Guidance

Changing the timing of the neonatal BCG immunisation programme to a 28 day immunisation programme: effective from 1 September 2021

Published 1 October 2021

Background

The United Kingdom (UK) Bacillus Calmette-Guerin (BCG) immunisation programme has undergone several changes since its introduction in 1953. This has come about in response to changing trends in the groups of people who get tuberculosis (TB) and improved understanding of the groups that benefit most from the vaccine.

It is now a risk-based programme, the key part being a neonatal vaccine programme targeted at protecting babies and young children most at risk of exposure to TB from the more serious childhood forms of the disease such as meningitis and disseminated TB.

Consequently, the BCG vaccine is not given as part of the routine National Health Service (NHS) vaccination schedule but given to newborn babies who have a parent or grandparent who was born in a country where the yearly incidence of TB is 40 per 100,000 or greater; and/or newborn babies living in areas of the UK where the yearly incidence of TB is 40 per 100,000 or greater.

The BCG vaccine contains live bacteria that have been weakened (attenuated) stimulating the immune system without causing the disease. However, the BCG vaccine should not be given to those who are immunosuppressed.

From 6 September 2021, Severe Combined Immunodeficiency (SCID) screening will form part of the routine newborn Blood Spot (NBS) screening test at 5 days of age

BCG vaccine is contraindicated in babies with SCID. To ensure that babies with SCID are not given the live attenuated BCG vaccine, the Joint Committee on Vaccination and Immunisation (JCVI) has advised that it is necessary to move the neonatal BCG vaccination to when a SCID screen outcome will be available, which will be by 28 days of age.

The JCVI decided that it was necessary to adopt this change nationally to ensure consistency and safety for all babies across the country.

Severe Combined Immunodeficiency (SCID)

SCID is a group of rare, usually recessively inherited conditions that cause major immune system problems. This leads to reduced and malfunctioning T and B lymphocytes, which are the specialist white blood cells made in the bone marrow and the thymus gland to fight infection.

About 1 out of 40,000 babies born in England have SCID (approximately 16 babies per year), about 30% of whom are identified by family history. SCID is more common when parents are related to each other. SCID can also happen when there is no family history. The delay in finding the remaining 70% means that they have been exposed to infection for longer before receiving treatment. These may not be serious for most babies but can be life-threatening for children with SCID. The average age of diagnosis is approximately 6 months. If babies with SCID are not treated, they will generally die before they are 1 year old. Treatment for SCID is far more likely to be successful if started early, rather than waiting until a baby becomes ill. Early screening and identification are very important.

Evaluation of the introduction of newborn screening for SCID

The SCID screening evaluation is taking place in 6 areas across England (Manchester, Birmingham, Sheffield, Newcastle, London Great Ormond Street Hospital and London Southeast Thames). It is necessary to evaluate how screening for SCID works in practice first. The results from the evaluation will inform whether SCID screening should become part of the NHS newborn blood spot (NBS) screening programme in England.

Babies in non-screening areas will be assigned a ‘SCID screening not offered’ outcome.

Accessing SCID screen outcomes

SCID screen outcome for a baby is made available through the local Child Health Information System (CHIS) and may be available from around day 14 to 17. It is therefore possible to arrange BCG vaccination earlier than 28 days providing the appropriate SCID screen outcome is available.

There may be movers-in who have been screened and have an outcome available from another area, it is important to use all opportunities to remind parents or guardians to bring the Red Book and the letter with the outcome of newborn bloodspot screening when they are contacted about BCG vaccination.

BCG providers should ensure that a protocol is in place highlighting local arrangements for immunisers to be able to access SCID screen outcomes, including having a robust mechanism in place to check the outcome again before giving the BCG vaccine. Access to the necessary information and processes to arrange BCG appointments need to be timely as it is important not to delay BCG administration longer than necessary.

There should be documented evidence of an appropriate SCID screen outcome with immunisers making robust efforts to find out the SCID screen outcome before proceeding with BCG vaccination. This would involve checking for a record in the Red Book, the GP record, screen outcome information provided by CHIS and letter provided by parents or guardians.

Possible SCID screen outcome and associated actions to take:

SCID screen – ‘suspected’

• the baby will be referred within 1 working day to immunology
• parent or guardian and the GP will receive a direct communication from the immunology team with the outcome of the immunology appointment and this will include information on whether live vaccines can be given or not
• the BCG provider must contact the baby’s GP for the outcome letter. GP should also forward this information to BCG provider
• it is important to have local processes in place to get the immunologist appointment outcome in a timely manner
• BCG can only be given once confirmation received via immunologist or GP that BCG vaccination can be given

SCID screen – ‘repeat needed’

• defer BCG until repeat SCID screen outcome is known

SCID screen – ‘not offered’

• babies in non-screening areas will be assigned a ‘SCID screening not offered’ outcome
• arrange or give BCG vaccine

SCID screen – ‘declined’

• ensure parents or guardians are aware of the implications of baby having SCID and giving live vaccines
• document the discussion
• arrange or give BCG vaccine

SCID screen – ‘not suspected’

• arrange or give BCG vaccine

SCID suspected infant inadvertently given BCG vaccine

If a baby with SCID receives BCG, they may develop serious complications, which could be fatal. If a baby is given BCG, then, as a result of SCID screening, is found to have a serious immunological problem, prompt treatment will reduce the risk of these complications. However, it makes the treatment of SCID even more complicated and exposes the child to more drugs and their complications.

To prevent this from happening all BCG providers should update their BCG administration protocols to ensure SCID screen outcomes are available to immunisers before BCG is given.

If a baby with a SCID suspected outcome is inadvertently given BCG vaccine their management should be discussed with the local specialist immunology team to whom they are referred. Remember to complete the Yellow Card scheme, in addition, this event should be regarded and managed as a serious untoward incident (SUI) and action should be taken to ensure that all immunisers are aware of the SCID screening evaluation and the BCG vaccination recommendations and contraindications for babies screened as part of this evaluation.

BCG and other primary immunisations

No interval is required between BCG vaccine and primary immunisations.

BCG vaccine can be given at the same time as the other vaccines, administered as part of the routine childhood immunisation programme, including rotavirus. However, it is important to remember that no vaccines should be given into the same arm for 3 months after BCG is given.

The recommendation for administering live vaccines either at the same time or after an interval of 4 weeks only applies to injectable live viral vaccines and not to BCG or to the oral rotavirus vaccines.

The SCID screen outcome has to be known before giving the rotavirus vaccine, which is a live attenuated vaccine, but not for inactivated primary immunisations.

If a baby is eligible and is due or overdue for another vaccination then they should be referred to their GP to receive the vaccination, the importance of the childhood immunisation programme should be stressed and the parent or guardian should be encouraged to contact their GP accordingly.

The baby may also be eligible for the targeted Hepatitis B vaccination at 28 days of age. The parent or guardian should be advised accordingly, to ensure there is no confusion arising from the similar timings of these vaccinations and they should be referred directly to their GP, so the baby can be immunised.

Further information

Read the TB, BCG and your baby leaflet.

Download the BCG Patient Group Direction (PGD) template. Practitioners must not use this PGD template until it has been authorised.

Further information is available in the Green Book TB chapter.

Read the SCID Screening blog.

Further information on the rotavirus vaccination programme is available.