COVID-19 vaccine-specific resources : Preparing the Pfizer-BioNTech Comirnaty Tozinameran

COVID-19 vaccine

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In this video, we will show you how to store, thaw, prepare and administer the Pfizer-BioNTech
COVID-19

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vaccine used in persons 12 years of age and older.

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There are two presentations of the Pfizer-BioNTech

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COVID-19 vaccine for adolescents and adults:

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One presentation which has a purple cap and purple border on the vial label and which MUST
be diluted before administration,

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and the 2nd presentation which has a grey cap and grey border on the vial label and for which
no dilution is required.

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Both presentations come frozen, in multi-dose vials containing six doses of vaccine.

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Let us first talk about how to store the vaccine. During transport and storage,

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both presentations of the vaccine in vials with purple caps and in vials with grey caps will be
kept in ultra-cold chain
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conditions, in temperatures between -60ºC to -90ºC.

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Vaccine in vials with purple caps can also be kept at the alternative storage temperature from -
25 to -15°C for a single period

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of up to two weeks

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while vaccines in vials with grey caps should not be kept at -25 to -15ºC.

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When the vaccine vials with purple caps are removed from the -90 to -60ºC and transferred to

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-25 to -15ºC,

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the expiry date must be updated.

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This is called "dynamic labeling".

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If a two week period is within the original expiry date printed on the tray box, cross out the
original expiry date on the

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traybox to mark as not valid. Write down the new expiry date which would be two weeks from
the date he removed the vaccine
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from the -92 to -60ºC conditions.

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If a two week period is longer than the original expiry date printed on the traybox respect the
original expiry date. The

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transfer to alternative storage temperature and expiry date updates should be done within
five minutes for closed-lid vial

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trayboxes and within three minutes for a number of vials or open-lid vial trayboxes.

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Once removed from -90 to -60°C and transferred to -25 to -15°C vaccine must not be returned
to the -92 to -60°C conditions.

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Remember, vaccines in vials with grey caps should not be stored in the freezer at -25 to -15ºC.

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Next, let us discuss how to throw the vaccine before administration. Undiluted, unopened
vaccine vials with purple caps can

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also be stored when thawed and kept at +2 to +8°C for a total of 31 days.

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Unopened vaccine vials with grey caps can be stored when thawed and kept at +2 to 8ºC for
up to 10 weeks after
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removal from the ultra-cold chain conditions. Apply dynamic labeling

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when the vaccine vials are removed from the freezer to a vaccine refrigerator at +2 to 8°C. If a
31 day period for vials with

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the purple cap, or a 10 week period for vials with the grey cap is within the original expiry date
printed on the traybox,

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cross out

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the original expiry date on the traybox to mark as not valid. Write down the new expiry date
which would be 31 days for

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the vials with the purple cap or 10 weeks for the vials with the grey cap from the date you
removed the vaccine from the

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freezer.

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If a 31 day period for the vials with the purple cap or a 10 week period for the vials with the
grey cap is

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longer than the original

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The transfer of vaccine vials and dynamic labeling should be done within three minutes for
closed-lid vile trayboxes

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and within one minute when a number of vials or open-lid vial trayboxes are transferred in the
ambience temperatures of

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up to 25 degrees Celsius. Before being administered to vaccine recipients,

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both presentations of the Pfizer-BioNTech vaccine need to be thawed. When moved from a
freezer to a vaccine refrigerator

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at temperatures between 2 and 8°C, vials with the purple caps will throw out in up to three
hours.

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A carton of 10 vials with grey caps can take up to six hours to thaw.

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Remember, vials that have been thought must never be returned to a freezer and refrozen.
While the vials are in storage or

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in use, minimize any exposure to light. Avoid exposure to direct sun or ultraviolet light.
Because these vaccines have very

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it is important that you plan ahead carefully for their use, to avoid any wastage.

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Now, let us talk about how to prepare each vaccine presentation for administration.

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Before use, verify that the vaccine vial has a purple or grey cap.

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Invert the vaccine vial 10 times gently and do not shake.

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Remember, vaccine in vials with purple caps must be diluted while the vaccine in vials with
grey caps is ready to use and

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does not need to be diluted.

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When diluting the vaccine in the vial with the purple cap first draw up 1.8 ml of the diluent.

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The only diluent to be used is the sterile, preservative free 0.9% sodium chloride.

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Look carefully at the syringe graduation marks

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Before removing the needle from the vial, equalize the pressure inside the vial by withdrawing
1.8 ml of air into the empty

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diluent syringe. Dispose of the syringe and diluent vial with remaining diluent immediately.

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Never use the same diluent vial for the preparation of the next vaccine vial.

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Now, gently invert the diluted vaccine 10 times.

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Do not shake the vial

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For both vaccine presentations, visually inspect the contents of the vial after inverting it both
diluted and ready to use

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vaccines should appear as an off-white solution with no particulates visible.

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If you see particulates or if the vaccine is discolored, you should discard the vial. After diluting
the vaccine in a vial

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with a purple cap or after the first puncture of a vaccine vial with a grey cap, write the day's
date and time directly on
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the vial label.

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Keep vaccine vials at 2°C to 8°C. Discard the vaccine vials six hours after diluting or opening or
at the end of the vaccination

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session,

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whatever comes first. Recording the time of dilution on the vial will be important to help you
keep track of whether the

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vaccine can be used safely.

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Let us review how to administer both presentations of this vaccine.

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For both presentations, draw up the vaccine doses from the vial at the time of administration.

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Preloading of syringes is not recommended. Before withdrawing each subsequent vaccine

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Do not shake. If any liquid remains in the vial after withdrawing the final dose, discard the vial.

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either diluted or ready-to-use, draw up a 0.3 millimeter dose of the vaccine into an auto
disabled syringe.

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If you need to make any adjustments to remove air bubbles,

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do so while keeping the needle in the vial to avoid wasting any of the vaccine. Use an
intramuscular injection technique

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to administer the vaccine in the upper arm of the recipient.

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Follow safe injection practices to avoid any needlestick injuries. Dispose of used syringes and
empty vials in a safety

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box.

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To ensure the vaccine recipients safety, ask them to sit nearby for observation for 15 minutes
after the injection, or for

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30 minutes if they have ever had any allergic reactions in the past. You should now know how
to store, thaw, prepare and administer

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the Pfizer-BioNTech COVID-19 vaccines for adolescents and adults.