Vaccines for Routine Administration

The contents of this chapter are based on the current recommendations from the National Advisory Group on Immunisation (NAGI). 

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BCG (Bacillus calmette-guerin)

Hexavalent (DTaP-IPV-HB-Hib) vaccine

Tdap (Tetanus, reduced diphtheria and acellular pertussis vaccine)

bOPV (Oral polio vaccine)

RV (Rotavirus vaccine)

PCV (Pneumococcal conjugated vaccine)

Measles/Rubella

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Vaccine and Form	Dose and Route	Recommended site	Age
BCG, Powder	0.05ml, Intra-dermal	Right upper arm, at the deltoid muscle	Birth
OPV, Liquid	2 drops, Oral	Oral	Birth, 6 weeks
RV, Liquid	Administer the full vial (1 or 2ml depending on the product used), Oral	Oral	6, 14 weeks
Hexavalent (DTaP IPV-HB Hib), Liquid and Powder	0.5ml, IM	< 1 year: lateral aspect of the left thigh ≥ 1 year: left upper arm	6,10,14 weeks, 18 months
Measles/Rubella, Powder	0.5ml, SC	< 1 year: lateral aspect of the left thigh ≥ 1 year: right upper arm	6, 12 months
PCV, Liquid	0.5ml, IM	Lateral aspect of the right thigh	6, 14 weeks, 9 months
Tdap, Liquid	0.5ml, IM	Upper arm	5-7 years, ≥12 years

BCG (Bacillus calmette-guerin)

ICD 10 code: Z23.2

Protects against TB meningitis and miliary TB in children < 2 years of age.

BCG, 0.05 mL of reconstituted intradermal BCG vaccine

• Administered into the skin (intradermally) on the right upper arm, overlying insertion of the deltoid.
• Storage
  • Fridge: In a vaccine fridge at 2–8°C.
  • Discard opened vial after 6 hours or at end of immunisation session, whichever comes first. (It is acceptable to open a BCG vial for just one infant)
• Adverse events
  • Initial reaction to intradermal vaccination is a papule formation that lasts a maximum of 4–6 weeks. This develops into a scar (visible in 40% of vaccinated infants).
  • In 1–10% there is oozing, ulceration and lymphadenopathy after vaccination. This is a usual reaction and not a cause for alarm. Lymphadenopathy < 1.5 cm is not clinically significant. 
  • Occasionally the papule becomes a pustule.
  • Complete AEFI notification and refer all cases with significant lymphadenopathy or a draining sinus.
• Recommendations for providing BCG Vaccine
  • Initial dose of BCG vaccine
    • All newborns regardless of HIV status or TB exposure status should receive BCG at discharge.
    • For infants that are transferred to a neonatal unit, the timing of BCG vaccination will depend on the infant’s clinical status. Neonatal units should have a policy to ensure vaccination occurs prior to hospital discharge.
• Repeat dose of BCG vaccine
  • If the infant initiates TPT or TB treatment in the first six weeks of life, the effectiveness of the live, attenuated BCG vaccine may be negatively impacted. Therefore, the BCG vaccine should be repeated on completion of either TPT or TB treatment.
  • Infants or children living with HIV should only receive a repeat dose if they are 1) on ART, 2) clinically well, and 3) have a CD4 > 25%.
  • If the criteria to receive BCG are not met, i.e., the infant is 1) Not on ART, 2) or Unwell, or 3) CD4 < 25%.
    • Delay repeat dose of BCG until on ART and immunologically stable (CD4 > 25%)
    • Start/continue TPT until the child is eligible to receive BCG.
  • After TPT/TB treatment is completed, a CD4 count should be done to determine if the infant meets the above criteria for receiving BCG even if the annual CD4 count is not yet due. Do not wait for the routine annual CD4 count, as this delay may result in many infants not receiving BCG at all.
  • If the infant received the standard first-line TB treatment regimen BCG vaccination may be administered from 24 hours after the last anti-TB treatment dose. If the infant received rifapentine give BCG from 5 days after the last dose, and if the infant received bedaquiline or clofazamine give BCG vaccination two months after the last dose.
• Catch-up dose of BCG vaccine
  • A ‘catch-up’ BCG should be administered to any child <10 years of age who did not get a BCG at birth.
  • Infants or children living with HIV should only receive "catch up" BCG vaccinations if they are 1) on ART, 2) clinically well, and 3) have a CD4 > 25% (if ≤5 years of age) or >200 cells (if >5 years of age).
  • Children older than > 10 years of age should not get BCG vaccination.

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CAUTION

Children with suspected or confirmed inborn errors of immunity or other acquired immunodeficiencies should be evaluated by an expert before BCG vaccination.

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LoE:IVb

Hexavalent (DTaP-IPV-HB-Hib) vaccine

ICD 10 code: Z27.8

(Diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B and Haemophilus influenzae type b vaccine).

Protects against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B infection, and invasive infections caused by Haemophilus influenzae type b.

Hexavalent (DTaP-IPV-HB-Hib), IM, 0.5 mL

• < 1 year of age: administer into outer side of left thigh.
• > 1 year of age: administer into upper left arm.

Hexavalent (DTaP-IPV-HB-Hib) vaccine is a fully liquid combination of diphtheria toxoid, Tetanus toxoid, acelluar pertussis vaccine, inactivated polio vaccine, hepatitis B vaccine and Haemophilus influenzae type b vaccine.

• Storage
  • Fridge: In a vaccine fridge at 2–8°C.
  • Hexavalent (DTaP-IPV-HB-Hib) vaccine should never be frozen.
• Adverse events
  • Irritability.
  • Fever ≥ 38°C and acute illness.
  • Redness and induration at the site of the injection.
• Contraindications
  • Known hypersensitivity to any component of the vaccine or pertussis vaccine (acellular or whole cell pertussis) or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substance.

Tdap (Tetanus, reduced diphtheria and acellular pertussis vaccine)

ICD 10 code: Z27.8

Protects against diphtheria, tetanus and pertussis.

Tdap, IM, 0.5 mL in upper arm

• Storage
  • Fridge: In a vaccine fridge at 2–8°C.
  • Easily damaged by freezing.
• Adverse events
  • Mild fever.
  • Pain
  • Local swelling occasionally.
• Contraindications
  • Previous anaphylaxis to the vaccine.
  • Children < 4 years of age should not get Tdap.

Tdap in pregnancy

Tdap protects pregnant women and newborn infants against tetanus, diphtheria and pertussis.

• Pregnant women should routinely receive a single dose of Tdap during each pregnancy between 26–34 weeks’ gestation to maximise protection of preterm infants.
• If not administered between 26–34 weeks, a catch-up dose should be given at any time, including in the immediate post-partum period.

bOPV (Oral polio vaccine)

ICD 10 code: Z24.0

Protects against polio.

bOPV, oral, 2 drops given by mouth

• If spat out or vomited, repeat immediately.
• Not affected by feeding (breast or other).
• Storage
  • Fridge: In a vaccine fridge at 2–8°C; or freezer (in pharmacy).
  • Not damaged by freezing.
• Easily damaged by temperature > 8°C.
  • Keep open, uncontaminated vials at the correct temperature.
  • Record date of opening on the vial.
  • Discard after 30 days.
• Adverse events:
  • May be associated with a flu-like illness and gastroenteritis.
  • Mild fever.
• Contraindications:
  • Previous anaphylaxis to the vaccine.
  • bOPV is not contraindicated in HIV-infected children but should not be administered to children with primary immune deficiency.

RV (Rotavirus vaccine)

ICD 10 code: Z25.8

Protects against gastro-enteritis caused by rotavirus.

RV, oral, administer the full vial (1 or 2 mL depending on the product used)

• Squeeze the entire contents of the tube in the inner cheek.
• Storage
  • Fridge: In a vaccine fridge at 2–8°C.
  • Easily damaged by freezing.
  • Protect the vaccine from light.
• Adverse events
  • Mild fever.
  • Irritability.
• Contraindications
  • Previous anaphylaxis to rotavirus or any ingredients in the formulation.
  • Do not give rotavirus vaccine if a child has a history of chronic gastro-intestinal disease or severe diarrhoea including children with any history of uncorrected congenital malformation of the gastrointestinal tract. Refer the child for medical opinion.
  • A history of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever).
  • Rotavirus vaccine should not be given after 24 weeks of age (See: Childhood Immunisation Schedule, table: Catch-up doses).

PCV (Pneumococcal conjugated vaccine)

ICD 10 code: Z23.8

Protects against invasive pneumococcal disease (meningitis, septicaemia), pneumonia and otitis media.

PCV, IM, 0.5 mL

• < 1 year of age: administer into outer side of right thigh.
• > 1 year of age: administer into upper arm in the deltoid muscle.
• PCV and Hexavalent (DTaP-IPV-HB-Hib) can be administered at the same time, but at different sites.
• Storage
  • Fridge: middle shelf at 2–8°C.
  • Do not freeze as the vaccine is easily damaged by freezing.
  • Do not mix PCV in the same syringe with other vaccines.
  • Shake the vaccine well before use.
• Contraindications
  • Previous anaphylaxis to the vaccine.

Measles/Rubella

ICD 10 code: Z24.4

Measles/Rubella vaccine, SC, 0.5 mL

• < 1 year of age: administer subcutaneously on lateral aspect of the left thigh.
•  ≥ 1 year of age: administer subcutaneously on right upper arm.
• Avoid administering the measles/rubella vaccine at the same time as other vaccines at 6 months of age. However, it is considered safe to co-administer the measles/rubella vaccine with other vaccines in children 9 months and older. If a child requires measles/rubella vaccine and other vaccines at 6 months, give measles/rubella vaccine immediately and schedule visit to receive remaining vaccines 1 month later.
• Storage
  • Fridge: In a vaccine fridge at 2–8°C.
  • Discard opened vial after 6 hours or at end of immunisation session (whichever comes first).
• Adverse events
  • Burning or stinging at the injection site, fever.
  • Transient morbilliform rash and mild pyrexia up to 30 days after vaccination.
• Contraindications
  • Previous anaphylaxis.
  • Uncontrolled convulsions: consult a doctor.

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Standard Treatment Guidelines and Essential Medicines List for South Africa, Primary Healthcare, 2020-2024_Version1.1_6 December 2024

Chapter 13: Immunisation_13.3 Vaccines for Routine Administration