AstraZeneca plans to apply for emergency use authorization for the Covid-19 vaccine in the first half of April

A vaccinator administers the Oxford-AstraZeneca Covid-19 vaccine at a medical center in Bridport, England, on March 20.
A vaccinator administers the Oxford-AstraZeneca Covid-19 vaccine at a medical center in Bridport, England, on March 20. Finnbarr Webster / Getty Images

AstraZeneca’s Covid-19 vaccine showed 79% efficacy against symptomatic diseases and 100% efficacy against serious illness and hospitalization in a new clinical trial based in the United States, the company said on Monday.

The findings of the new Phase 3 trial, which included tens of thousands of participants, may boost confidence in the vaccine, which was 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 emergency vaccine authorization in the country, AstraZeneca reported.

The trial showed that the vaccine was well tolerated and did not identify safety problems, 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,” according to AstraZeneca.

The new data came 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 “data from previous tests from the United Kingdom, Brazil and South Africa, as well as impact data in the UK’s real world,” 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 controversial earlier this month when several 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) came to the conclusion last Thursday 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: The co-creator of the vaccine and professor of vaccinology at the University of Oxford, Sarah Gilbert, welcomed the data for providing “more confirmation of the vaccine’s safety and efficacy”.

Lead vaccine investigator and professor of pediatric infection and immunity at Oxford University, Andrew Pollard, said the AstraZeneca data was “consistent with the results of tests conducted by Oxford”, adding that he expected a “strong impact against COVID-19 at all ages and for people of different backgrounds due to the widespread use of the vaccine. ”

.Source