Tozinameran COVID-19 mRNA Vaccine (nucleoside modified) ‒ COMIRNATY® (Pfizer‒BioNTech) Training

27 January 2021

For more COVID-19 vaccine country readiness and delivery

resources, please visit: https://www.who.int/initiatives/act-

accelerator/covax/covid-19-vaccine-country-readiness-and-delivery

If you have queries or feedback, please email:

CRDresources@who.int

This resource may be

updated as new

information becomes

available.

2

Section Slide number

Training learning objectives 3

1. Overview of Tozinameran COVID-19 mRNA vaccine

(Pfizer–BioNTech)4

3. Administration of Tozinameran COVID-19 mRNA vaccine 16

4. Ultra-cold chain (UCC) storage and transportation 22

5. Indicative delivery strategies for Tozinameran COVID-19 mRNA

vaccine 43

6. Indemnification and liability 49

2. Vaccine safety and regulatory considerations 13

7. Acceptance and uptake 53

Contents

3

Learning

objectives

By the end of this training, you should be able to:

describe what is new and different for introducing Tozinameran

COVID-19 mRNA vaccine (Pfizer–BioNTech); and

identify key programmatic considerations involved in introducing this

vaccine.

This training is intended to be used in conjunction with:

training1 and guidance on the development of a National Vaccination

and Deployment Plan (NDVP) for COVID-19 vaccines2;

COVID-19 vaccination training for health workers3; and

guidance and resources available at the WHO Country Readiness

and Delivery webpage4.

1https://openwho.org/courses/covid-19-

ndvp-en2https://www.who.int/publications/i/item/W

HO-2019-nCoV-Vaccine_deployment-

2020.13 https://openwho.org/courses/covid-19-

vaccination-healthworkers-en4 https://www.who.int/initiatives/act-

accelerator/covax/covid-19-vaccine-

country-readiness-and-delivery

4

1. Overview of Tozinameran COVID-19

mRNA vaccine (Pfizer–BioNTech)

5

COMIRNATY® –

vaccine type

and presentation

Messenger RNA (mRNA) based vaccine encoding the viral spike

glycoprotein (S), unique to SARS-CoV-2

Formulated in lipid nanoparticles

Frozen, sterile, preservative and adjuvant free multi-dose

concentrate for dilution before administration

One vial (0.45mL) contains 6 doses of vaccine after dilution.

Diluent is unpreserved 0.9% sodium chloride solution for

injection; 1.8mL of diluent is required per 6-dose vaccine vial.

Date of WHO EUL: December 31, 2020 (https://extranet.who.int/pqweb/sites/default/files/documents/TAG-EUL_PublicReport_BioNTech_DEC20.pdf )

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Dosage and administration

Recommended

for age

16 years and older, without an upper age limit

Dose / route / site

of administration

0.3 mL (after dilution), intramuscular injection in the deltoid muscle

Vaccine syringe and needle: 0.3 mL auto-disable (AD) syringe, needle 23G x 1”

(0.60 x 25 mm)

Mixing syringe and needle: 3 mL or 5 mL reuse prevention (RUP) syringe, needle

21G or narrower

Recommended

schedule

2 doses necessary for protection

Dose 1 – at the start date

Dose 2 – 21 to 28 days after first dose

If the 2nd dose is accidently administered earlier than 21 days, the dose need not be

repeated. If administration of the second dose is inadvertently delayed, it should be given

as soon as possible thereafter.

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Contraindications Precautions

Known history of a severe allergic reaction

(e.g. anaphylaxis) to any component of this

vaccine

Do not administer to individuals with known

allergic reaction to polyethylene glycol (PEG)

or related molecules.

Do not administer to individuals who

developed an immediate allergic reaction

(e.g. anaphylaxis, respiratory distress) to the

first dose of this vaccine.

Defer vaccination of people with acute

severe febrile illness (over 38.5 °C) or acute

infection, including symptomatic SARS-CoV-

2 infection, until they have recovered from

acute illness.

Observe post-vaccination for at least 15

minutes. Persons with known history of any

immediate allergic reaction to any other

vaccine or injectable therapy should be

observed 30 minutes post vaccination.

Counsel about the risks which should not

outweigh the benefits of vaccination.

Food, contact or seasonal allergies,

including to eggs, gelatine and latex, are

NOT considered precautions or

contraindications.

8

Vaccination of special population groups

Persons with comorbidities such as hypertension, diabetes, asthma, and stable and well controlled infections (e.g.

hepatitis B or C) – vaccination recommended.

Pregnant women – Vaccination is not currently recommended during pregnancy unless the benefit of vaccinating (e.g.

health workers at high risk of exposure and pregnant women with comorbidities) outweighs the potential vaccine risks.

WHO does not recommend pregnancy testing prior to vaccination.

Lactating women – a woman who is a part of a group recommended for vaccination should be offered vaccination.

WHO does not recommend discontinuing breastfeeding after vaccination.

Immunocompromised persons – may be vaccinated if part of a recommended group for vaccination.

Persons with autoimmune conditions – may be vaccinated if no contraindications to vaccination.

HIV-positive persons – can be vaccinated if well controlled on highly active antiretroviral therapy and are part of a

group recommended for vaccination.

Persons with history of Bell’s palsy – may be vaccinated if no contraindications.

Persons who received monoclonal antibodies of convalescent plasma as part of COVID-19 therapy – defer

vaccination for at least 90 days.

More information: https://apps.who.int/iris/bitstream/handle/10665/338484/WHO-2019-nCoV-vaccines-

SAGE_recommendation-BNT162b2-2021.1-eng.pdf

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Stability and storage

Vaccine storage temperature Ultra-low temperatures

• at -80 to -60 °C in freezer; or

• at -90 to -60 °C in thermal shipper as temporary storage for up to 30 days from delivery

(should be re-iced every 5 days if opened up to 2 times a day, less than 3 minutes at a

time).

Diluent storage temperature Room temperature

Shelf life at different

temperatures

Undiluted vaccine at storage temperature -90 to -60 °C : 6 months after the time of

manufacturing

Undiluted thawed vaccine at +2 to +8 °C: up to 120 hours (5 days) prior to dilution

Undiluted thawed vaccine at temperatures up to +30 °C: up to 2 hours

Diluted vaccine at +2 to +30 °C: 6 hours after dilution

Freeze sensitivity Do not refreeze thawed vials.

Do not freeze diluted vaccine.

Light sensitivity Minimize exposure to room light.

Avoid exposure to direct sunlight and ultraviolet light.

Conditions before use At room temperature (up to 30 °C) before dilution and use

Wastage rates Will be dependent on country context

Buffer stock needed Will be dependent on country context

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Special storage and handling precaution

After vial trays are returned to frozen storage following room temperature

exposure, they must remain in frozen storage for at least 2 hours before

they can be removed again.

Closed-lid vial trays removed from frozen storage (< -60 °C) may be

at room temperature (< 25 °C) for a maximum of 5 minutes when

transferring from one ultra-low temperature environment to another.

Open-lid vial trays, or trays with less than 195 vials removed from

frozen storage (< -60 °C) may be at room temperature (< 25 °C) for a

maximum of 3 minutes when removing a number of vials needed for

the vaccination session or when transferring from one ultra-low

temperature environment to another. Once a vial is removed from the

vial tray, it should be thawed for use.

For handling dry ice and

ultra-low temperature

freezers, ensure that

protective gear (i.e.

cryogenic gloves and

goggles) are available.

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Labelling and packaging

Currently available information:

Initial pandemic supply will not include a vaccine vial monitor (VVM)

Secondary packaging

‒ Vaccine: trays holding 195 vials/1170 doses, 22.9 x 22.9 x 4 cm; volume per dose = 1.8 cm³

‒ Diluent: carton containing 25 diluent vials (10 mL vial), 13.5 x 15 x 5.6 cm

Tertiary packaging

‒ Vaccine: insulated box containing 5 secondary cartons with a total of 975 vials (5 850 doses),

40 x 40 x 56 cm

‒ Diluent: box containing 16 secondary cartons with a total of 400 vials, 29.5 x 29.0 x 24.5 cm;

the pallet holds 60 boxes containing 16 secondary cartons with a total of 24 000 vials, pallet

dimensions 121.92 x 101.6 x 137.16 cm

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Safety information (from clinical studies)

Possible events (by frequency)

Very common

(≥1/10)

headache, arthralgia, myalgia, injection site pain, fatigue, chills, pyrexia

(higher frequency after 2nd dose), injection site swelling

Common

(≥1/100 to ˂1/10)

nausea, injection site redness

Uncommon

(≥1/1 000 to ˂1/100)

lymphadenopathy, insomnia, pain in extremity, malaise, injection site itching

Rare

(≥1/10 000 to ˂ 1/1 000)

Bell’s palsy (acute peripheral facial paralysis)

Not known

(cannot be estimated

from available data)

anaphylaxis, hypersensitivity

Co-administration of vaccines

There should be a minimum interval of 14 days between administration of this and any other vaccine (against other

diseases).

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2. Vaccine safety and regulatory

considerations

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AEFI

surveillance

cycleImportant: For more information please see:

COVID-19 vaccination training for health workers Module 4 – AEFI

monitoring for COVID-19 vaccination*

COVID-19 Vaccines Safety Surveillance Manual:

https://apps.who.int/iris/bitstream/handle/10665/338400/9789240018280-

eng.pdf?sequence=1&isAllowed=y

Vaccine safety

Preventing, identifying, reporting, and handling AEFI events

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* https://openwho.org/courses/covid-19-vaccination-healthworkers-en

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Tozinameran COVID-19 mRNA vaccine ‒ COMIRNATY® received emergency use regulatory

authorizations from the listed regulatory authorities and WHO Emergency Use Listing:

1. December 2, 2020 by MHRA, the National Regulatory Authority of the United Kingdom

2. December 9, 2020 by Health Canada, the National Regulatory Authority of Canada

3. December 11, 2020 by US FDA, the National Regulatory Authority of United States

4. December 21, 2020 by EMA, the European Medicine Agency of the EU

5. December 31, 2020 by WHO, received the WHO Emergency Use Listing (EUL).

Regulatory approvals Tozinameran COVID-19 mRNA vaccine, COMIRNATY®

• These emergency, time limited approvals have been provided based on thorough assessment of mandatory information

requested by regulatory authorities and WHO, and submitted by manufacturers.

• This information includes data on the vaccine safety, efficacy and quality as a part of a risk-benefit analysis.

• Phase III clinical trials showed that the vaccine is effective at preventing COVID-19 in people from 16 years of age.

• The vaccine should receive in-country regulatory authorization before deployment and vaccination

(https://openwho.org/courses/covid-19-ndvp-en?locale=en).

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3. Administration of Tozinameran

COVID-19 mRNA vaccine

(Pfizer–BioNTech)

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Dilution of the vaccine: key stepsThaw vaccine before dilution:

Ensure that vials reach room temperature before dilution and that they are diluted within 2 hours.

Thaw vaccine (up to 3 hours at +2 to +8 °C in refrigerator or for 30 minutes at 25 °C before

dilution).

Dilute vaccine before use:

Before dilution, invert vaccine vial gently 10 times, do not shake.1

Discard mixing syringe in safety box (do not reuse the mixing syringe) and discard the vial with

remaining diluent.4

Gently invert the vial with diluted vaccine 10 times to mix; do not shake.5

Record date and time of dilution on the vaccine vial label.7

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Remember multi-dose

vial policy!

Discard any unused

vaccine 6 hours after

dilution, or at the end of

the immunization session,

whichever comes first.For more information, please refer to COVID-19 vaccination training for health workers- Module 3:

Organizing COVID-19 vaccination sessions.

2 Draw 1.8 mL of diluent from the diluent vial.

Draw up the vaccine dose at the time of administration, pre-loading vaccine into syringes is not

recommended. Use all vaccine within 6 hours after dilution.8

Add 1.8 mL of diluent into the vaccine vial; level/equalize the pressure in the vial before

removing the needle by withdrawing 1.8 mL of air into the empty mixing syringe.

3

Inspect to make sure that the vaccine is an off-white uniform suspension; do not use if

discoloured or if containing particles.

6

Important to note:

Diluent vials are single

use only. After first use,

discard. Never keep the

used diluent vial for the

preparation of the next

vaccine vial.

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Safe vaccine administration

Administer only where appropriate medical treatment to

manage anaphylaxis is immediately available*.

*

* Polyethylene glycol

1. Before, during and after vaccination, follow current

guidance for public health and social measures.

2. Position yourself sideways to the vaccine recipient.

3. Allow time for discussion about the vaccine and ask

the vaccine recipient if there are any questions.

4. Screen for contraindications and precautions

(see diagram).

5. Ensure that the person is comfortably seated.

6. Administer prepared vaccine following steps for

intramuscular injection.

For more information, please refer to COVID-19 vaccination

training for health workers- Module 3: Organizing COVID-19

vaccination sessions.

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*

* Anaphylactic reactions after administration of COMIRNATY have been

reported outside of clinical trials.

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Management of anaphylaxis

• Anaphylactic reactions after administration of this vaccine have been reported outside of clinical trials.

• Anaphylaxis is rare but potentially life-threatening reaction; proper diagnosis and urgent management are essential.

Important points in management:

• Position patient lying flat on the back with legs elevated (‘supine position’).

• If unconscious, position the patient in recovery position to ensure that the airway is clear.

• Administer adrenaline intramuscularly in the opposite deltoid to that in which vaccine was administered, or in upper

lateral thigh (see dosage and frequency in the table below).

• Call for professional assistance/ambulance and never leave the patient alone.

• Inform the AEFI focal point by phone and fill in the COVID-19 AEFI reporting form with details of the occurrence.

For more information and example of the treatment protocol for anaphylaxis see:

https://www.who.int/publications/i/item/9789241511254 (Annex 7).

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Post

vaccination

1. Discard the needle and syringe straight into the safety box, do not

recap. Dispose of empty vaccine vials and other waste in a

separate container or a waste bag.

2. Record vaccination in personal, facility and other appropriate

records.

3. Advise vaccine recipient about possible post-vaccination

symptoms (slide 12: Safety information).

4. Ensure that the vaccine recipient remains comfortably seated for

post-vaccination observation for at least 15 minutes. People with

a history of allergic reactions should be observed for 30

minutes after receiving the vaccine. You may encourage

vaccine recipients to stay for the full duration by providing the

vaccination card/home based record after the observation period.

5. Advise the vaccine recipient that he/she may take analgesics or

antipyretics to alleviate pain or temperature, if needed.

6. After the first dose of COMIRNATY, encourage a vaccine recipient

to complete the vaccination series and schedule the time for the

second dose.

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4. Ultra-cold chain (UCC) storage

and transportation

22

Orientation to the SoftBox shipper

To ensure UCC conditions are maintained

through international and in-country this

vaccine arrives in a specialized shipping

box.

22

Key datapoints

Shipping and Handling Infosheet (English-USA, Pfizer)

Resources

Vaccine capacity: Each shipper can contain up to five trays of

vaccine, for a total of 5,850 doses. Each tray contains 195 vials,

for a total of 1,170 doses per tray.

Weight: When fully loaded (i.e. five trays of vaccine, and freshly

re-iced) the shipper weighs ~36.5kg (81lbs). Carrying is facilitated

by straps on opposite sides of the shipper.

Holdover: When fully loaded with dry ice (20kgs) and opened <2

day for <5 min per opening, the shipper will maintain UCC

conditions for up to 8 days. However, it is strongly recommended

to be re-iced upon arrival and every 5 days.

(https://www.cvdvaccine-us.com/images/pdf/Shipping_and_Handling_Guidelines.pdf)

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Receiving the SoftBox shipper

International shipping of ultra-low temperature (ULT) vaccine is the responsibility of manufacturer.

On arrival, the country team needs to:

ensure rapid process of clearance from customs

transport to central storage point.

Manager Logistics focal point

Assign responsible staff to

manage receipt, clearance and

transport.

Confirm all processes and

paperwork for clearance at

least 7 days before first

shipment.

Validate content of each

shipper.

Remove vaccine trays and load

in ULT freezers in <3 minutes

to prevent exposure to ambient

temperature.

Store dry ice in ULT freezer for

re-use during in-country

distribution.

Role

Key

Tasks

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Take all shipping containers to well ventilated area.

Staff receiving the vaccine from international shipment must first wash hands thoroughly and wear PPEs (cryogenic

gloves and eye shield) before handling the vaccine boxes, vaccine vials and throughout the handling operation.

Open the shipping boxes one by one – open only second container once all the inspection, recording and

transferring of the vaccine and dry ice to ULT freezer have been completed for the previous container.

Once a box is opened, locate the temperature data logger and stop the device – make sure to check indicator that

device is indeed deactivated. Stopping the device may be tricky as it may also be frozen due to ULT.

Quickly check the vaccine content, lot number and quantities in each box and immediately transfer the vaccines to

ULT freezer.

‒ Do this one sequentially one tray at a time and make sure the vaccine is not exposed to room temperature for

longer than 3 minutes.

• Repeat the process for the succeeding containers.

• Complete the vaccine arrival report form (VAR) for Tozinameran COVID-19 mRNA vaccine (Pfizer–BioNTech).

• Once all vaccines are loaded to the ULT freezer, check the recorded temperature history during international

transport by downloading the data from the temperature data logger to a computer.

• Share the VAR and pdf report of the recorded temperature to concerned parties (identified per national guidelines).

Procedures for receiving international shipment: central store

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Receiving the SoftBox shipperWhen receiving the SoftBox shipper, there are several special considerations

The SoftBox shipper has product-specific receiving protocols in order to (i) confirm the potency of the vaccine and

(ii) ensure the safety of the vaccine and handlers during handling.

Video overview can be found here, in “Chapter 1: Storage and Handling” (English-USA, Pfizer).

Comprehensive protocol (including dry ice handling) can be found at this link (English-USA, Pfizer).

Dry ice safety sheet can be found here (English-USA, Pfizer) - https://www.cvdvaccine-us.com/ .

It is expected that the holdover time for the thermal shipper is at least 24h from the time of arrival. If the shipper is

not emptied within 24h of arrival, it is strongly recommended to re-ice it (see “Re-Icing the Softbox shipper”).

Ensure that shippers are stored in temperate (15-25 °C) and well-ventilated room. This latter is critical, because

dry ice sublimates into CO2 gas over time and can create a suffocation risk in confined areas.

Ensure that appropriate protective gear (i.e. insulated gloves and goggles) are available.

Open the shipping boxes one by one – open only second container once all the inspection, recording and

transferring of the vaccine and dry ice to ULT freezer has been completed (as applicable).

If transferring closed lid vaccine trays to UCC storage, ensure that this transfer occurs within 5 minutes of

opening the shipper. Do not open the trays or touch the vials directly.

If transferring vaccine trays to +2 to +8 °C storage, ensure that the time of removal is clearly marked on the trays.

This vaccine must be used within 5 days (120 hours). Thawed vaccine cannot be refrozen.

SoftBox shippers have an embedded temperature monitoring device. This should be deactivated upon arrival,

after which the shipment data will be made available over email and can be read from the device.

Complete the Vaccine Arrival Report (VAR), download the pdf report of the recorded temperature, and share both

to concerned parties (identified per national guidelines).

Overview

Resources

Highlights

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Re-icing the SoftBox shipperRe-icing is the process of adding more dry ice to the SoftBox shipper

Unlike many thermal vaccine shippers, the SoftBox unit can be re-iced to extend its cold life. This allows the shipper

to serve as temporary storage for up to 30 days. It is recommended that the thermal shipping container not be opened

more than 2 times a day, and should not be opened for more than 3 minutes at a time.

Video Overview can be found here, in “Chapter 1: Storage and Handling” (English-USA, Pfizer)*.

Printable protocol can be found at this link (English-USA, Pfizer)*.

Dry ice safety sheet can be found here (English-USA, Pfizer)*. – * https://www.cvdvaccine-us.com/

Dry Ice Feasibility Assessment for UCC Vaccine Storage (English, TechNet, Project Last Mile)

Re-icing occurs under any of the following conditions:

‒ if the shipper will be used to store vaccine >24h after receipt from the manufacturer

‒ if 5 days (120h) have elapsed since the last full re-icing.

To function appropriately, the dry ice used for re-icing must be in 10mm – 16mm pellet format. Other common formats

(e.g. pucks) will not provide the same insulation, and should not be used.

The SoftBox shipper is qualified with a minimum of 20 kg of dry ice pellets. The amount of dry ice needed for re-icing is

dependent on the number of openings and use. Per Pfizer dry ice re-icing guidelines, it is estimated that 15 kg of dry ice

are needed to replenish each thermal shipper during each re-icing.

Observe all dry ice handling practices (see link above), including protective gear and operating in a well-ventilated area.

During the dry-icing process, pellets will be poured around the payload, and into a bag that sits on top of the payload.

Both fills are required to ensure UCC conditions are maintained.

Once the SoftBox shipper is opened, the re-icing process should be completed in <5 minutes to avoid thawing of the

vaccine. Ensure all materials are ready before commencing the process.

Overview

Resources

Highlights

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Returning the SoftBox shipper

Unlike most vaccine shippers which are disassembled on arrival, the SoftBox shipper is reusable and should be

returned to the manufacturer via its delivery agent.

Individual SoftBox shippers must be returned ~20-30 days after receipt, requiring dedicated protocols.

Overview

Video Overview can be found here, in “Chapter 3: Returning the Thermal Shipper Container”

(English-USA, Pfizer): https://www.cvdvaccine-us.com/product-storage-and-dry-ice

Printable protocol can be found at this link (English-USA, Pfizer): https://www.cvdvaccine-

us.com/images/pdf/HH1114697_XXX_C20_PGS_Materials_ReturnInstructions.pdf .

Resources

Once a shipper is no longer required, dispose of any remaining dry ice. This is best achieved by leaving the shipper

open in a well ventilated area. When disposing, do not (i) leave dry ice to sublime (i.e. turn to gas) in an enclosed

area, as this creates a risk of suffocation, (ii) dispose down a drain, toilet, trash bin or other closed system.

Physical return of the shipper will be managed by the manufacturer’s delivery agent. The user is only responsible

for the following:

1. ensuring that all dry ice has been removed from the package;

2. ensuring that all materials (e.g. dry ice pouch, payload container) are inside the SoftBox container, and that it is

taped closed;

3. applying the pre-printed delivery label to the exterior of the box; and

4. contacting the manufacturer’s delivery provider to arrange pick-up.

Highlights

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ULT storage

and transport

options

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Storage equipment Description Requirements

Ultra-low temperature

freezers

• Active freezing: ULT equipment

• High vaccine storage capacity

• Used to store vaccine and PCM packs/ dry ice

• Temperature display (actual and set point)

• High/low temp alarms with remote monitoring

• Open door and power failure alarms

• Require stable and continuous electricity

supply

• Require AC room for efficient operation

(working ambient temperature at <30 °C)

• Require large floor space for installation and

handling

• Strategically located in or near an open/well-

ventilated area to allow ease of loading

vaccines into shipping containers for

transport and distribution, especially when

using dry ice

• Insulated gloves for safe working with ultra-

low temperatures

• Training on installation, management and

maintenance

SoftBox thermal

shipper supplied by

Pfizer

• Passive freezing: ULT insulated container

• Maintain the vaccine temperature at -80 °C to -

60°C for up 8 days when fully loaded with 20

kgs of dry ice and opened <2x per day for <5

minutes per opening

• Low-vaccine storage capacity: 5 850 doses (195

vials)

• No energy consumption involved

• Easy transport and handling.

• Can be used as alternative storage longer

provided consistent re-filling with dry ice is

ensured

• May require multiple units to store larger

number of doses

• Always check dry ice level (~20kg per

thermal shipper) and ensure secured dry ice

supply to allow regular re-icing.

• Identify a backup dry ice supplier in case

there is an interruption in supply from the

primary provider.

• Safety eye shield/goggles and insulated

gloves for handling of dry ice.

• Training on proper handling and

management

ULT vaccine: central storage options

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Choice of container Choice of coolant Description Requirements

Arktek long-duration passive

ultra cooler

Special ULT PCM • Durable material, with vial rack system

• Arktek is designed for use with PCM packs

• Large capacity range: 7.9 liters

• Weight fully loaded: 39.5 kg

• Weight empty: 22 kg

• Number of required PCM accumulators: 8

• Diameter: 52.8 cm x 74.7 cm

• With built-in temperature SMS data logger

• Cold life: -80° to -60 °C when used with ULT

PCM (frozen at -80°C ) last for 5 days without

PCM replacement with multiple opening

• Remaining PCM can be reused

• Initial high investment cost (~$5 000 each)

• Relatively bulky and not transport ergonomic

• When used with PCM:

• Each Arktek requires total of 16 metal

PCM packs to prepare for ULT storage

• two-stage freezing requirement to

condition PCM to -80 °C

• Separate ULT freezer for freezing and

storing PCM

• PCM for ULT is corrosive to plastic

material. Only metal/Aluminum PCM

packs can be used for ULT

• Training on proper handling and

management

Other commercial thermal

shippers

Dry ice only • Use only thermal shipper labeled for dangerous

goods/ dry ice use, e.g. with ‘UN1845’ (dry ice)

marking

• Some products may come with built-in

temperature data logger and vial rack system. If

none, vial rack and data logger should be

procured separately and provided per shipper

during transport.

• Large capacity range: product-specific

• Although the cold life at -80° to -60 °C is

product-specific, it can be extended with

re-icing.

• Ensure enough quantity is available for

vaccine storage and transport

• Can be re-used with proper care

• Only use this for ULT storage and with dry

ice; not to be used for other forms of

storage.

• Per IATA guidelines, 200 kg is the maximum

dry ice load allowed for cargo for UN1845

(dry ice)

• Continuous supply of dry ice:

• Procuring dry ice machine, or

• Commissioning a local supplier

• Training on proper handling and

management

ULT vaccine: remote storage and transport options

© WHO/unifeed180529i

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Transport and storage

options at service

points

Transporting and storing frozen vaccine at session site for later use (session

scheduled >24 hours up to >5 days from vaccine receipt):

• Make sure each vaccine delivery/receipt is documented per SOP, including labelling

vials / trays with date and time they were taken out of ULT storage

• For transport, use either:

a. Arktek packed with PCM for ULT with built-in temperature device;

b. thermal shipper with dry ice: presence of dry ice indicates ULT is maintained

(-80°C to -60°C).

Check dry ice level daily. If dry ice is depleting rapidly, it means frequent re-

icing is necessary. Make sure there is secured local supplier of dry ice.

During transport, reusable temperature data logger for recording ULT that has

internal sensor and external digital monitor is preferred. Disposable, sensor-

less data logger for ULT may also be used.

• Upon receipt, check delivery for content, quantity, quality, and temperature. Do this

in a way vaccine is not exposed to ambient temperature for more than 3 minutes.

• If using dry ice, regularly check the level of pellets in the shipper and re-ice as

needed.

• When vaccination date is confirmed, follow procedures for thawing vaccines and

maintaining cold chain for undiluted thawed vaccine.

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Preparing a

thermal shipper

with dry ice for

transport periods

over 24 hours

• Inspect each thermal shipper. Make sure it is clean and without

damage or signs of wear and tear.

• Estimate the number of thermal shipper and vaccine trays needed to

deliver the desired quantity of vaccine.

• Thermal shipper may come in different sizes with different

storage capacity for vaccine and dry ice.

• Take all thermal shipper to well a ventilated area.

• Staff in-charge of preparing the vaccine for transport must first wash

hands thoroughly and wear PPEs (insulated gloves and eye shield)

throughout the handling operation.

• Prepare the thermal shipper one by one. Load second box only

once the first box is completely loaded, sealed and labeled for

delivery.

• Using a small metal or hard plastic shovel, fill the bottom 1/3 of the

box with dry ice.

• Place a tray, box or transparent plastic that will hold the vaccine in

the middle of the box.

33

Preparing a

thermal shipper

with dry ice for

transport periods

over 24 hours

• Load the sides with dry ice not exceeding the rim of the tray/box.

• Load vaccines into the vaccine tray/box taking note of the vaccine

content, quantity, lot number and expiration/manufacturing date (if

available).

• Place dry ice on top of the vaccine tray/box with the use of aluminum

package, heavy duty plastic or tray to make dry ice easier to remove

when inspecting or taking vaccine vials.

• Enclose a temperature data logger in the box by placing on top of the

dry ice pack.

• Seal and label the thermal shipper before preparing another box.

• Make sure the delivery documents are duly completed and shared

per protocol.

• Check that receiving facility has secured source of dry ice for re-icing

if shipper will be used as storage.

• Prepare appropriate vehicle transport ensuring package is secured

and integrity maintained.

• Do not keep the thermal shipper with dry ice in an enclosed

compartment.

34

Preparing the Arktek with ULT PCM for transport/storage >24H

Cross section view of Arktek long-

duration passive ultra-cooler (LDPU)

1. Preparing the PCM (e.g. Plusice E-65 or other -60ºC compatible PCM)

• Wear protective gloves with long sleeves or use long sleeve shirt. The opening rim of

Arktek is extremely cold and can cause frostbite on direct skin contact.

• Shake first the liquid PCM.

• Remove the screw cover of the metal PCM packs with the use of a tool provided with the

equipment.

• With the use of a metal funnel, fill the PCM packs. Each contains 1 liter of liquid PCM.

• Fortify the screw with white tape before putting back to cover the PCM packs. This will

prevent any leakage during use.

• Once all 8 PCM packs are filled proceed with the two-stage PCM freezing process:

1. First step is conditioning the PCM for ULT ‒freezing the PCM to -20 °C for at least

24 hours.

2. Next, transfer the PCM to ULT freezer for conditioning to -80 °C (at least 48 hours).

▪ The introduction of PCM in ULT freezer may set an alarm due to sudden

elevation of temperature.

▪ To prevent this alarm, first set the ULT freezer to -50 °C, after the system

stabilizes, set to -70 °C. When the temperature again stabilizes, set to the

original setting of -85 °C.

▪ Once the first 8 PCM packs are conditioned and fully frozen, start freezing

process for next 8 PCM packs.

1. Vaccine cup stacks

2. Insulative vacuum

space

3. Removable assess

cap

4. Protective outer

shell

5. Inner shell

© Global Good/Intellectual Ventures

35

Preparing the Arktek with ULT PCM for transport/storage >24H

(continued) • Do not condition PCM in the ULT freezer where vaccine is stored. Use smaller ULT

freezer for preparing and storing PCM.

• Transfer the frozen PCM to Arktek as needed.

2. Loading the Arktek

• Make sure the Arktek is clean and labelled.

• Conditioning of Arktek to -80 °C:

• Conditioning may take a while and requires checking of temperature monitor.

• Open Arktek and with use of insulated gloves with long sleeves, carefully load

the 8 frozen PCM packs and pre-cool Arktek for 4 hours or more.

• If -75 °C to -65 °C temperature has been reached, replace the PCM pack with

another freshly frozen set. Return the first set of PCM to ULT freezer for

reuse.

• Take the vaccine out of ULT freezer and place vaccine in the vials racks. Make sure

the taller vial rack is always placed in the middle.

• Minimize vaccine exposure to ambient temperature to less than 3 minutes.

• Close the Arktek lid.

• Insert the batteries into the temperature monitoring device. They should not be

activated until the Akrtek is used.

• When ready to use, turn on the temperature control monitor.

• Vaccine stays in ULT without replacement of PCM for up to 5 days.

Internal temperature monitoring

system and screen and probes

location

Vial rack system

©Global Good/Intellectual Ventures

©Global Good/Intellectual Ventures

36

Managing

vaccine

storage and

transport at

service points

©

WH

O/C

O P

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pp

ines

37

Ph

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• Prepare the following:

• High density vaccine carrier with conditioned ice packs

and temperature monitoring device – main vaccine

storage during transport

• Regular vaccine carrier with conditioned ice packs – for

storing diluted vial during session

• Regular vaccine carrier or smaller thermal shipper

loaded with spare frozen ice packs – to replenish

conditioned ice packs mid-session

• Estimate needed quantity based on target population

• Load vaccine into the high density vaccine carrier

• Ensure vaccine is labeled with date it was taken out of

ULT storage

• Place vaccine in a container/plastic bag – keeps vaccine

label dry and intact

• Place a temperature monitoring device

• Document the loading time and arrival time, including

temperature at upon arrival

Ph

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: W

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• If temperature exceeds 30 ºC and

vaccine stayed in transit for more than

2 hours, notify supervisor, document

temperature reading and mark the

vaccine “DO NOT USE: Temperature >30ºC ‒ for discard”.

Ph

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: W

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Transporting undiluted thawed vaccine at +2 to +8 °C for use in a community outreach vaccination session

(short distance and session to be completed on same day/<24 hours).

• Two options for monitoring temperature

throughout the transportation:

• Temperature monitoring device with internal

sensor attached to external monitor –

secure external monitor on the vaccine

carrier and keep the sensor inside.

• Digital temperature monitoring device –

Kept inside the carrier throughout the

transport period. Do not open the carrier

while in transit. Check temperature only

upon arrival.

38

Managing vaccine

cold chain:

community outreach

session

Key considerations:

‒ Consider expanding vaccination team composition to ensure a

person will be dedicated to maintain vaccine cold chain throughout

the day.

‒ Ensure transport of vaccination team and logistics is integrated in

the microplan.

‒ Conduct outreach session in a shaded/covered area to keep the

vaccine carriers protected from direct sunlight/heat exposure

‒ Always check the vial label for date vaccine was taken out of ULT

storage. If label is peeled off or is unreadable, do not use. Document

and mark for discard.

‒ Regularly check the conditions of ice pack in the carriers with

vaccine; replace conditioned ice packs as needed.

‒ Ensure frozen ice packs are conditioned before replenishing vaccine

carriers to prevent risk of re-freezing vaccine. Re-freezing

completely thawed vaccine affects vaccine stability/potency.

‒ Document and report logistics information, including usage and

wastage.

39

.

Undiluted vaccine stored in high-density vaccine carrier

- Keep the undiluted vaccine vials in the high-density vaccine

carrier with temperature monitoring device.

- Open only to take out a vial to be diluted. At the same time

check temperature and condition of ice packs

- If temperature rises, replace the conditioned ice packs.

- If the vaccine carrier temperature exceeds 30 ºC for > 2h,

notify supervisor, document temperature and mark the vaccine “DO NOT USE: Temperature >30ºC ‒ for discard”.

Diluted vaccine stored in regular vaccine carrier

- Dilute one vial at a time and write time of dilution on the label.

- Diluted vaccine can be handled in room-light condition at

temperatures not exceeding 30 °C. AVOID direct exposure to

sunlight/UV light.

- Place diluted vaccine on the foam pad of a separate vaccine

carrier with conditioned ice packs for ease of access.

- Discard diluted vaccine vial after 6 hours of dilution or at the

end of the immunization session, whichever comes first.

© WHO/Lindsay Mackenzie

Managing vaccine

cold chain:

community outreach

session

High density vaccine carrier has longer cold

life than regular vaccine carrier.

40

Key considerations:

Do not open the vial trays or remove vials from ULT storage until

you are ready for thawing and use.

Plan ahead by first reviewing the number of target population for

the vaccination session.

Thaw only the number of vials needed to vaccinate your target.

Make sure vaccine is marked with date the vaccine is taken out

of ULT storage.

Use first the vaccine vials thawed earlier.

Keep the vaccine label dry. If label is peeled off or is unreadable,

do not use. Document and mark for discard.

Thawed undiluted vaccines can be kept at +2 to +8 °C for up to

5 days or at >8 °C to +30 °C for 2 hours – DISCARD vaccine if

not used within the specified period and temperature conditions.

The management of diluted vaccine in a facility-based service

delivery is same as the outreach.

Facility-based vaccination has the advantage of having easy

access to supply of conditioned ice packs.

Managing vaccine

cold chain: facility-

based session

Reminder:

Diluent vials are single

use only. After first use,

discard. Never keep the

used diluent vial for the

preparation of the next

vaccine vial.

41

Additional

resources on

ULT active

and passive

equipment

and UCC

systems

1. COVID-19 vaccination training for health workers Module 2 –

Storage, handling, delivery, and waste management for COVID-19

vaccines

2. COVID-19 vaccination: supply and logistics guidance (TechNet)

3. Dry Ice Feasibility Assessment for UCC Vaccine Storage (English,

TechNet, Project Last Mile)

4. Putting vaccines to use with an ultra-cold chain (UCC) system. A

briefing for country and programme focal points, January 2021

(WHO, TechNet)

5. Ultra-low temperature (ULT) storage & transport for vaccines: An

overview of options & challenges. January 2021 (WHO, TechNet)

6. IATA Packing Instruction 954 Passenger and cargo aircraft for UN

1845 (carbon dioxide solid or dry ice) – (IATA Website, visit to request

access) (Alternative Link)

42

5. Indicative delivery strategies for

Tozinameran COVID-19 mRNA vaccine

(Pfizer–BioNTech)

43

These slides present delivery strategies for this vaccine.

Countries can prioritize whom to vaccinate in line with the WHO SAGE

roadmap and their needs.

These strategies are designed to observe the following principles:

Minimize UCC infrastructure requirements, in order to enable broader

access and uptake of Tozinameran COVID-19 mRNA vaccine (Pfizer–

BioNTech) without significant UCC investment.

Reduce wastage risk given the novelty of UCC products to many contexts

and the stringent management requirements for this vaccine.

This section covers three major areas:

A basic single-site model with on-site administration

Considerations when expanding to multiple UCC hubs

Considerations when providing off-site administration.

Delivery

strategies

44

Ensure there is sufficient +2-8 °C vaccine storage capacity on site to thaw and

store vials ahead of administration. To limit opening of ULT freezers/shippers,

calculate estimated number of immunization per day, and transfer vaccines for

thawing in 2-8 °C storage at the start of the day. Undiluted vaccines can be

kept at +2-8 °C for 5 days.

Diluted vaccines should be used within 6 hours, so dilute periodically

calibrating to the pace of consumption.

Ensure the site is organized to minimize vaccine exposure to sunlight and

ultraviolet light.

Plan for when vaccinees should arrive on which day (e.g. by facility or

department).

General considerations

Tozinameran COVID-19 mRNA vaccine is stored at a centralized hub that serves

as both storage location and primary immunization site. To receive immunization,

vaccinees travel from within a reasonable distance to the hub.

Description

44

Core delivery model – centralized, single hub

The core form of delivery will involve conducting all administration

at the UCC storage site.

UCC

hub

In this model, vaccinees travel from within a

reasonable distance to receive immunization on-

site at the UCC hub.

45

Core delivery model – centralized, single hub

45

ULT freezers Ensure that there is sufficient secondary UCC capacity to allow periodic defrosting of equipment. In most settings,

and single additional freezer (or temporary use of the shipper) will be sufficient to allow sequential rotation and

defrosting.

Ensure that the site meets all readiness requirements described in the COVID-19 vaccination training for health

workers module 3: Organizing COVID-19 vaccination sessions and in any materials provided by the ULT freezer

manufacturer. A single power fluctuation could permanently damage the UCC freezer and place all doses at risk.

Wherever possible, prepare a contingency plan for the storage of this vaccine. In most contexts, this would be

access to an emergency delivery of dry ice. This will allow transfer of the vaccine from a ULT freezer to the

shipper.

Dry ice + SoftBox

shipper

Review storage and transport practices described in COVID-19 vaccination training for health workers module 2:

Storage, handling, delivery, and waste management for COVID-19 vaccines.

Ensure the stable performance of the thermal shipper, ensure protocols are in place to minimize the number of

times that the thermal shippers are opened to remove product each day to below two (2) times per day.

Ensure that there is sufficient dry ice supply to provide regular re-icing every five days. This is estimated to be

15kg of dry ice, per shipper, every five days. Wherever possible, identify a backup dry ice supplier in case there is

an interruption in supply from the primary provider.

In most contexts, dry ice will need to be transported from the provider to the storage hub. Dry ice in transit

sublimates at ~10% per day, so ensure volume calculations account for any delivery timing.

Considerations

if using:

Depending on the type of UCC solution being used, different considerations will apply

© HZJZ Croatia

© HZJZ Croatia

46

Ensure there is a clear plan for how vaccines will maintain UCC if transported

between hubs. If using the thermal shipper, ensure it is re-iced before any

delivery to avoid risk of excursions.

‒ In some countries, this has been supplemented by sending a delivery of dry

ice 1-2 days after the delivery of the shipper.

If using ULT freezers, each site will need to meet all conditions detailed in

COVID-19 vaccination training for health workers module 2: Storage, handling,

delivery, and waste management for COVID-19 vaccines

If using dry ice, note that dry ice is often most available near airports and

commercial capitals. For more distant hubs, ensure that delivery timing and

sublimation rates (10% / day of transit) are considered.

Ensure all relevant trainings (e.g. UCC management, vaccine administration)

have been provided to staff operating at each hub.

General considerations

In this model, there are multiple UCC hubs in a given country, likely in the largest urban

centres. The increases access to the vaccine, but also increases the scale of UCC equipment

and immunization management.

Description

46

Delivering vaccine from multiple hubs

In many settings there may be the need to have multiple hubs in order

to reach all identified target populations.

Under this approach, several hubs are established

(e.g. in major urban centers) in order to better

reach target population.

Hub A

Hub B

Hub C

200km (for illustrative purpose

only)

Illustrative example of multi-hub system

47

Off-site administration of vaccinesDelivery of vaccine at offsite locations can increase access,

but must be carefully coordinated.

Strong microplanning and coordination is needed to ensure that (i) vaccinator teams travel

with the right number of doses, and (ii) that all target populations are aware of where to go

to receive vaccination.

Limit the distance of travel from the hub to allow return and redeployment of unused doses

(e.g. <1 day of travel).

Ensure that there are protocols in place to indicate when a vaccine left UCC storage, as it

must be used within 5 days. Labelling directly on the vial or secondary packaging is

recommended.

To ensure that the vaccine is stored safely, ensure that offsite administration points have +2-8 °C storage available. Reliance on a passive storage device is not recommended.

If unused doses are returned to the hub or other storage site, ensure those doses are set

aside in a dedicated storage area and prioritized for use the next day.

Ensure that all vaccination sites meet standards described in COVID-19 vaccination

training for health workers Module 4: AEFI monitoring for COVID-19 vaccination, and in

Orientation to national deployment and vaccination planning for COVID-19 vaccines:

Vaccine safety monitoring, management of adverse events following immunization, and

injection safety.

General considerations

In this adaptation, immunization is conducted both at the central hub and at secondary locations. At these additional sites, vaccine is stored at +2-8 °C, which requires careful

monitoring to avoid undue wastage.

Description

47

UCC

Hub

In this model, nearby vaccinees travel to the UCC hub. To reach further away vaccinees, +2-8 °C

storage hubs are established as secondary

immunization centres.

2-8C

Immun.

Hub

2-8C

Immun.

Hub

2-8C

Immun.

Hub

Movement of Vaccine (2-8C)

Movement of People

Illustrative example of off-site admin model

48

6. Indemnification and liability

49

As previously communicated to countries, each AMC 92 country receiving vaccines will need to sign up to

an indemnity in the form of the Model Indemnity with the relevant manufacturer.

Countries will need to have the Model Indemnity signed and in force with Pfizer in advance of delivery.

Each country will be supported in finalizing the Model Indemnity ready for signing and put in contact with

Pfizer in order to sign.

It is important that each country undertakes the necessary process to have the indemnity agreement in

place, including concluding any necessary legislative or regulatory changes as discussed during the

country consultations, as quickly as possible.

Gavi country support teams will be the first point of contact for questions relating to the process for

agreements to be signed up to.

The Model Indemnity and the COVAX no-fault compensation program for AMC eligible economies will

apply to vaccines delivered through COVAX to AMC 92 countries.

Indemnification and liability

50

The purpose of the COVAX no-fault compensation program for AMC eligible economies (the

“Program”) is to provide no-fault lump-sum compensation in full and final settlement of any

claims to persons who suffer a serious adverse event (SAE) resulting in permanent

impairment or death associated with a COVID-19 vaccine procured or distributed through the

COVAX Facility, or its administration, in any Gavi AMC eligible economies

Before supply of vaccines of COVAX-distributed vaccines begins, it is important that each

AMC 92 country:

Determine whether the acceptance by individuals of no-fault compensation under the

Program in full and final settlement of any claims relating to permanent impairment or death

resulting from COVAX-distributed vaccines or their administration, requires any implementing

legislation within the country; and

If implementing legislation is required (see above), take all necessary steps to draft and fully

enact such legislation in a timely manner.

COVAX no-fault compensation program (1/2)

51

COVAX no-fault compensation program (2/2)

Once the Compensation Program has been established, AMC92 countries should:

Make available to vaccine recipients the instructions on “How to Submit an Application” under the Program,

which will be provided to MoHs and to organizations distributing the humanitarian buffer.

Inform Registered Healthcare Professionals of the need to carefully track/keep records of the following information

about the vaccine and its diluent (if any). Such information (among other) will be required as part of the supporting

evidence that must accompany an application under the Program: (1) name of vaccine and its diluent (if any), (2) dose,

(3) batch or lot number, and (4) expiry date.

Work with the Program’s independent claims administrator to facilitate the submission and investigation of claims,

as well as the exchange of safety information.

Raise awareness within the country about the existence of the Program, including by making individuals and MOHs

aware that:

‒ individuals will have ample time to submit an application for compensation under the Program for SAEs resulting in

permanent impairment or death, even if such SAEs arise from COVAX-distributed vaccines administered before the

Program is fully operational; and

‒ individuals will, in any event, need to wait 30 days following the administration of a COVAX-distributed vaccine

before they can complete and submit an application for compensation under the Program. The reason for this

30-day waiting period is to avoid that persons who suffer non-serious adverse events submit an application for

compensation.

52

7. Acceptance and uptake

53

Acceptance and uptake

Theme Key message

Vaccine benefits COVID-19 vaccine is a safe way to protect yourself from coronavirus disease. In clinical trials,

the efficacy of the vaccine in people with or without prior SARS-CoV-2 infection and who

received 2 doses of the vaccine was about 95%.

Eligibility Due to the limited availability of COVID-19 vaccine, countries need to prioritize groups to

receive the vaccines first in line with SAGE recommendations or country needs. Priority groups

for vaccination may include health workers, older persons, people with chronic health conditions

and other essential workers.

Trusted community

resources

If you have questions about this COVID-19 vaccine, contact your local health facility. You can

get the latest information on the COMIRNATY vaccine explainer available at:

https://www.technet-21.org/en/library/main/6857-covid-19-vaccine-explainer---comirnaty-(pfizer-

europe-ma-eeig)

Follow-up It is important that vaccinees receive the 2nd dose of the vaccine 21-28 days following the first

dose, and within six weeks. Both doses are necessary to ensure protection.

Protection

against COVID-19

Vaccination is an important way to reduce your risk for COVID-19. Before, during, and after

vaccination, vaccinees should continue to wear a mask, practice physical distance, wash their

hands regularly.