Evusheld Has anybody heard when and where we can get it.

[johnliston]

I'd like to be able to get it before Christmas. And once you have the shot how long before you have protection?

john

[neurodervish]

My CLL specialist said I would be able to get it through his office. My understanding (from fda.gov/media/154701/download ) about how long it's good for is:

"Repeat Dosing Longer term data from the study PROVENT indicate that EVUSHELD may be effective for preexposure prophylaxis for 6 months post-administration [see Clinical Studies (14)]. While SARS-CoV-2 remains in circulation, individuals who qualify for EVUSHELD, per the conditions of the EUA, can be redosed every 6 months."

[OaktownN in reply to neurodervish]

If I may ask, where are you located and who is your Dr. Thanks!!

[neurodervish in reply to OaktownN]

I messaged you. I'm in Oregon. They're still waiting for doses, but he has let me know I'll be eligible as soon as they get it. The NBC news report suggests that "The first doses should be available “very soon,” with all doses delivered in a few months..." Hopefully we won't have to wait as long as we did for the vaccine!

[clljon in reply to neurodervish]

I’m in Oregon as well. I’m with Dr Spurgeon at OHSU. Any luck getting Evusheld? I’m still looking.

[Pin57 in reply to clljon]

Checkout this federal website locator … the far right columns shows how many Evusheld per pharmacy location per state.

healthdata.gov/Health/COVID...

[neurodervish in reply to clljon]

I just messaged you.

[Jonquiljo]

Can we get vaccines If we get injected with Evushield? The double protection would be ideal.

[johnliston in reply to Jonquiljo]

I think the clinical trial patients were allowed to get vaccines, but not before they started the trial. I'm hoping to get protection from both Evusheld and IVIG

john

[gardening-girl]

john, the Evusheld will be administered as two separate consecutive intramuscular (IM) injections (thankfully corrected by SeymourB ) which will be absorbed and in circulation within a few hours, but it may take a few days to reach peak concentration in the blood. If administered by IV it would be in circulation within seconds. In terms of how soon it would reach nasal and lung tissue, I haven't seen that data, but for the Regen-CoV (the casirivimab and imdevimab cocktail) a reduction in viral load as determined by nasal swab was seen within 48 hours.

[SeymourB in reply to gardening-girl]

gardening-girl -

I believe it's actually intramuscular into the gluteal muscles (butt cheeks), with tixagevimab in one cheek, and cilgavimab in the other.

fda.gov/media/154701/download

=seymour=

[gardening-girl in reply to SeymourB]

Thank you Seymour! I've corrected my post!

[E-Lynn]

I wonder when it will be available. Right now it's just emergency approval.

[E-Lynn in reply to E-Lynn]

And people should get vaccinated as well!! We all need all the help we can get, for ourselves and especially for each other. I'm horrified that some states that were anti-vax and anti-mask have offered unlimited monclonal antibody drive-in treatment, while making the vax political.

[SeymourB in reply to E-Lynn]

E-Lynn -

The FDA's Emergency AUthorization (EUA) means that it is legal to be given in the US. All of the vaccines, antiviral, and monoclonal antibody drugs were original also allowed under EUAs.

What remains are logistics of shipping, and policies set by each clinic that decides to order the drug from AstraZeneca distributors. It might take weeks. I don't think most clinics see this as being as urgent as we do.

I suggest that you ask your oncologist first, as they are likely to see more of the target population of immune compromised people than your GP might. My oncologist office had not heard of it as of Thursday. I think I primed the pump, though, and I'll call again next week.

=seymour=

[bennevisplace]

Background for readers fiercepharma.com/pharma/ast...

Evusheld is not yet approved in the UK and it seems the government has cancelled the pre-order of 1 million doses.

If given by IV protection should be more or less instantaneous and good for 6 months plus, with the major caveat that nobody knows how effective the drug is against Omicron.

[SeymourB in reply to bennevisplace]

bennevisplace -

re: UK approval

I do hope NHS reconsiders Evusheld. I hope that the pre-order was cancelled only because of a temporary decline in cases months ago. I also hope that AZ can ramp up production quickly.

re: IV administration

It's only 150mg of each drug, so it's done by intramuscular injection. That opens up many more possible sites, and should make scheduling easier.

There is a notice of some cardiovascular risk on the FDA EUA Healthcare Provider document that may cause some hesitation:

fda.gov/media/154701/download

"In PROVENT there was a higher rate of cardiovascular serious adverse events (SAEs), including myocardial infarction (one fatal SAE) and cardiac failure, in subjects who received EVUSHELD compared to placebo [see Adverse Reactions (6.1)]. All subjects who experienced cardiac SAEs had cardiac risk factors and/or a prior history of cardiovascular disease, and there was no clear temporal pattern. A causal relationship between EVUSHELD and these events has not been established. There was no signal for cardiac toxicity or thrombotic events identified in the nonclinical studies."

In the PROVENT trial, there were 8 myocardial infarctions in EVUSHELD group, but only 1 in the placebo group, with twice as many participants in the PROVENT group as the placebo group. N=5,197 total participants.

See Table 3 on page 8 in the above Healthcare Provider document.

Yet, in that document, in the STORM CHASER study, no such cardiovascular risk was seen:

"In STORM CHASER (N= 1,121) no cardiac SAEs were reported (median follow-up approximately 6 months)."

I suspect there were different participant demographics.

PROVENT was pre-exposure. STORM CHASER was post-exposure.

PROVENT had roughly 5 times as many participants as STORM CHASER.

I don't see much difference in the exclusion or inclusion criteria between the 2 studies on clinicaltrials.gov

PROVENT

clinicaltrials.gov/ct2/show...

STORM CHASER

clinicaltrials.gov/ct2/show...

The study results haven't been published or pre-printed yet.

re: Omicron

I keep the AstraZeneca press-release page open, and refresh it occasionally.

astrazeneca.com/media-centr...

Their December 8, 2021 release said:

"Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant. "

[bennevisplace in reply to SeymourB]

Thanks for the additional info. I should have remembered it's an injection.

It's not clear to me what's going on with Evusheld in the UK. 1/2 to 1 million people with weakened immune systems are waiting to hear. Informed doctors are waiting to hear. According to dailymail.co.uk/news/articl... the UK government has ordered 1 million doses, giving the impression that it's just a matter of the MHRA waving the drug through to marketing authorisation.

But has anyone seen a statement that AZ has even submitted an application? I suspect that behind the scenes there's some horse trading, with price one issue and efficacy against Omicron another, and that the government order was always conditional. Cancellation of the order was reported 7 months ago by Bloomberg, see link in healthunlocked.com/cllsuppo....

[Chemtrails-USA]

If one contracts COVID after getting Evusheld, are treatment options more limited? Regeneron? - Bobby