AstraZeneca’s Covid-19 vaccine showed 79% efficacy against symptomatic diseases and 100% efficacy against serious illness and hospitalization in a new US-based clinical trial, the company said Monday.
The findings of the new phase 3 study, which involved tens of thousands of participants, may increase confidence in the vaccine, originally developed by the University of Oxford.
The data will be sent to US regulators, the Food and Drug Administration (FDA), as part of an application for an emergency authorization for the vaccine in the country, AstraZeneca said.
The trial showed that the vaccine was well tolerated and did not identify any safety concerns, 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,” said AstraZeneca.
The new data came from a phase 3 clinical study conducted in the United States, Chile and Peru. AstraZeneca says it plans to submit the findings to a scientific journal for peer review.
Oxford University said the findings add “to previous research data from the United Kingdom, Brazil and South Africa, as well as real-world impact data from the United Kingdom,” according to a press release.
As part of the study, more than 32,000 recruited volunteers of all ages received either two doses of the vaccine or a placebo vaccine at an interval of 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 rollout due to reports of blood clotting in patients following inoculation.
An emergency study by the European Medicines Agency (EMA) last Thursday concluded 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.”
What the data means: Co-designer of the vaccine and professor of vaccinology at the University of Oxford, Sarah Gilbert, praised the data for providing “further confirmation of the safety and effectiveness” of the vaccine.
Lead investigator for the vaccine and professor of pediatric infection and immunity at the University of Oxford, Andrew Pollard, said AstraZeneca’s data was “consistent with the results of Oxford-led studies,” adding that he had a “strong impact against COVID. 19 was expected across all ages and for people of all different backgrounds due to widespread use of the vaccine. “