The Expanded Program On Immunization (EPI)

By Prof. Drs Asmaa ABelAziz Alaa Hassan

The Expanded Program On Immunization (EPI)

The Objectives of the lecture:

State the objectives of EPI. Outlines the schedule of compulsory immunization of KSA. Recognize the scientific principles of immunization . List the contraindications to vaccination. Explain the four strategies for the vaccine delivery.

Define missed opportunity for immunization.

Mention the reasons for missed opportunity. Define the cold chain. Discuss the three components of the cold chain. Interpret the tools for the cold chain monitoring.

The objectives of EPI:

1. To achieve 100% coverage with all EPI vaccines. Example: The coverage rate for measles vaccine by the year 2002 in a city Y=

The No. of the infants received measles vaccine in the year 2002 in city Y X100 The total No. of the targeted infants during the same year & locality

2. Eradication of polio to maintain polio free status.

3. Elimination of measles.

4. Reduce

seroprevalence of
(HBsAg)to <1%

among under five.

HBV

5.Elimination of Neonatal Tetanus .

6. To maintain zero level of diphtheria.

7.Prevention of severe forms of TB ( TB meningitis &military TB).

12 year old girl with TB meningitis

8. To reduce the incidence of whooping cough

9-Reduce the incidence of Bacteria Meningitis due to haemophelus influenza

9. To maintain immunization safety.

10.To prepare for introduction of new vaccines

The Schedule of Compulsory Vaccination in KSA

At birth

Diseases

Type of vaccine

Dose

Rout of administration

1-BCG

TB

Live attenuated, variant

0.01ml ID injection in left deltoid

2-HBV

Hepatitis B

Recombinant, yeast derived HBs antigen

0.5 ml

IM thigh

2ndmonth

Diseases

Type of vaccine

Dose

Rout of administration oral IM thigh

1-OPV 2-HiB

Polio Hib disease

Live attenuated polysaccharide conjugate

2 drops 0.5 ml

3-HBV

Hepatitis B

Recombinant, yeast derived HBs antigen

Toxoid (D) Toxoid (T) Killed pertussis (P)

0.5 ml

IM thigh

4-DPT

Diphtheria Tetanus Whooping cough

0.5 ml

IM thigh

4th month

Diseases

Type of vaccine

Dose

Rout of administration oral IM thigh

1-OPV 2-HiB

Polio Hib disease

Live attenuated polysaccharide conjugate

2 drops 0.5 ml

3-DPT

Diphtheria Tetanus Whooping cough

Toxoid (D) Toxoid (T) Killed pertussis (P)

0.5 ml

IM thigh

6 th month

Diseases

Type of vaccine

Dose

Rout of administration oral IM thigh

1-OPV 2-HiB

Polio Hib disease

Live attenuated polysaccharide conjugate Recombinant, yeast derived HBs antigen Toxoid (D) Toxoid (T) Killed pertussis (P)

2 drops 0.5 ml

3-HBV

Hepatitis B

0.5 ml

IM thigh

4-DPT

Diphtheria Tetanus Whooping cough

0.5 ml

IM thigh

12th month

The disease
Measles, Mumps German Measles

Type of the vaccine

Dose

Mode of administration

1-MMR

All Live attenuated

0.5 ml

Subcutaneous

18th month

Diseases

Type of vaccine

Dose

Rout of administration oral IM thigh

1-OPV 2-HiB

Polio Hib disease

Live attenuated polysaccharide conjugate

2 drops 0.5 ml

3-DPT

Diphtheria Tetanus Whooping cough

Toxoid (D) Toxoid (T) Killed pertussis (P)

0.5 ml

IM thigh

4- 6th years

Diseases

Type of vaccine

Dose

Rout of administration oral

1-OPV 2-MMR

Polio - Measles - Mumps - German Measles

Live attenuated All Live attenuated

2 drops

0.5 ml

IM thigh

3-DPT

Diphtheria Tetanus Whooping cough

Toxoid (D) Toxoid (T) Killed pertussis (P)

0.5 ml

IM thigh

BCG (At birth)

Live attenuated variant. 0.01ml . ID injection in left deltoid (Why)

HB Vaccine:
at birth,2nd,6th month Recombinant, yeast derived HBs antigen
0.5 ml IM anterolateral of the thigh

OPV : (Sabin)
2nd , 4th, 6th, 18th& 4- 6th years

OPV live attenuated ,2drops ,Oral

Hib Vaccine

Haemophilus influenzae type b

Severe bacterial infection, particularly among infants During late 19th century believed to cause influenza Immunology and microbiology clarified in 1930s

Haemophilus influenzae type b Pathogenesis

Organism colonizes nasopharynx In some persons organism invades bloodstream and cause infection at distant site Antecedent upper respiratory tract infection may be a contributing factor

Haemophilus influenzae type b

Clinical Features*
Epiglottitis 17% Meningitis 50% Pneumonia 15%

Osteomyelitis 2% Arthritis 8% Cellulitis 6%

Bacteremia 2%

*prevaccination era

The Type of Hib vaccine inactivated polysaccharide

conjugate vaccine,
It is made by joining a piece of the polysaccharide capsule that surrounds the Hib bacterium to a protein carrier.

This joining process is called conjugation.

Haemophilus influenzae type b Meningitis

Accounted for approximately 50%-65% of cases in the prevaccine era Hearing impairment or neurologic sequelae in 15%30% Case-fatality rate 2%-5% despite of effective antimicrobial therapy

Incidence*of Invasive Hib Disease, 1990-2004

25 20
*Rate per
100,000 in children <5 years of age

Incidence

15 10 5 0
1990 1992 1994 1996 1998 2000 2002 2004

Year

After a Hib primary series of two or three doses,95% of infants develop protective antibodies

Although Hib vaccines provide long lasting immunity the

duration of immunity is not known The recommended dose for all is 0.5 mL. Always administer by the IM injection in the thigh. The preferred injection site in older children and adults is the deltoid muscle in the upper arm.

Small child receiving Hib vaccine into the muscles of the thigh.

Adolescent receiving Hib vaccine into the deltoid muscle of the arm.

Storage of the vaccine

The vaccine should not kept frozen or exposed to
freezing Store at 2 to 8C Shake vial vigorously before withdrawal and use. Do not use if resuspension does not occur with vigorous shaking. The vaccine should be administered shortly after withdrawal from the vial.

Give all infants, including premature infants, a primary series of Hib vaccine beginning at 2 months of age. Do not administer Hib vaccine to infants younger than 6 weeks of age because this

may induce immunologic tolerance to further

doses of Hib vaccine.

The most common adverse reactions after Hib

vaccination are
1-local reactions: swelling, redness, or pain at the injection site. 2-Fever also can occur in as many as 5% of recipients. Fever usually starts within the 1st 24 hours of vaccination and may last for 2 to 3 days. These reactions can be treated with

a non-aspirin pain reliever, if needed.

local reactions: swelling, redness, or pain at the injection site.

The main contraindication to Hib vaccine :

Severe allergic reaction Do not give Hib-containing vaccine to anyone who has had a prior severe allergic reaction to a dose of Hib vaccine or to a component in the vaccine. Persons who are severely allergic to diphtheria toxoid, meningococcal vaccine, or tetanus toxoid

also may be sensitive to a particular Hib vaccine

because of the protein carriers used to create the conjugate vaccines.

DPT vaccine:
2nd, 4th ,6th, 18th months& 4-6 years
(D ,T) Toxoid & Diphtheria , (P) Killed pertussis

0.5 ml ,IM thigh

DPT:
2nd, 4th ,6th, 18th months& 4-6 years

DT:
No pertussis component

It is given as subsequent doses to an infant who showed severe adverse effects

due to pertussis component.

dT:
No pertussis component. A small dose of diphtheria toxoid is given at school entry or after the age of six years.

MMR Vaccination:
12th month& 4-6 years Live attenuated ( Three : measles, German measles& Mumps) 0.5 ml Subcutaneous arm

Basic Principles to be considered in immunization schedule:

1-All EPI antigens are safe and effective if administered

simultaneously.
2-The recommended interval between two doses of - Live attenuated vaccine . - Inactivated vaccines. 3-The only live attenuated vaccine given to HIV child is

measles

4-Tetanus immunoglobulin (250 IU) must be given to

babies : i) Born outside hospital in unsanitary home conditions ii) Seen within 10 days after birth. ii) Whose mothers are not given two documented doses of TT. 5- Introduction of HB vaccine in 1990.

6-MMR vaccine is given not before the 12months not to

be neutralized by maternal antibodies

Contraindications to vaccinations:
Absolute

Temporary

Contraindications to live attenuated vaccines:

Absolute:
1- History of anaphylactic reactions. 2- Subsequent doses of pertussis vaccines are absolutely contraindicated if the child gets (within 48 hours of vaccination ) Fever (40.5) , Collapse or shock .

Persistent crying for 3 hours without apparent cause.

Convulsion with or without fever within 3 hours after vaccination. 3- HIV infection is an absolute contraindication to administration of live attenuated vaccines ( OPV & BCG).

Temporary:
1- Pregnancy. 2- Severe illness that needs hospitalization. 3- Immunosuppression. 4- Recent receipt of blood.

The strategy for the vaccine delivery:

(I) The static immunization strategy.

(II) The National Immunization Days (NIDs).

(III) Mopping up Immunization. (IV) Outreach immunization.

I) The static immunization strategy:

Advantages of integration of immunization services through (MCH): 1-Available resources.

2- Cold Chain maintenance.

3- Save ,time, effort and money.

(II) The National Immunization Days (NIDs):

It is periodic immunization of all the eligible targets in a defined group over a large geographic areas within a short period of time. It is one of the strategy for polio eradication and tetanus elimination.

For successful NIDs for polio:

Two doses of OPV are given to all children in the age group
0-59 months within 1-3 days. It is conducted in two rounds (4-6weeks apart). The doses of OPV given are extradoses and do not replace the routine doses given during infancy.

The NIDs are conducted during low season of polio transmission

Most countries conduct NIDs annually for at least three years and until polio is reduced from being an endemic disease to a disease that occurs only in focal areas. Then the Mopping Up Immunization is conducted.

(III) Mopping up Immunization:

It is house-to-house immunization with OPV in high risk districts. It consists of two to three rounds 4-6 weeks apart .

Each round should be completed within a short period of time (3days). High risk districts are those: Where the wild polio virus is still circulating

( polio case in the last 36 months) .

With low immunization coverage. Transient population, with overcrowding poor sanitary environment and low access to health services.

(IV) Outreach immunization:

What is the difference between the NIDs and the out reach Strategy?
The outreach is carried for routine immuniation that is compusory

for the targets in certain areas where:

- immunization services are not accessible. - vaccination coverage is Low.

The outreach is carried during any time without specific duration.

Limitations: (i) Expensive (ii) Cold chain failure. (iii) Difficulty to arrange the immunization schedule.

Missed opportunity :
It occurs when a child or a woman in child bearing period comes to the health facility or outreach site and does not receive any of the vaccine doses for which he or she is eligible.

The reasons for missed opportunity are:

Health workers` practices.
Logistical problems.

Failure to administer simultaneously all the vaccines for which the child is eligible.
False contraindications to immunization.

False contraindications to immunization:

Conditions that are wrongly considered as contraindications: Minor illness( respiratory tract infections ,diarrhea, fever < 38.5C). Prematurely or small for date infants. Child being breast-fed. Family history of convulsion.

History of jaundice at birth

Chronic health problems: Malnutrition ,allergy, asthma, other atopic manifestations, hay fever ,chronic diseases of heart, lungs, kidney or liver, cerebral palsy & Down syndrome ,dermatoses, local skin lesion. Treatment with antibiotics, low dose corticosteroids( local or inhaled)

The cold chain:

It is the system of storage and transportation of the vaccine at low temperature (cold condition) from the manufacture till it is consumed. Polio vaccine is the most sensitive vaccine to heat.

Live attenuated vaccines are allowed to be frozen

(OPV, Measles, MMR and BCG). Inactivated vaccines must not be frozen ( DPT, DT, dT , TT and HB) .

The levels of cold chain

The administrative levels of cold chain according to the duration of the storage and the temperature required to keep the vaccine potent The administrative level Central & regional stores Storage period Temperature The vaccines OPV, Measles, MMR,BCG

Maximum - 20 to- 30C three months +2 to +8C

DPT, DT, dT, TT& HB,Hib

OPV, Measles, MMR, BCG

Districts stores& local immunization centers

Maximum one month

0C to+8C

+2 to +8C

DPT, DT, dT, TT& HB,Hib

The components of the cold chain :

The equipment and tools

The health staff

The procedures

Refrigeration equipment:
Refrigerator Cold boxes Vaccine carriers The ice packs retained in the freezer -To stabilize the temperature of the refrigerator at the

optimum level.
- Fully frozen ice-packs are used for lining the vaccines carriers and the cold boxes during storing the vaccines

1-The refrigerator :
Placed in the coolest place of the health centers away from sunlight Well ventilated and adequate air circulation around it . Kept locked and open only when necessary. Defrosted regularly . Ice packs are kept in the freezer.

Its temperature is recorded twice daily.

Drugs, drinks or food must not be stored in the refrigerator. Both the monitor and thermometer are placed in the refrigerator. The temperature chart is stuck on the door outside the refrigerator. The diluents should be kept on the lowest shelf.

Question:
What is the optimum Temperature of the

refrigerator in the health center?

+2 C to +8C

Cold box

ice Packs

Vaccine carrier

Vaccine carrier

Tools for monitoring the cold chain:

1- Cold Chain Monitor Card. 2- Freeze Watch Indicator 3- Cold Chain Refrigerator Graph 4- Vaccine Vial Monitors

5- Shake Test

+8C +2C

Cold Chain Refrigerator Graph

The vaccines are stored in refrigerators, they are monitored twice a day and readings are recorded on a chart to ensure a safe temperature is maintained. Emergency provisions made. Vaccines moved to cold storage for 48 hours.

2-Cold Chain Monitor Card: is used to show cumulative exposure to Temp. above the safe range during storage& transportation . It has an indicator that responds to two different Temps: the first part marked as ABC, responds to Temp above +10C; the 2nd part marked as D responds to Temps. above +34C.

2-Cold Chain Monitor Card:

The front of the cold chain monitor has: (1)A record form that health workers fill in to show when vaccines are received. (2) An indicator that is a heat-sensitive strip with four windows, marked A, B, C and D. (3) An interpretation guide explaining what to do with vaccines that have been exposed to high temperatures. (4) A space for filling in the following information: name of supplier/manufacturer, type of vaccine.

The back of the cold chain monitor has:

Instructions on use. A table giving information on the time and temperature characteristics of the Monitor.

3-Vaccine vial monitors:

Every vial is also shipped with a temperature-sensitive label, that health

workers monitor during vaccination

sessions.

SAFE If the inner square is lighter than the outer ring and the expiration date is valid, the vaccine is usable

SPOILED If the inner square matches or is darker than the outer ring, the vaccine must be discarded.

4-The shake test

DPT, hepatitis B and tetanus toxoid vaccines can all be damaged by freezing. By shaking two

vials, side-by-side, one

that might have been frozen and one that has

never been frozen, health

workers can determine if a vaccine has spoiled.

What damage the Vaccines?

1. Any defect in the cold chain.

2. Out date expiry.

3. Using skin antiseptic at the site of injection (e.g. BCG). 4. Using the reconstituted vaccine (MMR, measles, BCG) after the recommended period ( 6 hours). 5. Exposure of the vaccine to unacceptable temperature during the immunization session. 6. Exposure of the vaccine to direct sunlight (BCG)