Is this the Evusheld/AZD7442 trial that Cardiff Clinical Trials Unit are leading shortly? (I saw a Twitter posting on this last evening and sent an email query into BCUK support line last night). Very very frustrating news that there has to be yet another trial here in the U.K. when Provent has shown it to be safe. And lab tests show it is effective against Omicron (albeit less effective than against Delta). Why is the U.K. not doing as the US and France have done and issuing it already to immunocompromised patients? Two years of shielding is enough. Anything that can help us NOW is welcomed. The news of another trial and yet more delay is thoroughly depressing.
3 Likes
I couldn’t agree more! Also I reckon that on rollout, whenever it is, there will be so many hoops to jump through and will it depend on that mysterious list that so many so many of us have been left off???
2 Likes
Hi @CaroleCW Blood Cancer UK might have already got back to you but I will re-send it to them for you @BloodCancerUK
Thanks Erica. Just got a very comprehensive email from Bav at BCUK so all good now. Thanks.
1 Like
Is there any further information about the implications of this clinical trial? I imagine a further trial does not preclude authorisation for immediate use? Or perhaps the MHRA have decided to wait for the results of the trial? Some transparency about the process would be helpful, particularly as for many of us this could be a game-changer.
2 Likes
Hello @davecpep, the understanding we have is that the clinical trial is still awaiting results in relation to Omicron before releasing further information, here is the updates information from our webpages:
Tixagevimab and cilgavimab (Evusheld) – monoclonal antibodies from AstraZeneca’s PROVENT trial
For the first time, a long-acting antibody treatment has been found to prevent covid in people who take it.
A trial called PROVENT tested two antibodies, tixagevimab and cilgavimab (Evusheld) to see if they could prevent serious illness in people at high risk from covid. The trial was run by the drug manufacturer AstraZeneca and the antibody combination was originally known as AZD7442.
In the trial, two thirds of people were given the antibody treatment, and one third weren’t. The groups were then monitored to see how many people in each group got covid. The aim was to see whether giving this treatment to people could prevent them getting covid.
The trial found that there was a 77% reduced risk of developing symptomatic covid in people who had the treatment.
In people treated with Evusheld, there were no cases of severe covid or covid-related deaths. In the group who weren’t treated, there were three cases of severe covid and two deaths.
The trial involved over 5,000 people who did not have covid at the time and had not already had covid vaccines. Approximately 43% of participants were 60 years and over. More than 75% of participants had other health conditions that put them at a higher risk from covid, including people with immunosuppression due to disease or medical treatment.
What is Evusheld?
Evusheld is a combination of two long-acting antibodies called tixagevimab and cilgavimab. These are called human monoclonal antibodies. They were taken from blood donations from other people who had covid themselves and developed the antibodies.
This treatment is thought to give protection for up to 12 months. It is given using two injections into a muscle. In the trial, people tolerated the drugs well and there were no serious concerns about side effects.
AstraZeneca have said they aim to submit their trial results to the regulators (MHRA in the UK) to seek approval to make this drug available to people. If the MHRA approves its use, the government and health departments will need to plan whether and how to roll out this medicine to people in the UK.
Update: Evusheld and omicron
The PROVENT trial was completed before the omicron variant appeared. Two recent studies in the US and UK suggest that Evusheld may be effective against it, but these studies were conducted in the lab, not in humans, and have not yet been reviewed by other experts.
More data is needed to confirm the level of protection Evusheld will offer people against the omicron variant.
We will monitor the situation closely and update our information as soon as we hear more. See the original press release about this trial, and a more recent press release from December 2021
3 Likes
Many thanks @GemmaBloodCancerUK for your reply. I still feel a little puzzled and uncertain about the process. I wonder if you know which of these is a correct description of the position:
- Evusheld has been considered by the MHRA and they have commissioned further clinical trials prior to approval
- Evusheld has been considered by the MHRA and they have decided to await the results of the ongoing clinical trails before considering approving
- Evusheld is still awaiting consideration by the MHRA (and the ongoing clinical trials are not necessarily connected to that)
- something else
Sorry if this sounds a bit pedantic but it feels like this could be such a life-changer for many of us that there is understandable frustration at the lack of clarity. We know that it is being rolled out in the US, Egypt and elsewhere based on existing data, including presumably safety data. Judging by the comments on this forum there would be no shortage of volunteers for a large human trial of Evusheld! If the delay is due to waiting for more proof that it works against Omicron, we may find that by the time it is approved there is another variant is on the scene! Meantime many lives could might have possibly been saved/improved. I know that Blood Cancer UK is doing stirling work in keeping this on the agenda and that is very much appreciated.
3 Likes
Hi @GemmaBloodCancerUK i guess there weren’t really any answers to my questions above? Are you aware of anything further re Evusheld? Many thanks
1 Like
Hi Dave, I got a reply from the DHSC on 11 Feb to an email (from December) which said this “ Thank you for your suggestion that we look at Evusheld which, as you note, is being developed as a potential prophylactic treatment. AstraZeneca announced positive interim data for Evusheld from the PROVENT Phase III Trial for Pre-Exposure Prophylaxis of COVID-19 in Adults. However, this trial took place before the emergence of the Omicron variant. The Therapeutics Taskforce is engaging with AstraZeneca on emerging data around the impact of Omicron on Evusheld, because Omicron is the dominant variant in the UK / worldwide, it is essential the department understands how effective Evusheld remains.” So it seems they are waiting for more data re Omicron effectiveness (could also be viewed as a delaying tactic ……), frustrating when other countries like US, France and Israel are already issuing it, but guess it at least shows some discussions are in progress. Blood Cancer U.K. may have additional info for us.
3 Likes
What I do not understand is why they keep giving booster’s when they don’t even know if they will give any protection. And they don’t do antibody testing on the nhs.
I do think preventative antibody treatment is the answer.
They can’t keep delaying as more variants are probably going to appear. But they still keep jabbing with the same vaccines and don’t delay because of a new variant.
3 Likes
How are you doing @Ted369 ?
@Ted369
If you are in England, you can get a free nhs antibody test, you can sign up here, I did mine though this, and do have antibodies
2 Likes
Thanks @CaroleCW This doesn’t ring completely true - AstraZeneca have reported data showing that Evusheld retains its effectiveness against Omicron. Given that the next variant could be just around the corner it would make no sense to seek gold standard effectiveness data over a long period , by which time it may be redundant! For whatever reason, I think delaying tactic seems the most likely explanation!
2 Likes
I agree. No time to waste, and some protection is better than no protection.
1 Like
Hi @Ted369 hope you’re doing okay. Antibodies are only one measure of vaccine effectiveness. If someone has no antibodies after their Covid vaccines they might still have T cells, and a booster dose could increase the number of these valuable cells. In addition to this, we know from research that the number of people developing antibodies increases as they have more doses. One study found that while a majority of people with blood cancer had no antibody response after two vaccine doses, over half of these people developed antibodies after a third dose. There is good reason to believe that antibody response will be improved even more after a booster. There’s more info on this page - Covid vaccine efficacy and blood cancer | Blood Cancer UK. As we learn more we will continue to update the community.
2 Likes
Hi @Margarett just wondering how you are doing? I somehow managed to avoid catching covid and everything is ok at the moment. Still waiting on Evusheld of course and the recent announcements have not done anything to make me feel safer. Hope you are doing ok.
2 Likes
Hi @davecpep I am doing fine thanks. I did not test positive for Covid even after isolating with my husband due to having the same symptoms. I am glad you managed to avoid catching Covid as well. Hopefully we can get Evusheld soon to give us a bit more positivity going forwards. Hope you and your family stay safe and keep well.
3 Likes
This whole thing seems to have fallen off the radar, especially with testing being phased out which is rather worrying. I hope that we’re not about to become the forgotten people again.
3 Likes
Hopefully this may lead somewhere. Thanks Vicky Foxcroft for fighting our corner 
3 Likes
I don’t think the government intends to ever make Evusheld available to us, and the ‘new varient’ excuse’ is a convenient, endless one. It doesn’t seem to stop other reputable health authorities from doing so.
Is it possible to buy Evusheld from one the countries that have authorised it’s use and are stocking it?
Perhaps Blood Cancer UK could look into that possibility.
1 Like