INTRODUCING NEW VACCINES INTO NATIONAL EPI

1

• INTRODUCING NEW VACCINES INTO NATIONAL EPI

WHO/AFRO
2
Specific objectives

• Train health workers in the introduction of new
  vaccine
• Use and disposal of AD
• Management of new vaccines
• Demonstrate
• Use and disposal of AD
• Reconstitution of vaccines (if necessary)
• Vaccine administration
• Burden of disease of the country

WHO/AFRO
3
EPIDEMIOLOGY
WHO/AFRO
4
Hepatitis B (HepB)

• HepB infection is caused by HepB virus
• It can be found in the blood and other body
  fluids of infected individuals
• It Highly infectious
• The disease causes inflammation of the liver
  cells

WHO/AFRO
5
Hepatitis B Clinical features

• Acute hepatitis B
• Loss of appetite
• Tiredness
• Muscle and joint pains
• Jaundice (yellow skin eyes)
• Chronic Hepatitis
• Liver damage (liver cirrhosis)
• Liver cancer

WHO/AFRO
6
Hepatitis B Mode of spread

• Mother to baby at birth
• Child to child
• Unsafe injection
• Unprotected sex
• Traditional practices (circumcision, body
  piercing etc)

WHO/AFRO
7
Haemophilus Influenzae type b (Hib)

• Hib is one of six types of strains of the Hib
  bacteria
• The bacteria live in the nose and throat of
  infected individuals
• It mostly affect children lt5 years of age
• It accounts for 95 of life threatening Hib
  infection in infants

WHO/AFRO
8
Haemophilus Influenzae type b (Hib)Mode of
transmission

• Child to child
• Children sharing toys and other items they put in
  the mouth

WHO/AFRO
9
FORMULATIONS AND PRESENTATIONS OF NEW VACCINES
WHO/AFRO
10
Monovalent Hep B Vaccine
WHO/AFRO
11
Monovalent Hib Vaccine
WHO/AFRO
12
Combination vaccines
WHO/AFRO
13
Advantages of combined vaccines
For children and parents Comfort - fewer
injections Convenience - fewer clinic visits
For providers Compliance - increased acceptance
and coverage Simplified logistics -
surveillance/record keeping Delivery
infrastructure - potential efficiency savings
For the community Reduced disease burden -
reductions in costs
WHO/AFRO
14
Reconstitution of vaccines

• Fully liquid vaccines do not require
  reconstitution.
• Freeze-dried vaccines require reconstitution.
• The liquid for reconstitution may be a diluent or
  another vaccine (e. g. the pentavalent vaccine)

WHO/AFRO
15
VACCINE MANAGEMENT
WHO/AFRO
16
LOGISTICS AND COLD CHAIN
WHO/AFRO
17
Vaccine Forecasting

• There are two methods of forecasting needs
• Target population method (table 1)
• Previous period consumption rate method (table 2)

WHO/AFRO
18
Vaccine Forecasting

• Critical data for population method
• Target population,
• Population growth rate
• wastage rate
• Immunization coverage rate
• Vial size
• Number of doses per child

WHO/AFRO
19
Vaccine Forecasting

• Critical data for previous consumption method
• Vaccine stock level at the beginning of the
  period
• Quantity of vaccine received during the period
• Stock at the end of the period
• Quantity of vaccine wasted during the period
• Immunization coverage target

WHO/AFRO
20
Vaccine Forecasting

• Table 1 Population based method

WHO/AFRO
21
Vaccine Forecasting Table 2 previous
consumption rate method
WHO/AFRO
22
Buffer Stock

• The buffer stock ensures that sufficient stock to
  tide over sudden and unexpected shortages
• The buffer stock is calculated only once (the
  first year) and it is generally estimated at
  around 25

WHO/AFRO
23
Vaccine wastage

• Wastage must be monitored and reported
• Deliberate efforts should be made to reduce
  vaccine wastage to a strict minimum of 5

WHO/AFRO
24
How to reduce vaccine wastage

• Careful planning ordering vaccine can reduce
  wastage due to expiration
• Proper storage and handling will reduce waste
• Correct reconstitution and correct administration
  can minimise wastage
• Small dose-vials can minimize wastage

WHO/AFRO
25
Vaccine storage

• Hep B freezes at 0. 5ºC
• Monovalent Hep B or in combination should not be
  allowed to reach 0ºC or lower
• These vaccines must be store at 2C to 8C

WHO/AFRO
26
How to prevent freezing

• Reset friges to maintain temp between 2C to
  8C
• If freezing is likely, set friges closer to 8C
• Stock DTP-HepB or DTP-HepBHib or HepB on lower
  racks in a front opening refrigerator.
• Avoid storing these vaccines in the lower third
  of the top-opening refrigerator

WHO/AFRO
27
Vaccine Storage
Ice Packs in freezing compartment
DTP/HepBHib,
Thermostat
Opened vials should be kept here
WHO/AFRO
28
Vaccine Storage
Do not store DTP, HeB, Hib vaccines near
freezing (ice pack) compartment
Ice pack compartment
Vaccine compartment
Do not store vaccine in the Bottom 3/4
Icelined refrigerator, MK 304
WHO/AFRO
29
Vaccine Storage
Icelined refrigerator, MK 204 with no ice pack
compartment
WHO/AFRO
30
How to conduct the shake test
See field guide for detail
WHO/AFRO
31
Vaccines- practical tips

• If freezing is suspected, try the shake test. If
  shake test is normal, probably the vaccine is ok
• If in doubt (and if vaccine quantity is small)
  discard, but if quantity is large, contact your
  program in-charge for further advice

WHO/AFRO
32
VACCINE ADMINISTRATION
WHO/AFRO
33
Appropriate site for IM Injections in Infants
WHO/AFRO
34
Positioning Children for IM Injections
WHO/AFRO
35
Tetravalent Vaccine administration

• Tetravalent (DTP-HepB or DTP-Hib) are liquid
  formulations that do not require reconstitution
  or any additional injection equipment than what
  DTP normally required
• The tetravalent vaccines are injected
  intramuscularly into the antero-lateral aspect of
  the thigh of infant
• The dose is 0.5 ml
• Do not use tetravalent vaccine as a HepB birth
  dose

WHO/AFRO
36
PENTAVALENT VACCINE

• The pentavalent (DTP-HepBHib) uses liquid
  DTP-HepB to reconstitute the Hib component
• The pentavalent is a two dose preparation
• Every vial of the pentavalent requires one
  reconstitution syringe and two ADs for injection

WHO/AFRO
37
Pentavalent vaccine reconstitution

• The DTP-HepB must be entirely withdrawn from the
  vial using a reconstitution syringe and put into
  the vial containing the lyophilised Hib pellet.
• Shake well before use
• Check for impurities

WHO/AFRO
38
Pentavalent vaccineadministration

• The dose is 0.5 ml
• It is injected intramuscularly into the
  antero-lateral aspect of the thigh of the infant
• do not inject into the buttock,
• do not use the arm of the infant, the muscle mass
  is too small

WHO/AFRO
39
Side Effects

• Mild reactions following immunization are common
• They include pain swelling at the site of
  injection, fever, irritability, malaise
• They are self-limiting, hardly requiring even
  symptomatic treatment
• But it is important to reassure parents about
  such events so that they know about it
• Side effects are not contra-indications for
  vaccination!

WHO/AFRO
40
Contraindication

• A child with known history of severe allergic
  reaction to a previous injection with any vaccine
  should not be given that vaccine
• HIV positive status is NOT a contraindication
• BCG, yellow fever and measles should not be given
  to a child with AIDS.

WHO/AFRO
41
Injection Safety and Waste Management
WHO/AFRO
42
Injection Safety

• Reconstitution needles and syringes should never
  be used for vaccine administration
• use of auto-disable syringes for all vaccinations
• Use safety boxes for the disposal of all used
  needles and syringes

WHO/AFRO
43
Waste Disposal/management

• Where available high temperature incineration is
  the best.
• Other methods include (by order of preference)
• Burning and Burial in designated areas
• Burial in deep pit in designated areas

WHO/AFRO
44
Safety boxes

• The quantity of safety boxes should match the
  quantity of needles and syringes to disposed-of
• Safety box should not be overfill (fill only ¾ of
  the capacity)
• Safety box contents should not be transferred to
  other containers nor manipulated

WHO/AFRO
45
Safety Boxes

• Do not open them or reach inside
• Destroy (incinerate/burn and bury) as soon as
  possible at the end of session
• If leaks while transporting by vehicle, disinfect
  vehicle with bleach/water solution (1 to 10 to 1
  to 100)
• Do not sit on top of safety boxes

WHO/AFRO
46
Samples of Safety boxes
Do not fill above 3/4
The boxes come folded Like the above
WHO/AFRO
47
Injection Safety

• Preventing needle stick injury
• Do NOT recap needles
• Do NOT bend needles
• Do NOT manually remove needles from syringes
• Do NOT transport without sharp container or
  safety boxes

WHO/AFRO
48
Safe Vaccination Practices

• Do not store vaccines diluents with other
  medicines such as insulin or laboratory reagents
• Do not inter-change diluents
• Never use expired vaccines or diluents
• Never use vaccines or diluents that show signs of
  contamination

WHO/AFRO
49
Ensuring vaccine safety

• Discard leaking or cracked vials
• Discard vaccines or diluents with abnormal
  appearance
• Discard vaccines or diluents submerged in water
• Discard vaccines reconstituted more than 6 hours
  or at the end of the session

WHO/AFRO
50
Keeping needles and syringes sterile

• Do NOT touch parts that come into contact with
  the vaccine or the injection site
• Never touch the needle with your fingers (for
  non-touch areas, see next slide).

WHO/AFRO
51
Do NOT touch
Do NOT touch
Do NOT touch
WHO/AFRO
52
Examples of ADs
WHO/AFRO
53
Monitoring Adverse Events Following Immunization
(AEFI)
WHO/AFRO
54
AEFI

• AEFIs are events or reactions observed after
  immunization. Some of these events may be due to
  the vaccine, some due to error in the
  administration of the vaccine or some may be pure
  coincidence in time
• AEFIs may range from mild side effects to
  potentially life-threatening, but rare,
  complications

WHO/AFRO
55
AEFI Corrective Actions

• Action must not wait for investigation to be
  completed
• Treat the patient(s) as the first response
• Once the investigation is completed, publicise
  the results
• Take corrective actions, where necessary
• Training of health workers supervision to
  prevent avoidable AEFIs in future

WHO/AFRO
56
Monitoring New Vaccine Introduction Process

• Monitoring introduction process of new vaccines
  is keeping a close watch on the various
  operational aspects of the introduction process
  to ensure that all pieces are in place. Such
  pieces include
• Training of health workers
• supplies of vaccines injection equipment
• cold chain and logistics
• advocacy and social mobilisation
• adaptation of forms, registers, cards etc.

WHO/AFRO
57
Monitoring Implementation

• Monitoring implementation of new vaccine plan
  should be part of regular monitoring of the EPI
  activities
• it involves regular collection of routine
  reports, analysis of the data collected, and
  feedback for action where relevant

WHO/AFRO
58
Monitoring Implementation Indicators

• Important indicators for monitoring are
• coverage with the new vaccines
• drop out rates
• vaccine wastage rate
• adverse events following immunization
• stocks, consumption, supply of vaccines,
  injection cold chain equipment and waste
  disposal

WHO/AFRO
59
Impact Evaluation

• For Hib disease, having a good laboratory that
  can culture and differentiate Hib is crucial to
  assess the decline in Hib meningitis rates
• While it is more difficult to attribute reduction
  in pneumonia to Hib, there may be decline in
  overall deaths due to pneumonia

WHO/AFRO
60
Impact Evaluation (IE)

• IE is to see if the vaccination has reduced the
  disease burden
• For hepB, it takes many years before any
  significant impact can be measured.

WHO/AFRO