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

COVID-19 (Coronavirus)
123

Thanks for posting this @CaroleCW! We welcome the Medicines & Healthcare products Regulatory Agency’s approval of Evusheld and we hope it means people with blood cancer who may not have responded well to the vaccines could have another option available to them in the future.

💉 The high infection rate has meant many of them have felt left behind as the rest of society gets back to normal, and Evusheld offers them hope of getting a similar level of protection against Covid as most of the population have already got from the vaccines

💊 But while the approval is welcome, the Govt is yet to set out how it plans to use Evusheld. We’ve been urging the Govt to set out its approach to using preventative treatments for people who haven’t responded well to the vaccines, and it’s disappointing it’s not yet done so.

👪 We hope the MHRA’s approval of Evusheld will prompt a sense of govt urgency on this that’s so far been lacking. Many people with blood cancer have spent almost two years avoiding social interaction – the Govt needs to do more to support them to start getting back to normal.

🩸 It’s important people with blood cancer understand that while Evusheld is potentially game changing, there are still unanswered questions. We’re confident it gives good protection against previous variants and there is reason to think it will also protect against Omicron.

🦠 But we have not yet seen real-world data on how much protection it gives against Omicron, or for how long. We are pleased to hear

MHRA plans to monitor this, as it’s vital people who have Evusheld are kept up to date, so they can make their own informed decisions.

We will keep updating the blood cancer community as we learn more.

7 Likes
124

I have been following Evusheld since last year and trying to find something after the farce of trying to get the 3rd vaccination before starting chemo sept 2021
I have told my surgery I’m now holding out for when it’s approved in this country

Though I have discovered I have antibodies after having Covid 3 weeks ago amazingly

6 Likes
125

It would be great if this drug gets rolled out but my faith in such things has taken a dent in the last couple of years as there never seems to be any planning behind it. I think I can guess which party your MP is from @Margarett :wink: My MP usually engages very well with me and sends proper replies straight away. Great news on the antibodies @2DB ! Thanks for posting about Evusheld @CaroleCW .

5 Likes
126

Hi @Franko, Let’s hope we can get this treatment sooner rather than later. My MP is a Hyndburn Conservative but she has been a great help in the past. I have asked her to see if she can find out any information regarding the timing of Evusheld been rolled out.

3 Likes
127

Just a thought about writing to MPs. I too had a response which was largely positive - I haven’t copied it here because the news of the Evusheld approval came through. I did challenge some evidence he included suggesting that the immunosuppressed might have a similar level of protection from the vaccine as the general population!! Since the news about Evusheld came through, I have further responded to him, emphasising the importance of an early roll out and asking him to keep me informed. This is the part of the process politicians have most influence over to honest, so I do think it’s still worth an email to your MP or a follow up if you sent one already. This should help to support the excellent advocacy of Blood Cancer UK.

5 Likes
128

According to the i and the daily mail online not a single dose of Evusheld has been purchased. The government is still prevaricating! Does anyone know if this is correct? My MP hasn’t bothered to reply to my first email but I think I might be sending her a second one…

2 Likes
129

Hi @Bronte I believe this is correct and there are negations to take place before a contract is agreed, mostly on price, an order placed, manufactured and supplied etc.
We await

3 Likes
130

@Erica It’s kind of ironic as we all spend our lives, to a lesser or greater degree, waiting for the next step with our blood cancer and as you say, we await to see if we will be offered the possible protection this drug will offer us….after 2 years we just carry on waiting!

2 Likes
131

I’ve just received this very disappointing letter from the DHSS via my MP. Whilst one can understand that it would be wrong to give people misplaced reassurance that they were protected, if that weren’t the case, I wonder how likely it is scientifically that Evusheld’s efficacy in the lab would not be replicated in the real world? And whether by the time the data is there, there will be a new variant on the scene?! It seems that for the foreseeable, we are destined to catch Covid and hope the treatment system works for us.

From the Lord Kamall Parliamentary Under Secretary of State for Innovation (Lords)
39 Victoria Street London SW1H 0EU
5 April 2022

Your Ref: NE56305 PO-1398064
The Rt Hon Nigel Evans MP
By email to: evansn@parliament.uk
Dear Nigel,
Thank you for your correspondence of 14 March on behalf of a number of your constituents about COVID-19 treatments.
I am grateful to you for raising your constituents’ concerns.

Immunocompromised individuals are a priority group for research into therapeutic and prophylactic (preventative) treatments such as monoclonal antibody therapies, novel antivirals and repurposed compounds. Identifying effective new treatments is especially important for people who cannot take a vaccine for medical reasons, or for whom vaccines may be less effective.

The prophylactic monoclonal antibody treatment Evusheld is a mixture of tixagevimab and cilgavimab. It received a conditional marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) on 17 March.
However, the Evusheld trial took place before the emergence of the Omicron variant. This means there is not yet enough data to know how effective Evusheld is against Omicron, or the duration of any effects it may have against this variant. The MHRA will continue to work to establish this.

The UK Health Security Agency is also carrying out further testing on Evusheld’s effectiveness against this variant. The results of these tests will help inform any decisions on the next steps for this treatment, including procurement.

The RAPID C-19 collaboration has enabled multi-agency oversight of national and international trial evidence as it emerges for potential treatments and promising prophylactic therapies. This collaboration reviews all promising compounds to assess whether these should be considered for use in the NHS.

To date, the evidence has most strongly supported treatment rather than prophylaxis. The evidence on preventative therapies will continue to be reviewed to ensure efficacy and safety.

Non-hospitalised individuals who are in the highest risk group and receive a positive COVID-19 test result are able to access treatments. Eligible patients who receive a positive test result will be contacted by a clinician from a COVID Medicines Delivery Unit to discuss what treatments would be most suitable for them. This could be either sotrovimab or nirmatrelvir with ritonavir (Paxlovid), and those who are unable to receive these treatments will be offered remdesivir (Veklury) and then molnupiravir.
Further information on COVID-19 treatments, including monoclonal antibody and antiviral treatments, can be found at CAS - Coronavirus (COVID-19) Alerts.

I hope this reply is helpful.
LORD KAMALL

2 Likes
132

I’ve read the MHRA announcement again - it doesn’t mention the approval being conditional. I think this is primarily a political decision.

3 Likes
133

I am shocked and angry about that Lord Kamall letter and have so many questions from a variety of perspectives. Think I will sleep on it before I react. I do agree this is almost certainly a political decision with the Govt not wanting to fund the cost of Evusheld but would like to understand if other scientists agree with the “scientific”conclusion in the letter from RAPID C19 collaboration etc (@Adrian have you see the letter posted above?)

3 Likes
134

Hi @davecpep I will copy your post to @BloodCancerUK, I do not know what to say

2 Likes
135

In vitro evidence of efficacy now confirmed in vivo……

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

3 Likes
136

Hi Dave
Having read the Astra Zeneca article nothing surprises me with the pathetic excuses this government comes up with to deny so many people the chance of a near normal life again .
Clearly this is down to money . They quote the efficacy of the jabs unfortunately in a fair proportion of the immunosuppressed the jabs do not build antibodies and we are out on a limb again .
Hopefully your petition to parliament will gather momentum and they will have to rake note . Thankyou for all you are doing to bring it to their attention

6 Likes
137

Looks like we will have to continue to wear our stand back I’m shielding badge, face masks and having more vaccines even though we don’t know if we have any antibodies or T cells. I guess 500,000 people doesn’t win an election.

5 Likes
138

I think there is a question mark over its head as to whether its that effective against omicron B too which won’t encourage government to order any sadly

1 Like
139

Hi Folks,

Very interesting contributions on this thread…

Just put a callout to my FB friends to sign the petition

Fund Evusheld the preventative COVID19 antibody for immunocompromised - Petitions (parliament.uk)

From what I have read in this thread, Evusheld is effective against all variants.
With the NHS up to its tonsils in Covid patients, it seems like a no brainer to me!

Have just written to my MP too, so thanks for the useful info.

6 Likes
140

I have put the petition up on a forum that I’m a moderator on
Hopefully get a few more sign ups

7 Likes
141

Lord Mendelsohn asked a written question in Parliament about Evusheld. Here is Lord Kamall’s latest answer - I note the heavier hint on cost effectiveness , that’s what I suspect the real issue is here

3 Likes
142

@CaroleCW @davecpep
Yes, I wonder how they measure cost effectiveness? Is it comparing Evusheld against:

  1. cost of successful post-infection treatment with anti-virals; or
  2. cost of post-infection treatment if anti-virals not given on time or are unsuccessful?

(2) seems to be an increasingly likely outcome for too many immunocompromised people due to the unsustainable pressure on the NHS.

The BMJ has published a very interesting article (Should we be clinically assessing antibody responses to covid vaccines in immunocompromised people? | The BMJ) suggesting that antibody testing should be used to find immunocompromised people who haven’t responded to the vaccine. The testing would be done as a screening process after vaccination. They suggest Evusheld could be given to those people rather than giving all 500,000 of us Evusheld. Potentially a more cost effective approach.

They also say that if an antibody test showed that some immunocompromised people have had an immune response to the 4 dose regime, then they should be confident that the 5th dose would also give them protection. For those with a response of “undetermined significance” and with an “intermediate risk”, the BMJ suggest that they could be prioritised for therapeutic treatment, thereby reducing the toll on the NHS.

This article gives me hope that common sense should prevail soon.

5 Likes