On December 8, AstraZeneca announced that its long-acting new coronavirus neutralizing antibody Evusheld (AZD7442) has been authorized by the US FDA for emergency use (EUA) for specific adults and adolescents (age ≥ 12 years old, weight ≥ 40 kg) ) Prevention of new coronavirus infection (COVID-19) before exposure. The press release shows that this is currently the only pre-exposure prophylaxis authorized for COVID-19 in the United States. Key Phase 3 clinical trial data show that in high-risk groups, one-dose treatment has a strong curative effect and long-term protection.

About 2% of people in the world may not respond well to the new crown vaccine due to various reasons, such as blood cancer patients receiving chemotherapy, patients receiving dialysis, multiple sclerosis or rheumatoid arthritis patients taking immunosuppressive drugs, etc. , And long-acting neutralizing antibodies may provide them with long-term protection and provide a new option for controlling the epidemic.

Evusheld's EUA is based on data from a randomized, double-blind, placebo-controlled clinical trial called PROVENT. A total of 3441 people received Evusheld in the trial, and 1731 received placebo. Preliminary analysis showed that compared with subjects who received placebo, subjects in the Evusheld group had a 77% reduction in the risk of COVID-19, a statistically significant difference. Additional analysis showed that participants in the Evusheld group had a reduced risk of COVID-19 for 6 months. The safety and effectiveness of Evusheld for pre-exposure prevention of COVID-19 are still being evaluated.

Evusheld is a long-acting neutralizing antibody combination therapy jointly developed by AstraZeneca and Vanderbilt University Medical Center. It consists of two neutralizing antibodies that bind to different epitopes of the new coronavirus spike protein, respectively. tixagevimab and cilgavimab. AstraZeneca has optimized the antibodies to extend their half-life to three times that of ordinary monoclonal antibodies. The goal is to provide up to 12 months of protection after a single injection. The results of in vitro studies indicate that Evusheld neutralizes other recent SARS-CoV-2 virus variants, including Delta and Mu variants. In addition, Evusheld is also studying as a potential treatment for hospitalized COVID-19 patients.

According to the FDA announcement, the product is only authorized for individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to the environment infected with the SARS-CoV-2 virus. In addition, the authorization also requires the individual to have one of the following conditions: 1) Due to medical conditions, or due to taking immunosuppressive drugs or receiving immunosuppressive treatments, moderate to severe immune system damage, and may not be vaccinated against COVID-19 Adequate immune response; 2) There is a history of serious adverse reactions to the COVID-19 vaccine and/or the components of these vaccines. Therefore, it is not recommended to vaccinate the existing COVID-19 vaccine in accordance with the approved or authorized program.

Reference materials:

[1] Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals. Retrieved 2021-12-09, from https://www.fda.gov/ news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure

[2]Evusheld (formerly AZD7442) long-acting antibody combination authorised for emergency use in the US for pre-exposure prophylaxis (prevention) of COVID-19. Retrieved 2021-12-09, from https://www.astrazeneca.com /media-centre/press-releases/2021/evusheld-long-acting-antibody-combination-authorised-for-emergency-use-in-the-us-for-pre-exposure-prophylaxis-prevention-of-covid-19 .html