Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of (1) the level of unmet need of immunocompromised patients for protection against COVID-19, and (2) whether the MHRA has sufficient staff so that it can appropriately prioritise regulatory decisions in support of such patients.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
As set out in the Living with COVID-19 Strategy, the Government and the UK Health Security Agency will continue to communicate to people most vulnerable to COVID-19 about available clinical interventions, including vaccination and treatments, as well as testing and public health advice.
All individuals aged six months old or above who are immunosuppressed were offered a vaccination in the Autumn 2023 COVID-19 vaccination programme, along with those in other clinical risk groups. The immunosuppressed group will be offered a further dose as part of the spring programme announced in February, that is being rolled out in England from mid-April. This follows the Joint Committee on Vaccination and Immunisation’s advice that those who are immunosuppressed are at particular risk of serious disease from COVID-19.
The Medicines and Healthcare products Regulatory Agency (MHRA) is looking at novel and standard ways to develop staff capability and expertise. New assessor capacity is being supplemented with an additional fixed-term resource of appropriately experienced and qualified specialists, to support the training and supervision of new staff. The MHRA also continues to recruit to additional roles in its assessment teams.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether the COVID-19 monoclonal antibody Evusheld 2.0 is being treated as a priority for assessment; and whether they have any plans to rollout a programme to be fast-tracked to vulnerable patients.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
AZD-3152, which has been referred to as Evusheld 2.0, will be evaluated through the National Institute for Health and Care Excellence’s (NICE) standard appraisal process. The NICE is the independent body responsible for developing evidence-based guidance on whether new medicines should be routinely funded by the National Health Service, based on an assessment of their costs and benefits.
The NICE has formally started its appraisal of AZD-3152, ahead of the Medicines and Healthcare products Regulatory Agency’s (MHRA) decision on whether it should be given a United Kingdom marketing authorisation, and expects to invite stakeholder submissions in April 2024. Timelines for both the NICE’s guidance and licensing depend on data from the SUPERNOVA trial being available. AstraZeneca intends to submit clinical data to the NICE and the MHRA at the same time, with the aim that both organisations are able to reach decisions as close together as possible.
If AZD-3152 is recommended as clinically and cost effective by the NICE, the NHS in England will be under a statutory requirement to fund AZD-3152 for eligible patients, in line with the NICE’s recommendations. There are no plans for the NHS to routinely fund the medicine ahead of it achieving a licence or a positive technology appraisal recommendation from the NICE.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the impact to the NHS of the 16.9 per cent uptake rate, as at 29 October, for the autumn COVID-19 booster vaccine by immunocompromised patients; and what steps they will take to increase uptake among that cohort before the vaccination programme is due to end on 15 December.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Data published by NHS England reported the number of immunosuppressed individuals aged between five and 64 years old that had received vaccination by 29 October 2023 as 326,143. It is not understood where the 16.9% uptake rate within the question has been derived. The published data shows a total number of individuals who have received autumn vaccination broken down by four cohorts.
We continue to work with NHS England and the UK Health Security Agency to improve immunosuppressed uptake nationally, by understanding drivers of hesitancy, improving the quality of our published data, ensuring it is easy and convenient to book and access vaccinations, and by continuing a variety of campaign activities throughout the winter including the Get Winter Strong campaign. This was launched on 1 November 2023 and encourages those eligible, specifically the clinically most vulnerable, who have not yet come forward for the flu and COVID-19 vaccines to do so.
NHS England has produced and shared a range of targeted communications materials encouraging people who are immunosuppressed to take up their offer of a COVID-19 booster vaccine, including posters, display screen visuals and social media cards. There are also materials to raise awareness that immunosuppressed household contacts are also eligible for vaccination. These assets have been translated into 28 languages to reach people from a wide range of communities through their native languages and have helped general practices, vaccination centres, pharmacies and other sites to promote COVID-19 and flu vaccination this autumn and winter.
The Government’s Chief Medical Officer, Prof Sir Chris Whitty, also wrote to the main charities representing the clinically most vulnerable patient cohorts, to publicise this Autumn’s campaign, and to enable them to signpost the offer to their patient communities.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure that eligible patients will have access to Paxlovid this winter.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department procured stock of Paxlovid during the pandemic and has set up a distribution network to both primary and secondary care in England so that all eligible patients can access the treatment in line with recommendations from the National Institute for Health and Care Excellence (NICE).
NICE is in the process of developing recommendations for the National Health Service on the potential expanded use of Paxlovid. NICE published final draft guidance that recommends expanded use of Paxlovid in August 2023. Following discussions between the Department, NHS England and NICE, NICE has recently consulted on an NHS England proposal to vary the funding requirement that normally applies three months after the publication of NICE guidance to allow a phased rollout to all eligible patients, considering the capacity of the NHS to implement NICE’s recommendations in full.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure that the stock of approved antiviral treatments of COVID-19, including those recommended by the National Institute for Health and Care Excellence in August are made readily available to all vulnerable patients.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The stock of COVID-19 antivirals owned by the Department is available to those who are eligible for treatment in line with an interim clinical commissioning policy for England and the Devolved Nations or National Institute for Health and Care Excellence (NICE) recommendations. Stocks are distributed in England in response to orders received from community pharmacies and National Health Service secondary care trusts who operate under arrangements put in place by the relevant NHS Commissioning Boards. Proportionate allocations have been made to the Devolved Nations and detailed distribution arrangements lie within the remit of the respective national systems.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what plans they have to increase awareness of (1) eligibility for COVID-19 post-exposure treatments, and (2) how to access to COVID-19 post-exposure treatments.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Information for patients’ awareness of COVID-19 treatments and how to access treatments is published by the National Health Service and is available on the NHS.uk website in an online-only format. The NHS will continue to communicate to people, including those most vulnerable to COVID-19, about available clinical interventions, including vaccination and treatments, as well as testing and public health advice.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the UK Health Security Agency’s observation that “in the UK, the current surveillance systems do not support an assessment of comparative severity between variants”, published on 14 September; and what plans they have to increase PCR testing and COVID-19 surveillance in England.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Trends in disease severity and outcomes can be monitored over time through hospital data. The UK Health Security Agency (UKHSA) receives vital data from those who are admitted to hospital with symptoms, and UKHSA is using genome sequencing to detect and assess severity and vaccine effectiveness against new variants.
While reduced polymerase chain reaction (PCR) testing in the community limits comparisons of variant severity, surveillance metrics based on current testing continue to provide useful indicators of recent trends.
UKHSA retains laboratory capacity and an ability to scale PCR and lateral flow device testing back up should it be needed.
Planning for the restart of community surveillance for the winter season, when health pressures usually rise, is in progress. A national surveillance report is published every two weeks, and this will increase to once every week in the winter season.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government (1) what plans they have to monitor the development of the BA.2.86 COVID-19 variant in the UK; and (2) to what extent PCR testing will support monitoring the BA.2.86 COVID-19 variant.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The UK Health Security Agency conducts routine monitoring and surveillance of COVID-19 and the emergence and spread of new variants internationally via a range of surveillance systems and genomics capabilities, which report infection rates, hospitalisations and the risks posed by new variants, including the BA.2.86 variant.
The Government has maintained essential COVID-19 surveillance activities in primary and secondary care, and in high-risk settings. Currently a technical briefing is published every week, reviewing the data and risk assessing BA.2.86 and other variants.
We use Polymerase Chain Reaction testing for genomic sequencing to monitor and detect and assess vaccine effectiveness against new variants.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, following the detection of the BA.2.86 COVID-19 variant in the UK, what assessment they have made of COVID-19 PCR testing (1) capacity, and (2) availability in England.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Appropriate levels of testing for COVID-19, including polymerase chain reaction (PCR) testing have remained to support diagnosis for clinical care and treatment, and to protect very high-risk individuals and settings.
Lateral flow device (LFD) testing is predominantly used and continues to be effective in detecting positive results, including of new variants. The UK Health Security Agency (UKHSA) currently holds a stock of LFDs to support current testing policy and enable expanded deployment, should cases rise or risks to the National Health Service increase.
UKHSA continues to monitor prevalence and other factors to determine if additional testing, either LFD or PCR, is needed.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what support, including financial, Integrated Care Boards have received to enact the Government’s precautionary action to bring forward COVID-19 and flu vaccinations this autumn.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The acceleration of the COVID-19 and flu programme was laid out in a system letter on 30 August 2023, which has been published on NHS.UK in an online-only format.
In addition to the financial arrangements set out in the Autumn 2023 GP and Community Pharmacies enhanced service specifications, and Standard Contract schedules, interim arrangements to support programme acceleration have been put in place to recognise additional administrative, organisation and delivery costs.
Commissioned providers are able to claim an additional acceleration payment of £10, in addition to the Item of Service (IoS) fee, for each COVID-19 vaccination administered to care home residents between Monday 11 September and Sunday 22 October 2023 inclusive; and a separate one-off additional payment of £200 for each completed care home by 11.59pm on Sunday 22 October 2023 that is confirmed to the commissioner by the submission of a live time survey no later than 11.59pm on Sunday 29 October 2023.
To support the acceleration of COVID-19 vaccinations to other eligible cohorts, an additional £5 acceleration payment, in addition to the IoS fee, is available for each COVID-19 vaccination administered to eligible people between 11 September and 31 October 2023, excluding care home residents, housebound people, and any health and care worker vaccinations commissioned under the NHS Standard Contract.
The COVID-19 vaccination primary care service specifications and NHS Standard Contract schedules have been updated to reflect the financial arrangements outlined above in line with usual processes.