AstraZeneca’s Antibody Becomes the First Pre-exposure COVID-19 Treatment in the US

As the COVID-19 pandemic continues, companies are searching for new ways to protect the most vulnerable. Even after the development of highly effective vaccines in record time, not everyone can receive get the jab. Immunocompromise individuals rely on herd immunity to be protected. Unfortunately, only 60.1% of the US is fully vaccinated, this is not sufficient to provide herd immunity. For this reason, companies are competing to develop new therapies to protect individuals that can’t get vaccinated.

Today, the Food and Drug Administration (FDA) granted an emergency use authorization to AstraZeneca’s dual antibody therapy as a preventive treatment against COVID-19. This is welcome news for AstraZeneca as its vaccine program has been plagued by negative headlines and setbacks. 

AstraZeneca v.s COVID-19

Since the beginning of the pandemic, AstraZeneca has been at the vanguard fighting COVID-19. They successfully develop a vaccine against COVID-19, and it was the third vaccine to receive emergency authorization from the World Health Organization (WHO).

Although the vaccine is 80% efficient in preventing symptomatic COVID-19 their vaccine has been plagued by negative headlines. Early in its rollout, there was confusion about its efficacy and dosing regimen. Furthermore, several countries restricted the use of the vaccine after it was linked to the development of blood clots. 

It is essential to point out that infection with COVID-19 is most likely to cause clots than the vaccine. However, this has damaged the trust people had in the vaccine.

Evusheld as a pre-exposure treatment for COVID-19

On December 8th, the FDA approved Evusheld making it the first and only antibody therapy authorized for pre-exposure prophylaxis in the US. The therapy consists of two long-acting antibodies, as a preventative treatment for patients 12 and older that are immunocompromised or suffer from severe reactions to a COVID-19 vaccine.

First developed by  Vanderbilt University, Evusheld was derived from antibodies isolated from B-cells donated by convalescent patients. The two monoclonal antibodies, tixagevimab and cilgavimab, target the spike protein of the virus, and they have been modified to extend their half-life. 

The approval was granted based on two Phase 3 clinical trials that showed Evusheld reduced symptomatic COVID-19 by over 80% after a single dose in at-risk populations. Evusheld is administered via two subsequent intramuscular injections. The protection lasts at least six months but could last as long as 12 months.

AstraZeneca is pursuing additional indications for Evusheld, which is currently in clinical trials for the treatment of hospitalized COVID-19 patients.

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 authorized in the US to prevent COVID-19 symptoms before virus exposure, while also providing long-lasting protection with a single dose.  Evusheld neutralizes 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.”

Author

Daniel Ojeda