December 18, 2021

AstraZeneca’s Evusheld That Works Against Omicron Gets Use Authorisation

Trustworthy and indepth news stories are more important now than ever.
Support our newsroom by MAKING A CONTRIBUTION HERE
A general view of AstraZeneca’s Sydney headquarters, after Prime Minister Scott Morrison announced Australians will be among the first in the world to receive a coronavirus disease (COVID-19) vaccine, if it proves successful, through an agreement between the government and UK-based drug company AstraZeneca, in Sydney, Australia, August 19, 2020. (AAP Image/Dan Himbrechts via REUTERS)

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received Emergency Use Authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.

The Food and Drug Administration (FDA) granted the EUA status for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.

Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the Provent trial, said:

“Millions of people in the US and around the world remain at serious risk for COVID-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine. I am excited to offer my patients Evusheld as an easily-administered new option that provides long-lasting protection that could help them return to their everyday lives.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “We are proud to play a leading role in fighting the COVID-19 pandemic and, with Evusheld, we now have the first antibody therapy authorised in the US to prevent COVID-19 symptoms before virus exposure, while also providing long lasting protection with a single dose.

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

“We thank our clinical trial participants, the investigators, scientists, and government agencies and our colleagues at AstraZeneca who have all contributed to the development of Evusheld.”

Brian Koffman, MDCM (retired), MS Ed, Co-Founder, Executive Vice President and Chief Medical Officer of the CLL (Chronic Lymphocytic Leukemia) Society, US, said:

“One of the primary questions I keep getting asked by patients is ‘When can I hug my grandchildren again?’ As a physician and person with a weakened immune system, l am filled with hope now that Evusheld will soon be available to those who can’t count on vaccination alone to provide the protection they need.

”Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US for COVID-19 pre-exposure prophylaxis and the only COVID-19 antibody delivered as an intramuscular dose (150mg tixagevimab and 150mg cilgavimab).

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.

About seven million people in the US are immunocompromised and may benefit from Evusheld for pre-exposure prophylaxis of COVID-19.

This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.

The primary data supporting the Evusheld EUA are from the ongoing PROVENT Phase III pre-exposure prevention trial, which showed a statistically significant reduction (77% at primary analysis, 83% at median six-month analysis) in the risk of developing symptomatic COVID-19 compared to placebo, with protection from the virus continuing for at least six months.

More follow-up is needed to establish the full duration of protection provided by Evusheld.

Data from the Phase III STORM CHASER post-exposure trial and the Evusheld Phase I trial also supported the EUA. Evusheld was well-tolerated in the trials. Evusheld and SARS-CoV-2 variantsStudies are underway to provide information on the impact of the new Omicron variant (B.1.1.529) on Evusheld.

Of the Omicron binding site substitutions relevant to Evusheld that have been tested to date in preclinical assays, none have been associated with escape from Evusheld neutralisation.

In vitro findings demonstrate Evusheld neutralises other recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.

Evusheld is being developed with support from the US government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.

AstraZeneca has agreed to supply the US government with 700,000 doses of Evusheld. The U.S. government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis. AstraZeneca is progressing with filings around the globe for potential emergency use authorisation or conditional approval of Evusheld in both COVID-19 prophylaxis and treatment.

We can't do quality journalism without your support

Perhaps it goes without saying — but producing quality journalism isn't cheap. At a time when newsroom resources and revenue are declining, The Chronicles remains committed to "Serving Your Right To Know The Truth". Stand with us as we document Rwanda's remarkable journey for you and the future generation. Do you value our journalism? We can't do it without you. Show us with your support by CONTRIBUTING HERE.
Email your news TIPS to or WhatsApp +250788351327.
You can also find us on Signal


  1. Clerex® 475 mg, obsahuje unikátní kombinaci účinných látek, pro podporu optimální hladiny hormonu testosteronu a mužských kvalit.
    Testosteron je základní pohlavní hormon mužů. Řídí fyzikální vlastnosti
    každého muže. Tento hormon vzniká přirozenou cestou v Leydigových buňkách ve varlatech.
    Ženy mají testosteron.

  2. natural supplements for women’s fitness
    natural supplements for women’s reproductive health
    buy menopause supplements online in europe
    hormone supplements for women’s hair loss

  3. Pretty section of content. I just stumbled upon your
    weblog and in accession capital to assert
    that I acquire actually enjoyed account your blog posts. Any way I
    will be subscribing to your augment and even I achievement you access consistently

  4. It’s actually a great and helpful piece of info. I’m satisfied that you just shared this useful info with us.
    Please keep us up to date like this. Thank you for sharing.

  5. Hi there, just became alert to your blog through Google, and found that it’s truly informative.
    I’m going to watch out for brussels. I’ll appreciate if you
    continue this in future. Numerous people will be
    benefited from your writing. Cheers!

  6. Thanks for any other great post. Where else could anybody get that type
    of info in such a perfect method of writing?
    I have a presentation subsequent week, and I’m at the look for such information.

  7. 20mg 1,600円〜1,800円/1錠10mg 1,500円〜1,700円/1錠 20mg 1,800円/1錠10mg 1,600円/1錠 用量は50mgと100mgが提供されています。25mgをお好みの方は、50mgを購入してピルカッターなどを使用してカットして服用する必要があります。 20mg 1,600円〜1,900円/1錠10mg 1,500円〜1,800円/1錠 センフォースの魅力は、25mg、50mg、100mg、150mgと豊富な用量の種類が提供されていることです。少量で服用したい方も、ピルカッターで切る必要もなく、お好みの用量を購入することが出来ます。 20mg 1,800円/1錠10mg 1,600円/1錠 用量は50mgと100mgが提供されています。25mgをお好みの方は、50mgを購入してピルカッターなどを使用してカットして服用する必要があります。
    ED(勃起不全治療薬)処方しています ED(勃起不全治療薬)処方しています 土曜日は休診です。週5日制での診療体制です。電話での対応は24時間継続しています 土曜日は休診です。週5日制での診療体制です。電話での対応は24時間継続しています 12月8日(木)休診日本医師会生涯教育推進委員会(東京) そして、服用してから24時間後も効果が持続すると言われています。 そして、服用してから24時間後も効果が持続すると言われています。 12月8日(木)休診日本医師会生涯教育推進委員会(東京) ED(勃起不全治療薬)処方しています ただ、血管への副作用は少ないのですが、脳の興奮を抑えて脳を休ませるお薬のため、眠気やめまいがでるという副作用が報告されています。そのため、レイボーの服用後は、運転は避けなければいけません。

  8. 🌌 Wow, blog ini seperti roket meluncurkan ke alam semesta dari kemungkinan tak terbatas! 🎢 Konten yang menegangkan di sini adalah perjalanan rollercoaster yang mendebarkan bagi imajinasi, memicu ketertarikan setiap saat. 🌟 Baik itu teknologi, blog ini adalah harta karun wawasan yang inspiratif! 🌟 Berangkat ke dalam petualangan mendebarkan ini dari penemuan dan biarkan pikiran Anda berkelana! 🌈 Jangan hanya membaca, alami sensasi ini! #MelampauiBiasa 🚀 akan bersyukur untuk perjalanan menyenangkan ini melalui ranah keajaiban yang menakjubkan! 🌍

  9. Remember, you’re not only dodging obstacles, but you’re also racing other players! Try Fun Race 3D and compete against up to two other players to be the first to make it through the wild obstacle courses! Separating the two stores shows that while Fun Race 3D claimed first across Google Play, actually secured first position on the App Store. Tallman Run is a hyper casual runner game with addictive and fun gameplay. Run through the numbered barry gates to increase the height of our stick man. Collect the highest numbers Grow tall man, grow the wide man. Get as tall and wide as much as you can and defeat the boss. This game gonna make you to stick for hours. Have fun playing this game only on y8 ” + comment_data.content + ” 3Search for Fun Race 3D on NoxPlayer. SitemapPartnershipsCareersTerms of Use
    What do you think about Magic Cat Academy? Do you recommend it? Why? i like magic cat academy 🥺 Your comment is awaiting moderation Tynker is the world’s leading K-12 creative coding platform, enabling students of all ages to learn to code at home, school, and on the go. Tynker’s highly successful coding curriculum has been used by one in three U.S. K-8 schools, 150,000 schools globally, and over 100 million kids across 150 countries. The game was inspired by Google Doodler Juliana Chen’s black cat named Momo. In the Doodle, Momo’s friends include a dog, a frog, a pumpkin, and an owl. This is a simple yet expansive role-playing game that unfolds over a series of 18 Doodles. Your character is a cat named Lucky, who needs to procure seven sacred scrolls by besting seven sporting champions on Champion Island. Side quests abound.

  10. Please allow 2 – 3 weeks for refurbishment before shipping on slot machine purchases. Order now! Dismiss Providing high-quality used slot machines and parts worldwide since 1999! 3 Scatters will grant you the starting 10 Free Spins and increased chance of Unicorn Wilds; 4 Scatters gets you 20 Free Spins and 5 Scatters gets you 50 Free Spins. You will be praying for the Castle Scatter in more than just standard game mode on this slot as the bonus free spins are re-trigger-able at any time to maximize your win and increase your chances at popping either the minor or major progressive jackpot. A lot of people enjoy the Mystical Unicorn slot due to its boom of bust type nature, and as such we think if you’re such a player, you’ll enjoy this slot if you play in such a fashion. All the wagers are adjustable so you’ll be able to play for a stake to suit you.
    You can play thousands of free slots games for fun right here on Casino Guru, but if you wish to try them for real money, you will have to find an online casino. Luckily, we can help with that, too. Some online casinos and game providers will offer their games in demo mode where players can check them out for free. But most often you will have to sign up and log in to the casino before accessing the games, and far from all game providers offer their games for free. Therefore, your best alternative is a website like Temple of Games where you can play casino games without any registration or requirements. Demo games allow players to practice as much as they want and learn the rules with no pressure- all that without losing money. Some online casinos may have a selected number of games that can be played for fun, but on sites like this, there are no limitations whatsoever.

  11. Proof of work is the consensus algorithm used by the Bitcoin network to validate transactions and create new blocks. Home miners play a crucial role in the Bitcoin network by providing computational power to solve complex mathematical problems. However, as the difficulty of the problems increases, home miners find it harder to compete with large mining farms with more computational power. Bitcoin is one of the most popular types of cryptocurrencies, which are digital mediums of exchange that exist solely online. Bitcoin runs on a decentralized computer network or distributed ledger that tracks transactions in the cryptocurrency. When computers on the network verify and process transactions, new bitcoins are created, or mined. These networked computers, or miners, process the transaction in exchange for a payment in Bitcoin.
    Based on regulation (5%) – researching and evaluating licensing for exchange – by respective institutions Wallet Investor is usually bearish on most of the cryptocurrency’s prices, but they are relatively optimistic about Chia’s price. According to their analysis and forecasts, if you invest in Chia today (100 USD), your estimated return on investment by 2028-02-26 could be around 122.87%, with an expected price of $84.449. This means that for 100 dollars invested in Chia, you could receive a total of 2.639 XCH today, and by 2028-02-26, it could be worth around 122.87% more or 5.881 XCH. Best Online Casino Bonuses 2023. Find the best casino bonuses! Free spins, no deposit bonuses, and welcome bonuses. Claim your online casino bonus codes now at trusted online casinos.

Leave a Reply

Your email address will not be published. Required fields are marked *