Twelfth Special Report
The Health and Social Care Committee published its Tenth Report of Session 2022–23, Prevention in health and social care: vaccination (HC 1764), on 27 July 2023. The Government response was received on 6 October 2023 and is appended below along with Appendix 2.
Appendix: Government Response
Introduction
This is the Government’s formal response to the recommendations made by the Health and Social Care Committee in its report, ‘Prevention in health and social care: vaccination’.
The Department of Health and Social Care welcomes the Health and Social Care Committee’s report. We are grateful to everyone who contributed their time and expertise to the inquiry, and for the recommendations on ensuring the UK remains a world leader in vaccination as part of the wider health and social care prevention agenda. This document sets out the Government’s reply to each of these recommendations.
As recognised in the committee’s report, the UK has long been one of the global leaders on vaccination, with world leading extensive immunisation programmes. The UK was the first country to implement a universal Men B programme in 2015 and one of the first to introduce a universal measles mumps and rubella (MMR) programme in 1988 and a human papillomavirus (HPV) programme in 2008. The COVID-19 vaccination programme has been one of the most successful and effective initiatives in the history of UK science and public administration. The UK was the first country in the world to authorise and deploy the Pfizer and Oxford / AstraZeneca COVID-19 vaccines and the first major European economy and first G20 member to vaccinate 50% of its population with at least one dose, and to provide boosters to 50% of the population. The COVID-19 programme continues through a targeted seasonal vaccination offer for those most at risk.
The Government is committed to learning lessons from all vaccination programmes, including COVID-19, to support pandemic preparedness and strengthen delivery for all immunisation programmes. This has included the announcement of a new strategic partnership with Moderna to establish mRNA research and development and manufacturing facilities in the UK and the development of NHS England’s new integrated Vaccination and Immunisation Delivery Strategy.
The COVID-19 pandemic demonstrated the importance of driving high uptake across all sectors of society, including demographics and communities with typically low vaccine uptake. The Department, and its partners across the health system, continue to use population health data and intelligence, including qualitative insights, to enable targeting of under-vaccinated populations, including those groups with low vaccination rates for COVID-19 and influenza. Evaluation of the COVID-19 outreach work started in the Spring 2023 booster campaign, looking at how local interventions have been tailored for different communities identified through data. We are building on this work in the Autumn/Winter 2023 campaign, supplementing with local evidence to inform future vaccination campaigns.
While the majority of people have had their routine vaccinations, there has been a steady decline in uptake of some vaccinations over the last 10 years. This has been further exacerbated by the COVID-19 pandemic. Of particular concern are MMR, HPV and polio containing (6-in-1 and 4-in-1) vaccine uptake. There are known disparities with specific communities, including ethnic and religious groups, having lower uptake than the national average. There are also significant regional disparities that are not evident in national coverage. An example is Hackney and City of London, where polio vaccine coverage at age 12 months is 64.0% in 2021/22, despite the national coverage being 91.8%. Areas with historically lower uptake risk becoming pockets of unprotected populations at significant risk of local outbreaks.
Improving MMR uptake remains a high priority for the Government, NHS England and UK Health Security Agency (UKHSA). During 2023–24 NHS England has been developing an MMR Plan to support regions to deliver local action plans to improve uptake and meet the MMR Elimination Strategy (2019) recommendations1, with the goal of regaining World Health Organisation (WHO) Elimination Status.
Following the Joint Committee on Vaccination and Immunisation (JCVI) advice in response to the detection of poliovirus in London sewage in 2022, NHS London offered all 1- to 9-year-olds a polio vaccine as a booster or catch-up dose. All eligible children in London were invited to receive their vaccine and, by December 2022, more than 340,000 vaccines had been administered (out of an eligible population of ~1.03m). NHS London launched the next phase of their polio campaign in May 2023, delivering a primary care and schools catch-up for children aged 1–11 in London for polio and MMR.
Catch up efforts for adolescent programmes, focused on HPV, following a drop in uptake due to pandemic school closures, have also been underway. These ensure that anyone who has missed their immunisations for any reason can take up their vaccination offer. This has resulted in improvement to HPV vaccination uptake in the year 10 cohorts, reflected in the December 2022 published HPV report2 and catch-up efforts will continue aligned with the move to a single dose HPV programme.
The Government is committed to improving vaccination uptake and coverage rates to fully protect the public from vaccine preventable diseases. Actions for increasing uptake include: improving access to services to make getting vaccinated easier for the public; improving access to timely data for both local systems and individuals; and clear communications to support accurate and up to date information about vaccines and to reduce the spread of misinformation.
We welcome the Committee’s focus on this area and the evidence and recommendations contained in the report. This document sets out our response to each of the Committee’s five recommendations. The structure of this memorandum corresponds to the recommendations in the committee’s report. The text taken from the Select Committee report is highlighted in italics.
Recommendations
Recommendation 1
To ensure that nobody misses out on vital vaccine protection because of practical challenges such as convenient times or locations, a more flexible delivery model, that makes the most of the wide range of healthcare professionals, is needed. We recommend that the Government carries out a consultation on whether to amend the Human Medicines Regulations 2012 to give medical and nursing students, and recently retired staff, a greater role in routine immunisation delivery. (Paragraph 19)
Response
The Department of Health and Social Care (DHSC) is working closely with UKHSA and NHS England to improve access to our world-leading immunisation system and protect public health. This includes reviewing how the use of unregistered medical health professionals (including medical and nursing students and recently retired previously registered health professionals) can continue to support vaccine delivery, learning the lessons from their role in the COVID-19 vaccination programme.
As part of the response to the COVID-19 pandemic, amendments to the Human Medicines Regulations 2012 were laid in Parliament on 16 October 2020 to provide regulatory flexibility to support the rollout of the COVID-19 vaccination campaign and upscale the influenza vaccination programme in the UK, while protecting public safety. These amendments followed a public consultation held from 28 August to 18 September 2020. Following the consultation, amendments were made to Regulation 247A (R247A) which enabled the use of an expanded workforce legally and safely able to administer a COVID-19 or influenza vaccine without the input of a prescriber, when an approved national protocol was in place. This included those who are registered healthcare professionals who cannot ordinarily administer medicines or vaccines without the input of a prescriber (such as nursing associates, pharmacy technicians, operating department practitioners) and non-registered healthcare workers (such as assistant practitioners, healthcare assistants or maternity support workers). Medical and nursing students, as well as retired staff, were able to support the vaccination effort through signing up to non-registered healthcare roles.
Condition A of R247A requires for there to be a pandemic in order to use an expanded workforce. Given that this condition will no longer apply at some point, as COVID-19 transitions to endemic state, DHSC launched a consultation on 7 August 2023 which includes the option to amend further regulations 247A of the Human Medicines Regulations 2012 for COVID-19 and influenza vaccine3. The consultation ran for 6 weeks and closed on 18 September 2023. As part of the consultation the government is suggesting that a time limited amendment (covering until April 2026) is made to the regulation to remove condition A. This amendment will allow for R247A to be used outside of pandemic status for COVID-19. This would support the ongoing use of registered and non-registered healthcare professionals. We therefore expect, as part of this consultation to hear views on the ongoing use of an expanded workforce (such as medicine and nursing students and retired professionals) in the delivery of COVID-19 and influenza vaccinations.
Alongside this consultation to support short term changes to the regulation, we are also working closely with system partners including NHS England, UKHSA, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Devolved Governments to explore options for a longer-term solution which would permit the continued use of an expanded workforce to deliver national vaccine campaigns. This will include a consideration of how medical and nursing students, and retired staff can continue to be utilised in a way that best support their needs as well as any future vaccination programme.
Recommendation 2
The NHS England integrated vaccination and immunisation strategy must:
a. have a strong focus on the action that is needed to tackle the practical challenges that limit access to vaccination;
b. set out how to make best use of the wide range of healthcare professionals able to administer vaccinations;
c. empower local leaders to pursue ways of addressing uptake in their own areas;
d. set out guidance and examples of best practice around how voices other than NHS England can be used to communicate important messaging about vaccination programmes. (Paragraph 28).
Response
NHS England, in collaboration with DHSC, UKHSA and other partners, is developing a vaccination and immunisation delivery strategy, that aims to improve uptake and coverage of vaccinations and reduce inequalities of uptake and coverage. Latest thinking focuses on empowering system leaders with the flexibility to plan and deliver local services. These services will be simple, high quality and conveniently tailored to the needs of local people and supplemented by targeted outreach to increase uptake in underserved communities. They will be delivered in a joined-up way by integrated teams, involving a range of professionals, working across the NHS and other organisations, to improve patient experience, build trust and deliver value for money. Working with partner organisations, we will continue to utilise a wide range of national voices and support local co-design with voluntary and community sector partners of messaging for vaccination programmes.
The strategy will be published later in 2023.
Recommendation 3
We are deeply concerned to hear about the decline in clinical trial activity and the risk to the UK’s position as a global leader in this area. The challenges highlighted by witnesses, particularly around the administrative aspects of running a trial, are clearly fixable and it is vital that they are addressed if the UK is to make the most of its world-leading academic and research expertise. (Paragraph 33)
Response
We note the concerns raised by the Committee which is based on data published by the Association of the British Pharmaceutical Industry (ABPI) which show a decline in the number of commercial clinical trials initiated in the UK between 2017 and 2021. Overall, however, there has been an increase in the number of participants recruited to clinical studies in England since 2018. During the pandemic (in 2020 and 2021), many non-COVID studies were paused to focus on nationally prioritised COVID-19 studies. The Department, working in partnership with NHS England, has taken action to recover the UK’s capacity to deliver research through the Research Reset programme. We currently have over 5,700 studies on the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) portfolio and 80% are open and recruiting to time and target. As of August 2023, an average of over 79,000 people were recruited to studies on the NIHR CRN portfolio each month, 10,000 more than the monthly average prior to the pandemic in 2019/20.
The Government remains committed to regaining the UK’s position as a global leader in clinical trials. This is critical to delivering the ambitions set out in the Life Sciences Vision and to positioning the UK as a science superpower. In March 2021 the Government published Saving and Improving Lives: The Future of UK Clinical Research Delivery4 setting out our ambitions to reform clinical research delivery in the United Kingdom. This sets out how we will improve patient access to clinical trials in all areas, including Cancer. This will include enhancing the use of data to support recruitment and improving processes to make study set-up and delivery faster, more efficient, and more innovative, so that clinical research participation is more accessible than ever.
Vaccine innovation and clinical trials remain a priority. In December 2022, the Government signed the Moderna-UK Strategic Partnership, which will see a new innovation and technology centre built in the UK5. The partnership will see Moderna invest substantial funding in UK-based research and development activities over a 10-year period. This will include running a significant number of clinical trials in the UK and the company has also pledged to fund grants for UK universities, including PhD places.
Recommendation 4
We welcome Lord O’Shaughnessy’s review of commercial clinical trials, which chimed with a lot of the evidence that we heard in this part of our inquiry. The Government’s positive response to the recommendations is encouraging. We especially endorse the following recommendations and will be keeping a watching brief on the Government’s progress in implementing them, which we expect to be swift:
a. Recommendations 2, 3 and 4 to address overly slow and bureaucratic clinical trial set-up and approval processes, in particular the goal for a 60-day turnaround for approvals
b. Recommendations 14 - 17 to address the absence of conversation about research from interactions between clinicians and patients and increase the profile and awareness of research among disadvantaged or marginalised groups
c. Recommendation 27 to develop an action plan outlining how the Government and delivery partners will implement the recommendations of the review. (Paragraph 34)
Response
The Government has previously welcomed all recommendations from Lord O’Shaughnessy’s review of commercial clinical trials in principle and will consider delivery of all the recommendations.
As an immediate first step, the Government has made five headline commitments, published alongside the review and backed by up to £121 million6. These headline commitments will improve the speed of commercial clinical trials in the UK. In addition, we will take forward the foundational actions that will be adopted as part of the Government and the health system’s on-going work to support commercial clinical trials. An implementation update will be provided in the autumn, which will outline progress against these commitments as well as responding in full to the remaining review recommendations.
Recommendation 5
The Department of Health and Social Care and NHS England must lay before Parliament a plan for how they intend to ensure all relevant regulatory and delivery systems are ready to assess and deliver these new innovations to patients. As part of that plan, the JCVI and the MHRA must be adequately resourced and supported, focusing on modelling capability at the JCVI and, at the MHRA, on recruiting and retaining expertise relevant to new innovations, especially in personalised health. (Paragraph 42)
Response
The regulatory and delivery processes for the introduction of new medicines, including novel vaccines, is outlined in Annex A, for which partner organisations own planning responsibility. In the Department’s sponsorship capacity, DHSC continues to monitor partners’ role in supporting the introduction of such medicines. The Department recognises the key role of UKHSA in providing secretariat, modelling and health economics capacity support for JCVI as captured in the Department’s strategic remit letter to UKHSA7 and UKHSA’s 3-year strategic plan8.
The UK system for reviewing new immunisation products for potential programmes is effective and responsive. It is grounded in scientific review of evidence and allows for a fast response to outbreaks, and to new products being developed. The JCVI membership is comprised of experts in a wide range of relevant fields and their combined expertise ensures robust and timely review of new and emerging evidence in the field.
If it is needed, the JCVI can recruit members with specific skills and expertise to its sub-committees. These sub-committees then report to the main committee.
JCVI reviews modelling work to assess a potential vaccination programme’s cost-effectiveness and impact. Where necessary, second opinion modelling may also be sought. Various modelling groups have supported the JCVI including UKHSA modellers and academic groups. DHSC also commissions second-opinion modelling to support the work of the JCVI via the Mathematical & Economic Modelling for Vaccination and Immunisation Evaluation (MEMVIE) project. During the COVID-19 pandemic, modelling resource was pivoted to focus on the COVID-19 response and therefore was not available for other vaccination programme work.
The Department is working closely with the JCVI and UKHSA to support resources being available to support outbreak response, as with the London polio response, and regular improvement of all extant immunisation programmes, as with the recent changes to Shingles and HPV programmes. This support includes funding for external modelling contracts as well as internal resource allocation.
At Spring Budget, the Chancellor announced a total of £10 million over the next two years for MHRA to help bring innovative new medicines and medical technologies to UK patients more quickly. The funding will be used to accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as the those made and approved by other trusted regulatory partners globally.
Appendix 2: Standard regulatory and delivery processes for new vaccines
Footnotes
1 UK Measles and Rubella elimination strategy 2019 (publishing.service.gov.uk)
2 Human papillomavirus (HPV) vaccination coverage in adolescents in England: 2021 to 2022 (publishing.service.gov.uk)
3 Amendments to regulations 3A, 19 and 247A of the Human Medicines Regulations 2012 to support the ongoing delivery of COVID-19 and influenza vaccination - GOV.UK (www.gov.uk)
4 Saving and Improving Lives: The Future of UK Clinical Research Delivery - GOV.UK (www.gov.uk)
5 UK cements 10-year-partnership with Moderna in major boost for vaccines and research - GOV.UK (www.gov.uk)
6 Government response to the Lord O’Shaughnessy review into commercial clinical trials in the UK - GOV.UK (www.gov.uk)
7 Letter from Maria Caulfield MP to Professor Dame Jenny Harries, UKHSA chief executive - GOV.UK (www.gov.uk)