Evusheld significantly protected against symptomatic COVID-19 for at least six months.
Evusheld significantly protected against symptomatic COVID-19 for at least six months in PROVENT phase III trial in high-risk populations.
Detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s Evusheld (tixagevimab and cilgavimab), formerly AZD 7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six month follow-up analysis, compared to placebo. There were no cases of severe disease or COVID-19 related deaths in the Evusheld group through the six-month follow-up.
More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised and may have an inadequate immune response to vaccination. Additional pharmacokinetic data showed that Evusheld concentrations remained elevated in serum for six months after administration, supporting that a single dose could provide long-term protection against COVID-19 lasting at least six months.
Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and PROVENT 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, including immunocompromised individuals and those who cannot be vaccinated. These important data now published in the New England Journal of Medicine provide confidence that one easily administered intramuscular dose of Evusheld could provide vulnerable populations long-lasting protection. In addition, Evusheld has been shown to neutralise BA.2, currently the dominant circulating COVID-19 variant.”
In the primary efficacy analysis, a single 300 mg intramuscular (IM) dose of Evusheld reduced the risk of developing symptomatic COVID-19 compared to placebo by 77% (95% confidence interval [CI] 46, 90; p<0.001) at a median follow up of 83 days. symptomatic covid-19 occurred in 8 3441 (0.2%) and 17 1731 (1.0%) participants in the evusheld and placebo groups, respectively.
Compared to the primary analysis, the extended follow-up analysis demonstrated a greater reduction in COVID-19 incidence in the Evusheld group, with an 83% relative risk reduction (95% CI 66, 91) with Evusheld compared to placebo at a median follow up of 196 days. Symptomatic COVID-19 occurred in 11/3441 (0.3%) and 31/1731 (1.8%) participants in the Evusheld and placebo groups, respectively. Efficacy was generally consistent across participant subgroups, where evaluable. There were no cases of severe/critical COVID-19, COVID-19-related deaths or hospitalisations in the Evusheld group by the six-month follow-up analysis; there were five cases of severe/critical disease, seven hospitalisations and two COVID-19-related deaths in the placebo group.
The data were published online in the New England Journal of Medicine. See- "Intramuscular AZD 7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19"- Myron J. Levin, M.D., Andrew Ustianowski, M.D., Ph.D., Stéphane De Wit, M.D., et al., for the PROVENT Study Group. April 20, 2022. DOI: 10.1056/NEJMoa2116620.
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