The results 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 the vaccine to be well tolerated and did not identify any safety issues, the company said. An independent committee “found no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine,” according to AstraZeneca.
The new data comes from a Phase 3 clinical trial conducted in the United States, Chile and Peru. AstraZeneca has announced its intention to submit the results to a scientific journal for peer review.
For its part, Oxford said the results are in addition to “data from previous trials from the UK, Brazil and South Africa, as well as real-world impact data from the UK.” , according to a press release from the university.
As part of the trial, more than 32,000 recruited volunteers of all ages received either two doses of the vaccine or a placebo vaccine four weeks apart.
The Oxford-AstraZeneca vaccine was the subject of controversy earlier this month, when a number of European countries, including Norway, France and Denmark, decided to temporarily suspend its deployment due to reports of coagulation in patients after inoculation.
An emergency investigation by the European Medicines Agency (EMA) came to the conclusion last Thursday that the vaccine is “safe and effective” in preventing coronavirus and “not associated with an increased overall risk of thromboembolic events or blood clots ”.
Vaccine co-designer and professor of vaccinology at the University of Oxford, Sarah Gilbert, praised the data for providing “further confirmation of the safety and efficacy” of the vaccine.
Lead vaccine investigator and professor of pediatric infection and immunity at the University of Oxford, Andrew Pollard, said AstraZeneca’s data was “consistent with the results of trials conducted by Oxford,” adding that ‘he expected a’ strong impact against COVID-19 at all ages and for people of all walks of life different from the widespread use of the vaccine. ”
The data will be sent to U.S. regulators, the Food and Drug Administration (FDA), as part of a request for emergency clearance of the vaccine in the country, AstraZeneca said.