The AstraZeneca US Phase III trial of AZD1222 demonstrated vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization.
This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19, reports AstraZeneca in a press release. The trial had a 2:1 randomization of vaccine to placebo. Vaccine efficacy was consistent across ethnicity and age. In participants aged 65 years and over, vaccine efficacy was 80%.
“In participants aged 65 years and over, vaccine efficacy was 80%.”
The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.
“These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
AstraZeneca will continue to analyze the data and prepare for the primary analysis to be submitted to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks, it states.
Photo of Mene Pangalos: AstraZeneca