Breaking News! The AZD7442 PROVENT Phase III Prophylaxis Trial met its primary endpoint in preventing symptomatic COVID-19!

[bkoffman]

Clinical Trial Breaking News Today! CLL Society is delighted to share today's readout from the AZD7442 PROVENT Phase III Prophylaxis Trial, which met its primary endpoint in preventing symptomatic COVID-19 in a study group in which over 75% of participants had co-morbidities, including conditions that have been reported to cause impaired immune response to vaccination. In vitro data suggest it will be effective against the delta strain. Dr. Koffman was a participant in this trial. This offers hope for the many CLL patients who are not well protected by vaccinations. Please read Dr. Koffman's write-up here. cllsociety.org/2021/08/azd7...

[DRM18]

Wow, beautiful! … So, what does this mean—when might it become available?

[bkoffman CLL CURE Hero in reply to DRM18]

6 months?

[HopeRose]

Great news, indeed!! It brings hope and joy!

[Elle_V]

Exciting and wonderful news! Hope it becomes available soon!

[DRM18 in reply to Elle_V]

Yeah. I asked about that myself. I’m glad it protects against Delta, but, if it’s not gonna be widely available for, like, 3 years, then, well …

[DriedSeaweed in reply to DRM18]

Perhaps emergency use authorization?

[DRM18 in reply to DriedSeaweed]

Hope so! It’s a mystery lol!

[bkoffman CLL CURE Hero in reply to DRM18]

Hopefully 6 months, maybe sooner.

[Davidcara in reply to bkoffman]

Hello, any update about what is happening with this?

[Eucalyptus22]

Best news I've heard in a very long time. Given me quite a lift. 😀

[Psmithuk]

🤞🤞🤞🤞🤞 Though it isn’t likely to happen in the UK I imagine.

Cx

[mrsjsmith in reply to Psmithuk]

I live in hope Chris,

The trial took place in England and parts of Europe as well as a number of sites in the USA. 🤞

Colette

[Psmithuk in reply to mrsjsmith]

Now that cheers me up! Thank you 🙂Cx

[DriedSeaweed in reply to Psmithuk]

AstraZeneca. UK should be good.

[Psmithuk in reply to DriedSeaweed]

Hope so!Cx

[Fran57 in reply to Psmithuk]

Hopefully, yes. Sajid Javid announced it too.🤞🏻Fran 😉

[bennevisplace in reply to Psmithuk]

Astrazeneca has applied for marketing authorisation in the UK. I imagine the MHRA could process this within 2 months if prioritised. It's a big 'if' though.

[Mystic75]

Awesome news!!

[dmmck]

What exciting news!! Thank you.

[Raquel22]

Just need to keep being extra careful for the next 6 months then hopefully our anxieties may lighten a little.This is fabulous news for all the immune compromised.

I have a little hope for the future! Well done to all who were involved with this break through. 😁

[Getlucky]

Thank you for this wonderful news!!

[bennevisplace]

This is great news for us. AZ has applied for marketing authorisation in the UK, don't know about elsewhere.

Edit: Having read AZ's press release I doubt they have yet submitted an application.

[KMac1969]

That is awesome news..

[Doremefasol]

I could have bet that Dr. Koffman would be a participant in that trial.

[bkoffman CLL CURE Hero in reply to Doremefasol]

Never miss a chance to dedicate my body to science. LOL.

[Doremefasol in reply to bkoffman]

Yes, LOL indeed.

[SueTG in reply to bkoffman]

...and your efforts are sincerely appreciated...

[Wpooh]

I keep on hearing that antibodies are a small part of our immune defense and therefore it is is difficult to interpret different levels of spike protein antibodies. Does this disprove that approach, as the simple addition of antibodies does have this very significant effect?

[bkoffman CLL CURE Hero in reply to Wpooh]

They are not mutually exclusive. Great antibodies reduce 3/4 of symptomatic disease, but not all of it and immunity is still multi-layered.

[Monetfan2017]

Terrific news. Please clarify how such a prophylaxis is different from current approved preventive monoclonal antibodies (Regeneron, etc).

[bkoffman CLL CURE Hero in reply to Monetfan2017]

AZD7442 was studied pre-exposure, Regen-Cov is only authorized post-exposure or if test positive early in the disease.

[CLLerinOz Administrator Volunteer in reply to bkoffman]

Hi Brian, Not being in the US, I may have misunderstood but I took it from Regeneron Pharmaceuticals' recent press release that their authorisation has been extended to include prophylactic use of REGEN-COV in certain circumstances and for certain patients there.

healthunlocked.com/cllsuppo...

I guess the caveat on the prophylactic use is that it has to be 'post-exposure' not just because of an immunocompromised condition.

[bkoffman CLL CURE Hero in reply to CLLerinOz]

Correct

[CLLerinOz Administrator Volunteer in reply to bkoffman]

👍

[Doremefasol in reply to CLLerinOz]

You are always correct and have most interesting posts.

[bkoffman CLL CURE Hero]

It's been in front of the FDA for review for a couple weeks. I have written to and received encouraging response from decision makers at the FDA.

Hoping the JAMA article where I am featured: Monoclonal Antibodies for COVID-19 Pre-exposure Prophylaxis Can’t Come Fast Enough for Some People [cllsociety.org/2021/10/mono...] will help.

Also trying to get the word out in the general press through interviews and OP/EDs.

Even if gets EUA, there is still much work to do with the CDC, the White House, AZ and others. We need to get the word out and make sure first it gets authorized and then is available for us.

CLL Society is working with LLS and LRF and many other organizations and individuals advocating to make this happen.

Stay strong, we are all in this together

Brian

[Davidcara in reply to bkoffman]

Thanks for the update