AstraZeneca US Phase III trial of AZD1222 met primary efficacy endpoint in preventing COVID-19 at interim analysis
This interim safety and efficacy analysis based on 32,449 participants found that AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.
Source:
AstraZeneca Plc.
SPS commentary:
The trial included two doses administered at a four week interval. Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%. The independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. It had conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) and 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. AstraZeneca will continue to analyse the data and prepare for the primary analysis to be submitted to the FDA for Emergency Use Authorization in the coming weeks.