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2 Immunisation

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Contents

Objectives

When you have completed this chapter you should be able to:

Introduction

2-1 What is immunity?

Children may become infected with many bacteria or viruses, which can cause fatal illness. Some of these organisms may also produce toxins that result in serious damage. Following most infections the body develops protection (resistance) against further infections by the same organism or against the toxins which these organisms produce. The body is now said to be immune to (protected against) that specific organism or toxin. This protection is called immunity. The body produces immunoglobulins (antibodies) and white cells to provide immunity (protection). Immunity can follow a natural infection or be induced by immunisation.

Immunity is the protection which the body develops against further infection or damage by an organism or toxin.

2-2 What is immunisation?

Immunisation is a method of artificially stimulating the immune system to provide protection against specific serious infections. This is done by giving a vaccine. A vaccine may be any one of the following:

Immunisation is a method of preventing some serious infectious diseases.

Note
It is best not to use the word ‘vaccination’ as it means to immunise with vaccinia (cowpox) to protect against smallpox. However, the word vaccine is still used. Therefore, a vaccine is used to immunise child.

2-3 What are the advantages of immunisation?

Immunisation is strongly recommended as it can prevent many serious infections. The introduction of immunisation for all children has been one of the most important advances in modern medicine and saves the lives of millions of children throughout the world each year. It is far better to prevent an infectious illness than to treat the illness and its complications. Immunisation is therefore very cost effective and has greatly reduced the mortality rate of children in many countries.

Immunisation of young children is strongly recommended.

2-4 What immunisations should be given to children?

All children should be routinely immunised against the following 11 important infections:

  1. Tuberculosis
  2. Polio (poliomyelitis)
  3. Diphtheria
  4. Whooping cough (pertussis)
  5. Tetanus
  6. Hepatitis B
  7. Haemophilus influenzae
  8. Pneumococcus
  9. Rota virus
  10. Measles
  11. Human papilloma virus

In South Africa, children are immunised against these 11 infections as part of the national immunisation programme. As a result, many of these infections (polio, diphtheria, whooping cough, tetanus, hepatitis B and measles) have become uncommon.

In future, MMR (measles, mumps and rubella) vaccine will replace measles vaccine alone, while other vaccines such as hepatitis A and chickenpox (varicella) should be added to the immunisation schedule. These new vaccines are very important, but are expensive. Many are already being given to children who have access to private health care.

Some additional immunisations may be given to specific children when indicated, e.g. viral influenza (flu), typhoid and meningococcal vaccine. Yellow fever immunisation is routinely given in countries where yellow fever occurs.

2-5 What is the expanded programme on immunisation

The Expanded Programme on Immunisation (EPI) of the World Health Organisation recommends that all children be immunised against a range of infections. It aims to provide free immunisation for children against the important childhood infections.

Note
EPI was started in 1974. It was called ‘expanded’ as measles and polio vaccines were added to BCG and diphtheria/tetanus/pertussis vaccine, and the number of children immunised in developing countries was greatly increased. The purpose of EPI is to prevent the childhood diseases for which vaccines exist, to provide high quality vaccines, and surveillance of these diseases.

2-6 How are immunisations given?

Vaccines may be given as drops by mouth, as with oral polio immunisation, or by intramuscular injection, as with hepatitis B. BCG vaccine is injected into the skin and measles under the skin.

2-7 Which vaccines are used in South Africa?

It is easier to give combined vaccines, such as hexavalent (“6-in-1”) vaccine (IPV, DTaP, Hib, HepB), as fewer injections are needed. In future more combination vaccines will be available.

2-8 When should immunisations be given?

The recommended schedule for immunisation lists the age at which specific immunisations should be given. Some immunisations need only be given once while others have to be repeated a number of times.

The method of labelling the schedule of immunisation for children in South Africa (see Table 2.1) is as follows:

The primary (initial) immunisations are given between birth (BCG and OPV), 6 weeks (IPV/DTaP/HepB/Hib 1/PCV 1/RV 1) and 6 months (measles). The repeated immunisations are often called ‘boosters’ as they help to improve the immune response produced by primary immunisation.

DTaP, IPV,Hib and HepB are usually given together as a combination of 6 vaccines (hexavalent or “6-in-1” vaccine). Immunisations by injection are given into the thigh of infants and arm of older children. Some immunisations are given on the left side and others on the right side. Immunisations are never given into the buttocks. Some live vaccines are given orally.

Table 2.1: The schedule for the immunisation of children in South Africa (ID intradermal, IM intramuscular and SC subcutaneous).

When Vaccines Site
At birth BCG
OPV 0		 ID Right arm
Oral
At 6 weeks OPV 1
IPV/DTaP/HepB/Hib 1
PCV 1
RV 1		 Oral
IM Left thigh
IM Right thigh
Oral
At 10 weeks IPV/DTaP/Hep B/Hib 2 IM Left thigh
At 14 weeks IPV/DTaP/HepB/Hib 3
PCV 2
RV 2		 IM Left thigh
IM Right thigh
Oral
At 6 months Measles 1 SC Right thigh
At 9 months PCV 3 IM Right thigh
At 12 months Measles 2 SC Right arm
At 18 months IPV/DTaP/Hib/Hep B 4 IM Left arm
6 years Td IM Left arm
9 years HPV1 IM Left arm
9.5 years HPV2 IM Left arm
12 years Td IM Left arm
Note
In private practice varicella vaccine is given at 18 months and again at 6 years. MMR (measles, mumps and rubella vaccine) replaces measles vaccine alone at 18 months and is then repeated at 6 years. Hep A vaccine is also given at 18 months and then repeated at 6 years.
  1. If an immunisation is given too early (e.g. if measles immunisation is given at 3 months), the infant may not develop the expected resistance to the illness due to the immune system still being too immature to respond fully.
  2. If an immunisation is given too late (e.g. not giving measles immunisation until 12 months), the infant may develop that illness before the immunisation can be given.
  3. If immunisations are given too soon after the previous immunisation (e.g. if DPaT immunisations are given a week apart), the infant may not develop the expected resistance to the illness.

All the most important immunisations should be given by the time the child reaches 9 months of age as these illnesses are most severe in infants.

It is important to give immunisations at the recommended time according to the immunisation schedule.

2-10 What should be done if immunisations are missed or never started?

This depends on how old the child is and what immunisations have been missed.

If the immunisation schedule was not started when it should have been, immunisations can be started immediately with the normal time intervals between immunisations, e.g. the second hexavalent vaccine would follow 4 weeks after the first.

However, some immunisations may not be given as they are no longer needed or they are not safe in an older child:

If immunisations were started correctly, but later immunisations were missed, these can be given using the normal time intervals between immunisations. If the immunisation schedule is interrupted it need not be started again from the beginning.

2-11 Why are immunisations opportunities often missed?

Many opportunities to immunise children are missed. This is a serious mistake as the child may become ill, or even die, from a preventable disease. Children often visit doctors or attend clinics or hospitals without being immunised because of stock shortages, because the child’s immunisation status is not checked on the Road-to-Health Booklet or because it is too much trouble to give the correct immunisations.

Whenever a child visits a doctor or clinic, the opportunity must be used to detect and give missing immunisations. In addition, a visit to a doctor or nurse often exposes an unimmunised child to other children with preventable infections such as measles. It is important to look at the infants immunisation record in the Road-to-Health at every visit to a clinic or hospital and to make sure that all the recommended immunisations have been given. Outstanding immunisations must be given immediately before the child goes home.

Opportunities for immunisation are also lost when health facilities do not offer immunisation services every day. Therefore, this essential service should be made available on a daily basis at all clinics and hospitals where children are managed.

Some parents incorrectly believe that immunisations are dangerous and can cause illness.

A child may develop a serious infection as the result of a missed immunisation.

2-12 How should immunisations be recorded?

It is very important that all immunisations are carefully recorded on the infant’s Road-to-Health Booklet. Both the type and the date of the immunisation must be recorded. It is an essential and important part of primary health care to record all immunisations carefully. Even though some combined vaccines are used and given as a single injection, they must be recorded in the booklet. The Road-to-Health Booklet is the official immunisation record needed for clinic visits, hospital admission and attendance at crèche and school.

2-13 What should be done if the Road-to-Health Booklet is lost?

All mothers have the right to carry a Road-to-Health Booklet. If the booklet is lost or destroyed, the mother should be given a new booklet, clearly marked as a duplicate. All available information must be entered. The mother should be asked whether the infant has been immunised and which immunisations have been given. If she can give a good account of her child’s immunisations or if they are recorded in the clinic records, these should be entered in the new booklet and do not need to be repeated. If she is uncertain of the child’s immunisation history, the missing immunisations should be repeated. It is not dangerous to repeat an immunisation, provided that the child is not too old.

2-14 Should infants born to HIV-positive women be immunised?

Yes. It is particularly important that these infants are immunised as they are at high risk of infections if they later develop AIDS. The immune system of infants born to HIV-positive women is usually normal in the first few months after delivery. This provides an opportunity for routine immunisations to be given, even to those children who have been exposed or infected with HIV. However, most infants born to HIV-positive women are not infected with HIV. All immunisations can be given according to the normal schedule to HIV-exposed infants provided they have no clinical signs of HIV infection.

2-15 Should infants with HIV infection be immunised?

Infants who are known to be infected with HIV but have no clinical signs of HIV infection (and a normal CD4 count) should be immunised. There is no danger giving them most live vaccines such as polio and measles as their immune system is still functioning normally. However, BCG should not be given.

In contrast, infants with clinical signs of HIV infection should not be given any live virus vaccines, such as BCG, oral polio, rota virus and measles, but should receive the other routine immunisations. Giving BCG to infants with HIV infection may result in a generalised infection with BCG as their immune system is damaged and not able to control the spread of BCG. Children with AIDS on antiretroviral therapy my benefit from waiting until the CD4 count is normal before giving measles and other live immunisations.

Note
Infants with immunosuppression due to other causes, such as leukaemia or cytotoxic drugs or large doses of steroids should not be given live vaccines. They must be protected from exposure to these illnesses.

Infants who are exposed to HIV but are otherwise well should receive routine immunisations.

2-16 Should malnourished infants be immunised?

Yes. Malnutrition (undernutrition) is not a contraindication to immunisation. Even children with severe acute malnutrition (kwashiorkor or marasmus) should be given the routine immunisations. Measles immunisation can be given when these children are admitted for care. The rest of the immunisation schedule must be started before discharge home. It is important to make sure that they will receive all the routine immunisations.

2-17 Should small or sick newborn infants be immunised?

Low birth weight (less than 2500 g) or sick newborn infants should be given BCG and oral polio vaccine when they are well enough to be discharged home from hospital. By this time some preterm infants may already be a few months old. After discharge they can follow the routine immunisation schedule. If a preterm infant is 6 weeks or older when they are discharged home, the routine immunisation schedule can be started. It is uncommon that preterm infants need immunisation before they are ready for discharge.

2-18 Should routine immunisations be given to a sick child?

There are very few general contraindications to immunisation. Infants with a skin rash or minor illness such as a ‘cold,’ cough or mild fever below 38 °C should be immunised. If the infant has diarrhoea oral polio vaccine can still be given. It is important to immunise sick and malnourished children to protect them against these illnesses. If a child is not immunised because of a minor illness, they may not be brought back later and the opportunity to immunise is lost.

Minor illnesses and malnutrition are not a contraindications to immunisation.

2-19 Can immunisations be safely given to an allergic child?

Yes. Allergic reactions to immunisations are rare, even in children with signs of allergy (e.g. eczema).

2-20 When are immunisations contraindicated?

There are very few contraindications to immunisations and serious thought must be given before deciding not to give a scheduled immunisation. Mild illness is not a contraindication. Neither is a skin rash or eczema. Antibiotics or allergic illnesses are also not contraindications. If an ill or malnourished child is well enough to go home, they can be immunised before going home.

An infant who is well enough to go home is well enough to be immunised.

Contraindications are:

  1. A seriously ill child who needs hospitalisation can be given measles immunisation on admission. The other immunisations can be postponed and given when the child has recovered, but before discharge from hospital.
  2. Live viruses (polio, measles and BCG) should not be given in infants with clinical signs of HIV infection (or a low CD4 count). However, all scheduled immunisations can be given if the infant is HIV positive without signs of HIV infection (and a normal CD4 count).
  3. Live viruses should not be given to children with immunosuppression such as children with leukaemia or receiving cytotoxic drugs. Kwashiorkor, marasmus and low dose or inhaled steroid treatment are not contraindications.
  4. DTaP vaccine should not be given to infants with:
    • A high temperature (38 °C or above).
    • Fits or collapse within 3 days of a previous DTaP immunisation
    • A serious progressive neurological abnormality such as repeated fits.

    In these situations Td should be used instead of DTaP to avoid the pertussis vaccine.

2-21 Is immunisation safe?

Yes. Serious complications of immunisation are rare. However, mild fever and irritability are common, especially 6 to 12 hours after DTaP immunisation. A mild fever, irritability and slight rash are common about a week after measles and MMR immunisation. These mild side effects can be treated with paracetamol (Panado) 6 hourly for 4 doses if needed (2.5 ml if under 1 year and 5 ml if 1 to 5 years). The benefits of immunisation are far greater than the risks. Therefore, as many infants as possible should be fully immunised.

Note
There is no evidence that immunisation increases the risk of cot death.

BCG immunisation

2-22 What is BCG?

BCG (Bacille Calmette Guerin) is a freeze-dried, live but weakened (attenuated) form of Mycobacteria, the bacteria which causes tuberculosis (TB). BCG reduces the risk of TB meningitis and disseminated (miliary) TB in young children. Unfortunately it is less effective in preventing pulmonary TB, especially in malnourished children. It also gives less protection in adults.

Note
In South Africa the Danish strain of BCG is being used.

2-23 How should BCG be stored and mixed?

BCG vaccine should be stored in a refrigerator (fridge) between 2 and 8 °C and must not be frozen. Keep it and the diluent on the middle shelf. It must also be kept out of direct sunlight. To prepare the vaccine for administration the vial of diluent should be added to the vial of dried vaccine. Do not use alcohol or ether to clean the top of the vial as it may kill the BCG. After making up the vaccine it will last for 6 hours if kept in a refrigerator or cool box.

2-24 When should BCG be given?

BCG should be given to well infants at birth or on the day of discharge from hospital. If not given before discharge it should be given at a clinic soon after discharge. BCG is not usually given to children older than 1 year.

2-25 How is BCG given?

BCG is given by intradermal injection over the deltoid muscle of the right upper arm as follows:

  1. Inject 1 ml of diluent into the vial (brown) containing BCG. Gently turn the vial upside down at least 5 times until fully mixed. Do not shake.
  2. The reconstituted BCG vaccine can be stored up to 6 hours in a refrigerator between 2 and 8 °C.
  3. Draw up 0.05 ml of BCG vaccine in a sterile syringe (a special syringe to measure 0.05 ml accurately ).
  4. Clean an area of skin over the right deltoid muscle (upper arm) with soap and water, not alcohol which may kill the live vaccine.
  5. Stretch the skin over the right deltoid muscle with your thumb and forefinger. Slowly insert the needle intradermally (bevel facing up). Insert the needle for less than 2 mm into the skin. The needle can be seen through the skin.
  6. Inject the 0.05 ml of vaccine. A weal (raised lump) indicates that the intradermal injection has been given successfully. The most common error is to inject under the skin when no weal will be seen. With no weal, start again at a different site and inject into the skin.

2-26 What are the side effects of BCG immunisation?

In the majority of infants a raised nodule develops at the site of the immunisation after 2 to 4 weeks. A small crust may develop or it may ulcerate. The nodule will heal by itself and no dressing should be applied. After 8 weeks the nodule starts to decrease in size and by 6 months a small flat scar will form. The lymph nodes in the axilla on that side may enlarge slightly, which is normal. BCG immunisation does not always leave a scar in an infant. It is not necessary to repeat the BCG immunisation if no scar is seen.

The most common side effects are local pain and ulceration at the site of the immunisation and enlarged lymph nodes in the axilla and sometimes the neck.

Serious side effects which require referral are very rare. They include:

Note
BCG lymphadenitis or local abscess must be reported to the local health authorities. Rarely suppurative adenitis may require needle drainage or a sinus may form. Antituberculous treatment is seldom needed (usually in immunocompromised children only).

2-27 What are the contraindications to BCG immunisation?

BCG can be given to HIV-exposed or well HIV-infected infants but not HIV infected infants with clinical signs of HIV disease. It is not used over 1 year of age.

Polio immunisation

2-28 Which polio vaccine is used?

In South Africa both live, oral (Sabin) and killed, intramuscular (Salk) vaccines are used to protect against polio. Oral vaccine has been weakened (attenuated) to give immunity without causing clinical infection. The killed vaccine is equally effective as the live vaccine and is given as part of the hexavalent vaccine. Both are trivalent vaccines against all 3 strains of polio virus. It is hoped that universal immunisation will eradicate polio worldwise as has happened to smallpox.

Note
Live (oral) attenuated polio vaccine was introduced in 1962. It is excreted in the stool and can infect others asymptomatically and thereby boost the immunity of the whole community. It is best used in communities where wild polio virus may still occur. With the elimination of clinical polio in a population, the inactivated (intramuscular) Salk vaccine can be used instead. Both vaccines are used in South Africa as polio is rare but still occurs in some other African countries.

2-29 How should oral polio vaccines be stored?

Both live and dead polio vaccines must always be kept cold. This ia particularly important in live vaccines to avoid heat killing the virus. In a standard clinic or hospital refrigerator it should be stored at 2 to 8 °C. Direct sunlight kills the vaccine. Keep the vial of vaccine cool in a home refrigerator or cool bag while it is being used. It can be safely kept in this way for up to 30 days.

Note
Oral polio vaccine can be stored for years at –20 °C or for one year at –10 °C.

2-30 How is live polio vaccine given?

Two drops are given directly into the infant’s mouth from the plastic dropper bottle. If the drops are spat out or vomited the dose should be immediately repeated. It is not necessary to avoid either a bottle or breastfeed before or after giving the vaccine.

Note
Live Sabin vaccine should not be given to immunosuppressed children, e.g. children with clinical signs of HIV infection.

Usually, a single dose of oral polio vaccine is given at the same time as BCG after delivery and then a further oral dose at 6 weeks. This is followed by doses if intramuscular polio vaccine at 6, 10 and 14 weeks and again at 18 months. The first dose is called OPV0 as it is given at birth.

2-31 Should oral polio immunisation be given to a breastfeeding infant?

Breastfeeding is not a contraindication to immunisation. There is no need to avoid a breastfeed before or after giving oral polio immunisation.

Breastfed infants can be given oral polio immunisations.

2-32 What are the contraindications to polio immunisation?

Only the killed (Salk) vaccine can safely be used in children with symptomatic HIV infection. However, the live vaccine is safe in infants who are HIV infected but well.

Oral polio vaccine can be given to children with diarrhoea and vomiting and an extra dose is not needed as additional intramuscular polio vaccine is part of the immunisation schedule.

Note
Very rarely (1 in 500 000), paralysis can follow use of oral Sabin polio vaccine, usually in children with depressed immunity. This does not occur with the killed Salk vaccine. All cases of acute flaccid paralysis must be notified to determine whether wild polio has been eradicated.

Immunisation against diphtheria, tetanus and pertussis

2-33 What is DTaP vaccine?

It is a combined vaccine against diphtheria, tetanus and pertussis. Pertussis is another name for whooping cough. The vaccine contains both diphtheria and tetanus toxoids, as well as killed pertussis (whooping cough) bacteria. Unlike the older whole cell vaccine (P) the much safer acellular vaccine (aP) is now used.

Toxoids are inactivated toxins. Toxins are produced by the diphtheria and tetanus bacteria and cause most of the clinical signs in these infections. Toxoids stimulate the body to produce immunity to these toxins.

Currently DTaP vaccine is given together with intramuscular polio, Hib and HepB vaccines in the form of a hexavalent vaccine. This combination vaccine therefore contains 6 separate vaccines.

Hexavalent vaccine combines IPV, DTaP, Hib and HepB vaccines in a single intramuscular injection.

2-34 How should hexavalent vaccine be stored?

In a refrigerator or cold box at 2 to 8 °C. Do not freeze hexavalent vaccine as this damages the vaccine. Avoid direct sunlight as this may also damage the vaccine. It is best to keep hexavalent vaccine on the middle shelf of a fridge.

Do not freeze hexavalent as this damages the vaccine.

2-35 How is hexavalent vaccine given?

  1. The liquid vaccine comes in a prefilled syringe with a needle. Add the vaccine to a vial of powdered Hib vaccine. Shake well and withdraw the mixed vaccine. Remove the needle used for mixing.
  2. Use a new 23 gauge needle for each child. Never use the same needle for more than one child.
  3. Clean an area over the skin on the outer side of the left thigh (upper leg NOT buttocks) with an alcohol swab.
  4. Inject the vaccine intramuscularly.

Three doses of hexavalent vaccine are given 6, 10 and 14 weeks. A follow up (booster) dose of hexavalent vaccine is given at 18 months.

2-36 What are the side effects of DTaP immunisation?

Minor side effects to DTaP immunisation are common and are not a contraindication to further immunisations.

If infants are not fully immunised with DTaP because of minor side effects, they may later develop diphtheria, whooping cough or tetanus which remain very serious illnesses.

The side effects can usually be managed with paracetamol 6 hourly for 2 days.

2-37 What are the possible serious reactions to pertussis immunisation?

Very rarely, fever above 40.5 °C, fits, collapse and shock, severe irritability with persistent crying and screaming attacks or drowsiness, confusion and brain damage (encephalopathy) may follow pertussis immunisation. The risk of fever and fits is one in a thousand infants immunised with pertussis vaccine while the risk of encephalopathy is one in a million. If a serious reaction occurs, pertussis vaccine must not be given again.

The new, safer, cell-free pertussis vaccine (aP) is now used as it has fewer local and systemic side effects than the older whole cell (P) vaccine.

Note
Fever above 40.5 °C within 2 days, fits within 3 days or encephalopathy within 7 days of DTaP immunisation must be reported to the local health authorities.

2-38 When should pertussis vaccine not be given?

Pertussis immunisation should not be given to the following infants:

These infants should be given Td vaccine instead.

Mild fever and redness with some pain is common with DTaP immunisation and are not contraindications to future immunisations. A family history of convulsions is also not a contraindication. Neither are cerebral palsy and Down syndrome.

Pertussis vaccine should not be given if the child had a severe reaction to a previous DTaP immunisation.

2-39 What is Td vaccine?

Td vaccine contains a reduced dose of diphtheria vaccine, standard tetanus vaccine but no pertussis vaccine. It is used in teenagers and adults as well as infants with a contraindication to aP vaccine. The method of storing and giving Td vaccine is the same as that for hexavalent vaccine. The dose is 0.5 ml intramuscularly.

Additional tetanus immunisation (TT) alone should also be given after an injury, especially if the wound is contaminated with soil. Usually, this is not needed if tetanus immunisation has been given within the past 5 years.

Note
It is important that all pregnant women have received tetanus immunisation as this protects newborn infants against neonatal tetanus. If not, they should be immunised during the pregnancy with pure tetanus toxoid (TT), 3 doses given 1 month apart. In areas where neonatal tetanus still occurs, women who have been previously immunised against tetanus should be given a single booster dose of tetanus vaccine during pregnancy. Tetanus immunisation is safe during pregnancy as it is a toxoid and not a live vaccine.

2-40 Why is pertussis vaccine not given after 18 months?

Because whooping cough is a far less serious illness in older children and the risk of side effects increases after 18 months.

Measles immunisation

2-41 What measles vaccine is used?

Measles vaccine is a freeze-dried preparation of a live but weakened (attenuated) virus. Usually, the Schwartz strain of vaccine is used.

2-42 How should measles vaccine be stored?

As with other live vaccines such as BCG, rota virus and oral polio vaccines, the storage of measles vaccine is very important. If incorrectly stored, these live vaccines are ineffective. The vials of measles vaccine and the diluent should be kept in a refrigerator or cool bag at 2 to 8 °C. Place the vaccine on the top shelf just under the freezer compartment. Do not freeze or expose to direct sunlight.

2-43 How is measles vaccine given?

  1. Add 5 ml of diluent to the 10 ml vial of the vaccine. Do not use alcohol to clean the top of the vial as this may kill the virus. If kept cool and out of direct sunlight, the reconstituted vaccine will last up to 8 hours.
  2. Use a new syringe and new 23 gauge needle for each patient.
  3. Give 0.5 ml of the vaccine by subcutaneous injection into outer side (lateral aspect) of the right thigh or right arm. Clean the skin with soap and water and not alcohol.
  4. Always discard any remaining vaccine at the end of the day. Do not keep vaccine overnight.

2-44 When should measles immunisation be given?

The first dose of measles vaccine is given at 6 months. This is followed by a second dose at 12 months.

Antibodies from the mother usually protect the infant against measles during the first few months of life. During this time measles vaccine is often ineffective as the vaccine virus may be killed by the maternal antibodies.

Unfortunately, infants often get infected with measles when they come into contact with other children at health clinics, outpatient departments or in hospital wards. Any infant of 6 months or more who visits a clinic or hospital and does not have measles immunisation documented on their Road-to-Health Booklet should immediately be given a dose of measles vaccine.

Note
Measles immunisation is usually ineffective before 6 months so is not given earlier even if there is an epidemic. Some older schedules gave measles immunisation at 9 and 18 months.

2-45 What are the complications of measles immunisation?

A mild fever about 7 days after the immunisation occurs in up to 25% of children. Less commonly a faint rash may occur.

Note
Claims that measles/mumps/rubella immunisation causes autism has been proven to be false.

2-46 What are the contraindications to measles immunisation?

It should not be given to children with untreated tuberculosis. These children can receive measles immunisation once the TB treatment has been started. Mild fever, ‘colds’ or influenza, otitis media, bronchitis or diarrhoea are not contraindications to measles immunisation.

Note
A previous anaphylactic reaction to measles or MMR immunisation may be due to egg allergy. This is a contraindication to further immunisation with measles or MMR vaccine.

2-47 What is MMR vaccine?

Vaccines against measles, mumps and rubella can be given together (MMR vaccine) at 12 months instead of measles vaccine alone. Although more expensive than measles vaccine, MMR offers important protection against meningitis, which may complicate mumps, and serious congenital abnormalities in the fetus, which may complicate maternal rubella during pregnancy.

Although not yet part of the national EPI policy, children who received MMR at 12 months in private health practice should be given a second dose of MMR when they start school. MMR vaccine needs to be kept cold during storage in the same way as the measles vaccine. The dose and method of administration is the same as the measles vaccine.

Note
Children who are immunised twice with MMR will have lifelong immunity against rubella. In girls this avoids the risk of congenital rubella in their infants. Likewise, MMR gives protection against mumps, which avoids the risk of orchitis and resultant sterility in boys in later life.

Immunisation against Hepatitis B

2-48 What is hepatitis B?

Acute infectious hepatitis (infection of the liver) is caused by a number of different viruses. The hepatitis B virus may cause a severe form of hepatitis, which can result in liver failure. This virus may also cause chronic liver infection resulting in cirrhosis or cancer of the liver years after the person becomes infected. Following hepatitis B the person may remain infectious for many years and spread the virus to their children and other family members (i.e. they are a hepatitis B virus ‘carrier’). Hepatitis B is common in poor countries. Although the vaccine is expensive, immunisation against hepatitis B is, therefore, important in developing countries.

Note
Hepatitis B immunisation has already resulted in a falling rate of liver cancer in some countries.

2-49 When and how is hepatitis B vaccine given?

Hepatitis B vaccine (HepB) is given as part of the hexavalent vaccine into the right thigh in 3 doses at 6, 10 and 14 weeks.

2-50 What are the side effects of hepatitis B vaccine?

These include mild fever, pain and local swelling but are very uncommon.

2-51 What is the management of an infant born to a mother who is infected with hepatitis B ?

People with either acute or chronic hepatitis B virus infection have pieces of viral protein, called hepatitis B surface antigen (HbSAg), circulating in their blood stream. These people often excrete the virus and may spread the infection to others. Infants are at high risk of infection during a vaginal delivery if the mother is excreting the virus. Therefore, infants born to women who have hepatitis B during pregnancy or are HbSAg positive (i.e. have a chronic viral infection) need special management at delivery to protect them against infection. They should also receive a dose of hepatitis B vaccine. This should be followed by the standard schedule of hexavalent immunisation at 6, 10 and 14 weeks. Depending on further blood tests on the mother these infants may need in addition 0.5 ml of hyperimmune hepatitis B immunoglobulin by intramuscular injection with 72 hours of delivery.

Note
If the mother is a hepatitis B carrier she will be e antigen positive and be shedding virus which can infect her infant at birth. These are the infants who need hepatitis B vaccine plus hepatitis B immunoglobulin after delivery to protect them.

Immunisation against Haemophilus influenzae, rota virus and Pneumococcus

2-52 What is Haemophilus influenzae?

Haemophilus influenzae B (Hib) is a bacterium which can cause serious and often fatal infections in childhood, especially meningitis, pneumonia and epiglottitis (a severe infection of the throat and epiglottis which often obstructs the upper airway). Children under 2 years are most at risk.

2-53 What is Hib vaccine?

An effective vaccine against Haemophilus influenza B is now available (the Hib vaccine) and is part of the South African national immunisation schedule. Unfortunately it is expensive and, therefore, has still not been included into the immunisation schedules of some poor countries. Hib is a vaccine made from dead Haemophilus bacteria and has few side effects.

2-54 How is Hib vaccine stored and given?

Hib vaccine is stored and given as part of the hexavalent vaccine by intramuscular injection into the outer part of the left thigh at 6, 10 and 14 weeks.

2-55 What is rota virus vaccine?

This is an oral live vaccine against the rota virus (RV) which is the main cause of severe gastroenteritis especially in small children. As gastroenteritis is an important cause of infant mortality this vaccine should help reduce the mortality and morbidity of infants.

Mild side effects of the RV vaccine are loose stools and runny nose.

Note
A rare but serious complication of RV vaccine is bowel intersusception.

2-56 How is rotavirus vaccine stored and given?

Vials of RV vaccine should be stored at 2 to 8 °C. The diluent can be stored at room temperature. Neither must be frozen. The vial of vaccine should be reconstituted with the prefilled oral applicator and used immediately. The vaccine is given orally at 6 and 14 weeks.

2-57 What is PCV vaccine?

Pneumococcal conjugate vaccine (PCV) protects against 13 different types of Pneumococcus (Streptococcus pneumonia). This is an important vaccine as bacterial pneumonia is a common cause of infant mortality and morbidity.

2-58 How is PCV vaccine stored and given?

The vaccine comes in a prefilled syringe and should be stored at 2 to 8 °C. It is given by intramuscular injection at 6 and 14 weeks and then again at 9 months.

2-59 What is HPV vaccine?

Human papilloma virus (HPV) vaccine has recently been added to the immunisation schedule. HPV is sexually spread and causes cervical and penile cancer. HPV vaccine is a dead vaccine and protects against most strains of cancer causing HPV infections. The vaccine is given by intramuscular injection to girls in grade 4 (about 9 years of age) and then repeated 6 months later. In future it may also be given to boys in grade 4. It is important that HPV vaccine is given before the age when sexual activity starts.

General Comments

2-60 Which other immunisations are available?

Other immunisations are available but are not given routinely. For example, influenza vaccine should be offered to children with serious chronic lung diseases. Influenza vaccine must not be confused with Hib vaccine.

Note
Varicella (chicken pox), meningococcal and hepatitis A vaccines may be included in the immunisation schedule in future. Yellow fever vaccine is needed for international travel while rabies vaccine is given to children exposed to a bite from a rabid animal. To protect children, who have been exposed to serious infections, specific immunoglobulin is sometimes used. For example, hyperimmune immunoglobulin can be offered to children exposed to hepatitis B virus. The use of immunoglobulin is not as effective as immunisation as the protection is short-lived.

2-61 Why is a booster dose of vaccine given?

Hexavalent vaccine is repeated at 18 months as a follow up or booster immunisation. Measles vaccine is repeated at 12 months. This makes sure that the body develops immunity against these important infections. At 6 and 12 years children are given a further booster dose of Td (but not pertussis) vaccine.

2-62 Why are some immunisations given on the left and others on the right side of the body?

By convention, BCG is given into the skin over the right deltoid. This helps to find the scar.

Hexavalent vaccine is given into the left thigh in young children or into the left deltoid in older children (18 months). The 6 vaccines can be combined and given together as they do not interfere with each others.

Other immunisations in young children are usually given into right thigh and into the right deltoid in older children. The left upper arm is used in school children as discomfort in the right arm may interfere with school work.

There is no medical reason for giving a vaccine on a specific side.

2-63 What equipment is used to give intramuscular immunisations?

Usually, a 1 ml syringe is used with a 23-gauge needle to give immunisations into the deltoid or thigh muscles. Injections are never given into the buttocks of young infants as with little muscle it is possible to damage nerves or blood vessels. Never re-use syringes or needles.

2-64 What is ‘herd immunity’?

If enough children in a community are immunised against an infection, that infection will no longer be passed from one child to another. The few non-immunised children are then partially protected as they are unlikely to be exposed to that infection. As a result, the whole community (herd) is protected against that infection (herd immunity). It is, therefore, of benefit to the whole community when a child is immunised. Due to the high immunisation rate, some infections such as smallpox have disappeared. The goal in South Africa is to have 90% of all children fully immunised.

2-65 Which infectious diseases in children are notifiable?

In South Africa most of the childhood diseases, for which vaccines are routinely given, are notifiable (not rota virus infection). This helps to monitor the number of cases still occurring and also enables the health authorities to control any outbreaks with mass immunisation. This is particularly important for any case of suspected polio.

Cases of polio, neonatal tetanus, whooping cough, diphtheria, hepatitis B and measles are now rare in South Africa while smallpox was eradicated worldwide in 1975.

2-66 What are mass immunisation campaigns?

These are arranged separately to the routine immunisations programme, and are once-off events to increase the number of immunised children in a region and, thereby, help to eradicate the disease. They are used in regions or whole countries where the immunisation rates are low and also to control unexpected outbreaks of one of the important infectious diseases. Mass immunisation campaigns have been very effective against measles and polio.

Handling vaccines

2-67 What is important about storing and handling vaccines?

All live vaccines (BCG, polio, measles, RV, MMR vaccines) must be kept correctly stored or they will be damaged. Sunlight, the incorrect temperature and antiseptics damage vaccines. In a clinic, all vaccines should be stored in a refrigerator between 2 and 8 °C (not in the freezer compartment) and kept in a cool bag during handling. Only polio vaccine can be safely kept frozen during storage for long periods. Freezing damages other vaccines. Live vaccines, which have been frozen in error, have a granular appearance with a deposit on standing, and must be discarded.

Vaccines rapidly lose their effectiveness if they are not kept cold.

Avoid direct sunlight and do not use alcohol to clean vials of live vaccines or the skin as this may kill the vaccine. If necessary, the skin can be cleaned with soap and water. Only draw up the vaccine into the syringe when you are ready to give it. The vaccines often come in brown vials to protect them from the light. All vaccines have an expiry date, and must not be used after the expiry date.

Oral polio vaccine has a heat sensitive spot on each vial. Normally the dot is white but it darkens if the vaccine is not kept cool correctly. If the dot is the colour of the surrounding circle, or darker, it is damaged and must not be used.

Figure 2-1 Oral polio vaccine vial monitor

Figure 2-1 Oral polio vaccine vial monitor

2-68 What is ‘the cold chain’?

Not only do vaccines need to be kept cold during storage but they must also be kept cold during handling. When live vaccines are moved from the central cold store to a clinic or hospital they should be moved in a cool box. They should also be kept in a cool box in the clinic after the vial has been opened. Vaccines must be kept cool continuously at 2–8 °C. Measles and MMR are commonly inactivated by not being kept cool continuously. From the time the vaccine is produced to the time it is given it must be kept cold. The chain of travel from factory to store to health clinic to patient is called the cold chain. If possible, vaccines should be kept in a separate vaccine fridge at the health facilities. There must be a temperature chart on the vaccine fridge and the fridge temperature should be recorded twice a day. Where gas fridges are used a spare gas tank must be at hand. The expiratory date on vaccines is only valid if they have been kept cool during transport and storage.

Vaccines must be kept cool at all times.

2-69 What is the correct use of a vaccine fridge?

A dedicated fridge (the same type as that used in the home) with a freezer compartment and 3 shelves must be made available at every site where immunisations are given. The main section of the fridge must be kept at 2–8 °C while the freezer compartment will be below 0 °C. This fridge must be used for vaccines only. Medicines, drugs, formula feeds and food must not also be kept in the vaccine fridge as repeated opening and closing of the fridge door raises the fridge temperature and this may damage the vaccines.

The coolest part of the fridge that does not freeze is the top shelf (below the freezer compartment). This is the best place to store oral polio and measles vaccines. Other vaccines are best stored on the middle shelf. A fridge thermometer must be kept on the middle shelf and the temperature measured and recorded daily. The thermostat of the fridge must be adjusted to keep the temperature between 2 and 8 °C. If the fridge is warmer or freezes, vaccines may be damaged.

Bottles of water should be stored on the bottom shelf as this helps to maintain the correct temperature in the fridge if there is a power failure. The freezer compartment can be used to freeze and store ice packs and ice cubes for use in cool boxes. The door must be kept closed at all times except when removing or replacing vaccines.

2-70 What is a cool box?

Keeping vaccines cold in rural regions and during transport is particularly difficult when a fridge is not available. Under these circumstances, a cool box is very useful. Usually, a cool box consists of a closable polystyrene container. Frozen ice packs (they should rattle when shaken) are placed inside the cool box on the bottom and sides as well as under the lid.

Measles and polio vaccines should be placed at the bottom where it is coldest. The other vaccines can then be placed above them. Vaccines must never be allowed to freeze. Keep the top firmly on to protect the vaccines from sunlight.

2-71 What is an opened multidose vial policy?

To make sure that vaccines remain effective with as little wastage as possible, a policy of managing opened vials is needed. Opened vials can be used to withdraw a number of doses if they are stored correctly.

Open vials of oral polio vaccine may be stored for up to 1 month provided the expiry date is not past, cold chain conditions have been maintained and aseptic technique is used to withdraw doses.

Hexavalent, pneumococcal and rota virus vaccines are in single dose packs.

Open vials of measles and BCG must not be kept for more than 6 hours.

All opened vials must be discarded immediately if the aseptic procedures have not been followed or there is any suspicion that the vial is contaminated (a change in the normal appearance of the vaccine).

Table 2-2: Summary of immunisations routinely used

Vaccine Description Storage Administration Comment
BCG
Bacillus Calmette Guerin		 Live attenuated
Mycobacterium		 2–8 °C
Store on middle shelf
Discard open vial after 6 hours		 0.05 ml intradermal
Right upper arm		 Should not be given in children over 1 year. Do not give if symptomatic HIV. Small ulcer after a few weeks common
Hexavalent Combination of 6 vaccines (IPV,D,T,aP,Hib,HepB) 2–8 °C
Store on middle shelf
Use immediately		 0.5 ml intramuscular
Left thigh up until 1 year
Left upper arm if 1 year or more		 Mild fever, pain, local swelling common, Not used after 18 months
dT
Diphtheria (reduced dose)Tetanus		 d – toxoid
T – toxoid		 2–8 °C
Store on middle shelf
Discard open vial after 30 days		 0.5 ml intramuscular
Left thigh up until 1 year
Left upper arm if 1 year or more		 Mild fever, pain, local swelling common
RV
Rota virus		 Live attenuated virus 2–8 °C
Store on middle shelf		 Drops into mouth with applicator Mild loose stools and runny nose
PCV
Pneumococcal conjugate		 Dead vaccine 2–8 °C
Store on middle shelf		 Intramuscular right thigh Local tenderness and swelling common
HepB
Hepatitis B		 Part of the virus 2–8 °C
Store on middle shelf
Discard open vial after 30 days		 0.5 ml intramuscular
Right thigh up until 1 year
Right upper arm if over 1 year		 Mild fever, pain and local swelling occasionally
OPV
Oral Polio		 Live attenuated virus 2–8 °C
Store on top shelf
Can use if inner square lighter than outer circle
Discard open vial after 30 days		 Two drops by mouth
If vomited or spat out can repeat immediately		 Mild flu like illness or mild diarrhoea may occur
Measles Live attenuated virus 2–8 °C
Store on top shelf
Discard open vial after 6 hours		 0.5 ml subcutaneous
Right thigh up until 1 year
Right upper arm if 1 year or more		 Mild fever or transient red rash are not uncommon 6–11 days post immunisation
HPV Human papilloma virus Dead vaccine 2–8 °C
Store on middle shelf		 0.5 ml intramuscular
Left upper arm		 Local tenderness and swelling common

Case study 1

During a woman’s pregnancy, she and her husband ask the doctor whether it will be necessary for their infant to be immunised. They also want to know which immunisations are given straight after delivery and whether they would still be given if the infant were born prematurely and is breastfed. The mother mentions that she had hepatitis years ago and is known to be hepatitis B positive.

1. Why should the infant receive routine immunisations?

It is very important that all infants be immunised unless there is a medical reason not to do so. Immunisation protects the infant against many dangerous infections. Immunising children also helps to decrease the spread of that infection in the community.

2. What immunisations are given after delivery?

It is routine to give BCG and polio drops in the first few days after delivery. These immunisations should be given before an infant is discharged from the hospital or clinic.

3. Are immunisations given to preterm infants?

It is very important to give all routine immunisations to preterm infants. Usually, the BCG and first polio immunisations are given when the infant is ready for discharge from hospital. After discharge the routine immunisation schedule is followed.

4. Should breastfed infants be given oral polio drops?

Yes. Breast milk does not inactivate the live polio virus in the oral drops.

5. Would loose stools be a contraindication to oral polio immunisation?

No.

6. What should be done, as the mother is hepatitis B-positive?

As there is a high risk that the infant will be infected with the hepatitis B virus at or soon after delivery, the infant must be given a dose of hepatitis B vaccine after birth to be followed by the routine hepatitis B immunisations starting at 6 weeks. Depending on further tests on the mother the infant may also need 0.5 ml of hyperimmune hepatitis B immunoglobulin by intramuscular injection within 72 hours after birth.

Case study 2

A mother who is known to be HIV-positive delivers a clinically well infant at term. The staff tells her that her infant should not be immunised as it may already be infected with HIV. This will make immunisation dangerous.

1. Should routine immunisations be given to infants born to HIV-positive mothers?

Yes. It is particularly important that these infants are immunised as they are at high risk of many infections if they become HIV infected. The immune system of infants born to HIV-positive mothers is usually normal in the first few months after delivery, which gives an opportunity to safely give the routine immunisations. Most infants born to HIV-positive mothers are not HIV infected themselves.

2. Should routine immunisations be given to healthy infants with HIV infection?

Yes. These infants without clinical signs of HIV infection still have an intact immune system and should be given routine immunisations.

3. Should infants with clinical signs of HIV infection be given routine immunisations?

As these infants have a damaged immune system, they should not be given live vaccines such as BCG, oral polio and measles until they are clinically well with a normal CD4 count.

4. What is the danger of giving BCG to an infant with symptomatic HIV infection?

As these infants have a damaged immune system, they may develop a generalised infection with BCG.

Case study 3

A healthy 6-week-old infant is given her first DTaP immunisation. The day after the immunisation the infant has a mild fever and is slightly irritable. She also has some pain and swelling at the site of the injection. The mother gives a history of febrile convulsions when she was a child. She also heard on the radio that DTaP immunisation could cause mental retardation. Because of this mild reaction and the mother’s anxiety, the staff advises that no further DTaP immunisations should be given.

1. What does DTaP stand for?

Diphtheria, tetanus, acellular pertussis (whooping cough).

2. At which site should the DTaP injection be given?

DTaP is given as part of the combined hexavalent vaccine. This should be given by intramuscular injection into the left thigh. In older children it can be given into the left deltoid muscle. Never give a child an injection into the buttock, because young children have little muscle over the buttock, and important nerves and blood vessels lie close under the skin and may be damaged.

3. Are side effects common after DTaP immunisation?

Many infants have mild local tenderness and swelling at the site of the immunisation for a few days. Mild fever and some irritability are also common. If necessary the infant can be treated with paracetamol syrup 2.5 ml 6 hourly.

4. Can DTaP cause dangerous complications?

Very rarely, pertussis vaccine can cause a high fever (above 40 °C), severe irritability with screaming attacks, drowsiness, convulsions and mental retardation. The risk of severe complications is only 1 per million children. The risk of severe side effects is much lower with the newer acellular pertussis vaccine (aP) which is used today.

5. Should the second dose of DTaP be given if the infant has mild side effects after the first dose?

Yes. The second dose of DTaP as part of the combined hexavalent vaccine should be given at 10 weeks. If the infant has had a severe complication to the first dose of DTaP, only Td should be given at 10 and 14 weeks and at 18 months. The other vaccines included in hexavalent vaccine will have to be given separately.

6. Should DTaP be given if the mother had febrile convulsions as a child?

It is important that DTaP immunisation, as part of the hexavalent vaccine, is still given. A family history of fits is not a contraindication to DTaP immunisation.

No. At 5 years only Td should be given, as the chance of complications with pertussis vaccine is higher in older children (above 18 months).

Case study 4

A week after the second routine immunisation with measles at 12 months, an infant develops a mild fever and a fine pink rash, which lasts for 2 days. As the infant had a slight cough at the time of the immunisation, the mother is worried that the fever and rash may be dangerous.

1. Is the mild fever and rash dangerous?

About 25% of infants develop a mild fever after measles immunisations. A rash is less common. Both are not dangerous and resolve in a few days.

2. What combined immunisation instead of measles alone can be given?

Measles, mumps and rubella (MMR vaccine).

3. When should measles immunisation not be given?

Measles immunisation should be delayed in children with untreated tuberculosis. Malnourished infants can safely be given measles immunisations. This is particularly important, as measles can be a fatal infection in malnourished children.

4. Should the measles immunisation have been given to this infant with a mild cough?

A mild illness, such as loose stools, cold or cough, is not a contraindication to measles immunisation. Infants who are well enough to go home are well enough to be immunised.

5. Why is it important to record measles immunisation on the Road-to-Health Booklet?

It is very important to note all immunisations on the Road-to-Health Booklet, as this is the official record of the child’s immunisation status. This is needed when the child is taken to another clinic or hospital and when the child is admitted to a crèche or play school.

Case study 5

A doctor notices that the fridge, which stores the vaccines in a clinic, is not working and that the vaccines are warm. He therefore cools the vaccines by placing them in the freezer compartment. He also notices that the expiratory date on some of the vaccines has been reached.

1. Does it matter if vaccines are not kept cool?

It is very important that all vaccines are kept cool, between 2 and 8 °C. Otherwise they will be damaged and live vaccines possibly killed. The commonest cause of failure of immunisation to protect an infant is the incorrect storage of vaccine.

2. Is it dangerous to freeze vaccines?

With the exception of oral polio vaccine, freezing damages or kills vaccines. Exposure to sunlight also damages vaccines.

3. What should be done with the vaccines, which were allowed to warm and were then frozen?

They must be discarded. Vaccines should also be discarded if the expiratory date has been passed.

4. What is meant by the ‘cold chain’?

This is the method that keeps vaccines cold from the time of manufacture until they are given to the patient. The cold chain makes sure that the vaccines are not damaged by becoming warm. A vaccine, especially measles vaccine, may not be effective if the cold chain has been broken.

5. What can be done to keep vaccines cool if the clinic cannot afford a fridge?

A cool bag or cool box can be used to keep vaccines cool for a few hours. When used for an immunisation clinic, this is adequate.

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