1. Introduction

1.1 The NHS respiratory syncytial virus (RSV) vaccination programme is a general practice essential service. All practices are required to offer eligible registered patients the RSV vaccination in line with the UK Vaccination and Immunisation Schedule and this contractual guidance.

1.2 This contractual guidance sets out the RSV vaccination programme requirements for practices. It provides practices with information on the eligible cohorts, clinical codes required to record RSV vaccination events and outlines how payments will be supported through the General Practice Extraction Service (GPES) and Calculating Quality Reporting Service (CQRS).

2. Background and rationale for RSV vaccination service

2.1 RSV is one of the common viruses that cause coughs and colds in winter. It is transmitted by large droplets and by secretions from contact with an infected person. The virus can survive on surfaces or objects for about 4 to 7 hours and the incubation period is about 3 to 5 days.

2.2 RSV circulates in temperate climates and epidemics generally start around October and last for 4 to 5 months, peaking in December. The sharp winter peak varies little in timing or magnitude, in contrast to influenza virus infection which is much less predictable in its timing. In most people, RSV infection causes a mild respiratory illness, but for a small number of people who are at risk of more severe respiratory disease, it might cause pneumonia or even death.

2.3 High risk groups are the very young (under 1 year of age) and older adults. Infants aged less than 6 months frequently develop the most severe disease and require hospitalisation. Children born prematurely or with underlying lung disease, and the elderly with chronic illness are also at risk of developing severe disease.

2.4 The Joint Committee on Vaccination and Immunisation (JCVI) has advised that an RSV immunisation programme, that is cost effective, should be developed for both infants and older adults. This advice was accepted by the government.

2.5 As set out in the UK Health Security Agency (UKHSA) and NHS England bipartite letter on the 24 June 2024, two RSV vaccinations programmes will be implemented from 1 September 2024:

• an older adult programme, and
• a programme during pregnancy to protect infants. 

3. Eligible patient cohorts

3.1 Eligible patients can be immunised at any point in the year in accordance with the eligibility set out in this section 3. RSV vaccinations should be offered to patients across a range of appointment times, considering patient preferences that are most likely to support high uptake.

Older adult programme

3.2 From 1 September 2024, practices are required to offer and provide RSV vaccination to eligible patients as follows:

• adults turning 75 years (older adult routine programme). These patients will remain eligible until they attain 80 years and will not be eligible thereafter
• adults aged 75 to 78 years on 31 August 2024 (older adult catch-up programme). These patients will remain eligible until they attain 80 years and will not be eligible thereafter
• adults aged 79 years on the 31 August 2024 (older adult catch-up programme). These patients will remain eligible until the 31 August 2025 (so, exceptionally, will be eligible aged 80) and will not be eligible thereafter

3.3 Practices are required to proactively call and recall older adults in accordance with Vaccination and Immunisations Standards and must also offer vaccination to eligible registered patients on request. Practices must also offer vaccination opportunistically and if clinically appropriate when an individual attends the practice for another reason. This includes registered patients residing in care homes or who are housebound.

3.4 For those adults turning 75 years, the initial offer should be made as soon as the patient becomes eligible from their 75^th.

3.5 For those adults aged 75 to 79 years on 31 August 2024, the initial offer should be made as soon as possible. To offer the best protection, practices are asked to vaccinate as many people as possible during September and October 2024 prior to the expected RSV season and with the majority completed in the first 12 months of the programme.

3.6 one dose of RSV vaccine is to be administered per eligible patient.

Programme for pregnant women to protect infants

3.7 From 1 September 2024, practices are required to offer and provide RSV vaccination to all eligible registered patients from 28 weeks of pregnancy either opportunistically or on request. They will remain eligible until birth (after 36 weeks the vaccine is prescribed off-label).

3.8 Where a practice is aware of a patient’s pregnancy and there is no RSV vaccination in their medical record, it would be clinical best practice to check with the patient whether they have been vaccinated and offer this vaccination given the importance of protection to the infant.

3.9 One dose of RSV vaccine is to be administered per pregnancy.

4. Service description

4.1 The practice must:

• ensure that vaccinations are provided in line with the relevant Patient Group Direction (PGD) and Green Book guidance, including relevant details on the treatment of anaphylaxis and secure storage and disposal of clinical waste. The practice must ensure that it has a process in place to check any updates to the Green Book,
• comply with any relevant guidance and standard operating procedures for managing RSV vaccinations (as updated from time to time), including following all current guidance published by the JCVI, the commissioner, Medicines and Healthcare products Regulatory Agency (MHRA) and/or UKHSA; and
• identify those eligible for the RSV vaccination and encourage them to be vaccinated

4.2 In the event of a conflict between guidance issued by JCVI, the commissioner, MHRA and/or UKHSA, the commissioner shall confirm which guidance shall be adopted.

4.3 Each patient being administered a vaccine, or their carer, must be given written information about the vaccine. As a minimum, a copy of the manufacturer’s patient information leaflet must be provided to the Patient (the Patient may be directed to a web-based version of that leaflet where the Patient agrees).

5. Collaboration

5.1 Practices may collaborate within their Primary Care Networks (PCNs), under the Network Contract Directed Enhanced Service during both core hours and enhanced access hours, to offer the RSV vaccine to their collective registered eligible patients. This includes the PCN’s collective registered patients residing in care homes that are eligible for the RSV vaccine.

5.2 Practices will be required to set out the collaboration arrangements within Schedule 8 of the Network Agreement.

6. RSV vaccine

6.1 Practices must ensure that all vaccines are received, stored and prepared according to the relevant manufacturer’s instructions. They must additionally adhere to the UKHSA’s ordering, storing and handling protocol and the commissioner’s instructions and all associated guidance set out in the ‘Storage distribution and disposal of vaccines’ chapter of the Green Book and all associated Standard Operating Procedures. Receipt, storage, and preparation of vaccines must be undertaken with appropriate cold chain management, clinical oversight and governance.

Vaccine supply and information

6.2 Abrysvo® is supplied in single dose packs measuring 73mm x 35mm x 116mm (H x W x D). Each pack will include a vial for reconstitution (containing drug product), a pre-filled syringe (containing sterile water diluent) and one unattached needle for administration. Practices should order Abrysvo® via the ImmForm website from 1 August 2024. Practices will be able to monitor their orders and deliveries through ImmForm.

6.3 Although the products are the same, UKHSA has listed the vaccines for the older adult programme and programme for pregnant women are listed as separate products on ImmForm and practices must place separate orders for the vaccination of each cohort. Where vaccine ordered for the older adult programme has been administered to a pregnant individual, replacement stock should be ordered via ImmForm.

6.4 Vaccine supply has been frontloaded to support rapid rollout of the catch-up programme alongside the routine programmes. It is recommended that practices hold no more than 2 weeks’ worth of stock to prevent wastage due to cold chain incidents. High level ordering caps will be in place to prevent errors.

6.5 A summary of the key product characteristics for Abrysvo® is included in Table 1.

Table 1: key product characteristics

RSV vaccine co-administration

6.6 Practices should ensure they keep up to date on the latest advice on RSV vaccine administration in chapter 27a of the Green Book . They should also access the UKHSA publication titled RSV programme: information for healthcare professionals.

6.7 Details of vaccine co-administration arrangements for the older adult programme and programme for pregnant women are set out below.

Vaccine co-administration arrangements

Older adults

• Abrysvo® should not be routinely scheduled to be given to older adults at the same appointment or on the same day as an influenza or COVID-19 vaccine. No specific interval is required between administering the vaccines. 
• If it is thought that the individual is unlikely to return for a second appointment or immediate protection is necessary, Abrysvo® could be administered at the same time as influenza and/or COVID-19 vaccine.
• Abrysvo® can be given at the same time as pneumococcal, shingles vaccine and any live vaccines.

Pregnant women from 28 weeks

• Pregnant women can have Abrysvo® co-administered with inactivated influenza vaccine, COVID-19 vaccine and/or anti-D immunoglobulin, if necessary. When more than one vaccine is administered, it should be at different sites, preferably different limbs. 
• If a pertussis containing vaccine has not been given by the time of attendance for Abrysvo® RSV vaccine, both vaccines can and should be given at the same appointment to ensure prompt development of immune response. 

7. Monitoring, reporting and record keeping

7.1 Practices must adhere to defined standards of record keeping ensuring that the vaccination event is recorded the same day that it is administered. Further information on the defined standards is set out in Part 5(18)(12) of the SFE and the Green Book (chapter 4).

7.2 Practices must comply with any reasonable requirement for information from the commissioner relating the provision of RSV vaccinations.

7.3 Practices are responsible for recording adverse events and providing patients with information on the process to follow if they experience an adverse event in the future after vaccination, including signposting to the Yellow Card service.

7.4 Practices are expected to follow the UKHSA: “Vaccine incident guidance”, when responding to errors in vaccine storage, handling and administration.

7.5 Appropriate records to ensure effective ongoing delivery and governance must be maintained and managed in line with ‘Records Management Code of Practice for Health and Social Care’. Where the records relate to a RSV vaccination in pregnancy, records must be retained for a period of 25 years in line with Records Management Code of Practice.

7.6 Practices are reminded that where RSV vaccination is delivered by another provider, the practice does not need to enter the vaccination event information into the patient’s medical record, as it will automatically flow via the Data Processing Service (DPS).

Clinical codes for recording RSV vaccinations

7.7 Practices will be required to use both of the clinical codes set out in Table 2 to record RSV vaccinations, contraindications or declines.

7.8 The procedure code must be used for the both the adult programme and vaccination in pregnancy programme. Where payment is automated via GPES, failure to use this code will result in the vaccination event not being captured by the GPES extract and practices will need to re-code the vaccination event accordingly in the patient’s medical record, claiming the relevant payment as outlined in section 8.

Table 2: RSV clinical SNOMED codes

8. Payments

8.1 Practices will be paid an item of service payment per dose administered as set out in Part 5 of the Statement of Financial Entitlements (SFE).

9. Technical implementation of the RSV

9.1 To support the implementation of the RSV vaccination programme, GPES and CQRS have been updated.

9.2 Commissioners must offer the services in CQRS to practices from August 2024. Practices are required to accept and participate in the RSV services as both form part of essential services.

Technical implementation of the RSV older adult programme

9.3 Data will be extracted monthly through GPES to support the automated payments for the RSV vaccination events administered to patients in the preceding month for those:

• aged 75 years on or after 1 September 2024 and until they attain the age of 80 years, and
• aged 75 to 79 years on the 31 August 2024 and until they attain the age of 80 years.

9.4 Where an individual aged 79 years on 31 August 2024 turns 80 and is vaccinated before the 31 August 2025 at age 80, then the practice will be required to manually claim for these individuals. This payment claim will need to be made outside of CQRS.

9.5 RSV vaccination events not correctly recorded or not recorded within GP IT systems within the month they took place, may not be included in the monthly extract. In these circumstances, the practice will need to raise the missing vaccination events with their commissioner and the claim will either need to be through a:

• manual adjustment in CQRS before the payment is approved by the service provider and commissioner in CQRS, or
• payment variation managed outside of CQRS.

9.6 The following payment, management information and cohort counts will apply for older adult programme:

Payment count (RSV001)

• Monthly count of the number of registered patients who turn 75 years on or after 1 September 2024 and who have a record of receiving a dose of RSV carried out by the practice within the reporting period whilst aged at least 75 but aged less than 80.

Payment count (RSV002)

• Monthly count of the number of registered patients aged 75 to 79 years (inclusive) on 31 August 2024 who have a record of receiving a dose of RSV carried out by the practice during the reporting period whilst the patient was aged 75 to 79 inclusive. Patients remain eligible up to and including the day before they attain 80 years.

Management information (RSVMI001)

• Monthly count of the number of patients aged at least 75 years on or after 1 September 2024, who have not yet attained the age of 80 years, for whom the RSV vaccination was contraindicated up to the end of the reporting period.

Management information (RSVMI002)

• Monthly count of the number of patients aged 75 years on or after 1 September 2024, who have not yet attained the age of 80 years, who have declined a dose of RSV vaccine up to the end of the reporting period.

Management information (RSVMI003)

• Monthly count of the number of patients aged 75 to 79 years on 31 August 2024 for whom the RSV vaccination was contraindicated up to the end of the reporting period.

Management information (RSVMI004)

• Monthly count of the number of patients aged 75 to 79 years on 31 August 2024 who declined a dose of RSV vaccine up to the end of the reporting period.

Cohort counts (RSVCC001)

• The number of registered patients aged 75 years on or after 1 September 2024 and who are 75 years or over but no more than 80 years at the quality service end date.

Cohort counts (RSVCC002)

• The number of registered patients aged 75 to 79 on the 31 August 2024.

Technical implementation of the RSV vaccination in pregnancy programme

9.7 Practices will be required to manually enter the number of vaccination events given each month into CQRS. This will continue until notice is provided of the automation of the service via GPES.

9.8 The following payment count will apply for the vaccination in pregnancy programme:

Payment count

• Monthly count of the number of registered patients from 28 weeks of pregnancy who have a record of receiving a dose of RSV carried out by the GP practice within the reporting period.

No management information or cohort counts will apply for this programme. Please note that this may be subject to change at the point the service is automated.

10. Helpful resources

10.1 The following resources have been published:

• RSV vaccination programme bipartite letter: GOV.UK
• RSV Patient Group Directions (PGD) template: GOV.UK
• RSV vaccination programme document collection: GOV.UK. This site includes various resources and training information.
• RSV programme: information for healthcare professionals: GOV.UK. This guidance is for health practitioners implementing the vaccination programme to protect pregnant women and older adults from RSV.
• Green Book Chapter 27a: GOV.UK
• The manufacturer (Pfizer) video of how to prepare the ABRYSVO RSV Vaccine
• UKHSA training resources: GOV.UK
• Health Publications webpage. This site includes publications created by The Department for Health and Social Care (DHSC), NHS England and UKHSA. Practices can order and download these publications.
• Older adults leaflet – order via Health Publications product code: C24RSV01EN
• Older adults poster – order via Health Publications product code: RSVOAEN
• RSV for pregnant women leaflet – order via Health Publications product code: C24RSV03EN
• RSV poster for pregnant women – order via Health Publications product code: RSVPGEN

Publication reference: PRN01462