The findings of the new Phase 3 trial, which included more than 32,000 participants, may boost confidence in the vaccine, which was originally developed by the University of Oxford.
The trial showed that the vaccine was well tolerated and did not identify safety problems, the company said. An independent committee “found no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants who received at least one dose of the vaccine,” according to AstraZeneca.
The new data came from a Phase 3 clinical trial conducted in the United States, Chile and Peru. AstraZeneca says it plans to submit the findings to a scientific journal for peer review.
For his part, Oxford said the findings add up to “the data from previous tests in the UK, Brazil and South Africa, as well as the UK real-world impact data,” according to a university press release. .
As part of the trial, more than 32,000 volunteers recruited at all ages received two doses of the vaccine or a placebo vaccine over a four-week interval.
An emergency investigation by the European Medicines Agency (EMA) concluded last Thursday that the vaccine is “safe and effective” in preventing coronavirus and “is not associated with an increase in the overall risk of thromboembolic events or blood clots “.
The co-creator of the vaccine and Professor of Vaccinology at the University of Oxford, Sarah Gilbert, welcomed the data for providing “more confirmation of the vaccine’s safety and efficacy”.
The lead investigator for the vaccine and professor of Pediatric Infection and Immunity at the University of Oxford, Andrew Pollard, said the AstraZeneca data were “consistent with the results of tests conducted by Oxford”, adding that he expected a “strong impact against COVID-19 at all ages and for people of all backgrounds other than widespread use of the vaccine. “