The AstraZeneca Covid-19 vaccine demonstrated 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization in a new US clinical trial, the company said Monday.
The findings of the new Phase 3 study, which included tens of thousands of participants, could boost confidence in the vaccine, which was originally developed by Oxford University.
The data will be sent to the US Food and Drug Administration (FDA) as part of an application for emergency authorization of the vaccine in the country, AstraZeneca said.
The study showed that the vaccine was well tolerated and did not identify safety issues, the company said.
An independent committee “did not find an increased risk of thrombosis or thrombotic events among the 21,583 participants who received at least one dose of vaccine,” according to AstraZeneca.
The new data came from a phase 3 clinical trial in the United States, Chile and Peru. AstraZeneca says it intends to present the findings of a scientific journal for peer review.
Oxford University said the findings add to “data from previous studies in the United Kingdom, Brazil and South Africa, as well as real impact data from the United Kingdom,” according to a press release.
As part of the study, more than 32,000 volunteers recruited of all ages received either two doses of vaccine or a placebo vaccine every four weeks.
Recent controversy: The Oxford-AstraZeneca vaccine became the subject of controversy earlier this month, when a number of European countries, including Norway, France and Denmark, decided to temporarily suspend its launch due to reports of blood clotting in patients after inoculation.
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 increased risk of thromboembolic events or blood clots”.
What the data means: Co-designer of the vaccine and professor of vaccinology at Oxford University, Sarah Gilbert, welcomed the data to provide “further confirmation of the safety and efficacy” of the vaccine.
Vaccine Principal Investigator and Professor of Infection and Pediatric Immunity at Oxford University Andrew Pollard said the AstraZeneca data are “consistent with the results of Oxford-led studies”, adding that he expected a “strong impact against COVID-19 in all ages and for people from all walks of life from the widespread use of the vaccine. ”