MINNESOTA DEPARTMENT OF HEALTH

Appendix A: Pfizer-BioNTech
COVID-19 Vaccine
12/1/2021

Read the full provider guide: Interim COVID-19 Vaccine Provider Guide
(www.health.state.mn.us/diseases/coronavirus/vaccine/guide.pdf).

This appendix contains information on both formulations of Pfizer COVID-19 vaccine. Please make
sure you are reading the correct section for the vaccine product you are using.

COVID-19 vaccine for people 12 years and older (purple cap)..................................................................... 2

COVID-19 vaccine for children 5 to 11 years (orange cap) ......................................................................... 14

Resources .................................................................................................................................................... 23

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APPENDIX A: COVID-19 VACCINE FOR PEOPLE 12 YEARS AND OLDER (PURPLE CAP)

COVID-19 vaccine for people 12 years and older

(purple cap)
Summary of Pfizer COVID-19 vaccine for people 12 years and older (purple cap)

Primary series Primary series Presentation/pre Storage and

Age indication Notes
dose/route schedule paration handling

Ultra-cold freezer
(-90°C to
-60°C/-130°F to
-76°F): until
expiration date.** Purple vial cap
Thermal shipper and label.
(-90°C to Recommended to
-60°C /-130°F to use the same
-76°F): up to 30 vaccine product
days from to complete the
delivery, if primary series
Multi-dose: 6 replenished with (and for an
doses per vial* dry ice upon additional dose
receipt and every for people with
Reconstitute with five days.
12 years and older 0.3 mL (30 µg) IM 0, 21 days diluent; diluent certain
ships separately Freezer immunocomprom
from vaccine. (-25⁰C to -15⁰C/ ising conditions, if
-13⁰F to 5⁰F): up indicated).
No preservative. to two weeks.
Use vaccine
Refrigerator*** within six hours
(2⁰C to 8°C/36°F once vial is
to 46°F): up to punctured.
one month. If not Cannot place
used, discard. thawed vaccine
Room back in freezer.
temperature***:
Thawed vials must
be reconstituted
within two hours.

*The Pfizer-BioNTech COVID-19 vaccine multi-dose contains six 0.3 milliliter (mL) doses. Refer to the
vaccine preparation section for more information.

**Regardless of storage condition, vaccine should not be used past the nine-month expiry (six months
printed on the vial plus additional three months).

***Once reconstituted (after first puncture), must use within six hours (discard unused vaccine).

Shipping
Ultra-cold vaccine will be shipped from the manufacturer in thermal shippers packed with dry ice. In
addition to vaccine, each site will receive ancillary kits. Each shipper will have a GPS-enabled
temperature monitoring device (logger) that the manufacturer uses to track the vaccine and monitor for
out-of-range temperatures.

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APPENDIX A: COVID-19 VACCINE FOR PEOPLE 12 YEARS AND OLDER (PURPLE CAP)

The thermal shipping container may be heavy and will vary in weight depending on the amount of
vaccine ordered. It is not recommended to transport vaccine in the shipping container to alternate sites.

Medium Ultra-Low Cold Thermal Shipper (ULT)

 Holds one to five cartons of 195 vial packs or 3 cartons of 25 vials.

 Can be used for temporary storage.

Upon thermal shipper arrival:

 Work in a well-ventilated area before opening the shipper and when working with dry ice.
 Never handle dry ice with bare hands. Wear waterproof insulated (cryogenic) gloves and safety
glasses with side shields or safety goggles to remove the dry ice pod from the shipper.
▪ Review the Dry Ice Safety Data Sheet included with the shipper. Read more on dry ice safety at
CDC: Pfizer-BioNTech COVID-19 Vaccine (www.cdc.gov/vaccines/covid-19/info-by-
product/pfizer/index.html).
▪ Dry ice disposal: Once you are done with the shipper, open the container and leave it at room
temperature in a well-ventilated area where the dry ice will change from a solid to a gas.
▪ Do not leave dry ice in an unsecured area.
▪ Do not place dry ice in a drain, flush down a toilet, or dispose in the trash.
▪ Do not place dry ice in a closed area.
 Follow the manufacturer’s instructions for unpacking and returning the shipper found at Pfizer:
Product Storage and Dry Ice (www.cvdvaccine-us.com/product-storage-and-dry-ice).

Vaccine presentations
Pfizer 1170-dose pack

The Pfizer-BioNTech vaccine for people 12 years and older (purple cap) comes in a 1170-dose pack. The
pack includes 195 multi-dose vials per tray. Ancillary kits for the 1170 packaging are configured with 20%
1.5-inch needles for adult patients and 80% 1-inch needles that may be used for adult and adolescent
patients.

Pfizer 450-dose packs

There are limited amounts of 450-dose packs (3 cartons with 25 vials each).

Vaccine storage options

Storing and handling ultra-cold COVID-19 vaccine correctly is very important. If the cold chain is not
properly maintained, vaccine may be damaged and unusable.

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APPENDIX A: COVID-19 VACCINE FOR PEOPLE 12 YEARS AND OLDER (PURPLE CAP)

Please note there are differences in storing the vaccine for people 12 years and older (purple cap) and
the vaccine for children 5 to 11 years (orange cap). Refer to the “COVID-19 vaccine for children 5 to 11
years (orange cap)” section for storing the vaccine for 5- to 11-year-olds.

Ultra-cold temperature freezer storage: Place vaccine in an ultra-cold temperature freezer where it is
stable at -90 to -60 degrees Celsius (-130 to -76 degrees Fahrenheit) until expiration. Cartons and vials of
Pfizer-BioNTech 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 authorized storage
conditions between -90 to -60 degrees Celsius (-130 to -76 degrees Fahrenheit) have been maintained.
The expiration date extension does not apply to vials dated July 2021 and earlier.

 Do not remove the vial out of ultra-cold freezer to change the expiration date. Label the tray with
the expanded date and then use the expanded expiration date to determine the 31-day beyond use
date (BUD) when moving to refrigerated temperatures.
 Ultra-cold temperatures in the shipper: If using the thermal shipper for temporary vaccine storage,
for up to 30 days, refer to the manufacturer instructions. Review Pfizer-BioNTech vaccine thermal
shipper materials at Pfizer: Vaccination Storage & Dry Ice Safety Handling (www.cvdvaccine-
us.com/product-storage-and-dry-ice).
 Vaccine freezer storage: Upon receiving the shipper, unpack the vaccine and place in a freezer that
is maintaining temperatures at -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit) for up to two
weeks (14 days); cumulative time at this temperature. Place a note on your calendar, or a large note
on the freezer, to ensure awareness of the date the vaccine was moved to freezer temperatures.
The vaccine may be returned one time to ultra-cold temperatures. The vaccine can be moved to the
refrigerator anytime within 14 days and used within one month. Do not refreeze. Vaccine storage
with this option would be up to 14 days at freezer temperatures, then up to one month in the
refrigerator. Discard vaccine if not used within storage timelines.
 Refrigerator storage: Immediately place vaccine in the refrigerator and store the undiluted vials at 2
to 8 degrees Celsius (36 to 46 degrees Fahrenheit) for up to one month. Discard vaccine if not used
within storage timeline.
▪ BUD: with the extended expiration date for Pfizer, vaccine that has been stored at ultra-cold or
freezer temperatures and recently moved to the refrigerator can be used through the BUD date.
So, vaccine that was moved to the fridge on Aug. 15, 2021 and has an expiration date of Aug. 31,
2021 can be used through Sept. 15, 2021, instead of discarding it on Aug. 31, 2021.
 Total storage time for undiluted Pfizer vials stored in the freezer and then moved to the refrigerator
should not exceed 45 days.

Temperature monitoring and documentation

When storing Pfizer-BioNTech vaccine in an ultra-cold storage unit, monitor the vaccine using a
continuous temperature monitoring device that can read ultra-cold temperatures.

If you are using the thermal shipper, you must use a continuous temperature monitoring device to
ensure the temperature in the thermal shipping container is stable. If you do not have an on-site

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APPENDIX A: COVID-19 VACCINE FOR PEOPLE 12 YEARS AND OLDER (PURPLE CAP)

monitor, reactivate and use the Controlant real-time monitor that came with the thermal shipper by
contacting Controlant customer service at 701-540-4039.

For all other storage situations, use a continuous temperature monitoring device (e.g., digital data
logger) to monitor vaccine. Learn more at COVID-19 Vaccine Temperature Monitoring Devices
(www.health.state.mn.us/diseases/coronavirus/vaccine/devices.pdf). Remember to deactivate the
Controlant real-time monitor from the shipper.

At the start of each workday:

 Document minimum (lowest) and maximum (highest) temperature in storage unit

 Record date, time, and staff name or initials
 Document electronically or on a paper log (keep temperature documentation for three years)
▪ CDC has temperature logs available to download at Pfizer-BioNTech COVID-19 Vaccine
(www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html).

If the temperature goes out of range, take action immediately. Do not use the vaccine until the
manufacturer is contacted about the viability of the vaccine. Refer to the Managing out-of-range
temperatures (excursions) section in the provider guide.

Vaccine recommendations for Pfizer-BioNTech COVID-19 vaccine for

people 12 years and older (purple cap)
 Pfizer BioNTech COVID-19 vaccine (purple cap) is a two-dose series administered three weeks apart
(days 0 and 21) for ages 12 years and older.
▪ Every attempt should be made to schedule the person to return on day 21 or shortly thereafter
for their second dose. Schedule the appointment for the second dose when the person receives
their first dose.
▪ The second dose of Pfizer-BioNTech vaccine should be administered as close to the three-week
recommended interval as possible, but not earlier. However, people who receive the second
dose up to four days before, or at any time after the recommended date can be considered fully
vaccinated. Administering the second dose early should not be a routine practice.
▪ If vaccine administration occurs before day 17, the dose is invalid and must be repeated.
Complete a Vaccine Adverse Event Reporting System (VAERS) report to report the error and
refer to CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendix A. Vaccine
administration errors and deviations (www.cdc.gov/vaccines/covid-19/clinical-
considerations/covid-19-vaccines-us.html#Appendix-A).
▪ There is no maximum interval. CDC does not recommend restarting the series or giving
additional doses if the interval is greater than six weeks.
▪ For primary series and additional doses (if indicated), it is recommended to use the same
vaccine product. If two doses of different mRNA COVID-19 products are administered, no
additional doses of either vaccine are recommended at this time. Such people are considered
fully vaccinated against COVID-19 at least 2 weeks after receipt of the second dose.

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APPENDIX A: COVID-19 VACCINE FOR PEOPLE 12 YEARS AND OLDER (PURPLE CAP)

 Coadministration of COVID-19 vaccines and other vaccines: Refer to CDC’s interim clinical
considerations (link at the end of this section).

Additional dose for people with certain immunocompromising conditions

As of Aug. 13, 2021, ACIP recommended that people 12 years of age and older with moderately and
severely immunocompromising conditions should receive an additional dose of mRNA COVID-19
vaccine as part of their primary series.

 The additional dose should be of the same mRNA COVID-19 vaccine product received initially and
administered at least 28 days after completion of the initial two-dose series. If the mRNA COVID-19
vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine
product may be administered.
 Additional information, including more specific details about moderate and severe
immunocompromising conditions and people who received COVID-19 vaccine outside of the United
States or as part of a clinical trial, is published in CDC’s interim clinical considerations (link at the end
of this section).
 People who are immunocompromised (including people who receive an additional mRNA COVID-19
vaccine dose after an initial two-dose primary mRNA COVID-19 vaccine series) should be counseled
about the potential for a reduced immune response to COVID-19 vaccines and the need to continue
to follow current prevention measures to protect themselves against COVID-19 until advised
otherwise by their health care provider.

Booster dose

All persons age 18 years and older should receive a booster dose of COVID-19 vaccine (Table 2 below).
Currently, CDC does not recommend a booster dose in children age 5-17 years. As more data become
available, this recommendation may be updated. The CDC interim clinical considerations sections on
Considerations for COVID-19 vaccination in moderately or severely immunocompromised
people, People who received COVID-19 vaccine outside the United States, and People who received
COVID-19 vaccine as part of a clinical trial should be consulted for booster dose recommendations in
these groups.

Any of the COVID-19 vaccines can be used for booster vaccination, regardless of the vaccine product
used for primary vaccination. Pregnant people can receive any of the FDA-approved or FDA-authorized
COVID-19 vaccines as a booster dose. Individual benefit-risk assessment considerations for selecting
which booster dose can be found in CDC’s interim clinical considerations (link at the end of this section).

When a heterologous, or “mix and match,” booster dose is administered, the eligible population and
dosing intervals are those of the vaccine used for primary vaccination. If the person received an mRNA
vaccine (Pfizer-BioNTech or Moderna) for their primary series, a booster dose can be given at least 6
months after the completion of the primary series. If the person received the Janssen vaccine for their
primary series, a booster dose can be given at least 2 months (eight weeks) after the completion of the
primary series.

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The booster dose and volume are the same regardless of whether the dose is homologous (same as
primary series) or heterologous (different than primary series).

TABLE 2. COVID-19 vaccines: booster dose

Vaccine manufacturer Booster dose Booster volume
Pfizer-BioNTech 30 µg 0.3 mL
Moderna* 50 µg 0.25 mL
Janssen 5×1010 viral particles 0.5 mL

*Note: the booster dose for Moderna vaccine is half the original dose; 0.25 mL instead of 0.5 mL.

Vaccinators should check a person’s age, what vaccine they received for their primary series, and the
correct dose interval for that product, before administering a booster dose. This information can be
verified by checking the Minnesota Immunization Information Center (MIIC). After giving a booster dose,
make sure to update the patient’s vaccine card if they brought it, or give them a new one reflecting all
doses of COVID-19 vaccine they have received.

Find the full listing of vaccine recommendations, at CDC: Interim Clinical Considerations for Use of
COVID-19 Vaccines Currently Authorized in the United States (www.cdc.gov/vaccines/covid-
19/clinical-considerations/covid-19-vaccines-us.html).

Contraindications and precautions

CDC considers a history of the following to be a contraindication to vaccination with COVID-19 vaccines:

 Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19
vaccine.
 Immediate allergic reaction of any severity to a previous dose or known (diagnosed) allergy to a
component of the vaccine (an immediate allergic reaction to a vaccine or medication is defined as
any hypersensitivity-related signs or symptoms such as urticaria; angioedema; respiratory distress
(e.g., wheezing, stridor); or anaphylaxis that occur within four hours following administration.)

The full listing of contraindications and precautions are at CDC: Interim Clinical Considerations for Use
of COVID-19 Vaccines Currently Authorized in the United States: Contraindications and precautions
(www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-
us.html#Contraindications).

Ingredient listing for Pfizer-BioNTech BNT162b2 COVID-19 vaccine for people 12 years and
older
 Lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
 0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide
 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol)

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▪ 0.01 mg potassium chloride

▪ 0.01 mg monobasic potassium phosphate
 0.36 mg sodium chloride
 0.07 mg dibasic sodium phosphate dihydrate
 6 mg sucrose

More information:

 Diluent: 0.9% sodium chloride injection, USP.

 The Pfizer-BioNTech COVID-19 vaccine does not contain preservative.
 The vial stoppers are not made with natural rubber latex.

Taken from the full Emergency Use Authorization (EUA) prescribing information Pfizer-BioNTech COVID-19 vaccine found in
Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers (www.fda.gov/media/144413/download).

Appropriate medical treatment used to manage immediate allergic reactions (e.g., epinephrine)
must be immediately available in the event an acute anaphylactic reaction occurs following
administration of the vaccine.

Warnings

Myocarditis and pericarditis: Ongoing safety monitoring of the mRNA COVID-19 vaccines (Pfizer or
Moderna) has found increased risks of myocarditis and pericarditis, particularly following the second
dose, predominantly in male adolescents and young adults 16 years of age and older. Typically, onset of
symptoms has been within a few days following receipt of the mRNA COVID-19 vaccines. Available data
from short-term follow-up suggest that most people have had resolution of symptoms, but information
is not yet available about potential long-term effects. CDC continues to recommend COVID-19
vaccination for everyone 5 years of age and older given the risk of COVID-19 illness and related, possibly
severe complications, such as long-term health problems, hospitalization, and even death.

Clinicians should consult the CDC: Clinical Considerations: Myocarditis and Pericarditis after Receipt of
mRNA COVID-19 Vaccines Among Adolescents and Young Adults (www.cdc.gov/vaccines/covid-
19/clinical-considerations/myocarditis.html) when deciding whether to administer an mRNA COVID-19
vaccine to someone with a history of myocarditis or pericarditis or when a patient presents with
symptoms of myocarditis or pericarditis.

It is critical to educate providers and patients (Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for
Recipients and Caregivers [www.fda.gov/media/144414/download]) about this warning to ensure that
all recipients, especially male adolescents and young adults, are aware of the increased risk for
myocarditis after receipt of the Pfizer COVID-19 vaccine.

Recipients of Pfizer COVID-19 vaccine should be instructed to seek immediate medical attention if they
develop chest pain, shortness of breath, and/or feelings of having a fast-beating, fluttering, or pounding
heart.

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Find updated FDA EUA fact sheets for health care providers at Comirnaty and Pfizer-BioNTech COVID-19
Vaccine (www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-
19/pfizer-biontech-covid-19-vaccine).

Altered immunocompetence: Immunocompromised people, including those receiving

immunosuppressive therapy, may have a diminished response to Pfizer-BioNTech COVID-19 vaccine. The
Pfizer-BioNTech COVID-19 vaccine may not protect all vaccine recipients.

Syncope (fainting) may occur in association with administration of injectable vaccines, particularly in
adolescents. Procedures should be in place to avoid injury from fainting.

Adverse reactions (side effects)

Adverse reactions following the Pfizer-BioNTech COVID-19 vaccine that have been reported in clinical
trials include injection site pain, redness and/or swelling; fatigue (tired); headache; muscle pain; chills;
joint pain; fever; nausea; malaise; and lymphadenopathy (swollen glands); decreased appetite; rash; and
pain in extremity.

Severe allergic reactions, including anaphylaxis and other hypersensitivity reactions (e.g., rash, pruritis,
urticaria, angioedema), diarrhea, vomiting, and pain in extremity (arm) and syncope have been reported
following administration of the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials.

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-
19 vaccine outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more
widespread use of the Pfizer-BioNTech COVID-19 vaccine.

This information is taken from the full Emergency Use Authorization (EUA) prescribing information for Pfizer-BioNTech COVID-
19 vaccine, found in Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers for 12 years of age and older,
purple cap (must dilute) (www.fda.gov/media/153713/download).

Vaccine preparation
Thawing vials

If you are storing your vaccine in the ultra-low cold freezer, it is important to plan how to thaw your vials
and administer vaccine to avoid wasting vaccine. Before taking vaccine out of the ultra-cold temperature
storage unit or thermal shipper, ensure you will have the correct quantities to vaccinate your
population. Once the vaccine has thawed it cannot be refrozen.

 Plan your day: You need one multi-dose vial for every six people.
▪ If less than a full tray is needed, remove the number of vials needed from the tray as quickly as
possible and return the tray to frozen storage.
▪ Trays should not be exposed to room temperature for more than a few minutes, as the vials can
thaw very quickly.

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 Thawed or reconstituted vaccine can be handled in normal room light. Avoid exposure to direct
sunlight or ultraviolet light.
 Gloves allowing manual dexterity should be worn while handling frozen vials (i.e., unsterile gloves in
the correct size). It is not necessary to use insulated (cryogenic) gloves to handle vials.

Thawing methods for Pfizer-BioNTech COVID-19 vaccine:

 Vials can be thawed in the refrigerator. Transfer frozen vials directly to a refrigerator at 2 to 8
degrees Celsius (36 to 46 degrees Fahrenheit). It may take up to two to three hours for a carton of
25 or 195 vials to thaw. A smaller number of vials may thaw more quickly.
▪ Vials may be stored in the refrigerator prior to reconstitution (dilution) for up to one month for
the adult/adolescent vaccine. If the vaccine is not used within these time frames, it must be
discarded.
 Vials needed for immediate use can be removed directly from frozen storage and thawed at room
temperature (up to 25 degrees Celsius or 77 degrees Fahrenheit) for 30 minutes prior to
reconstitution. Vials need to be reconstituted within 2 hours at room temperature.
 Using either thawing method, vials must reach room temperature before reconstitution and must
be reconstituted within two hours. Do not place thawed vaccine back into an ultra-cold temperature
storage unit, a freezer unit, or the thermal shipper.

Diluent

As with other vaccines that require reconstitution, this vaccine must use only the diluent specified by
the manufacturer. Diluent will be provided in the mixing kit (along with syringes, needles, and other
needed supplies). Store diluent at room temperature.

Reconstitute each thawed vial with exactly the dosage of 0.9% Sodium Chloride Injection, USP
recommended for each vaccine product.

 Use 1.8 milliliters of diluent for each vial.

 DO NOT use bacteriostatic normal saline or any other diluents.
 DO NOT use or save the remaining vaccine diluent to mix additional vaccine or for other uses.
 The optimal diluent vial size is 2 milliliters of 0.9% sodium chloride injection.
▪ IMPORTANT: If using a larger volume single-use vial of 0.9% sodium chloride injection, you can
use it only once for reconstitution (i.e., after removing the correct dosage, discard remaining
diluent).

Reconstitution steps

When reconstituting vaccine, use an aseptic technique to prevent contamination (e.g., hand hygiene,
etc.). On-site reconstitution is required. Reconstitute vaccine just prior to administration.

To reconstitute thawed Pfizer-BioNTech vaccine:

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 Invert the vial gently 10 times to mix. Do not shake!

 Clean the top of the 0.9% sodium chloride vial with a single-use alcohol swab.
 Draw up 1.8 milliliters of diluent with a 3 milliliter or 5 milliliter syringe using a 21 gauge or narrower
needle.
 Clean the top of the thawed Pfizer BioNTech vaccine vial with a single-use alcohol swab.
 Add the 0.9% sodium chloride drawn up into the vaccine vial.

Photo from Pfizer-BioNTech

 Before removing the needle from the vial, equalize pressure in the vial by withdrawing 1.8 milliliters
of air into the empty diluent syringe.

Photo from Pfizer-BioNTech

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 Remove needle/syringe from the vial, invert the vial, and gently mix 10 times. Do not shake! Vaccine
will be an off-white suspension. There should be no particulates or discoloration.

Photo from Pfizer-BioNTech

 Record date and time of reconstitution on the Pfizer-BioNTech COVID-19 vaccine label.

Photo from Pfizer-BioNTech

 Store reconstituted vaccine at 2 to 25 degrees Celsius (35 to 77 degrees Fahrenheit) and use within
six hours.
 Once the multi-dose vial has been reconstituted, you must discard it after six hours, even if all
doses have not been administered.
▪ Important: Administering this vaccine after six hours of being reconstituted may cause harm, as
it poses a risk of bacterial infection.

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Preparing individual doses

Follow strict aseptic technique when preparing the vaccine dose for administration.

 Gather ancillary kit supplies. Use low dead-volume syringes and/or needles to withdraw six doses.
Refer to Pfizer’s Low Dead-Volume (LDV) Syringes and/or Needles Guide (https://www.cvdvaccine-
us.com/images/pdf/Low-Dead-Volume-Syringe-Brochure.pdf).
▪ Refer to Pfizer-BioNTech COVID-19 Vaccine: Vaccine Preparation (www.cdc.gov/vaccines/covid-
19/info-by-product/pfizer/downloads/diluent-poster.pdf) for “do’s and don’ts” when mixing
vaccine and withdrawing six doses of vaccine from the vial.
 Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw
0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume syringe
and/or needle.

Photo from Pfizer-BioNTech

 When withdrawing additional doses from the same vial, clean the vial stopper each time with a new
single-use sterile alcohol swab. Insert the needle into a different place on the vial stopper. Do NOT
use the same insertion point every time or the vial may leak.
 Since there is no preservative in the Pfizer-BioNTech multi-dose vial, discard the vial when there is
not enough vaccine to obtain a complete dose. Do not "pool" or combine residual vaccine from
multiple vials to obtain a dose.

Administration
Follow strict aseptic technique when administering vaccine.

 Before administering the vaccine, inspect each dose in the dosing syringe. Reconstituted vaccine will
be in an off-white suspension.
▪ Verify final dosing volume of 0.3 milliliters.
▪ Confirm the vaccine in the syringe has no particulates and is not discolored.
 Administer immediately.

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 APPENDIX A: COVID-19 VACCINE FOR CHILDREN 5 TO 11 YEARS (ORANGE CAP)

COVID-19 vaccine for children 5 to 11 years

(orange cap)
Summary of Pfizer COVID-19 vaccine for children 5 to 11 years (orange cap)

Primary series Primary series Presentation/pre Storage and

Age indication Notes
dose/route schedule paration handling

Ultra-cold freezer
(-90°C to Orange vial cap
-60°C/-130°F to - and label.
76°F): for up to 6 Recommended to
months from date
of manufacture use the same
Multi-dose: 10 vaccine product
printed on the to complete the
doses per vial** carton/vial.
primary series.
Reconstitute with Refrigerator**
Use vaccine
5 to 11 years 0.2 mL (10 µg)* IM 0, 21 days diluent; diluent (2⁰C to 8°C/36°F to within 12 hours
ships separately 46°F): up to ten
from vaccine. weeks. If not used, once vial is
punctured.
discard.
No preservative. Once thawed, do
Room
temperature***: not refreeze.
Thawed vials must Cannot be stored
be reconstituted or in the regular
refrigerated within freezer.
12 hours.

*The vaccine for 12 years and older (purple cap) cannot be used to prepare doses for children 5 to 11
years.

**The Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years multi-dose contains ten 0.2
milliliter (mL) doses. Refer to the vaccine preparation section for more information.

***Once reconstituted (after first puncture), must use within twelve hours (discard unused vaccine).

Shipping
Ultra-cold vaccine will be shipped from the manufacturer in thermal shippers packed with dry ice. Each
shipper will have a GPS-enabled temperature monitoring device (logger) that the manufacturer uses to
track the vaccine and monitor for out-of-range temperatures. In addition to vaccine, each site will
receive ancillary kits.

The Pfizer 5- to 11-year-old vaccine (orange cap) comes in a new, single-use thermal shipping container.
These thermal shipping containers have less dry ice and are lighter than the original thermal shippers.
The single use shippers cannot be used to store vaccine or transport vaccine to alternate sites.

Upon thermal shipper arrival:

 Work in a well-ventilated area before opening the shipper and when working with dry ice.

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 Never handle dry ice with bare hands. Wear waterproof insulated (cryogenic) gloves and safety
glasses with side shields or safety goggles to remove the dry ice pod from the shipper.
▪ Review the Dry Ice Safety Data Sheet included with the shipper. Read more on dry ice safety at
CDC: Pfizer-BioNTech COVID-19 Vaccine (www.cdc.gov/vaccines/covid-19/info-by-
product/pfizer/index.html).
▪ Dry ice disposal: Once you are done with the shipper, open the container and leave it at room
temperature in a well-ventilated area where the dry ice will change from a solid to a gas.
▪ Do not leave dry ice in an unsecured area.
▪ Do not place dry ice in a drain, flush down a toilet, or dispose in the trash.
▪ Do not place dry ice in a closed area.
 Follow the manufacturer’s instructions for unpacking and returning the shipper found at Pfizer:
Product Storage and Dry Ice (www.cvdvaccine-us.com/product-storage-and-dry-ice).

Vaccine presentations
Pfizer 100-dose cartons

The Pfizer-BioNTech vaccine for children 5 to 11 years (orange cap) comes in a 100-dose carton. The
carton includes ten 10-dose multi-dose vials. Ancillary kits for the pediatric 100-dose cartons are
configured with 100% 1-inch needles that may be used for pediatric patients.

Vaccine storage options

Storing and handling ultra-cold COVID-19 vaccine correctly is very important. If the cold chain is not
properly maintained, vaccine may be damaged and unusable.

Please note there are differences in storing the vaccine for children 5 to 11 years (orange cap) and for
people 12 years and older (purple cap) and the vaccine. Refer to the “COVID-19 vaccine for people 12
years and older (purple cap)” section for storing the vaccine for people 12 years and older.

 Ultra-cold temperature freezer storage: Place vaccine in an ultra-cold temperature freezer where it
is stable at -90 to -60 degrees Celsius (-130 to -76 degrees Fahrenheit) for 6 months from the date of
manufacture printed on the vial and cartons.
 Refrigerator storage: Immediately place vaccine in the refrigerator and store the undiluted vials at 2
to 8 degrees Celsius (36 to 46 degrees Fahrenheit) for up to ten weeks. Discard vaccine if not used
within storage timeline. Be sure to label vaccine that is put in the refrigerator with the 10-week
beyond use date (BUD). Vaccine should be used or discarded by the 10-week BUD or expiration date
whichever comes first.
 Never store the 5–11-year vaccine (orange cap) in the freezer.

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Temperature monitoring and documentation

For all storage situations, use a continuous temperature monitoring device (e.g., digital data logger) to
monitor vaccine. When storing Pfizer-BioNTech vaccine in an ultra-cold storage unit, monitor the
vaccine using a continuous temperature monitoring device that can read ultra-cold temperatures.

Learn more at COVID-19 Vaccine Temperature Monitoring Devices

(www.health.state.mn.us/diseases/coronavirus/vaccine/devices.pdf). Remember to deactivate the
Controlant real-time monitor from the shipper.

At the start of each workday:

 Document minimum (lowest) and maximum (highest) temperature in storage unit

 Record date, time, and staff name or initials
 Document electronically or on a paper log (keep temperature documentation for three years)
▪ CDC has temperature logs available to download at Pfizer-BioNTech COVID-19 Vaccine
(www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html).

If the temperature goes out of range, take action immediately. Do not use the vaccine until the
manufacturer is contacted about the viability of the vaccine. Refer to the Managing out-of-range
temperatures (excursions) section in the provider guide.

Vaccine recommendations for Pfizer-BioNTech COVID-19 vaccine for

5- to 11-year-olds (orange cap)
 Pfizer BioNTech COVID-19 vaccine for 5-to 11-year-olds (orange cap) is a two-dose series
administered three weeks apart (days 0 and 21).
▪ Every attempt should be made to schedule the person to return on day 21 or shortly thereafter
for their second dose. Schedule the appointment for the second dose when the person receives
their first dose.
▪ The second dose of Pfizer-BioNTech vaccine should be administered as close to the three-week
recommended interval as possible, but not earlier. However, people who receive the second
dose up to four days before, or at any time after the recommended date can be considered fully
vaccinated.
▪ If vaccine administration occurs before day 17 the dose is invalid and must be repeated.
Complete a Vaccine Adverse Event Reporting System (VAERS) report to report the error and
refer to CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendix A. Vaccine
administration errors and deviations (www.cdc.gov/vaccines/covid-19/clinical-
considerations/covid-19-vaccines-us.html#Appendix-A).
▪ There is no maximum interval. CDC does not recommend restarting the series or giving
additional doses if the interval is greater than six weeks.
▪ Children should receive the vaccine dosage and formulation based on their age on the day of
vaccination with each dose, regardless of their size or weight. Children who will turn 12 years of

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age between their first and second dose in the primary regimen may receive, for either dose,
either the Pfizer-BioNTech COVID-19 vaccine formulation authorized for use in individuals 5
through 11 years of age (each 0.2 mL dose containing 10 mcg in an orange cap vial); or the
Pfizer-BioNTech COVID-19 Vaccine formulations authorized for use in individuals 12 years of age
and older (each 0.3 mL dose containing 30 mcg in a purple cap vial).
▪ CDC does not recommend restarting the series if the interval is greater than six weeks.
 Coadministration of COVID-19 vaccines and other vaccines: Refer to CDC’s interim clinical
considerations (link at the end of this section).

Contraindications and precautions

CDC considers a history of the following to be a contraindication to vaccination with COVID-19 vaccines:

 Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19
vaccine.

The full listing of contraindications and precautions are at CDC: Interim Clinical Considerations for Use
of COVID-19 Vaccines Currently Authorized in the United States: Contraindications and precautions
(www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-
us.html#Contraindications).

Ingredient listing for Pfizer-BioNTech BNT162b2 COVID-19 vaccine for children 5 to 11 years

Each dose of the Pfizer-BioNTech BNT162b2 5- to 11-year-old COVID-19 vaccine (orange cap) includes
the following ingredients:

Vaccine for children 5 to 11 years

 lipids (0.14 mg (4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
 0.02 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide
 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine 0.06 mg cholesterol)
 10.3 mg sucrose
 0.02 mg tromethamine
 0.13 mg tromethamine hydrochloride

More information:

 Diluent: 0.9% sodium chloride injection, USP.

 Buffer: this formulation uses a tris-sucrose buffer which allows a lower concentration of mRNA for
10 mcg dosing. Only the 10 µg tris-sucrose buffer formulation (orange cap) is authorized for use in
children aged 5–11 years.
 The Pfizer-BioNTech COVID-19 vaccine does not contain preservative.

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 The vial stoppers are not made with natural rubber latex.

Taken from the full Emergency Use Authorization (EUA) prescribing information Pfizer-BioNTech COVID-19 vaccine found in
Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers for 5-11 years of age, orange cap, (must dilute)
(www.fda.gov/media/153714/download).

Appropriate medical treatment used to manage immediate allergic reactions (e.g., epinephrine)
must be immediately available in the event an acute anaphylactic reaction occurs following
administration of the vaccine.

Warnings

Myocarditis and pericarditis: Myocarditis is a rare, serious adverse event that has been reported after
receipt of the second dose of mRNA COVID-19 vaccines, with the highest risk currently observed in
males aged 12–29 years. FDA has authorized and ACIP and CDC have recommended Pfizer-BioNTech
vaccines in children aged 5–11 years and adolescents aged 12–17 years based on the determination that
the benefits of COVID-19 vaccination outweigh risks in these populations. More information on
myocarditis and COVID-19 vaccination can be found at CDC: Interim Clinical Considerations for Use of
COVID-19 Vaccines: Considerations for mRNA COVID-19 vaccines: Pfizer-BioNTech and Moderna
(www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#considerations-
pfizer-biontech-moderna) under “Myocarditis and pericarditis.”

Altered immunocompetence: Immunocompromised people, including those receiving

immunosuppressive therapy, may have a diminished response to Pfizer-BioNTech COVID-19 vaccine. The
Pfizer-BioNTech COVID-19 vaccine may not protect all vaccine recipients.

Syncope (fainting) may occur in association with administration of injectable vaccines, particularly in
adolescents. Procedures should be in place to avoid injury from fainting.

Adverse reactions (side effects)

Adverse reactions following the Pfizer-BioNTech COVID-19 vaccine that have been reported in clinical
trials include injection site pain, redness and/or swelling; fatigue (tired); headache; muscle pain; chills;
joint pain; fever; nausea; malaise; and lymphadenopathy (swollen glands); decreased appetite; and rash.

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-
19 Vaccine outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more
widespread use of the Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years (orange cap).

(EUA) prescribing information for Pfizer-BioNTech COVID-19 vaccine, found in Pfizer-BioNTech COVID-19 Vaccine EUA Fact
Sheet for Healthcare Providers for 5-11 years of age, orange cap, (must dilute) (www.fda.gov/media/153714/download).

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Vaccine preparation
Thawing vials

It is important to plan how to thaw your vials and administer vaccine to avoid wasting vaccine. Before
taking vaccine out of the ultra-cold temperature storage unit, ensure you will have the correct quantities
to vaccinate your population. Once the ultra-cold vaccine is removed from ultra-cold temperature
storage (either to the refrigerator or to room temperature), it must be used within a certain amount of
time and cannot be returned to ultra-cold storage once thawed. Follow these instructions:

 Plan your day to avoid wastage: You need one multi-dose vial for every ten children. There are ten
vials in each carton.
 Thawed or reconstituted vaccine can be handled in normal room light. Avoid exposure to direct
sunlight or ultraviolet light.
 Gloves allowing manual dexterity should be worn while handling frozen vials (i.e., unsterile gloves in
the correct size). It is not necessary to use insulated (cryogenic) gloves to handle vials.

Thawing methods for Pfizer-BioNTech COVID-19 vaccine:

 Transfer frozen vials immediately to a refrigerator at 2 to 8 degrees Celsius (36 to 46 degrees

Fahrenheit). It may take up to four hours for a carton of 10 vials to thaw.
▪ Vials may be stored in the refrigerator prior to reconstitution (dilution) for up to one month for
the adult/adolescent vaccine (purple cap) and up to 10 weeks for the 5–11-year-old vaccine
(orange cap). If the vaccine is not used within these time frames, it must be discarded.
 Vials needed for immediate use can be removed directly from ultra-cold storage and thawed at
room temperature (up to 25 degrees Celsius or 77 degrees Fahrenheit) for 30 minutes prior to
reconstitution.
 Using either thawing method, vials must reach room temperature before reconstitution and must
be reconstituted within twelve hours. Do not place thawed vaccine back into an ultra-cold
temperature storage unit.

Diluent

As with other vaccines that require reconstitution, this vaccine must use only the diluent specified by
the manufacturer. Diluent will be provided in the mixing kit (along with syringes, needles, and other
needed supplies). Store diluent at room temperature.

Reconstitute each thawed vial with exactly the dosage of 0.9% Sodium Chloride Injection, USP
recommended for each vaccine product.

 Vaccine for children 5 to 11 years (orange cap): use 1.3 milliliters of diluent.
 DO NOT use bacteriostatic normal saline or any other diluents.
 DO NOT use or save the remaining vaccine diluent to mix additional vaccine or for other uses.

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 The optimal diluent vial size is 2 milliliters of 0.9% sodium chloride injection.
▪ IMPORTANT: If using a larger volume single-use vial of 0.9% sodium chloride injection, you can
use it only once for reconstitution (i.e., after removing the correct dosage, discard remaining
diluent).

Reconstitution steps

When reconstituting vaccine, use an aseptic technique to prevent contamination (e.g., hand hygiene,
etc.). On-site reconstitution is required. Reconstitute vaccine just prior to administration.

To reconstitute thawed Pfizer-BioNTech vaccine:

 Invert the vial gently 10 times to mix. Do not shake!

 Clean the top of the 0.9% sodium chloride vial with a single-use alcohol swab.
 Draw up 1.3 milliliters for the vaccine for children 5 to 11 years (orange cap) with a 3 milliliter or 5
milliliter syringe using a 21 gauge or narrower needle.
 Clean the top of the thawed Pfizer BioNTech vaccine vial with a single-use alcohol swab.
 Add the 0.9% sodium chloride drawn up into the vaccine vial.

Photo from Pfizer-BioNTech

 Before removing the needle from the vial, equalize pressure in the vial by withdrawing 1.3 milliliters
of air into the empty diluent syringe.

Photo from Pfizer-BioNTech

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 Remove needle/syringe from the vial, invert the vial, and gently mix 10 times. Do not shake! Vaccine
will be an off-white suspension. There should be no particulates or discoloration.

Photo from Pfizer-BioNTech

 Record date and time of reconstitution on the Pfizer-BioNTech COVID-19 vaccine label.

Photo from Pfizer-BioNTech

 Store reconstituted vaccine at 2 to 25 degrees Celsius (35 to 77 degrees Fahrenheit) and use within
12 hours. The storage recommendations listed in the EUA fact sheet for health care providers
supersedes what is printed on vial labels and cartons.
 Once the multi-dose vial has been reconstituted, you must discard it after 12 hours, even if all
doses have not been administered.
▪ Important: Administering this vaccine after 12 hours of being reconstituted may cause harm, as
it poses a risk of bacterial infection.

Preparing individual doses

Follow strict aseptic technique when preparing the vaccine dose for administration.

 Gather ancillary kit supplies. Use low dead-volume syringes and/or needles to withdraw ten doses.
▪ Refer to Pfizer-BioNTech COVID-19 Vaccine: Vaccine Preparation (www.cdc.gov/vaccines/covid-
19/info-by-product/pfizer/downloads/diluent-poster.pdf) for “do’s and don’ts” when mixing
vaccine and withdrawing six doses of vaccine from the vial.

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 Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw
0.2 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume syringe
and/or needle.

Photo from Pfizer-BioNTech

 When withdrawing additional doses from the same vial, clean the vial stopper each time with a new
single-use sterile alcohol swab. Insert the needle into a different place on the vial stopper. Do NOT
use the same insertion point every time or the vial may leak.
 Since there is no preservative in the Pfizer-BioNTech multi-dose vial, discard the vial when there is
not enough vaccine to obtain a complete dose. Do not "pool" or combine residual vaccine from
multiple vials to obtain a dose.

Administration
Follow strict aseptic technique when administering vaccine.

 Before administering the vaccine, inspect each dose in the dosing syringe. Reconstituted vaccine will
be in an off-white suspension.
▪ Verify final dosing volume of 0.2 milliliters.
▪ Confirm the vaccine in the syringe has no particulates and is not discolored.
 Administer immediately.

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Resources
 CDC: Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19
Vaccination Sites (www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-
anaphylaxis.html)
 Morbidity and Mortality Weekly Report: The Advisory Committee on Immunization Practices’
Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December
2020 (www.cdc.gov/mmwr/volumes/69/wr/mm6950e2.htm?s_cid=mm6950e2_w)
 Pfizer: Pfizer-BioNTech COVID-19 Vaccine Resources (www.cvdvaccine-us.com/resources)
▪ Vaccine preparation and administration, and storage and handling.
▪ EUA Fact Sheet for Healthcare Providers; EUA Fact Sheet for Recipients and Caregivers.
▪ Contact information:
▪ Medical information: PfizerMedicalInformation.com, 1-800-438-1985.
▪ General product inquiries: 1-877-829-2619.
▪ Shipment support, U.S. Trade Customer Service: 1-800-666-7248 (option 8) for temperature
excursions/vaccine viability questions, or email CVGovernment@Pfizer.com.
 CDC: Pfizer-BioNTech COVID-19 Vaccine (www.cdc.gov/vaccines/covid-19/info-by-
product/pfizer/index.html)
▪ Pfizer beyond use date (BUD) guidance and labels, and storage and handling summary and
labels.
▪ Temperature logs (Celsius or Fahrenheit): Ultra-cold, refrigerator.
▪ EUA Fact Sheet for Healthcare Providers; EUA Fact Sheet for Recipients and Caregivers.
 Immunization Courses: Webcasts and Self Study (www.cdc.gov/vaccines/ed/courses.html)
▪ Course: Pfizer-BioNTech COVID-19 Vaccine: What Healthcare Professionals Need to Know.
 CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the
United States (www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html)
 Pediatric COVID-19 Vaccination (www.health.state.mn.us/diseases/coronavirus/vaccine/peds.html)
 Vaccine protocol templates available at COVID-19 Vaccine Providers
(www.health.state.mn.us/diseases/coronavirus/vaccine/provider.html) under “Forms and
templates”

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