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

I am one of the lucky ones who managed to get my third vaccine, and I’m grateful for it. It is also reassuring to know that various antibody treatment are coming on stream should you be unlucky enough to catch covid. I wonder, though,if anyone else is anxiously awaiting news of the AstraZeneca antibody jab which the PROVENT study showed could be highly effective? With the uncertainty around the efficacy of the vaccines for people with blood cancer, the possibility of a jab which directly introduces covid antibodies into the system rather than relying on the body to produce these, as vaccines do, seems to be potentially a game changer. As I understand it, application has been made for approval by the MHRA. Does anyone know how the process works and what the likely timescales might be? If it gained approval, would it then need to go to the JCVI, though I guess it’s not actually a vaccine? Thanks for your help.

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Hi @davecpep good questions, no answers for me, I await others.
Look after yourself

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I don’t think that’s been fully launched yet but don’t quote me. It will certainly make life easier for the likes of us when it’s available.

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Hi @davecpep, thank you for starting this thread, you’re certainly not alone in your questions around this. AstraZeneca have shared data with the MHRA but the MHRA are yet to come to a decision on this. We are not aware at this stage as to what is causing the delay, but Blood Cancer UK is in close communication with AstraZeneca in order to support the review process in any way we can. While we wait to hear from the MHRA around their decision around this, we are calling for the government to give a clear idea for the roll out procedures of available antiviral and Monoclonal antibody treatments for Covid, both as preventative and post-exposure treatments for immunocompromised individuals, and are campaigning for clearer timelines around this. We want to ensure that the best available treatments are available for blood cancer patients.

You may find this page of our website helpful to read through – Antibody treatments for people with blood cancer | Blood Cancer UK. We continue to monitor the situation and will keep the blood cancer community updated as we learn more.

You might also find it useful to read our new article published yesterday - Antivirals and monoclonal antibodies – what’s the difference? | Blood Cancer UK.

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Thank you for all the work you are doing on behalf of the Blood Cancer community both publicly and behind the scenes. I am keen for this to be rolled out and accessed easily as I am due to start treatment early next year and preventative medication would help ease the stress of Covid enormously.

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I am immunosuppressed as a result of my blood cancer type, and from reading information on this site, I am likely to have received little or no antibody protection benefit from my 2 previous vaccinations.
These circumstances have been addressed on this site, and the conclusion was that Monoclonal antibody vaccinations now under test would give far more reliable protection in a booster jab.
The government is now proposing to give sufferers like myself a booster jab of the same type of vaccine that has already been proved not to produce antibodies in cases like mine.

Not only is this likely to be useless, but it is stated that another booster cannot be administered within the following 6 months. So, if monoclonal antibody vaccinations are available by the end of this year as hoped, I won’t be able to have it.

There is never a mention of the this monoclonal development by the government, I wonder why, could it possibly be they are not keen on us knowing of it’s potential?

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Surely a monoclonal antibody treatment cannot be called a booster??

It is a first-time injection or infusion of antibodies.

The Government might add that it is likely to be very expensive. We might have to end up by clubbing together and getting Roche to sell some to us!! Otherwise, we will have to shield for a very long time.

Jumbo4

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Hi @MANS643 a great big welcome, yes, I think you have voiced what so many of us are thinking.
Personally, not medically trained, I think I agree with @jumbo4 that monoclonal antibody treatment cannot be called a booster.
However perhaps a reliable antibody test is required whether we have had 2 or 3 vaccinations before we know if monoclonal antibody treatment is required.
I am as confused as everyone else.

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Hello Mans643 welcome. Yes it is all of a minefield isn’t it! I think the idea of the third vaccine is the belief a third one may be effective to “kick start” compromised immune systems that have struggled to respond on two doses, thought to be effective particularly if it is a mRNA based vaccine like Pfizer. The monoclonal antibody is as others said an alternative and different to the vaccines in administering manufactured antibodies direct into the blood system with the benefit our compromised immune systems haven’t got to be asked to produce anything. I believe the Astra Zeneca treatment of this is now up for approval, how long that may take who knows, and yes I do believe it is expensive treatment.
It is a confusing time, we want the help out there but it is difficult to get direction as there are so many ifs on what’s available, to who and when!! At least we all have empathy with each other and usually good medical teams we deal with as well as all the excellent help from BCUK.

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It’s a very complicated issue and not an exact science but I can fully understand the anxiety. I’m a patient participant in the Rudy study at Oxford University and provide them with blood samples. They tell me what the outcome of their tests is and suggested that I’ve had quite good protection on both an antibody an t-cell basis.

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@Franko that’s good news and you know about your antibodies and t-cell responses too.

Whether the Monoclonal treatment is called a “booster” or not, would we be able to have it if we have had the proposed 3rd vaccination?

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Hi @MANS643 another good question and dilemma which we need to know before we go ahead with a 3rd vaccine, if we are offered it!!!

Having just watched the televised briefing on the booster jab plans and the Health Secretary’s House of Commons statement, I am, predictably, none the wiser regarding Monoclonal possibilities.

My only option is to take the 3rd or booster vaccination, whichever you choose to call it, and hope I get some protection. Of course I will never know if I have, as there are no tests available.

Keep smiling

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Oh I’m smiling @MANS643 you word it so well

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I like Franko am part Rudy study at Oxford University and provide them with blood samples. And again like Franko They tell me what the outcome of their tests is and suggested that I’ve had quite good protection on both an antibody an t-cell basis.

I have MM and I am starting my Stem Cell Transplant Monday Oct 20 which will kill the anti bodies etc. But I will be asking for the first vaccine before I leave hospital.

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Hi @AndyMeer great to hear from you again and that you are on the Oxford Rudy study.
I am glad that you have a date for your stem cell transplant. Scary times. There is a post on this forum here for people undertaking stem cell transplants where people are sharing their experiences.
Please let us know how you get on.

Hi @MANS643 and welcome to the forum. We totally understand the confusion and lack of information around the 3rd vaccine, booster vaccine and monoclonal antibody treatment.

The UK government has announced that severely immunosuppressed adults and children aged 12 and over will get a third dose of the covid vaccine this autumn.

The third dose is for people who had weakened immune systems at the time of their first or second vaccination, and who might not have produced enough antibodies from the vaccine. The third dose is part of the primary treatment and aims to increase the level of immunity gained from the vaccine. Please note that this is different from the booster jab, which other vulnerable groups are being offered, and which aims to extend the length of time the protection lasts. People who get a third dose of the vaccine this autumn may also get a booster vaccination in around six months’ time, but this hasn’t been confirmed.

The group offered a third dose includes people who:
• are having treatment for blood cancer, or are in remission after having treatment in the previous 12 months
• had either an allogeneic or autologous stem cell transplant in the previous 24 months
• had a stem cell transplant more than 24 months before, but had ongoing immunity issues
• are on watch and wait (active monitoring) for any type of blood cancer.

We’ve been assured that there is room for clinical judgement on who gets the third dose. So groups that aren’t specifically mentioned in the guidance but are considered to be at high risk can get a third dose.

The government has also announced that a vaccine booster programme is starting in September 2021 across the UK. This is a separate programme from the third dose for severely immunosuppressed people (see above).

The booster programme aims to extend the protection that people with healthy immune systems have already gained from their first and second doses. The same priority groups that were used for the vaccine roll-out will be used for the booster programme, with added flexibility on timing to make sure that people get their booster six months after their second dose.

The groups offered a booster include:
• Anyone ‘clinically extremely vulnerable’ or ‘clinically vulnerable’ who doesn’t have immunosuppression (because anyone with immunosuppression should be given a third primary dose instead - see above).
• Household contacts and unpaid carers (aged 16 or over) of people with blood cancer (household contacts and unpaid carers aged 12-15 won’t be offered a booster yet, if they’ve only had their second dose recently).
• those living in residential care homes for older adults
• all adults aged 50 years or over
• frontline health and social care workers

It is advised that the third primary dose should ideally be given at least 8 weeks after the second dose – although special attention should be paid to current or planned immunosuppressive therapies. The booster will be offered no earlier than 6 months after completion of the primary vaccine course.

For more information about the third dose and/or the booster, visit our webpage How to get a covid vaccine if you have blood cancer | Blood Cancer UK

With reference to Monoclonal antibody treatment from AstraZeneca (PROVENT trial). AstraZeneca have said they will now prepare 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 how to roll out this medicine to people in the UK. We haven’t got the details about how this will be administered and the gap from last dose of vaccine to Monoclonal antibody treatment.

We will monitor this closely and update our information as soon as we hear more, but this is positive news for people with blood cancer.

We hope this is helpful to you, but please do remember, our Support Services Team are always here if there’s anything you’d like to talk through further: Blood cancer information and support by phone and email | Blood Cancer UK

Best Wishes
Bav

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I would rather just have the antibody injection even if I had to try and pay for it.

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I would be willing pay for anything that will give me protection. I have already paid for 2 antibody tests which apparently are not available through the NHS. The first test showed I had no antibodies at all. The second showed I had between 0.8 and 5 which is very weak and not enough to give protection. My GP is less than helpful and couldn’t answer any of my questions. He actually said I could get run over by a bus when I asked what is likely to happen if I catch covid and should I be going the places I have been to recently.

He has given me false information about the flu vaccine. I was supposed to have one today but I cancelled it because he said if I had it I wouldn’t be able to have the vovid vaccine for 7 days. He couldn’t tell me when I would be able to have the covid jab but I wasn’t prepared to risk not being able to have it ASAP. I told him the government are are impending having both together but he said the latest information he had was to leave a 7 day gap. I am seeing my hospital consultant on Tuesday so hopefully I will get better information from him.

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