Studying vaccines in immunodeficient people can only be done when the characteristics of the immune response have been established for the specific vaccine in healthy individuals. Therefore, this cannot be requested in clinical trials taking place before marketing authorisation is granted by the Medicines and Healthcare products Regulatory Agency (MHRA).

Given the diversity of immunodeficient populations, which is difficult to represent in pre-authorisation clinical trials, the MHRA can recommended at the time of authorisation of a new vaccine that the manufacturer commits to undertaking post authorisation studies focusing on effectiveness and safety in these patient groups. This was the case for the new COVID-19 vaccines authorised in the United Kingdom, given that immunodeficient patients are at increased risk of severe COVID-19.

Another way to collect post-marketing data on the safety of vaccines in immunodeficient groups is by targeted active monitoring. As part of the MHRA’s proactive surveillance strategy to monitor the safety of the COVID-19 vaccines, this was undertaken in certain groups of vaccine recipients, including those with immunodeficiencies. The aim was to compare the frequency and severity of side effects to groups included in the pre-authorisation clinical trials, and ultimately help to further characterise the safety profile of the vaccines in these patient groups.

The Life Sciences Vision committed the Government to delivering a Vaccines Healthcare Mission which will build on the UK’s deep expertise in vaccines to strengthen the UK life sciences ecosystem, with a particular focus on new and novel technologies. This will include maximising the opportunities to continue to improve core immunology, vaccinology and clinical trial design and infrastructure as well as deepening expertise in vaccine formulation and delivery.

NHS England is responsible for delivery COVID-19 treatments to eligible patients who have been identified as those who are at the highest risk from COVID-19.

Patients who are clinically eligible for COVID-19 treatments have been identified digitally, where possible, and should have been notified of their eligibility to receive these treatments. The Government will also send patients in this cohort free lateral flow tests.

In the event of a positive lateral flow result, a local COVID Medicines Delivery Unit (CMDU) will contact the majority of patients directly to confirm their eligibility and arrange treatment if appropriate. In the event a patient is not contacted directly by the National Health Service within 24 hours of a positive lateral flow result, they are encouraged to phone their general practitioner practice or 111 for an urgent referral to a CMDU.

The Department commissioned the Independent Advisory Group to identify a set of patient conditions based on who is at the highest risk of an adverse COVID-19 outcome, particularly hospitalisation and death.

Due to the success of the COVID-19 vaccines most people who were part of the ‘Clinically extremely vulnerable’ (CEV) cohort are no longer at substantially greater risk than the general population and are advised to follow the same guidance as everyone else on staying safe and preventing the spread of COVID-19 and other respiratory infections, as well as any further advice received from their healthcare professional. The term ‘Clinically extremely vulnerable’ is therefore no longer used.

However, there remains a smaller number of people whose weakened immune system means they may be at higher risk of serious illness from COVID-19, despite vaccination. The welfare of this group of patients remains a priority and are offered enhanced protections including COVID-19 treatments, booster vaccinations, free lateral flow tests and tailored guidance.

In England, over 1.8 million people are eligible for COVID-19 treatments. The Government regularly reviews the guidance available to this group of individuals which was last updated on the 30 January 2023. The UK Health Security Agency (UKHSA) continues to have in place surveillance arrangements that enable the monitoring of any emerging variants and to assess their potential impact, including in relation to severe outcomes. This information is shared between UKHSA, the Department and NHS England.

Due to the success of the COVID-19 vaccines most people who were part of the ‘Clinically extremely vulnerable’ (CEV) cohort are no longer at substantially greater risk than the general population and are advised to follow the same guidance as everyone else on staying safe and preventing the spread of COVID-19 and other respiratory infections, as well as any further advice received from their healthcare professional. The term ‘Clinically extremely vulnerable’ is therefore no longer used.

However, there remains a smaller number of people whose weakened immune system means they may be at higher risk of serious illness from COVID-19, despite vaccination. The welfare of this group of patients remains a priority and are offered enhanced protections including COVID-19 treatments, booster vaccinations, free lateral flow tests and tailored guidance.

In England, over 1.8 million people are eligible for COVID-19 treatments. The Government regularly reviews the guidance available to this group of individuals which was last updated on the 30 January 2023. The UK Health Security Agency (UKHSA) continues to have in place surveillance arrangements that enable the monitoring of any emerging variants and to assess their potential impact, including in relation to severe outcomes. This information is shared between UKHSA, the Department and NHS England.

Due to the success of the COVID-19 vaccines most people who were part of the ‘Clinically extremely vulnerable’ (CEV) cohort are no longer at substantially greater risk than the general population and are advised to follow the same guidance as everyone else on staying safe and preventing the spread of COVID-19 and other respiratory infections, as well as any further advice received from their healthcare professional. The term ‘Clinically extremely vulnerable’ is therefore no longer used.

However, there remains a smaller number of people whose weakened immune system means they may be at higher risk of serious illness from COVID-19, despite vaccination. The welfare of this group of patients remains a priority and are offered enhanced protections including COVID-19 treatments, booster vaccinations, free lateral flow tests and tailored guidance.

In England, over 1.8 million people are eligible for COVID-19 treatments. The Government regularly reviews the guidance available to this group of individuals which was last updated on the 30 January 2023. The UK Health Security Agency (UKHSA) continues to have in place surveillance arrangements that enable the monitoring of any emerging variants and to assess their potential impact, including in relation to severe outcomes. This information is shared between UKHSA, the Department and NHS England.

Due to the success of the COVID-19 vaccines most people who were part of the ‘Clinically extremely vulnerable’ (CEV) cohort are no longer at substantially greater risk than the general population and are advised to follow the same guidance as everyone else on staying safe and preventing the spread of COVID-19 and other respiratory infections, as well as any further advice received from their healthcare professional. The term ‘Clinically extremely vulnerable’ is therefore no longer used.

However, there remains a smaller number of people whose weakened immune system means they may be at higher risk of serious illness from COVID-19, despite vaccination. The welfare of this group of patients remains a priority and are offered enhanced protections including COVID-19 treatments, booster vaccinations, free lateral flow tests and tailored guidance.

In England, over 1.8 million people are eligible for COVID-19 treatments. The Government regularly reviews the guidance available to this group of individuals which was last updated on the 30 January 2023. The UK Health Security Agency (UKHSA) continues to have in place surveillance arrangements that enable the monitoring of any emerging variants and to assess their potential impact, including in relation to severe outcomes. This information is shared between UKHSA, the Department and NHS England.

NHS England has contacted eligible individuals to let them know they should receive their Government issued lateral flow tests within two weeks, to use should they become symptomatic. NHS England commissions NHS Digital to run weekly searches to identify newly eligible people to ensure they are notified of their potential access to treatment and sent tests as quickly as possible. If their tests run out, they can be re-ordered online or by calling 119.

The decision not to procure Evusheld at this time for prevention through emergency routes is based on independent clinical advice by the multi-agency RAPID C-19 and a national expert policy working group. The decision is based on a range of evidence, including clinical trial data, in vitro analysis and emerging observational studies. RAPID C-19 monitors activity in clinical trials for emerging evidence and where treatments are proven to be clinically effective, enables access for National Health Service patients. The Chief Medical Officer for England is content that the correct process for providing clinical advice has been followed and it should now be referred to the National Institute for Health and Care Excellence for further evaluation. The Antivirals and Therapeutics Taskforce has published this analysis of evidence, which is available at the following link:

https://www.gov.uk/government/publications/rapid-c-19-oversight-group-report-to-chief-medical-officer-review-of-evusheld

A letter was issued to patient groups on 5 September on the evidence and expert analysis for the decision, which is available at the following link:

https://www.gov.uk/government/publications/decision-on-evusheld-as-a-coronavirus-covid-19-treatment-letter-to-patient-groups

The hon. Lady continues to be a loud voice for those who are immunosuppressed, and I commend her for that. As she is aware, Evusheld was awarded conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency, which outlined some remaining questions, including about the amount of protection and the dose needed. My Department has been conducting an assessment of Evusheld, looking at the data available and the options for the NHS. We have asked clinicians to look at what we can do for future patient cohorts; we are considering their advice and will update the House shortly.

No specific estimate has been made. Individuals eligible for community COVID-19 treatments via COVID Medicines Delivery Units (CMDUs) are outlined in the United Kingdom-wide clinical access policy for non-hospitalised individuals at highest risk from COVID-19. This includes patients who are immunocompromised.

Since December 2021, CMDUs have provided antiviral or monoclonal antibody treatments to over 40,000 patients in England. The average time for patients to receive treatment is 3.5 to four days from symptom onset and this average includes all four treatment options currently available via the CMDUs. Oral antivirals are suitable to be taken at home, whereas other treatment options must be administered intravenously within a clinic setting. As such, treatment times are normally faster for oral antivirals.

The information requested falls under the remit of the UK Statistics Authority.

A response to the hon. Member’s Parliamentary Question of 22 April is attached.

I thank the hon. Lady very much; she is absolutely right to speak up for those who are shielding and who are anxious. We are doing everything we can to protect and reassure them. On Evusheld, we are evaluating it at the moment, but I will ensure that she has a meeting as soon as possible with the Department of Health.

We will continue to meet with charities and stakeholders representing those who are immunosuppressed or immunocompromised. The Chief Executive of the UK Health Security Agency, Dr Jenny Harries, is the clinical lead for programmes supporting these patients and has met with charities at stakeholder engagement sessions.

From 1 April 2022, access to free asymptomatic and symptomatic testing for the general public in England will end. We will provide free testing to a number of at risk groups. Further information on eligible groups will be made available in due course.

A range of new treatment options have been made available to non-hospitalised patients at higher risk from COVID-19 to reduce severe disease, hospitalisation and death. Patients who receive a positive test can access treatments through COVID Medicines Delivery Units (CMDUs). Treatments include the oral antivirals molnupiravir and PF-07321332+ritonavir, the antiviral infusion Remdesevir and the monoclonal antibody treatment sotrovimab.

A clinician will contact eligible patients to assess whether these treatments are appropriate. If prescribed sotrovimab or Remdesivir, the patient will be required to attend a CMDU for an infusion. If prescribed an antiviral, this could be collected or delivered to the patient’s home.

From 1 April 2022, free access to asymptomatic and symptomatic tests for the public in England will end. We will continue to make testing available for a small number of at-risk groups. Further details on eligible groups will be made available in due course.

The RAPID C-19 collaboration has enabled active multi-agency oversight of national and international trial evidence as it emerges for COVID-19 therapies, both in potential treatment and prophylactic indications. To date, the evidence has most strongly supported treatment use, although the evidence on prophylactic use will continue to be reviewed.

As part of the PANORAMIC national study, there will be a post-exposure prophylaxis (PEP) sub-study which is expected to begin later in spring. This PEP sub-study will investigate the effect of prescribing oral antivirals to those who are a household contact of a COVID-19 positive individual. In addition, the PROTECT-V study is trialling sotrovimab and niclosamide as prophylactic drugs administered over a six-month period in vulnerable renal and immunosuppressed patients.

The Department of Health and Social Care have the lead and alongside UK Health Security Agency released guidance on COVID-19: guidance for people whose immune system means they are at higher risk . This was most recently updated on 25 February 2022. In order to assist employers, the Health and Safety Executive provides a link to this guidance on its website.

From 1 April 2022, free access to lateral flow device tests for the public in England will end. We will continue to make testing available for a small number of at-risk groups. Further details on eligible groups will be made available in due course.