Resbakuna - Comirnaty PoU Deck For Site Training and Education-FINAL-013122

Pfizer BioNTech
COVID-19 Vaccine
Point-of-Use Training
References:
Philippines EUA Product information for healthcare professionals (Tris/Sucrose 10mcg/dose
formulation) revision number: 0.0
Philippines EUA Product information for healthcare professionals revision number: 3.0
Philippines EUA Product information for healthcare professionals (Tris/Sucrose 30mcg/dose
formulation) revision number: 0.0
The Pfizer-BioNTech COVID-19 Vaccine is indicated for active immunization for the prevention of COVID-19 caused
by SARS-COV-2 in individuals 5 years of age and older. Pfizer-BioNTech COVID-19 Vaccine does not have marketing
authorization in the Philippines. Information provided is based on the Emergency Use Authorization (EUA) issued
by the Food and Drug Administration (FDA) Philippines. This material will be updated as more information
becomes available.
Report vaccine adverse reactions to FDA Philippines via online reporting through the FDA website
at https://www.fda.gov.ph/pharmacovigilance/ or to Pfizer, Inc.
at https://www.pfizersafetyreporting.com/#/en or via email at PHL.AEReporting@pfizer.com | Fax number 1 800
1110 1520 (Toll Free) |+63 9178108146 +63 2 8451 9288 +63 2 8415 9200 ext 19288. Please submit your medical
information enquires to https://pmiform.com/CONS/PH or to MIS.Inquiry@Pfizer.com.
References:
Philippines EUA Product information for healthcare professionals (Tris/Sucrose 10mcg/dose formulation) revision number: 0.0
Philippines EUA Product information for healthcare professionals revision number: 3.0
Philippines EUA Product information for healthcare professionals (Tris/Sucrose 30mcg/dose formulation) revision number: 0.0
Current as of 6 December 2021

Pfizer BioNTech COVID-19 mRNA Vaccine (nucleoside modified)
Training & Education
Objectives Agenda
1. Product Packaging Overview
Vaccination Center Providers will 2. Storage
be able to:
3. Transfer
• Properly receive, store and administer
4. Vaccine Shipment
the Pfizer BioNTech COVID-19 mRNA
Vaccine (nucleoside modified) 5. Preparation & Administration
• Provide resources to get further 6. Undesirable Effects
information and ask questions
7. Additional Resources
8. Q&A

Product Packaging
Overview
Applicable to the following cap colors:
PURPLE ORANGE
Product Packaging Overview: Dilute to use,
12 years & older
5 to 11 years old, Dilute to
use
Vials and Cartons

VIALS CARTON
Different size cartons hold 10 vials or 195

vials:
2 mL type 1 glass multi-dose vials (MDV), does

not contain preservative Purple Orange
Purple cap: 6 doses per vial for 12 years and older (195 vials/carton) (10 vials/carton)
(Dilute to use) Carton Dimensions
(L x H x W)
Orange cap: 10 doses per vial for 5 to 11 years old 37 x 47 x 89 mm
(Dilute to use)

Storage
PURPLE ORANGE
Dilute to use, 5 to 11 years old, Dilute to
12 years & older use
General Considerations for Storage

During storage, minimize exposure Vials are made of glass
to room light. Avoid exposure to and should be handled
direct sunlight and ultraviolet light with care
Vials should always

Do not refreeze thawed
remain upright in cartons
during storage vials
Product should be
retained in the original Do not freeze diluents
vial cartons until ready
for use

PURPLE ORANGE
General Considerations for Storage
The vaccine can be stored and transported at -90°C to -60°C and +2°C to +8°C.
Shelf life is significantly reduced as the vaccine is transferred from one temperature
environment to another.

PURPLE
Dilute to use,
Storage Options and Shelf-Life: 12 years & older
12 years & older, Dilute to use
The expiry date of the product is printed on the vial and carton labels. Within the 9-month shelf life and not past
the expiry date printed on the label are the following storage options:
Ultra-Low-Temperature (ULT) Freezer Refrigerator
-90 ºC to -60 ºC 2 °C to 8 °C
Can be stored up to
Can be stored up to
9 months 31 days
at this temperature,
within the 9-month shelf life
Once vaccine has been thawed, it should not be re-frozen.

ORANGE
Storage Options and Shelf-Life: use
5 to 11 years old, Dilute to use

NOTE: 5 to 11 years old, Dilute to use Multi-Dose Vial should NOT BE STORED at standard freezer temperature of -25 °C to -15 °C.
The expiry date of the product is printed on the vial and carton labels. Within the 9-month shelf life and not past
the expiry date printed on the label are the following storage options:
Ultra-Low-Temperature (ULT) Freezer Refrigerator
-90 ºC to -60 ºC 2 °C to 8 °C
Can be stored up to
Can be stored up to
9 months 10 weeks
at this temperature,
within the 9-month shelf life
Once vaccine has been thawed, it should not be re-frozen.

PURPLE ORANGE
Updated Expiry Information Dilute to use,
12 years & older
5 to 11 years old, Dilute
to use
Dilute to use, 12 years & older

All available formulations have been updated with the new shelf-life for the frozen vial. Shelf-life has been extended from 6 months
to 9 months. The storage conditions remain unchanged (-90 C to -60 C).
Cartons and vials of Pfizer-BioNTech COVID-19 mRNA Vaccine Dilute to use, 12 years and older, with an expiry date of September
2021 through March 2022 printed on the label may remain in use for 3 months beyond the printed date as long as authorized storage
conditions between -90 C to -60 C have been maintained.
• Updated expiry can apply as long as vials are handled according to the approved storage conditions and do
not exceed the limits of storage at the alternative temperatures
• All vials with an expiry date beyond March 2022 will already reflect the 9 months shelf-life

PURPLE ORANGE
Updated Expiry Information Dilute to use,
12 years & older
use
Dilute to use, 5 to 11 years old

All available formulations have been updated with the new shelf-life for the frozen vial. Shelf-life has been extended from 6 months to
9 months. The storage conditions remain unchanged (-90 C to -60 C).
Cartons and vials of Pfizer BioNTech COVID-19 mRNA Vaccine, 5 to 11 years old, Dilute to use, with an expiry date
of April 2022 through July 2022 printed on the label may remain in use for 3 months beyond the printed date as long as authorized
storage conditions between -90 C to -60 C have been maintained.
• Updated expiry can apply as long as vials are handled according to the approved storage
conditions and do not exceed the limits of storage at the alternative temperatures.
• All vials with an expiry date beyond July 2022 will already reflect the 9 months shelf-life.

PURPLE ORANGE
Managing Shelf-life
Upon moving the vaccine at +2°C to +8°C storage from ULT environment (-90°C
to -60°C), the updated expiry date must be written on the outer carton and
the vaccine should be used or discarded by the updated expiry date. The
original expiry date should be crossed out.
Dynamic labelling is the process of manually updating the vaccine expiration

date as the vaccine moves from one temperature environment to another.

Transfer
PURPLE ORANGE
General Considerations for Transferring 12 years & older use
Vial Cartons Between Storage Environments

Do not touch vials until there is a need to remove them from the vial carton for use or transfer
Protective gloves allowing manual dexterity should be worn while handling frozen vials
When removing vials from a carton, to protect the vials that will remain in the freezer:
• When possible, keep the carton in the frozen environment while transferring the vials to a secondary
container
• If vial cartons must be removed, follow the recommended transfer times on the following slide
Once an individual vial is removed from a carton at room temperature, it should not be returned to frozen
storage and should be thawed for use
NOTE: Temperature must always be monitored to ensure adherence to
temperature requirements for different storage conditions is being met in
Do not re-freeze thawed vials alignment with site Standard Operating Procedures.

PURPLE ORANGE
Transferring Vial Cartons Between Dilute to use,
12 years & older
use
Storage Environments
When removing vials from a carton, when possible, keep the carton in the frozen environment while transferring the vials.
From
From Thermal
Ultra-Low-Temperature Freezer
For Purple Cap Only Shipping Container
(ULT) Freezer -25 °C to -15 °C
-90 °C to -60 °C
-90 °C to -60 °C
Time unopened, full cartons
195 vial packs can be at room temperature 5 minutes 3 minutes
(up to 25 °C)
Time opened cartons (<195 vials)
can be at room temperature 3 minutes* 1 minute**
(up to 25 °C)
Time required to stay in frozen No specified time
environment after room temperature At least 2 hours before they can be removed again before they can be
exposure during transfer
*The Thermal Shipping Container should not be opened for more than 3 minutes at a time. taken out again
**If possible, open-lid cartons should be left in the -25°C to -15°C environment when removing vials for use. If the carton must be removed from the freezer,
return to freezer in less than 1 minute.
Once removed from thermal shipper, if transferring orange cap vial cartons
For Orange Cap to a ULT freezer, unopened cartons may be expose at room temperature (<
25 °C) for up to 5 minutes.

On-Time Delivery Strategy
▪ This model involves delivery of Pfizer-BioNTech vaccines to +2°C to +8°C
storage hubs from the national vaccine warehouse. The vaccine is received at
a facility/vaccination site that can serve as storage location and/or
immunization site.
▪ The vaccine will be delivered to +2°C to +8°C storage hubs in frozen state.
▪ Ensure there is enough +2°C to +8°C vaccine storage capacity at the delivery
site to thaw and store vials taken out from the ULT environment (Dry Ice
Credo Box).
▪ Unopened vials may be stored in the refrigerator at +2°C to +8°C for up to 1
month (31 days) for purple cap and 10 weeks for orange cap, prior to
dilution.
▪ Once thawed, the vaccine should not be re-frozen.
▪ At the +2°C to +8°C storage hubs, regular temperature monitoring is crucial
to avoid vaccine wastage.
Shipping: Local Redistribution
▪ To ensure ultra-low temperature

(-90°C to -60°C) conditions are
maintained during local
redistribution, the vaccines will be
shipped using thermal shipping
containers (Dry Ice Credo Box).
▪ Thermal shipping containers are
insulated containers with dry ice
and temperature data logger,
used for in-country transport of
vaccines from the national
warehouse to recipient sites
identified by NVOC.
▪ Choice of coolant for ULT Transport: Dry Ice

Arrival at +2°C to +8°C Storage Hubs
▪ Ensure that the refrigerator at your level has been prepared in advance and
has been turned on for at least 24 hours prior to actual arrival of the vaccines,
without any incident of temperature excursion.
▪ Ensure that the thermal shipper containers are placed in a well-ventilated
room. This is critical because dry ice sublimates to into CO2 gas over time and
can create risk of suffocation in confined areas.
▪ Dry ice can be hazardous. Staff receiving the shipment must first wash hands
thoroughly and wear appropriate PPE (waterproof insulated gloves and safety
goggles/glasses with side shield) before handling the vaccine trays/boxes and
throughout the handling operation.
▪ Open the thermal container one by one – open the second container once all
inspection, recording and transferring of the vaccine to refrigerator has been
completed.

Arrival at +2°C to +8°C Storage Hubs
▪ Once thermal shipper is opened, locate the temperature data logger and deactivate
the device. Quickly check the condition, lot number and quantities in each tray.
▪ Transfer vaccine trays directly to the refrigerator (+2°C to +8°C). Do this
sequentially, one tray at a time, making sure the vaccine is not exposed to room
temperature for extended period.
▪ Note the date/time when vaccine was taken out of ULT environment (Dry Ice Credo
Box) and update the expiry date. Unopened vaccine vials have a shelf-life of 1
month (31 days) for purple cap and 10 weeks for orange cap when stored at
+2°C to +8°C environment. Thawed vaccines cannot be re-frozen.
▪ Complete the Vaccine Arrival Report form (VAR) and Property Transfer Report (PTR)
then share with the concerned parties. Once all vaccines are loaded into the
refrigerator, check the recorded temperature history for any indication of
temperature excursion during transit.
▪ Continue monitoring the temperature inside the refrigerator as per SOP.

PURPLE
Dilute to use,
12 years & older
Potential Transportation Options

If local redistribution is needed and full cartons containing vials cannot be transported at -90 °C to -60 °C:
Option 1 Option 2
Redistributing individual vials or full Redistributing individual vials or full

cartons at standard freezer temperature cartons at refrigeration temperature
-25 °C to -15 °C 2 ºC to 8 ºC
Any hours used for transport count against

Available data support transportation for up to 12 hours
the 2-week limit for storage
Do not re-freeze thawed vials

Frozen vials transported or stored may be returned one time
to the recommended ULT storage condition of -90 ºC to -60 ºC
If vials are delivered at 2 ºC to 8 ºC,
vaccine needs to stay at 2 ºC to 8 ºC.
If local redistribution is used, ensure there is one vial of diluent (sterile 0.9% Sodium Chloride Injection, USP) for each vial of the vaccine

ORANGE
Potential Transportation Options

use
If local redistribution is needed, undiluted Orange cap vials may be transported

Option 1
Individual vials or full cartons at
refrigeration temperature
• Do not store in standard freezer
2 ºC to 8 ºC
• Do not re-freeze thawed vials
OR • If vials are delivered at 2 ºC to 8 ºC,
Option 2 vaccine needs to stay at 2 ºC to 8 ºC
Full cartons at • Check that the carton has been updated to
ultra cold temperature reflect the 10-week refrigerated expiry date
-90 °C to ‑60 °C
If local redistribution is used for Orange cap vaccine, ensure there is one vial of diluent (sterile 0.9% Sodium Chloride Injection, USP) for each vial of the
vaccine.

Preparation and
Administration
PURPLE ORANGE
Vaccine Formulations Guide
Formulation Dilute to use, 12 years and older 5 to 11 years old, Dilute to use
Vial Multi-dose Vial Multi-dose Vial
Vial Cap Color Purple Orange
Summary of Product Characteristics Summary of Product Characteristics Summary of Product Characteristics

Dosage 30 mcg 10 mcg
Dilution Dilution required Dilution required
Amount of Diluent Needed per Vial 1.8 mL 1.3 mL
Vial Size 2 mL 2 mL
Doses per Vial 6 doses per vial (after dilution) 10 doses per vial (after dilution)
Injection Volume per Dose 0.3 mL 0.2 mL
Fill Volume per Vial 0.45 mL 1.3 mL
Refrigeration Storage Time (2ºC to 8ºC) 1 month 10 weeks
ULT Freezer Storage Time
9 months (shelf life) 9 months (shelf life)
(-90ºC to -60ºC)
Room Temperature 2 hours prior to dilution 12 hours prior to dilution
(8ºC to 30ºC) (including any thaw time) (including any thaw time)
After First Puncture of Dilution
Discard 6 hours after dilution Discard 12 hours after dilution
(2ºC to 30ºC)
Package Size 195 vials 10 vials
Administration Overview:
ORANGE CAP & PURPLE CAP
(5 to 11 years old, Dilute to use) (Dilute to use, 12 years and older)
BEFORE ADMINISTRATION OF THE VACCINE, YOU MUST REVIEW THE

APPROPRIATE SUMMARY OF PRODUCT CHARACTERISTICS FOR
VACCINATION PROVIDERS
PURPLE ORANGE
Administration of Pfizer BioNTech 12 years & older use
COVID‑19 mRNA Vaccine (nucleoside modified)
Vaccine Administration
• Pfizer BioNTech COVID-19 Vaccine Dilute to use, 12 years and older and 5 to 11 years old, Dilute to use should be
administered intramuscularly after dilution.
After dilution, vials of Dilute to use, 12 years and After dilution, vials of 5 to 11 years old, Dilute to
older contain 6 doses of 0.3 mL of vaccine. In use contain 10 doses of 0.2 mL of vaccine. In
order to extract 6 doses from a single vial, low order to extract 10 doses from a single vial, low
dead-volume syringes and/or needles should be dead-volume syringes and/or needles should be
used. used.
• The low dead-volume syringe and needle combination should have a dead volume of no more than
35 microlitres.
• If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose
from a single vial.
PURPLE ORANGE
In-Use Stability: Vials After Dilution

Dilution
• The vaccine is provided as a multiple dose vial
• The vaccine must be diluted with sterile 0.9% Sodium Chloride Solution for Injection before
administering the vaccine
• ONLY use sterile 0.9% Sodium Chloride Solution for Injection as the diluent
ORANGE CAP (5 to 11 years old) PURPLE CAP (12 years and older)
• After dilution with 1.3 mL of 0.9% Sodium • After dilution with 1.8 mL of 0.9% Sodium
Chloride Solution for Injection the vial contains Chloride Solution for Injection the vial contains
10 doses of 0.2 mL (10 mcg) 6 doses of 0.3 mL (30 mcg)
• Do not add more than 1.3 mL of diluent • Do not add more than 1.8 mL of diluent
IMPORTANT: regardless of the volume of the diluent vial, it must be used for ONE TIME dilution (after withdrawal,
the remaining diluent must be discarded)
PURPLE ORANGE
Storage and Timing Considerations

• Diluted vials should be stored between 2 ºC to 30 ºC
• During storage, minimize exposure to room light, and avoid exposure to direct
sunlight and ultraviolet light
Do not refreeze
ORANGE CAP (5 to 11 years old) PURPLE CAP (12 years and older)
• Undiluted orange cap vaccine may be stored at room • Undiluted purple cap vials may be stored at room
temperature for a total of 12 hours prior to dilution temperature for no more than 2 hours
• Any vaccine remaining in vials (or syringes) should be • Diluted vaccine - use within 6 hours from the time of
discarded 12 hours after dilution dilution
• Any vaccine remaining in vials (or syringes) must be

discarded after 6 hours
PURPLE ORANGE
Dose Preparation
Supplies needed per vial For diluent withdrawal and mixing For vaccine administration (intramuscular injection) –
• 1 Vial 0.9% Sodium Chloride • ONE 3 mL syringe (optimal size) Orange 5 to 11 years old, Dilute to use
Solution for Injection or 5 mL syringe to withdraw diluent • TEN 1 mL syringes
• Other materials such as alcohol • ONE 21 gauge or narrower needle • TEN 22-25 -gauge needles for intramuscular injection
swabs, gloves, PPE should be used to withdraw the • Needle lengths appropriate for varied body sizes – 5/8”,
diluent. Use the same needle to 1”, 1 ½
add the diluent to the vial
For vaccine administration (intramuscular injection) – Pur

Dilute to use, 12 years and older
• SIX 1 mL syringes
• 1 syringe for each dose/patient
• SIX 22-25 -gauge needles for intramuscular injection
• Needle lengths appropriate for varied body sizes – 5/8”,
1”, 1 ½”

PURPLE ORANGE
Preparation Instructions: Dilute to use,
12 years & older
use
Dilution and Thawing Orange Cap, 5 to 11 years old

DOSE VERIFICATION OF Pfizer BioNTech 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
• Verify that the vial has an orange plastic cap.

• If the vial has a purple plastic cap, please make reference to the Product Information for Pfizer BioNTech
COVID-19 Vaccine 30 micrograms/dose concentrate for dispersion for injection.
HANDLING PRIOR TO USE OF Pfizer BioNTech 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
• If the multidose vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to
an environment of 2 °C to 8 °C to thaw; a 10 vial pack may take 4 hours to thaw. Ensure vials are
completely thawed prior to use.
• Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton.
• Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C within the 9-month shelf life.
• Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
• Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C. Thawed
vials can be handled in room light conditions.

PURPLE ORANGE
Preparation Instructions: Dilute to use,
12 years & older
use
Dilution and Thawing Purple Cap, 12 years and older

DOSE VERIFICATION OF Pfizer BioNTech 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
• Verify that the vial has a purple plastic cap.

• If the vial has an orange plastic cap, please make reference to the Product Information for
Pfizer BioNTech COVID-19 Vaccine 10 micrograms/dose concentrate for dispersion for
injection.
THAWING PRIOR TO DILUTION OF Pfizer BioNTech 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
• The multidose vial is stored frozen and must be thawed prior to dilution. Frozen vials should
be transferred to an environment of 2 °C to 8 °C to thaw; a 195 vial pack may take 3 hours
to thaw. Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to
30 °C for immediate use.
• The unopened vial can be stored for up to 1 month at 2 °C to 8 °C within the 9-month shelf
life. Within the 1-month shelf life at 2 °C to 8 °C, up to 12 hours may be used for
transportation.

PURPLE ORANGE
Preparation Instructions: Dilution

MIXING PRIOR TO DILUTION OF Pfizer BioNTech COVID-19 THAWING PRIOR TO DILUTION OF Pfizer BioNTech COVID-19
10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION
FOR INJECTION (CHILDREN 5 TO 11 YEARS) FOR INJECTION (12 YEARS AND OLDER) (cont’d)
• Allow the thawed vial to come to room temperature and gently • Allow the thawed vial to come to room temperature. Prior to
invert it 10 times prior to dilution. Do not shake. use, the unopened vial can be stored for up to 2 hours at
temperatures up to 30 °C. Thawed vials can be handled in
• Prior to dilution, the thawed dispersion may contain white to
room light conditions.
off-white opaque amorphous particles.
• Gently invert the vial 10 times prior to dilution. Do not shake.
• Prior to dilution, the thawed dispersion may contain white to
off-white opaque amorphous particles.
DILUTION OF Pfizer BioNTech COVID-19

DILUTION OF Pfizer BioNTech COVID-19
30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION
10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION
FOR INJECTION
FOR INJECTION (CHILDREN 5 TO 11 YEARS)
(12 YEARS AND OLDER)
• The thawed vaccine must be diluted in its original vial with • The thawed vaccine must be diluted in its original vial with
1.3 mL sodium chloride 9 mg/mL (0.9%) solution for 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for
injection, using a 21 gauge or narrower needle and aseptic injection, using a 21 gauge or narrower needle and aseptic
techniques. techniques.
PURPLE ORANGE

DILUTION OF Pfizer BioNTech 10 MICROGRAMS/DOSE DILUTION OF Pfizer BioNTech 30 MICROGRAMS/DOSE
CONCENTRATE FOR DISPERSION FOR INJECTION CONCENTRATE FOR DISPERSION FOR INJECTION
(CHILDREN 5 TO 11 YEARS) (Cont’d.) (12 YEARS AND OLDER) (Cont’d.)
• Equalise vial pressure before removing the • Equalise vial pressure before removing the
needle from the vial stopper by withdrawing needle from the vial stopper by withdrawing
1.3 mL air into the empty diluent syringe. 1.8 mL air into the empty diluent syringe.
• Gently invert the diluted dispersion 10 times. • Gently invert the diluted dispersion 10 times. Do
Do not shake. not shake.
• The diluted vaccine should present as a white • The diluted vaccine should present as an
to off-white dispersion with no particulates off-white dispersion with no particulates visible.
visible. Do not use the diluted vaccine if Do not use the diluted vaccine if particulates or
particulates or discolouration are present. discolouration are present.
PURPLE ORANGE

DILUTION OF Pfizer BioNTech COVID-19 DILUTION OF Pfizer BioNTech COVID-19
10 MICROGRAMS/DOSE CONCENTRATE FOR 30 MICROGRAMS/DOSE CONCENTRATE FOR
DISPERSION FOR INJECTION (CHILDREN 5 TO DISPERSION FOR INJECTION
11 YEARS) (Cont’d.) (12 YEARS AND OLDER) (Cont’d.)
• The diluted vials should be marked • The diluted vials should be marked
with the appropriate date and with the appropriate date and
time. time.
• After dilution, store at 2 ºC to 30 ºC • After dilution, store at 2 ºC to 30 ºC
and use within 12 hours. and use within 6 hours, including
• Do not freeze or shake the diluted any transportation time.
dispersion. If refrigerated, allow • Do not freeze or shake the diluted
the diluted dispersion to come to dispersion. If refrigerated, allow
room temperature prior to use. the diluted dispersion to come to
room temperature prior to use.
PURPLE ORANGE
Preparation of Individual 0.2 mL Doses

for Administration Orange Cap, 5 to 11 years old
• After dilution, the vial contains 2.6 mL from which 10 doses of 0.2 mL can be
extracted.
• Using aseptic technique, cleanse the vial stopper with a single use antiseptic
swab.
• Withdraw 0.2 mL of Pfizer BioNTech COVID-19 Vaccine for children age 5 to
11 years. Low dead-volume syringes and/or needles should be used in order
to extract 10 doses from a single vial. The low dead-volume syringe and
needle combination should have a dead volume of no more than 35
microlitres. If standard syringes and needles are used, there may not be
sufficient volume to extract ten doses from a single vial.
• Each dose must contain 0.2 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of
0.2 mL, discard the vial and any excess volume.
• Discard any unused vaccine within 12 hours after dilution.
PURPLE
Dilute to use,
12 years & older
Preparation of Individual 0.3 mL Doses for Administration

Purple Cap, 12 years and older
• After dilution, the vial contains 2.25 mL from which 6 doses of 0.3 mL can be
extracted.
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic
swab.
• Withdraw 0.3 mL of Pfizer BioNTech COVID-19 Vaccine. Low dead-volume
syringes and/or needles should be used in order to extract 6 doses from a
single vial. The low dead-volume syringe and needle combination should have
a dead volume of no more than 35 microlitres. If standard syringes and
needles are used, there may not be sufficient volume to extract a sixth dose
from a single vial.
• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3
mL, discard the vial and any excess volume.
• Discard any unused vaccine within 6 hours after dilution.
PURPLE ORANGE
Administration of COMIRNATY 12 years & older use

All Formulations
• Each dose must contain 0.3 mL of vaccine. • Each dose must contain 0.2 mL of vaccine.
• If the amount of vaccine remaining in the • If the amount of vaccine remaining in the
vial cannot provide a full dose of 0.3 mL, vial cannot provide a full dose of 0.2 mL,
discard the vial and any excess volume. discard the vial and any excess volume.
• Do not pool excess vaccine from multiple vials.

• The preferred site is the deltoid muscle of the upper arm.
• Do not inject the vaccine intravascularly, subcutaneously or intradermally.
• The vaccine should not be mixed in the same syringe with any other vaccines or medicinal
products.
PURPLE ORANGE
Administration of Pfizer BioNTech

• Administer the Pfizer BioNTech COVID-19 Vaccine intramuscularly

• Administer a single dose at the first visit
• The second dose of Pfizer BioNTech COVID-19 Vaccine should be given 3 weeks after the first dose
The second dose should be Pfizer BioNTech COVID-19 Vaccine.

There are no data available on interchangeability with other COVID-19 vaccines
• A booster dose (third dose) of Pfizer BioNTech COVID-19 Vaccine may be administered intramuscularly at least 3
months after the second dose in individuals 18 years of age and older
How to vaccinate
adolescents and
children
References:
US-CDC, You Call the Shots
HOW SERIOUS IS VACCINE ADMINISTRATION?
• Vaccination can be a stressful experience
• Children and adolescents may experience fear and anxiety
• If healthcare providers don't address these fears, they can have long-term effects.
For example: children and adolescents may avoid needed health care throughout their
lifetime. Your practices can improve their experiences and attitudes about vaccination.
Consider strategies to manage pain and potential acute reactions.

YOU NEED TO DISTRACT:
• Distract children and adolescents to reduce stress and ease pain
• Interact with vaccinee throughout the appointment
• Use clinician-led distraction techniques (e.g., point out interesting things in the room
and ask the patient to describe what they see, tell an age-appropriate story)
• Use patient-led distraction techniques (e.g., games, videos, music, books)
• Remind children and adolescents to stay focused on the distraction strategy if their
attention wanders to the vaccination
• Suggest vaccinee to engage in slow, deep breathing or exhalation during vaccination
• Avoid telling children and adolescents “It won’t hurt.”

VACCINATION TECHNIQUE FOR CHILDREN:

SOME BEST PRACTICES OF VACCINE ADMINISTRATION:
• Have children or adolescents sit upright or lie down during injection
• If sitting, ask them to:
- Sit in a straight-backed chair
- Rest their feet flat on the floor
- Relax their forearms and place hands on their upper thighs
- Relax their shoulders
• Administer vaccine using a rapid injection technique without aspiration

Undesirable Effects
PURPLE
Dilute to use,
12 years & older
Undesirable effects - 12 years and older

• Adverse reactions from Pfizer BioNTech COVID-19 Vaccine clinical trials and post-authorisation experience in individuals 12 years of age and
older
• Adverse reactions observed during clinical studies are listed below according to the following frequency categories:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare
(< 1/10,000), Not known Rare Not known (cannot be
Very(cannot
common be estimated from the available data).
Common Uncommon
System Organ Class (≥ 1/10,000 to estimated from the
(≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1,000 to < 1/100)
< 1/1,000) available data)
Blood and lymphatic system
Lymphadenopathya
disorders
Immune system disorders Hypersensitivity reactions (e.g. rash,
Anaphylaxis
pruritus, urticaria,b angioedemab)
Metabolism and nutrition
Decreased appetite
disorders
Psychiatric disorders Insomnia
Nervous system disorders Acute peripheral
Headache Lethargy
facial paralysisc
Cardiac disorders Myocarditis;d Pericarditisd
Gastrointestinal disorders Diarrhoead Nausea; Vomitingd
Skin and subcutaneous tissue
Hyperhidrosis; Night sweats Erythema multiformed
disorder
Musculoskeletal and connective
Arthralgia; Myalgia Pain in extremitye
tissue disorders
General disorders and Extensive swelling of
Injection site pain; Fatigue; Chills;
administration site conditions Injection site redness Malaise; Injection site pruritus vaccinated limb;d
Pyrexiaf; Injection site swelling
Facial swellingg
a. A higher frequency of lymphadenopathy (5.2% vs 0.4%) was observed in participants receiving a booster dose (third dose) compared to participants receiving 2 doses.
b. The frequency category for urticaria and angioedema was Rare.
c. Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or palsy) was reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after
Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.
d. Adverse reaction determined post‑authorisation.
e. Refers to vaccinated arm.
f. A higher frequency of pyrexia was observed after the second dose compare to the first dose.
g. Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post-marketing phase.
PURPLE ORANGE
Undesirable effects – 5 to 11 years old

• Adverse reactions from Pfizer BioNTech COVID-19 Vaccine clinical trials and post-authorisation experience in individuals 5 years of age and older
• Adverse reactions observed during clinical studies are listed below according to the following frequency categories:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not
known (cannot be estimated from the available data).
Rare Not known (cannot be
Very common Common Uncommon
System Organ Class (≥ 1/10,000 to estimated from the
(≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1,000 to < 1/100)
< 1/1,000) available data)
Blood and lymphatic system
Lymphadenopathya
disorders
Immune system disorders Hypersensitivity reactions (e.g. rash,
Anaphylaxis
pruritus, urticaria,b angioedemab)
Metabolism and nutrition
Decreased appetite
disorders
Psychiatric disorders Insomnia
Nervous system disorders Acute peripheral
Headache Lethargy
facial paralysisc
Cardiac disorders Myocarditis;d
Pericarditisd
Gastrointestinal disorders Diarrhoead Nausea; Vomitingd
Skin and subcutaneous tissue
Hyperhidrosis; Night sweats Erythema multiformed
disorder
Musculoskeletal and connective
Arthralgia; Myalgia Pain in extremitye
tissue disorders
General disorders and Extensive swelling of
Injection site pain; Fatigue; Chills;
administration site conditions Injection site rednessh Malaise; Injection site pruritus vaccinated limb;d
Pyrexiaf; Injection site swelling
Facial swellingg
a. A higher frequency of lymphadenopathy (5.2% vs 0.4%) was observed in participants receiving a booster dose (third dose) compared to participants receiving 2 doses.
b. The frequency category for urticaria and angioedema was Rare.
c. Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or palsy) was reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after
Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.
d. Adverse reaction determined post‑authorisation.
e. Refers to vaccinated arm.
f. A higher frequency of pyrexia was observed after the second dose compared to the first dose.
g. Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post-marketing phase.
h. Injection site redness occurred at a higher frequency (very common) in children 5 to 11 years of age.
PURPLE ORANGE
Undesirable effects (cont’d)
• The safety profile in 545 subjects receiving Pfizer BioNTech COVID-19 Vaccine, that were seropositive for SARS-CoV-2 at
baseline, was similar to that seen in the general population.
Reporting of suspected adverse reactions
• Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected
adverse reactions via the national reporting system at https://www.fda.gov.ph/pharmacovigilance/ and include batch/Lot
number if available.
Overdose
Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received
58 micrograms of Pfizer BioNTech COVID-19 Vaccine. The vaccine recipients did not report an increase in reactogenicity or
adverse reactions.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Additional Resources
HCP Website Landing Page
www.comirnatyglobal.com
• The HCP website has been

developed to provide specific
information for HCPs.
• The vaccine vial cartons in the
Thermal Shipping Container have a
QR code that the Vaccination
Centers can use to access this
Landing Page. Vaccination Centers
can access the website from the
landing page.
HCP Resources (www.comirnatyglobal.com)
COMIRNATY Vaccine Formulations Guide

• This PDF gives a quick overview of the packaging, dosing information, and
storage requirements for each of the formulations of COMIRNATY
‘How to Prepare and Administer the Vaccine’ Guide
• This brochure provides step-by-step instructions for the storage,

preparation, and administration of the COMIRNATY COVID-19
mRNA Vaccine (nucleoside modified)
HCP Resources (www.comirnatyglobal.com)
COMIRNATY Dry Ice Replenishment Brochure

• This PDF will assist HCPs and their staff regarding dry ice replenishment,
with a breakdown of step-by-step unpacking and refilling instructions
Shipping and Handling Guidelines Brochure

• This brochure contains guidelines on dry ice handling, dry ice
replenishment, safety data sheet information, and instructions for the
return of the temperature-monitor device and thermal shipping
container
Thank you
COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified), which is
based on BioNTech proprietary mRNA technology, was developed by
both BioNTech and Pfizer.
Pfizer, Inc.
19F–20F, 8 Rockwell Bldg., Hidalgo Drive
Rockwell Center, Poblacion, Makati City 1210
Metro Manila, Philippines
January 2022
PP-CMR-PHL-0019

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Pfizer BioNTech

Current as of 6 December 2021

Current as of 6 December 2021

Vials and Cartons

Different size cartons hold 10 vials or 195

2 mL type 1 glass multi-dose vials (MDV), does

Current as of 6 December 2021

General Considerations for Storage

Vials should always

Current as of 6 December 2021

General Considerations for Storage

Current as of 6 December 2021

Storage Options and Shelf-Life: 12 years & older

12 years & older, Dilute to use

Ultra-Low-Temperature (ULT) Freezer Refrigerator

Once vaccine has been thawed, it should not be re-frozen.

Current as of 6 December 2021

Storage Options and Shelf-Life: use

5 to 11 years old, Dilute to use

Ultra-Low-Temperature (ULT) Freezer Refrigerator

Once vaccine has been thawed, it should not be re-frozen.

Current as of 6 December 2021

Dilute to use, 12 years & older

Current as of 6 December 2021

Dilute to use, 5 to 11 years old

Current as of 6 December 2021

Dynamic labelling is the process of manually updating the vaccine expiration

Current as of 6 December 2021

General Considerations for Transferring 12 years & older use

Vial Cartons Between Storage Environments

Current as of 6 December 2021

Current as of 6 December 2021

▪ To ensure ultra-low temperature

▪ Choice of coolant for ULT Transport: Dry Ice

Current as of 6 December 2021

Current as of 6 December 2021

Potential Transportation Options

Redistributing individual vials or full Redistributing individual vials or full

Any hours used for transport count against

Do not re-freeze thawed vials

Current as of 6 December 2021

Potential Transportation Options

If local redistribution is needed, undiluted Orange cap vials may be transported

Current as of 6 December 2021

Summary of Product Characteristics Summary of Product Characteristics Summary of Product Characteristics

BEFORE ADMINISTRATION OF THE VACCINE, YOU MUST REVIEW THE

Administration of Pfizer BioNTech 12 years & older use

COVID‑19 mRNA Vaccine (nucleoside modified)

In-Use Stability: Vials After Dilution

• The vaccine is provided as a multiple dose vial

Storage and Timing Considerations

• Any vaccine remaining in vials (or syringes) must be

For vaccine administration (intramuscular injection) – Pur

Current as of 6 December 2021

Dilution and Thawing Orange Cap, 5 to 11 years old

• Verify that the vial has an orange plastic cap.

Current as of 6 December 2021

Dilution and Thawing Purple Cap, 12 years and older

• Verify that the vial has a purple plastic cap.

Current as of 6 December 2021

Preparation Instructions: Dilution

DILUTION OF Pfizer BioNTech COVID-19

Preparation Instructions: Dilution