Evusheld approved by FDA

[goingtotravel]

Didn't see this posted yet so thought it was worth passing along. DH and I have been anxiously awaiting this news since DH is on multiple immunosuppressive medications and probably got very little protection despite 3 full doses of the vaccine. He qualifies for this treatment according to the FDA guidelines. This treatment consists of injecting two monoclonal antibodies that are supposed to last 6 months and give protection to people who are on certain immunosuppressants and unable to get adequate responses from the vaccines. This is a pre-exposure treatment. not a treatment given after contracting COVID. Also, today AstraZeneca announced that this treatment works against the new variant too.

This link is the press announcement from the FDA:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure

This is an article from today discussing Omicron and these antibodies.

https://www.businesswire.com/news/home/20211216005736/en/EVUSHELD-long-acting-antibody-combination-retains-neutralizing-activity-against-Omicron-variant-in-independent-FDA-study

Edit: According to the last article there is a phase III trial now to give these antibodies post-exposure but the current EUA doesn't cover that treatment yet.

 

[Linney]

I have also been following the rollout of Evusheld as my DH is also immunocompromised and has little protection from covid despite getting 4 covid shots (2 shots of Pfizer + 2 boosters).

The following article on NY Times website talks about the rollout and the news isn't good: https://www.nytimes.com/2022/03/06/us/politics/evusheld-covid-treatment.html

NOTE!! This article is behind the NYT paywall, sorry! I don't know if it is available elsewhere. So here are some of the key points:

"High Demand for Drug to Prevent Covid in the Vulnerable, Yet Doses Go Unused"

"As much of the nation unmasks amid plummeting caseloads and fresh hope that the pandemic is fading, the Biden administration has insisted it will continue protecting the more than seven million Americans with weakened immune systems who remain vulnerable to Covid. Evusheld, which was developed by AstraZeneca with financial support from the federal government, is essential to its strategy."

"There is so much confusion about the drug among health care providers that roughly 80 percent of the available doses are sitting unused in warehouses and on pharmacy and hospital shelves"

"Interviews with doctors, patients and government officials suggest the reasons the drug is going unused are varied. Some patients and doctors do not know Evusheld exists. Some do not know where to get it. Government guidelines on who should be prioritized for the drug are scant. In some hospitals and medical centers, supplies are being reserved for patients at the highest risk"

"The Biden administration is trying to address the confusion. Top federal health officials have been working to raise awareness among state health officials, providers and patients."

"Some who cannot find a dose of Evusheld have turned to online communities instead of health care organizations. They are seeking help from other immunocompromised people, such as Dr. Vivian G. Cheung, a physician in Bethesda, Maryland. Dr. Cheung got a dose in January after calling various medical institutions for two weeks, and she has been helping others navigate the process since then. She receives up to 10 requests for help every day, but she estimates that only a quarter of those who have reached out have succeeded in getting Evusheld."

 

[audreyh1]

Well that’s exciting! I certainly hope it provides good protection for those immunocompromised since precautions are dropping everywhere.

Too bad about the total confusion in terms of distribution. There has to be a better way!

 

[Linney]

What follows is a personal story on Evusheld, in case it is helpful to someone else who has an immunocompromised family member or friend.

My DH is severely immunocompromised. People don't know unless he tells them -- he is active, physically robust and is otherwise exceptionally healthy. Respiratory illnesses are his nemesis and he's careful to avoid them.

So covid was BAD news. We had to isolate these past two years. Not just him to protect himself, but I had to isolate too. I'm super healthy but if I caught it (even if I sailed through the experience) and then transmitted it to him, there's a good chance it would land him in the hospital ICU. I've gone nearly crazy with the isolation and read Harlee's post on depression with much sympathy.

Enter Evusheld. The announcement back in December filled us with hope. A way out, finally! My DH immediately contacted his doctor and was told that his medical provider was using the lottery system since there were so many patients who needed Evusheld and only so many doses available. So we waited. And waited. In February, his provider left a voicemail saying that he would be called in soon for his Evusheld dose. They didn't call back.

Meanwhile, our state announced the impending end to mask mandates. DH decided to stop waiting and start being annoying. He talked to his doctor again ("What, you haven't gotten it yet?") He called, and called, and called, and finally got the name of the doctor in charge of the Evusheld rollout for his provider. "We're backlogged with patients, but because you called, we'll book you right now." And they did. My DH got his Evusheld dose a couple days ago. While it will take 3 weeks to reach full strength, I can already see the lightness in his step!

If you have an immunocompromised family member or dear friend, make sure they know about Evusheld so they can ask their doctor if they are a candidate. Be willing to listen when they're frustrated and angry at having to work so hard to get a dose, when the rest of the world is taking off their masks and moving on without them.

 

[audreyh1]

Thanks!

 

[Linney]

Well that’s exciting! I certainly hope it provides good protection for those immunocompromised since precautions are dropping everywhere.

Yes! Especially since Evusheld is 1 of only 2 authorized antibody therapies that show neutralizing activity against Omicron and all other variants of concern. There were concerns that Evusheld might not be as active against certain subvariants of Omicron BA.1 and BA.1.1, but it could be if the dosage were increased. So the FDA doubled the recommended dose as of Feb 25. My DH received the updated, higher dosage. No side effects except he slept longer than usual for a couple nights following the treatment.

Too bad about the total confusion in terms of distribution. There has to be a better way!

Yup, that's why I wanted to update this thread -- trying to get the word out!

 

[Act2]

Thank you for this info. An immunocompromised family member has been told about this as a result of this thread and his oncologist has ordered it for him. Good info!

 

[harllee]

Thanks for this information. DH has a call into his doctor about this.

 

[skyking1]

Great thread thank you all for posting and contributing
DW is on a biologic for RA and probably qualifies. I will let her know.

 

[Linney]

Here's an article about Evusheld that isn't behind a paywall. It references the NY Times article and talks about what needs to happen to address the distribution issues:

https://www.advisory.com/daily-briefing/2022/03/08/evusheld

Excerpt: "The recent flood of news about the Evusheld predicament is a very good thing. It brings this preventive treatment into the spotlight, and it can have a butterfly effect on how much effort is put into distilling out concise, clear, and consistent guidance about Evusheld's use. This is what happened with Covid-19 antivirals. What started out as a few news clips and discussions snowballed into wide-scale coverage and billions of dollars in funding. It's nowhere near perfect, but we are in a much better place to get antivirals to the patients who need them. The same can happen for Evusheld and immunocompromised patients, but there needs to be collective advocacy, outreach, and demands."

 

[Linney]

Cool website showing Evusheld availability -- by state, city and provider!

This was mentioned in the article I just linked above: "Government data sets about Evusheld’s availability were so complex and confusing that Rob Relyea, a software developer in the Seattle area, developed his own mapping tool to track which providers have the drug for his wife."

Evusheld Inventory:
https://rrelyea.github.io/evusheld/?

 

[skyking1]

very cool! DW needs to talk with her rheumatologist and see if he recommends it for her.
Her employer has it in stock

 

[harllee]

Want to bring back up Evusheld. DH qualifies for it because he has an autoimmune disease and is on Humira. In the spring he discussed Evusheld with his doctor and they tested his antibodies, they were high due to the vaccine and boosters so the doctor said to delay Evusheld. Recently he has had the antibody test again and his antibodies are dropping so now the doctor now recommends Evusheld and DH is trying to schedule the shots. Anybody have an experiences with the shots? Should DH expect side effects?

 

[Linney]

Recently he has had the antibody test again and his antibodies are dropping so now the doctor now recommends Evusheld and DH is trying to schedule the shots. Anybody have an experiences with the shots? Should DH expect side effects?

My DH slept a bit more than usual in the 48 hours following his Evusheld shots (normally sleeps 6 hours a night, slept 8 hours instead). No other side effects observed.

That's just one data point - I'm hoping more people respond with their experiences so we can compare notes.

 

[harllee]

DH got his Evusheld shots this morning. So far no side effects at all, not even sore at the injection site. He did have trouble finding a place to get the shots, seems like there is a shortage of the shots in our area.

 

[Linney]

Well.... it happened. DH caught covid from me.

I went to visit my elderly parents and a niece who was also present at the visit had asymptomatic covid. The day after the visit the niece had a PCR test in preparation for a school field trip and.... she tested positive. Two days later, I started coughing and had a fever and congestion. Two days after that, my DH started getting congested and coughing too.

DH was pretty worried. He had Evusheld antibody therapy administered back in March but not sure how well it will actually work. He went into Kaiser for a PCR test the day after symptoms started but it was negative. Meanwhile, I started testing positive and continued to test positive for over a week. It sucks to have covid but I didn't suffer too much.

DH had the same symptoms that I had, but he was only sick for 2-1/2 days! We were surprised and thrilled! He never did test positive for covid (viral load not high enough?). Our best guess is that he did catch it from me but the Evusheld antibodies knocked it down right away.

I wish we had more data about peoples' experiences with covid after Evusheld therapy so we would know if this is typical or not. Anyway, wanted to relay this one data point. DH is feeling mighty safe now and will continue getting Evusheld injections every six months per current protocol.

--Linney

 

[harllee]

Linney, thanks for this report! Good news indeed.

Regarding Evusheld and the new Omicron booster. DH got the Evusheld treatment on 8/4. He has an appointment to get the new omicron booster on 9/12. His doctor says he should go a head with the vaccine. For those of you who have had Evusheld are you going ahead and and getting the new booster now?