Detailed results from the Provent phase 3 pre-exposure prophylaxis trial have demonstrated that AstraZeneca’s Evusheld reduced the risk of developing symptomatic COVID-19.
This risk decreased by 77% in the primary analysis and by 83% in the six-month follow-up analysis, compared to the placebo. There were no cases of severe disease or COVID-19-related deaths in the Evusheld group during the additional six-month follow-up.
More than 75% of participants at baseline had co-morbidities that typically put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised or have an inadequate immune response to vaccination.
Further data showed that Evusheld concentrations remained elevated in serum for six months after administration, supporting the notion that a single dose could provide long-term protection against COVID-19, lasting at least six months.
The trial results also revealed that there were no cases of severe or critical COVID-19 deaths related to the coronavirus or hospitalisations in the Evusheld group following the six-month analysis. In the placebo group there were five cases of severe or critical disease, seven hospitalisations and two COVID-19-related deaths.
Mene Pangalos, executive vice president at BioPharmaceuticals R&D, AstraZeneca, said: “This data adds to the growing body of evidence supporting the use of Evusheld to help prevent symptomatic and severe COVID-19. Evusheld is now available in many countries around the world, and we are progressing filings in pre-exposure prophylaxis as well as mild-to-moderate treatment.”
Myron Levin, professor of paediatrics and medicine at the University of Colorado School of Medicine and principal investigator on the trial, said: “While COVID-19 vaccines have been highly effective at reducing hospitalisation and death, cases continue to surge and many individuals remain at high risk.
“This data provides confidence that one easily administered intramuscular dose of Evusheld could provide vulnerable populations with long-lasting protection. In addition, Evusheld has been shown to neutralise BA.2, currently the dominant circulating COVID-19 variant,” he added.
Approximately 2% of the global population is considered to be at increased risk of an inadequate response to mainstream COVID-19 vaccinations and may therefore benefit from the use of Evusheld.