Any news about authorisation of the preventative antibody treatment from the PROVENT study?

Yes I saw the BMJ article. Felt like it was a start, let’s really identify those at very high risk (zero antibodies to the vaccine, maybe reserve Evusheld preventative for these only, I think it costs around $1000 per person very roughly) vs those who may have had a lower than normal vaccine response (give them antivirals if they get Covid). I think it’s naive of the Govt just to compare Evusheld cost to vaccine/antivirals cost as there is also the economic cost to the country of a huge group of people and their families still shielding and not spending as they might do normally. And also the fact that those with no antibodies may help the virus mutate if they were to catch Covid as it hangs around for longer in them. As you say let’s hope that the BMJ article may be a potential way forward

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@CaroleCW, totally agree. The goverment’s current approach is very short-sighted and not sensible. Cross fingers that the BMJ comments will be taken on board by the government soon. I am very pleased about how supportive and empathetic that the BMJ has been towards immunocompromised people’s plight.

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Little bit concerned. I read on here somewhere that people with indolent B cell lymphomas might mount some antibody response to the jab but these antibodies are pretty pathetic at fighting Covid. If antibodies are to be measured, how do you test if they are strong enough to protect you. My fear would be you could fall through the cracks.

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Hi @Bronte, that is a very good question and I don’t know whether it has been answered yet from what I can see.
I do know that there are clinical trials happening in the US and UK focussing on blood cancers and vaccine efficacy. You may/may not have already read this page on the Blood Cancer UK website Covid vaccine efficacy and blood cancer | Blood Cancer UK
There’s a recent study that showed (within a small group of people with indolent blood cancer) that a new vaccine was effective against it. But further phase 3 clinic trials have yet to be completed.
So there is hope.
Novel COVID-19 vaccine may provide protection for cancer patients with B-cell deficiencies (medicalxpress.com)

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Yes I think it’s true that it’s both quantity and quality of antibodies that matter against Covid (although I don’t believe there is a stated minimum number yet determined for them to be effective). There have been some studies done by UCL and the PROSECO study (lymphoma specific) led by the Univ of Southampton (funded by Blood Cancer U.K.) which provide some insight on the quality aspect. Here is the link to the latest PROSECO findings Immune responses against SARS-CoV-2 variants after two and three doses of vaccine in B-cell malignancies: UK PROSECO study | Nature Cancer (sorry it’s quite technical language in it).

(I am one of the PROSECO study participants , with indolent B cell lymphoma , gave my latest bloods after my 4 th jab so they will likely issue further updated findings for the study in due course)

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There is some hope then. Meanwhile I am having to turn down work, mostly due to lack of or any regulation of air flow and people not wanting to wear masks in places like village halls. Don’t mean to moan but the lack of good direction and the “it’s all over” attitude really isn’t helpful. I would like to get back to my life too! You’ve really given me reason to hope…thank you…

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More good news…looks like things might start happening and thank you for the link I will check it out…
I tried to get on the trial but I live in the wrong place so it’s just a waiting game till the findings come out. Hope it’s good news for you……

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@Bronte, I’m glad.
I can completely understand the frustration of not being able to get back to your life. I am in the same boat. I have had to stop working because it is difficult to work remotely and part-time. I want it all and now! :wink:
I am enjoying volunteering instead, though.
Sometimes new circumstances can force us down a path we wouldn’t have chosen at that time. But that path can lead to a place that we may find equally/even more fulfilling.
It’ll all come good in the end. :slightly_smiling_face:

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Hi @Bronte and @purdy1966 it is so difficult isn’t it and I am tussling with this issue too.
My son says the world is really returning to what was ‘normal’ 2 +yrs ago.
I have gone on long walks over the bank holiday and a towpath I have walked along I could count the number of people with masks on on one hand.
My mind is coming round to the thinking that the world is not going to change for me and that I am going to have to find a way to integrate into the world.
It is very difficult when a workplace and other workers are involved and of course there are financial implications for you to consider to. Financial insecurities are so rarely discussed on our forum. Good luck to you both.

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Hello @Erica and @purdy1966 You’re right financial insecurities are rarely discussed but must be very real for many of us. I am an artist and I usually supplement my income teaching workshops. The pandemic has meant both have come to rather an abrupt halt. On the plus side it’s given me time to have a good go at sorting out my messy IT and to develop new work as well. Always busy, interested, curious and occupied but as a teacher, I really miss those lovely interactions with all sorts of people. And that is really the issue, the type of work I usually do means lots of contacts and I have been told this is not a good idea at all! Onwards and upwards, let’s hope these new treatments help the situation.

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Fantastic written questions submitted to Parliament yesterday by Daisy Cooper MP and Andrew Gwynne MP pushing for answers on what the hold up is re Evusheld (you can track responses via this link Search for evusheld in the 'Written Answers' - TheyWorkForYou)


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Wow…I just got brushed off by my MP. She did write to DH&SC and she sent me a copy of Lord Kamall’s answer which was the usual stuff about them needing more trial information. She would not ask a question in the House….just follows the party line!

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Summary of Parliamentary Questions and answers on Evusheld since approval

24/3/2022

Duncan Baker Conservative, North Norfolk

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 20 December 2021 to Question 92097 and following the Conditional Marketing Authorisation awarded by the Medicines and Healthcare products Regulatory Agency on 17 March 2022, what plans he has to ensure that severely immunocompromised patients have access to Evusheld; and what estimate he has made of when the first patients will start to receive that treatment.

Maggie Throup The Parliamentary Under-Secretary for Health and Social Care

We are unable to provide the information requested as it is commercially sensitive. Any public announcement on the procurement of treatments would be made after an agreement is reached with companies. The Department is scoping the potential introduction of pre-exposure prophylaxis. This includes identification of the most appropriate patient groups which could benefit and the potential deployment and administration process. However, treatments must be clinically cost-effective and demonstrate sufficient efficacy against Omicron and new variants.

28/3/2022

Daisy Cooper Liberal Democrat Spokesperson (Health and Social Care)

To ask the Secretary of State for Health and Social Care, when Evusheld will be made available to (a) adults and children over 12 who have primary and secondary antibody deficiency, and who may not produce an adequate response to Covid vaccines (b) those for whom vaccination is not recommended.

Maggie Throup The Parliamentary Under-Secretary for Health and Social Care

We are unable to provide the information requested as this is commercially sensitive. Any public announcement on the procurement of treatments would be made after an agreement is reached with companies.

To ask the Secretary of State for Health and Social Care, in the context of the Conditional Marketing Authorisation awarded by the Medicines and Healthcare products Regulatory Agency on 17 March 2022, what plans he has to (a) procure Evusheld and (b) roll out the treatment to severely immunocompromised patients.

28/3/2022

Henry Smith Conservative, Crawley

To ask the Secretary of State for Health and Social Care, how many doses of the MHRA approved Evusheld covid-19 preventative treatment for immunocompromised patients his Department plans to procure; and when he expects to outline eligibility to receive this treatment.

Henry Smith Conservative, Crawley

To ask the Secretary of State for Health and Social Care, in the context of the Conditional Marketing Authorisation awarded by the Medicines and Healthcare products Regulatory Agency on 17 March 2022, what plans he has to (a) procure Evusheld and (b) roll out the treatment to severely immunocompromised patients.

Maggie Throup The Parliamentary Under-Secretary for Health and Social Care

We are unable to provide the information requested as this is commercially sensitive. Any public announcement on the procurement of treatments would be made after an agreement is reached with companies.

12/4/2022

Lord Mendelsohn Labour

To ask Her Majesty’s Government whether, other than Evusheld, they are aware of any monoclonal antibody treatment that can protect the clinically extremely vulnerable through pre-exposure prophylaxis (PREP) against Omicron and its variants; and, if so, to list them.

Lord Kamall The Parliamentary Under-Secretary for Health and Social Care

The Department’s Antivirals and Therapeutics Taskforce is scoping the potential for pre-exposure prophylaxis with experts from the Prophylaxis Oversight Group, the UK Health Security Agency and the multi-agency group RAPID C-19.

The Medicines and Healthcare products Regulatory Agency has approved two such products Evusheld and Ronapreve. However, treatments must demonstrate sufficient efficacy against Omicron and new variants. Ronapreve has been withdrawn from general use as it has since been found to be ineffective against the Omicron variant. We are therefore gathering data on how Evusheld performs against new variants.

19/4/2022

Daisy Cooper Liberal Democrat Spokesperson (Health and Social Care)

To ask the Secretary of State for Health and Social Care, when the results of Government’s tests on the effectiveness of the drug Evusheld against covid-19 omicron sub variants will be published.

Maggie Throup The Parliamentary Under-Secretary for Health and Social Care

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.

20/4/2022

Daisy Cooper Liberal Democrat Spokesperson (Health and Social Care)

To ask the Secretary of State for Health and Social Care, whether the Government has undertaken an assessment of which immunocompromised patients should be eligible for treatment with the drug, Evusheld, due to their lack of response to the covid-19 vaccine; and whether the Government has plans to undertake antibody testing on those individuals to assess their response.

Maggie Throup The Parliamentary Under-Secretary for Health and Social Care

The Department is reviewing the potential introduction of pre-exposure prophylaxis treatments, such as Evusheld. This includes the identification of appropriate patient groups, the potential deployment and administration process and assessment of antibody testing prior to treatment.

Andrew Gwynne Shadow Minister (Health and Social Care)

To ask the Secretary of State for Health and Social Care, what estimate his Department has made of the timeframe for Evusheld being available for eligible patients following its recent MHRA approval.

Maggie Throup The Parliamentary Under-Secretary for Health and Social Care

We are unable to provide the information requested as it is commercially sensitive. Any public announcement on the procurement of treatments would be made after an agreement is reached with companies.

Daisy Cooper Liberal Democrat Spokesperson (Health and Social Care)

To ask the Secretary of State for Health and Social Care, whether he plans to place an order for the drug, Evusheld.

Maggie Throup The Parliamentary Under-Secretary for Health and Social Care

We are unable to provide the information requested as it is commercially sensitive. Any public announcement on the procurement of treatments would be made after an agreement is reached with companies.

Daisy Cooper Liberal Democrat Spokesperson (Health and Social Care)

To ask the Secretary of State for Health and Social Care, for what reason the Government is conducting tests of the drug, Evusheld, on covid-19 omicron sub variants in the context of the United States Food and Drug Administration and the European Medicines Agency having demonstrated through similar studies that that drug maintains protection.

Daisy Cooper Liberal Democrat Spokesperson (Health and Social Care)

To ask the Secretary of State for Health and Social Care, when the results of Government’s tests on the effectiveness of the drug Evusheld against covid-19 omicron sub variants will be published.

Maggie Throup The Parliamentary Under-Secretary for Health and Social Care

The Department’s Antivirals and Therapeutics Taskforce is scoping the potential for pre-exposure prophylaxis, alongside experts from the Prophylaxis Oversight Group, the UK Health Security Agency (UKHSA) and the multi-agency group RAPID C-19. As part of this evaluation, treatments must demonstrate sufficient efficacy against Omicron and new variants to avoid escape mutations. Therefore, the UKHSA is undertaking further testing on Evusheld’s effectiveness against the Omicron variant. The timing of these results is dependent on the success of the testing assays, therefore we are currently unable to confirm when these results may be published.

The Medicines and Healthcare products Regulatory Agency has authorised Evusheld for use in the United Kingdom. However, it has noted in its Summary of Product Characteristics that no clinical data is available on the use of Evusheld against Omicron variants and there is uncertainty on the dosage and duration of effectiveness, as in vitro data has shown reduced efficacy against some variants, including Omicron.

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I have written to my MP as many have done and in six pages referred to the 5 TESTs the Government were asked to consider in there living with Covid Plan and their atrocious performance generally but more specifically in relation to test 5, ref was made to the excuses made so far.

5 Point Plan

In relation to efficacy against omicron

https://www.astrazeneca.com/media-centre/medical-releases/evusheld-long-acting-antibody-combination-retains-neutralising-activity-against-omicron-variants-including-ba2-in-new-independent-studies.html

in relation to confidentiality

The government have also apparently hidden behind the suggestion of commercial confidentiality, although this situation was strongly denied in an article in I News on April 5th Health Section (subscription only). Hence no link. See also Adrian Warnock’s website

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Wow, thanks so much @MCA for these very comprehensive 2 posts.
Look after yourself.

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This response from Lord Kamall of 21 April is useful in that it makes it clear that the JCVI remit is purely vaccines. And that the remit of whether, when and how Evusheld (or other prophylactics and treatments) are the remit of the DHSC Antivirals and Therapeutics Taskforce (bit concerned that means lack of independent input and oversight but at least there is clarity on who makes the decisions re Evusheld).

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Thanks @davecpep and @CaroleCW for keeping us all up to date.
Look after yourselves both of you

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It does appear that a tougher threshold is being applied to prophylactic treatments than to vaccines. After all, clinical trials are ongoing with vaccines, for efficacy against new variants etc but they continue to be rolled out of course. Evusheld is effectively equivalent to a vaccine for those who are immunosupressed.

I imagine that in discussion of efficacy the psychological dimension is under- appreciated. Yes, there are effective treatments if you get covid, for which we should be extremely thankful; however, If there was an armed killer on the loose, would you rather have an electric fence round your property or be able to summon a SWAT team, but only when the killer was already in the garden … will they pick up? will they respond? will they be in time? Psychologically, the prophylactic “fence” wins every time.

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