Evusheld and risk

[naddude]

Hi. I read that there is little evidence of the effectiveness of Evusheld and there is a degree of risk for side effects such as cardiac incidents. I have moderately severe vascular disease, so I was wondering if the risks out weigh the efficacy of the drug or vice versa. Any thoughts?

[AussieNeil Administrator]

Where are you hearing "that there is little evidence of the effectiveness of Evusheld"? Can you share any references? This maintained pinned post notes that FDA approved doubling the Evusheld dose so that it would continue to maintain effectiveness against Omicron variants. Also, very recent FDA advice is that effectiveness is still maintained on that dose provided a booster shot is given after 6 months:

healthunlocked.com/cllsuppo...

With respect to cardiac risk, that's something you should discuss with your cardiologist.

Neil

[naddude in reply to AussieNeil]

Hi Neil: there is an increased risk of bleeding with Evusheld and having it may disqualify us from other antivirals such as paxloid. What are your thoughts on that?

[AussieNeil Administrator in reply to naddude]

It would help if you provided a reference about the claimed increased bleeding risk, because I can't find one, e.g. no mention of bleeding in drugs.com/sfx/evusheld-side... That does note that "All patients who experienced cardiac serious adverse events had cardiac risk factors and/or history of cardiovascular disease at baseline."

[CLLerinOz Administrator Volunteer in reply to AussieNeil]

I found this statement on the Australian TGA information sheet for Evusheld:

“Clinically significant bleeding disorders

As with any other intramuscular injections, EVUSHELD should be given with caution to patients with thrombocytopenia or any coagulation disorder”

tga.gov.au/sites/default/fi...

So, that’s nothing Evusheld specific as such, is my reading.

[AussieNeil Administrator in reply to CLLerinOz]

Thank you CLLerinOZ,

That phrase"As with any other intramuscular injection" clarifies that the risk is from the administration process possibly puncturing a blood vessel and not from the effect of the Evusheld monoclonal antibodies.

naddude, I'm also unable to find any mention of COVID-19 antivirals being contraindicated if you've had Evusheld and I know of cases where people have had both. Again, can you provide a reference about this concern?

Neil

[Mijoed]

This letter below should address the question about efficacy. Personally, I have had Evusheld on the trial. Once in Jan 21 and again in Feb 22. Both were the standard dose 150 ml and I remain Covid free. Over the last 4 - 5 months, I have been getting on with life as normal…ie not shielding.

A very recent letter from Astra Zeneca CEO or his department. It is related to government purchase excuses in the UK.

Dear Mr *******

Thank you for reaching out. We have provided all the necessary data since a little while, showing Evusheld remains active against new variants, including the most recent BA4 and BA5. This data was independently produced by two independent laboratories: the FDA (Food and Drug Administration in the US) and Oxford University.

Evusheld has been bought by 26 countries including the US, Canada, Australia, European countries and many other countries around the world, including developing countries.

The data showing continued efficacy against new variants has also been provided to them.

Each country has to make their own decision as it relates to how they deploy their healthcare budget and we of course fully respect the decision made in the U.K.

[Mijoed]

5197 people were recruited in the trial in a 2:1 ratio of treatment vs placaebo. 8 deaths occurred with one being due to myocadial infarction. These were determined to be unrelated to Evusheld.I don’t have any real world info from after they started using this post trial.

Eight deaths occurred; two deaths (both in the placebo group) were assessed by the adjudication committee and were confirmed by testing as being related to Covid-19 (Table 2). The other deaths were the result of illicit-drug overdose (in 4 participants [0.1%], 2 each in the AZD7442 and placebo groups), myocardial infarction (in 1 participant [<0.1%] in the AZD7442 group), and renal failure (in 1 participant [<0.1%] in the AZD7442 group). All the deaths were assessed by the site investigators as being unrelated to AZD7442 or placebo.

[KatieBlue in reply to Mijoed]

To be fair, the initial trial took place during Delta. Efficacy during Delta was in the 77-83% range and efficacy against micron variants has been further reduced to varying degrees.

That said, if they will still administer it next month when I’m due back, I will go in for it. But that doesn’t mean I will change any of the other mitigations I’ve undertaken to avoid covid.

[Mijoed in reply to KatieBlue]

I had the original standard dose and still remain free of any version of Covid / Omicron. I was careful last year but have got on with life this year. It is also reassuring that antivirals exist just in case.

[KatieBlue in reply to Mijoed]

I know someone who isn’t vaccinated, does not mask, travels extensively, and remains covid free. He doesn’t have evusheld, so is unable to attribute remaining covid free to it.

Antivirals have contraindications, any covid infection can expose oneself to long covid.

There is real concern out there that the virus isn’t too far from completely evading the vaccines, evading the monoclonals, evading the antivirals, as well as increasing transmissibility and lethality.

As an aside, the “have got on with life comments I see seem to imply that those who remain cautious somehow aren’t “living their life.”

The tendency these days has been to say “you do you,” which is the antithesis of public health. Unfortunately, public health leaders/agencies have more or less opted to leave it up to individuals to assess each one’s own risk, without providing accurate information in order to make informed decisions. Rest in peace, PH. You had a good run while it lasted.

[Cllsller]

I went on a short vacation to San Diego last month with my husband, kids and grandsons. Upon arriving back in Colorado, most of them got Covid. My husband and I did not; I think the reason is because I had Evusheld. (My husband had it a few months ago and was negative) I totally believe it works.

[1935husband]

I received Evusheld in April, got Covid in late June and got monoclonal antibodies within 2 days. I would say that I had a mild case and except for a little coughing have recovered.I’m still on Ibrutinib and except for WBC at 15, all other blood work is normal.

[LovecuresCLL]

My immunoglobulin levels are normal and my Covid antibody levels are high and my oncologist said I do not fit the criteria to receive it. But it was a consideration at one point to protect me from getting Covid again. Just FYI.

[Doggoneit101]

My aunt whom has a CLL diagnosis and a mechanic heart valve ( takes warfarin) recently received her Evusheld. the oncologist cleared it with her cardiologist group. We both actually got 2 injections each that day of Evusheld. It was recommended by our oncologist that we both be covered so if we do test positive hopefully we won't end up hospitalized or deathly ill. I think you should probably talk to your cardiologist for clarification on your particular medical situation. Best of luck to you.