AstraZeneca's vaccine is safe, says Dr. Huerta 1:10
(CNN) -
AstraZeneca's covid-19 vaccine was 79% effective against symptomatic illnesses and 100% effective against serious illness and hospitalization in a new US-based clinical trial, the company said Monday.
The findings of the new phase 3 trial, which included tens of thousands of participants, may generate greater confidence in the vaccine, which was originally developed by the University of Oxford.
The data will be sent to the US regulator, the Food and Drug Administration (FDA), as part of a request for emergency authorization of 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.
WHO and EMA: AstraZeneca vaccine application is safe 5:49
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.
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The new data comes 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.
The University of Oxford said the findings add "to previous trial data from the UK, Brazil and South Africa, as well as real-world impact data from the UK," according to a press release.
As part of the trial, more than 32,000 recruited volunteers of all ages received two doses of the vaccine or a placebo within four weeks.
AstraZeneca vaccine controversy
The Oxford-AstraZeneca vaccine was the subject of controversy earlier this month when several European countries, including Norway, France and Denmark, decided to temporarily suspend its application 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 overall risk of events. thromboembolic or blood clots'.
What the new 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 efficacy" of the injection.
The vaccine's principal investigator and professor of pediatric infection and immunity at the University of Oxford, Andrew Pollard, said the AstraZeneca data was "consistent with the results of the Oxford-led trials," adding that he expected a "strong impact. against covid-19 in all ages and for people of different origins due to the widespread use of the vaccine.
AstraZenecaCoronavirus Vaccine
