Detailed results from the PROVENT Phase III
pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s Evusheld (tixagevimab and cilgavimab),
formerly AZD7442, reduced the risk of developing symptomatic
COVID-19 by 77 percent in the primary
analysis and by 83 percent in the six month follow-up analysis, compared to
placebo.
اضافة اعلان
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 percent of PROVENT participants at baseline had comorbidities
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, professor of pediatrics and medicine at the University of Colorado
School of Medicine, and PROVENT principal investigator on the trial, said: “While
COVID-19 vaccines have been highly effective at reducing hospitalization 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 couldprovide vulnerable populations long-lasting protection. In addition, Evusheld has been shown to neutralize BA.2, currently the dominant circulating COVID-19
variant.”
Mene Pangalos, executive vice president, BioPharmaceuticals R&D,
AstraZeneca, said: "These
data add to the growing body of evidence supporting the use of Evusheld to help prevent symptomatic and severe COVID-19, especially for those
individuals who can’t respond adequately to vaccination and need additional
protection. 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.”
The
data were published online in the
New England Journal of Medicine.
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