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

Copy of letter to my MP sent after one I sent erarlier (See Post Government Policy for Link)

Dear Bell Ribeiro-Addy,

Since writing to you earlier today further information has come to light

https://www.astrazeneca.com/media-centre/medical-releases/evusheld-long-acting-antibody-combination-retains-neutralising-activity-omicron-variants-ba4-ba5-according-new-study-university-oxford.html

I also note the Graham Stuart asked a question of the PM today. Furthermore the BBC are looking now investigating this debacle .

I implore you not to let the Government get away with any further procrastination hiding behind science.

The preventative benefits have already been established and hiding behind lengthy further testing for months on end can and will lead to unnecessary deaths and further phycological anxiety for a huge section of society.

Even in the Lords the excuses keep being churned out saying e.g that the testing carried out by FDA was in relation to a puesdovirus rather than real virus. Testing on the former is to achieve a quicker result due to the limited capacity of testing labs available to cope with the demands of testing a real live virus. In my letter under further info re Evusheld I referred under 1 to a real virus testing scenario and the Astra testing in vivo scenario which is far more realistic than in lab testing. The Government seem to be testing this drug in far greater depth than any including the vaccines why?

Many thanks

MCA

Get Outlook for iOS

3 Likes

I am sure others have receive the email this morning with regard to the petition which pushes the fact that antivirals are available so there is no desperate need for Evusheld. We all know that system is flawed so it really can’t be used. 24 hours after submitting a positive result I have received no call. Luckily i am feeling better (I had symptoms for 4 days and negative LTFs) as i am now beyond day 5 since symptoms started. Post covid antivirals is not a excuse not to buy Evusheld.

Also the argument about it effectiveness is now out of date due to the report from Astra Zeneca yesterday saying it was effective against the new Omicron variants. They appear to have run out of arguments now so i assume it is just a cost issue now.

2 Likes

How do the Government expect us to have faith in their alternative to Evusheld which is as mentioned by @Chrispy, i.e., the emergency treatment system via CMDU? The problems associated therewith formed part of the topics raised in my letter to my MP see my post under Government Policy.

I still read with great concern stories of the difficulties people with Blood Cancer have in accessing treatments for Covid. Its not giving any real confidence to “LIVE WITH COVID” that access to a viable alternative to the vaccine may provide e.g., EVUSHELD?

The word Broken in relation to the treatment system is being far too frequently used.

The majority of the 5 TESTs of Government Policy set out by BCUK and many other charities are clearly not being met!

Some things I have learnt.

In relation to any eligibility for treatment this appears to be a myth. There is no centrally recorded list with names and addresses of eligible patients. Why not you might well ask, surely by now they have had time to compile one, and furthermore for our clinicians to identify personally the appropriate treatment from those available.

Government acknowledges no list (see below)

Those who were in the 1.3 million sent a letter will note the wording which states “Your medical records show that you might be suitable for these treatments “if indeed you received a letter, after all that letter was not an entitlement it was advisory. No letter therefore would not appear to preclude treatment!

What there was after independent research was a list of cohorts or eligible groups.

The eligibility cohorts are listed in document pdf download link below;

https://www.google.com/search?client=firefox-b-d&q=UK+Interim+Clinical+Commissioning+Policy%3ATherapies+for+symptomatic+non-hospitalised+patients+with+COVID-19 w:-

Click link at top of the search page for pdf download.

I.e., if you condition is not listed you may not get treatment!

It appears the list of cohort groups is the first point of reference for the CMDU as they do not normally have any prior knowledge of a patient unless given specific information on the point of referral, by GP or Clinician.

As we are firstly advised to use 119 and if that fails 111 GP or Clinician the later instances of referral are largely by the endeavour of individuals after a failed 24hours awaiting a response. I doubt I personally will bother with 119 Should I catch covid.

So having found you are eligible the next step is determining which of the four treatments are they likely to give you.

First Line PAXLOVID (PF-07321332/ritonavir) antiviral pill combo- 2.75Million doses purchased (one dose 3 pills 2* day for 5 days) However, the list of drug interactions shown to preclude this treatment is very lengthy (see above document) hence a need to have a list of all medications including herbal ones handy should you need it. (See also Liverpool drug interaction checker referred to at bottom of the above pdf.)

I found there is not always a correlation to things listed with the drug checker but it does let you print off your own report of your medications in relation to their interaction with the 4 treatment options currently available which is handy should you need it

Evidence Basis for use of Paxlovid study in April 2022

Second Line Sotrovimab (mAbs) via infusion. One of the first of the treatments purchased by the Government. One of the others Ronapreve has been discontinued it is not effective against BA2. Nb FDA in USA in April also withdrew the authorisation for Sotrovimab due to doubts about its effectiveness against BA2. In the UK NICE have recommended further testing required. That does not seem to prevent the NHS relying upon it. Assumedly quite widely in view of limitations above.

Evidence Basis for use study published in Oct 2021 (NB Pre Omicron the first case of which recorded in SA was Nov 2021)

Third Line Remdesivir antiviral intravenously given.

Fourth Line Molunipriver antiviral pill 2.35m doses purchased, seemingly only given if above options N/A 30% efficacy.

Specifically, it states the first three have similar efficacies the fourth being much lower what they don’t say is that the efficacies are necessarily in relation to the BA2 variant

NB evidence basis is that referred to in

Interim Clinical Commissioning Policy: Antivirals or neutralising monoclonal antibodies for non-hospitalised patients with COVID-19 (Version 5)

Published in Feb 2022 the Pdf download above is referred to in that document and as such is part thereof.

1 Like

Please find link to my local look east news, with a piece about a transplant patient who has been shielding for over 2 years talking about Evusheld. There is also a piece about a Covid preventative nasal spray still in its trial phase.?

1 Like

I got this reply today sounds posative :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

Arghh! Same nonsensical response being trotted out! Nonsensical because …

The same level of evidence has never been demanded of vaccines
Many other countries seem entirely comfortable with existing evidence
( but most crucially)
There is now an abundance of evidence that Evusheld works!!

I found this to be a useful summary of the history of Evusheld procurement.

I know from my own contact with Lord Mendelsohn (Government Policy Posts) that he has written to the Secretary of State yesterday regarding the Goverment’s ineptitude and inconsistency in procurement detailing the case for the rapid deployment and purchase of Evusheld. The format of questions in the HofC and HofL is restrictive and the anwers rarely informative.

Although the one below is interesting and somewhat unique.

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.

Answer 16 June 2022

AstraZeneca commissioned the UK Health Security Agency (UKHSA) to complete testing as part of studies into the effectiveness of Evusheld against Omicron variants. Initial data has been shared with AstraZeneca and testing continues for the Omicron variant BA.4. As timing of the results are dependent on a number of factors, we are currently unable to confirm the date of completion. AstraZeneca will review such data and determine whether further testing should be commissioned.

When undertaking testing, the UKHSA follows strict processes designed to ensure such treatments are effective. These processes may differ from regulations in other jurisdictions.

They appear to suggest its AZ who asked them to carry out further testing rather than them commisioning there own testing because they didnt appear to accept that given by AZ. Puzzeling to say the least.

1 Like

My cynical view is that perhaps the Govt is trying to finger point at AZ as the cause of Evusheld delays - requesting testing etc - it doesn’t make sense as AZ have said all along they provided any data required to the Govt, Univ of Oxford testing has already proven efficacy against BA4 and BA5 variants , all previous Govt responses have said the testing is HSA-driven etc. My only hope is maybe it means the Govt is edging closer to Evusheld rollout but seeking to save face by blaming the delay (inappropriately) on Az. We shall see ….

1 Like

Article in daily mail today regarding evusheld .they are saying it would be £800 per person to issue the drug . The governments comment was the usual non committal wishy washy answer .
Some of the reader comments are disgusting re the cost .

My latest letter to my MP …

Dear Nigel

The weeks continue to roll by since Evusheld was approved by the MHRA, yet still we wait for it to be made available in the UK. Meanwhile society has still not opened up for the many immunosuppressed, like myself, who are required to shield (28 months and counting) or take avoidable risks. Questions have been asked of ministers including the PM from both sides of the house about Evusheld, but so far without result. Evidence of efficacy against Omicron is often sited at the reason for the delay, yet the evidence is mounting and is hugely compelling, such that 30 countries are now deploying Evusheld.

The PM likes to claim world leading status, yet in regard to protecting its immunosuppressed citizens the UK is lacking woefully behind. Surely this must be rectified at the earliest opportunity?

I would be grateful if you and your colleagues could use their good offices to press for early progress on this matter.

Kind Regards

5 Likes

Just received letter from Lord Kamall via my local MP. Same old same old, need to test against Omicron to prove effectiveness and peddling treatments including sotrovimab. Do they care about us?No need to answer.

1 Like

I have signed and shared the petition.
I read through most of thread yesterday evening and my head is spinning. So much to take in. I recognise the people’s hard work and dedication in fighting for a resolution -thank you.

@CaroleCW @davecpep @Ted369 etc This starts at 12 if your interested

1 Like

@CaroleCW @Ted369 @davecpep etc Sorry starts at 12 Central European time that’s 11am in UK

1 Like

I can’t attend will someone give a brief on what is said please?

Just seen your post can you let us know what was said please.

I’m really sorry it was an hour long. I did manage a couple of questions Gemma Peters acknowledged that she hoped we would follow Europe and Israel etc in adopting Evusheld but had no insight if we will and when. The Israeli representative said data on effectiveness in prevention of hospitalisation of Evusheld available next month.