LOGISTICS AND MANAGEMENT OF THE HPV

VACCINE

Adama Town
2023
 Module 4
Logistics

Cold Chain ,Vaccine and Waste Management

Content
The session has three sections

• IPV vaccine handling and management

• HPV vaccine handling and management

• Rota sill vaccine handling and management.

Section one Learning Objective :
By the end of the session, participants will be able to:
• Describe Cold Chain .Vaccine and waste management
• Describe the characteristics of IPV .
• Estimate Vaccine Requirements for planning second dose IPV introduction at
all levels
• Estimate required net volume for vaccine storage.
• Select Cold Chain Equipment and manage stocks
• Explain the importance and advantages of safe injection and waste
management practice
• Demonstrate how to prepare ice packs and vaccine carrier properly.

4
Presentation outline

• How to properly store vaccines in refrigerator?

• How to calculate the required Vaccine quantity and storage capacity?

• How to better manage vaccine and supply stock

• How to dispose waste materials after vaccination sessions ?

5
 Cold Chain
• It is a system used for keeping and distributing vaccines in good condition.

• The cold chain consists of a series of storage and transport links, which are designed to keep vaccines
within an acceptable temperature range (+2 to +8) until it reaches the end user.

6
 Basic Cold storage Principles
• Keep ~2 cm of space between rows for circulation of air
• In top-opening refrigerators, store IPV and other freeze-sensitive vaccines on top.
• In front-opening refrigerators, store IPV and other freeze-sensitive vaccines on the
lower shelves
• For cold boxes and carriers, IPV may be freeze damaged if placed in close contact with
ice packs.
• Keep ice packs at room temperature before placing them in the cold boxes and carriers.
 Basic Characteristics Of Inactivated Polio Vaccine

A.IPV has high heat sensitivity

● IPV has increased susceptibility to heat than many existing heat sensitive vaccines

● VVM on IPV may change color faster than other vaccines

● Proper temperature monitoring and stock management is required to avoid wasting

IPV vials with VVM reaching the discard point

 Earliest expiry, first out

 Darker VVM should be used sooner, regardless of a later expiry date

 IPV characteristics Cont..ed
B.IPV is freeze sensitive Warming vaccines
shortens shelf life
● IPV is freeze sensitive
 Unlike OPV, which can be frozen
Aim for 4⁰-5⁰C

 The “shake test” is ineffective in determining whether IPV has been frozen

 If you suspect that IPV may have been frozen, the vial must be discarded
Freezing KILLS vaccines!
● Do not use if vaccine has a cloudy appearance Except OPV, Vaccines
that have been frozen are
ineffective
● Check the VVM and the expiration date
 Checking the expiration date
● Before administering any vaccine, always check the expiration date

• Expiration date: 30AUG2021.

• Use through August 31, 2021.

• Do NOT use on or after August 31, 2021

 What should you do?

For some VVMs on IPV vials, the

innersquare is getting darker but is still
lighter than outer square What should
?you do
Checking the Vaccine Vial Monitor (VVM)
• IPV vial has a VVM on the vial cap
• The VVM registers cumulative heat exposure, and changes from light to
dark
• Check the VVM on each vaccine vial
• If inside square is the same color, or darker than the circle (stage 3 or 4),
do not use the vaccine

• VVM provides information about storage

conditions, but not about potency
• VVM may be OK, but vaccine may be
expired
Where do you store the vaccine?

● Store IPV in a refrigerator, between

+2⁰C and +8⁰C
● Do not open the door frequently
● Monitor fridge temperature regularly
● Do not put IPV in the freezer
 Which vaccine should be stored in front

Vaccines with later

expiration dates should
be stored in the back

Vaccines with earlier

expiration dates and
VVM at or near Stage 2 Earliest Expiry First Out (EEFO)
should be kept in front
and used first Principle
 What should you do?

What should you do if the

refrigerator stops
?functioning
Vaccine management

Effective management and storage of

supplies can help saves;
✓ program costs,
✓ prevent high wastage rates and
✓ stock-outs, and
✓ improve the safety of immunizations.
Vaccine management
● Estimating vaccine needs for IPV should be based on the number of
children to be vaccinated, target coverage and wastage factor
● The most common method for estimation of vaccine requirements is based
on target population.
● Recommended wastage rate for IPV is 10% (WF = 1.11)
Estimating vaccine needs on the basis of target population

Annual need of vaccines = Target population x Number of doses x

Desired immunization coverage x Wastage factor
● Maximum Stock: Facilities should not have more than their maximum stock level (125%)
● Minimum Stock: Facilities should not have less than minimum stock level (25%)
● Stock-outs -no vaccine/logistics
● Below minimum stock level and over stocks are not acceptable at all level.
● All levels should monitor vaccine wastage.
 Estimating required net volume for vaccine storage
Required Storage Volume in liters = Net volume of vaccines per fully immunized
child (in lit.) x Number of children under 11 months x Immunization coverage target
Storage Capacity = Vaccines Storage Volume X Equipment Volume Factor

● It need a multiplying factor or volume factor which is 2.0 for refrigerators or freezers
that takes into consideration the need for air circulation between vaccine boxes
 Example
If the total population and target (under one year old children) population

of one health centre is 120,000 and 3.5% respectively and planned

coverage is 100%,

A.Calculate the Annual Vaccines needed?

Calculate the required storage capacity for the annual and supply period
(one month)?

Use Wastage rate for IPV – 10%. And Net volume of FIC= 0.1395L
Answers
Annual Vaccines needed=TP*Number of doses* Coverage*Wastage Factor
TP=120,000*3.5%=4,200
Annual Vaccines needed=4,200*2*100%*1.11=9324
Storage Capacity=Vaccines storage Volume*Equipment Volume
factor
Storage Volume=Net Volume of Vaccines per FIC*# of children
under 1 year*Coverage target
Storage Volume=0.1395L*4,200*100%=585.9L
Storage Capacity=585.9L*2=1,171.8Litre
 Stock Management
● It is very essential to have adequate stock of vaccines at every stage of
cold chain
● Wherever vaccines are stored, a system of stock management must be in
place to record vaccines received, and vaccines dispatched or used.
● Maintain the principle of bundling :vaccines and safe-injection
equipment are always available together; corresponding the vaccine
quantities, at each level of the supply chain.
Factors associated with Vaccines Wastages
● Poor stock management
•Over-supply
•Vaccine reaches expiry before use (recall the EEFO principle)
•Lost, broken, stolen vials
VVM change
•Cold chain failure
•Loss of potency (high temperatures)
•Inactivated vaccine (freezing)
•Poor vaccination technique
•Administration of more than recommended 0.5 ml for each injection
 Health Care Waste Management

● All used health care products should be segregated, collected, and store as per their hazardous
characteristics before disposal.
● In immunization program during routine immunization and campaign sharp waste collected and
segregated using safety boxes
● Safety boxes
 Used needles and syringes should be placed in safety boxes immediately after administering
IPV.
 It should be filled upto ¾ redline
 All filled safety boxes must be kept in a safe location, preferably locked until disposal.
Injection waste treatment and disposal

All filled safety boxes should preferably be disposed by high temperature incineration.
Steps for burning in a high-temperature incinerator:

1. Take filled safety boxes to a high-temperature incinerator

2. The incinerator should be pre-heated to about 6000C
3. The safety boxes are introduced into the incinerator and burnt between 8000C and
10000C
4. The residual ash should be disposed of in a protected ash pit.
5. If there is no incinerator at that facility refer to the Infection prevention guideline
summary

• The cold chain consists of a series of storage and transport links, which are designed to keep
vaccines within an acceptable temperature range (+2 to +8) until it reaches the end user.

• IPV Vaccine is both Heat and Freeze sensitive(Store b/n (+2 to +8)

• IPV Vaccines have VVM (Use stage 1 & 2)

• To avoid overstock and understock of IPV Proper stock management should be in place

• All used health care products should be segregated, collected, and store as per their
hazardous characteristics before disposal.

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 Section two Presentation
Outline

 HPV Immunization Logistics Requirements.

 HPV Vaccine Handling and Management

 Estimating Cold Chain Capacity

 HPV Vaccine Handling and Management

• Storing vaccines properly is crucial to maintaining

their effectiveness.
• The HPV vaccine is typically stored in a refrigerator
between 2 to 8 degrees Celsius
• Keep the vaccines in their original packaging

Side /front opening refrigerators

 Arranged in shelf 2 or 3 below freezer compartment
away from the inner wall of the refrigerator.

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 HPV Vaccine Handling and Management

In Top-Opening Refrigerators

 Arranged away from the freezer

 Store the HPV vaccines on the middle shelves,
away from the refrigerator walls and the door to
prevent exposure to varying temperatures when the

door is opened frequently.

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 The Shake Test

• HPV vaccine should never be frozen; freezing

damages the vaccine.
• Shake test is used to test a vial that has been
suspected of freezing
• If the test procedure indicates that the test
sample has been damaged by freezing, you
should notify your supervisor immediately

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 Steps of Shake Test
1 3
Prepare a frozen control sample
• The same Vaccines(batch & Manufacturer)
• Freeze the vial until the contents are solid (at least 10
hours at -10°C) and then let it thaw.
• Mark the vial clearly “CONTROL” so that it is easily
identifiable and will not be used by mistake.
2
Choose a test sample.
• Take a vial of vaccine from the batch
that you suspect has been frozen. This
is the test sample.
Shake control & test samples.
• Hold control sample & test sample together in one
hand & shake gently for 10–15 seconds.
• Leave both vials to settle
4
Compare vials. .
• If test sample shows a much slower sedimentation rate
than the control sample (milky appearance), test sample
has most probably not been frozen & can be used.
• If sedimentation rate is similar to the control sample &
test sample contains flakes, the vial has probably been
damaged by freezing & should not be used.
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 The Shake Test

• Vaccine vial monitors are vaccine control indicators

mounted on vaccine vials or ampoules at the point of
manufacture (by the vaccine manufacturer).
• VVMs are the only temperature-monitoring tool that
routinely accompany the vaccine throughout the
entire supply chain.

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 Preparations for Vaccine Delivery

• Make sure there are adequate stocks of vaccines and injection

materials.
• Make sure the cold box or vaccine carrier is clean and not cracked.
• Make sure there are coolant packs.
• Estimate the number of vaccines to deliver depending on the supply
needed for the estimated session size for schools.
• First Expiry–First Out (FEFO) method should always be followed

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 How to Pack Vaccines in a Vaccine Carrier for an
Immunization Session

• Place four cool packs around the inside walls of the

vaccine carrier.
• Place a fridge tag in the vaccine carrier.
• Place vaccines in the vaccine carrier.
• Place a sponge on top of the vaccines
• Close the lid of the vaccine carrier.
• Do not overfill the vaccine carrier
 Vaccine Wastage

• Vaccine wastage is the loss of vaccine by use, decay, erosion, or leakage.

• The causes of vaccine wastage may be system or programme related.
• Causes of vaccine wastage include:
• Breakage of vials
• Freezing
• VVM color change to discard point
• Loss of labels
• Expiry
• Break down in the cold chain system
 Strategies to Reduce Vaccine Wastage

• Accurate data are used to estimate vaccine and injection materials needed. Using
accurate data prevents stock outs or over-stocking.
• Vaccine use & wastage are monitored. Please use Form 1a (see chapter 12) to monitor
wastage of vaccine vials.
• A checklist is used to carefully distribute vaccines and supplies to the health facilities.
• Cold chain maintenance is carried out to avoid fridge break down or freezing of
vaccines.
Section three Switch of Rotarix to
ROTASIIL Vaccine

Rotavirus vaccine
characterstics and Storage
conditions
Learning objectives
 At the end of the module, the participant will be able to:
 Describe the main attributes of ROTASIIL-Liquid vaccine
 Describe storage conditions of ROTASIIL-Liquid vaccine

 Duration
 45’
 Key issues
1
What is rotavirus vaccine
?presentation
2
?How safe is rotavirus vaccine

3
At which temperature should the
?vaccine be stored

4
?Where should the vaccine be stored
 Rota Virus Vaccines
• Currently available rotavirus vaccines are live, oral, attenuated rotavirus strains of human and/or
animal origin that replicate in the human intestine to elicit an immune response.
• WHO guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines are
available.

• RotaTeq27 (Merck )
• Rotarix (GSK)
• Rotavac (Bharat)
• ROTASIIL (Serum Institute of India, India).
 What is rotavirus vaccine (ROTASIIL-Liquid) presentation?

• ROTASIIL-Liquid vaccine is a ready-to-use, oral vaccine

in liquid formulation

• it comes in a 2-dose vial (4 ml)

• Dosage:
• 1 dose = 2 ml

• Route of administration
• Oral
 What is rotavirus vaccine (ROTASIIL-Liquid) presentation?

• The vaccine should be kept at 2–8 °C, protected from light, and should not be frozen.

• The vaccine tube has a VVM7 and a shelf life of 24 months.

• For all ROTASIIL vaccine presentations, the manufacturer’s recommended schedule

is 3 oral doses given 4 weeks apart beginning at 6 weeks of age; the series should be
completed during the first year of life.

• If the same rotavirus vaccine product is not available to complete the vaccination
series, the series can be completed with a different rotavirus vaccine product
 How safe is the vaccine?

• ROTASIIL-Liquid vaccine is safe and did NOT cause any serious adverse events in clinical trials

• Fever, irritability, decreased appetite, decreased activity level, vomiting and diarrhoea are
very common side effects of ROTASIIL-Liquid rotavirus vaccine and are similar to other
vaccines

• Most of these were of short duration and mild in severity

• ROTASIIL-Liquid vaccine may be given with other vaccines in the Expanded Programme on
Immunization (EPI) schedule without interfering with their effectiveness
 At what temperature must the vaccine be stored?

 ROTASIIL-Liquid vaccine should be stored between +2oC to +8oC until the

expiry or discard point of the vaccine vial monitor (VVM)
 Care should be taken that the vaccine is not frozen
 Where do you store the vaccine?

 The rotavirus vaccine (ROTASIIL-Liquid) should be

stored in a refrigerator

 ROTASIIL-Liquid oral syringes and adapters should

be stored in a cool, dry place e.g. with polio
droppers
 Which vaccine should be stored in front?

• Vaccines with early expiration dates should be kept in front

to be used first

Later expiry
date in back

Earlier expiry
“Use first” box for
date in front
vaccines brought
back unused from
fixed or outreach
sessions
 Rotarix Vs Rotasiil main product characteristics

Characteristics Rotarix® Rotasiil-Liquid®

Presentation Single dose squeezable tube 2 dose vial, with adaptor and 2 oral
administration syringes
Dose required 2 dose series 3 dose series
VVM type VVM 14 VVM 7
Freezing Cannot be frozen Cannot be frozen
Storage and preparation Liquid, ready-to-use: Liquid, ready-to-use:
Store in refrigerators between +2oC Store in refrigerators between +2oC to +8oC
to +8oC
During Transportation Can only be transported in vaccine Can only be transported in vaccine carriers
carriers with conditioned ice-packs with conditioned ice-packs
MDVP NA (single dose) Multi-dose vials should be discarded at the
end of the immunization session, or within
six hours of opening, whichever comes first
 Vaccine Forecasting

How can we forecast Rotasiil vaccine ,

• Total vaccine needed= Target population( SI) X coverage(100%) x no. of dose (3)
X wastage factor (1.11) + buffer 25%/over supply period

• Total required syringe = (total calculated vaccine in dose /2) X 2 syringe

• Total required Adapter =(total calculated vaccine in dose /2)

• Note: make sure syringe and adapter bunding

• Use 3 dose for VRF request and 10% wastage (1.11 WF)
 Key Messages

 ROTASIIL-Liquid is an oral vaccine in liquid formulation

 ROTASIIL-Liquid comes in 2 dose vials
 1 dose is 2 mL
 Fever, irritability, decreased appetite, decreased activity level and vomiting are very common side effects
of ROTASIIL-Liquid rotavirus vaccine
 Store vaccines between +2oC to +8oC
 Store oral syringes and adapters in a cool, dry place – with polio droppers
 Vaccines with early expiration dates and VVM at discard point (or nearing discard point) should be kept in
front of the refrigerator to be used first
 Do not open the refrigerator door often
 Regularly monitor the temperature of the refrigerator
 Thank you
!for your attention

?Questions