Independent report

Respiratory syncytial virus (RSV) immunisation programme: JCVI advice, 7 June 2023

Updated 11 September 2023

The Joint Committee on Vaccination and Immunisation (JCVI) is an independent expert committee with statutory basis in England and Wales that advises UK Governments on matters to do with immunisation.

JCVI recognises that there is a significant burden of respiratory syncytial virus (RSV) illness in the UK population and unmet public health need which has a considerable impact on NHS services during the winter months. JCVI is issuing a short statement of its advice on an RSV immunisation programme which has been shared with the Department of Health and Social Care (DHSC) to consider developing policy on RSV interventions and to allow sufficient lead in time for the necessary planning for a potential RSV immunisation programme.

JCVI has been monitoring products in development for several years and since January has been actively reviewing the latest evidence on immunisation products in late stages of development or newly licensed which could protect both neonates (newborns) and infants, and older adults against RSV infection and disease. A series of meetings of the JCVI RSV subcommittee have taken place in 2023. JCVI has reviewed evidence from manufacturers on the efficacy, safety and duration of protection of these immunisation products alongside clinical and epidemiological data on the burden of RSV in infants and older adults, and with consideration of programme delivery including ability to deliver high uptake in different population groups and clinical settings. Modelling of the impact and cost effectiveness of potential immunisation strategies by the London School of Hygiene and Tropical Medicine has been used to inform JCVI’s advice along with second opinion modelling by other academic groups. Cost effectiveness is a key factor in JCVIs considerations which is used to ensure that the finite resources of the health service are used to maximise the health of the population.

Programme to protect neonates and infants

Sanofi in partnership with AstraZeneca have developed a new long acting monoclonal Beyfortus® (nirsevimab) for passive immunisation against RSV infection and disease. Nirsevimab was licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) on 9 November 2022.

Pfizer have developed a bivalent RSV prefusion F maternal vaccine candidate, RSVpreF which has undergone clinical trials and has a potential licensing timeline in 2023.

Advice

The committee notes a seasonal, seasonal-with-catch-up or year-round passive immunisation (monoclonal antibody) programme for newborns could be cost effective over a range of potential prices that combine the cost of the product and its administration.

The committee notes a seasonal or year-round maternal active immunisation programme could be cost effective over a range of potential prices that combine the cost of the product and its administration.

JCVI advises that both products are suitable for a universal programme to protect neonates and infants from RSV. JCVI does not have a preference for either product and whether a maternal vaccination or a passive immunisation programme should be the programme chosen to protect neonates and infants. Therefore, subject to licensure of the maternal vaccine, both options should be considered for a universal programme.

JCVI advises a preference for a year-round offer for a passive immunisation or maternal immunisation programme to ensure high uptake and for reasons of operational effectiveness because this would be less complex and resource intensive to deliver, compared with running seasonal campaigns.

Programme for older adults

There are currently 3 RSV vaccine products in development from manufacturers (GSK adjuvanted PreF, Pfizer PreF and Moderna mRNA) with potential licensure timelines for 2023 or early 2024. The GSK product was very recently licensed by the European Medicines Agency. A fourth product, a Modified Vaccinia virus Ankara (MVA) vaccine from Bavarian Nordic, is currently in phase 3 trials.

Advice

The committee notes an RSV vaccine programme for adults aged 75 years and above could be cost effective at a potential price that combines the cost of the product and its administration, noting that this would be influenced by multi-year protection from a single dose.

JCVI advises a programme for older adults aged 75 years old and above. JCVI currently favours a one-off campaign as the strategy for this programme with the initial offer covering several age cohorts and then a routine programme for those turning 75 years old, with its delivery and implementation to be determined through further consultation between NHS England, DHSC, UKHSA and the devolved administrations.

JCVI currently does not have a preference among the products it has reviewed as efficacy is broadly comparable and there are no head-to-head studies to allow direct comparison, and so subject to licensure, they can be considered equally suitable for an older adult RSV immunisation programme at this time.

Conclusion

In summary, JCVI advises that a RSV immunisation programme, that is cost effective, should be developed for both infants and older adults.

Consultation period

A fuller statement providing more detail on the evidence considered and the key discussions and conclusions of the committee will be published alongside the minutes of the June meeting. Main committee minutes are usually published within 6 weeks of meetings.

The committee will continue to keep its advice under review as further evidence emerges and will update its advice when appropriate. The committee actively encourages feedback from key stakeholders during this period and welcomes the opportunity for engagement on its advice via the JCVI Secretariat at jcvi@ukhsa.gov.uk.

The Secretariat to JCVI is provided by officials from UKHSA, an executive agency of DHSC. The JCVI Secretariat supports and facilitates the work of the committee and collates the scientific evidence that is reviewed.