COVID-19 vaccination

training for health workers

Module 2:

Storage, handling, delivery,

and waste management for
COVID-19 vaccines
© WHO/Blink Media – Giliane Soupe
 |2

o Module 2 consists of three sections:

Module 2: Overview
• Part A: Programmatic implications of
COVID-19 vaccines

• Part B: Managing storage, transport,

and delivery of COVID-19 vaccines

• Part C: Cold-chain management at

the vaccination post and waste
management at the facility level
MODULE 2
Part A: Programmatic
implications of COVID-19
vaccines
 |4

At the end of this section, you should be:

Learning objectives o able to identify key programmatic
considerations that are new or different for
COVID-19 vaccines; and
o able to describe with key planning elements
to prepare for COVID-19 vaccine.
 |5

What can you expect to be

different in logistics for
COVID-19 vaccine introduction?
 |6

o There are many unknowns:

Stability data of
• Vaccine Vial Monitor (VVM) type;
candidate vaccines
are not yet available • qualification to multi-dose vial policy
(MDVP);
• shelf life ‒ some vaccines may only
show date of manufacture; and
• light sensitivity.

o Expiration information is likely to be

available in the product information
leaflet.

Refer to the package insert which may

be available through QR code and/or
manufacturer’s website link.
 |7

o Currently no COVID-19 vaccines are

WHO prequalification prequalified by WHO.
status of vaccines o Some vaccines may be prequalified at
the time of deployment.
o Most vaccines will be used under
WHO Emergency Use Listing (EUL)
procedures.

o What is EUL?
• EUL process is developed by WHO to
expedite the availability and use of
unlicensed medical products needed in
public health emergency situations.

https://www.who.int/medicines/regulation/prequalification/prequal-
vaccines/QA-EUL-General_July-2020.pdf
Vaccines may or may not have VVM on the label or cap |8

o The location of the VVM on

the vial (e.g. label or cap) will
depend on stability data and
the suitability of multi-dose
vial policy (MDVP).
o If the VVM is available, follow
the VVM guidelines to decide
which vaccine to use or
discard.
Planning for a successful introduction |9

Use the “How to prepare for COVID-19 vaccine management” checklist to guide you!

o Preparation for vaccine arrival o Transport o Storage

• Ensure efficient internal
communication and information
sharing.
• Maximize use of a traceability
system, such as barcode and/or
QR code.
• Track vaccine movement to
reduce the risk of fraud or
diversion.
• Keep the vaccine in secondary
packaging to enable scanning of
barcode/QR code.
• Ensure appropriate • Install reliable
equipment and continuous temperature
coolant-packs. monitoring system.
• Using temperature • Monitor temperature
dataloggers in each more frequently (more
transport box is than 2 times a day).
preferred. o Timing
• Maximize COVID-19
vaccinations to reduce
wastage.
MODULE 2
Part B: Managing storage,
transport, and delivery of
COVID-19 vaccines
 | 11

At the end of this section, you should be

Learning objectives able to:
o explain cold-chain requirements for
COVID-19 vaccines and diluents; and
o explain storage principles/conditions at
the health facility as well as for outreach
and campaign vaccination posts (e.g. for
vaccines and diluents).
 | 12

o COVID-19 vaccines candidates currently

Storage requirements being developed can be categorized by three
for COVID-19 vaccines storage requirements (as of December
2020):
Vaccines required to be The WHO guidance for
stored at +2 to +8 ºC managing vaccines will apply.

Vaccines required to be
stored at -20 ºC

Requires significant investment

in ultra-cold-chain (UCC)
Vaccines required to be storage and transport capacity.
stored at -70 ºC Training on handling of vaccines
will be necessary.
 Cold chain surge capacity options to manage COVID-19 vaccine | 13

Storage
Standard procedures If storage capacity is insufficient, consider:
temperatures
• Map all cold-chain storage points • procurement of solar direct drive (SDD),
(both public and private) at this ice-lined refrigerators (ILRs) and/or cold
temperature range. boxes and vaccine carriers;
+2 to +8 °C • Conduct a gap analysis to determine • leasing of a private facility;
cold-chain storage needs. • splitting shipments and increasing distribution
frequency; and
• staggering campaigns.
• Map all cold-chain storage points • procurement of freezers, cold boxes, and
(both public and private) at this vaccine carriers;
temperature range leveraging all • leasing of a private facility;
-20 °C
polio vaccine infrastructure. • splitting shipments and increasing distribution
• Conduct a gap analysis to determine frequency; and
cold-chain storage needs. • staggering campaigns.
Most health workers are not familiar with managing vaccines at this temperature range.
Follow the recommended strategy for managing ultra-cold-chain equipment, including
-70 °C
recommended coolant-packs and use of personal protective equipment (cryogenic gloves).
(Refer to COVID-19 ACT-A country guidance on supply, distribution and logistics)
 | 14

How to manage COVID-19 vaccine

stored at +2 to +8 ºC?
 | 15
What TO do:
o Ensure all vaccines and diluents are kept in their
8 principles for original secondary packaging and are clearly labeled.
COVID-19 vaccine o Whenever possible, keep both vaccine and diluent in
stored at +2 to +8 ºC the same refrigeration unit.
o Monitor and record temperature more frequently
(>2x/day).
o Investigate any fluctuation of temperature and correct
the root cause as soon as possible.
o Use a labeled container or tray for loose unopened
vaccine vials to facilitate inventory.
o Follow the “first manufacture/expiry, first out” principle:
• use first the vaccine with earlier manufacturing/expiry
date and/or darker VVM (if available) to minimize
wastage.
o Record and discard all wastage of vaccines
immediately according to national guidelines.
o Review and update contingency plan in case of power
failure, equipment breakdown, or cold chain breach.
 | 16

What NOT to do:

General principles for o Do not return opened vaccine vials to the cold
COVID-19 vaccine chain. Discard them according to existing
stored at +2 to +8 ºC standard operating procedures (SOPs).
o Never put vaccines in contact with or close to the
evaporator plate in the refrigerator.
• Since heat/freeze sensitivity information is not fully
known, keep vaccine vials in the middle section,
especially if the refrigeration unit has a freezer
compartment, to avoid freezing the vaccine.
o Do not keep reconstituted vaccines for more
than 6 hours after opening or after the end of an
immunization session, whichever comes first –
this may change once vaccine stability
information is available.
 | 17

How to manage COVID-19

vaccine stored at -70 ºC?
 What TO do: | 18

o In addition to general cold-chain management

How to effectively principles for +2 to +8ºC, when handling
store vaccine in vaccines stored at UCC, it is also essential to:
Ultra Cold Chain • follow existing guidance specific for UCC
management;
(UCC)
• use appropriate personal protective
equipment (e.g. cryogenic gloves) for
personnel in charge of managing UCC; and
• follow guidance and apply best practices for
managing and disposing of used phase-change
material (PCM).

All responsible personnel (supply-

chain/cold-chain personnel, vaccination
team and supervisors) should be trained
and demonstrate ability to manage UCC
according to SOPs.
 | 19

What NOT to do:

Principles for storing o Do not return opened vaccine vials to the cold
vaccines chain. Discard them according to existing
guidance.
o Do not store laboratory specimens, drinks,
food products, or expired health products with
vaccines.
o Do not keep vaccines with VVM that have
reached the discard point.
o Do not keep expired vaccines in the
refrigerator.
 | 20

What types of supplies/equipment are

needed for UCC?
 | 21
o UCC equipment is costly and not
recommended to be installed in every facility.
Storing COVID-19
• Establishing a UCC hub at national and strategically
vaccines requiring at sub-national level is a cost-effective approach.
UCC at facility level • Utilizing available cold-chain or UCC facilities from
private sectors with appropriate training and
monitoring system is a practical approach.
o Use of long-term passive containers and
Cryogenic gloves
thermal shippers to store vaccines and
to conduct immunization session is
favourable at facility level.
o UCC supplies/equipment recommended at the
facility level:
• cryogenic gloves
©WHO/unifeed180529i
https://www.unmultimedia.org/tv/unifeed/asset/2163/2163924/
• Arktek + PCM
• thermoshippers + dry ice
• dry ice box + dry ice.
There are 2 types of Arktek passive vaccine storage device | 22

1. Arktek passive vaccine storage device: a

super-insulated container optimized to safely
store vaccines between 0 to +10 ºC for
35 days or more, using only coolant-packs in
hot zone conditions.
2. Arktek + PCM: a modified version of the
Arktek device that uses phase-change
material rather than coolant-packs to
maintain a cold environment for up to 6 days.
© WHO/Sean Hawkey

Specific PCM packs are frozen around –70 °C

and have stable thermal characteristics.
 | 23
o Phase-change materials (PCMs) are substances
Phase-change that improve thermal performance when applied
to a cold-chain product by transitioning from
materials require solid to liquid or vice versa.
special considerations
Human health risk Environmental risk
UCC-suitable PCM • Health hazards posed by • The PCM CrodaTherm™ 5
the PCMs are minimal if is found to be toxic to some
their primary container is aquatic life.
intact. • Most other PCMs were
• Health hazards that can biodegradable and none
occur if PCMs leak out of were environmentally
their primary container are: persistent, bio-accumulative,
• potential serious eye or contained toxic
©Global Good/Intellectual Ventures irritation from leaking chemicals.
S8 salt hydrate; and • To minimize the risk,
+2 to +8ºC
suitable PCM • potentially fatal release of the PCMs into the
complications from environment should be
aspiration/ingestion of avoided.
paraffin PCM.

©WHO/Jawad Jalali
https://path.azureedge.net/media/documents/DT_pcm_summary_rpt1.pdf
 | 24

Managing transport and delivery of

COVID-19 vaccines
General considerations when transporting vaccines | 25

o Plan route of vaccine delivery and time to each destination to include time for
checking temperature based on existing guidance.
o Assess potential risk to delivery personnel and delay delivery for foreseeable reasons
(e.g. weather conditions), and include risk mitigation strategy in the plan.
o Ensure reliable transport and sufficient funds for fuel. Refrigerated vehicle equipped
with datalogger is preferred; consider renting, if needed.
o Bundle supplies when delivering to ensure all logistics are available for vaccination.
o Ensure required documentation is duly prepared and available before departure.
o Never transport multi-dose vials that are opened. Discard open multi-dose vials.

© WHO/Jawad Jalali © WHO/Lindsay Mackenzie © WHO/Sephi Bergerson © WHO/Sephi Bergerson

Transporting COVID-19 vaccine at +2 to +8 ºC | 26

o Use only recommended transport boxes with

adequate and appropriately prepared coolant-packs.
o Monitor temperature, preferably using dataloggers,
as this allows monitoring throughout the transport
period and download of data at the end of the trip.
• For the datalogger inside the container: check the
temperature at the end of the trip (avoid exposing vaccines
to temperature change from frequent openings).
• For dataloggers with outside reader: check temperature ©WHO/PQ website
at least 2 times during the trip.
o Complete deliveries in daytime if possible to reduce
risk of robbery and/or consider the safety of delivery
personnel.

©WHO/PQ website
 Transporting COVID-19 vaccine at UCC (-70 ºC ) | 27

When transporting vaccines in UCC, the following specialized

containers with dataloggers are recommended:

Arktek + PCM Dry ice +

thermoshippers

O
R

©WHO/unifeed180529i ©WHO/unifeed180529i
©WHO/PQ website ©Global Good/Intellectual Ventures Source: https://www.unmultimedia.org/tv/unifeed/asset/2163/2163924/
MODULE 2
Part C: Cold-chain management
at the vaccination post and
waste management at the
facility level
 | 29

At the end of this section, you should be

Learning objectives
able to:
o identify and describe actions in case of
insufficient cold-chain capacity at the health
facility level; and
o describe waste management options and
comply with procedures.
 | 30

Managing cold chain at the vaccination post

 Vaccine carriers (VC) | 31

Vaccine stored at +2 to +8 ºC: Vaccine stored at -70 ºC:

vaccine carriers thermal shippers
There are two different types of • Specific vaccine carriers requiring dry ice
vaccine carriers: • Temperature range: -80 to -60 ºC
• Capacity: 3.4 to 6.2 litres
1. Standard VC without a barrier • With vial rack system
separating the vaccine storage • Built-in temperature datalogger
compartment from the
©WHO/PQ website
conditioned ice-packs;
2. Freeze-preventive VC with a
barrier separating the vaccine
storage compartment from the
frozen ice-packs.

©WHO/unifeed180529i
©WHO/PQ website
https://www.unmultimedia.org/tv/unifeed/asset/2163/2163924/
Handling COVID-19 vaccine vials after opening
o Always check for latest information about
the suitability of vaccine to the MDVP.
o As a precaution to maintain vaccine safety
and quality, the following are recommended
until more information becomes available:
• For opened vials, if possible, use a separate
vaccine carrier with a temperature monitoring
device to allow monitoring of temperature
during use.
• Reconstituted vaccine should be discarded
6 hours after opening or at the end of
immunization session, whichever comes first.
| 32
o Do not use opened vials if
temperature in vaccine carrier is
found to exceed recommended
range – discard vials and replace
the coolant-packs as needed.
o Never expose opened vials to
direct heat, light or sunlight.
o Never transport or return opened
multidose vials used in vaccination
to the cold chain – discard them.
 | 33

What is reverse logistics?

When would you use reverse

logistics?
 Reverse logistics | 34

Reverse logistics is the process of retrieving unused vaccines either to dispose or reuse.

Possible reasons to conduct reverse logistics:

o Need to re-allocate vaccines to higher-risk areas based on latest epidemiological information

o Return of unused vaccine to higher-level store at the end of vaccination campaign (if relevant)
o During temporary pause of vaccination campaign for any reason
o To recall the vaccine for any reason
Reallocate

Store
COVID-19 vaccine
reverse logistics

Dispose
 | 35

Health-care waste management

at the facility level
Disposal of syringes | 36

o Use auto-disable (AD) syringes and dispose

of them as sharps waste.
o Without recapping the needle, discard the
used syringe into the safety box or safe
syringe container.
o Do not fill the safety box more than ¾ of its
capacity or up to the red line marked on the
container.
o Ensure the box is properly labeled with the
infectious substances symbol.
o Seal the safety box before transporting it to
the treatment site.
Disposal of vials | 37

o Put used vaccine vials and unopened

vaccine vials which have expired or
suffered heat exposure into a red or yellow
bag for infectious waste, or into a
biohazard container.
o Open vials posing a risk of cuts may be
classified as sharps waste.
o Ensure that bags/containers are properly
labeled with the infectious substances
symbol.
o Seal the containers before transporting
them to the treatment site.
Disposal of PPE | 38

o PPE includes single-use gloves, aprons and

gowns, surgical masks, face protectors in
the form of glasses, goggles or face shields.
o Use a room/place away from the vaccination
area to remove all used PPE.
o Consult the national guidelines to follow
special procedures for removing PPE.
o After safely removing used PPE, put them
into a special waste container or bag for
infectious waste (yellow or red).
o Ensure that bag/container is properly labeled
with the infectious substances symbol.
o Seal the containers before transporting them
to the treatment site.
Key considerations for used PCM | 39

PCM containers for Arktek

o PCM is held in plastic or metal
containers and as long as the containers
are intact, the PCM should not enter the
environment.
o But, plastic and metal will degrade over
time and the ambient conditions of many
cold-chain equipment (CCE) disposal
locations (e.g. open-air landfills or other
outdoor areas) will speed the degradation
or facilitate puncturing of the container.
o Therefore, PCM should ideally be
drained for proper disposal at the end
of their useful life. ©Global Good/Intellectual Ventures
Resources | 40

o COVID-19 Vaccination Country Guidance on Supply, Distribution and Logistics

o Policy brief on health products traceability
https://www.who.int/medicines/regulation/traceability/draft-policy-brief-on-traceability-health-products-comments/en/
o Prequalification resources
https://www.who.int/medicines/regulation/prequalification/prequal-vaccines/QA-EUL-General_July-2020.pdf
https://www.who.int/medicines/regulation/prequalification/prequal-vaccines/EUL_PQ_Vaccines/en/
o Waste management resources
https://www.euro.who.int/__data/assets/pdf_file/0012/268779/Safe-management-of-wastes-from-health-care-activities-Eng.pdf
https://www.technet-21.org/en/library/main/6388-appropriate-disposal-of-immunization-waste-(adiw)-platform
https://reliefweb.int/sites/reliefweb.int/files/resources/WMC-19.pdf
o Ultra-cold chain/Phase-change materials
https://path.azureedge.net/media/documents/DT_pcm_summary_rpt1.pdf
https://www.intellectualventures.com/buzz/insights/ivs-global-good-fund-a-legacy-of-impact-invention
o Learning from Ebola and Measles
https://www.who.int/csr/resources/publications/ebola/gevit_guidance_may2016.pdf
https://www.who.int/immunization/diseases/measles/SIA-Field-Guide.pdf