Government Policy

Having read a bit more I think the concern is that if Evusheld is overused, then the current Covid variant may become resistant to it and transform to become a new variant version which Evusheld might not work against (like overused antibiotics create resistance).

But yes i am generally cynical too, just feels the Govt has been dragging its heels for too long on rolling out Evusheld so I do tend to mistrust their silence/rationale, especially when some countries like the US have been issuing it for over 4 months now.

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Hi @CaroleCW,

Well we better not use the Vaccine too much in that case. I can not share the logic on that but im no scientist. The Government appear to be just unwiiling to treat us like the rest of the population.

Regards M

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A really excellent list of probing questions (although I agree it’s unlikely we will get any decent answers on any of them soon based on DHSC and Maggie Throup responses to Evusheld queries so far).

Couple of additional suggestions :

  1. re your question 4 on sotrovimab efficacy, you could also point to the fact that the US have stopped using sotrovimab since 5th April as it’s no longer effective against BA.2 variant (FDA updates Sotrovimab emergency use authorization | FDA)

  2. re your question 3, maybe also convey that due to the apparent lack of efficacy of sotrovimab against BA.2 variant and that Paxlovid is contraindicated for many CEV people due to the other drugs they may be taking, that many of the immunocompromised actually feel the “safety net” of treatments if we catch Covid just isn’t there, so bringing new treatments such as bebtelovimab onstream quickly is vital.

  3. I do worry about the Government’s relationship with Astra Zeneca given it’s shocking procurement approach re Evusheld (AZD7442), re ordering 1m in Nov 2020 then cancelling the order in May 2021. AZ are likely to be a key partner in keeping us (blood cancer and CEV communities) safe with newer treatments, I am heartened re their latest investment in RQ Bio who are looking at the generation of Covid antibody treatments beyond Evusheld AstraZeneca buys into startup RQ Bio's COVID antibodies -

I realise it will be a commercial relationship but the U.K. has been anything but professional in its procurement approach to date re Evusheld.

I too question if it would be much more efficient for our consultants to be able to directly prescribe antiviral/antibody treatments (maybe still to be administered by CMDU hubs). It’s crazy that CMDUs do not have direct access to our medical records, and rely on poorly Covid patients to tell them what drugs they are on and their medical situation .

Two responses re Evusheld today in www.theyworkforyou.com, same old stock responses re HSA testing efficacy vs Omicron prior to procurement etc. Why HSA are reinventing the wheel when 2 more recent studies issued findings last week that Evusheld is effective against Omicron (BA1 &2)

Thanks

Further to input from @CaroleCW I have made some amendmets to my list of questions.

1 What is the current budget for new drug treatments, either Antiviral or mAbs (Monoclonal Antibody) under current review or future review by the COVID-19 Antivirals and Therapeutics Taskforce and is this sufficient to meet an ever-evolving virus where new treatments need to evolve to keep pace with the disease?

2 Is the mAbs (Monoclonal Antibody) drug Beblitovimab under consideration for purchase having been currently proven to work against all strains of Omicron and given emergency authorisation by the FDA in USA if not why not? Can the Government name any other drug currently under review regarding suitability other than EVUSHELD?|

3 Is the purchase of e.g., Evusheld or Beblitovimab being influenced at all by the fact such drugs are relatively expensive and or by the purchase of previously much heralded drugs such as Ronapreve which reportedly cost £1000-2000 per person and had to ultimately to be withdrawn from use. Is the budget for such drugs already spent?

4 Does the Government consider its agreement with Astra Zeneca in 2021 to purchase one million doses of EVUSHELD and subsequent cancellation of that order has prejudiced its judgement in now reconsidering the matter of purchase. Furthermore, does it consider its ability to have good trading relationship with that Company damaged. Does it also recognise their failure to act earlier and procrastination now is only further damaging that relationship and the trust of the potential recipients? Why can they not announce in principle a desire to purchase if certain tests are met and work with the Company on speedily meeting those tests?

5 Given the fact that the First Line Treatment Paxlovid has a vast number of interactions with other common treatments are the Government aware that it cannot be given to very many of the recipients for which it was intended. This in turn has perhaps led to an over reliance on the Second Line of treatment Sotrovimab which has since the 5th April been withdrawn from use in the USA due to ineffectiveness against BA2.

6 Are all the current treatments available being reviewed in terms of efficacy and in particular is Sotrovimab, in view of the fact the FDA withdrew authorisation for its use on the 5th April 2022. If not why not?

7 How specifically and why is Evusheld being tested in labs in relation to its application as a preventative medicine. Indeed, why is the evidence of its preventative benefit from other sources being seemingly ignored.|

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Update to Parliamentary Questions & Answers 3

Asked 10/5/2022

Dr Rupa Huq Labour Ealing &Central Acton

To ask the Secretary of State for Health and Social Care, when his department plans to approve Evusheld on the NHS to help prevent covid-19 infections in immunocompromised people who cannot be vaccinated.

Answer 17/5/2022

Maggie Throup Conservative Erewash

Evusheld was granted a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) on 17 March 2022. However, the initial positive trial data on Evusheld was published prior to the emergence of the Omicron variant. Following its approval, the MHRA had indicated uncertainty on the appropriate dose needed for protection against Omicron. The UK Health Security Agency is currently testing the efficacy of Evusheld against the Omicron variant and the Department and National Health Service are identifying appropriate patient cohorts and approaches to the potential deployment of pre-exposure prophylaxis. Determining the efficacy of Evusheld against the Omicron variant will be necessary prior to any procurement or deployment, to ensure ongoing effective therapy against COVID-19.

Immunocompromised patients are a priority cohort receiving novel effective COVID-19 treatments such as antiviral drugs, which are available in community settings.

Asked on 11/5/2022

Lord Mendelsohn Labour House of Lords

To ask Her Majesty’s Government, further to the Written Answer by the Parliamentary Under-Secretary of State for the Department of Health and Social Care on 20 April (151279), what estimate they have made of when the UK Health Security Agency (UKHSA) will complete the testing of Evusheld against Omicron sub-variants; and why this has taken longer to complete than in (1) the US, and (2) the EU.

Due for answer today (25 May 2022)

Henry Smith Con Crawley

To ask the Secretary of State for Health and Social Care, what timeframe UKHSA are working to in order to assess the effectiveness of Evusheld against the Omicron variant of covid-19.

To ask the Secretary of State for Health and Social Care, how many immunocompromised people have (a) been hospitalised with and (b) died from covid-19 since the MHRA authorised Evusheld for use in the UK.

Awaiting Answers

To ask the Secretary of State for Health and Social Care, with reference to the Answer of 28 April 2022 to Question 141960, what progress has been made on assessing Evusheld for treating immunocompromised patients.

To ask the Secretary of State for Health and Social Care, with reference to the Answer of 28 March 2022 to Question 141960, when he expects patients in the UK to have access to Evusheld as a preventative treatment for covid-19.

Maggie Throup Conservative Erewash

Answered on 17 May 2022

The UK Health Security Agency has yet to complete testing on Evushelds efficacy against the Omicron variant. The timing of these results is dependent on the testing assays being completed successfully, which will inform any decisions on potential deployment.

Asked 12/5/2022

Sir Alan Campbell Lab Tynemouth

To ask the Secretary of State for Health and Social Care, what plans his department has to order Evusheld for use in the NHS.

Awaiting Answer

Asked 12/5/2022

Alex Cunningham Labour Stockton North

To ask the Secretary of State for Health and Social Care, what plans his department has to make Evusheld available to immunocompromised people.

This is a holding answer. It may be superseded/updated at a future date.

Maggie Throup Conservative Erewash

Answered on 18 May 2022

The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.

Asked 16/5/2022

Amy Callaghan Scottish National Party East Dunbartonshire

To ask the Secretary of State for Health and Social Care, whether the Government plans to procure the Evusheld drug for treatment of covid-19 for clinically extremely vulnerable people.

Maggie Throup Conservative Erewash

Answered on 24 May 2022

On 17 March 2022, Evusheld was granted conditional marketing approval by the Medicines and Healthcare products Regulatory Agency (MHRA). However, the MHRA highlighted uncertainty over the appropriate dose needed for protection against the Omicron variant. Understanding its efficacy is necessary prior to any procurement or deployment decisions. The UK Health Security Agency is currently undertaking further testing on the treatment’s effectiveness against the Omicron variant to inform any such decisions.

Lord Mendelsohn Lab House of Lords

Asked 17/5/2022

To ask Her Majesty’s Government, further to the Written Answer by Parliamentary Under Secretary of State (Minister for Vaccines and Public Health) in the Department of Health and Social Care on 20 April (151279), what level of efficacy against Omicron they would deem as “sufficient” in order to secure a supply of Evusheld.

Awaiting Answer

To ask Her Majesty’s Government, further to the Written Answer by Parliamentary Under-Secretary of State for the Department of Health and Social Care on 20 April (151279), on what date the UK Health Security Agency began further testing on Evushelds effectiveness against the Omicron variant.

To ask Her Majesty’s Government why they have not recognised the laboratory assay tests conducted in (1) the US, and (2) the EU, on Evusheld against Omicron subvariants.

To ask Her Majesty’s Government, further to the Written Answer by the Parliamentary Under-Secretary of State for the Department of Health and Social Care on 20 April (151279), what the in vitro data has shown about Evushelds efficacy against Omicron sub-lineage BA.2 VOC-22JAN-01.

Answered on 25 May 2022

Lord Kammal

The UK Health Security Agency began testing during March 2022.

We understand that the United States of America has increased the suggested dose of Evusheld, in line with in vitro results showing that Evusheld has reduced efficacy against some Omicron subvariants. The Food and Drug Administration’s in vitro data was pseudo virus data, whereas the tests being conducted by the UK Health Security Agency (UKHSA) are based on live virus data. The European Medicines Agency has acknowledged the possibility that Evusheld has reduced efficacy against Omicron subvariants, based on laboratory studies. The data generated by the UKHSA will enhance our understanding of the effectiveness of Evushelds neutralisation of Omicron subvariants, including BA.2.

The UK Health Security Agency is continuing further testing on the treatment’s effectiveness against the Omicron variants, including BA.1 and BA.2. The timing of these results is dependent on identification of new variants of concern and technical scientific assays.

Asked 17/5/2022

Chris Green Conservative Bolton West

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 28 March to Question 141960, whether he can provide an estimated date for the availability of Evusheld on the NHS.

Maggie Throup Conservative Erewash

Answered on 24 May 2022

Evusheld was granted a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency on 17 March 2022. However, the initial positive trial data on Evusheld was published prior to the emergence of the Omicron variant.

The UK Health Security Agency is currently testing the efficacy of Evusheld against the Omicron variant and the Department and National Health Service are identifying appropriate patient cohorts and approaches to the potential deployment of pre-exposure prophylaxis. There is no current estimated date for the availability of Evusheld in the NHS.

Asked 23/5/2022

Daisy Cooper Liberal Democrat St Albans

To ask the Secretary of State for Health and Social Care, with reference to the Answer of 20 April 2022 to Question 151279, on Evusheld, how long the Antivirals and Therapeutics Taskforce or its predecessor took to assess and make a recommendation on the available antiviral treatments for covid-19.

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 20 April 2022 to Question 151279 on Evusheld, when the UKHSA began testing Evushelds effectiveness against the covid-19 omicron variant; and whether UKHSA has guidance on how long that testing should take.

To ask the Secretary of State for Health and Social Care, with reference to the Answer of 20 April 2022 to Question 151279, on Evusheld, whether the UKHSA has reviewed studies published by the US Food and Drug Administration and European Medicines Agency on the effectiveness of Evusheld against the covid-19 omicron variant; and for what reason the UKHSA has decided to undertake duplicate studies on the effectiveness of that drug.

Due for answer today (25 May 2022)

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Also crazy that they are taking so long testing BA.2 that the U.K. will be on to variants BA.4 and BA.5 no doubt just as they publish their BA.2 testing results!

We should also remember that the MHRA took 3 months longer than the US to approve Evusheld , despite the Provent trial proving back in October that it was safe (there were U.K. participants in that trial) Ie there have been delays ever since then not just since March 2022 when the MHRA approved it. We also naively all assumed that the lobbying to get the MHRA to approve it would be all that was required

I got this reply today sounds positive :grinning:

Dear M

Thank you for getting in touch with Lord Mendelsohn.

I would be very happy to look at your suggested questions and table them. So you are aware we are restricted in the number we can submit in any week.

We will keep in touch on any information we receive in relation to Evusheld and continue to press the Government to take action.

Kind regards

Tracey

Tracey Allen MBE

Advisor to Lord Mendelsohn

07889 424441

allentj@parliament.com

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I have been exchanging e-mails with Tracey Allan to finalise the format of questions Lord Mendelshon will ask on our behalf in the House of Lords.

Just been sent this link, he is on our case!!!

Interview with Shielder and his brilliant daughter Katie :grinning: I coulnd’nt have put it better.

Lord Mendelshon also does interview, its good he’s actively on board!

However, the reporter said EVUSHELD is not licenced it is actually by the MHRA on 17th March 2022

The Answers given by the Goverment are simply not true.

There has been a wealth of testing in relation to OMICRON

Yes they have bought thousands of doses of antivirals but are failing to acknowledge that their are deficiences in there use and application and access can be a lottary see e.g recent posts @Chrispy.

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We also had a similar piece on our local look east news on Friday about a transplant patient who has been shielding for over 2 years talking about Evusheld. There was also a piece about a Covid preventative nasal spray still in its trial phase.?
The link was only there for 24 hours so isn’t available now.
So hopefully we are being listened to.

Also had a similar piece on BBC South today

@MCA DHSC have published this report today Defining the highest-risk clinical subgroups upon community infection with SARS-CoV-2 when considering the use of neutralising monoclonal antibodies (nMABs) and antiviral drugs: independent advisory group report - GOV.UK

Figure 1 appears to be the list of medical conditions that will qualify for Evusheld/other prophylactics

Just need the Govt to procure some and start rolling it out

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@CaroleCW I thought you would like to see the final list of questions that I agreed yesterday with Lord Mendelshons Assistant Tracey Alan MBE.

Certain protocols had to be observed so this is what for the time being we have ended up with.

If any one else has similer questions (the more probing the better) please let me know as we do seem to have someone in Lord Mendelshon who is on our side.

Thank you for your input @CaroleCW.

Set of Agreed Questions to be asked on your behalf by Lord Mendelsohn

To ask Her Majesty’s Government (1) what budget it has set for the purchase of new Antiviral or Monoclonal Antibody drug treatments for Covid 19, including those under current review like Evusheld, and those under future review by the COVID-19 Antivirals and Therapeutics Taskforce and (2) if these should prove efficacious in the protection of immunosuppressed patients is it confident that this funding will be sufficient to meet current supply needs for, initially, Evusheld.

To ask Her Majesty’s Government (1) if it is considering the purchase of the Monoclonal Antibody drug Beblitovimab which has been given emergency authorisation by the FDA due to its success in protecting patients against all strains of Omicron and (2) other than Evusheld, does the Government have any other drugs under consideration.

To ask Her Majesty’s Government whether its delay in purchasing drugs such as Evusheld or Beblitovimab is because of budget limitations largely caused by expenditure on other high-cost treatments which were later withdrawn due to ineffectiveness and whether the Government is willing to now allocate funding to purchase these new treatments which are proven to work.

To ask Her Majesty’s Government (1) if, with 50% of patients receiving emergency treatment using Sotrovimab, its strategy to protect the immune suppressed is not over reliant on a second line treatment which is preventing its withdrawal from use and (2) if this is also the case for Molnupiravir, a fourth line treatment prescribed to 13% of patients.

To ask Her Majesty’s Government if, given the reliance on a second line drug treatment, Sotrovimab for 50% of patients, and that only 35% of patients are being prescribed Paxlovid, a First Line Treatment, it will urgently review the treatments options available and consider viable alternative such as Beblitovimab.

To ask Her Majesty’s Government if it has data on the patients who are eligible to receive emergency Covid treatments and, if not, how it plans to ensure this is collated so patients know in advance of their inclusion and can be told which CMDU they will be dealing with to further save time.

To ask Her Majesty’s Government if it will enable a system whereby CMDUs can be contacted by patients directly for emergency treatment and where the CMDU has direct access to patient medical records so it can give the appropriate clinical advice.

To ask Her Majesty’s Government if it has data on the success of treatment provided by CMDU units in the UK and if it is looking at the data on patients unable to access a CMDU and their outcomes.

To ask Her Majesty’s Government if it has plans to establish a first point of emergency contact system, similar to 119, for Covid treatment but specific because the 119 service has proved to have failed patients on many occasions.

To ask Her Majesty’s Government if they will be reviewing the operation of and access to the CMDU system, with particular reference to the role of 119 in that process

Passed on to Bob Blackman MP to table

To ask the Secretary of State for Health and Social Care what monitoring and data systems are in place to evaluate the effectiveness of emergency treatments currently being administered to patients vulnerable to Covid 19.

To ask the Secretary of State for Health and Social Care why Evusheld, a drug authorised for use in the UK by the MHRA, is not currently even being used on a trial basis and whether he has plans to do so.

To ask the Secretary of State for Health and Social Care if all treatments for Covid 19 are being reviewed in terms of efficacy with the same stringency as Evusheld given that the FDA withdrew authorisation for the use of Sotrovimab on 5th April 2022.

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@MCA Excellent final list of questions, it’ll be interesting to see what replies these produce.

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Hi MCA we would like to thank you for all your time and effort that you have put into bringing this to the attention of the government. Doing the research and putting all the questions together must have taken a considerable amount of time, so thank you again from a still shielding immunocompromised person.:slightly_smiling_face:

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@Ted369 Thank you for those kind words much appreciated.

I have to get up to something whilst serving my shielding sentence (of a currently undetermined length).

Its such a shame the prison Governor (Government) is a hard nosed decietful character who fails to see righteousness. I hope the Lord (Lord M) will continue to look kindly upon us and help lead us to salvation (Evusheld) and that one day it will protect us from evil (Covid) and deliver us from incarceration (shielding). :laughing:

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@MCA that has made me chuckle, I promise to repeat your mantra at the foot of my bed every night.:slightly_smiling_face::slightly_smiling_face::slightly_smiling_face:

Lord Mendelsohn House of Lords Update 5 7/6/2022

Asked 11/5/2022

To ask Her Majesty’s Government, further to the Written Answer by the Parliamentary Under-Secretary of State for the Department of Health and Social Care on 20 April (151279), what estimate they have made of when the UK Health Security Agency (UKHSA) will complete the testing of Evusheld against Omicron sub-variants; and why this has taken longer to complete than in (1) the US, and (2) the EU.

Due Answer 25/5/2022

Asked 12/5/2022

To ask Her Majesty’s Government what assessment they have made of the number of individuals who are continuing to shield due to their immunocompromised condition.

Due For Answer 26/5/2022

Asked 17/5/2022

1 To ask Her Majesty’s Government what guidance they have given to Work Coaches for recommending employment requiring in-person attendance to immunocompromised individuals.

2 To ask Her Majesty’s Government what assessment they have made, if any, of the economic impact on immunocompromised individuals who are continuing to shield due to COVID-19.

3 To ask Her Majesty’s Government what assessment they have made, if any, of the psychological impact on immunocompromised individuals who are continuing to shield due to COVID-19.

4 To ask Her Majesty’s Government, further to the Written Answer by Parliamentary Under Secretary of State (Minister for Vaccines and Public Health) in the Department of Health and Social Care on 20 April (151279), what level of efficacy against Omicron they would deem as “sufficient” in order to secure a supply of Evusheld.

Answered on 30 May 2022

1 The Department is committed to providing the best possible support for all claimants to meet their individual circumstances. Claimants with a health condition or disability, including those who are immunocompromised, continue to have tailored commitments agreed based on their personal circumstances, including considering the impact of their health and wider situation.

Any work-related requirements are set in discussion with the claimant, tailored to their individual capability and circumstances, making them realistic and achievable. The guidance available to DWP staff outlines the easements which may be applied including that work search reflects the type and location of jobs which are appropriate to the individual.

Although DWP does not routinely provide guidance specifically on supporting people who are immunocompromised, we do ensure that staff are aware of the sources of information available to them relating to medical conditions that are associated with this. Staff are signposted to tools, guidance support and websites to effectively use resources from both internal and external sites, such as information directly from the NHS.

This ensures that staff can access the most up to date advice and can use this to inform how they support individual customers.

We empower our Work Coaches to use all available resources to best support each claimant, however they are not trained to provide comprehensive healthcare advice therefore while we do discuss the implications certain jobs may have on their health, we would not advise against jobs the claimant wishes to apply for.

2&3 Answered 27 May 2022

No specific assessment has been made. People designated as clinically extremely vulnerable (CEV) were advised to shield between 22 March 2020 to 15 September 2021. However, shielding is not current policy. Individuals previously considered as CEV include but are not limited to those who are immunocompromised.

The Office of National Statistics (ONS) recently conducted a survey of people previously considered to be CEV. In April 2022, the survey found that 46% were very or somewhat worried about the current effect of the pandemic on their life, with 25% reporting that the pandemic posed a major or significant risk to their mental health. The survey found that 29% were in paid employment, 7% reported they had lost income due to shielding or isolating and 20% worked from at home. Insights for those whose immune systems mean they continue to be at high risk from COVID-19 and who are continuing to shield will be included in a future ONS survey release in June 2022.

4 Answered 27 May 2022

There is no pre-determined view of a ‘sufficient’ level of efficacy. The Department will seek expert clinical advice on the results of the UK Health Security Agency’s testing to inform future decision making. RAPID C-19 will consider all data relating to the use of Evusheld as a pre-exposure prophylaxis treatment before providing advice to the Chief Medical Office

Asked 18/5/2022

  • To ask Her Majesty’s Government who is responsible for leading the COVID-19 enhanced protection programme (EPP); and what is the process for (1) charities, and (2) patient organisations, to be designated as stakeholders for the programme.
  • To ask Her Majesty’s Government what plans they have to (1) communicate, and (2) consult, with (a) charities, and (b) patient organisations, as part of the COVID-19 enhanced protection programme (EPP); and what format this will take.
  • To ask Her Majesty’s Government, further to the Written Answer by Lord Kamall on 27 April (HL7561), what conclusions they have reached following meetings with groups representing the immunocompromised community on how they can be involved in (1) creating, and (2) disseminating, (a) communication, and (b) guidance, to people about how to safely manage their ongoing risk.
  • To ask Her Majesty’s Government when they will appoint a ministerial lead specifically responsible for the immunocompromised in order to improve future (1) policy, (2) communication, and (3) guidance, for that group.
  • To ask Her Majesty’s Government what assessment they have made of the efficacy of existing COVID-19 antiviral treatments for eligible patients in reducing rates of hospitalisation and death.
  • To ask Her Majesty’s Government what percentage of eligible patients have received doses of COVID-19 antiviral therapies within the 5-day guidelines set out by the Joint Committee on Vaccination and Immunisation (JCVI).

1, 2&3 Answered on 6 June 2022

SAME ANSWER We regularly engage with charities and patient organisation representing and supporting immunocompromised and immunosuppressed people. Further to discussions with these groups, we are establishing an engagement forum for charities and patient organisations to discuss issues relating to the enhanced protection programme and to seek the views of these stakeholders in advance of any updates to guidance. We will continue to update these stakeholders on the enhanced protection programme through webinars, meetings and correspondence.

The enhanced protection programme is a tripartite scheme administered by the Department, NHS England and NHS Improvement and the UK Health Security Agency (UKHSA). Dame Jenny Harries, the Chief Executive of the UKHSA, is the senior responsible owner for the programme. There is no formal process for designating patient organisations as stakeholders

4 Answered 27/5/2022

The Parliamentary Under Secretary of State for Vaccines and Public Health (Maggie Throup MP) has Ministerial responsibility for immunocompromised groups.

5 Answered 27 May 2022

A range of treatment options are available to non-hospitalised patients at higher risk from COVID-19 to reduce severe disease, hospitalisation and death. These treatments are available through COVID Medicines Delivery Units and include the oral antivirals Nirmatrelvir+Ritonavir (Paxlovid), Molnupiravir and the infusion antiviral Remdesivir.

Evidence from clinical trials suggests these treatments can reduce the risk of hospitalisation. For Molnupiravir, interim results found a 50% reduction in the relative risk of hospitalisation or death compared to placebo. However, updated results indicate Molnupiravir reduces the relative risk of hospitalisation or death by 30% compared to placebo. Pfizer’s final analysis on the clinical trials of nirmatrelvir+ritonavir showed an 88% reduction in hospitalisation or death compared to a placebo within five days of symptom onset. No assessment of how these treatments have impacted rates of hospitalisation since December has been made.

Both Molnupiravir and nirmatrelvir+ritonavir are being trialled as part of the PANORAMIC national study. Results for Molnupiravir are expected in summer 2022. Recruitment for the nirmatrelvir + ritonavir opened on 11 April 2022. The study will collect further data on how these treatments work in a United Kingdom context where the majority of the population is vaccinated. It will also provide baseline information on how antivirals could be used for best clinical effect in combination with antibodies or other antiviral drugs as they become available. A 2021 trial showed that among non-hospitalised patients at high risk for COVID-19 progression, a three-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalisation or death than placebo.

6 Answered on 27 May 2022

Since they were established in December 2021, COVID Medicines Delivery Units have provided antiviral or monoclonal antibody treatments to over 43,000 patients in England. Of these, over 20,100 patients have been treated with antivirals. The clinical access policies specify that the oral antivirals Molnupiravir and nirmatrelvir+ritonavir must be administered within five days of the patient starting to experience symptoms. Over 95% of eligible non-hospitalised patients who have received an antiviral treatment to date were treated within five days from the onset of symptoms. However, the antiviral infusion remdesivir is suitable to be administered within seven days of the patient becoming symptomatic.

Asked 24/5/2022

To ask Her Majesty’s Government what data outcomes are being collected by the COVID-19 Medicines Delivery Unit following the administration of (1) anti-virals, and (2) Sotrovimab, to COVID-positive patients; and when this data will be published?

To ask Her Majesty’s Government whether clinical guidelines have been produced about the prescription of longer courses of anti-virals for refractory infections in immunocompromised individuals; if not, what assessment they have made of the impact of a lack of guidelines on doctors’ ability to issue appropriate prescriptions; and what assessment they have made of the impact of the COVID-19 Medicines Delivery Unit’s decision-making processes on treatment access for patients with immunodeficiency.

To ask Her Majesty’s Government, further to the Written Answers by Lord Kamall on 18 May (HL158 and HL159) and 20 May (HL160), what steps they are taking to improve the data they need to ensure that they can (1) make informed decisions regarding policies to protect the immunocompromised, and (2) deliver treatments where needed.

Due for Answer 9/6/2022

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Thanks for summarising the Q&A, really useful to have it all together. FYI I did a FOI request directly to U.K. HSA specific to Evusheld testing yesterday (FOI #867591) , primarily to keep up pressure on them (as Maggie Throup used the prorogation excuse not to respond to various MPs written questions on Evusheld testing) . Won’t hold my breath on getting any meaningful replies …. (They’ve accepted my request, response due by 4th July).

HERE ARE THE QUESTIONS THAT LORD MENDELSOHN agreed to ask on our behalf, more in the pipeline!

Lord Mendelsohn House of Lords Update 8/6/2022

Asked 7/6/2022

  • To ask Her Majesty’s Government whether access to Evusheld will form part of their commitment to providing early access to (1) life-saving, and (2) cutting-edge, medicines through the Innovative Medicines Fund.
  • To ask Her Majesty’s Government whether they will review the (1) operation of, and (2) access to, the COVID Medicines Delivery Unit (CMDU) system, with particular reference to the role of the 119 telephone number in that process.
  • To ask Her Majesty’s Government what data they have, if any, on the success of treatments provided by COVID Medicines Delivery Units in the UK; and whether they are looking at the data on patients unable to access a CMDU and their outcomes.
  • To ask Her Majesty’s Government what plans they have to enable a system whereby COVID Medicines Delivery Units (1) can be contacted by patients directly for emergency treatment, and (2) have direct access to patient medical records so it can give the appropriate clinical advice to each patient.
  • To ask Her Majesty’s Government what plans they have (1) to review the treatment options for immune-compromised individuals, and (2) to deploy Bebtelovimab as a treatment for such patients.
  • To ask Her Majesty’s Government what assessment they have made of whether their strategy to protect immuno-compromised individuals is over reliant on (1) second line treatments using Sotrovimab, and (2) fourth line treatments using Molnupiravir.

Asked 6/6/2022

  • To ask Her Majesty’s Government what data they hold on the patients who are eligible to receive emergency COVID treatments; and if they do not hold any, how they plan to ensure this is collated so patients know in advance of their eligibility and can be told which COVID Medicines Delivery Unit they will be dealing with.
  • To ask Her Majesty’s Government whether any delay in purchasing drugs such as Evusheld or Beblitovimab is because of budget limitations; and whether they are will now allocate funding to purchase these new treatments.
  • To ask Her Majesty’s Government whether they are considering the purchase of the Monoclonal Antibody drug Beblitovimab; and other than Evusheld, whether they have any similar drugs under consideration.

4 To ask Her Majesty’s Government what budget they have set for the purchase of new Antiviral or Monoclonal Antibody drug treatments for COVID-19, including (1) those under current review like Evusheld, and (2) those under future review by the COVID-19 Antivirals and Therapeutics Taskforce; and if these should prove efficacious in the protection of immunosuppressed patients, whether this funding will be sufficient to meet current supply needs.

In addition to the above some further questions were agreed to be asked on our behalf

Bob Blackman Con House of Commons

Asked 1/6/2022

To ask the Secretary of State for Health and Social Care, what monitoring and data systems are in place to evaluate the effectiveness of emergency treatments administered to patients vulnerable to covid-19.

To ask the Secretary of State for Health and Social Care, with reference to the US FDA’s withdrawal of authorisation for the use of Sotrovimab for treatment of covid-19 on 5 April 2022, what steps he is taking to ensure the (a) stringency and (b) consistency of his Department’s reviews of (i) Evusheld and (ii) other covid-19 treatments.

Asked 6/6/2022

To ask the Secretary of State for Health and Social Care, with reference to the MHRA press release on Evusheld approved to prevent covid-19 in people whose immune response is poor, published on 17 March 2022, whether the NHS (a) has made and (b) plans to make an assessment of the potential merits of trialling Evusheld in real-world evidence studies prior to its potential full rollout.