PFIZER-BIONTECH COVID-19 VACCINE

Vaccine Preparation and Administration Workflow

GENERAL INFORMATION:

VACCINE: Pfizer-BioNTech COVID-19 Vaccine INDICATION: 18 years old and above

PREPARATION: Multidose, six (6) doses per vial INTERVAL: 21 days, two (2) dose series
DOSES: 0.3 ml (Note: Only those given with first dose Pfizer
vaccine are allowed to receive the second
DILUENT: 0.9% sodium chloride, USP,
dose)
Preservative-free (2 ml or 10 ml vial) ADMINISTRATION: Intramuscular injection,
(Note: Only use the diluent provided specific for the
Pfizer vaccine. Do not use any normal saline solution as
deltoid muscle
diluent. Use a new diluent vial for every vial of Pfizer
vaccine.)

STORAGE: Vaccine: Ultra-low temperatures

1. At -80ºC to -60ºC in freezer; or
2. At -90 to -60ºC in thermal shipper as temporary storage for up to 30 days from delivery (should be
re-iced every five (5) days if opened up to two (2) times a day, less than three (3) minutes at a time).
Diluent: Room Temperature

SHELF LIFE: Undiluted vaccine at storage temperature -90 to -60ºC: six (6) months after the time of manufacturing
Undiluted thawed vaccine at +2 - +8ºC: up to 120 hours (5 days) prior to dilution
Undiluted thawed vaccine at temperatures up to +25ºC: up to two (2) hours
Diluted vaccine at +2 - +25ºC: up to two (2) hours

FREEZE Do not refreeze thawed vials

SENSITIVITY: Do not freeze diluted vaccine

LIGHT Minimize exposure to room light

SENSITIVITY: Avoid exposure to direct sunlight and ultraviolet light

CONDITIONS At room temperature (up to +25ºC) before dilution and use

BEFORE USE:

WORKFLOW:

Procedure I: Thawing the Vaccine

NOTE: Pfizer vaccines must be thawed before using. The thawing process should start and be conducted in the vaccination site.
Only trained pharmacists and nurses are allowed to perform this procedure. Wear protective gear when handling the ULF.
WORKFLOW Accomplished
1. Open the Ultra Low Freezer (ULF) and transfer a tray/s of vaccines to a +2 - +8⁰C refrigerator or vaccine
carrier.
a. The ULF or shipper’s box shall be opened for a maximum of three (3) mins at a given time
and twice (2x) a day only.
b. Thawing starts upon removal of the vaccine from an ULF. Unpunctured vial/s may be stored
in a +2 - +8⁰C refrigerator for up to five (5) days or 120 hours.
2. Get vaccine vial from the +2 - +8⁰C refrigerator or vaccine carrier for thawing at room temperature (only up
to +25⁰C). Unpunctured vials can only be kept at room temperature for two (2) hours only, including
thawing time. Thawed vaccine vial/s in room temperature should be diluted within two (2) hours.
3. Thaw the vaccine vial in a vaccine tray. Amount of time needed to thaw varies based on the temperature
of the room and number of vials.
4. DO NOT refreeze thawed vaccine.
5. Log details on the DOH label card/s to track date and time.
Procedure II: Diluting the Multiple Dose Vial
NOTE: Prepare the vaccines in the vaccine preparation area (most ideal, if near the vaccination area) of the vaccination site. Only
trained pharmacists and nurses are allowed to perform this procedure.
WORKFLOW Accomplished
1. Prepare work space.
2. Perform hand hygiene. Follow aseptic technique.
3. Get the diluent and thawed vaccine vial.
4. Check the expiration dates of the vaccine and diluent. Do not use expired vaccine or diluent.
5. Check if the vaccine is completely thawed. Check the temperature of the diluent and thawed vaccine vial
(at least +2 - +25⁰C). Check the color of the vaccine. The vaccine is white to off-white and may contain
opaque particles. Do not use if liquid is discolored.
6. If the vaccine is completely thawed, GENTLY invert the vial 10 times to mix. DO NOT SHAKE the vial.
7. Using a new, sterile alcohol swab, wipe off the stoppers of the diluent and vaccine vials. Use a different
swab for each vial.
8. Prepare the two (2) ml mixing syringe included in the Pfizer vaccine bundle or a 21-gauge (or narrower)
needle syringe. Retract the plunger of the syringe by 1.8 ml. Puncture the vial stopper and introduce 1.8 ml
of air, then withdraw 1.8 ml of 0.9% sodium chloride. Discard diluent vial and any remaining diluent every
after withdrawal. DO NOT use any other solutions such as bacteriostatic normal saline to mix the vaccine.
9. Slowly inject 1.8 ml 0.9% sodium chloride (normal saline, preservative-free) diluent into the vaccine vial.
10. Before extracting the syringe, remove/extract 1.8ml of air from the vaccine vial to equalize the pressure in
the vaccine vial.
11. After removing the syringe, invert the vial containing vaccine and diluent 10 times. The vaccine will be
off-white in color. Do not use if discolored or contains particulate matter. DO NOT SHAKE the vial. If the
vial is shaken, contact the DOH Supply Chain Management Service at 0916 877 5613 or 0997 206 1007.
12. With a marker, note the date and time the vaccine was mixed.
13. It is highly encouraged to place diluted vaccine in a tray with an ice pack, and give/endorse diluted
vaccine to the vaccinator. Ensure that the vaccine vial/s is/are not shaken while in transit.
14. Keep diluted vaccine between +2 - +25⁰C and administer within six (6) hours. Discard any unused vaccine
after six (6) hours. Do not return to freezer storage.

Procedure III: Administering the Vaccine

NOTE: Only trained vaccinators are allowed to perform this procedure
WORKFLOW Accomplished
1. Determine the number of vaccine recipients based on the prepared diluted vaccines.
2. Call the vaccine recipient.
3. Perform hand hygiene before every interaction with a vaccine recipient. Gloves are not required unless the
vaccinator is likely to have contact with potentially infectious body fluids or has open lesions. If worn,
perform hand hygiene and change gloves between patients.
4. Review the health screening form. Ensure that the vaccine recipient was cleared for vaccination. Review
vaccine history.
5. Prepare workplace and correct equipment. Follow aseptic technique.
a. Use a new, sterile needle and syringe for each injection. Use low dead-volume syringes/needles
to extract six (6) doses.
6. Disinfect the stopper of the vial of diluted vaccine with a new sterile alcohol swab.
7. Withdraw 0.3ml of diluted vaccine into the syringe.
a. Ensure that the amount of vaccine in the syringe equals 0.3ml. If the remaining vaccine in the
vial cannot provide FULL 0.3 ml dose, discard the vial and contents.
b. Puncture the rubber stopper at different sites in extracting the required doses.
c. DO NOT combine/pool vaccine from multiple vials.
8. Remove any significant air bubbles with the needle still in the vial to avoid loss of vaccine. Use the same
needle to withdraw and administer the vaccine. DO NOT pre-fill syringes.
9. Disinfect injection area in a circular motion (inner to outer direction) with a new sterile alcohol swab.
Discard alcohol swab.
10. Administer the vaccine immediately by intramuscular injection in the deltoid muscle.
11. Place a clean, dry cotton on the punctured site. Once the injection site stops bleeding, cotton can be
discarded.
12. Discard used syringe in the safety collector box. Do not recap.
13. Encode details in the vaccination card.
14. Instruct vaccine recipient to proceed to the post-vaccination area for observation.

Specific Guidance:
1. For Pfizer vaccines, determine and add one (1) more area in the vaccination site for vaccine preparation. The vaccine
preparation area must be near the vaccination area.
2. Identify at least two (2) trained health personnel to do the vaccine preparation (a pharmacist or a trained nurse). These
identified personnel shall be the only personnel allowed to prepare the vaccines at all times. Untrained personnel are not
allowed to perform the vaccine preparation (Procedures I and II).
3. The vaccine preparation must be done by a two-man team. One health personnel shall perform the task, while the other
health personnel ensures that all the steps are performed accordingly.
4. Only trained vaccinators are allowed to perform vaccine administration (Procedure III).
5. Determine the number of eligibles for Pfizer vaccines a day prior to vaccination schedule so that only a certain number of
doses/vials shall be removed from the frozen storage.
END