiving the 

same vaccine type 

 15 minutes: All other persons

Documentation

Document each recipient's vaccine administration 

information:

 Medical record: The vaccine and the date it was 

administered, manufacturer, lot number, vaccination site 

and route, name and title of the person administering 

the vaccine

 Vaccination record for recipient: Date of vaccination, 

product name/manufacturer, lot number, and name/

location of the administering clinic or health care 

professional 

 Immunization information system (IIS): Report the 

vaccination to the appropriate state/local IIS.

Report Adverse Events to the Vaccine Adverse 

Event Reporting System (VAERS)

 Adverse events that occur in a recipient following 

administration of any licensed or authorized COVID-19 

vaccine should be reported to VAERS, including: 

○ Vaccine administration errors, whether or not 

associated with an adverse event

○ Serious adverse events, irrespective of attribution to 

vaccination

○ Cases of Multisystem Inflammatory Syndrome (MIS) in 

adults and children

○ Cases of myocarditis

○ Cases of pericarditis

○ Cases of COVID-19 that result in hospitalization or 

death

Reporting is also encouraged for any other clinically 

significant adverse event, even if it is uncertain whether the 

vaccine caused the event. Information on how to submit a 

report to VAERS is available at https://vaers.hhs.gov or by 

calling 1-800-822-7967.