AZD 7442 and Third Covid Jab

[Clairdensheil]

I'd like to find out what I can about AZD 7442 Provent as a preventative measure, and about people's experience in getting the Covid third jab. Thank you!

[cajunjeff]

Provent is the name of the clinical trial for AZD 7442. AZD 7442 are longlasting monoclonal antibodies (mabs) designed from B cells of recovering covid patients.

The phase 3 trial for AZD 7442 was successful and it is expected the maker of the drug will soon apply for emergency use authorization. I don’t know of any way to get AZD until it gets EU approval. It is the type of drug that those of us who can’t make antibodies can use.

I assume people with Cll who benefitted from their vaccines should get the boosters. Some on here who took the vaccines and had no antibody response have developed antibodies in response to the booster so it’s probably worth trying. My guess is most who did not respond to vaccine will not respond to booster.

I think as a general rule everyone with Cll should rely on their doctors advice for vaccines since we are all so different.

[Clairdensheil in reply to cajunjeff]

Thanks very much. I've heard that it may be available to those with Covid, but that there's less certainly over it being given preventatively. Let's hope that if the trial continues to give positive results it will become open to all who may benefit.

[cajunjeff in reply to Clairdensheil]

I think it is designed to be used preventatively and the approval being sought will include preventive use.

Supply might certainly be an issue early on. I would argue that those of us who can show no antibody response to the vaccines should be first in line.

[Clairdensheil]

Yes that would be good. Here's hoping there's something positive as soon as possible.

[SlowCLL]

The following is the CLL Society's post on this.

AZD7442 PROVENT Phase III Prophylaxis Trial Met Primary UpdatesAugust 20, 2021

This content was current as of the date it was released. In science and medicine, information is constantly changing and may become out-of-date as new data emerge.

This is huge news.

This is the first study to show that pre-exposure prophylaxis, (PReP), with a mix of a long acting intramuscular (IM) injection of anti-COVID-19 monoclonal antibodies (AZD7442) is not only protective, significantly, it is protective in a high-risk population where “more than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination”.

There was a 77% reduction versus placebo in symptomatic COVID-19 with no deaths or severe disease in the active arm.

Side effects were similar between the placebo and active drug.

In “vitro” data suggest it will be effective against the delta strain. And early results seem to say that it doesn’t interfere with vaccine response. The one time “shots” given IM in the buttocks provide six to twelve months of protection.

Here is a link to background information on the trial we published back in March: Phase III Double-Blind, Placebo-Controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adults. (PROVENT): Worth Considering for Any Chronic Lymphocytic Leukemia (CLL) Patient

For more on the trial results, see the official press release: AZD7442 PROVENT Phase III Prophylaxis Trial Met Primary Endpoint in Preventing COVID-19.

This passive immunity prophylaxis offers hope for the many CLL patients who may not be well protected by vaccinations, even with a booster shot.

In full disclosure, I enrolled in this trial, and I am thrilled with this news. We are eagerly awaiting the full results.

Stay strong. We are all in this together.

Brian Koffman MDCM (retired) MS Ed

Co-Founder, Executive VP and Chief Medical Officer

CLL Society, Inc.

[bennevisplace]

Hi, indeed AZD7442 performed well as a pre-exposure prophylactic, based on the interim results of the PROVENT trial released in August. (In common with other monoclonals, AZD7442 did much less well as a treatment for patients already sick with Covid). As to when it will become generally available, one can only speculate at this stage.

But I do like to speculate (apologies to Admins).

It could be that Astrazeneca is now preparing a submission for emergency use in the US, to have their EUA in the next month or two...

{{BTW, which country are you in?}}

...Recently however I read a quote from Astra implying they were going to wait until they have 12 months of data, which makes sense if they are still pitching the drug as providing long-term protection: Astra previously estimated 6-12 months.

Without its confirmed Long-Acting credentials AZD7442 would be in competition with two-three other monoclonals that are already approved and in use. It would be similar in the European Union. 12 months data would mean the earliest they could obtain an EUA in the US would be January, but commercially Astra may see that as their best shot.

I would be very happy to read others' views.

[Clairdensheil in reply to bennevisplace]

Thank you very much. I'm in the UK. I'm very interested in anyone's speculation if it's allowed! Can you tell me what the other monoclonal antibodies approved and in use are? Are they used in the same way as AZD 7442 and are they as effective? Have they been used as prophylaxis? I hope you don't mind all the questions but I'm a bit behind on this one.

[bennevisplace in reply to Clairdensheil]

Well, the only monoclonal antibody (mAb for short) currently approved for use in the UK is Ronapreve, from the US company Regeneron. Under the name Regn-Cov, this drug has been in used to treat Covid in the States for 10 months or so (the President being among the first recipients). In the UK it was approved a month ago and the first patient received it last week. It will be used to treat patients without antibodies to SARS CoV-2 who are either aged 50 and over, or are aged 12 to 49 and are considered to be immunocompromised.

Antibody testing will first be used to determine whether patients are seronegative, meaning those who do not have an adequate existing antibody response, and will therefore receive the treatment. gov.uk/government/news/thou...

To gain maximum benefit from Ronapreve you have to catch Covid, have a PCR test to confirm it, get yourself admitted to hospital, and pass the no-antibodies test, all in the space of a few days. Ronapreve is not approved for pre-infection prophylaxis, the role AZD7442 may fulfill.

Another monoclonal to watch is Sotrovimab, from GSK-Vir. It has been approved in the USA, the EU and elsewhere, but not yet in the UK. Sotrovimab's USP is its superior resilience to evasion by new variants of the virus, but it is unlikely to compete with Ronapreve on price and in the UK that could seal its fate. More at healthunlocked.com/cllsuppo...

[Clairdensheil]

Thanks and best wishes to you all. The information is much appreciated. Very good to have the support.