Correspondence

BCG immunisation programme: changes from September 2021 letter

Published 27 July 2021

NHS England and NHS Improvement Regional Directors

NHS England and NHS Improvement Directors of Commissioning

NHS England and NHS Improvement Directors of Public Health and Primary Care

NHS England and NHS Improvement Heads of Public Health Commissioning

NHS England and NHS Improvement Heads of Primary Care

NHS England and NHS Improvement / Public Health England Screening and Immunisation Leads

NHS Trust Chief Executive Officers

Clinical Commissioning Groups Clinical Leaders

Clinical Commissioning Groups Accountable Officers

General Practitioners

Local Medical Committees

Local Authority Chief Executives

Local Authority Directors of Public Health

Heads of Midwifery

Paediatricians

TB Services

For information:

Chief Pharmacists of NHS Trusts

NHS Foundation Trusts

NHS Trusts

NHS Specialist Pharmacy Service

Royal College of Paediatrics and Child Health

Royal College of Midwives

Royal College of Physicians

Royal College of Nursing

Royal College of Obstetricians and Gynaecologists

Royal College of General Practitioners

27 July 2021

Changing the timing of the neonatal BCG immunisation programme to a 28-day immunisation programme

Dear Colleague,

This letter provides information on the forthcoming changes to the NHS neonatal Bacillus Calmette-Guérin (BCG) immunisation programme.

The BCG immunisation programme was introduced in the UK in 1953 and has undergone several changes in response to changing trends in tuberculosis (TB) epidemiology. The BCG vaccine is a live attenuated vaccine and is not given as part of the routine vaccination schedule but only when a child is at increased risk of coming into contact with TB. Eligible babies include all newborns whose parent(s) or grandparent(s) was born in a country where the annual incidence of TB is 40 per 100,000 or greater; and/or newborn babies living in areas of the UK where the annual incidence of TB is 40 per 100,000 or greater.

The BCG vaccine has been offered to babies that fall into one of the above categories soon after birth, often whilst the baby is still in hospital. The forthcoming evaluation of the addition of screening for Severe Combined Immunodeficiency (SCID) to the routine newborn screening test at 5 days of age makes it necessary to move the BCG vaccination to when a SCID screening outcome will be available, which will be by 28 days of age. This is to ensure that babies with SCID are not given the live attenuated BCG vaccine which is contraindicated in these babies.

The SCID screening evaluation is taking place in 6 areas across England and will cover about 60% of newborn babies (Manchester, Birmingham, Sheffield, Newcastle, London Great Ormond Street Hospital and London Southeast Thames). It is necessary to change the BCG programme nationally to ensure consistency and safety for all babies across the country and to guarantee data collection for the programme. This also provides an important opportunity to improve upon the existing BCG service.

The Joint Committee on Vaccination and Immunisation (JCVI) advised in the October 2018 meeting that the BCG vaccination is moved “from birth to after SCID screening results were available, as vaccination before testing would not be acceptable”. In February 2020, the JCVI noted that moving the timing of the BCG vaccination would not significantly impact TB cases in England, and the benefits from SCID screening would outweigh any increase in TB disease.

This letter is aimed at health professionals who will be responsible for implementing the changes to the BCG schedule. We encourage you to share this guidance with all those who will be involved in helping to deliver the national childhood immunisation schedule in your area.

Key points about the changes to the programme

1. From 1 September 2021, eligible babies born on or after this date should be offered the BCG vaccine at 28 days or soon after.

2. Providers are required to check the record for a negative SCID result, or confirmation that the child was not offered SCID screening, before administering the BCG vaccine. BCG immunisation appointment letters should include instructions for parents to bring the red book and the letter with the outcome of newborn bloodspot screening.

3. Vaccination may be administered earlier than 28 days provided that a SCID result is available.

4. The vaccine will continue to be available to order through the ImmForm website . See Annex A for how to register for an ImmForm account.

5. In the designated 6 areas SCID will form part of the routine newborn screening test at 5 days, with most results expected within 10 to 12 days. Those eligible babies that have participated in the SCID screening evaluation should have received their results of the screening test by 28 days when the BCG vaccine is scheduled.

6. All live vaccines are contraindicated in babies with a SCID diagnosis. SCID screening status will need to be checked before the offer of the rotavirus vaccine (Rotarix) at the 8 week vaccination appointment. Further guidance for health professionals will be issued in a specific communication about the rotavirus programme.

7. BCG vaccine contains a live attenuated strain of bacterium, derived from Mycobacterium bovis. BCG Vaccine AJV (AJ Vaccines) is the only licensed vaccine in the UK.

8. The parents of any baby that has received a result suggesting SCID may be present will be contacted by a specialist immunology team and an appointment arranged within 24 working hours of this contact. This team will recommend further diagnostic tests to confirm whether the baby has a problem with their immune system or not. Following diagnostic tests and where these are negative, a letter confirming the outcome of the investigations will be issued to parents and copied to GP and Health Visitor. This letter also confirms that vaccinations can now be given as usual including BCG and rotavirus vaccine.

9. There is no change to funding arrangements for the vaccine programme: the NHS neonatal BCG immunisation programme will continue to be funded through the Clinical Commissioning Group (CCG) Maternity Tariff.

Additional information

1. All relevant immunisation information for parents and care givers, including the immunisations up to 13 months leaflet, will be updated and available on the Public Health England (PHE) Immunisation webpage and available to order from the Health Publications website.

2. Further detailed healthcare professional information and guidance, including training slides, will be available in the Tuberculosis section of the PHE Immunisation webpage from August 2021.

3. The revised Tuberculosis chapter of the green book (Immunisation against infectious disease) will be published in August 2021.

4. An updated patient group direction (PGD) template for the administration of BCG will be available for NHS England and NHS Improvement areas to adopt and authorise for their commissioned services ahead of the change in delivery of the programme to those eligible babies.

5. An updated schedule 2 document for the neonatal BCG immunisation programme including patient pathway.

6. A summary of key issues relating to the changes in the schedule is set out in Annex A.

7. Details of how the COVER programme (the routine quarterly and annual childhood vaccine coverage data collection) will be modified to capture data on uptake of the BCG programme are set out in Annex B.

8. Annex C contains links to updated pathways for BCG vaccination data flows and patient care.

If you have any queries about the content of this letter please contact immunisation@phe.gov.uk

We would like to take this opportunity to thank all involved for their continuing hard work in delivering childhood immunisation programmes.

Yours faithfully

Deborah Tomalin

NHS England and NHS Improvement Director of Public Health Commissioning and Operations

Dr Mary Ramsay

Public Health England, Head of Immunisation