AstraZeneca’s Covid-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against serious illness and hospitalization in a new U.S.-based clinical trial, the company said Monday.
The findings of the new Phase 3 trial, which included tens of thousands of participants, may increase confidence in the vaccine, which was originally developed by Oxford University.
The data will be sent to U.S. regulators, the Food and Drug Administration (FDA), as part of an application for emergency authorization of the vaccine in the country, AstraZeneca said.
The trial showed the vaccine was well tolerated and did not identify safety issues, the company said.
An independent committee “found no increased risk of thrombosis or thrombosis-characterized events among the 21,583 participants who received at least one dose of the vaccine,” according to AstraZeneca.
The new data come from a phase 3 clinical trial conducted in the United States, Chile and Peru. AstraZeneca says it plans to present the results to a scientific journal for peer review.
Oxford University said the findings add to “data from previous trials in the UK, Brazil and South Africa, as well as impact data from the UK,” according to a 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.
Recent controversy: The Oxford-AstraZeneca vaccine became the subject of controversy earlier this month when several European countries, including Norway, France and Denmark, decided to temporarily suspend its implementation 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.” blood “.
What does the data mean: Vaccine co-designer and professor of vaccinology at Oxford University Sarah Gilbert hailed the data as providing “further confirmation of the safety and efficacy” of the vaccine.
Andrew Pollard, principal investigator of the vaccine and professor of pediatric infection and immunity at Oxford University, said AstraZeneca’s data was “consistent with the results of the Oxford-led trials,” adding that he expected a “strong impact against COVID-19 at all ages and for people of all backgrounds, from widespread use of the vaccine.”