The AstraZeneca U.S. Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization, the company announced. Thie interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomization of vaccine to placebo. Vaccine efficacy was consistent across ethnicity and age, Astra noted. In participants aged 65 years and over, vaccine efficacy was 80%. The vaccine was well tolerated, and the independent data safety monitoring board identified no safety concerns related to the vaccine, the company said. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. AstraZeneca said it will continue to analyze the data and prepare for the primary analysis to be submitted to the Food and Drug Administration for Emergency Use Authorization in the coming weeks. In parallel, the primary analysis will be submitted for publication in a peer-reviewed journal. Amongst participants in the interim analysis, approximately 79% were white/Caucasian, 8% black/African American, 4% native American and 4% Asian, and 22% of participants were Hispanic. This Phase III trial included two doses administered at a four week interval.
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