Evusheld in the United Kingdom

[Clairdensheil]

Does anyone have any information about whether or when Evusheld may become available? Many thanks.

[RogerPinner]

I've been asking the same question for months. It could change our lives or at least our attitude to the way we continue to shield. I can't believe it's not a cost issue. Paxlovid and Sotrovimab (Xevudy), may be effective treatments, but a prophylactic would be so much more mind-settling.Roger

[Eucalyptus22]

I was a bit cheeky and wrote to Astra Zenica to ask what the intention was to supply this in the UK! In their reply they said two things:

"Kindly note that AZD7442 is still under assessment with the Health Authorities, therefore we

are unable to provide a timeline for its availability. The MHRA are still reviewing the data

submitted by AstraZeneca, and this is the same data submitted to other regulators (including

the US FDA).

Furthermore, the UK Government has not communicated to AstraZeneca any confirmed

plans to access and rollout a pre-exposure prophylaxis (passive immunisation) in the UK."

You could take the second point two ways. I know Blood Cancer UK are pushing for Evushield but if you read the government's living with covid plan there is no mention of any plans to make Evushield available.

Perhaps we need to organise a campaign!

[sparkler in reply to Eucalyptus22]

Good on you for writing to AZ!

I remember reading quite a while ago (I don’t remember where, though it was a credible source) that the Govt did pre-order a number of doses but then cancelled it. As you say, it hasn’t been mentioned for a long time and I don’t believe we’ll be offered it. I hope I’m wrong but not holding my breath. It’s so painful to know it’s being used successfully in the US and yet not here.

We are not regarded as important enough to warrant the cost and as ever, CLL and immunosuppression continue to be misunderstood. This has been the case with CLL since my dx 12 years ago - depressing on its own even without adding Covid to the mix.

Again, thanks for writing to AZ and for posting their reply, which could be very useful.

We need to do something...?

Stay safe

sparkler x

[Unglorious in reply to Eucalyptus22]

We in Canada as well are waiting anxiously for Evusheld, it is is still under review. Although 100 thousand have been ordered. It boggles the mind that is is readily available in the USA but not elsewhere. The USA does its homework on all its drugs, so if it is safe enough for the community there, it should for the rest.

[bennevisplace]

It's not just the UK where Evusheld doesn't exist as a licensed product. AFAIK the only countries where it's authorised are the USA (emergency use) and Bahrain.

The MHRA in England and the EUA in the European Unon have had AZD7442 under review for many months. It seems to me that the results of the phase 3 PROVENT trial are good enough for these regulators to approve the drug (far easier to justify than Molnupiravir anyway!). The only rational objection I can think of is if regulators want to see evidence of efficacy against current variants of Covid. I don't know, but perhaps in response to this Astrazeneca initiated a sub-study of PROVENT to run for 18 months from last January-February. I'm fortunate to be in this sub-study.

It was either Forbes or Bloomberg that reported (last April) the UK government reneging on a pre-order of 1 million doses of AZD7442. Whether or not that was accurate, it's clear now that prophylactic monoclonal antibodies don't figure in the UK government's thinking. Instead, specifically for immunosuppressed candidates, we have mAb and antiviral treatments. I'm sure that this thinking is strongly influenced by cost comparisons.

[AussieNeil Partner Administrator in reply to bennevisplace]

In Australia, "Evusheld (tixagevimab/cilgavimab) was (recently) approved for the following therapeutic use:

Evusheld (tixagevimab and cilgavimab) has provisional approval for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg,

- who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination or

- for whom vaccination with any approved COVID-19 vaccine is not recommended due to a history of severe adverse reaction (for example., severe allergic reaction) to a COVID 19 vaccine(s) and/or COVID‐19 vaccine component(s).

:

Evusheld is not recommended as a substitute for vaccination in individuals for whom COVID 19 vaccination is recommended.

This decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety data from ongoing clinical trials."

tga.gov.au/apm-summary/evus...

As is the case elsewhere, it's in short supply.

Neil

[bennevisplace in reply to AussieNeil]

Thanks for the update. Do you know of any other countries that have approved it?

[AussieNeil Partner Administrator in reply to bennevisplace]

CLLerInOz and I keep the below pinned post up to date as we come across updates:

healthunlocked.com/cllsuppo...

We haven't heard of other Evusheld approvals.

[Clairdensheil]

Thank you all. I wish that we could get this issue some profile. I Google regularly and it is very rare for there to be any mention anywhere. I'm not equal to organising anything but would put my wholehearted support behind anyone who was able to initiate a campaign.

[Vikhi]

HiI’m from the UK. Evusheld has definitely been approved it was about 4 days ago.. here is the link to the government announcement,

gov.uk/government/news/evus....

What has not been said is how and when, I am keeping my fingers crossed that it will be a couple of months max, this would follow how the general vaccines worked. they have to setup NICE guidelines and cascade the info to the healthcare professionals, ie GPS and hospitals as it will probably be managed that way. All a bit vague but I have been following and there are a lot of UK charities who have joined forces to push on this so really hopeful that we will get a near normal life back. I’m a kidney transplant patient , had 3 jabs and no antibody response, take care all. 😀

[Clairdensheil in reply to Vikhi]

Thank you. Yes, I saw the approval announcement but then felt a little deflated when there seemed to be no follow-up. I really wish that this issue could find a higher profile. If our plight was common knowledge it would probably have more traction. But I'm heartened to hear your encouraging information. Hopefully this will be rolled out quickly and appropriately, and as you say, we can hope to get back to living more normal lives.