Adding new vaccinations to the NHS national immunisation programme

On 18 January 2024, the House of Lords is scheduled to consider the following question for short debate:

Baroness Ritchie of Downpatrick (Labour) to ask His Majesty’s Government what plans they have to accelerate the adoption of new innovative vaccines by the national immunisation programme.

1. What is the national immunisation programme and which vaccines are currently provided?

The national immunisation programme is a set of vaccinations offered to everyone as they reach certain ages. The NHS describes vaccination as “the most important thing we can do to protect ourselves and our children against ill health”.^[1] The NHS’s first mass vaccination programme took place in 1958 when everyone under the age of 15 was vaccinated against polio and diphtheria.^[2]

The UK Health Security Agency’s Green Book describes the purposes of the national immunisation programme:

• to provide early protection against infections that are most dangerous for the very young, followed by boosters for ongoing protection
• to protect against infections throughout life when eligible individuals reach an age where they can derive most benefit
• to provide optimal control of certain diseases for the population as a whole
• to protect individuals at additional risk due to an underlying medical condition or circumstances^[3]

Table 1 illustrates which vaccinations are available from NHS England across childhood and from age 65.^[4]

Other people at particular risk from underlying health conditions or other factors are offered vaccinations additional to those in the above table. For example people over 50 with a severely weakened immune system are eligible for the shingles vaccine. The NHS also offers whooping cough and flu vaccinations during pregnancy.

2. Which new vaccines have the Joint Committee on Vaccination and Immunisation recommended be adopted?

The Joint Committee on Vaccination and Immunisation (JCVI) is an advisory committee, set up to advise UK health departments on immunisation.^[5] While the JCVI has statutory status in England and Wales, it has no statutory basis for providing advice to ministers in Scotland or Northern Ireland.^[6] Health departments in these countries are advised of the committee’s recommendations and may choose to accept them.

In 2023 the JCVI advised that an immunisation programme for respiratory syncytial virus (RSV) should be developed for babies and older adults. The JCVI recommendation took the form of top line advice published in June 2023 followed by a full statement in September 2023.^[7]

RSV is a common respiratory virus that usually causes mild, cold-like symptoms.^[8] Globally, RSV infects up to 90% of children within their first two years and frequently reinfects older children and adults. Babies under one year and older adults are at the greatest risk of hospitalisation.

RSV causes an estimated 33,500 UK hospitalisations annually for children under five, and results in 20 to 30 deaths per year.^[9] A study in the New England Journal of Medicine published in December 2023 found that an immunisation for RSV protected babies against hospitalisation for RSV.^[10] There was an 83.4% reduction in hospitalisation for RSV in UK babies immunised in the trial.

In response to a recent written question the government confirmed it is considering the JCVI’s recommendations:

The 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. Officials across the department, UK Health Security Agency (UKHSA) and NHS England are developing policy options at speed based on JCVI’s advice regarding an expanded RSV immunisation programme to protect infants and older adults.^[11]

In November 2023, the JCVI recommended a childhood varicella (chickenpox) vaccine be offered as part of the childhood immunisation programme.^[12] It said two doses should be given, one at 12 months and one at 18 months. During the Covid-19 pandemic, restrictions on social mixing led to fewer cases in younger age groups, leaving a larger pool of children susceptible. The JCVI submitted its recommendations to the Department of Health and Social Care which will take a final decision. Professor Sir Andrew Pollard, chair of the JCVI, described the proposed programme as safe and effective, and explained the benefits of the recommendation:

Most parents will probably consider it a common and mild illness among children. But for some babies, young children and even adults, chickenpox or its complications can be very serious, resulting in hospitalisation and even death.

Adding the varicella vaccine to the childhood immunisation programme will dramatically reduce the number of chickenpox cases in the community, leading to far fewer of those tragic, more serious cases.^[13]

The JCVI had expressed concerns previously that a programme of varicella vaccinations might increase the incidence of shingles, which is caused by a reactivation of the varicella virus. However recent evidence from the USA, which has routinely vaccinated against varicella since 1995, demonstrated no correlation between varicella vaccination and shingles rates.^[14]

3. What factors affect the speed of adoption of new vaccines?

To be used in the UK, vaccines and immunisations must pass through research and development, including clinical trials, before being reviewed by the UK’s Medicines and Healthcare products Regulation Agency (MHRA).^[15] New products can take around a decade to pass through every stage of trial and approval. In the case of the Covid-19 pandemic, a fast-tracked regulatory process of ‘rolling review’ was adopted in response to public health need.

In July 2023, the House of Commons Health and Social Care Committee published its tenth report of session 2022–23, ‘Prevention in health and social care: Vaccination’. The committee took evidence highlighting that the MHRA has “capacity problems”. This echoed former health minister Lord O’Shaughnessy’s review of commercial clinical trials in the UK, which stated:

Industry leaders report that, although the MHRA as an organisation takes a future-looking approach to innovation, it is under-resourced, resulting in a backlog of approvals, causing delays and providing a barrier to recruiting and retaining the most talented regulatory leaders at all levels.^[16]

Following Lord O’Shaughnessy’s review, the government committed to a number of measures to regain “the UK’s position as a global leader in commercial clinical trials”, including a £3mn investment over three years to rebuild capacity and deliver reduced turnaround time for all approvals within statutory timelines.^[17] The government also committed to £20mn over two years to establish clinical trial acceleration networks, including one in the area of infectious disease vaccines.

MHRA-approved products are usually already available when being considered for addition to the national immunisation programme, in some cases being used in limited patient groups. For example, the MHRA has already approved RSV vaccines for use in the UK.^[18] There are also chicken pox vaccinations which are available on the NHS for certain patient groups.^[19]

The JCVI use mathematical modelling to assess the cost-effectiveness of new programmes. Professor Sir Andrew Pollard, chair of the JCVI, told the House of Commons Health and Social Care Committee that this was a “major area where we could speed up decision making if it was much better resourced”.^[20]

The committee also said that the JCVI, MHRA and NHS should be building capacity in preparation for advances in vaccine technology, including personalised cancer vaccinations, to minimise delay for patients.

In its advice on adopting an RSV immunisation programme, the JCVI indicated what needed to be achieved ahead of implementation:

Once there is a policy, the procurement process for a tender can have a long lead in time with all the processes required by HM Treasury. Alongside this there needs to be the necessary work for the planning and effective implementation of an RSV programme by NHS England and the devolved administrations in collaboration with DHSC [Department of Health and Social Care] and UKHSA. This is a significant and complex undertaking involving the coordination of multiple work streams and organisations to ensure the optimal delivery of immunisation services.^[21]

In a House of Lords debate on the RSV immunisation programme in October 2023, Lord Evans of Rainow, speaking for the government, described plans as “progressing rapidly”.^[22] He stated remaining challenges included the licensing, availability and pricing of products. He said that the Department of Health and Social Care was working with UKHSA and NHS England to “mitigate against any potential barriers to implementation”. He later stated, “All due diligence has to be followed, which is why the vaccine is not available for this winter, but we are hopeful that it will be available for winter 2024”.

4. What does the new NHS England vaccination strategy say?

NHS England published a new vaccination strategy on 13 December 2023.^[23] In the foreword to the strategy, Steve Russell, chief delivery officer and national director for vaccinations and screening at NHS England, highlighted a decline in vaccination programme uptake, particularly for childhood vaccinations:

Over the past decade, uptake of most vaccination programmes in England has fallen, with our highest immediate concern being the decline in MMR vaccine coverage. Reversing these downward trends and addressing challenges around vaccine confidence and accessibility are critical to preventing deaths and hospitalisations from vaccine-preventable diseases. I am therefore excited to see this strategy’s renewed focus on innovative delivery approaches that respond to local people’s needs.^[24]

The strategy included a range of measures to improve access and uptake, including expanding online booking options, and making family vaccination records available on the NHS app.^[25] The strategy committed to community delivery, targeted at underserved communities and delivered by multidisciplinary teams. There were also measures to ensure efficient and responsive supply chains. The strategy committed the NHS to support future vaccine pipelines by maximising support for clinical trials and clinical trial acceleration networks.

5. Read more

• Christine Loscher, ‘Chickenpox vaccine recommended for NHS: Here’s why a jab is better than getting the disease’, The Conversation, 17 November 2023
• Helen Bedford and Helen Skirrow, ‘Action to maximise childhood vaccination is urgently needed’, BMJ, 24 October 2023
• NHS Digital, ‘Childhood vaccination coverage statistics, England, 2022–23’, 28 September 2023
• Independent, ‘More babies will need hospital treatment over RSV vaccine delay, says top doctor’, 4 September 2023
• House of Commons Health and Social Care Committee, ‘UK’s world-leading role on vaccination at risk, warn MPs’, 27 July 2023

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Cover image by Freepik.