BCG Immunisation in the Newborn

Publication: 01/04/2004  --
Last review: 24/04/2017  
Next review: 21/04/2020  
Clinical Protocol
CURRENT 
ID: 202 
Approved By:  
Copyright© Leeds Teaching Hospitals NHS Trust 2017  

 

This Clinical Protocol is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

BCG Immunisation in the Newborn

Background and indications for protocol

There has been a steady increase in the incidence of TB since 1987 in this country of nearly 40% (DOH 2006). Protection given by BCG immunisation in the UK is long lasting, for approximately 15 years. BCG should be offered to neonates from the following categories:

  • all infants (aged 0 to 12 months) living in areas of the UK where the annual incidence of TB is 40/100,000 or greater
  • all infants (aged 0 to 12 months) with a parent or grandparent who was born in a country where the annual incidence of TB is 40/100,000 or greater
  • previously unvaccinated children aged one to five years with a parent or grandparent who was born in a country where the annual incidence of TB is 40/100,000 or greater. These children should be identified at suitable opportunities, and can normally be vaccinated without tuberculin testing
  • previously unvaccinated, tuberculin-negative children aged from six to under 16 years of age with a parent or grandparent who was born in a country where the annual incidence of TB is 40/100,000 or greater. These children should be identified at suitable opportunities, tuberculin tested and vaccinated if negative (see section on tuberculin testing prior to BCG vaccination)
  • previously unvaccinated tuberculin-negative individuals under 16 years of age who are contacts of cases of respiratory TB (following recommended contact management advice – see National Institute for Health and Clinical Excellence (NICE), 2006)
  • previously unvaccinated, tuberculin-negative individuals under 16 years of age who were born in or who have lived for a prolonged period (at least three months) in a country with an annual TB incidence of 40/100,000 or greater.(for country incidences click here)

People seeking vaccination for themselves or their children should be assessed for specific risk factors for tuberculosis. Those without risk factors should not be offered BCG vaccination but should be advised of the DOH policy and given written information.

Midwives undertaking BCG vaccination must adhere to their professional obligations in terms of accountability, responsibility and professional conduct as documented by the UKCC and NMC.

  • Code of Professional Conduct (NMC 2008)
  • The Scope of Professional Practice ((NMC 2001)
  • Guidance  for Professional Practice (NMC 2009 )
  • Guidelines for Records and Record Keeping (NMC 2005)
  • Midwives Rules and Standards (NMC 2012)

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Procedure method (step by step)

This procedure should be read in conjunction with the Protocol for BCG Immunisation. BCG vaccination must be prescribed by a Paediatrician using a standard prescription chart

Procedure for midwives

  • Explain and give information leaflet. Ensure parent(s) understands reason for vaccine
  • Check exclusion criteria
  • Complete the consent form in full. Ensure written consent is obtained on the Trust Neonatal BCG Vaccine Consent/Discharge advice note.
  • If the mother is known HIV positive or suspected HIV positive, do not obtain consent, document this in the maternal and neonatal records, refer to Consultant Neonatologist as in Exclusion Criteria.
  • Explain procedure to parent(s)
  • Confirm with parents whether Mum has taken immunosuppressant medication during pregnancy and/or breastfeeding
  • Check that BCG vaccine and sucrose analgesia (see guideline) is prescribed by paediatrician as appropriate.
  • Record in baby's medical records, public health notification records and information sheet for parent(s)
  • All eligible babies should be administered the vaccine prior to discharge from hospital, not at birth.

EXCLUSION CRITERIA

  • Lack of valid consent
  • Acute illness
  • Babies receiving corticosteroid or other immuno-suppressive treatment
  • The BCG vaccine should not be delayed because of surgery and anaesthesia.
  • Babies of known HIV positive mothers or suspected HIV positive, refer to Dr L. Miall.
  • Babies with generalised infected skin conditions
  • Previous BCG vaccination 

No further immunisation should be given in the arm used for BCG immunisation for at least three months because of the risk of regional lymphadenitis. The subject must always be advised of the normal reaction to the injection and about caring for the vaccination site.

BCG should ideally be given at the same time as other live vaccines such as MMR. If live vaccines cannot be administered simultaneously, a four-week interval is recommended.

Non-live vaccinations e.g. hepatitis B can continue to be given at any time - but NOT into the  BCG arm

If a baby has an exclusion criteria

  • seek medical advice
  • Babies of HIV positive mothers will be followed up by a Consultant Neonatologist (Dr Miall). The consultant will liase with Leeds Chest Clinic regarding these babies.
  • If parent does not consent, explore reasons for lack of valid consent, reinforce indications and benefits of immunisation and seek medical advice. Inform staff at Leeds Chest Clinic, who can provide advice for parents if required.

Only midwives who have received specific training in BCG vaccination and are confident in the technique should be administering intradermal injections. Paediatricians should not administer the vaccine unless they can demonstrate appropriate training.

Preparation

  • The vaccine should have been stored between 2-8'C and protected from light

From July 2016, the available product is InterVax BCG vaccine. Please refer to the Department of Health factsheet and training slide set for information on administration and use of the product: https://www.gov.uk/government/publications/intervax-bcg-vaccine-training-slideset-for-healthcare-professionals

Administering the vaccine

  • If all other criteria are met the vaccine may be given at any time during the hospital stay and not only on the day of discharge. However refer to lead Sister on postnatal wards (L36, J5) for current policy as this may change with restrictions of supply of BCG vaccine.
  • As per the Trust's Medicines Management policy (secton 11), check the identity of the baby on their name-band with a second health professional
  • Give vaccine in a quiet area with help of second midwife/HCA. It is inappropriate for parent to hold the baby, or to attempt this procedure without help.

The operator stretches the skin between the thumb and forefinger of one hand and with the other slowly inserts the needle, with the bevel upwards, about 3mm into the superficial layers of the dermis almost parallel with the surface. The needle can usually be seen through the epidermis. A correctly given intradermal injection results in a tense, blanched, raised bleb, and considerable resistance is felt when the fluid is being injected. A bleb is typically of 7mm diameter following a 0.1ml intradermal injection, and 3mm following a 0.05ml intradermal injection. If little resistance is felt when injecting and a diffuse swelling occurs as opposed to a tense blanched bleb, the needle is too deep. The needle should be withdrawn and reinserted intradermally before more vaccine is given.

If vaccine not successfully administered e.g. no bleb seen

  • Advise parent(s) that vaccine may not provide effective immunisation
  • Inform Leeds Chest Clinic of baby's details for follow up

Record Keeping
The following information should be recorded in the baby's medical notes also the midwifery care plan:

  • Assessment of inclusion criteria
  • Any exclusion criteria and action taken
  • Brand name of vaccine
  • Batch number and expiry date
  • Date & time of administration
  • Dose given
  • Site of injection
  • Advice given to parent(s)
  • Signature and printed name and designation
  • File a copy of the consent form in the baby's notes, send the other copies to the relevant departments as given at the bottom of the consent form
  • In addition, complete hand held record for parents (red book)

Advice to parents after BCG vaccination
BCG should not make baby unwell. Keep the site clean and dry, and do not bath the baby for 24 hours following administration. Within 2 or 3 weeks normally a small swelling at the injection site which may crust over. If the crust comes off, leave uncovered and it will leave a small sore (ulcer) but a new scab will soon form. If the parents are concerned in any way, discuss with GP, Midwife or Health Visitor. No ointment or antiseptic should be put on the injection site. Advise no further immunisations to be given for at least 3 months in the same arm used for BCG immunisation, however, this does not prevent baby from having recommended primary childhood immunisations at 8, 12 & 16 weeks.

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Provenance

Record: 202
Objective:

To standardise and optimise the administration of BCG immunization in the newborn population

Clinical condition:

N/A

Target patient group: Newborn infants
Target professional group(s): Secondary Care Doctors
Secondary Care Nurses
Allied Health Professionals
Adapted from:

N/A


Evidence base

  • WHO | Global Tuberculosis Report 2013
  • NMC (2008) Code of Professional Conduct London NMC
  • NMC (2001) The Scope of Professional Practice London. NMC
  • NMC (2009) Guidance for Professional Practice London. NMC
  • NMC (2005) Guidelines for Records and Record Keeping London. NMC
  • NMC (2012) Midwives Rules andStandards. NMC

Evidence levels:
A. Meta-analyses, randomised controlled trials/systematic reviews of RCTs
B. Robust experimental or observational studies
C. Expert consensus.
D. Leeds consensus. (where no national guidance exists or there is wide disagreement with a level C recommendation or where national guidance documents contradict each other)

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Document history

LHP version 1.0

Related information

Not supplied

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