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Update - AstraZeneca's Evusheld authorized as COVID-19 preventative for immunocompromised

February 25, 2022

Update

Data show that Evusheld retains neutralizing activity against Omicron variants BA.1 and BA.1.1 at a level comparable to natural infection, but lower than its neutralizing activity against previous COVID-19 variants. Accordingly, the U.S. Food and Drug Administration has updated its emergency use authorization (EUA) for Evusheld to recommend that the dose be doubled from its current level of 150 mg of each antibody (tixagevimab and cilgavimab) to 300 mg of each antibody. The antibodies will still be given as consecutive intramuscular shots during one healthcare visit. FDA is also recommending that patients who received Evusheld at the lower 150 mg dose secure a second 150 mg dose as soon as possible.

On February 14, 2022, prior to this dosing update, the U.S. government announced it had purchased an additional 500,000 doses, bringing the total available doses in the U.S. to 1.7 million. However, with the increase in recommended dosage, the number of doses is effectively cut in half to 850,000. Only the U.S. government can purchase Evusheld because of limitations in its EUA, which means that it cannot be made commercially available to pharmacies or doctors.

If your doctor has recommended that you receive Evusheld, but you have not been able to secure a dose (or cannot find a needed second dose), please contact us through AskIDF so that we can collect information and advocate for the government purchase and distribution of additional doses.


January 14, 2022 Update

The U.S. federal government has purchased an additional 500,000 doses of Evusheld in response to concerns that the original order of 700,000 doses would not be enough to cover the immunocompromised population in the U.S. The federal government is now shipping doses weekly rather than biweekly, as originally planned.

The National Institutes of Health (NIH) released treatment guidelines for Evusheld that specifically state that it is "not a substitute for COVID-19 vaccination and should not be used in unvaccinated individuals for whom COVID-19 vaccination is recommended." The guidelines also specifies that people with moderate to severe primary immunodeficiencies qualify to receive Evusheld under its emergency user authorization (EUA). 

Finally, two studies that have not yet been peer reviewed, one from Oxford University and the other from Washington University, provide additional evidence that Evusheld retains neutralizing activity against the Omicron variant of SARS-CoV-2.


Originally published Dec. 9, 2021

Evusheld, a combination of two long-acting monoclonal antibodies developed by AstraZeneca, has received emergency use authorization (EUA) as a prophylactic against COVID-19 from the U.S. Food and Drug Administration (FDA). It is the first monoclonal antibody product authorized specifically for use before any known exposure to the virus and could provide protection for up to six months.

“This new monoclonal antibody cocktail COVID-19 product is a game-changer for patients with PI who can not mount an adequate antibody response to the COVID vaccine,” said Dr. Mark Ballow, IDF’s Consulting Medical Director.

AstraZeneca table comparing antibodies to vaccines.
Antibody therapy, such as Evusheld, versus vaccines.
 

The EUA indicates that the drug is intended for those 12 and over who are moderately to severely immunocompromised, including those with moderate to severe primary immunodeficiency. It is not intended as a substitute for vaccination for the general public.

Initial availability will be through the federal government, which has purchased 700,000 doses to be distributed to states based on their populations. States will then determine distribution sites and will rely on forthcoming guidelines from the National Institutes of Health (NIH) on who is eligible to receive the drug. IDF is working closely with AstraZeneca and the government to ensure that those with PI will have access to Evusheld as quickly as possible.

In AstraZeneca’s PROVENT phase III trial, one dose of Evusheld provided 83% efficacy against symptomatic COVID-19 for six months in a population where 75% of trial participants had one or more risk factors for severe disease. The two antibodies, tixagevimab and cilgavimab, were each derived from convalescent sera from individuals recovered from COVID-19 infection. They are delivered as two sequential intramuscular injections.

The Omicron COVID-19 variant was not circulating when the PROVENT trial was conducted, but preliminary data from FDA scientists indicate that Evusheld may remain effective against the variant. AstraZeneca and others are completing additional studies to confirm the drug's effectiveness against Omicron.

AstraZeneca's proprietary YTE long-lasting antibodies.
AstraZeneca's proprietary YTE long-lasting antibodies.
 

The EUA is great news for our community, but patience is needed as we help guide this therapy through mandated processes. In the meantime, please maintain appropriate pandemic precautions. If you have not received a COVID-19 vaccine, please have a conversation with your physician to see if the vaccine is appropriate for you.

Read the latest updates on COVID-19 and PI.

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